A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Infants

Phase 3

Completed

Conditions: Meningitis, Meningococcal

Interventions: Biological: Meningococcal ACWY Conjugate Vaccine
Biological: DTaP-IPV-HBV
Biological: Hib
Biological: Rotavirus
Biological: Pneumococcal 7-valent Conjugate Vaccine
Biological: HAV
Biological: MMR-V
Biological: DTaP

Registration Number: NCT00474526

Lead Sponsor: Novartis Vaccines

Brief Summary: This study will evaluate the safety and immune response of the Novartis Meningococcal ACWY conjugate vaccine when administered with routine infant vaccinations to healthy infants.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 4545

Inclusion Criteria

Healthy term 2-month-old infants for whom a parent/legal representative has given written informed consent.

Exclusion Criteria

Subjects with a previous or suspected disease caused by Neisseria meningitidis, Corynebacterium diphtheriae, Clostridium tetani, Poliovirus, Hepatitis B, Haemophilus influenzae type b (Hib), Pneumococcus or Bordetella pertussis; previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s) or prior vaccination with Diptheria, Tetanus, Pertussis (acellular or whole cell), inactivated polio vaccineIPV or oral polio vaccineOPV, H. influenzae type b (Hib) or Pneumococcus; who have had household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis (serogroups A, C, W-135, or Y), B. pertussis, Hib, C. diphtheriae, Polio, or pneumococcal infection at any time since birth; Any serious acute, chronic or progressive disease

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
US1B (MenACWY-CRM + Infant Vaccines)	Hib	Received vaccines: MenACWY: 2, 4, 6, and 13 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
US1B (MenACWY-CRM + Infant Vaccines)	Meningococcal ACWY Conjugate Vaccine	Received vaccines: MenACWY: 2, 4, 6, and 13 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
US1B (MenACWY-CRM + Infant Vaccines)	DTaP-IPV-HBV	Received vaccines: MenACWY: 2, 4, 6, and 13 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
US1B (MenACWY-CRM + Infant Vaccines)	Rotavirus	Received vaccines: MenACWY: 2, 4, 6, and 13 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
US1A (MenACWY-CRM + Infant Vaccines)	Meningococcal ACWY Conjugate Vaccine	Received vaccines: MenACWY: 2, 4, 6, and 12 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
US1A (MenACWY-CRM + Infant Vaccines)	DTaP-IPV-HBV	Received vaccines: MenACWY: 2, 4, 6, and 12 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
US1A (MenACWY-CRM + Infant Vaccines)	Hib	Received vaccines: MenACWY: 2, 4, 6, and 12 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
US1A (MenACWY-CRM + Infant Vaccines)	Rotavirus	Received vaccines: MenACWY: 2, 4, 6, and 12 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
US4B (Infant Vaccines Only)	DTaP-IPV-HBV	Received vaccines: MenACWY: 13 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
US1A (MenACWY-CRM + Infant Vaccines)	Pneumococcal 7-valent Conjugate Vaccine	Received vaccines: MenACWY: 2, 4, 6, and 12 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
US1A (MenACWY-CRM + Infant Vaccines)	HAV	Received vaccines: MenACWY: 2, 4, 6, and 12 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
US1A (MenACWY-CRM + Infant Vaccines)	MMR-V	Received vaccines: MenACWY: 2, 4, 6, and 12 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
US1B (MenACWY-CRM + Infant Vaccines)	Pneumococcal 7-valent Conjugate Vaccine	Received vaccines: MenACWY: 2, 4, 6, and 13 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
US1B (MenACWY-CRM + Infant Vaccines)	HAV	Received vaccines: MenACWY: 2, 4, 6, and 13 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
US1B (MenACWY-CRM + Infant Vaccines)	MMR-V	Received vaccines: MenACWY: 2, 4, 6, and 13 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
US2 (Infant Vaccines Only)	Meningococcal ACWY Conjugate Vaccine	Received vaccines: MenACWY: 12 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
US2 (Infant Vaccines Only)	DTaP-IPV-HBV	Received vaccines: MenACWY: 12 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
US2 (Infant Vaccines Only)	Hib	Received vaccines: MenACWY: 12 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
US2 (Infant Vaccines Only)	Rotavirus	Received vaccines: MenACWY: 12 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
US2 (Infant Vaccines Only)	Pneumococcal 7-valent Conjugate Vaccine	Received vaccines: MenACWY: 12 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
US2 (Infant Vaccines Only)	HAV	Received vaccines: MenACWY: 12 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
US2 (Infant Vaccines Only)	MMR-V	Received vaccines: MenACWY: 12 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
US3 (MenACWY-CRM + Infant Vaccines)	Meningococcal ACWY Conjugate Vaccine	Received vaccines: MenACWY: 2, 4, 6, and 12 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
US3 (MenACWY-CRM + Infant Vaccines)	DTaP-IPV-HBV	Received vaccines: MenACWY: 2, 4, 6, and 12 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
US3 (MenACWY-CRM + Infant Vaccines)	Hib	Received vaccines: MenACWY: 2, 4, 6, and 12 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
US3 (MenACWY-CRM + Infant Vaccines)	Pneumococcal 7-valent Conjugate Vaccine	Received vaccines: MenACWY: 2, 4, 6, and 12 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
US3 (MenACWY-CRM + Infant Vaccines)	HAV	Received vaccines: MenACWY: 2, 4, 6, and 12 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
US3 (MenACWY-CRM + Infant Vaccines)	MMR-V	Received vaccines: MenACWY: 2, 4, 6, and 12 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
US4A (Infant Vaccines Only)	Meningococcal ACWY Conjugate Vaccine	Received vaccines: MenACWY: 12 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
US4A (Infant Vaccines Only)	DTaP-IPV-HBV	Received vaccines: MenACWY: 12 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
US3 (MenACWY-CRM + Infant Vaccines)	Rotavirus	Received vaccines: MenACWY: 2, 4, 6, and 12 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
US4A (Infant Vaccines Only)	Hib	Received vaccines: MenACWY: 12 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
US4A (Infant Vaccines Only)	Rotavirus	Received vaccines: MenACWY: 12 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
US4A (Infant Vaccines Only)	HAV	Received vaccines: MenACWY: 12 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
US4A (Infant Vaccines Only)	MMR-V	Received vaccines: MenACWY: 12 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
US4B (Infant Vaccines Only)	Meningococcal ACWY Conjugate Vaccine	Received vaccines: MenACWY: 13 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
US4B (Infant Vaccines Only)	Hib	Received vaccines: MenACWY: 13 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
US4B (Infant Vaccines Only)	Rotavirus	Received vaccines: MenACWY: 13 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
US4B (Infant Vaccines Only)	Pneumococcal 7-valent Conjugate Vaccine	Received vaccines: MenACWY: 13 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
US4B (Infant Vaccines Only)	HAV	Received vaccines: MenACWY: 13 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
US4B (Infant Vaccines Only)	MMR-V	Received vaccines: MenACWY: 13 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
US4C (Infant Vaccines Only)	Meningococcal ACWY Conjugate Vaccine	Received vaccines: MenACWY: 18 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
US4C (Infant Vaccines Only)	DTaP-IPV-HBV	Received vaccines: MenACWY: 18 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
US4C (Infant Vaccines Only)	Hib	Received vaccines: MenACWY: 18 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
US4C (Infant Vaccines Only)	Rotavirus	Received vaccines: MenACWY: 18 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
US4C (Infant Vaccines Only)	Pneumococcal 7-valent Conjugate Vaccine	Received vaccines: MenACWY: 18 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
US4C (Infant Vaccines Only)	HAV	Received vaccines: MenACWY: 18 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
US4C (Infant Vaccines Only)	MMR-V	Received vaccines: MenACWY: 18 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
LA1A (MenACWY-CRM + Infant Vaccines)	Meningococcal ACWY Conjugate Vaccine	Received vaccines: MenACWY: 2, 6, and 12 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
LA1A (MenACWY-CRM + Infant Vaccines)	DTaP-IPV-HBV	Received vaccines: MenACWY: 2, 6, and 12 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
LA1A (MenACWY-CRM + Infant Vaccines)	Hib	Received vaccines: MenACWY: 2, 6, and 12 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
LA1A (MenACWY-CRM + Infant Vaccines)	Rotavirus	Received vaccines: MenACWY: 2, 6, and 12 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
LA1A (MenACWY-CRM + Infant Vaccines)	Pneumococcal 7-valent Conjugate Vaccine	Received vaccines: MenACWY: 2, 6, and 12 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
LA1A (MenACWY-CRM + Infant Vaccines)	HAV	Received vaccines: MenACWY: 2, 6, and 12 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
LA1A (MenACWY-CRM + Infant Vaccines)	MMR-V	Received vaccines: MenACWY: 2, 6, and 12 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
LA1B (MenACWY-CRM + Infant Vaccines)	Meningococcal ACWY Conjugate Vaccine	Received vaccines: MenACWY: 2, 6, and 13 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
LA1B (MenACWY-CRM + Infant Vaccines)	DTaP-IPV-HBV	Received vaccines: MenACWY: 2, 6, and 13 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
LA1B (MenACWY-CRM + Infant Vaccines)	Hib	Received vaccines: MenACWY: 2, 6, and 13 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
LA1B (MenACWY-CRM + Infant Vaccines)	Rotavirus	Received vaccines: MenACWY: 2, 6, and 13 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
LA1B (MenACWY-CRM + Infant Vaccines)	Pneumococcal 7-valent Conjugate Vaccine	Received vaccines: MenACWY: 2, 6, and 13 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
LA1B (MenACWY-CRM + Infant Vaccines)	HAV	Received vaccines: MenACWY: 2, 6, and 13 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
LA1B (MenACWY-CRM + Infant Vaccines)	MMR-V	Received vaccines: MenACWY: 2, 6, and 13 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
LA2 (Infant Vaccines Only)	Meningococcal ACWY Conjugate Vaccine	Received vaccines: MenACWY: 12 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
LA2 (Infant Vaccines Only)	DTaP-IPV-HBV	Received vaccines: MenACWY: 12 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
LA2 (Infant Vaccines Only)	HAV	Received vaccines: MenACWY: 12 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
LA2 (Infant Vaccines Only)	Hib	Received vaccines: MenACWY: 12 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
LA2 (Infant Vaccines Only)	Rotavirus	Received vaccines: MenACWY: 12 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
LA2 (Infant Vaccines Only)	Pneumococcal 7-valent Conjugate Vaccine	Received vaccines: MenACWY: 12 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
LA2 (Infant Vaccines Only)	MMR-V	Received vaccines: MenACWY: 12 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
LA3A (MenACWY-CRM + Infant Vaccines)	Meningococcal ACWY Conjugate Vaccine	Received vaccines: MenACWY: 2, 4, 6, and 16 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months DTaP, Hib: 16 months Pneumococcal, HAV, and MMR-V: 12 months
LA3A (MenACWY-CRM + Infant Vaccines)	DTaP-IPV-HBV	Received vaccines: MenACWY: 2, 4, 6, and 16 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months DTaP, Hib: 16 months Pneumococcal, HAV, and MMR-V: 12 months
LA3A (MenACWY-CRM + Infant Vaccines)	Hib	Received vaccines: MenACWY: 2, 4, 6, and 16 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months DTaP, Hib: 16 months Pneumococcal, HAV, and MMR-V: 12 months
LA3A (MenACWY-CRM + Infant Vaccines)	Rotavirus	Received vaccines: MenACWY: 2, 4, 6, and 16 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months DTaP, Hib: 16 months Pneumococcal, HAV, and MMR-V: 12 months
LA3A (MenACWY-CRM + Infant Vaccines)	Pneumococcal 7-valent Conjugate Vaccine	Received vaccines: MenACWY: 2, 4, 6, and 16 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months DTaP, Hib: 16 months Pneumococcal, HAV, and MMR-V: 12 months
LA3A (MenACWY-CRM + Infant Vaccines)	HAV	Received vaccines: MenACWY: 2, 4, 6, and 16 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months DTaP, Hib: 16 months Pneumococcal, HAV, and MMR-V: 12 months
LA3A (MenACWY-CRM + Infant Vaccines)	MMR-V	Received vaccines: MenACWY: 2, 4, 6, and 16 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months DTaP, Hib: 16 months Pneumococcal, HAV, and MMR-V: 12 months
LA3A (MenACWY-CRM + Infant Vaccines)	DTaP	Received vaccines: MenACWY: 2, 4, 6, and 16 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months DTaP, Hib: 16 months Pneumococcal, HAV, and MMR-V: 12 months
LA3B (MenACWY-CRM + Infant Vaccines)	Meningococcal ACWY Conjugate Vaccine	Received vaccines: MenACWY: 2, 4, 6, and 17 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months DTaP, Hib: 16 months Pneumococcal, HAV, and MMR-V: 12 months
LA3B (MenACWY-CRM + Infant Vaccines)	DTaP-IPV-HBV	Received vaccines: MenACWY: 2, 4, 6, and 17 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months DTaP, Hib: 16 months Pneumococcal, HAV, and MMR-V: 12 months
LA3B (MenACWY-CRM + Infant Vaccines)	Hib	Received vaccines: MenACWY: 2, 4, 6, and 17 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months DTaP, Hib: 16 months Pneumococcal, HAV, and MMR-V: 12 months
LA3B (MenACWY-CRM + Infant Vaccines)	Rotavirus	Received vaccines: MenACWY: 2, 4, 6, and 17 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months DTaP, Hib: 16 months Pneumococcal, HAV, and MMR-V: 12 months
LA3B (MenACWY-CRM + Infant Vaccines)	Pneumococcal 7-valent Conjugate Vaccine	Received vaccines: MenACWY: 2, 4, 6, and 17 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months DTaP, Hib: 16 months Pneumococcal, HAV, and MMR-V: 12 months
LA3B (MenACWY-CRM + Infant Vaccines)	HAV	Received vaccines: MenACWY: 2, 4, 6, and 17 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months DTaP, Hib: 16 months Pneumococcal, HAV, and MMR-V: 12 months
LA3B (MenACWY-CRM + Infant Vaccines)	MMR-V	Received vaccines: MenACWY: 2, 4, 6, and 17 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months DTaP, Hib: 16 months Pneumococcal, HAV, and MMR-V: 12 months
LA3B (MenACWY-CRM + Infant Vaccines)	DTaP	Received vaccines: MenACWY: 2, 4, 6, and 17 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months DTaP, Hib: 16 months Pneumococcal, HAV, and MMR-V: 12 months
LA4 (Infant Vaccines Only)	Meningococcal ACWY Conjugate Vaccine	Received vaccines: MenACWY: 12 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months DTaP, Hib: 15 months Pneumococcal, HAV, and MMR-V: 12 months
LA4 (Infant Vaccines Only)	DTaP-IPV-HBV	Received vaccines: MenACWY: 12 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months DTaP, Hib: 15 months Pneumococcal, HAV, and MMR-V: 12 months
LA4 (Infant Vaccines Only)	Hib	Received vaccines: MenACWY: 12 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months DTaP, Hib: 15 months Pneumococcal, HAV, and MMR-V: 12 months
LA4 (Infant Vaccines Only)	Rotavirus	Received vaccines: MenACWY: 12 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months DTaP, Hib: 15 months Pneumococcal, HAV, and MMR-V: 12 months
LA4 (Infant Vaccines Only)	Pneumococcal 7-valent Conjugate Vaccine	Received vaccines: MenACWY: 12 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months DTaP, Hib: 15 months Pneumococcal, HAV, and MMR-V: 12 months
LA4 (Infant Vaccines Only)	HAV	Received vaccines: MenACWY: 12 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months DTaP, Hib: 15 months Pneumococcal, HAV, and MMR-V: 12 months
LA4 (Infant Vaccines Only)	MMR-V	Received vaccines: MenACWY: 12 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months DTaP, Hib: 15 months Pneumococcal, HAV, and MMR-V: 12 months
LA4 (Infant Vaccines Only)	DTaP	Received vaccines: MenACWY: 12 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months DTaP, Hib: 15 months Pneumococcal, HAV, and MMR-V: 12 months
LA5 (MenACWY-CRM + Infant Vaccines)	Meningococcal ACWY Conjugate Vaccine	Received vaccines: MenACWY: 2, 4, 6, and 12 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
LA5 (MenACWY-CRM + Infant Vaccines)	DTaP-IPV-HBV	Received vaccines: MenACWY: 2, 4, 6, and 12 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
LA5 (MenACWY-CRM + Infant Vaccines)	Hib	Received vaccines: MenACWY: 2, 4, 6, and 12 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
LA5 (MenACWY-CRM + Infant Vaccines)	Rotavirus	Received vaccines: MenACWY: 2, 4, 6, and 12 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
LA5 (MenACWY-CRM + Infant Vaccines)	Pneumococcal 7-valent Conjugate Vaccine	Received vaccines: MenACWY: 2, 4, 6, and 12 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
LA5 (MenACWY-CRM + Infant Vaccines)	HAV	Received vaccines: MenACWY: 2, 4, 6, and 12 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
LA5 (MenACWY-CRM + Infant Vaccines)	MMR-V	Received vaccines: MenACWY: 2, 4, 6, and 12 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
LA6A (Infant Vaccines Only)	Meningococcal ACWY Conjugate Vaccine	Received vaccines: MenACWY: 12, and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
LA6A (Infant Vaccines Only)	DTaP-IPV-HBV	Received vaccines: MenACWY: 12, and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
LA6A (Infant Vaccines Only)	Hib	Received vaccines: MenACWY: 12, and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
LA6A (Infant Vaccines Only)	Rotavirus	Received vaccines: MenACWY: 12, and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
LA6A (Infant Vaccines Only)	Pneumococcal 7-valent Conjugate Vaccine	Received vaccines: MenACWY: 12, and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
LA6A (Infant Vaccines Only)	HAV	Received vaccines: MenACWY: 12, and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
LA6A (Infant Vaccines Only)	MMR-V	Received vaccines: MenACWY: 12, and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
LA6B (Infant Vaccines Only)	Meningococcal ACWY Conjugate Vaccine	Received vaccines: MenACWY: 13 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
LA6B (Infant Vaccines Only)	DTaP-IPV-HBV	Received vaccines: MenACWY: 13 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
LA6B (Infant Vaccines Only)	Hib	Received vaccines: MenACWY: 13 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
LA6B (Infant Vaccines Only)	Rotavirus	Received vaccines: MenACWY: 13 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
LA6B (Infant Vaccines Only)	Pneumococcal 7-valent Conjugate Vaccine	Received vaccines: MenACWY: 13 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
LA6B (Infant Vaccines Only)	HAV	Received vaccines: MenACWY: 13 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
LA6B (Infant Vaccines Only)	MMR-V	Received vaccines: MenACWY: 13 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
LA6C (Infant Vaccines Only)	Meningococcal ACWY Conjugate Vaccine	Received vaccines: MenACWY: 18 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
LA6C (Infant Vaccines Only)	DTaP-IPV-HBV	Received vaccines: MenACWY: 18 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
LA6C (Infant Vaccines Only)	Hib	Received vaccines: MenACWY: 18 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
LA6C (Infant Vaccines Only)	Rotavirus	Received vaccines: MenACWY: 18 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
LA6C (Infant Vaccines Only)	Pneumococcal 7-valent Conjugate Vaccine	Received vaccines: MenACWY: 18 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
LA6C (Infant Vaccines Only)	HAV	Received vaccines: MenACWY: 18 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects With hSBA Titer >=1:8 - US Subjects	13 months of age (one month post-toddler vaccination)	Immunogenicity as measured by percentage of subjects with hSBA titer \>=1:8 directed against N. meningitidis serogroups A, C, W and Y; after four doses of MenACWY-CRM at 2, 4, and 6 and 12 months of age
Geometric Mean hSBA Titers - US Subjects	13 months of age (one month post-toddler vaccination)	Immunogenicity as measured by Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y; comparison of four doses of MenACWY-CRM at 2, 4, and 6 and 12 months of age versus a single dose at 12 months of age.

Secondary Outcome Measures

Name	Time	Method
Percentage of Subjects (95% CI) With hSBA ≥1:4 at 1 Month After Toddler MenACWY Vaccination - LA Subjects	13 or 17 Months of Age (one month post-toddler vaccination)	Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:4, directed against N. meningitidis serogroups A, C, W and Y.
Percentage of Subjects (95% CI) With hSBA ≥1:8 at 1 Month After Toddler MenACWY Vaccination - LA Subjects	13 or 17 Months of Age (one month post-toddler vaccination)	Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:8, directed against N. meningitidis serogroups A, C, W and Y.
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	7 days post-vaccination	Solicited local and systemic reactions reported post second vaccination was compared in subjects receiving MenACWY versus Hib Vaccines.
Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	7 days post-vaccination	Solicited local and systemic reactions reported post third vaccination was compared in subjects receiving MenACWY versus Hib Vaccines.
Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	7 days after vaccination	Solicited local and systemic reactions after receiving MenACWY-CRM vaccination at 12 months of age were compared in subjects receiving Infant Vaccines only and subjects receiving MenACWY-CRM concomitantly with Infant Vaccines.
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	7 days post vaccination	Solicited local and systemic reactions post first vaccination of toddler series were compared in subjects receiving Infant Vaccines only and subjects receiving MenACWY-CRM concomitantly with Infant Vaccines.
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	7 days post vaccination	Solicited local and systemic reactions post second vaccination of toddler series at 15 months of age.
Geometric Mean hSBA Titers Post-infant Series - US Subjects	7 months of age (one month post-infant series)	Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y was measured after three doses at 2, 4, and 6 months of age.
Geometric Mean hSBA Titers Post-infant Series - LA Subjects	7 months of age (one month post-infant series)	Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y was measured after two doses of MenACWY at 2 and 6 months (LA1) versus three doses at 2, 4, and 6 (LA3) months of age.
Percentage of Subjects With hSBA Titer >=1:8 - US Subjects	7 months of age (one month post-infant series)	Immunogenicity as measured by percentage of subjects with hSBA titer \>=1:8 directed against N. meningitidis serogroups A, C, W and Y; after three doses of MenACWY at 2, 4, and 6 months of age.
Percentage of Subjects With hSBA Titer >=1:4 - US Subjects	7 months of age (one month post-infant series)	Immunogenicity as measured by percentage of subjects with hSBA titer \>=1:4 directed against N. meningitidis serogroups A, C, W and Y; after three doses of MenACWY at 2, 4, and 6 months of age.
Percentage of Subjects With hSBA Titer >=1:8 - LA Subjects	7 months of age (one month post-infant series)	Immunogenicity as measured by percentage of subjects with hSBA titer \>=1:8 directed against N. meningitidis serogroups A, C, W and Y; after two doses of MenACWY at 2 and 6 months (LA1) versus three doses at 2, 4, and 6 months of age (LA3) .
Percentage of Subjects With hSBA Titer >=1:4 - LA Subjects	7 months of age (one month post-infant series)	Immunogenicity as measured by percentage of subjects with hSBA titer \>=1:4 directed against N. meningitidis serogroups A, C, W and Y; after two doses of MenACWY at 2 and 6 months (LA1) versus three doses at 2, 4, and 6 months of age (LA3) .
Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects	7 months of age (one month post-infant series)	Immunogenicity as measured by antibody GMCs / GMTs directed against DTaP, HBV, Hib, pneumococcal and polio antigens.
Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects	7 months of age (one month post-infant series)	Immunogenicity as measured by percentage of subjects with predefined seroprotective antibody titers against DTaP, HBV, Hib, pneumococcal and polio antigens.
Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects	7 months of age (one month post-infant series)	Immunogenicity as measured by antibody GMCs / GMTs directed against DTaP, HBV, Hib, pneumococcal and polio antigens.
Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects	7 months of age (one month post-infant series)	Immunogenicity as measured by percentage of subjects with predefined seroprotective antibody titers against DTaP, HBV, Hib, pneumococcal and polio antigens.
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	7 days post-vaccination	Solicited local and systemic reactions reported post first vaccination was compared in subjects receiving MenACWY versus Hib Vaccines.
Percentage of Subjects With Persistence Antibodies hSBA ≥1:4 at 12 Months of Age- US Subject	12 Months of Age (one month pre-toddler vaccination)	Persistence of Antibodies as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:4, directed against N.meningitidis serogroups A, C, W and Y.
Percentage of Subjects With Persistence Antibodies hSBA ≥1:8 at 12 Months of Age- US Subject	12 Months of Age (one month pre-toddler vaccination)	Persistence of Antibodies as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:8, directed against N.meningitidis serogroups A, C, W and Y.
Persistence Antibodies Geometric Mean Titers - US Subject	12 Months of Age (one month pre-toddler vaccination)	Geometric Mean hSBA Titers directed against N. meningitides serogroups A, C, W and Y was measured at 12 Months of Age.
Percentage of Subjects With Persistence Antibodies hSBA ≥1:4 at 12 or 16 Months of Age- LA Subject	12 or 16 Months of Age (one month pre-toddler vaccination)	Persistence of Antibodies as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:4, directed against N.meningitidis serogroups A, C, W and Y.
Percentage of Subjects With Persistence Antibodies hSBA ≥1:8 at 12 or 16 Months of Age- LA Subject	12 or 16 Months of Age (one month pre-toddler vaccination)	Persistence of Antibodies as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:8, directed against N.meningitidis serogroups A, C, W and Y.
Persistence Antibodies Geometric Mean Titers - LA Subjects	12 or 16 Months of Age (one month pre-toddler vaccination)	Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y was measured at 12 or 16 Months of Age.
Percentage of Subjects (95% CI) With hSBA ≥ 1:4 at 1 Month After Toddler MenACWY Vaccination - US Subjects	13 months of age (one month post-toddler vaccination)	Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:4 , directed against N.meningitidis serogroups A, C, W and Y.
Percentage of Subjects (95% CI) With hSBA ≥ 1:8 at 1 Month After Toddler MenACWY Vaccination - US Subjects	13 months of age (one month post-toddler vaccination)	Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:8 , directed against N.meningitidis serogroups A, C, W and Y.
Percentage of Subjects (95% CI) With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - US Subjects	13 months of age (one month post-toddler vaccination)	Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:16 , directed against N.meningitidis serogroups A, C, W and Y.
Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - US Subjects	13 months of age (one month post-toddler vaccination)	Immunogenicity as measured by Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y; comparison of four doses of MenACWY-CRM at 2, 4, and 6 and 12 months of age versus a single dose at 12 months of age.
Percentage of Subjects With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - LA Subjects	13 or 17 Months of Age (one month post-toddler vaccination)	Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:16, directed against N. meningitidis serogroups A, C, W and Y.
Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - LA Subjects	13 or 17 Months of Age (one month post-toddler vaccination)	Immunogenicity as measured by Serum bactericidal activity using human complement (hSBA) GMTs, directed against N. meningitidis serogroups A, C, W and Y.
Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - US Subjects	13 months of age (one month post-toddler vaccination)	Immunogenicity as measured by antibody GMTs, directed against pneumococcal antigens PnC 4, PnC 6B, PnC 9V, PnC 14, PnC 18C, PnC 19F and PnC 23F.
Percentage of Subjects With Pneumococcal Antibody GMCs ≥1.0 μg/mL at 1 Month After Toddler Vaccination - US Subjects	13 months of age (one month post-toddler vaccination)	Immunogenicity as measured by Percentage of Subjects with Pneumococcal Antibody GMCs ≥1.0 μg/mL directed against pneumococcal antigens PnC 4, PnC 6B, PnC 9V, PnC 14, PnC 18C, PnC 19F and PnC 23F.
Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - LA Subjects	13 months of age (one month post-toddler vaccination)	Immunogenicity as measured by antibody GMTs, directed against pneumococcal antigens PnC 4, PnC 6B, PnC 9V, PnC 14, PnC 18C, PnC 19F and PnC 23F.
Percentage of Subjects With Pneumococcal Antibody Concentration ≥1.0 μg/mL at 1 Month After Toddler Vaccination - LA Subjects	13 months of age (one month post-toddler vaccination)	Immunogenicity as measured by Percentage of Subjects with Pneumococcal Antibody GMCs ≥1.0 μg/mL directed against pneumococcal antigens PnC 4, PnC 6B, PnC 9V, PnC 14, PnC 18C, PnC 19F and PnC 23F
Geometric Mean Concentrations or Titers of DTaP and Hib Antigens at 1 Month After Toddler Vaccination - LA Subjects	17 months of age (one month post-toddler vaccination)	Immunogenicity as measured by antibody GMCs/GMTs, directed against DTaP and Hib Antigens
Seroresponse Rates to DTaP and Hib Antigens at 1 Month After Toddler Vaccination - LA Subjects	17 months of age (one month post-toddler vaccination)	Immunogenicity as measured by Percentage of Subjects with predefined seroprotective antibody titers against DTaP and Hib Antigens
Percentage of Subjects With hSBA ≥1:8 at 1 Month After 1st (LA2) or 2nd (LA4) Toddler MenACWY Vaccination - LA Subjects	12 or 15 months of age (one month post 1st or 2nd toddler vaccination)	Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:8, directed against N.meningitidis serogroups A, C, W and Y.
Geometric Mean hSBA Titers at 1 Month After 1st (LA2) or 2nd (LA4) Toddler MenACWY Vaccination - LA Subjects	12 or 15 months of age (one month post 1st or 2nd toddler vaccination)	Immunogenicity as measured by Serum bactericidal activity using human complement (hSBA) GMTs, directed against N. meningitidis serogroups A, C, W and Y.

Trial Locations

Locations (61): Children's Memorial Hospital
🇺🇸
Chicago, Illinois, United States
Kentucky Pediatric/Adult Research Inc.
🇺🇸
Bardstown, Kentucky, United States
Pediatric Associates of Fall River
🇺🇸
Fall River, Massachusetts, United States
Senders Pediatric Research at Dr. Senders and Associates
🇺🇸
Cleveland, Ohio, United States
Akron Children's Hospital
🇺🇸
Akron, Ohio, United States
Squirrel Hill Office
🇺🇸
Pittsburgh, Pennsylvania, United States
Pediatric Alliance, Greentree Division
🇺🇸
Pittsburgh, Pennsylvania, United States
South Hills Pediatrics
🇺🇸
Pittsburgh, Pennsylvania, United States
Primary Physicians Research, Inc
🇺🇸
Pittsburgh, Pennsylvania, United States
Research Across America
🇺🇸
Dallas, Texas, United States
Goodlettsville Pediatrics
🇺🇸
Madison, Tennessee, United States
CEDEPAP Rio IV
🇦🇷
Alvear 1439 PB Dpto, rio IV, Cordoba, Cordoba, Argentina
Buenos Aires, Argentina
🇦🇷
Buenos Aires, Argentina
Centro Estudios Infect
🇦🇷
Scalabrini Ortiz 676, Buenos Aires, Buenos Aires,, Argentina
Corporation Cientifica
🇨🇴
Ped Calle 5B5 No.37 BIS-28, Cali, Colombia
Comfenalco
🇨🇴
Calle 6#5-42, Cali, Colombia
Dartmouth Hitchcock Medical Center
🇺🇸
Lebanon, New Hampshire, United States
Creighton University
🇺🇸
Omaha, Nebraska, United States
Center for Vaccine Development
🇺🇸
Baltimore, Maryland, United States
Boston University Medical Center
🇺🇸
Boston, Massachusetts, United States
Alabama Clinical Therapeutics, LLC
🇺🇸
Birmingham, Alabama, United States
Kaiser Permanente Pleasanton
🇺🇸
Pleasanton, California, United States
Kaiser Permanente Santa Clara
🇺🇸
Santa Clara, California, United States
Kaiser Permanente Oakland
🇺🇸
Oakland, California, United States
Kaiser Permanente San Francisco
🇺🇸
San Francisco, California, United States
Longmont Medical Research Network
🇺🇸
Longmont, Colorado, United States
The Pediatric Center
🇺🇸
Frederick, Maryland, United States
Growing Up Pediatrics
🇺🇸
Birmingham, Alabama, United States
Premier Health Research Center, LLC
🇺🇸
Downey, California, United States
Annapolis Pediatrics
🇺🇸
Annapolis, Maryland, United States
Laurel Pediatrics
🇺🇸
Uniontown, Pennsylvania, United States
Mercury Pharma Services
🇺🇸
Houston, Texas, United States
Wee Care Pediatrics
🇺🇸
Layton, Utah, United States
Utah Valley Pediatrics - Timpanogos
🇺🇸
Orem, Utah, United States
Kaiser Permanente Med Group - Vaccine Study Ctr
🇺🇸
Oakland, California, United States
UPMC/Community Medicine, Inc.
🇺🇸
Greenville, Pennsylvania, United States
Family Healthcare Partners
🇺🇸
Grove City, Pennsylvania, United States
Pediatric Alliance, Southwestern
🇺🇸
Pittsburgh, Pennsylvania, United States
Kaiser Permanente Richmond
🇺🇸
Richmond, California, United States
The Children's Hospital
🇺🇸
Aurora, Colorado, United States
Children's Physicians Dundee
🇺🇸
Omaha, Nebraska, United States
Children's Health Care - West
🇺🇸
Erie, Pennsylvania, United States
Pediatrics Medical Associates
🇺🇸
Rydal, Pennsylvania, United States
CCP - Pittsburgh Pediatrics
🇺🇸
Wexford, Pennsylvania, United States
Scott and White Hospital
🇺🇸
Temple, Texas, United States
Foothill Family Clinic
🇺🇸
Salt Lake City, Utah, United States
Copperview Medical Center
🇺🇸
South Jordan, Utah, United States
Hospital Regional Luis Pasteur,
🇦🇷
Mendoza n°2152, Villa Maria, Cordoba,, Cordoba, Argentina
Monroe Medical Foundation
🇺🇸
Monroe, Wisconsin, United States
CdePAP, Centro De Desarrollo De Proyectos Avanzados Roma 1465,
🇦🇷
Cordoba, Argentina
Hospitales Materno Neonatal,
🇦🇷
Castro Barros 650 - Barrio San Martin, Cordoba, Cordoba, Argentina
Siloe
🇨🇴
Calle 1 #50-51, Cali, Colombia
Hospital C H Trujillo
🇨🇴
Calle 72U 28 F-00, Cali, Colombia
UCLA Center for Vaccine Research
🇺🇸
Torrence, California, United States
Pediatric Associates of Latrobe
🇺🇸
Latrobe, Pennsylvania, United States
Center for Clinical Trials, LLC
🇺🇸
Paramount, California, United States
Carnegie Pediatrics
🇺🇸
Carnegie, Pennsylvania, United States
Louis P. Brine, Jr., MD, Beeghley Medical Park
🇺🇸
Boardman, Ohio, United States
Pennridge Pediatric Associates
🇺🇸
Sellersville, Pennsylvania, United States
Pediatric Medical Associates
🇺🇸
Norristown, Pennsylvania, United States
Montefiore Medical Center
🇺🇸
Bronx, New York, United States