Safety and Immunogenicity of 2 or 3 Doses of MenACWY Conjugate Vaccine in Healthy Infants and the Effects of a Booster Dose of MenACWY Administered in the Second Year of Life

Phase 3

Completed

• Conditions: Meningococcal Disease; Meningococcal Meningitis
• Interventions: Biological: MenACWY-CRM; Biological: Routine Vaccines

• Registration Number: NCT01214837
• Lead Sponsor: Novartis Vaccines

Brief Summary

The purpose of this study was to assess immunogenicity of a 3-dose versus 4-dose infant vaccination schedule including kinetics of immune response in the early phases of the series.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-09-27
• Study Start: 2010-10
• Study First Submitted QC: 2010-10-04
• Study First Posted: 2010-10-05
• Disposition First Submitted: 2011-12-13
• Disposition First Submitted QC: 2011-12-13
• Disposition First Posted: 2011-12-22
• Primary Completion: 2012-04
• Study Completion: 2012-05
• Results First Submitted: 2014-08-20
• Results First Submitted QC: 2014-09-30
• Results First Posted: 2014-10-02
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-10
• Last Update Posted: 2018-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 751

Inclusion Criteria

• Infants of both genders who are in generally good health will be eligible for this study. For infants to be enrolled, the parents/legal representatives need to provide written informed consent and to be available for all study visits.

Exclusion Criteria

• Serious, acute, or chronic illnesses are reasons for exclusion.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MenACWY3	Routine Vaccines	Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
Routine Vaccines	Routine Vaccines	Subjects received routine vaccines only, including PCV-13, at 2, 4 and 6 months of age and a toddler dose at 12 months of age.
MenACWY3	MenACWY-CRM	Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
MenACWY4	MenACWY-CRM	All the subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
MenACWY4	Routine Vaccines	All the subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects With hSBA ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 4-Dose and 3-Dose Schedule of Men ACWY Vaccination.	13 months of age	The immune response was assessed in terms of percentage of subjects with hSBA ≥ 1:8 against N. meningitidis serogroups A, C, W and Y following 4 doses of Men ACWY vaccine given to infants at 2, 4,6 and 12 months of age and 3 doses of Men ACWY given to infants at 2, 4 and 12 months of age.
Percentage of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following a 4-dose Schedule of Men ACWY Vaccination.	13 months of age	The immune response was assessed in terms of percentage of subjects with hSBA ≥ 1:8 against N. meningitidis serogroups A, C, W and Y following 4 doses of Men ACWY vaccine given to infants at 2, 4, 6 and 12 months of age.

Secondary Outcome Measures

Name	Time	Method
GMTs at 13 Months of Age After Completion of 3- and 4-Dose Series of MenACWY.	13 months of age	Immune response was assessed in terms of GMTs against N meningitis serogroups A, C, W and Y at 1 month after completion of a 3- and 4- dose series of MenACWY.
Percentage of Subjects With hSBA ≥1:8 Following 2 and 3 Infant Doses of MenACWY.	12 months of age.	Percentage of subjects with hSBA ≥1:8 against N meningitis serogroups A, C, W and Y was assessed following 2 and 3 infant doses of MenACWY as measured prior to the toddler dose at 12 months of age.
Effect of Concomitant Administration of 3 or 4 Doses of MenACWY on Immune Response to PCV-13 Antigens at 13 Months of Age.	13 months of age.	Geometric mean concentrations (GMCs) of antibodies against PCV-13 vaccine antigens at 13 months of age following concomitant administration of a 3- or 4-dose series of MenACWY with PCV-13.
Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age.	Baseline (2 months of age), 3 months, 4 months , 5 months and 7 months of age	Antibody levels were assessed in terms of percentage of subjects with hSBA ≥ 1:8 against N. meningitidis serogroups A, C, W and Y at baseline (2 months of age) and at 3, 4, 5 and 7 months of age.
Geometric Mean hSBA Titers Following 2 and 3 Infant Doses of MenACWY.	12 months of age	The immune response was assessed in terms of GMTs against N. meningitidis serogroups A, C, W and Y following 2 and 3 infant doses of MenACWY as measured prior to the toddler dose at 12 months of age.
Effect of Concomitant Administration of 2 or 3 Doses of MenACWY on Immune Response to PCV-13 Antigens at 7 Months of Age.	7 months of age.	Percentage of subjects with IgG concentration ≥ 0.35 μg/mL against pneumococcal conjugate vaccine (PCV-13) antigens at 7 Months of age following concomitant administration of 2 or 3 doses of MenACWY with PCV-13.
Percentage Of Subjects Reporting at Least One Severe Systemic Solicited Adverse Event.	Within 7 days	Safety was assessed as the percentages of subjects who reported severe solicited systemic adverse events within 30 minutes through day 7 of MenACWY administration with concomitant vaccines vs. concomitant vaccines alone.
Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age.	Baseline(2 months of age), 3 months, 4 months , 5 months and 7 months of age.	Antibody levels were assessed in terms of geometric mean titers (GMTs) against N. meningitidis serogroups A, C, W and Y at baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age.
Number Of Subjects Reporting Solicited Local or Systemic Adverse Events.	Day 1 through Day 7	Safety was assessed as the number of subjects who reported solicited local or systemic adverse events between 6 hours and day 7 after administration of MenACWY with concomitant vaccines vs. concomitant vaccines alone.
Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination.	13 months of age
Percentage of Subjects With 4-fold Increase in hSBA Titers Against N Meningitis Serogroups A, C, W and Y Between 12 and 13 Months of Age.	13 months of age	The immune response was assessed in terms of percentage of subjects with 4-fold increase in hSBA titers between post and pre toddler dose against N meningitis serogroups A, C, W and Y, 1 month after completing a 3- or 4-dose series of MenACWY.

Trial Locations

Locations (6)

Children's Physicians Dundee; 🇺🇸 Omaha, Nebraska, United States

Rockwood Clinic P S; 🇺🇸 Spokane, Washington, United States

Bluegrass Clinical Research (Brownsboro Park Blvd); 🇺🇸 Louisville, Kentucky, United States

Cotton ONeil Clinical Research; 🇺🇸 Topeka, Kansas, United States

Bluegrass Clinical Research (Bardstown Road); 🇺🇸 Louisville, Kentucky, United States

Creighton Univ; 🇺🇸 Omaha, Nebraska, United States