Study of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Given With Routine Pediatric Vaccines in Healthy Infants and Toddlers in India and the Republic of South Africa

Phase 3

Active, not recruiting

• Conditions: Meningococcal Immunisation; Healthy Volunteers
• Interventions: Biological: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine; Biological: Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine; Biological: Pneumoccocal Vaccine; Biological: Oral bivalent types 1 and 3; Poliomyelitis Vaccine (OPV); Biological: Measles, Mumps, and Rubella Vaccine live (MMR); Biological: DTwP-HepB-Hib-IPV vaccine; Biological: DTaP-IPV-Hib-HepB vaccine; Biological: Rotavirus vaccine; Biological: Hepatitis A vaccine; Biological: Measles vaccine; Biological: Varicella vaccine live; Biological: Typhoid conjugate vaccine (TCV)

• Registration Number: NCT05794230
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief Summary

This open label randomized study will be conducted to evaluate and/or describe the immunogenicity and describe the safety of MenACYW conjugate vaccine when administered in infants and toddlers.

It will be conducted in India and the RSA in 2 cohorts:

* Cohort I: Infants and toddlers 6 months to 16 months of age (Cohort I)

* Cohort II: Infants and toddlers 6 weeks to 15 months of age (Cohort II) In Cohort I, eligible participants will be randomized in a 1:1 ratio to receive 2 intramuscular (IM) injections (1+1 vaccination schedule) of either MenACYW conjugate vaccine (Groups 1 and 3) or Menactra vaccine (Groups 2 and 4), co-administered with routine pediatric vaccines.

In Cohort II, eligible participants will be randomized in a 2:1 ratio to receive either 3 IM injections (2+1 vaccination schedule) of MenACYW conjugate vaccine co-administered with routine pediatric vaccines (Groups 5 and 7) or routine pediatric vaccines only (Groups 6 and 8).

The primary objectives of this study are:

* To demonstrate the non-inferiority of immunogenicity of 2 doses of MenACYW conjugate vaccine compared to 2 doses of Menactra® vaccine in infants and toddlers 6 months to 16 months of age (Cohort I) in terms of serum bactericidal assay using human complement (hSBA) seroprotection (titers ≥ 1:8) in India and the Republic of South Africa (RSA)

* To demonstrate the vaccine immune sufficiency of 3 doses of MenACYW conjugate vaccine in infants and toddlers 6 weeks to 15 months of age (Cohort II) in terms of hSBA seroprotection (titers ≥ 1:8) in India and the RSA

The secondary objectives of this study are:

* To describe the antibody titers to the meningococcal serogroups A, C, Y, and W:

* before and 30 days post primary series of MenACYW conjugate vaccine and before and 30 days post booster dose of MenACYW conjugate vaccine in infants and toddlers 6 weeks to 15 months of age (Cohort II) in India and the RSA when administered concomitantly with other age-recommended vaccines.

* before and after 30 days post each dose of MenACYW conjugate vaccine or Menactra vaccine in infants and toddlers 6 months to 16 months of age (Cohort I) in India and the RSA when administered concomitantly with other age-recommended vaccines.

* To describe the antibody responses against the antigens of the other age-recommended vaccines when administered concomitantly with MenACYW conjugate vaccine:

* in infants and toddlers 6 weeks to 15 months of age (Cohort II) in India and the RSA.

* in infants and toddlers 6 months to 16 months of age (Cohort I) in India and the RSA.

* To describe the safety profile of MenACYW conjugate vaccine and that of licensed Menactra vaccine in infants and toddlers 6 months to 16 months of age (Cohort I) in India and the RSA when administered concomitantly with other age-recommended vaccines.

* To describe the safety profile of MenACYW conjugate vaccine in infants and toddlers 6 weeks to 15 months of age (Cohort II) in India and the RSA when administered concomitantly with other age-recommended vaccines.

* To describe the safety profile of age-recommended vaccines:

* in infants 6 weeks to 15 months of age (Cohort II) in India and the RSA when administered concomitantly with MenACYW conjugate vaccine.

* in infants and toddlers 6 months to 16 months of age (Cohort I) in India and the RSA when administered concomitantly with MenACYW conjugate vaccine.

The duration of each participant's active participation in the study will be approximately 10 to 11 months for Cohort I and 13,5 to 14,5 months for Cohort II.

Detailed Description

The duration of each participant's active participation in the study will be approximately 10 to 11 months for Cohort I and 13,5 to 14,5 months for Cohort II.

Study Timeline

• Study First Submitted: 2023-03-20
• Study First Submitted QC: 2023-03-20
• Study Start: 2023-03-27
• Study First Posted: 2023-04-03
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-25
• Last Update Posted: 2024-11-27
• Primary Completion: 2025-12-02
• Study Completion: 2025-12-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1528

Inclusion Criteria

• Cohort I: 6 months of age (180 to 209 days of age) on the day of the first study visit
• Cohort II: 6-8 weeks of age (42 to 62 days of age) on the day of the first study visit
• Healthy infants as determined by medical history, physical examination, and judgment of the Investigator
• Participant and parent/ legally acceptable representative (LAR) are able to attend all scheduled visits and to comply with all study procedures
• Cohort I: Z-score ≥ -2 SD on the Weight-for-age table of the WHO Child Growth Standards.
• Cohort II: Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg.

Exclusion Criteria

Participants are excluded from the study if any of the following criteria apply:

• Known or suspected congenital or acquired immunodeficiency*; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).

  *Note: Participants with a history of HIV but without evident severe immunosuppression can be included.

• Family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated.

• Individuals with active tuberculosis.

• History of meningococcal infection, confirmed either clinically, serologically, or microbiologically.

• At high risk for meningococcal infection during the study (specifically, but not limited to, participants with persistent complement deficiency, with anatomic or functional asplenia, or participants travelling to countries with high endemic or epidemic disease).

• History of intussusception.

• History of any neurologic disorders, including any seizures and progressive neurologic disorders.

• History of Guillain-Barré syndrome (GBS).

• Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the study or to a vaccine containing any of the same substances, including neomycin, gelatin, and yeast.

• Verbal report of thrombocytopenia, as reported by the parent/LAR, contraindicating IM vaccination in the Investigator's opinion.

• Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination in the Investigator's opinion.

• Chronic illness (including, but not limited to, cardiac disorders, congenital heart disease, chronic lung disease, renal disorders, auto-immune disorders, diabetes, psychomotor diseases, and known congenital or genetic diseases) that, in the opinion of the Investigator, is at a stage where it might interfere with study conduct or completion.

• Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0°C). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.

• Receipt of any vaccine in the 4 weeks preceding the first study vaccination (except for Bacille Calmette-Guérin [BCG], birth dose OPV and birth dose of HepB vaccine) or planned receipt of any vaccine in the 4 weeks following each study vaccination except for the following vaccinations, which may be received at least 2 weeks before or 2 weeks after any study vaccination. This exception includes monovalent pandemic influenza vaccines, multivalent influenza vaccines, any COVID-19 vaccines, and administration of OPV on National Immunization Day in India.

• Previous vaccination against meningococcal disease with either the study vaccine or another vaccine (ie, mono- or polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, Y, or W; or meningococcal B serogroup-containing vaccine).

• For Cohort II: Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis (other than birth dose of OPV), Hepatitis A, measles, mumps, rubella, varicella; and of Hib, Streptococcus pneumoniae, and/or RV infection or disease.

• For Cohort II: Previous vaccination with more than 1 dose of HepB vaccine.

• Receipt of immune globulins, blood, or blood-derived products in the past 3 months.

• Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw.

• Participation at the time of study enrollment (or in the 4 weeks preceding the first study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure.

• Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 6 Cohort IIa (India)	Varicella vaccine live	routine pediatric vaccines only
Group 4 Cohort Ib (RSA)	Measles vaccine	2 injections of Menactra vaccine: at 9 months of age and second dose between 12 and 16 months of age + co-administered routine pediatric vaccines
Groups 3 Cohort Ib (RSA)	Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine	2 injections of MenACYW conjugate vaccine: at 6 months of age and second dose between 12 and 16 months of age + co-administered routine pediatric vaccines
Group 2 Cohort Ia (India)	Typhoid conjugate vaccine (TCV)	2 injections of Menactra vaccine: at 9 months of age and second dose at 16 months of age + co-administered routine pediatric vaccines
Group 2 Cohort Ia (India)	Varicella vaccine live	2 injections of Menactra vaccine: at 9 months of age and second dose at 16 months of age + co-administered routine pediatric vaccines
Groups 1a, 1b and 1c Cohort Ia (India)	Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine	2 injections of MenACYW conjugate vaccine: at 6 months of age and second dose at 12 months of age (group 1a) or at 15 months of age (group 1b) or at 16 months of age (group 1c) + co-administered routine pediatric vaccines
Groups 1a, 1b and 1c Cohort Ia (India)	Pneumoccocal Vaccine	2 injections of MenACYW conjugate vaccine: at 6 months of age and second dose at 12 months of age (group 1a) or at 15 months of age (group 1b) or at 16 months of age (group 1c) + co-administered routine pediatric vaccines
Groups 1a, 1b and 1c Cohort Ia (India)	Measles, Mumps, and Rubella Vaccine live (MMR)	2 injections of MenACYW conjugate vaccine: at 6 months of age and second dose at 12 months of age (group 1a) or at 15 months of age (group 1b) or at 16 months of age (group 1c) + co-administered routine pediatric vaccines
Groups 1a, 1b and 1c Cohort Ia (India)	DTwP-HepB-Hib-IPV vaccine	2 injections of MenACYW conjugate vaccine: at 6 months of age and second dose at 12 months of age (group 1a) or at 15 months of age (group 1b) or at 16 months of age (group 1c) + co-administered routine pediatric vaccines
Groups 1a, 1b and 1c Cohort Ia (India)	Hepatitis A vaccine	2 injections of MenACYW conjugate vaccine: at 6 months of age and second dose at 12 months of age (group 1a) or at 15 months of age (group 1b) or at 16 months of age (group 1c) + co-administered routine pediatric vaccines
Groups 1a, 1b and 1c Cohort Ia (India)	Typhoid conjugate vaccine (TCV)	2 injections of MenACYW conjugate vaccine: at 6 months of age and second dose at 12 months of age (group 1a) or at 15 months of age (group 1b) or at 16 months of age (group 1c) + co-administered routine pediatric vaccines
Groups 1a, 1b and 1c Cohort Ia (India)	Varicella vaccine live	2 injections of MenACYW conjugate vaccine: at 6 months of age and second dose at 12 months of age (group 1a) or at 15 months of age (group 1b) or at 16 months of age (group 1c) + co-administered routine pediatric vaccines
Group 2 Cohort Ia (India)	Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine	2 injections of Menactra vaccine: at 9 months of age and second dose at 16 months of age + co-administered routine pediatric vaccines
Group 2 Cohort Ia (India)	Pneumoccocal Vaccine	2 injections of Menactra vaccine: at 9 months of age and second dose at 16 months of age + co-administered routine pediatric vaccines
Group 2 Cohort Ia (India)	Measles, Mumps, and Rubella Vaccine live (MMR)	2 injections of Menactra vaccine: at 9 months of age and second dose at 16 months of age + co-administered routine pediatric vaccines
Group 2 Cohort Ia (India)	DTwP-HepB-Hib-IPV vaccine	2 injections of Menactra vaccine: at 9 months of age and second dose at 16 months of age + co-administered routine pediatric vaccines
Group 2 Cohort Ia (India)	Hepatitis A vaccine	2 injections of Menactra vaccine: at 9 months of age and second dose at 16 months of age + co-administered routine pediatric vaccines
Groups 3 Cohort Ib (RSA)	Oral bivalent types 1 and 3; Poliomyelitis Vaccine (OPV)	2 injections of MenACYW conjugate vaccine: at 6 months of age and second dose between 12 and 16 months of age + co-administered routine pediatric vaccines
Groups 3 Cohort Ib (RSA)	Pneumoccocal Vaccine	2 injections of MenACYW conjugate vaccine: at 6 months of age and second dose between 12 and 16 months of age + co-administered routine pediatric vaccines
Groups 3 Cohort Ib (RSA)	DTaP-IPV-Hib-HepB vaccine	2 injections of MenACYW conjugate vaccine: at 6 months of age and second dose between 12 and 16 months of age + co-administered routine pediatric vaccines
Groups 3 Cohort Ib (RSA)	Measles vaccine	2 injections of MenACYW conjugate vaccine: at 6 months of age and second dose between 12 and 16 months of age + co-administered routine pediatric vaccines
Groups 3 Cohort Ib (RSA)	Varicella vaccine live	2 injections of MenACYW conjugate vaccine: at 6 months of age and second dose between 12 and 16 months of age + co-administered routine pediatric vaccines
Groups 3 Cohort Ib (RSA)	Measles, Mumps, and Rubella Vaccine live (MMR)	2 injections of MenACYW conjugate vaccine: at 6 months of age and second dose between 12 and 16 months of age + co-administered routine pediatric vaccines
Groups 3 Cohort Ib (RSA)	Hepatitis A vaccine	2 injections of MenACYW conjugate vaccine: at 6 months of age and second dose between 12 and 16 months of age + co-administered routine pediatric vaccines
Group 4 Cohort Ib (RSA)	Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine	2 injections of Menactra vaccine: at 9 months of age and second dose between 12 and 16 months of age + co-administered routine pediatric vaccines
Group 4 Cohort Ib (RSA)	Oral bivalent types 1 and 3; Poliomyelitis Vaccine (OPV)	2 injections of Menactra vaccine: at 9 months of age and second dose between 12 and 16 months of age + co-administered routine pediatric vaccines
Group 4 Cohort Ib (RSA)	Pneumoccocal Vaccine	2 injections of Menactra vaccine: at 9 months of age and second dose between 12 and 16 months of age + co-administered routine pediatric vaccines
Group 4 Cohort Ib (RSA)	DTaP-IPV-Hib-HepB vaccine	2 injections of Menactra vaccine: at 9 months of age and second dose between 12 and 16 months of age + co-administered routine pediatric vaccines
Group 4 Cohort Ib (RSA)	Varicella vaccine live	2 injections of Menactra vaccine: at 9 months of age and second dose between 12 and 16 months of age + co-administered routine pediatric vaccines
Group 4 Cohort Ib (RSA)	Measles, Mumps, and Rubella Vaccine live (MMR)	2 injections of Menactra vaccine: at 9 months of age and second dose between 12 and 16 months of age + co-administered routine pediatric vaccines
Group 4 Cohort Ib (RSA)	Hepatitis A vaccine	2 injections of Menactra vaccine: at 9 months of age and second dose between 12 and 16 months of age + co-administered routine pediatric vaccines
Groups 5a and 5b Cohort IIa (India)	Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine	3 injections of MenACYW conjugate vaccine: at 6-8 weeks of age and second dose at 14-16 weeks of age with a booster dose administered at 12 months of age (group 5a) or at 15 months of age (group 5b) + co-administered routine pediatric vaccines
Groups 5a and 5b Cohort IIa (India)	Pneumoccocal Vaccine	3 injections of MenACYW conjugate vaccine: at 6-8 weeks of age and second dose at 14-16 weeks of age with a booster dose administered at 12 months of age (group 5a) or at 15 months of age (group 5b) + co-administered routine pediatric vaccines
Groups 5a and 5b Cohort IIa (India)	Measles, Mumps, and Rubella Vaccine live (MMR)	3 injections of MenACYW conjugate vaccine: at 6-8 weeks of age and second dose at 14-16 weeks of age with a booster dose administered at 12 months of age (group 5a) or at 15 months of age (group 5b) + co-administered routine pediatric vaccines
Groups 5a and 5b Cohort IIa (India)	DTwP-HepB-Hib-IPV vaccine	3 injections of MenACYW conjugate vaccine: at 6-8 weeks of age and second dose at 14-16 weeks of age with a booster dose administered at 12 months of age (group 5a) or at 15 months of age (group 5b) + co-administered routine pediatric vaccines
Groups 5a and 5b Cohort IIa (India)	Hepatitis A vaccine	3 injections of MenACYW conjugate vaccine: at 6-8 weeks of age and second dose at 14-16 weeks of age with a booster dose administered at 12 months of age (group 5a) or at 15 months of age (group 5b) + co-administered routine pediatric vaccines
Groups 5a and 5b Cohort IIa (India)	Typhoid conjugate vaccine (TCV)	3 injections of MenACYW conjugate vaccine: at 6-8 weeks of age and second dose at 14-16 weeks of age with a booster dose administered at 12 months of age (group 5a) or at 15 months of age (group 5b) + co-administered routine pediatric vaccines
Groups 5a and 5b Cohort IIa (India)	Varicella vaccine live	3 injections of MenACYW conjugate vaccine: at 6-8 weeks of age and second dose at 14-16 weeks of age with a booster dose administered at 12 months of age (group 5a) or at 15 months of age (group 5b) + co-administered routine pediatric vaccines
Group 6 Cohort IIa (India)	Pneumoccocal Vaccine	routine pediatric vaccines only
Group 6 Cohort IIa (India)	Measles, Mumps, and Rubella Vaccine live (MMR)	routine pediatric vaccines only
Group 6 Cohort IIa (India)	DTwP-HepB-Hib-IPV vaccine	routine pediatric vaccines only
Group 6 Cohort IIa (India)	Hepatitis A vaccine	routine pediatric vaccines only
Group 6 Cohort IIa (India)	Typhoid conjugate vaccine (TCV)	routine pediatric vaccines only
Group 7 Cohort IIb (RSA)	Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine	3 injections of MenACYW conjugate vaccine: at 6-8 weeks of age and second dose at 14-16 weeks of age with a booster dose administered between 12 and 15 months of age + co-administered routine pediatric vaccines
Group 7 Cohort IIb (RSA)	Oral bivalent types 1 and 3; Poliomyelitis Vaccine (OPV)	3 injections of MenACYW conjugate vaccine: at 6-8 weeks of age and second dose at 14-16 weeks of age with a booster dose administered between 12 and 15 months of age + co-administered routine pediatric vaccines
Group 7 Cohort IIb (RSA)	Pneumoccocal Vaccine	3 injections of MenACYW conjugate vaccine: at 6-8 weeks of age and second dose at 14-16 weeks of age with a booster dose administered between 12 and 15 months of age + co-administered routine pediatric vaccines
Group 7 Cohort IIb (RSA)	DTaP-IPV-Hib-HepB vaccine	3 injections of MenACYW conjugate vaccine: at 6-8 weeks of age and second dose at 14-16 weeks of age with a booster dose administered between 12 and 15 months of age + co-administered routine pediatric vaccines
Group 7 Cohort IIb (RSA)	Measles vaccine	3 injections of MenACYW conjugate vaccine: at 6-8 weeks of age and second dose at 14-16 weeks of age with a booster dose administered between 12 and 15 months of age + co-administered routine pediatric vaccines
Group 7 Cohort IIb (RSA)	Varicella vaccine live	3 injections of MenACYW conjugate vaccine: at 6-8 weeks of age and second dose at 14-16 weeks of age with a booster dose administered between 12 and 15 months of age + co-administered routine pediatric vaccines
Group 7 Cohort IIb (RSA)	Measles, Mumps, and Rubella Vaccine live (MMR)	3 injections of MenACYW conjugate vaccine: at 6-8 weeks of age and second dose at 14-16 weeks of age with a booster dose administered between 12 and 15 months of age + co-administered routine pediatric vaccines
Group 7 Cohort IIb (RSA)	Hepatitis A vaccine	3 injections of MenACYW conjugate vaccine: at 6-8 weeks of age and second dose at 14-16 weeks of age with a booster dose administered between 12 and 15 months of age + co-administered routine pediatric vaccines
Group 8 Cohort IIb (RSA)	Oral bivalent types 1 and 3; Poliomyelitis Vaccine (OPV)	routine pediatric vaccines only
Group 8 Cohort IIb (RSA)	Pneumoccocal Vaccine	routine pediatric vaccines only
Group 8 Cohort IIb (RSA)	DTaP-IPV-Hib-HepB vaccine	routine pediatric vaccines only
Group 8 Cohort IIb (RSA)	Rotavirus vaccine	routine pediatric vaccines only
Group 8 Cohort IIb (RSA)	Measles vaccine	routine pediatric vaccines only
Group 8 Cohort IIb (RSA)	Varicella vaccine live	routine pediatric vaccines only
Group 8 Cohort IIb (RSA)	Measles, Mumps, and Rubella Vaccine live (MMR)	routine pediatric vaccines only
Group 8 Cohort IIb (RSA)	Hepatitis A vaccine	routine pediatric vaccines only
Groups 1a, 1b and 1c Cohort Ia (India)	Rotavirus vaccine	2 injections of MenACYW conjugate vaccine: at 6 months of age and second dose at 12 months of age (group 1a) or at 15 months of age (group 1b) or at 16 months of age (group 1c) + co-administered routine pediatric vaccines
Group 2 Cohort Ia (India)	Rotavirus vaccine	2 injections of Menactra vaccine: at 9 months of age and second dose at 16 months of age + co-administered routine pediatric vaccines
Groups 3 Cohort Ib (RSA)	Rotavirus vaccine	2 injections of MenACYW conjugate vaccine: at 6 months of age and second dose between 12 and 16 months of age + co-administered routine pediatric vaccines
Group 4 Cohort Ib (RSA)	Rotavirus vaccine	2 injections of Menactra vaccine: at 9 months of age and second dose between 12 and 16 months of age + co-administered routine pediatric vaccines
Groups 5a and 5b Cohort IIa (India)	Rotavirus vaccine	3 injections of MenACYW conjugate vaccine: at 6-8 weeks of age and second dose at 14-16 weeks of age with a booster dose administered at 12 months of age (group 5a) or at 15 months of age (group 5b) + co-administered routine pediatric vaccines
Group 6 Cohort IIa (India)	Rotavirus vaccine	routine pediatric vaccines only
Group 7 Cohort IIb (RSA)	Rotavirus vaccine	3 injections of MenACYW conjugate vaccine: at 6-8 weeks of age and second dose at 14-16 weeks of age with a booster dose administered between 12 and 15 months of age + co-administered routine pediatric vaccines

Primary Outcome Measures

Name	Time	Method
Percentage of participants with anti-meningococcal serogroups A, C, Y, W antibody titers above predefined thresholds after 2 doses of MenACYW conjugate vaccine compared to 2 doses of Menactra® vaccine in infants and toddlers 6 months to 16 months of age	30 days after the second vaccination	Antibody (Ab) titers against meningococcal serogroups A, C, Y, and W will be measured in infants and toddlers 6 months to 16 months of age (\[Group 1 + Group 3\] versus \[Group 2 + Group 4\]); The following threshold values will be considered: ≥ 1:8
Percentage of participants with anti-meningococcal serogroups A, C, Y, W Ab titers above predefined thresholds after 3 doses of MenACYW conjugate vaccine in infants and toddlers 6 weeks to 15 months of age	30 days after the booster vaccination	Ab titers against meningococcal serogroups A, C, Y, and W will be measured in infants and toddlers 6 months to 15 months of age (Group 5 + Group 7); The following threshold values will be considered: ≥ 1:8

Secondary Outcome Measures

Name	Time	Method
Number of participants reporting serious adverse events (SAEs)	From Day 1 to Month 18	SAEs
Geometric Mean Titers (GMTs) of Ab against meningococcal serogroups A, C, Y, and W when MenACYW conjugate vaccine administered concomitantly with other age-recommended vaccine in infants 6 weeks to 15 months of age	Baseline; 30 days after primary series of vaccination; Before and 30 days after booster vaccination	Ab titers against meningococcal serogroups A, C, Y, and W will be measured Group 5 versus Group 6 in India Group 7 versus Group 8 in RSA Group 5 + Group 7 versus Group 6 + Group 8
Geometric Mean Titers Ratio (GMTR) of Ab against meningococcal serogroups A, C, Y, and W when MenACYW conjugate vaccine administered concomitantly with other age-recommended vaccine in infants 6 weeks to 15 months of age	Baseline; 30 days after primary series of vaccination; Before and 30 days after booster vaccination	Ab titers against meningococcal serogroups A, C, Y, and W will be measured Group 5 versus Group 6 in India Group 7 versus Group 8 in RSA Group 5 + Group 7 versus Group 6 + Group 8
GMTs of Ab against meningococcal serogroups A, C, Y, and W when MenACYW conjugate vaccine or Menactra vaccine when administered concomitantly with other age-recommended vaccines in infants and toddlers 6 months to 16 months of age	Baseline; Before and 30 days after each vaccination	Ab titers after vaccination with MenACYW conjugate vaccine or Menetra® will be measured Group 1 versus Group 2 in India Group 3 versus Group 4 in the RSA Group 1 + Group 3 versus Group 2 + Group 4
GMTR of Ab against meningococcal serogroups A, C, Y, and W when MenACYW conjugate vaccine or Menactra vaccine when administered concomitantly with other age-recommended vaccines in infants and toddlers 6 months to 16 months of age	Baseline; Before and 30 days after each vaccination	Ab titers after vaccination with MenACYW conjugate vaccine or Menetra® will be measured Group 1 versus Group 2 in India Group 3 versus Group 4 in the RSA Group 1 + Group 3 versus Group 2 + Group 4
Percentage of participants with anti-meningococcal serogroups A, C, Y, and W Ab titers met the predefined criteria when MenACYW conjugate vaccine administered concomitantly with other age-recommended vaccine in infants 6 weeks to 15 months of age	Baseline; 30 days after primary series of vaccination; Before and 30 days after booster vaccination	Ab titers against meningococcal serogroups A, C, Y, and W will be measured; * hSBA titer ≥ 1:4 and ≥ 1:8; * hSBA titer ≥ 4-fold rise from pre-vaccination to post-vaccination; * hSBA vaccine seroresponse
Percentage of participants with anti-meningococcal serogroups A, C, Y, and W Ab titers met the predefined criteria when MenACYW conjugate vaccine administered concomitantly with other age-recommended vaccine in infants and toddlers 6 to 16 months of age	Baseline; Before and 30 days after each vaccination	Ab titers after vaccination with MenACYW conjugate vaccine or Menetra® will be measured; * hSBA titer ≥ 1:4 and ≥ 1:8; * hSBA titer ≥ 4-fold rise from pre-vaccination to post-vaccination; * hSBA vaccine seroresponse
GMCs of Ab against the antigens of age-recommended vaccines in infants and toddlers 6 weeks to 15 months of age	Baseline	The following Ab concentrations will be measured: - Anti-pertussis Ab concentrations (pertussis toxin \[PT\], filamentous hemagglutinin \[FHA\]), fimbriae types 2, 3 \[FIM\], and pertactin \[PRN\])
GMCR of Ab against the antigens of age-recommended vaccines in infants and toddlers 6 weeks to 15 months of age	Baseline	The following Ab concentrations will be measured: - Anti-pertussis Ab concentrations (pertussis toxin \[PT\], filamentous hemagglutinin \[FHA\], fimbriae types 2, 3 \[FIM\], and pertactin \[PRN\])
GMCs/GMTs of Ab against the antigens of age-recommended vaccines in infants and toddlers 6 weeks to 15 months of age	-30 days after:-Dose3 of DTwP-HepB-Hib-IPV/DTaP-IPV-Hib-HepB;-1ry series of PCV13;-measles,mumps & rubella: Dose1 in RSA;Dose2 in India;-1st dose of varicella vaccine -30 days at least after booster dose of PCV13 -Before & 30 days after 1ry series of RV	The following Ab concentrations/titers will be measured: * against the antigens of DTwP-HepB-Hib/DTaP-IPV-Hib-HepB; * against the antigens of PCV13; * against the antigens of RV (serum RV immunoglobulin \[Ig\]A); * against the antigens of measles, mumps and rubella; * against the antigens of varicella vaccine
GMCRs/GMTRs of Ab against the antigens of age-recommended vaccines in infants and toddlers 6 weeks to 15 months of age	-30days after:-1ry series of DTwP-HepB-Hib-IPV/DTaP-IPV-Hib-HepB;-1ry series of PCV13;-measles,mumps & rubella:Dose1 in RSA;Dose2 in India;-1st dose of varicella vaccine -30days at least after booster dose of PCV13 -Before&30 days after 1ry series of RV	The following Ab concentrations/titers will be measured: * against the antigens of DTwP-HepB-Hib-IPV/DTaP-IPV-Hib-HepB; * against the antigens of PCV13; * against the antigens of RV (serum RV immunoglobulin \[Ig\]A); * against the antigens of measles, mumps and rubella; * against the antigens of varicella vaccine
Percentage of participants with Ab concentrations/titers met the predefined criteria in infants and toddlers 6 weeks to 15 months of age	30 days after: - Primary series of RV - Dose 1 of measles, mumps and rubella in RSA - Dose 2 of measles, mumps and rubella in India - first dose of varicella vaccine	The following Ab concentrations/titers will be measured: * Anti-RV seroresponse; * Anti-measles Ab concentrations (serostatus cutoff: 255 mIU/mL); * Anti-mumps Ab concentrations (serostatus cutoff: 10 Mumps antibody units/mL); * Anti-rubella Ab concentrations (serostatus cutoff: 10 IU/mL); * Anti-varicella Ab concentrations (serostatus cutoff: 5gpELISA unit/mL)
GMCs/GMTs of Ab against the antigens of age-recommended vaccines in infants and toddlers 6 months to 16 months of age	30 days after: - first dose of varicella vaccine - the booster dose of PCV13 - Dose 1 of measles, mumps and rubella in RSA - Dose 2 of measles, mumps and rubella in India - after booster dose of DTwP-HepB-Hib-IPV	The following Ab concentrations will be measured: * against the antigens of varicella; * against the antigens of PCV13; * against the antigens of measles, mumps and rubella; * against the antigens of DTwP-HepB-Hib-IPV
GMCRs/GMTRs of Ab against the antigens of age-recommended vaccines in infants and toddlers 6 months to 16 months of age	30 days after: - first dose of varicella vaccine - the booster dose of PCV13 - Dose 1 of measles, mumps and rubella in RSA - Dose 2 of measles, mumps and rubella in India - after booster dose of DTwP-HepB-Hib-IPV	The following Ab concentrations/titers will be measured: * against the antigen of varicella; * against the antigens of PCV13; * against the antigens of measles, mumps and rubella; * against the antigens of DTwP-HepB-Hib-IPV
Percentage of participants with Ab concentrations/titers met the predefined criteria in infants and toddlers 6 months to 16 months of age	30 days after booster dose of DTwP-HepB-Hib-IPV	The following Ab concentrations/titers will be measured: * anti-tetanus Ab concentrations ≥ 0.01 IU/mL, ≥ 0.1 IU/mL and ≥ 1.0 IU/mL; * anti-diphtheria Ab concentrations ≥ 0.01 IU/mL, and ≥ 0.1 IU/mL; * anti-PRP Ab concentrations ≥ 0.15 µg)/mL and ≥ 1.0 μg/mL; * pertussis vaccine seroresponse for anti-PT, anti-FHA, anti-FIM, and anti-PRN; * anti-HBsAg Ab concentrations ≥ 10 mIU/mL and ≥ 100 mIU/mL; * anti-poliovirus types 1, 2, and 3 Ab titers ≥ 1:8
GMCs of Ab against the antigens of age-recommended vaccines in infants and toddlers 6 months to 16 months of age	Pre-booster dose vaccination of DTwP-HepB-Hib-IPV	The following Ab concentrations will be measured: - Anti-pertussis Ab concentrations (pertussis toxin \[PT\], filamentous hemagglutinin \[FHA\], fimbriae types 2, 3 \[FIM\], and pertactin \[PRN\])
GMCR of Ab against the antigens of age-recommended vaccines in infants and toddlers 6 months to 16 months of age	Pre-booster dose vaccination of DTwP-HepB-Hib-IPV	The following Ab concentrations will be measured: - Anti-pertussis Ab concentrations (pertussis toxin \[PT\], filamentous hemagglutinin \[FHA\], fimbriae types 2, 3 \[FIM\], and pertactin \[PRN\])
Number of participants reporting immediate adverse events (AEs)	Within 30 minutes post-vaccination	Unsolicited (spontaneously reported) systemic AEs
Percentage of participants reporting solicited injection site and systemic reactions	Within 7 days post-vaccination	Solicited injection site reactions: - tenderness, erythema, swelling; Solicited systemic reactions: - fever, vomiting, crying abnormal, drowsiness, appetite lost, irritability
Number of participants reporting unsolicited AEs	Up to Day 31 post-vaccination	Unsolicited AEs

Trial Locations

Locations (15)

Investigational Site Number : 3560006; 🇮🇳 Chennai, India

Investigational Site Number : 3560007; 🇮🇳 Hyderabad, India

Investigational Site Number : 3560016; 🇮🇳 Kanpur, India

Investigational Site Number : 3560009; 🇮🇳 Kolkata, India

Investigational Site Number : 3560011; 🇮🇳 Manipal, India

Investigational Site Number : 3560013; 🇮🇳 Mysore, India

Investigational Site Number : 3560004; 🇮🇳 Mysore, India

Investigational Site Number : 3560003; 🇮🇳 New Delhi, India

Investigational Site Number : 3560002; 🇮🇳 Pune, India

Investigational Site Number : 3560001; 🇮🇳 Pune, India

Investigational Site Number : 7100002; 🇿🇦 Cape Town, South Africa

Investigational Site Number : 7100003; 🇿🇦 Cape Town, South Africa

Investigational Site Number : 7100006; 🇿🇦 George, South Africa

Investigational Site Number : 7100005; 🇿🇦 Johannesburg, South Africa

Investigational Site Number : 7100001; 🇿🇦 Middelburg, South Africa