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
Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in India and the Republic of South Africa
2 other identifiers
interventional
1,528
2 countries
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2023
Typical duration for phase_3
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 20, 2023
CompletedStudy Start
First participant enrolled
March 27, 2023
CompletedFirst Posted
Study publicly available on registry
April 3, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 15, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 15, 2025
CompletedJanuary 21, 2026
January 1, 2026
2.6 years
March 20, 2023
January 16, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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
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
30 days after the second vaccination
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
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
30 days after the booster vaccination
Secondary Outcomes (22)
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
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
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
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
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
- +17 more secondary outcomes
Study Arms (8)
Groups 1a, 1b and 1c Cohort Ia (India)
EXPERIMENTAL2 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)
ACTIVE COMPARATOR2 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)
EXPERIMENTAL2 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)
ACTIVE COMPARATOR2 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)
EXPERIMENTAL3 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)
OTHERroutine pediatric vaccines only
Group 7 Cohort IIb (RSA)
EXPERIMENTAL3 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)
OTHERroutine pediatric vaccines only
Interventions
Liquid solution - intramuscular
Liquid solution - intramuscular
Oral suspension - oral
Suspension for injection - intramuscular
Lyophilized powder for injection - subcutaneous
Suspension - intramuscular
Liquid solution - intramuscular
Lyophilized powder for injection - subcutaneous
Oral solution - oral
Suspension for injection - intramuscular
Freeze-dried powder for reconstitution and injection - subcutaneous
Sterile powder and diluent for injection - subcutaneous
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Investigational Site Number : 3560006
Chennai, 603203, India
Investigational Site Number : 3560007
Hyderabad, 500018, India
Investigational Site Number : 3560016
Kanpur, 208002, India
Investigational Site Number : 3560009
Kolkata, 700017, India
Investigational Site Number : 3560011
Manipal, 576104, India
Investigational Site Number : 3560013
Mysore, 570001, India
Investigational Site Number : 3560004
Mysore, 570004, India
Investigational Site Number : 3560003
New Delhi, 110002, India
Investigational Site Number : 3560002
Pune, 411011, India
Investigational Site Number : 3560001
Pune, 411043, India
Investigational Site Number : 7100002
Cape Town, 7505, South Africa
Investigational Site Number : 7100003
Cape Town, 7937, South Africa
Investigational Site Number : 7100006
George, 6530, South Africa
Investigational Site Number : 7100005
Johannesburg, 2013, South Africa
Investigational Site Number : 7100001
Middelburg, 1055, South Africa
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Sciences & Operations
Sanofi Pasteur, a Sanofi Company
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 20, 2023
First Posted
April 3, 2023
Study Start
March 27, 2023
Primary Completion
November 15, 2025
Study Completion
November 15, 2025
Last Updated
January 21, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org