CompletedPhase 3

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

India, South Africa1,528 participantsStarted 2023-03-27

Plain-language 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.

Who can participate

Age range

6 Weeks – 6 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 d…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 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

Timeframe: 30 days after the booster vaccination

Trial details

NCT IDNCT05794230

SponsorSanofi Pasteur, a Sanofi Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-11-15

View on ClinicalTrials.gov More Meningococcal Immunisation trials