CompletedPhase 3

Safety and Immunogenicity of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the Russian Federation and Mexico

Mexico, Russia525 participantsStarted 2018-10-17

Plain-language summary

Primary Objective: 1. To describe the vaccine seroprotection (antibody titer greater than or equal to \[\>=\] 1:8) to the antigens (meningococcal serogroups A, C, Y, and W) present in MenACYW Conjugate vaccine or Menveo® measured by serum bactericidal assay using human complement (hSBA), for Groups 1 and 2 when administered concomitantly with routine pediatric vaccines in healthy infants and toddlers in Mexico. 2. To describe the vaccine seroprotection (antibody titer \>=1:8) to the antigens (meningococcal serogroups A, C, Y, and W) present in MenACYW Conjugate vaccine measured by hSBA, for Group 3, when administered concomitantly with routine pediatric vaccines in healthy infants and toddlers in the Russian Federation. Secondary Objective: 1. To describe hSBA vaccine seroresponse to the antigens (meningococcal serogroups A, C, Y, and W) 30 days after the last vaccination of the infant series, when administered concomitantly with routine pediatric vaccines in healthy infants and toddlers in Mexico and Russian Federation (RF). 2. To describe immunogenicity profile of routine pediatric vaccines when administered concomitantly with MenACYW Conjugate vaccine or Menveo®; or when administered alone. 3. To describe hSBA antibody responses against meningococcal serogroups A, C, Y, and W when MenACYW Conjugate vaccine and Menveo® are administered concomitantly with routine pediatric vaccines in Mexico and RF. 4. To describe antibody titers to the antigens present in MenACYW Conjugate vaccine and Menveo®, before the first vaccination and 30 days after the last vaccination of the infant series and in the second year of life, when administered concomitantly with routine pediatric vaccines in a subset of participants in Mexico and RF.

Who can participate

Age range2 Months – 12 Months

SexALL

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

Inclusion criteria: An individual must fulfill all of the following criteria in order to be eligible for trial enrollment: * Infants 2 months of age (60 to 89 days of age) on the day of the first study visit.\* * Born after a full-term pregnancy, with an estimated gestation age \>= 37 weeks and a birth weight \>= 2.5 kilograms. * Informed consent form has been signed and dated by the parent(s) or guardian(s), as required by local regulations.† * Participant and parent/guardian were able to attend all scheduled visits and to comply with all trial procedures. * In good health as determined by medical history and physical assessment. * For the Russian Federation: The participant's parents were able to verbally report or provide written documentation that the participant's mother was hepatitis B antigen negative during pregnancy with the participant. * \* "2 months" means from the 2nd month after birth to the day before the 3rd month after birth (2 months to 2 months 29 days); "60 days" means from the 60th day after birth to the day before the 90th day after birth (60 to 89 days). * † In the Russian Federation, as per local regulations, only the participant's parent(s) were entitled to sign an informed consent form. A child under the responsibility of a guardian would not be included in the study. Exclusion criteria: An individual fulfilling any of the following criteria was to be excluded from trial enrollment: * Participation at the time of study enrollment or in t…

What they're measuring

Percentage of Participants With Antibody Titers Greater Than or Equal to (>=) 1:8 Against Meningococcal Serogroups A, C, Y, and W Following Last Vaccination With MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2

Timeframe: 30 days after the last vaccination at the age of 12 months (i.e., at the age of 13 months)

Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Last Vaccination With MenACYW Conjugate Vaccine: Group 3

Timeframe: 30 days after the last vaccination at the age of 12 months (i.e., at the age of 13 months)

Trial details

NCT IDNCT03630705

SponsorSanofi Pasteur, a Sanofi Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-02-18

Results submitted2023-09-06

View on ClinicalTrials.gov More Healthy Volunteers (Meningococcal Infection) trials

Plain-language summary

Who can participate

Age range2 Months – 12 Months

SexALL

See this in plain English?

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

What they're measuring

Timeframe: 30 days after the last vaccination at the age of 12 months (i.e., at the age of 13 months)

Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Last Vaccination With MenACYW Conjugate Vaccine: Group 3

Timeframe: 30 days after the last vaccination at the age of 12 months (i.e., at the age of 13 months)