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 (MET33)

  • STATUS
    Not Recruiting
  • participants needed
    525
  • sponsor
    Sanofi Pasteur, a Sanofi Company
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Updated on 20 August 2022
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Accepts healthy volunteers

Summary

Primary Objective:

  1. To describe the vaccine seroprotection (antibody titer≥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 subjects in Mexico and RF

Description

Study duration per participant is approximately 12 months

Details
Condition Healthy Volunteers (Meningococcal Infection)
Treatment Hepatitis B vaccine, Pneumococcal 13-valent Conjugate Vaccine, Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine, Varicella Virus Vaccine, Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine, Measles, Mumps, and Rubella Virus Vaccine Live, Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine MenACYW conjugate vaccine, Diphtheria, tetanus, pertussis (acellular component), hepatitis B, poliomyelitis (inactivated), and Haemophilus influenzae type b conjugate vaccine, Diphtheria, Tetanus, Pertussis (Acellular, Component) Poliomyelitis (inactivated) Vaccine, and Haemophilus influenza type b Conjugate Vaccine, Rotavirus Vaccine, Live, Pentavalent, Japanese encephalitis vaccine (live, attenuated)
Clinical Study IdentifierNCT03630705
SponsorSanofi Pasteur, a Sanofi Company
Last Modified on20 August 2022

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