Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers
Condition: Healthy Volunteers (Meningococcal Infection)
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to demonstrate the non-inferiority of the vaccine
      seroresponse to meningococcal serogroups A, C, Y, and W following administration of 2 doses
      of MenACYW conjugate vaccine compared to 2 doses of MENVEO® when given concomitantly with
      routine pediatric vaccines to infants and toddlers 6 to 7 months of age and 12 to 13 months
      of age.

      The secondary objectives of the study are:

        -  To demonstrate the non-inferiority of the percentage of participants with antibody
           titers to meningococcal serogroups A, C, Y, and W ≥ 1:8 following administration of 2
           doses of MenACYW conjugate vaccine compared to 2 doses of MENVEO® when given
           concomitantly with pediatric routine vaccines to infants and toddlers at 6 to 7 months
           of age and 12 to 13 months of age.

        -  To describe the antibody response against meningococcal serogroups A, C, Y, and W 30
           days after the second vaccination at 12 to 13 months of age with MenACYW conjugate
           vaccine or MENVEO®.

        -  To describe the antibody response against meningococcal serogroups A, C, Y, and W 30
           days and 6 months after the first vaccination at 6 to 7 months of age with MenACYW
           conjugate vaccine or MENVEO®.

        -  To describe the antibody response against meningococcal serogroups A, C, Y, and W 30
           days after the second vaccination at 20 to 23 months of age with MenACYW conjugate
           vaccine or Menactra®.
    

Detailed description: 
      Study duration per participant is approximately 1 year in Group 1 and Group 2, and 10 months
      in Group 3 and Group 4. This duration includes a safety follow-up contact at 6 months after
      the last vaccination.
    

Intervention name(s): Meningococcal Polysaccharide (Serogroups A,C,Y and W) Tetanus Toxoid Conjugate vaccine MenACYW conjugate vaccine; Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine; Meningococcal Polysaccharide (serogroups A,C,Y and W-135) Diphtheria Toxoid Conjugate Vaccine; Diphtheria and Tetanus Toxoids and Acellular Pertussis, inactivated Poliovirus and Haemophilus b Conjugate Vaccine; Diphtheria and Tetanus Toxoids and Acellular Pertussis, Hepatitis B and Inactivated Poliovirus Vaccine; Haemophilus b Conjugate Vaccine; Pneumococcal 13-valent Conjugate Vaccine; Rotavirus Vaccine, Live, Oral, Pentavalent; Hepatitis B Vaccine; Measles, Mumps, and Rubella Virus Vaccine Live; Varicella Virus Vaccine Live
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): Pharmaceutical form:Solution for injection Route of administration: Intramuscular, 0.5 mL; Pharmaceutical form: Solution for injection Route of administration: Intramuscular, 0.5 mL; Pharmaceutical form: Solution for injection Route of administration: Intramuscular, 0.5 mL; Pharmaceutical form:Suspension for injection Route of administration: Intramuscular, 0.5 mL; Pharmaceutical form: Suspension for injection Route of administration: Intramuscular, 0.5 mL; Pharmaceutical form:Solution for injection Route of administration: Intramuscular, 0.5 mL; Pharmaceutical form: Suspension for injection Route of administration: Intramuscular, 0.5 mL; Pharmaceutical form:Oral solution Route of administration: Oral, 2 mL; Pharmaceutical form:Suspension for injection Route of administration: Intramuscular, 0.5 mL; Pharmaceutical form: Lyophilized live virus vaccine Route of administration: Subcutaneous, 0.5 mL; Pharmaceutical form:Suspension for injection Route of administration: Subcutaneous, 0.5 mL
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention