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
Condition: Healthy Volunteers (Meningococcal Infection)
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      Study duration per participant was approximately 12 months.
    

Intervention name(s): Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine; Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine; Measles, Mumps, and Rubella Virus Vaccine Live; Pneumococcal 13-valent Conjugate Vaccine; Diphtheria, Tetanus, Pertussis (Acellular, Component) Poliomyelitis (inactivated) Vaccine, and Haemophilus influenza type b Conjugate Vaccine; Hepatitis B Vaccine; Rotavirus Vaccine, Live, Pentavalent; Diphtheria, tetanus, pertussis (acellular component), hepatitis B, poliomyelitis (inactivated), and Haemophilus influenzae type b conjugate vaccine
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): Pharmaceutical form: Liquid solution Route of administration : Intramuscular; Pharmaceutical form: Lyophilized powder combined with liquid component Route of administration : Intramuscular; Pharmaceutical form: Lyophilized live virus vaccine Route of administration : Subcutaneous; Pharmaceutical form: Suspension for injection Route of administration: Intramuscular; Pharmaceutical form: Powder and suspension for injection Route of administration: Intramuscular; Pharmaceutical form: Suspension for injection Route of administration: Intramuscular; Pharmaceutical form: Oral solution Route of administration: Oral; Pharmaceutical form:Suspension for injection Route of administration: Intramuscular
Other intervention name(s): Menveo®; M-M-R®II; Prevnar 13®; Pentaxim®; ENGERIX-B®; RotaTeq®; Hexacima®
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention