Study of a Pneumococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Toddlers and Infants
Condition: Pneumococcal Immunisation; Diphtheria Immunisation; Tetanus Immunisation; Pertussis Immunisation; Hepatitis B Immunisation; Haemophilus Influenzae Type b Immunisation; Polio Immunisation; Measles Immunisation; Rubella Immunisation; Varicella Immunisation; Mumps Immunisation
MeSH terms: Hepatitis B; Diphtheria; Rubella
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary objectives:

        -  To assess the safety profile of each SP0202 formulation and Prevnar 13 in toddlers and
           infants (after each and any injection).

        -  To assess the immune response (serotype specific IgG concentration) of the SP0202
           formulations and Prevnar 13 1 month after the administration of one dose in toddlers
           (Groups 1-4)

        -  To assess the immune response (serotype specific IgG concentration) of the SP0202
           formulations and Prevnar 13 1 month after the administration of 3 doses in infants
           (Groups 5-8)

        -  To assess the immune response (serotype specific IgG concentration) of the SP0202
           formulations and Prevnar 13 1 month after administration of a 4-dose schedule in infants
           (Groups 5-8)

      Secondary objectives:

        -  To assess the immune response (serotype specific OPA titer) of the SP0202 formulations
           and Prevnar 13 1 month after the administration of one dose in toddlers (Groups 1-4)

        -  To assess the immune response (serotype specific OPA titer) of the SP0202 formulations
           and Prevnar 13 1 month after the administration of 3 doses in a subset of infants
           (Groups 5-8)

        -  To assess the immune response (serotype specific OPA titer) of the SP0202 formulations
           and Prevnar 13 1 month after administration of a 4-dose schedule in a subset of infants
           (Groups 5-8)

        -  In toddlers: to describe the Ab responses against Pentacel antigens before and 1 month
           following injection of Pentacel

        -  In infants: to describe the Ab responses against antigens of the routine pediatric
           vaccines (Pentacel, RotaTeq, ENGERIX-B, M-M-RII, and VARIVAX) when administered
           concomitantly with either SP0202 or Prevnar 13 (at pre-Dose 1 (as applicable) for
           RotaTeq, Diphteria, Tetanus and Pertussis antigens; at PD3 for ENGERIX-B, RotaTeq, and
           Pentacel; at PD4 for M-M-RII and VARIVAX])
    

Detailed description: 
      For toddlers, the duration of each participant's participation in the study will be
      approximately 6 months for subjects enrolled in Groups 1, 2, 3, and 4.

      For infants, the duration of each participant's participation in the study will be
      approximately 16 to 19 months for subjects enrolled in Groups 5, 6, 7, and 8.
    

Intervention name(s): Pneumococcal Conjugate Vaccine formulation 1; Pneumococcal Conjugate Vaccine formulation 2; Pneumococcal Conjugate Vaccine formulation 3; Varicella Virus Vaccine Live; Measles, Mumps, and Rubella Virus Vaccine Live; Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]; Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate); Rotavirus Vaccine, Live, Oral, Pentavalent; Hepatitis B Vaccine* [Recombinant] *as applicable
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): Pharmaceutical form:liquid Route of administration: intramuscular; Pharmaceutical form:liquid Route of administration: intramuscular; Pharmaceutical form:liquid Route of administration: intramuscular; Pharmaceutical form:liquid Route of administration: subcutaneous; Pharmaceutical form:liquid Route of administration: subcutaneous; Pharmaceutical form:liquid Route of administration: intramuscular; Pharmaceutical form:liquid Route of administration: intramuscular; Pharmaceutical form:liquid Route of administration: oral; Pharmaceutical form:liquid Route of administration: intramuscular
Other intervention name(s): SP0202-IIb; SP0202-VI; SP0202-VII; Varicella vaccine, VARIVAX®; MMR vaccine, M-M-R ®II; Prevnar 13®; DTaP-IPV// Hib vaccine, Pentacel®; Rotavirus vaccine, RotaTeq; Hepatitis B vaccine, ENGERIX-B®
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention