Study of a Pneumococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Toddlers and Infants
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\])
Timeline
- Start
- 2020-05-22
- Primary completion
- 2023-08-10
- Completion
- 2023-08-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) | Vaccine | — | Intramuscular |
| Subject | Hepatitis B vaccine | Vaccine | — | Intramuscular |
| Subject | Measles, Mumps, and Rubella Virus Vaccine Live | Vaccine | — | Subcutaneous |
| Comparator | Pneumococcal 13-valent Conjugate Vaccine | Vaccine | — | Intramuscular |
| Subject | Pneumococcal Conjugate Vaccine formulation 1 | Vaccine | — | Intramuscular |
| Subject | Pneumococcal Conjugate Vaccine formulation 2 | Vaccine | — | Intramuscular |
| Subject | Pneumococcal Conjugate Vaccine formulation 3 | Vaccine | — | Intramuscular |
| Subject | Rotavirus Vaccine, Live, Oral, Pentavalent | Vaccine | — | Oral |
| Subject | Varivax | Vaccine | — | Subcutaneous |