Study of DTwP-HepB-Hib-IPV (SHAN6™) Vaccine Administered Concomitantly With Routine Pediatric Vaccines to Healthy Infants and Toddlers in Thailand
Summary
Primary Objective: To demonstrate the non-inferiority of the SHAN6™ vaccine to the licensed SHAN5™ given with bOPV and IPV vaccines when coadministered with PCV and ORV Secondary Objective: * To describe the immunogenicity profile of the SHAN6™ vaccine 3-dose primary infant vaccination and that of the control vaccines (SHAN5™ given with bOPV and IPV) * To describe the immune response to co-administered ORV-1 (Rotarix™) in a subset of participants from each group * To describe the immune response to co-administered PCV-13 (Prevnar 13®) in a subset of participants from each group * To describe the persistence of the antibodies against SHAN6™ antigens following a 3-dose primary series of SHAN6™ or SHAN5™ given with bOPV and IPV * To describe the immunogenicity profile of SHAN6™ 28 days after the single booster dose of SHAN6™ * To describe the safety profile of the SHAN6™ vaccine and the control vaccines (SHAN5™ given with bOPV and IPV), when administered concomitantly with routine pediatric vaccines
Timeline
- Start
- 2020-06-28
- Primary completion
- 2021-02-26
- Completion
- 2021-11-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Attenuvax | Vaccine | — | Oral |
| Comparator | DTwP-HepB-Hib pentavalent vaccine | Vaccine | — | Intramuscular |
| Subject | DTwP-HepB-Hib-IPV hexavalent vaccine | Vaccine | — | Intramuscular |
| Comparator | Inactivated Polio Vaccine | Vaccine | — | Intramuscular |
| Subject | Pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed) | Vaccine | — | Intramuscular |
| Comparator | Poliomyelitis Vaccine bivalent types 1 and 3 | Vaccine | — | Oral |