Trials / Completed
CompletedNCT04429295
Study of DTwP-HepB-Hib-IPV (SHAN6™) Vaccine Administered Concomitantly With Routine Pediatric Vaccines to Healthy Infants and Toddlers in Thailand
Immunogenicity and Safety of a DTwP-HepB-Hib-IPV (Shan6™) Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in Thailand
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 460 (actual)
- Sponsor
- Sanofi Pasteur, a Sanofi Company · Industry
- Sex
- All
- Age
- 8 Weeks – 11 Weeks
- Healthy volunteers
- Accepted
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
Detailed description
The duration of each participant's active participation in the study will be approximately 14-17 months (416-506 days) in addition to the 2 MedDRA terms: Polio immunisation 10054175 Hepatitis B immunisation 10054181 Haemophilus influenzae type B immunisation 10069533 Tetanus immunisation 10054131 Rotavirus immunisation 10076886 Pneumococcal immunisation 10069578
Conditions
- Pertussis Immunisation
- Diphtheria Immunisation
- Polio Immunisation
- Hepatitis B Immunisation
- Haemophilus Influenzae Type B Immunisation
- Tetanus Immunisation
- Rotavirus Immunisation
- Pneumococcal Immunisation
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | DTwP-HepB-Hib-IPV hexavalent vaccine (Diphtheria toxoid, Tetanus toxoid, whole cell pertussis, Hepatitis B surface antigen (HBsAg), Haemophilus influenzae type b, inactivated poliovirus) | Pharmaceutical form:Suspension for injection Route of administration: Intramuscular |
| BIOLOGICAL | DTwP-HepB-Hib pentavalent vaccine (Diphtheria toxoid, Tetanus toxoid, whole cell pertussis, Hepatitis B surface antigen (HBsAg), Haemophilus influenzae type b) | Pharmaceutical form:Suspension for injection Route of administration: Intramuscular |
| BIOLOGICAL | Inactivated Poliomyelitis Vaccine | Pharmaceutical form:Suspension for injection Route of administration: Intramuscular |
| BIOLOGICAL | Poliomyelitis Vaccine bivalent types 1 and 3 | Pharmaceutical form:Oral suspension Route of administration: Oral |
| BIOLOGICAL | Human Rotavirus, live attenuated | Pharmaceutical form:Oral suspension Route of administration: Oral |
| BIOLOGICAL | Pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed) | Pharmaceutical form:Suspension for injection Route of administration: Intramuscular |
Timeline
- Start date
- 2020-06-28
- Primary completion
- 2021-02-26
- Completion
- 2021-11-20
- First posted
- 2020-06-12
- Last updated
- 2025-09-22
Locations
3 sites across 1 country: Thailand
Source: ClinicalTrials.gov record NCT04429295. Inclusion in this directory is not an endorsement.