drugset / Trial / NCT04636827
Evaluation of Safety and Immunogenicity of Combined Immunization of sIPV, DTaP and HepA
Phase 4
Unknown
600 enrolled
China National Biotec Group Company Limited
Beijing Institute of Biological Products Co Ltd. · collabHubei Provincial Center for Disease Control and Prevention · collabShaanxi Provincial Center for Disease Control and Prevention · collab
RandomizedParallel-groupSingle-blindPrevention
Summary
Eligible,healthy infants who have finished the 3-dose-schedule of sIPV+DTaP combined vaccination clinical trial (NCT04053010) will be recruited and divided into 4 groups, and will receive vaccination at the age of 18-month-old as follows: 1. Group 1: sIPV + DTaP + HepA, 2. Group 2: sIPV only, 3. Group 3: DTaP only, 4. Group 4: HepA only. The immunogenicity and safety of the 4 groups will be compared and analyzed before and 30-40 days after vaccination.
Timeline
- Start
- 2020-11-11
- Primary completion
- 2021-08
- Completion
- 2021-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Diphtheria, Tetanus, Pertussis (DTaP) Vaccine | Unknown | 0.5 ml | — |
| Comparator | Diphtheria, Tetanus, Pertussis (DTaP) Vaccine | Unknown | 0.5 ml | — |
| Comparator | Diphtheria, Tetanus, Pertussis (DTaP) Vaccine | Unknown | 0.5 ml | — |
| Comparator | Diphtheria, Tetanus, Pertussis (DTaP) Vaccine | Unknown | 0.5 ml | — |
| Comparator | Live Attenuated Hepatitis A Vaccine | Unknown | 0.5 ml | — |
| Comparator | Live Attenuated Hepatitis A Vaccine | Unknown | 0.5 ml | — |
| Comparator | Live Attenuated Hepatitis A Vaccine | Unknown | 0.5 ml | — |
| Comparator | Live Attenuated Hepatitis A Vaccine | Unknown | 0.5 ml | — |
| Comparator | Sabin-strain Inactivated Polio Vaccine | Unknown | 0.5 ml | — |
| Comparator | Sabin-strain Inactivated Polio Vaccine | Unknown | 0.5 ml | — |
| Comparator | Sabin-strain Inactivated Polio Vaccine | Unknown | 0.5 ml | — |
| Comparator | Sabin-strain Inactivated Polio Vaccine | Unknown | 0.5 ml | — |
Indications
No indication recorded.