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A Phase IV, Non-Inferiority, Observer Blind, Randomized Clinical Study Comparing Safety And Immunogenicity Of DTP-HB-Hib Vaccination by Disposable-Syringe Jet Injector To Vaccination By Needle And Syringe In Healthy Infants In India
This is a study planned to determine and compare immunogenicity and reactogenicity of DTP-HB-Hib vaccine of SIIL delivered either with disposable-Syringe Jet Injector (DSJI) or disposable-syringe needle in total 340 Indian infants aged 6 to 8 weeks at the time of enrollment. It will provide information to aid managers, device regulatory control officials, immunization programs, and clinicians who make decisions on safe clinical practice standards.
Details
| Lead sponsor | Serum Institute of India Pvt. Ltd. |
|---|---|
| Phase | Phase 4 |
| Status | TERMINATED |
| Enrolment | 211 |
| Start date | 2015-01 |
| Completion | 2016-03 |
Conditions
- Immune Response to DTP-HB-Hib Vaccine
Interventions
- DTP-HB-Hib vaccine
- Disposable Syringe Jet Injector (DSJI)
- Needle & Syringe
Primary outcomes
- Percentage of seroprotection and geometric mean titers (GMT) for diphtheria, tetanus, hepatitis-B, H. Influenzae and percentage sero-positivity and GMT for B. Pertussis — one month after administration of third dose of the vaccine
Countries
India