WHO ICTRP trial
Safety, Immunogenicity & lot consistency study of DPT-HepB-Hib pentavalent…
CTRI/2012/08/002872 · Clinical Trials Registry India (CTRI) · Not Recruiting
Key facts
| Trial ID | CTRI/2012/08/002872 |
|---|---|
| Public title | Safety, Immunogenicity & lot consistency study of DPT-HepB-Hib pentavalent vaccine (Shan 5)as compared to a comparator pentavalent vaccine. |
| Scientific title | Safety, Immune Lot-to-Lot Consistency and Non-Inferiority of Shan 5 (DTwP-HepB-Hib) Vaccine in Comparison to Pentavac SD When Administered as a Single Booster Dose at 15-18 months and Three Doses at 6-8, 10-12 and 14-16 Weeks of Age in Healthy Indian Children and Infants. |
| Primary sponsor | Shantha Biotechnics Limited |
| Registry | Clinical Trials Registry India (CTRI) |
| Recruitment status | Not Recruiting |
| Study type | Interventional |
| Phase | Phase 3 |
| Countries | India |
| Interventions | Intervention1: Shan 5â?¢: DTwP-HepB-Hib pentavalent combination vaccine Dose:0.5 ml Frquency:3 dose series with 1 month gap between each dose (i.e at 6-8 week, 10-12 week and 14-16 week) and Single dose at 15-18 month Duration: Not… |
| Registration date | Sep 8, 2012 |
| Target size | 1100 |
| Secondary IDs | SH501 Version 1.0 dated 14 APRIL 2012 |
| Registry page | ctri.nic.in |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: