WHO ICTRP trial
A clinical study to assess the safety & immune response of Hepatitis-B vaccine…
CTRI/2020/05/025012 · Clinical Trials Registry India (CTRI) · Not Recruiting
Key facts
| Trial ID | CTRI/2020/05/025012 |
|---|---|
| Public title | A clinical study to assess the safety & immune response of Hepatitis-B vaccine when given in new born within 24 hours of birth and doses at 6 and 14 weeks. |
| Scientific title | A multicentre single blind, parallel randomized phase-IV non-inferiority study to evaluate the immunogenicity and safety of Biological Eââ?¬â?¢s monovalent Hepatitis-B (rDNA) vaccine when administered first dose to neonates within 24 hours of birth followed by a dose at 6 and 14 weeks of age in… |
| Primary sponsor | Biological ELimited |
| Registry | Clinical Trials Registry India (CTRI) |
| Recruitment status | Not Recruiting |
| Study type | Interventional |
| Phase | Phase 4 |
| Countries | India |
| Conditions | Health Condition 1: Z23- Encounter for immunization |
| Interventions | Intervention1: Biological Es Hepatitis-B vaccine.: 1. Doses: Three doses, 0.5mL per single dose 2. Frequency: Day 0, Day 42 & Day 98 3. Route of administration: intramuscular injection 4. Total duration of therapy:126 days. Control… |
| Registration date | Apr 5, 2020 |
| Target size | 468 |
| Secondary IDs | BECT058/rHepB-Birth_Dose-PIV/CTP-02 Ver: 2.0 dated:11.11.19 |
| Registry page | ctri.nic.in |
At a glance
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About WHO ICTRP trial registrations
The WHO ICTRP combines trial registrations from primary registries worldwide into a single searchable index. Contact and ethics-committee details are not shown here.
Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: