WHO ICTRP trial
A first in human clinical trial to assess safety and formation of protective…
CTRI/2017/06/008759 · Clinical Trials Registry India (CTRI) · Not Recruiting
Key facts
| Trial ID | CTRI/2017/06/008759 |
|---|---|
| Public title | A first in human clinical trial to assess safety and formation of protective antibodies against pneumonia and meningitis caused by streptococcus pneumoniae bacteria with BEâ??s 14-antigen Pneumococcal conjugate vaccine in 18-45 year-old healthy male adults. |
| Scientific title | A single arm open label non-comparative Phase-I study to evaluate safety, reactogenicity and immunogenicity of single intramuscular dose of 14-valent pneumococcal polysaccharide conjugate vaccine (without preservative) of Biological E. Limited in 18-45 year-old healthy adults. - None |
| Primary sponsor | Biological E Limited |
| Registry | Clinical Trials Registry India (CTRI) |
| Recruitment status | Not Recruiting |
| Study type | Interventional |
| Phase | Phase 1 |
| Countries | India |
| Conditions | Health Condition 1: Z23- Encounter for immunization |
| Interventions | Intervention1: Pneumococcal Conjugate Vaccine (Adsorbed) (14 Valent) (Thiomersal Free)- Single Human dose -0.5mL: 1. Dose: 0.5 mL single dose 2. Frequency: One dose only 3. Route of administration: Intra-muscular injection in deltoid muscle… |
| Registration date | May 6, 2017 |
| Target size | 24 |
| Secondary IDs | BECT043/PCV-Phase-I/CTP-01 Version:1.0 dated:20.04.17 |
| 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: