WHO ICTRP trial

Quimi-Hib® and Quimi-Hib(AlPO4) vaccines in an accelerated 6-10-14 weeks primary…

RPCEC00000135 · Registro Público Cubano de Ensayos Clínicos (RPCEC) · Not Recruiting

Key facts

Trial ID RPCEC00000135
Public title Quimi-Hib® and Quimi-Hib(AlPO4) vaccines in an accelerated 6-10-14 weeks primary vaccination series
Scientific title “Immunogenicity, tolerance and reactogenicity of Quimi-Hib and alum phospate adjuvanted Quimi-Hib vaccines in healthy infants according to 6 – 10 – 14 weeks primary vaccination series. A multicenter, controlled, randomized, doubled blind clinical trial.”
Primary sponsor Center for Genetic Engineering and Biotechnology
Secondary sponsors Ministry of Public Health, CUBA
Registry Registro Público Cubano de Ensayos Clínicos (RPCEC)
Recruitment status Not Recruiting
Study type Interventional
Phase 2
Countries Cuba
Conditions Haemophilus influenzae type b infection prophylaxis
Interventions Group I (Experimental): alum phosphate adjuvanted Quimi-Hib, 10µg, intramuscular route, 6-10-14 weeks schedule Group II (Control): Quimi-Hib, 10µg, intramuscular route, 6-10-14 weeks schedule
Registration date Dec 9, 2012
Target size 208
Secondary IDs IG/QHI/SE/1001
Registry page rpcec.sld.cu

At a glance

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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date:

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