drugset / Trial / NCT01047202

Sinovac, Pandemic Influenza A/H1N1 Vaccine in 6 to 35 Months Infants

NCT01047202 ↗

Phase 4 Completed 310 enrolled Sinovac Biotech Co., Ltd
RandomizedParallel-groupDouble-blindPrevention

Summary

A single center, observer-masked, randomized clinical trial is to be conducted in 6-35 months infants to evaluate the safety and immunogenicity of Sinovac's influenza A/H1N1 Vaccine (PANFLU.1).

Timeline

Start
2009-12
Primary completion
2010-03
Completion
2010-05

Drugs

EvaluationDrugModalityDoseRoute
Subject PANFLU.1 Vaccine 7.5 ug Intramuscular
Subject PANFLU.1 Vaccine 15 ug Intramuscular
Comparator Trivalent Inactivated Influenza Vaccine Vaccine 7.5 ug Intramuscular

Indications