Safety and Immunogenicity of IPOVAC in Young Children

Summary

A dose escalating study with 3 different dosing regimens of the studied vaccine (IPOVAC- POLYVAC-Vietnam) and a licensed vaccine (IMOVAC-Sanofi Pasteur- France) is conducted in Vietnamese children, aged 2 months and above to assess the safety and immunogenicity. Two hundred and forty children are enrolled and placed randomly into 4 groups (60 children/group), each of which receive 3 doses of vaccine subcutaneously, at 4 week interval. Safety issues included immediate reaction at the site of injection and systemic reaction within 30 min of administration, within 7 days after each dose, unexpected event occur within 30 days of each dose, SAE (from start of dose 1 to 30 days after dose 3), blood cell count, urea, ALT,AST. Immunogenicity outcomes include seroconversion of neutralising antibodies for each of vaccine serotypes.

Timeline

Start

2015-11

Primary completion

2016-07-25

Completion

2016-10-31

Drugs

Indications