Poliomyelitis Clinical Trial
Official title:
Safety and Immunogenicity of an Inactivated Poliomyelitis Vaccine (IPOVAC) in Vietnamese Children
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.
The use of oral poliomyelitis vaccine (OPV) in Vietnam expanded immunisation program has
resulted in successful eradication of polio in Vietnam. However due to the concern of
OPV-related poliomyelitis cases occurred worldwide, WHO has recommended the countries to
gradually change to inactivated polio vaccine (IPV). In Vietnam, POLYVAC has been approved
and sponsored by the Ministry of Science and Technology to produce IPV under Japanese
technology. The vaccine consisting of 3 serotypes (Serotype 1,2 and 3) has been proven
safety in volunteer adults.
In this study, a dose escalating study with 3 different dosing regimens of the studied
vaccine (IPOVAC) 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 evaluated include 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. Seroconversion rates of neutralising antibodies for each of
vaccine serotypes are to be assessed.
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