Poliomyelitis Clinical Trial
Official title:
Immunogenicity and Safety of Different Sequential Schedules of Inactivated Poliomyelitis Vaccine (IMOVAX Polio®) Followed by Oral Poliomyelitis Vaccine in Healthy Infants in China Versus Oral Poliomyelitis Vaccine Alone.
The purpose of this study is to generate data to support the registration extension of
IMOVAX Polio to be used in a sequential vaccination.
Primary objective:
- To demonstrate the non-inferiority of Inactivated Poliomyelitis Vaccine (IPV)-(Oral
Poliomyelitis Vaccine) (OPV)-OPV (Sequential 1) and IPV-IPV-OPV (sequential 2)
poliovirus vaccine administrations versus OPV-OPV-OPV (Reference) in terms of
seroprotection rate 28 to 42 days after the third dose of the primary vaccination
series.
Secondary objectives:
- To evaluate the safety profile of the investigational vaccines after each
administration in each group.
- To describe the humoral immune response to poliovirus serotypes (types 1, 2 and 3)
before the first dose and 28 to 42 days after the third primary series dose of vaccine
in each group.
- To describe the persistence of antibodies against poliovirus serotypes (types 1, 2 and
3) after the third primary series dose administration, at 18 months of age in each
group.
Study participants will be randomized to receive either 3 doses of a commercially available
Oral Poliovirus Vaccine (OPV), or 1 dose of Sanofi Pasteur's injectable Inactivated
Poliovirus Vaccine IMOVAX Polio (IPV) followed by 2 doses of OPV, or 2 doses of IPV followed
by 1 dose of OPV.
These vaccines will be administered at 2, 3 and 4 months of age as primary vaccination for
the prevention of poliomyelitis. Participants will be followed up through their 18th- to
19th-month birthday.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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