The goal of this study is to compare the immunogenicity and safety of sIPV administered via subcutaneous and intramuscular injection routes
Infants of 2 months old (aged 56-84 days).
Have a parent/legal guardian who has provided written informed consent after being fully informed about the study.
Be able to provide the vaccination records since birth.
The infant's mother is tested negative for HIV, syphilis, hepatitis B, and hepatitis C during or before the infant's enrollment to this study (test results obtained during pregnancy are acceptable, if provided).
History of any polio vaccination.
History of severe allergic reaction to previous vaccinations or hypersensitivity to any vaccine component.
Premature infants (born before week 37 of gestation).
History of asphyxia rescue or nervous system injury.
Parallel
2wIPV+1sIPV
Biological/VaccineFirst 2 doses: wIPV. 3rd dose: sIPV In each intervention group, two-thirds of the participants will receive the full-course vaccination via intramuscular injections, while the remaining one-third will receive it via subcutaneous injections.
1wIPV+2sIPV
Biological/Vaccine1st dose: wIPV. 2nd \& 3rd doses: sIPV In each intervention group, two-thirds of the participants will receive the full-course vaccination via intramuscular injections, while the remaining one-third will receive it via subcutaneous injections.
3wIPV
Biological/Vaccinethree doses of wIPV with an interval of 28 days (+14 days) between doses; In each intervention group, two-thirds of the participants will receive the full-course vaccination via intramuscular injections, while the remaining one-third will receive it via subcutaneous injections.
3sIPV
Biological/VaccineThree doses of sIPV with an interval of 28 days (+14 days) between doses. In each intervention group, two-thirds of the participants will receive the full-course vaccination via intramuscular injections, while the remaining one-third will receive it via subcutaneous injections.
The SPR of nab against polioviruses of three types at day 28 after three doses of vaccination
SPR indicates seropositivity rate; seropositivity is defined as a nab titer ≥1:8
The frequency of adverse reactions within 28 days after vaccination
The SCR of nab against polioviruses of three serotypes at day 28 after three doses of vaccination
SCR indicates seroconversion rat；nab indicates neutralizing antibody; seroconversion is defined as a fold increase in nab titer after vaccination for participants who are seropositive (≥1:8) at baseline, or a post-vaccination nab titer ≥1:8 for participants who are seronegative (\<1:8) at baseline
The GMT of nab against polioviruses of three serotypes at day 28 after three doses of vaccination
GMT indicates geometric mean titer
The GMFR of nab against polioviruses of three serotypes at day 28 after three doses of vaccination
GMFR indicates geometric mean fold increase
The frequency of SAEs from the first vaccination to 28 days after the last vaccination
SAE indicates serious adverse events
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Sinovac Biotech Co., Ltd
Lead sponsor
Aga Khan University
Collaborator
