The goal of this study is to compare the immunogenicity and safety of sIPV administered via subcutaneous and intramuscular injection routes
This is an open-labelled, randomized, controlled clinical trial. Totally 480 healthy infants of 2 months old (aged 56-84 days) are planned to be enrolled, and then randomized in a 1:1:1:1 ratio into four groups (group A, B, C, D). Group A-D will receive three doses of primary immunization against polio as per the 2wIPV+1sIPV (First 2 doses: wIPV. 3rd dose: sIPV), 1wIPV+2sIPV (1st dose: wIPV. 2nd \& 3rd doses: sIPV), 3wIPV, 3sIPV vaccination regimen, 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. For all the participants, the immediate reactions within 30 minutes after each dose of vaccination will be observed on study site. Guardians of participants will utilize the diary card to record adverse events (AEs) from the time of vaccination for 7 days after each dose of vaccination, and will utilize the diary card to record any AEs from 8 days up to 28 days after each dose of vaccination. SAEs arise from the time of vaccination up to 28 days after the last vaccination will be collected. About 3.0 ml venous blood will be collected before the first vaccination and 28 days (+14 days) after the last vaccination. Neutralizing antibody (Nab) titer against polioviruses of three serotypes will be determined for immunogenicity evaluation. Approximately 5.0 ml of venous blood will be drawn from the mothers to test for these disease infections. Alternatively, mothers may provide relevant test results obtained during pregnancy for these infections. This approach will enable the investigators to identify any potential perinatal transmission to the infant and offer appropriate guidance and management for both the mother and the child.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
480
First 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.
1st 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.
three 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.
Centennial Clindev Research and Development of Medical Sciences
Kawit, Cavite, Philippines
RECRUITINGIloilo Doctors' Hospital
Iloilo City, Philippines
RECRUITINGHealth Index Multispecialty Clinic - Research and Development on Medical Sciences
Imus, Philippines
RECRUITINGThe 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
Time frame: day 28 after three doses of vaccination
The frequency of adverse reactions within 28 days after vaccination
Time frame: day 0-28 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
Time frame: day 28 after three doses of vaccination
The GMT of nab against polioviruses of three serotypes at day 28 after three doses of vaccination
GMT indicates geometric mean titer
Time frame: day 28 after three doses of vaccination
The GMFR of nab against polioviruses of three serotypes at day 28 after three doses of vaccination
GMFR indicates geometric mean fold increase
Time frame: day 28 after three doses of vaccination
The frequency of SAEs from the first vaccination to 28 days after the last vaccination
SAE indicates serious adverse events
Time frame: From the first vaccination to 28 days after the last vaccination
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Three 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.