This is a phase I/II randomized, double-blind, and positive-controlled study. Participants in the phase I toddler group will receive 1 dose of either high dose VLP-Polio (Dose H) or control vaccine in a ratio of 3:1. The phase I infant cohort will have 4 arms randomly assigned to receive either investigational vaccine (Low-adjuvant dose VLP-Polio, Medium dose VLP-Polio, or High dose VLP-Polio or control vaccine in a ratio of 3:1. Phase II infant cohort will have 4 arms randomly assigned to receive either investigational vaccine (Low-adjuvant dose VLP-Polio, Medium dose VLP-Polio, or High dose VLP-Polio or control vaccine in a ratio of 3:1. Each infant participant will be administrated 3 doses of the assigned vaccine with 28 days apart, and the booster dose will be given when the infant is 12-18 months old. Enrollment of Phase I and Phase II will be staggered in descending order of age group but ascending order of dosing levels. Blood and mucosal samples will be collected for immunogenicity evaluation over the time course of the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
480
4 doses of VLP-Polio vaccine (0.5ml) at 2, 3, 4 months and 12-18 months of age for infants
4 doses of VLP-Polio vaccine (0.5ml) at 2, 3, 4 months and 12-18 months of age for infants
1 dose of VLP-Polio vaccine (0.5ml) on day 0 for toddlers, 4 doses at 2, 3, 4 months and 12-18 months of age for infants
1 dose of IPV vaccine (0.5ml) on day 0 for toddlers, 4 doses at 2, 3, 4 months and 12-18 months of age for infants
Dr. Cipto Mangunkusumo Hospital
Jakarta, Indonesia
Phase I: Percentage of participants with solicited adverse events (AEs)
Time frame: Within 7 days after each vaccination
Phase II: Percentage of participants with solicited adverse events (AEs)
Time frame: Within 7 days after each vaccination
Phase II: Seroconversion rate of neutralizing antibodies against Sabin and wild-type poliovirus type 1, 2, and 3
Time frame: Day 0 before vaccination and on Day 28 after the 3rd dose vaccination
Phase I: Percentage of participants with unsolicited AEs
Time frame: Within 28 days after each vaccination
Phase I: Percentage of participants with solicited AEs
Time frame: Within 30 minutes after each vaccination
Phase I: Percentage of participants experiencing serious adverse events (SAEs)
Time frame: Through study completion, Toddlers about 6 months, Infant about 20-22 months.
Phase I: Geometric mean titer (GMT) of neutralizing antibodies against Sabin and wild-type poliovirus type 1, 2, and 3 in toddlers
Time frame: Day 0 before vaccination and on Day 28 after the vaccination
Phase I: Seroprotection rate of neutralizing antibodies against Sabin and wild-type poliovirus type 1, 2, and 3 in toddlers
Time frame: Day 0 before vaccination and on Day 28 after the vaccination
Phase I: Seroconversion rate of neutralizing antibodies against Sabin and wild-type poliovirus type 1, 2, and 3 in toddlers
Time frame: Day 0 before vaccination and on Day 28 after the vaccination
Phase I: GMT of neutralizing antibodies against Sabin and wild-type poliovirus type 1, 2, and 3 in infants
Time frame: Day 0 before vaccination and on Day 28 after the 3rd dose vaccination
Phase I: Seroprotection rate of neutralizing antibodies against Sabin and wild-type poliovirus type 1, 2, and 3 in infants
Time frame: Day 0 before vaccination and on Day 28 after the 3rd dose vaccination
Phase I: Seroconversion rate of neutralizing antibodies against Sabin and wild-type poliovirus type 1, 2, and 3 in infants
Time frame: Day 0 before vaccination and on Day 28 after the 3rd dose vaccination
Phase II: Percentage of participants with unsolicited AEs
Time frame: Within 28 days after each vaccination
Phase II: Percentage of participants with solicited AEs
Time frame: Within 30 minutes after each vaccination
Phase II: Percentage of participants experiencing SAEs
Time frame: Through study completion, Toddlers about 6 months, Infant about 20-22 months.
Phase II: GMT of neutralizing antibodies against Sabin and wild-type poliovirus type 1, 2, and 3
Time frame: Day 0 before vaccination and on Day 28 after the 3rd dose vaccination
Phase II: Seroprotection rate of neutralizing antibodies against Sabin and wild-type poliovirus type 1, 2, and 3
Time frame: Day 0 before vaccination and on Day 28 after the 3rd dose vaccination
Phase II: GMT of neutralizing antibodies against Sabin and wild-type poliovirus type 1, 2, and 3 in extended immunogenicity subgroup participants.
Time frame: Month 6 after the 3rd dose vaccination
Phase II: Seroprotection rate of neutralizing antibodies against Sabin and wild-type poliovirus type 1, 2, and 3 in extended immunogenicity subgroup participants.
Time frame: Month 6 after the 3rd dose vaccination
Phase II: Seroconversion rate of neutralizing antibodies against Sabin and wild-type poliovirus type 1, 2, and 3 in extended immunogenicity subgroup participants.
Time frame: Month 6 after the 3rd dose vaccination
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