This is a randomized, observer-blind, positive-controlled study. There will be 3 treatment groups, in each treatment group, participants will be randomly assigned to receive either investigational vaccine (Low-adjuvant dose VLP-Polio, Medium dose VLP-Polio, or High dose VLP-Polio that are defined as Dose A, Dose M, and Dose H, respectively) or control vaccine in a ratio of 3:1 in each group. Distribution of participant's gender should be balanced in each group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
72
1 dose of VLP-Polio vaccine (0.5ml) on Visit 1
1 dose of IPOL vaccine (0.5ml) on Visit 1
1 dose of VLP-Polio vaccine (0.5ml) on Visit 1
Nucleus Network Pty Ltd
Geelong, Victoria, Australia
Nucleus Network Pty Ltd
Melbourne, Victoria, Australia
Occurrence of solicited adverse reactions (AEs) within 7 days post vaccination.
Time frame: Within 7 days post vaccination
Occurrence of unsolicited AEs within 28 days post-vaccination.
Time frame: Within 28 days post-vaccination
Occurrence of solicited AEs within 30 mins post-vaccination.
Time frame: Within 30 mins post-vaccination
Occurrence of abnormal safety laboratory parameters on Day 3, Day 8.
Time frame: Day 3, Day 8 post-vaccination
Occurrence of serious adverse events (SAEs) during the study period.
Time frame: Through study completion, an average of 6 months
Geometric mean titer (GMT) of neutralizing antibodies against poliovirus type 1, 2, and 3 on Day 1 before vaccination and Day 29 and Day 180 after the vaccination.
Time frame: Day 1 before vaccination and Day 29 and Day 180 after the vaccination
Geometric mean fold increase (GMI) of neutralizing antibodies against poliovirus type 1, 2, and 3 on Day 1 before vaccination and Day 29 and Day 180 after the vaccination.
Time frame: Day 1 before vaccination and Day 29 and Day 180 after the vaccination
Seroconversion rate of neutralizing antibodies against poliovirus type 1, 2, and 3 on Day 1 before vaccination and Day 29 and Day 180 after the vaccination.
Time frame: Day 1 before vaccination and Day 29 and Day 180 after the vaccination
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1 dose of IPOL vaccine (0.5ml) on Visit 1
1 dose of VLP-Polio vaccine (0.5ml) on Visit 1
1 dose of IPOL vaccine (0.5ml) on Visit 1