Poliomyelitis
Conditions
Keywords
Vaccine, Trivalent, Immunogenicity, Safety, 12-18 months toddlers, 2 months infants
Brief summary
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.
Interventions
BIOLOGICALRecombinant Trivalent Poliomyelitis Vaccine (Sf-RVN Cell) (VLP-Polio) low adjuvant dose
4 doses of VLP-Polio vaccine (0.5ml) at 2, 3, 4 months and 12-18 months of age for infants
BIOLOGICALVLP-Polio medium dose
4 doses of VLP-Polio vaccine (0.5ml) at 2, 3, 4 months and 12-18 months of age for infants
BIOLOGICALVLP-Polio high dose
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
BIOLOGICALVaccine Poliomyelitis Inactivated (IPV)
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
Sponsors
CanSino Biologics Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Weeks to 18 Months
Healthy volunteers
Yes
Inclusion criteria
* Healthy toddlers aged 12-18 months at the time of screening, and have completed primary immunization of polio vaccine according to the national government program in the first year of life. * Healthy infants aged 6 weeks to 2 months (42 to 98 days, with the day of birth considered day of life 1), and who have not received any polio vaccines. * Able to obtain written informed consent from parent(s) or legal guardian(s). * Participants and their parents or legal guardian(s) can comply with trial procedures, are available for the duration of follow-up, and have a suitable telephone contact available.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I: Percentage of participants with solicited adverse events (AEs) | Within 7 days after each vaccination |
| Phase II: Percentage of participants with solicited adverse events (AEs) | Within 7 days after each vaccination |
| Phase II: Seroconversion rate of neutralizing antibodies against Sabin and wild-type poliovirus type 1, 2, and 3 | Day 0 before vaccination and on Day 28 after the 3rd dose vaccination |
Secondary
| Measure | Time frame |
|---|---|
| Phase I: Percentage of participants with unsolicited AEs | Within 28 days after each vaccination |
| Phase I: Percentage of participants with solicited AEs | Within 30 minutes after each vaccination |
| Phase I: Percentage of participants experiencing serious adverse events (SAEs) | 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 | 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 | 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 | 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 | 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 | 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 | Day 0 before vaccination and on Day 28 after the 3rd dose vaccination |
| Phase II: Percentage of participants with unsolicited AEs | Within 28 days after each vaccination |
| Phase II: Percentage of participants with solicited AEs | Within 30 minutes after each vaccination |
| Phase II: Percentage of participants experiencing SAEs | 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 | 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 | 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. | 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. | 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. | Month 6 after the 3rd dose vaccination |
Countries
Indonesia
Contacts
PRINCIPAL_INVESTIGATORNina Putri, Dr
Dr. Cipto Mangunkusumo Hospital
Outcome results
None listed