Poliomyelitis
Conditions
Brief summary
The purpose of the study is to evaluate safety and immunogenicity of inactivated poliomyelitis vaccine based on Sabin strain (LBVC) in healthy infants to select optimal dose of LBVC as well as to demonstrate the lot-to-lot consistency and non-inferiority of LBVC.
Interventions
BIOLOGICALInactivated Poliomyelitis Vaccine (Sabin strain)
Investigational IPV based on Sabin strain (LBVC). Should be injected by intramuscular three injections in the anterolateral aspect of thigh at 6, 10 and 14 weeks of age.
BIOLOGICALInactivated Poliomyelitis Vaccine (Salk strain)
Commercialized IPV based on Salk strain (Imovax Polio). Should be injected by intramuscular three injections in the anterolateral aspect of thigh at 6, 10 and 14 weeks of age.
Sponsors
LG Chem
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Weeks to 8 Weeks
Healthy volunteers
Yes
Inclusion criteria
* Healthy infants of either sex who have reached at least 42 days (6 weeks) of age and not more than 56 days (8 weeks) of age at the time of enrollment * Born at full term of pregnancy (Gestational age ≥37 weeks) * Body weight ≥ 3.2 kg at the time of screening * Born to HIV negative mother * The parents or Legally Acceptable Representative (LAR) able to understand and comply with planned study procedures * Signed informed consent by subject's parents or Legally Acceptable Representative (LAR)
Exclusion criteria
* Previously received any polio vaccines (OPV or IPV) * History of previous or concurrent vaccinations other than HepB, BCG, DTP, Hib, Rotavirus vaccine and PCV * History of bleeding disorder contraindicating intramuscular injection. * Experienced fever ≥ 38 °C/ 100.4 °F within the past 3 days prior to the screening * Receipt of immunoglobulin or blood-derived product since birth * History of allergic reactions to any vaccine components, including excipients and preservatives (neomycin, streptomycin and polymyxin B, etc.) * Known or suspected immune disorder, or received immunosuppressive therapy * History of poliomyelitis * History of any neurological disorders or seizures * Known or suspected febrile, acute or progressive illness * Household contact and/or intimate exposure in the previous 30 days to an individual with poliomyelitis * Participation in another interventional trial within 30 days before to the enrollment or simultaneous participation in another clinical study * Infants whose families are planning to leave the area of the study site before the end of the study period * Infants who is considered unsuitable for the clinical study by the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stage1: Seroconversion rate(%) | 4 weeks after 3rd vaccination | Proportion of subjects achieving seroconversion of each poliovirus serotype using microneutralization assay |
| Stage2: Seroconversion rate(%) | 4 weeks after 3rd vaccination | Proportion of subjects achieving seroconversion of each poliovirus serotype using microneutralization assay |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stage1: Seroconversion rate (%) | 4 weeks after 2nd vaccination | Proportion of subjects achieving seroconversion of each poliovirus serotype using microneutralization assay |
| Stage2: Seroprotection rate (%) | 4 weeks after 3rd vaccination | Proportion of subjects achieving seroprotection of each poliovirus serotype using microneutralization assay |
| Stage1: GMTs (Geometric Mean Titers) | 4 weeks after 2nd and 3rd vaccination | Comparison of GMTs and GMT ratios |
| Stage2: GMTs (Geometric Mean Titers) | 4 weeks after 3rd vaccination | Comparison of GMTs and GMT ratios |
Countries
Philippines, Thailand
Outcome results
None listed