A prospective, multi-national, multi-center, double-blind, randomized, active controlled, parallel-group, seamless Phase II/III clinical study to evaluate the safety and immunogenicity of LBVC (Sabin Poliomyelitis Vaccine (Inactivated)) compared with Imovax Polio (Poliomyelitis Vaccine (Inactivated)) in healthy infants.
- Conditions
- Active immunization in infants against poliomyelitis caused by poliovirus.
- Registration Number
- TCTR20161210001
- Lead Sponsor
- G Life Sciences Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 336
1.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
2.Born at full term of pregnancy (Gestational age ≥37 weeks)
3.Body weight ≥ 3.2 kg at the time of screening
4.Born to HIV negative mother
5.The parents or Legally Acceptable Representative (LAR) able to understand and comply with planned study procedures
6.Signed informed consent by subject’s parents or Legally Acceptable Representative (LAR)
1.Previously received any polio vaccines (OPV or IPV)
2.History of previous or concurrent vaccinations other than BCG, DTP, Hib, Rotavirus vaccine and PCV
3.History of bleeding disorder contraindicating intramuscular injection.
4.Experienced fever ≥ 38 °C/ 100.4 °F within the past 3 days prior to the screening
5.Receipt of immunoglobulin or blood-derived product since birth
6.History of allergic reactions to any vaccine components, including excipients and preservatives (neomycin, streptomycin and polymyxin B, etc.)
7.Known or suspected immune disorder, or received immunosuppressive therapy
8.History of poliomyelitis
9.History of any neurological disorders or seizures
10.Known or suspected febrile, acute or progressive illness
11.Household contact and/or intimate exposure in the previous 30 days to an individual with poliomyelitis
12.Participation in another interventional trial within 30 days before to the enrollment or simultaneous participation in another clinical study
13.Infants whose families are planning to leave the area of the study site before the end of the study period
14.Infants who is considered unsuitable for the clinical study by the investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Study vaccine is not inferior to the standard vaccine 3rd vaccination seroconversion
- Secondary Outcome Measures
Name Time Method Safety of the study vaccine is not inferior to the standard vaccine Whole study period Adverse event