Active immunization in infants against poliomyelitis caused by poliovirus. Active immunization in infants against poliomyelitis caused by poliovirus.
Conditions
Interventions
IM vaccination
Experimental Other
Study Vaccine
Sponsors
LG Life Sciences Ltd.
LG Life Sciences Ltd.
Eligibility
Sex/Gender
All
Age
42 Days to 56 Days
Inclusion criteria
Inclusion criteria: 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)
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Study vaccine is not inferior to the standard vaccine 3rd vaccination seroconversion | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety of the study vaccine is not inferior to the standard vaccine Whole study period Adverse event | — |
Countries
Thailand
Contacts
Public ContactJae Juhn
LG Life Sciences
Outcome results
None listed