Assessing Immunogenicity of Intramuscular Sabin Inactivated Poliovirus Vaccine and Non-inferiority of Intradermal Fractional Inactivated Poliovirus Vaccine
Poliomyelitis
About this trial
This is an interventional prevention trial for Poliomyelitis focused on measuring Sabin Inactivated Poliovirus Vaccine, poliovirus vaccines, immunization, antibodies
Eligibility Criteria
Inclusion Criteria:
- Healthy infants 6 weeks of age (range: 42-48 days).
- Parents that consent for participation in the full length of the study (i.e., 34 weeks).
- Parents that are able to understand and comply with planned study procedures.
Exclusion Criteria:
- A diagnosis or suspicion of immunodeficiency disorder either in the infant or in an immediate family member.
- A diagnosis or suspicion of bleeding disorder that would contraindicate parenteral administration of sIPV or collection of blood by venepuncture.
- Acute diarrhoea, infection or illness at the time of enrollment (6 weeks of age) that would require infant's admission to a hospital.
- Acute vomiting and intolerance to liquids within 24 hours before the enrollment visit (6 weeks of age).
- Evidence of a chronic medical condition identified by a study medical officer during physical exam.
- Receipt of any polio vaccine (OPV or IPV) before enrollment based upon documentation or parental recall.
- Known allergy/sensitivity or reaction to polio vaccine, or its contents.
- Infants from multiple births. Infants from multiple births will be excluded because the infant(s) who is/are not enrolled would likely receive OPV through routine immunization and transmit vaccine poliovirus to the enrolled infant.
- Infants from premature births (<37 weeks of gestation).
Sites / Locations
- Icddr,B Study Clinics
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Active Comparator
Active Comparator
Active Comparator
IMBCAMS Sabin IPV full dose at 14 weeks and 9 months
IMBCAMS Sabin IPV fractional dose at 14 weeks and 9 months
BIBP Sabin IPV full dose at 14 weeks and 9 months
BIBP Sabin IPV fractional dose at 14 weeks and 9 months
Participants will receive two full doses of Sabin IPV intramuscularly at 14 weeks and 9 months produced by Institute of Medical Biology Chinese Academy of Medical Sciences, Kunming (IMBCAMS).
Participants will receive two fractional (1/5) doses of Sabin IPV intradermally at 14 weeks and 9 months produced by Institute of Medical Biology Chinese Academy of Medical Sciences, Kunming (IMBCAMS).
Participants will receive two full doses of Sabin IPV intramuscularly at 14 weeks and 9 months produced by Beijing Bio Institute Biological Products (BIBP).
Participants will receive two fractional (1/5) doses of Sabin IPV intradermally at 14 weeks and 9 months produced by Beijing Bio Institute Biological Products (BIBP).