Poliomyelitis
Conditions
Brief summary
The study aimed to evaluate the safety and immunogenicity of a Sabin strain-based inactivated polio vaccine in infants aged two months (60\ 89 days).
Interventions
BIOLOGICALsIPV
sIPVs were developed by Biominhai (Beijing Minhai Biotechnology Co. Ltd.)
BIOLOGICALwIPV
wIPVs were developed by Sanofi Pasteur
Sponsors
Beijing Minhai Biotechnology Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
60 Days to 89 Days
Healthy volunteers
Yes
Inclusion criteria
1. Healthy permanent residents aged 2 months (60\ 89 days); 2. Infant's legal guardians agree to sign the informed consent forms voluntarily; 3. Infant's legal guardians are able to comply with the requirements of the clinical trial protocol; 4. Armpit temperature ≤ 37.0 ℃
Exclusion criteria
1. preterm birth (gestational age \< 37 weeks); 2. the presence of congenital malformations, developmental disorders, genetic defects, or severe malnutrition; 3. had a history of poliomyelitis; 4. had a personal or family history of allergy, convulsions, epilepsy, encephalopathy, or psychiatric disorders; 5. had known hypersensitivity to any component of the study vaccine or a history of severe allergic reaction (e.g., anaphylaxis) to any previous vaccination; 6. had immunodeficiency or receipt of immunosuppressive therapy; 7. diagnosed coagulation disorders (including factor deficiencies, coagulopathies, platelet abnormalities) or evidence of significant bruising/bleeding diathesis; 8. had known or investigator-suspected concurrent acute or active chronic diseases (including respiratory, cardiovascular, hepatic, renal, or dermatological conditions) or acute infection, or maternal HIV infection; 9. occurrence of fever (axillary temperature ≥ 38.0 °C) within the 3 days preceding enrollment; 10. had acute illness requiring systemic antibiotic or antiviral treatment within the 7 days preceding enrollment; 11. administration of blood products within the 3 months preceding enrollment; 12. had receipt of any live attenuated vaccine within the 14 days preceding enrollment; 13. had receipt of any inactivated or subunit vaccine within the 7 days preceding enrollment; 14. had recent administration of any other experimental product and any other condition deemed by the investigator as potentially interfering with the assessment of trial outcomes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the seroconversion rates of poliovirus type I, type II and type III neutralizing antibodies | 30 days after the primary immunization |
Countries
China
Outcome results
None listed