drugset / Trial / NCT05460377
Assessing Immunogenicity of Intramuscular Sabin Inactivated Poliovirus Vaccine and Non-inferiority of Intradermal Fractional Inactivated Poliovirus Vaccine
Phase 4
Completed
1224 enrolled
Centers for Disease Control and Prevention
Centers for Disease Control and Prevention, China · collabInternational Centre for Diarrhoeal Disease Research, Bangladesh · collabWorld Health Organization · collab
RandomizedParallel-groupOpen-labelPrevention
Summary
This is an open label and off label, phase IV, randomized clinical trial that will compare the immune response among infants that receive either two full doses of Sabin IPV intramuscularly or two fractional (1/5) dose of Sabin IPV intradermally at 14 weeks and 9 months of age from two different manufacturers.
Timeline
- Start
- 2022-07-26
- Primary completion
- 2023-07-22
- Completion
- 2024-12-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Sabin Inactivated Poliovirus Vaccine | Vaccine | — | Intramuscular |
| Comparator | Sabin Inactivated Poliovirus Vaccine | Vaccine | — | Intrathecal |