Safety and Immunogenicity of a Recombinant Poliomyelitis Vaccine (rPV) in Comparison With IPOL Vaccine in Healthy Adults
NCT07688369 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36
Last updated 2026-07-10
Summary
The primary purpose of this study is to test a new experimental recombinant Poliomyelitis vaccine (rPV) in comparison to the commercially available inactivated poliovirus vaccine. The design of the study is double-blinded, randomised and active controlled. The active controlled product is considered the commercially available vaccine (IPOL).
Conditions
- Polio Immunity
Interventions
- BIOLOGICAL
-
Recombinant Poliomyelitis Vaccine (rPV)
Recombinant Poliomyelitis Vaccine (VLP) is manufactured by Serum Institute of India Pvt. Ltd.
- BIOLOGICAL
-
Inactivated Poliomyelitis Vaccine (IPOL)
IPOL (inactivated poliovirus vaccine) is a marketed Sanofi
Sponsors & Collaborators
-
Serum Institute of India Pvt. Ltd.
lead INDUSTRY
Principal Investigators
-
Dr Hitt Sharma, MBBS MBA · Serum Institute of India Pvt. Ltd.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-07-31
- Primary Completion
- 2026-11-30
- Completion
- 2027-03-31
Countries
- Australia
Study Locations
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