Polio vaccine safety test in healthy adults (rPV vs IPOL)
Official title: A Phase 1, Double-blinded, Randomised, Active Controlled, Clinical Trial to Assess the Reactogenicity, Safety and Immunogenicity of a Recombinant Poliomyelitis Vaccine (rPV) in Comparison With IPOL Vaccine in Healthy Adults
Run by Serum Institute of India Pvt. Ltd. · NCT07688369 · Data updated 2026-11-12
A small, early-stage study will test a new recombinant polio vaccine (rPV) in healthy adults 18–60 and compare it to the standard IPOL vaccine to see if it is safe.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Enrollment | 36 (estimated) |
| Sponsor | Serum Institute of India Pvt. Ltd. Industry-sponsored |
| Locations | 1 site (East Melbourne, Victoria) |
| Status | Recruiting |
| Started | September 11, 2026 |
| Main results expected | November 2026 |
| Study ends | March 2027 |
| Registry record updated | September 29, 2026 |
| Trial ID | NCT07688369 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Healthy adults aged 18–60 without a history of polio who meet all eligibility criteria.
✕Probably not a fit
Individuals with recent polio vaccination, pregnancy, BMI above 35, or significant health issues may not benefit and could be excluded.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a Phase 1, double-blind, randomized, active-controlled study at one site in Australia. Up to 36 healthy adults will receive a single intramuscular dose of either the investigational rPV or the IPOL vaccine in a 2:1 ratio. Participants will be monitored for 30 days to assess safety, tolerability, and any adverse reactions. The trial will exclude individuals with prior polio vaccination within 30 days or other major health issues.
Why it matters
Potential benefit: If successful, the study could support the safety profile of the new recombinant polio vaccine for further development.
How similar studies have gone: Similar early-phase vaccine trials often establish safety profiles; this study is evaluating a novel recombinant polio vaccine against an established control.
Who can join: the full rules
Show full inclusion / exclusion criteria
Key Inclusion Criteria: * Healthy Volunteers aged between 18 to 60 years inclusive. * Good physical and mental health based on medical history, physical examination, clinical laboratory,electrocardiogram (ECG), and vital signs, as judged by the Investigator. * Participants must refrain from strenuous exercise within 96 hours (4 days) prior to Screening, Day 1, Day 8,and Day 30.. * Willing and able to comply with restrictions of nicotine (i.e., tobacco and nicotine products) usethroughout the study is not permitted from within 48 hours (2 days) prior to Screening, from Day 1 until Day8, and within 48 hours (2 days) prior to the end of study visit. * Participants must agree to use highly effective contraception from Day 1 until 90 days after the last studyvisit. Key Exclusion Criteria: * History of Polio * Any vaccination received 30 days before Screening and Day 30 * Pregnant or lactating females * BMI \>35.0kg/m2 * History of alcohol abuse or drug addiction * Have received any polio vaccines within 6 months prior to screening. * History of major surgeries * History of receipt of a blood transfusion, other blood products, or immunoglobulins in 3 months prior tostudy vaccination * any confirmed or suspected congenital or acquired immunosuppressive or immunodeficient condition.
Where it's running
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Doherty Clinical Trials Limited
East Melbourne, Victoria, Australia Recruiting
Study contacts
- Study coordinator: Dr Hitt Sharma, MBBS MBA
- Email: drhjs@seruminstitute.com
- Phone: +91-9822418354
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.