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NCT07688369From ClinicalTrials.govRecruiting

Safety and Immunogenicity of a Recombinant Poliomyelitis Vaccine (rPV) in Comparison With IPOL Vaccine in Healthy Adults

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

  • Polio Immunity

At a glance

Phase
Phase 1
Study type
Interventional
Sponsor
Serum Institute of India Pvt. Ltd.
Enrolment target
36
Started
11 September 2026
Main results due
November 2026
Study sites
1
Registry updated
29 September 2026

Can you take part?

  • Ages 18 years to 60 years.
  • Open to any sex.
  • Healthy volunteers can take part.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility 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.

What this study is about

In the sponsor’s own words, from the registry.

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).

Study sites(1)

  • Doherty Clinical Trials Limited

    East Melbourne, Victoria, Australia

    Recruiting

Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07688369. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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Safety and Immunogenicity of a Recombinant Poliomyelitis Vaccine (rPV) in Comparison With IPOL Vaccine in Heal | Trialion