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

June 30, 2026 updated by: Serum Institute of India Pvt. Ltd.

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

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a double-blinded, randomised, active controlled, Phase 1 clinical study, to determine the safety, tolerability, and reactogenicity of Serum Institute of India Pvt Ltd (SIIPL) rPV vaccine in comparison to the commercially available inactivated poliovirus vaccine (IPOL®, Sanofi) in up to 36 healthy adults aged between 18 and 60 years. This study will be conducted at a single study site in Australia.

Participants will be randomised in a 2:1 ratio, to receive either investigational vaccine (rPV) or comparator vaccine (IPOL), respectively. The study vaccine will be administered as a single intramuscular (IM) injection into the deltoid muscle of the non-dominant upper arm. The participants will be followed for 30 days post vaccination.

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
    • Victoria
      • East Melbourne, Victoria, Australia, 3002
        • Doherty Clinical Trials Limited
        • Contact:
        • Principal Investigator:
          • Dr Gail Cross, MBBS FRACP PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Recombinant Poliomyelitis Vaccine (rPV)
Biological: Recombinant Poliomyelitis Vaccine (rPV)
Recombinant Poliomyelitis Vaccine (VLP) is manufactured by Serum Institute of India Pvt. Ltd.
Active Comparator: Inactivated Poliomyelitis Vaccine (IPOL)
Biological: Inactivated Poliomyelitis Vaccine (IPOL)
IPOL (inactivated poliovirus vaccine) is a marketed Sanofi

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The incidence, severity and relationship of solicited adverse events (AEs) during 7-day and unsolicited AEs during 30-day follow-up period after rPV and IPOL vaccination
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of participants achieving seroprotection/seroconversion for poliovirus Types 1, 2 and 3, on Day 30.
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Serum Institute of India Pvt. Ltd.

Investigators

  • Study Director: Dr Hitt Sharma, MBBS MBA, Serum Institute of India Pvt. Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

June 19, 2026

First Submitted That Met QC Criteria

June 30, 2026

First Posted (Actual)

July 7, 2026

Study Record Updates

Last Update Posted (Actual)

July 7, 2026

Last Update Submitted That Met QC Criteria

June 30, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SII-rPV-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Summary results

IPD Sharing Time Frame

12 months after completion of the study

IPD Sharing Access Criteria

Researchers who provide a methodologically sound proposal may be provided the access afterSponsor permission and if signed data-access agreements are in place.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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