A Study in Healthy Adults Comparing a Recombinant Polio Vaccine (rPV) With the IPOL Vaccine to Assess Safety, Immune Response, and Vaccine Reactions.

A Phase 1, double-blinded, Randomized, 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.

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12626000806369

Enrollment

Registered

2026-07-06

Start date

2026-09-30

Completion date

2026-10-10

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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).

Interventions

Investigational vaccine : Recombinant Poliomyelitis Vaccine (rPV) Dose: 0.5mL once only Duration of treatment: Vaccine administered once only Mode of Delivery: Intramuscular injection The vaccine will be administered by the study doctor or a registered study nurse.

Study design

Allocation

Randomised controlled trial

Primary purpose

Prevention

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Healthy volunteers

Yes

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) use throughout the study is not permitted from within 48 hours (2 days) prior to Screening, from Day 1 until Day 8, 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 study visit.

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 to study vaccination - any confirmed or suspected congenital or acquired immunosuppressive or immunodeficient condition. - Positive drug and/or alcohol screen

Outcome results