Polio ImmunityPhase 1NCT07688369
Safety and Immunogenicity of a Recombinant Poliomyelitis Vaccine (rPV) in Comparison With IPOL Vaccine in Healthy Adults
A Phase 1 study testing Recombinant Poliomyelitis Vaccine (rPV) and Inactivated Poliomyelitis Vaccine (IPOL) in people with Polio Immunity, run by Serum Institute of India Pvt. Ltd. at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Polio Immunity
- What is being tested?
- Recombinant Poliomyelitis Vaccine (rPV) and Inactivated Poliomyelitis Vaccine (IPOL)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteAustralia
- Study dates
- 11 Sep 2026to Mar 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Doherty Clinical Trials Limited
East Melbourne, Victoria, 3002
Nicola Byrne, +61 03 9970 4200, nbyrne@dohertyclinicaltrials.com
Dr Gail Cross, MBBS FRACP PhD
About this study
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
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).
Read the 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.
- Conditions
- Polio Immunity
- Being tested
- Recombinant Poliomyelitis Vaccine (rPV), Inactivated Poliomyelitis Vaccine (IPOL)
- Keywords
- recombinant, polio
- Medical subject headings
- Poliomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Poliomyelitis Vaccine (rPV)Biological
Recombinant Poliomyelitis Vaccine (VLP) is manufactured by Serum Institute of India Pvt. Ltd.
Inactivated Poliomyelitis Vaccine (IPOL)Biological
IPOL (inactivated poliovirus vaccine) is a marketed Sanofi
| Study group | Role | What they receive |
|---|---|---|
| Recombinant Poliomyelitis Vaccine (rPV) | Experimental | Not described Receives: Biological: Recombinant Poliomyelitis Vaccine (rPV) |
| Inactivated Poliomyelitis Vaccine (IPOL) | Active comparator | Not described Receives: Biological: Inactivated Poliomyelitis Vaccine (IPOL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days
Secondary outcomes (1)
Percentage of participants achieving seroprotection/seroconversion for poliovirus Types 1, 2 and 3, on Day 30.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start11 Sep 2026
- Primary completionNov 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polio ImmunityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Serum Institute of India Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr Hitt Sharma, MBBS MBA, Study director, Serum Institute of India Pvt. Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07688369
- Sponsor's protocol ID
- SII-rPV-01
- Status last verified
- Sep 2026
- First submitted
- 19 Jun 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Summary results
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07688369
- Acronym / sponsor ID
- SII-rPV-01
- Conditions
- Polio Immunity
- Keywords
- recombinant, polio
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Serum Institute of India Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Sep 2026 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 7 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recombinant Poliomyelitis Vaccine (rPV) | Experimental | Biological: Recombinant Poliomyelitis Vaccine (rPV) |
| Inactivated Poliomyelitis Vaccine (IPOL) | Active comparator | Biological: Inactivated Poliomyelitis Vaccine (IPOL) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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 (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant Poliomyelitis Vaccine (rPV)Recombinant Poliomyelitis Vaccine (VLP) is manufactured by Serum Institute of India Pvt. Ltd. | Biological | Recombinant Poliomyelitis Vaccine (rPV) |
| Inactivated Poliomyelitis Vaccine (IPOL)IPOL (inactivated poliovirus vaccine) is a marketed Sanofi | Biological | Inactivated Poliomyelitis Vaccine (IPOL) |
Primary outcome
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
1 secondary outcome
Percentage of participants achieving seroprotection/seroconversion for poliovirus Types 1, 2 and 3, on Day 30.
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: Yes. Summary results
Related trials for Polio Immunity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr Hitt Sharma, MBBS MBA study director
Serum Institute of India Pvt. Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Recombinant Poliomyelitis Vaccine (rPV) and Inactivated Poliomyelitis Vaccine (IPOL) in people with Polio Immunity, run by Serum Institute of India Pvt. Ltd. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Hitt Sharma, MBBS MBA (+91-9822418354, drhjs@seruminstitute.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.