AzTrials
AzTrials

PoliomyelitisPhase 3NCT05163561

Evaluation of Safety and Immunogenicity of Inactivated Adjuvanted Polio Vaccine in Comparison With Licensed Inactivated Poliovirus Vaccine

A Phase 3 study testing SII Inactivated Salk Polio Vaccine (Adsorbed) - Lot A, SII Inactivated Salk Polio Vaccine (Adsorbed) - Lot B and SII Inactivated Salk Polio Vaccine (Adsorbed) - Lot C in people with Poliomyelitis, run by Serum Institute of India Pvt. Ltd. at 1 site in Bangladesh.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This Phase III study has been designed to compare the SII Inactivated Salk Polio Vaccine (Adsorbed) with Sii licensed IPV by testing the vaccine in infants (three doses administered 4 weeks apart, starting at 6-8 weeks of age) in order to demonstrate the non-inferiority in the induction of specific poliovirus… Read more about this study

Who is it for?
Ages 6 to 8 weeksHealthy volunteers can take part
Conditions the study is for
Poliomyelitis
What is being tested?
SII Inactivated Salk Polio Vaccine (Adsorbed) - Lot A, SII Inactivated Salk Polio Vaccine (Adsorbed) - Lot B and SII Inactivated Salk Polio Vaccine (Adsorbed) - Lot C
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,072 participants
Where
1 siteBangladesh
Study dates
9 Jan 2022to 29 Apr 2023
Phase
Phase 3
Are there results?
None posted in the registry

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 6 to 8 weeks
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Healthy infants as established by medical history and clinical examination before entering the study
  • Age: 6-8 weeks at the time of enrolment
  • Parental ability and willingness to provide informed consent
  • Parent who intends to reside in the area with the infant during the study period

Who cannot join

  • Presence of fever on the day of enrolment [Temporary exclusion criteria].
  • Acute disease at the time of enrolment [Temporary exclusion criteria].
  • Prior receipt or intent to receive OPV/IPV/IPV containing vaccines during the study period.
  • OPV vaccination or known exposure to poliovirus (wild or vaccine derived) in household (living together) within 3-months prior to inclusion or planned during the study.
  • Presence of significant malnutrition (weight-for-height z-score < -3SD median)
  • Known or suspected impairment of immunological function based on medical history and physical examination.
Show all 10Show fewer
  • Presence of any systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrine, immunological, dermatological, neurological, cancer, or autoimmune disease) as determined by medical history and / or physical examination which would compromise the participant's health or is likely to result in nonconformance to the protocol.
  • A known sensitivity or allergy to any components of the Investigational Product.
  • Receipt of immunoglobulin therapy and / or blood products since birth or planned administration during the study period
  • Planned concurrent participation in another clinical study at any point throughout the entire study period

Trial locations and contacts

1 site in 1 country.

Bangladesh1 site

  • International Centre for Diarrhoeal Disease Research, Bangladesh (ICDDR,B)

    Dhaka, 128

Other trials in Bangladesh

About this study

Official title: A Phase III, Double Blind, Randomized, Active Controlled Study to Evaluate Safety and Immunogenicity of Inactivated Adjuvanted Polio Vaccine in Comparison With Licensed Inactivated Poliovirus Vaccine

This Phase III study has been designed to compare the SII Inactivated Salk Polio Vaccine (Adsorbed) with Sii licensed IPV by testing the vaccine in infants (three doses administered 4 weeks apart, starting at 6-8 weeks of age) in order to demonstrate the non-inferiority in the induction of specific poliovirus neutralizing antibody (PVNA) to poliovirus type 1, type 2 and type 3 by these vaccines. The study will also evaluate lot-to-lot consistency in the manufacture of SII Inactivated Salk Polio Vaccine (Adsorbed) by demonstrating equivalence in the induction of PVNA across three production lots.

Read the detailed description

The study is designed as a double-blind, randomized, active-controlled Phase III study with four groups of infants (n=268 per group) receiving either SII Inactivated Salk Polio Vaccine (Adsorbed) from the three lots or Sii licensed IPV.

Participants will be screened for eligibility with their parental consent and will be selected for the study according to inclusion and exclusion criteria. A total of 1072 participants will be enrolled.

Following vaccination, enrolled participants will remain in the clinic for at least 30 minutes for observation. During this time, they will be closely monitored for any immediate adverse events. Safety will be evaluated by active surveillance for solicited adverse events over the 4-day period after each vaccination in all participants. In addition, surveillance for unsolicited AEs and SAEs will be carried out over the period from first vaccination and 28 days after the third vaccination in all participants.

The immunogenicity will be assessed by measuring the PVNA to poliovirus type 1, type 2 and type 3 using a standardized microneutralization test in the sera samples of the participants.

Conditions
Poliomyelitis
Being tested
SII Inactivated Salk Polio Vaccine (Adsorbed) - Lot A, SII Inactivated Salk Polio Vaccine (Adsorbed) - Lot B, SII Inactivated Salk Polio Vaccine (Adsorbed) - Lot C, Sii Licensed IPV
Medical subject headings
Poliomyelitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SII Inactivated Salk Polio Vaccine (Adsorbed) - Lot ABiological

    SII Inactivated Salk Polio Vaccine (Adsorbed) produced by Serum Institute of India Pvt. Ltd., is a sterile suspension of three types of inactivated poliovirus: Type 1 (Mahoney), Type 2 (MEF-1), and Type 3 (Saukett). It is a highly purified, adjuvanted reduced antigen content of inactivated poliovirus vaccine.

  • SII Inactivated Salk Polio Vaccine (Adsorbed) - Lot BBiological

    SII Inactivated Salk Polio Vaccine (Adsorbed) produced by Serum Institute of India Pvt. Ltd., is a sterile suspension of three types of inactivated poliovirus: Type 1 (Mahoney), Type 2 (MEF-1), and Type 3 (Saukett). It is a highly purified, adjuvanted reduced antigen content of inactivated poliovirus vaccine.

  • SII Inactivated Salk Polio Vaccine (Adsorbed) - Lot CBiological

    SII Inactivated Salk Polio Vaccine (Adsorbed) produced by Serum Institute of India Pvt. Ltd., is a sterile suspension of three types of inactivated poliovirus: Type 1 (Mahoney), Type 2 (MEF-1), and Type 3 (Saukett). It is a highly purified, adjuvanted reduced antigen content of inactivated poliovirus vaccine.

  • Sii Licensed IPVBiological

    Poliomyelitis Vaccine (Inactivated), produced by Serum Institute of India Pvt. Ltd., is a sterile suspension of three types of inactivated poliovirus: Type 1 (Mahoney), Type 2 (MEF-1), and Type 3 (Saukett). Poliomyelitis Vaccine (Inactivated) is a highly purified, inactivated poliovirus vaccine.

Study groups in NCT05163561
Study groupRoleWhat they receive
SII Inactivated Salk Polio Vaccine (Adsorbed) Lot AExperimentalSII Inactivated Salk Polio Vaccine (Adsorbed) Lot A
Receives: Biological: SII Inactivated Salk Polio Vaccine (Adsorbed) - Lot A
SII Inactivated Salk Polio Vaccine (Adsorbed) Lot BExperimentalSII Inactivated Salk Polio Vaccine (Adsorbed) Lot B
Receives: Biological: SII Inactivated Salk Polio Vaccine (Adsorbed) - Lot B
SII Inactivated Salk Polio Vaccine (Adsorbed) Lot CExperimentalSII Inactivated Salk Polio Vaccine (Adsorbed) Lot C
Receives: Biological: SII Inactivated Salk Polio Vaccine (Adsorbed) - Lot C
Sii Licensed IPVActive comparatorSii Licensed IPV
Receives: Biological: Sii Licensed IPV

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of participants with type-specific seroconversion

    Percentage of participants with type-specific seroconversion* on Day 28 after the third vaccination for SII Inactivated Salk Polio Vaccine (Adsorbed) and Sii Licensed IPV

    Measured: Day 28 after third vaccination

Secondary outcomes (4)

  1. Geometric Mean Titers

    Type-specific geometric mean titers on day 28 after the third vaccination of three cGMP lots of SII Inactivated Salk Polio Vaccine (Adsorbed) and Sii Licensed IPV.

    Measured: Day 28 after third vaccination

  2. Reverse cumulative distribution curves of antibody titers

    Type-specific reverse cumulative distribution curves of antibody titers on pre-vaccination and 28 days after third vaccination of three cGMP lots of SII Inactivated Salk Polio Vaccine (Adsorbed) and Sii Licensed IPV.

    Measured: pre-vaccination and 28 days after third vaccination

  3. Percentage of participants with type-specific seroprotection

    Percentage of participants with type-specific seroprotection (titers ≥ 8) on Day 28 after the third vaccination of three cGMP lots of SII Inactivated Salk Polio Vaccine (Adsorbed) and Sii Licensed IPV.

    Measured: Day 28 after the third vaccination

  4. Percentage of participants with type-specific post-vaccination titers ≥ 4-fold above the estimated titer of maternal antibody

    Percentage of participants with type-specific post-vaccination titers ≥ 4-fold above the estimated titer of maternal antibody on day 28 after the third vaccination of three cGMP lots of SII Inactivated Salk Polio Vaccine (Adsorbed) and Sii Licensed IPV.

    Measured: Day 28 after the third vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2021
  2. Study start9 Jan 2022
  3. Primary completion29 Apr 2023
  4. Study completion29 Apr 2023

Resources

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Study participants aged 6 to 8 weeks will be enrolled and randomized into 1:1:1:1 ratio to receive either the SII inactivated Salk polio vaccine (adsorbed) from one of the three lots (Lot A or Lot B or Lot C) or the Sii licensed inactivated poliovirus vaccine (IPV).
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,072 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05163561
Sponsor's protocol ID
IPV:02
Status last verified
Oct 2023
First submitted
3 Dec 2021
Last updated
23 Oct 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kulkarni PS, Zaman K, Desai SA, Bharati S, Goswami DR, Sharmeen AT, Rana S, Haque W, Khandelwal A, Manney S, Tyagi P, Gairola S, Zade JK, Pisal SS, Dhere RM, Poonawalla CS, Lamberigts C, Parulekar V, Potey AV. Safety and immunogenicity of a reduced-dose inactivated poliovirus vaccine versus a full-dose inactivated poliovirus vaccine in infants in Bangladesh: a double-blind, non-inferiority, randomised, controlled, phase 3 trial. Lancet Infect Dis. 2025 Oct;25(10):1128-1137. doi: 10.1016/S1473-3099(25)00215-4. Epub 2025 Jun 9.

    PubMed 40505670

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SII Inactivated Salk Polio Vaccine (Adsorbed) - Lot A, SII Inactivated Salk Polio Vaccine (Adsorbed) - Lot B and SII Inactivated Salk Polio Vaccine (Adsorbed) - Lot C in people with Poliomyelitis, run by Serum Institute of India Pvt. Ltd. at 1 site in Bangladesh.

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 4 inclusion and 10 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: finished, as of the sponsor's last update on 23 Oct 2023. 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 Bangladesh. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of participants with type-specific seroconversion (time frame: Day 28 after third vaccination). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05163561, which also lists 1 linked publication.

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 23 Oct 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in