PoliomyelitisPhase 4NCT05460377
Assessing Immunogenicity of Intramuscular Sabin Inactivated Poliovirus Vaccine and Non-inferiority of Intradermal Fractional Inactivated Poliovirus Vaccine
A Phase 4 study testing Full dose Sabin Inactivated Poliovirus Vaccine produced by IMBCAMS, Fractional (1/5) Dose Sabin Inactivated Poliovirus Vaccine produced by IMBCAMS and Full dose Sabin Inactivated Poliovirus Vaccine produced by BIBP in people with Poliomyelitis, run by Centers for Disease Control and Prevention at 1 site in Bangladesh.
Trial summary
This is an open label and off label, phase IV, randomized clinical trial that will compare the immune response among infants that receive either two full doses of Sabin IPV intramuscularly or two fractional (1/5) dose of Sabin IPV intradermally at 14 weeks and 9 months of age from two different manufacturers. Read more about this study
- Who is it for?
- Ages 42 to 48 daysHealthy volunteers can take part
- Conditions the study is for
- Poliomyelitis
- What is being tested?
- Full dose Sabin Inactivated Poliovirus Vaccine produced by IMBCAMS, Fractional (1/5) Dose Sabin Inactivated Poliovirus Vaccine produced by IMBCAMS and Full dose Sabin Inactivated Poliovirus Vaccine produced by BIBP
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,224 participants
- Where
- 1 siteBangladesh
- Study dates
- 26 Jul 2022to 1 Dec 2024
- Phase
- Phase 4
- 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 42 to 48 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy infants 6 weeks of age (range: 42-48 days).
- Parents that consent for participation in the full length of the study (i.e., 34 weeks).
- Parents that are able to understand and comply with planned study procedures.
Who cannot join
- A diagnosis or suspicion of immunodeficiency disorder either in the infant or in an immediate family member.
- A diagnosis or suspicion of bleeding disorder that would contraindicate parenteral administration of sIPV or collection of blood by venepuncture.
- Acute diarrhoea, infection or illness at the time of enrollment (6 weeks of age) that would require infant's admission to a hospital.
- Acute vomiting and intolerance to liquids within 24 hours before the enrollment visit (6 weeks of age).
- Evidence of a chronic medical condition identified by a study medical officer during physical exam.
- Receipt of any polio vaccine (OPV or IPV) before enrollment based upon documentation or parental recall.
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- Known allergy/sensitivity or reaction to polio vaccine, or its contents.
- Infants from multiple births. Infants from multiple births will be excluded because the infant(s) who is/are not enrolled would likely receive OPV through routine immunization and transmit vaccine poliovirus to the enrolled infant.
- Infants from premature births (<37 weeks of gestation).
Trial locations and contacts
1 site in 1 country.
About this study
This is an open label and off label, phase IV, randomized clinical trial that will compare the immune response among infants that receive either two full doses of Sabin IPV intramuscularly or two fractional (1/5) dose of Sabin IPV intradermally at 14 weeks and 9 months of age from two different manufacturers.
Read the detailed description
After OPV cessation, which is expected within a year of polio eradication certification, IPV will be the only polio vaccine used in essential immunization programs. SAGE has recommended a two-dose intramuscular IPV or intradermal fractional IPV (fIPV) schedule after OPV cessation. While it is expected that there shall be sufficient IPV available - in large part because of several manufacturers establishing production of IPV using Sabin strains (sIPV) - it is dependent on these manufacturers being able to meet promised product development and manufacturing timeline and meet WHO prequalification. It is likely that countries that have introduced intradermal fIPV pre-eradication will continue to use intradermal fIPV post-eradication. Therefore, it is important to generate evidence on immunogenicity of intradermal fractional sIPV in addition to intramuscular sIPV for the schedule recommended by SAGE.
This clinical trial assesses and compares the immunogenicity of full and fractional (1/5) dose Sabin IPV given at 14 weeks and 9 months of age from two different manufacturers. Healthy infants 6 weeks of age will be enrolled in Dhaka, Bangladesh, and randomized to one of four arms:
- IMBCAMS full dose sIPV at 14 weeks and 9 months B. IMBCAMS fractional dose sIPV at 14 weeks and 9 months C. BIBP full dose sIPV at 14 weeks and 9 months D. BIBP fractional dose sIPV at 14 weeks and 9 months
Participants will be followed until 10 months of age through clinic visits. Blood samples will be collected for measuring immune response.
- Conditions
- Poliomyelitis
- Being tested
- Full dose Sabin Inactivated Poliovirus Vaccine produced by IMBCAMS, Fractional (1/5) Dose Sabin Inactivated Poliovirus Vaccine produced by IMBCAMS, Full dose Sabin Inactivated Poliovirus Vaccine produced by BIBP, Fractional (1/5) dose Sabin Inactivated Poliovirus Vaccine produced by BIBP
- Keywords
- Sabin Inactivated Poliovirus Vaccine, poliovirus vaccines, immunization, antibodies
- Medical subject headings
- Poliomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full dose Sabin Inactivated Poliovirus Vaccine produced by IMBCAMSBiological
The Sabin antigen content is 30, 32 and 45 D-antigen units (DU) for types 1, 2 and 3, respectively and will be delivered intramuscularly by needle and syringe.
Fractional (1/5) Dose Sabin Inactivated Poliovirus Vaccine produced by IMBCAMSBiological
The Sabin antigen content is 30, 32 and 45 D-antigen units (DU) for types 1, 2 and 3, respectively and will be delivered intradermally by needle and syringe.
Full dose Sabin Inactivated Poliovirus Vaccine produced by BIBPBiological
The Sabin antigen content is 15 DU, 45 DU, 45 DU for types 1, 2, and 3, respectively and will be delivered intramuscularly by needle and syringe
Fractional (1/5) dose Sabin Inactivated Poliovirus Vaccine produced by BIBPBiological
The Sabin antigen content is 15 DU, 45 DU, 45 DU for types 1, 2, and 3, respectively and will be delivered intradermally by needle and syringe
| Study group | Role | What they receive |
|---|---|---|
| IMBCAMS Sabin IPV full dose at 14 weeks and 9 months | Active comparator | Participants will receive two full doses of Sabin IPV intramuscularly at 14 weeks and 9 months produced by Institute of Medical Biology Chinese Academy of Medical Sciences, Kunming (IMBCAMS). Receives: Biological: Full dose Sabin Inactivated Poliovirus Vaccine produced by IMBCAMS |
| IMBCAMS Sabin IPV fractional dose at 14 weeks and 9 months | Active comparator | Participants will receive two fractional (1/5) doses of Sabin IPV intradermally at 14 weeks and 9 months produced by Institute of Medical Biology Chinese Academy of Medical Sciences, Kunming (IMBCAMS). Receives: Biological: Fractional (1/5) Dose Sabin Inactivated Poliovirus Vaccine produced by IMBCAMS |
| BIBP Sabin IPV full dose at 14 weeks and 9 months | Active comparator | Participants will receive two full doses of Sabin IPV intramuscularly at 14 weeks and 9 months produced by Beijing Bio Institute Biological Products (BIBP). Receives: Biological: Full dose Sabin Inactivated Poliovirus Vaccine produced by BIBP |
| BIBP Sabin IPV fractional dose at 14 weeks and 9 months | Active comparator | Participants will receive two fractional (1/5) doses of Sabin IPV intradermally at 14 weeks and 9 months produced by Beijing Bio Institute Biological Products (BIBP). Receives: Biological: Fractional (1/5) dose Sabin Inactivated Poliovirus Vaccine produced by BIBP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaccine response
Dichotomous (yes/no) variable defined as participants who are either seronegative (<1:8 titers) at baseline who become seropositive (≥1:8) after vaccination (seroconversion) or participants who demonstrate a four-fold rise in titers after vaccination between two specimens, e.g. a change from 1:8 to 1:32, after adjusting for expected decay in maternal antibodies. Antibody titers at 14 weeks of age will be the starting point for the expected decline in maternal antibodies, assuming at half-life of 28 days.
Measured: Measured 4 weeks after administration of study vaccine
Secondary outcomes (2)
Reciprocal antibody titers
Variable of the observed reciprocal antibody titer results.
Measured: Measured 4 weeks after administration of study Vaccine
Priming
Dichotomous (yes/no) variable defined as participants who are either seronegative (<1:8 titers) at baseline who become seropositive (≥1:8) after vaccination (seroconversion) or participants who demonstrate a four-fold rise in titers after vaccination between two specimens, e.g. a change from 1:8 to 1:32, after adjusting for expected decay in maternal antibodies. Antibody titers at 14 weeks of age will be the starting point for the expected decline in maternal antibodies, assuming at half-life of 28 days.
Measured: Measured 7 days after challenge dose (e.g. 9 months + 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2022
- Study start26 Jul 2022
- Primary completion22 Jul 2023
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PoliomyelitisStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh, World Health Organization, Centers for Disease Control and Prevention, China
- Responsible party
- Sponsor
- Investigators
- Khalequ Zaman, PhD, Principal investigator, International Centre for Diarrhoeal Disease Research, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05460377
- Sponsor's protocol ID
- PR-21092
- Status last verified
- Mar 2025
- First submitted
- 13 Jul 2022
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Immunogenicity of Intramuscular Sabin Inactivated Poliovirus Vaccine and Non-inferiority of Intradermal Fractional Inactivated Poliovirus Vaccine
- ClinicalTrials.gov ID
- NCT05460377
- Acronym / sponsor ID
- PR-21092
- Conditions
- Poliomyelitis
- Keywords
- Sabin Inactivated Poliovirus Vaccine, poliovirus vaccines, immunization, antibodies
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,224 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh, World Health Organization, Centers for Disease Control and Prevention, China
- Study start
- 26 Jul 2022 (actual)
- Primary completion
- 22 Jul 2023 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 15 Jul 2022 (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.
This is an open label and off label, phase IV, randomized clinical trial that will compare the immune response among infants that receive either two full doses of Sabin IPV intramuscularly or two fractional (1/5) dose of Sabin IPV intradermally at 14 weeks and 9 months of age from two different manufacturers.
Detailed description
After OPV cessation, which is expected within a year of polio eradication certification, IPV will be the only polio vaccine used in essential immunization programs. SAGE has recommended a two-dose intramuscular IPV or intradermal fractional IPV (fIPV) schedule after OPV cessation. While it is expected that there shall be sufficient IPV available - in large part because of several manufacturers establishing production of IPV using Sabin strains (sIPV) - it is dependent on these manufacturers being able to meet promised product development and manufacturing timeline and meet WHO prequalification. It is likely that countries that have introduced intradermal fIPV pre-eradication will continue to use intradermal fIPV post-eradication. Therefore, it is important to generate evidence on immunogenicity of intradermal fractional sIPV in addition to intramuscular sIPV for the schedule recommended by SAGE.
This clinical trial assesses and compares the immunogenicity of full and fractional (1/5) dose Sabin IPV given at 14 weeks and 9 months of age from two different manufacturers. Healthy infants 6 weeks of age will be enrolled in Dhaka, Bangladesh, and randomized to one of four arms:
- IMBCAMS full dose sIPV at 14 weeks and 9 months B. IMBCAMS fractional dose sIPV at 14 weeks and 9 months C. BIBP full dose sIPV at 14 weeks and 9 months D. BIBP fractional dose sIPV at 14 weeks and 9 months
Participants will be followed until 10 months of age through clinic visits. Blood samples will be collected for measuring immune response.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| IMBCAMS Sabin IPV full dose at 14 weeks and 9 months | Active comparator | Biological: Full dose Sabin Inactivated Poliovirus Vaccine produced by IMBCAMSParticipants will receive two full doses of Sabin IPV intramuscularly at 14 weeks and 9 months produced by Institute of Medical Biology Chinese Academy of Medical Sciences, Kunming (IMBCAMS). |
| IMBCAMS Sabin IPV fractional dose at 14 weeks and 9 months | Active comparator | Biological: Fractional (1/5) Dose Sabin Inactivated Poliovirus Vaccine produced by IMBCAMSParticipants will receive two fractional (1/5) doses of Sabin IPV intradermally at 14 weeks and 9 months produced by Institute of Medical Biology Chinese Academy of Medical Sciences, Kunming (IMBCAMS). |
| BIBP Sabin IPV full dose at 14 weeks and 9 months | Active comparator | Biological: Full dose Sabin Inactivated Poliovirus Vaccine produced by BIBPParticipants will receive two full doses of Sabin IPV intramuscularly at 14 weeks and 9 months produced by Beijing Bio Institute Biological Products (BIBP). |
| BIBP Sabin IPV fractional dose at 14 weeks and 9 months | Active comparator | Biological: Fractional (1/5) dose Sabin Inactivated Poliovirus Vaccine produced by BIBPParticipants will receive two fractional (1/5) doses of Sabin IPV intradermally at 14 weeks and 9 months produced by Beijing Bio Institute Biological Products (BIBP). |
Who may qualify
- Ages
- 42 to 48 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Healthy infants 6 weeks of age (range: 42-48 days).
- Parents that consent for participation in the full length of the study (i.e., 34 weeks).
- Parents that are able to understand and comply with planned study procedures.
Key exclusion criteria (9 listed)
- A diagnosis or suspicion of immunodeficiency disorder either in the infant or in an immediate family member.
- A diagnosis or suspicion of bleeding disorder that would contraindicate parenteral administration of sIPV or collection of blood by venepuncture.
- Acute diarrhoea, infection or illness at the time of enrollment (6 weeks of age) that would require infant's admission to a hospital.
- Acute vomiting and intolerance to liquids within 24 hours before the enrollment visit (6 weeks of age).
- Evidence of a chronic medical condition identified by a study medical officer during physical exam.
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 |
|---|---|---|
| Full dose Sabin Inactivated Poliovirus Vaccine produced by IMBCAMSThe Sabin antigen content is 30, 32 and 45 D-antigen units (DU) for types 1, 2 and 3, respectively and will be delivered intramuscularly by needle and syringe. | Biological | IMBCAMS Sabin IPV full dose at 14 weeks and 9 months |
| Fractional (1/5) Dose Sabin Inactivated Poliovirus Vaccine produced by IMBCAMSThe Sabin antigen content is 30, 32 and 45 D-antigen units (DU) for types 1, 2 and 3, respectively and will be delivered intradermally by needle and syringe. | Biological | IMBCAMS Sabin IPV fractional dose at 14 weeks and 9 months |
| Full dose Sabin Inactivated Poliovirus Vaccine produced by BIBPThe Sabin antigen content is 15 DU, 45 DU, 45 DU for types 1, 2, and 3, respectively and will be delivered intramuscularly by needle and syringe | Biological | BIBP Sabin IPV full dose at 14 weeks and 9 months |
| Fractional (1/5) dose Sabin Inactivated Poliovirus Vaccine produced by BIBPThe Sabin antigen content is 15 DU, 45 DU, 45 DU for types 1, 2, and 3, respectively and will be delivered intradermally by needle and syringe | Biological | BIBP Sabin IPV fractional dose at 14 weeks and 9 months |
Primary outcome
Vaccine response
Time frame: Measured 4 weeks after administration of study vaccine
Dichotomous (yes/no) variable defined as participants who are either seronegative (<1:8 titers) at baseline who become seropositive (≥1:8) after vaccination (seroconversion) or participants who demonstrate a four-fold rise in titers after vaccination between two specimens, e.g. a change from 1:8 to 1:32, after adjusting for expected decay in maternal antibodies. Antibody titers at 14 weeks of age will be the starting point for the expected decline in maternal antibodies, assuming at half-life of 28 days.
2 secondary outcomes
Reciprocal antibody titers
Time frame: Measured 4 weeks after administration of study Vaccine
Priming
Time frame: Measured 7 days after challenge dose (e.g. 9 months + 7 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Khalequ Zaman, PhD principal investigator
International Centre for Diarrhoeal Disease Research, Bangladesh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Full dose Sabin Inactivated Poliovirus Vaccine produced by IMBCAMS, Fractional (1/5) Dose Sabin Inactivated Poliovirus Vaccine produced by IMBCAMS and Full dose Sabin Inactivated Poliovirus Vaccine produced by BIBP in people with Poliomyelitis, run by Centers for Disease Control and Prevention 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 3 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: finished, as of the sponsor's last update on 19 Mar 2025. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Vaccine response (time frame: Measured 4 weeks after administration of study vaccine). 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 19 Mar 2025; AzTrials last refreshed its copy on 8 Nov 2026.