Assessing Immunogenicity of Intramuscular Sabin Inactivated Poliovirus Vaccine and Non-inferiority of Intradermal Fractional Inactivated Poliovirus Vaccine
1 other identifier
interventional
1,224
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jul 2022
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 13, 2022
CompletedFirst Posted
Study publicly available on registry
July 15, 2022
CompletedStudy Start
First participant enrolled
July 26, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 22, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedMarch 19, 2025
March 1, 2025
12 months
July 13, 2022
March 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 4 weeks after administration of study vaccine
Secondary Outcomes (2)
Reciprocal antibody titers
Measured 4 weeks after administration of study Vaccine
Priming
Measured 7 days after challenge dose (e.g. 9 months + 7 days)
Study Arms (4)
IMBCAMS Sabin IPV full dose at 14 weeks and 9 months
ACTIVE COMPARATORParticipants 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 COMPARATORParticipants 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 COMPARATORParticipants 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 COMPARATORParticipants 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).
Interventions
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.
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.
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
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Icddr,B Study Clinics
Dhaka, Bangladesh
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Khalequ Zaman, PhD
International Centre for Diarrhoeal Disease Research, Bangladesh
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 13, 2022
First Posted
July 15, 2022
Study Start
July 26, 2022
Primary Completion
July 22, 2023
Study Completion
December 1, 2024
Last Updated
March 19, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share