Duration of IPV Priming and Antibody Decay
Duration of Priming and Antibody Decay With Full-dose Inactivated Poliovirus Vaccine (IPV) Administered With or Without Bivalent Oral Poliovirus Vaccine (bOPV)
1 other identifier
interventional
1,645
1 country
2
Brief Summary
This is an open-label randomized phase IV clinical trial assessing immunogenicity of poliovirus vaccines.Participants will be enrolled at 6 weeks of age and followed to 18 months of age. The study will recruit 1645 participants in five arms.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 2017
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2017
CompletedFirst Posted
Study publicly available on registry
June 29, 2017
CompletedStudy Start
First participant enrolled
November 5, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2019
CompletedNovember 25, 2020
November 1, 2020
1.9 years
June 23, 2017
November 24, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Immunogenicity of IPV vaccination schedule
Immunogenicity will be assessed by measuring type-specific poliovirus antibody titers and assessing the change in antibody titers after receiving study vaccine compared to 6 weeks of age. The cumulative proportion of participants who demonstrate an immune response one month after receiving the last IPV dose of the experimental schedule. Immune response will be defined as either seronegative participants (\<1:8 titers) who become seropositive (≥1:8) \[seroconversion\] or participants who demonstrate a four-fold increase in titer (boosting).
Change after receiving vaccine compared to that at 6 weeks of age
Poliovirus type 2 priming with IPV
The proportion of participants who demonstrate type 2 immune response one week after receiving an additional IPV dose (secondary vaccination) after the proposed primary IPV vaccination series will be determined. Priming is the proportion of participants that demonstrate type 2 immune response among those who have not previously responded to the primary IPV vaccination series.
Proportion who demonstrate type 2 response at 18 months and 1 week among those who did not respond at 19 weeks
Study Arms (5)
IPV at ages 14 weeks and 18 months
ACTIVE COMPARATORParticipants in this arm will receive bivalent oral poliovirus vaccine (bOPV) at 6, 10 and 14 weeks of age and inactivated poliovirus vaccine (IPV) at 14 weeks and 18 months of age
IPV at ages 14 weeks, 18 weeks and 18 months
ACTIVE COMPARATORParticipants in this arm will receive bivalent oral poliovirus vaccine (bOPV) at 6, 10 and 14 weeks of age and inactivated poliovirus vaccine (IPV) at 14 weeks, 18 weeks and 18 months of age
IPV at ages 14 weeks and 9 months
ACTIVE COMPARATORParticipants in this arm will inactivated poliovirus vaccine (IPV) at 14 weeks and 9 months of age
IPV at ages 6 weeks and 9 months
ACTIVE COMPARATORParticipants in this arm will inactivated poliovirus vaccine (IPV) at 6 weeks and 9 months of age
IPV at ages 6 and 14 weeks
ACTIVE COMPARATORParticipants in this arm will inactivated poliovirus vaccine (IPV) at 6 and 14 weeks of age
Interventions
bOPV at 6, 10 and 14 weeks of age
IPV at 14 weeks and 18 months of age
IPV at 14 weeks, 18 weeks and 18 months of age
IPV at 14 weeks and 9 months of age
IPV at 6 weeks and 9 months of age
IPV at 6 and 14 weeks of age
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.
- Parents that are able to understand and comply with planned study procedures.
You may not qualify if:
- Parents and infants who are unable to participate in the full length of the study.
- 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 IPV or collection of blood by venipuncture.
- 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 (2)
International Center for Diarrhoeal Disease Research, Bangladesh
Dhaka, Bangladesh
Mirpur clinic (International Center for Diarrhoeal Disease Research, Bangladesh)
Dhaka, Bangladesh
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
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
June 23, 2017
First Posted
June 29, 2017
Study Start
November 5, 2017
Primary Completion
October 1, 2019
Study Completion
October 1, 2019
Last Updated
November 25, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share
Summary tables to be shared December 2019