Study Stopped
Regulatory timelines for approval expired
A Study to Evaluate Immunogenicity of Various Schedules of Inactivated Polio Vaccine
A Phase 3, Open-label, Randomized Trial to Evaluate Humoral Immunogenicity of Various Schedules of Intramuscular Full Dose and Intradermal Fractional Dose of Inactivated Polio Vaccine in Infants
1 other identifier
interventional
N/A
0 countries
N/A
Brief Summary
The study will evaluate the humoral immunogenicity in various schedule combinations of full dose inactivated polio vaccines (IPV) via intramuscular administration (IM) and of the fractional dose of inactivated poliovaccine (f-IPV) via intradermal administration (ID).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jul 2017
Shorter than P25 for phase_3
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
January 5, 2017
CompletedFirst Posted
Study publicly available on registry
January 11, 2017
CompletedStudy Start
First participant enrolled
July 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2018
CompletedJune 27, 2017
June 1, 2017
1.3 years
January 5, 2017
June 26, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Seroconversion
Seroconversion will be defined as a change from seronegative to seropositive (antibody titers of ≥1:8) and in infants seropositive at baseline (assumed to be from maternally-derived antibody titers), as a ≥4-fold rise in antibody titers post-vaccination, computed by assuming an exponential decay model with a half-life of 24 days.
To be assessed four weeks after the second vaccination for all groups receiving 2 doses of IPV and four weeks after the second vaccination for all groups receiving 2 doses of f-IPV.
Secondary Outcomes (5)
Seroconversion
To be assessed four weeks after the second or third vaccination, respectively, for the groups receiving IPV and four weeks after the second or third vaccination, respectively, for the groups receiving f-IPV.
Median titers
To be assessed four weeks after the second or third vaccination, respectively, for the groups receiving IPV and four weeks after the second or third vaccination, respectively, for the groups receiving f-IPV.
SAEs (Serious Adverse Events)
To be assessed throughout the complete study period, approx. 18 months.
IMEs (Important Medical Events)
To be assessed throughout the complete study period, approx. 18 months.
Severe local reactions
To be assessed throughout the complete study period, approx. 18 months.
Study Arms (6)
Group A
EXPERIMENTAL3 doses IPV IM at 10, 14 \& 36 weeks of age incl. blood sampling at 10, 18, 36 \& 40 weeks.
Group B
EXPERIMENTAL3 doses f-IPV ID at 10, 14 \& 36 weeks of age incl. blood sampling at 10, 18, 36 \& 40 weeks.
Group C
EXPERIMENTAL2 doses IPV IM at 14 \& 36 weeks of age incl. blood sampling at 14, 18, 36 \& 40 weeks.
Group D
EXPERIMENTAL2 doses f-IPV ID at 14 \& 36 weeks of age incl. blood sampling at 14, 18, 36 \& 40 weeks.
Group E
EXPERIMENTAL3 doses IPV IM at 6, 14 \& 36 weeks of age incl. blood sampling at 6, 18, 36 \& 40 weeks.
Group F
EXPERIMENTAL3 doses f-IPV ID at 6, 14 \& 36 weeks of age incl. blood sampling at 6, 18, 36 \& 40 weeks.
Interventions
Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)
Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)
Eligibility Criteria
You may qualify if:
- Infants of 6 weeks of age (-7 to + 7 days) on date of first vaccination
- Healthy, as assessed from medical history and physical examination by a study physician
- Written informed consent obtained from parents or legal representatives that they have been properly informed about the study and are able to comply with planned study procedures
You may not qualify if:
- A household contact with OPV vaccination history in the past 4 weeks
- HIV infection or pharmacologic immunosuppression.
- Known allergy to any component of the study vaccines (phenoxyethanol, formaldehyde)
- Uncontrolled coagulopathy or blood disorder contraindicating intramuscular and intradermal injections.
- Acute severe febrile illness on day of vaccination deemed by the Investigator to be a contraindication for vaccination.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fidec Corporationlead
- Bill and Melinda Gates Foundationcollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stella Gutierrez, MD
CASMU Polyclinic 8 de Octubre 3310 Montevideo, Uruguay
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 5, 2017
First Posted
January 11, 2017
Study Start
July 1, 2017
Primary Completion
October 1, 2018
Study Completion
November 1, 2018
Last Updated
June 27, 2017
Record last verified: 2017-06