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Immunogenicity of IPV vs f-IPV Schedules in Infants
NCT03016949Phase 3
Key facts
- Status
- Withdrawn
- Start
- Jul 2017
- Primary completion
- Oct 2018
- Sponsor
- Fighting Infectious Diseases in Emerging Countries
- Modality
- Recombinant Proteins and Enzymes, Vaccines & Immunotherapeutics
- Conditions
- poliomyelitis
01
Overview
Phase 3, randomised, open-label trial of trivalent inactivated polio vaccine in poliomyelitis (6 arms), sponsored by Fighting Infectious Diseases in Emerging Countries. Primary endpoint: Seroconversion. Planned start Jul 2017; status: withdrawn.
02
Design
6 arms- Study design
- RandomizedOpen-label
Group A
3 doses IPV IM at 10, 14 & 36 weeks
Group B
3 doses f-IPV ID at 10, 14 & 36 weeks
Group C
2 doses IPV IM at 14 & 36 weeks
Group D
2 doses f-IPV ID at 14 & 36 weeks
Group E
3 doses IPV IM at 6, 14 & 36 weeks
Group F
3 doses f-IPV ID at 6, 14 & 36 weeks
03
Who it enrols
Healthy infants 6 weeks of age (-7 to +7 days) without prior polio vaccination or HIV infection.
04
Endpoints
Primary
Seroconversion
Secondary
Seroconversion
Median titers
Serious Adverse Events
Important Medical Events
Severe local reactions
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