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TRAP-HPV
NCT01824537Phase 4
Key facts
- Status
- Completed
- Start
- Jan 2014
- Primary completion
- Nov 2022
- Countries
- 1
- Sponsor
- McGill University
- Modality
- Vaccines & Immunotherapeutics
- Conditions
- human papillomavirus infection
01
Overview
Phase 4, randomised, double-blind trial of recombinant human papillomavirus 9-valent vaccine in human papillomavirus infection (2 arms), sponsored by McGill University. Primary endpoint: HPV Incidence Rates at 12 months. Started Jan 2014; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
HPV vaccine, Gardasil 9
Gardasil 9 administered at Months 0, 2, and 6
Hepatitis A vaccine
Avaxim administered at Months 0 and 6, with a saline placebo at Month 2
03
Who it enrols
Healthy heterosexual couples aged 18-45 in a new relationship (<= 6 months), planning to remain in Montreal for >= 1 year, with no prior Gardasil 9 vaccination, no history of specific cancers, and not pregnant.
04
Endpoints
Primary
HPV Incidence Rates
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