CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 2,409 enrolled
Drug / intervention
Comparator: HPV 16 L1 Vaccine +1 morebiological
Likely dose
HPV 16 L1 Vaccine 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6AI-extracted
Key inclusion· 5
  • ✓Healthy females aged 16 to 23 years
  • ✓Intact uterus
  • ✓Not pregnant at enrollment
  • ✓Limited sexual history: 0–5 lifetime male partners with insertive intercourse
Key exclusion· 4
  • ✕Prior HPV vaccination
  • ✕Any other vaccination within 1 month before enrollment or planned within 1 month before/after any study vaccine dose
  • ✕History of abnormal Pap test showing squamous intraepithelial lesion (SIL)
  • ✕History of cervical biopsy showing cervical intraepithelial neoplasia (CIN)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00365378
NCT00365378Phase 2Completed
CompareCT.gov

Study of Pilot Manufacturing Lot of HPV 16 Virus-Like Particle (VLP) Vaccine in the Prevention of HPV 16 Infection in 16- to 23-Year-Old Females

Merck Sharp & Dohme LLC·interventional·Posted Aug 17, 2006·Updated Oct 23, 2015

In Brief

A Phase 2 clinical trial evaluating Comparator: HPV 16 L1 Vaccine and Comparator: Placebo for HPV 16 Infection. Completed, enrolled 2,409 participants.

Detailed Summary

Subjects received HPV 16 L1 VLP vaccine or placebo (1:1 ratio). Endpoints included efficacy, immunogenicity, and safety.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHPV 16 Infection
Countries--
Collaborators--

Timeline

Phase 2CompletedFinished
19992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 17, 2006
Enrollment StartSep 1, 1999
Primary CompletionMar 1, 2004
Study CompletionJul 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 19.9 years ago

Interventions

Comparator: HPV 16 L1 Vaccinebiological

A 0.5 intramuscular injection given at Day 1, Month 2, and Month 6

Comparator: Placebobiological

A 0.5 intramuscular placebo injection given at Day 1, Month 2, and Month 6