Phase 4
N=1,030
V501 Safety and Efficacy Study in Japanese Women Aged 16 to 26 Years (V501-110)
Cervical Cancer · Cervical Intraepithelial Neoplasia · Adenocarcinoma in Situ
Bottom Line
View on ClinicalTrials.gov: NCT01544478 ↗Enrolled (actual)
1,030
Serious AEs
0.8%
Results posted
Jul 2017
Primary outcome: Primary: Combined Incidence of Cervical Intraepithelial Neoplasia (CIN) 2/3 or Worse Related to Human Papillomavirus (HPV) Type 6, 11, 16, or 18 — 0.0 Cases per 100 person-years at risk
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- V501 (Biological)
- Age
- Pediatric, Adult · 16+ yrs
- Sex
- Female
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Aug 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Combined Incidence of Cervical Intraepithelial Neoplasia (CIN) 2/3 or Worse Related to Human Papillomavirus (HPV) Type 6, 11, 16, or 18 |
0.0 | — |
Summary
This study evaluated the long-term safety of quadrivalent Human Papillomavirus (HPV) types 6, 11, 16, 18 vaccine and its effectiveness in the prevention of cervical intraepithelial neoplasia (CIN), adenocarcinoma in situ, and cervical cancer related to HPV in Japanese women.
Eligibility Criteria
Inclusion Criteria
- Healthy Japanese females
- Not pregnant at Screening and agree to use effective contraception through Month 7 of the study
- Lifetime history of 0 to 4 male or female sexual partners
- No oral temperature ≥37.5 centigrade within 24 hours prior to injection
Exclusion Criteria
- Received a marketed HPV vaccine
- Prior abnormal Papanicolaou smear (PAP) or biopsy showing CIN
- Known history of positive test for HPV
- Known history of genital warts
- Received immune globulin or blood products within 6 months prior to first injection or plan to receive any through Month 7 of the study
- History of splenectomy, known immune disorders, or receiving immunosuppressives
- Immunocompromised or diagnosed as having human immunodeficiency virus (HIV)
Data sourced from ClinicalTrials.gov (NCT01544478). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.