Phase 3
N=3,006
Prevention of Human Papillomavirus (HPV) in 20 to 45 Year Old Chinese Women (V501-041)
HPV Infections
Bottom Line
View on ClinicalTrials.gov: NCT00834106 ↗Enrolled (actual)
3,006
Serious AEs
2.7%
Results posted
Oct 2017
Primary outcome: Primary: Base Study: Combined Incidence of 6-Month Persistent Infection, Cervical Intraepithelial Neoplasia (CIN+), and External Genital Lesions Related to Human Papillomavirus (HPV) Type 6, 11, 16, or 18 in 20 to 45 Year Old Participants (Test of Hypothesis) — 0.3; 1.2 Cases per 100 person-years of follow-up
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (Biological); Comparator: placebo (unspecified) (Biological)
- Age
- Adult · 20+ yrs
- Sex
- Female
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- May 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Base Study: Combined Incidence of 6-Month Persistent Infection, Cervical Intraepithelial Neoplasia (CIN+), and External Genital Lesions Related to Human Papillomavirus (HPV) Type 6, 11, 16, or 18 in 20 to 45 Year Old Participants (Test of Hypothesis) |
0.3; 1.2 | — |
| PRIMARY Base Study: Combined Incidence of 6-Month Persistent Infection, CIN+, and External Genital Lesions Related to Human Papillomavirus (HPV) Type 6, 11, 16, or 18 in 20 to 26 Years Old Participants (Test of Hypothesis) |
0.2; 1.2 | — |
| PRIMARY Entire Study: Combined Incidence of CIN2+ Related to HPV Types 16 or 18 in 20 to 45 Year Old Participants (End of Study Test of Hypothesis) |
0.0; 0.1 | 0.0072 sig |
| PRIMARY Base Study: Percentage of Participants With One or More Solicited Injection-site Adverse Events |
37.6; 27.8 | — |
| PRIMARY Base Study: Percentage of Participants With One or More Systemic Adverse Events |
50.4; 48.7 | — |
| PRIMARY Base Study: Percentage of Participants Discontinued From Study Vaccination Due to an Adverse Event |
0.1; 0.2 | — |
| PRIMARY Entire Study: Percentage of Participants With One or More Vaccine-related Serious Adverse Events |
0.0; 0.1 | — |
| PRIMARY Entire Study: Percentage of Participants Who Died |
0.1; 0.0 | — |
| SECONDARY Entire Study: Combined Incidence of 12-Month Persistent Infection, CIN+, and External Genital Lesions Related to Human Papillomavirus (HPV) Type 6, 11, 16, or 18 in 20 to 45 Year Old Participants (End of Study Update) |
0.1; 0.7 | — |
| SECONDARY Entire Study: Combined Incidence of 12-Month Persistent Infection, CIN+, and External Genital Lesions Related to Human Papillomavirus (HPV) Type 6, 11, 16, or 18 in 20 to 26 Year Old Participants (End of Study Update) |
0.0; 0.6 | — |
Summary
A study to test the safety and effectiveness of Quadrivalent HPV (types 6, 11, 16, 18) L1 VLP vaccine against combined incidence of HPV 6/11/16/18-related persistent infection and vaccine type-specific genital disease among Chinese females between the ages of 20 and 45.
Eligibility Criteria
Inclusion Criteria
- Healthy women between the ages of 20 and 45
- Have used effective contraception for 2 weeks prior to starting in the study
- Does not have a temperature within 24 hours before the first injection
Exclusion Criteria
- Prior history of genital warts
- More than 4 lifetime sexual partners
- Have undergone hysterectomy
- Have active cervical disease or history of cervical disease
Data sourced from ClinicalTrials.gov (NCT00834106). 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.