Phase 3 N=14,840 Randomized Double-blind Prevention

Broad Spectrum HPV (Human Papillomavirus) Vaccine Study in 16-to 26-Year-Old Women (V503-001)

Cervical Cancer · Vulvar Cancer · Vaginal Cancer · Genital Warts · Human Papillomavirus Infection

Bottom Line

View on ClinicalTrials.gov: NCT00543543 ↗

Enrolled (actual)

14,840

Serious AEs

2.5%

Results posted

Dec 2014

Primary outcome: Primary: Base Study: Combined Incidence of HPV Type 31/33/45/52/58-related Disease (Test of Hypothesis) — 0.5; 15.8 Cases per 10,000 person-years follow-up — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Comparator: GARDASIL (Biological); Experimental: V503 (Biological)
Age: Pediatric, Adult · 16+ yrs
Sex: Female
Sponsor: Merck Sharp & Dohme LLC
Primary completion: Apr 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Base Study: Combined Incidence of HPV Type 31/33/45/52/58-related Disease (Test of Hypothesis)	0.5; 15.8	<0.0001 sig
PRIMARY Base Study: Combined Incidence of HPV Type 31/33/45/52/58-related Disease (End-of-study Update)	0.5; 19.0	—
PRIMARY Base Study: Geometric Mean Titers (GMTs) to HPV Types 6/11/16/18/31/33/45/52/58	893.1; 875.2; 666.3; 830.0; 3131.1; 3156.6	<0.001 sig
PRIMARY Base Study: Percentage of Participants With One or More Adverse Event	92.6; 94.2; 92.8; 91.1	—
PRIMARY Base Study: Percentage of Participants With One or More Injection-site Adverse Event	87.7; 90.7; 90.5; 84.9	—
PRIMARY Base Study: Percentage of Participants With One or More Non-injection-site (Systemic) Adverse Event	53.5; 55.8; 51.1; 54.9	—
PRIMARY Base Study: Percentage of Participants With One or More Vaccine-related Adverse Event	90.0; 92.2; 92.8; 87.6	—
PRIMARY Base Study: Percentage of Participants With Study Medication Withdrawn Due to an Adverse Event	0.6; 0.1; 0.0; 0.1	—
SECONDARY Base Study: Combined Incidence of HPV Type 31/33/45/52/58-related Persistent Infection	21.5; 538.8	—
SECONDARY Base Study: Percentage of Participants Who Are Seropositive for HPV Types 6/11/16/18/31/33/45/52/58	99.8; 99.8; 100; 99.9; 100; 100	—

Summary

The purpose of this study was to evaluate the safety, efficacy, and immunogenicity of V503 in comparison to GARDASIL. The primary hypotheses tested in the study were 1) V503 administered to 16- to 26-year-old adolescents and young women is generally well-tolerated, 2) V503 reduces combined incidence of Human Papillomavirus (HPV) Type 31/33/45/52/58-related disease compared with GARDASIL, and 3) V503 induces non-inferior geometric mean titers for HPV Type 6/11/16/18 antibodies compared with GARDASIL.

Eligibility Criteria

Inclusion Criteria

Female between 16- to 26-years-old
Has never had Pap testing or has only had normal Pap (Papanicolaou) test results
For the immune memory substudy in the extension (Cohort 1): was randomized to V503 in the base study and was in the per-protocol immunogenicity population for ≥1 HPV type
For the 3-dose V503 vaccination substudy in the extension (Cohort 2): was randomized to GARDASIL in the base study and received ≥1 dose of GARDASIL

Exclusion Criteria

History of an abnormal cervical biopsy result
History of a positive test for HPV
History of external genital/vaginal warts
Currently a user of any illegal drugs or an alcohol abuser
History of severe allergic reaction that required medical attention
Are pregnant
Received marketed HPV vaccine or participated in an HPV trial
Currently enrolled in a clinical trial
Currently has or has a history of certain medical conditions or is currently taking or has taken certain medications (details will be discussed at the time of consent.)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00543543). 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.