Phase 3 N=12,167 Randomized Double-blind Prevention

Cervical Intraepithelial Neoplasm (CIN) in Women (Gardasil) (V501-015)

Cervical Cancer · Genital Warts

Bottom Line

View on ClinicalTrials.gov: NCT00092534 ↗

Enrolled (actual)

12,167

Serious AEs

0.6%

Results posted

Nov 2009

Primary outcome: Primary: Incidence of the Composite Endpoint of Human Papillomavirus (HPV) 16/18-related Cervical Intraepithelial Neoplasia (CIN) 2 or Worse in the Base Study — 0.0; 0.4 Incidence per 100 person-years

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine (Biological); Matching Placebo (Biological)
Age: Pediatric, Adult · 16+ yrs
Sex: Female
Sponsor: Merck Sharp & Dohme LLC
Primary completion: Jul 2007

Outcome Measures

Outcome	Result	p-value
PRIMARY Incidence of the Composite Endpoint of Human Papillomavirus (HPV) 16/18-related Cervical Intraepithelial Neoplasia (CIN) 2 or Worse in the Base Study	0.0; 0.4	—
PRIMARY Incidence of the Composite Endpoint of Human Papillomavirus (HPV) 16/18-related Cervical Intraepithelial Neoplasia (CIN) 2 or Worse in the Long-term Follow-up (LTFU) Study	0.0	—
PRIMARY Incidence of the Composite Endpoint of HPV16/18-related CIN 2 or Worse in the Long-term Follow-up (LTFU) Study	—	—
SECONDARY Number of Participants With Anti-Human Papillomavirus (HPV) 6 Titer ≥20 mMU/mL Based on Competitive Luminex Immunoassay (cLIA) in the Base Study	1054; 13	—
SECONDARY Number of Participants With Anti-Human Papillomavirus (HPV) 11 Titer ≥16 mMU/mL Based on Competitive Luminex Immunoassay (cLIA) in the Base Study	1054; 5	—
SECONDARY Number of Participants With Anti-Human Papillomavirus (HPV) 16 Titer ≥20 mMU/mL Based on Competitive Luminex Immunoassay (cLIA) in the Base Study	1014; 15	—
SECONDARY Number of Participants With Anti-Human Papillomavirus (HPV) 18 Titer ≥24 mMU/mL Based on Competitive Luminex Immunoassay (cLIA) in the Base Study	1133; 12	—
SECONDARY Incidence of the Composite Endpoint of Human Papillomavirus (HPV) 31/33/35/39/45/51/52/56/58/59-related Cervical Intraepithelial Neoplasia (CIN) Grade 2 or Worse in the Long-term Follow-up (LTFU) Study	0.2	—
SECONDARY Incidence of the Composite Endpoint of HPV 6/11/16/18-related CIN (Any Grade), AIS, Cervical Cancer, Vulvar Cancer or Vaginal Cancer the Long-term Follow-up (LTFU) Study	—	—
SECONDARY Incidence of the Composite Endpoint of HPV 6/11/16/18-related CIN (Any Grade), AIS, Cervical Cancer, Vulvar Cancer or Vaginal Cancer the Long-term Follow-up (LTFU) Study	—	—
SECONDARY Geometric Mean Titers (GMTs) to HPV Types 6, 11, 16, and 18 at Month 108 Assessed by Competitive Luminex Immunoassay (cLIA) in the Long-Term Follow-Up (LTFU) Study	89.2; 85.2; 348.6; 32.5	—
SECONDARY Geometric Mean Titers (GMTs) to HPV Types 6, 11, 16, and 18 at Month 168 Assessed by Competitive Luminex Immunoassay (cLIA) in the Long-Term Follow-Up (LTFU) Study	78.4; 66.8; 291.2; 26.1	—
SECONDARY Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 108 Assessed by Competitive Luminex Immunoassay (cLIA) in the Long-Term Follow-Up (LTFU) Study	94.4; 95.5; 99.1; 59.9	—
SECONDARY Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 168 Assessed by Competitive Luminex Immunoassay (cLIA) in the Long-Term Follow-Up (LTFU) Study	90.6; 91.1; 98.3; 52.4	—
SECONDARY Geometric Mean Titers (GMTs) to HPV Types 6, 11, 16, and 18 at Month 108 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA) in the Long-Term Follow-Up (LTFU) Study	95.2; 67.4; 346.1; 46.1	—
SECONDARY Geometric Mean Titers (GMTs) to HPV Types 6, 11, 16, and 18 at Month 168 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA) in the Long-Term Follow-Up (LTFU) Study	81.2; 53.5; 290.2; 36.5	—
SECONDARY Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 108 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA) in the Long-Term Follow-Up (LTFU) Study	97.6; 96.3; 100.0; 91.4	—
SECONDARY Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 168 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA) in the Long-Term Follow-Up (LTFU) Study	98.1; 98.0; 100.0; 93.8	—
SECONDARY Geometric Mean Titers (GMTs) to HPV Types 6, 11, 16, and 18 at Month 216 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA) in the Long-Term Follow-Up (LTFU) Study	—	—
SECONDARY Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 216 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA) ) in the Long-Term Follow-Up (LTFU) Study	—	—
SECONDARY Geometric Mean Titers (GMTs) to HPV Types 6, 11, 16, and 18 at Month 264 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA) in the Long-Term Follow-Up (LTFU) Study	—	—
SECONDARY Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 264 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA) in the Long-Term Follow-Up (LTFU) Study	—	—

Summary

The primary purpose of the study is to determine if GARDASIL™ (V501) is able to prevent cervical cancer.

Eligibility Criteria

Inclusion Criteria for the Base Study:

Healthy women with an intact uterus with lifetime history of 0-4 sexual partners

--For Extension Phase:

Participant received placebo or an incomplete vaccination series in the original study

--For LTFU:

Participant was randomized into the Base Study from Denmark, Iceland, Norway, or Sweden.
Agreed to allow passive follow-up (retrospective review of registry data), analysis of biopsy specimens, future contact from National Registry Study Center and serum collection

Exclusion Criteria for the Base Study:

Prior Human Papilloma Virus (HPV) vaccination
Prior abnormal Paps
Prior history of genital warts

--For Extension Phase:

Prior complete HPV vaccination series
Subject lives in a country in which Gardasil is approved and is within the age range of the local labeling for Gardasil

--For LTFU Study:

There were no exclusion criteria that did not overlap the inclusion criteria for this study.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00092534). 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.