Phase 3
N=2,520
Multivalent HPV (Human Papillomavirus) Vaccine Study in 16- to 26-Year Old Men and Women (V503-003)
Genital Warts · Anal Cancer · Anal Intraepithelial Neoplasia
Bottom Line
View on ClinicalTrials.gov: NCT01651949 ↗Enrolled (actual)
2,520
Serious AEs
2.0%
Results posted
Mar 2015
Primary outcome: Primary: Geometric Mean Titers (GMTs) to the HPV Types Contained in the 9vHPV Vaccine — 782.0; 703.9; 568.9; 616.7 milli Merck Units/mL — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 9vHPV Vaccine (Biological)
- Age
- Pediatric, Adult · 16+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Geometric Mean Titers (GMTs) to the HPV Types Contained in the 9vHPV Vaccine |
782.0; 703.9; 568.9; 616.7; 564.9; 437.7 | <0.001 sig |
| PRIMARY Percentage of Participants With One or More Injection-site Adverse Experiences Prompted on the Vaccination Report Card |
66.7; 84.0; 20.7; 32.2; 63.4; 82.5 | <0.001 sig |
| PRIMARY Percentage of Participants With Elevated Oral Body Temperature (>=37.8° C, >=100° F) |
4.4; 5.9 | 0.091 |
| PRIMARY Percentage of Participants With an Adverse Event |
76.2; 89.4 | — |
| PRIMARY Percentage of Participants Who Had Study Vaccine Discontinued Due to an Adverse Event |
0.1; 0.3 | — |
| SECONDARY Percentage of Participants With Seroconversion to the HPV Types Contained in the 9vHPV Vaccine |
99.6; 99.6; 99.4; 100; 99.9; 100 | <0.001 sig |
Summary
This study is designed to evaluate the immunogenicity and tolerability of 9vHPV (9-valent HPV vaccine, V503) in 16- to 26-year old men and women. The overall goal is to bridge 9vHPV efficacy findings in young women to young men based on the demonstration of similar immunogenicity and safety profiles. The primary hypothesis is that 9vHPV induces antibody responses at 4 weeks postdose 3 in heterosexual males that are non-inferior to antibody responses in young women.
Eligibility Criteria
Inclusion Criteria
- Good physical health
- Has never had Papanicolaou testing (Pap, cervical or anal) or has only had normal Pap test results
- Other inclusion criteria will be discussed with the investigator
Exclusion Criteria
- History of severe allergic reaction that required medical intervention
- Currently enrolled in a clinical trial
- If participant is female, pregnant
- Currently immunocompromised or having received immunosuppressive therapy in the last year
- Positive test for HPV
- History of HPV-related external genital lesions or HPV-related anal lesions or anal cancer
- If participant is female, history of abnormal cervical biopsy results
- Other exclusion criteria will be discussed with the investigator
Data sourced from ClinicalTrials.gov (NCT01651949). 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.