Phase 3 N=1,212 Prevention

Immunogenicity and Tolerability of Broad Spectrum Human Papillomavirus (HPV) Vaccine in Adult and Young Adult Women (V503-004)

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

Bottom Line

View on ClinicalTrials.gov: NCT03158220 ↗

Enrolled (actual)

1,212

Serious AEs

1.2%

Results posted

Nov 2019

Primary outcome: Primary: Anti-HPV Geometric Mean Titers (GMTs) for Each Anti-HPV Type — 787.8; 638.4; 598.7; 453.5 mMU/mL — p=< 0.001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: V503 (Biological)
Age: Pediatric, Adult · 16+ yrs
Sex: Female
Sponsor: Merck Sharp & Dohme LLC
Primary completion: Nov 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Anti-HPV Geometric Mean Titers (GMTs) for Each Anti-HPV Type	787.8; 638.4; 598.7; 453.5; 3075.8; 2147.5	< 0.001 sig
SECONDARY Percentage of Participants That Experienced at Least 1 Adverse Event (AE)	92.8; 92.5	—
SECONDARY Percentage of Participants Who Had Study Vaccine Discontinued Due to Adverse Event.	0.0; 0.2	—
SECONDARY Percentage of Participants With at Least 1 Solicited Injection-site Adverse Event	87.2; 84.7	0.212
SECONDARY Percentage of Participants That Reported at Least 1 Systemic Adverse Event	66.3; 64.4	—
SECONDARY Percentage of Participants With Elevated Temperature (Fever)	3.5; 2.5	0.300
SECONDARY Percentage of Participants Who Seroconverted to Each of the Anti-HPV Types	99.8; 100.0; 100.0; 99.8; 100.0; 100.0	—

Summary

This study will assess the safety and immunogenicity of GARDASIL®9 (V503) in 16- to 45-year-old women. The primary hypothesis of the study states that anti-HPV 16, 18, 31, 33, 45, 52, and 58 geometric mean titers (GMTs) at 4 weeks postdose 3 are non-inferior in adult women as compared with GMTs in young adult women.

Eligibility Criteria

Inclusion Criteria

good physical health

Exclusion Criteria

history of an abnormal Pap (Papanicolaou) test or abnormal cervical biopsy results
history of HPV-related condition
history of known prior vaccination with an HPV vaccine
pregnant
user of recreational or illicit drugs
history of severe allergic reaction, including known allergy to any vaccine component
immunocompromised
history of certain medications or is currently taking or has taken certain medications (details will be discussed at the time of consent)
has thrombocytopenia or other coagulation disorder
concurrently enrolled in a clinical study of investigational agent

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03158220). 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.