Phase 3 Completed N=924 Randomized Double-blind Prevention

A Study of V503, a 9-valent Human Papillomavirus (9vHPV) Vaccine in Females 12-26 Years of Age Who Have Previously Received GARDASIL™ (V503-006)

Cervical Cancer · Vulvar Cancers · Vaginal Cancers · Genital Warts

Source: ClinicalTrials.gov NCT01047345 ↗

Enrolled (actual)

924

Serious AEs

0.8%

Results posted

Dec 2014

Primary outcomePrimary: Percentage of Participants Who Experience an Injection-site Adverse Event (AE) - Base Study — 91.1; 43.9 Percentage of Participants

Summary

This study will evaluate whether V503 (9vHPV vaccine), is well tolerated in girls and women between 12 and 26 years old who have previously been vaccinated with GARDASIL™. Participants will receive vaccination with 9vHPV vaccine or placebo on Day 1, Month 2, and Month 6 of the Base Study. Participants who receive placebo in the Base Study will be eligible to receive vaccination with 9vHPV vaccine on Day 1, Month 2, and Month 6 of the Extension Study.

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants Who Experience an Injection-site Adverse Event (AE) - Base Study	91.1; 43.9	—
PRIMARY Percentage of Participants With Body Temperature ≥100.0°F (≥37.8ºC) - Base Study	6.5; 3.0	0.026 sig
PRIMARY Percentage of Participants Who Experience a Systemic AE - Base Study	59.7; 55.7	—
PRIMARY Percentage of Participants Who Experience a Serious Adverse Event (SAE) Within 15 Days of Any Vaccination - Base Study	0.3; 0.3	—
PRIMARY Percentage of Participants Who Experience a Vaccine-related SAE Any Time During Study- Base Study	0.2; 0.3	—
PRIMARY Percentage of Participants Who Experience a Severe Injection-site AE - Base Study	11.2; 1.0	—
SECONDARY Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine - Base Study	100.0; 100.0; 100.0; 99.6; 100.0; 100.0	<0.001 sig

Eligibility Criteria

Inclusion Criteria

Participants Age 12 to 15 Years:

Participant is in good health
Parent/legal guardian and participant agree to provide study personnel with a primary telephone number for follow-up
Participant received a 3-dose regimen of marketed GARDASIL™ within a 1 year period and the last dose of GARDASIL™ was at least 1 year from study day 1
Participant has not received any other HPV vaccine
Participant is not yet sexually active

Participants Age 16 to 26 Years:

Participant is in good health
Participant agrees to provide a primary telephone number for follow-up
Participant received a 3-dose regimen of marketed GARDASIL™ within a 1 year period and the last dose of GARDASIL™ was at least 1 year from study day 1
Participant has not received any other HPV vaccine
Participant has never had Papanicolaou (Pap) testing or has only had normal results
Participant has a history of 0 to 4 lifetime sexual partners at enrollment

Exclusion Criteria

All participants:

Participant has a history of severe allergic reaction that required medical intervention
Participant has any disorder that would contraindicate intramuscular injections
Participant is pregnant
Participant is immunocompromised or has an autoimmune condition
Participant has had a splenectomy
Participant has received any immune globulin product or blood-derived product
Participant has participated in a HPV vaccine clinical trial

Participants Age 16 to 26 Only:

Participant expects to donate eggs during the study
Participant has a history of abnormal cervical biopsy result
Participant has a history of HPV-related external genital lesions, external genital cancer, HPV-related vaginal lesions, or vaginal cancer

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01047345). 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. Informational only — not medical advice.