A Randomized, Double-Blind, Multicenter, Biphasic, Controlled With GARDASIL™ Dose-Escalation Study of Octavalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and ISCOMATRIX™ (IMX)
18 Years
24 Years
Female
Human Papilloma Virus, Cervical Cancer, Vulvar Cancer, Vaginal Cancer, Genital Warts
Trial Information
A Randomized, Double-Blind, Multicenter, Biphasic, Controlled With GARDASIL™ Dose-Escalation Study of Octavalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and ISCOMATRIX™ (IMX)
The study was performed in 2 staggered phases, Phase A and Phase B. In Phase A, participants
were randomized to qHPV, Octavalent HPV with 15 mcg IMX/AAHS, or Octavalent HPV with 30 mcg
IMX/AAHS. After the safety for Phase A was reviewed, Phase B was initiated. In Phase B,
participants were randomized to qHPV, Octavalent HPV with 60 mcg IMX/AAHS or Octavalent HPV
with 120 mcg IMX/AAHS.
Inclusion Criteria:
- Participant is in good physical health
- Participant has had a lifetime history of 0 to 4 sexual partners
- Females between 18-to-24 years
Exclusion Criteria:
- Participant has a history of abnormal Pap test
- Participant has a history of positive test for HPV
- Participant has a history of recent or ongoing alcohol or drug abuse
- Participant is immunocompromised or has an autoimmune condition
- Participant has received immunosuppressive therapy within a year of screening
- Participant has previously received an HPV vaccine
- Participant is pregnant
- Participant has a history of external genital/vaginal warts
- Participant is currently enrolled in a clinical trial
- Participant has a history of a severe allergic reaction that required medical
attention
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Outcome Measure:
Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase A
Outcome Description:
The quadrivalent HPV (GARDASIL™) vaccine has types 6, 11, 16, 18, and the octavalent HPV has types 6, 11, 16, 18, 31, 45, 52, and 58. Serum antibody titres to the HPV type were obtained using a competitive Luminex immunoassay (cLIA) after vaccination with GARDASIL™ or the octavalent HPV vaccine. GMTs were calculated and are reported as the antibody concentration in milli-Merck Units per milliliter (mMU/mL) of neutralizing monoclonal antibody equivalent.
Outcome Time Frame:
4 weeks postdose 3 (Phase A)
Safety Issue:
No
Principal Investigator
Medical Monitor
Investigator Role:
Study Director
Investigator Affiliation:
Merck
Authority:
Australia: National Health and Medical Research Council
Study ID:
V502-002
NCT ID:
NCT00851643
Start Date:
April 2006
Completion Date:
November 2009
Related Keywords:
- Human Papilloma Virus
- Cervical Cancer
- Vulvar Cancer
- Vaginal Cancer
- Genital Warts
- Uterine Cervical Neoplasms
- Condylomata Acuminata
- Papilloma
- Vaginal Neoplasms
- Vulvar Neoplasms
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