Broad Spectrum HPV Vaccine Dose Ranging Study (V502-001)

Cervical Cancer Clinical Trial

Official title:

A Randomized, International, Double-Blinded (With In-House Blinding), GARDASIL-Controlled, Dose-Ranging Study of Octavalent Human Papillomavirus (HPV) L1 Virus-like Particle (VLP) Vaccine Administered to 16- to 23- Year-Old Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00260039
• Other study ID #: V502-001
• Secondary ID: 2005_086
• Status: Completed
• Phase: Phase 2
• First received: November 28, 2005
• Last updated: June 5, 2015
• Start date: December 2005
• Est. completion date: August 2007

Study information

• Verified date: June 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This dose-ranging study is to evaluate an investigational vaccine with the following objectives: (1) To demonstrate that the vaccine is well-tolerated in women (2) To evaluate immune responses in women who are between 16 and 23 years of age at enrollment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 680
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 23 Years

Eligibility

Inclusion Criteria:

• Lifetime history of 0-4 sexual partners

Exclusion Criteria:

• History of abnormal PAP test or abnormal cervical biopsy result; history of external genital/vaginal warts; history of positive HPV test

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cervical Cancer
• HPV
• Premalignancy Anogenital Warts
• Uterine Cervical Neoplasms

Intervention

Biological:
• Comparator: Gardasil
0.5 mL intramuscular injection administered at Day 1, Month 2 and Month 6
• Comparator: octavalent HPV Vaccine - dose formulation 1
0.5 mL octavalent HPV vaccine - intramuscular injection administered at Day 1, Month 2 and Month 6
• Comparator: octavalent HPV Vaccine - dose formulation 2
0.5 mL octavalent HPV vaccine - intramuscular injection administered at Day 1, Month 2 and Month 6
• Comparator: octavalent HPV Vaccine - dose formulation 3
0.5 mL octavalent HPV vaccine - intramuscular injection administered at Day 1, Month 2 and Month 6

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Luxembourg A, Brown D, Bouchard C, Giuliano AR, Iversen OE, Joura EA, Penny ME, Restrepo JA, Romaguera J, Maansson R, Moeller E, Ritter M, Chen J. Phase II studies to select the formulation of a multivalent HPV L1 virus-like particle (VLP) vaccine. Hum Vaccin Immunother. 2015;11(6):1313-22. doi: 10.1080/21645515.2015.1012010. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The octavalent HPV VLP vaccine, when administered in a 3-dose regimen, induces acceptable responses for specific HPV types at 4 weeks Post dose 3. Immune responses measured by an HPV competitive Luminex immunoassay.		4 weeks post dose 3 injection	No