Status:
COMPLETED
Broad Spectrum HPV Vaccine Dose Escalation Study (V502-002)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Human Papilloma Virus
Cervical Cancer
Eligibility:
FEMALE
18-24 years
Phase:
PHASE1
Brief Summary
This study will examine the safety and tolerability of octavalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) vaccine formulated with amorphous aluminum hydroxysulfate (AAHS) and ISCOMATRI...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
158 Patients enrolled
Trial Details
Trial ID
NCT00851643
Start Date
April 1 2006
End Date
November 1 2009
Last Update
February 3 2016
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.