Status:
COMPLETED
Preparedness Study - HPV Vaccine
Lead Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Sexual Transmission of Infection
Eligibility:
FEMALE
16-24 years
Phase:
NA
Brief Summary
Moffitt Cancer Center is the Coordinating Center for this study. The purpose of this study is to develop and test the infrastructure to conduct a future Phase III vaccine efficacy trial to assess tri...
Detailed Description
The study vaccine will be blindly administered as supplied on Day 1, Month 2, and Month 6. Both HPV and placebo vaccines will be in identical bottles, and all treatment codes will be kept under lock a...
Eligibility Criteria
Inclusion
- Women ages 16-24 years of age residing in a region of South Africa with a high HIV incidence and prevalence
- HIV negative
- has ever had vaginal intercourse
- has never had Papanicolaou smear (Pap) testing or has only had normal Pap test results
- fully understands study procedures, risks involved in the study, and voluntarily agrees to participate by giving written informed consent
- agrees to refrain from douching/vaginal cleansing and using vaginal medications or preparations for 2 calendar days prior to the Day 1 visit as well as other future visits that include collection of cervical specimens
- agrees to refrain from sexual intercourse for 2 calendar days prior to the Day 1 visit as well as other future visits that include collection of cervical specimens
- agrees to utilize effective contraception during sexual intercourse (excluding the rhythm method, withdrawal alone, and emergency contraception) during the vaccination period.
- Informed consent procedures for females \<18 years of age: Informed consent and informed assent will be obtained from parents/legal guardians and adolescents respectively, prior to participation. The consent form will include information about the study and individual request for consent of participants to participate in the study. It will be emphasized that participation is voluntary and that participants are free to withdraw from the study at any stage without any disadvantage to them. An assessment of understanding will be conducted at screening to ensure that consent is informed.
Exclusion
- have a history of severe allergic reaction
- have a known allergy to any vaccine component (e.g., aluminum, yeast, or BENZONASE)
- are currently immuno-compromised
- have received a marketed HPV vaccine, or are pregnant and lactating
Key Trial Info
Start Date :
September 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
406 Patients enrolled
Trial Details
Trial ID
NCT01489527
Start Date
September 1 2012
End Date
December 1 2014
Last Update
February 6 2015
Active Locations (2)
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1
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
2
Stellenbosch University
Parow, South Africa, South Africa, 7505