Status:
COMPLETED
HPV Vaccination Study in Postpartum Women
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
HPV
Immunization
Eligibility:
FEMALE
15-45 years
Phase:
PHASE4
Brief Summary
The human papillomavirus (HPV) is the most common sexually transmitted infection (STI) in the United States (U.S.) and is responsible for a wide range of conditions, including cancers within the anoge...
Detailed Description
This is a pilot, non-inferiority clinical trial using historical controls. Participants will have whole blood drawn at 0 months, 6 months, and 7 months and receive the HPV vaccine at 0 months, 6 month...
Eligibility Criteria
Inclusion
- Participants biologically born as females between the ages of 15 through 45 who have delivered a live born baby within the past 72 hours.
Exclusion
- Pregnancy
- Severe allergic reaction to vaccine components
- Prior receipt of an HPV vaccine dose
- Fetal demise or stillbirth
- Allergy to latex or yeast
- Moderate or severe acute illness (deemed by the investigator to exclude)
- Immunosuppression (e.g., HIV, solid organ transplant).
Key Trial Info
Start Date :
August 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2023
Estimated Enrollment :
225 Patients enrolled
Trial Details
Trial ID
NCT04274153
Start Date
August 3 2020
End Date
February 1 2023
Last Update
August 29 2023
Active Locations (2)
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1
Johns Hopkins University
Baltimore, Maryland, United States, 21205
2
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224