NCT04311528

9-valent HPV Vaccine in Postpartum Women

Immunogenicity, Compliance, Knowledge and Attitudes in Postpartum Women During a Two Dose 9-valent HPV Vaccination Series

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Augusta University · Academic / Other
• Sex: Female
• Age: 16 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate the immunogenicity of the 9-valent HPV vaccine in post-partum women age 16-45.

Detailed description

Women age 16-45 who are pregnant or who have just delivered will be eligible to participate in a study involving the 9-valent HPV vaccine. For clarification, women who are pregnant are eligible to sign consent, but the first vaccine will not occur until after delivery. Vaccine # 1 must occur within seven days of delivery. The main objective of the study is to determine the immunogenicity of the vaccine in postpartum women. The immunogenicity results will be compared to that of non-postpartum women of the same age, 16-45. Women will participate for approximately 12 months and will complete a total of 4 visits during that time frame.

Conditions

• Human Papilloma Virus

Interventions

Type	Name	Description
BIOLOGICAL	9-valent HPV vaccine	9-valent HPV vaccine

Timeline

• Start date: 2020-04-01
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2020-03-17
• Last updated: 2020-03-17

Regulatory

• FDA-regulated drug study