9-valent HPV Vaccine in Postpartum Women
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04311528|
Recruitment Status : Not yet recruiting
First Posted : March 17, 2020
Last Update Posted : March 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|Human Papilloma Virus||Biological: 9-valent HPV vaccine||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||open label; all subjects will receive the 9-valent HPV vaccine|
|Masking:||None (Open Label)|
|Official Title:||Immunogenicity, Compliance, Knowledge and Attitudes in Postpartum Women During a Two Dose 9-valent HPV Vaccination Series|
|Estimated Study Start Date :||April 1, 2020|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2021|
- Biological: 9-valent HPV vaccine
9-valent HPV vaccine
- Geometric mean titer [ Time Frame: Day 0, Month 7 and Month 12 ]immunogenicity testing using 9-plex competitive Luminex Immuno Assay (9-plex cLIA)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04311528
|Contact: Angela Goebel, BSfirstname.lastname@example.org|
|Contact: Daron Ferris, MDemail@example.com|