Postpartum HPV Vaccination
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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. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03451071 |
Recruitment Status :
Completed
First Posted : March 1, 2018
Results First Posted : October 4, 2021
Last Update Posted : October 4, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HPV-Related Malignancy | Drug: Gardasil9 | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 195 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Health Services Research |
Official Title: | Postpartum HPV Vaccination: Acceptability, Uptake and Immunogenicity |
Actual Study Start Date : | April 29, 2019 |
Actual Primary Completion Date : | June 1, 2020 |
Actual Study Completion Date : | December 30, 2020 |
Arm | Intervention/treatment |
---|---|
Experimental: Gardasil9 |
Drug: Gardasil9
Gardasil 9 |
- Patient Indication of Willingness to Accept the Vaccine Based on Survey [ Time Frame: 1 day (at the time of initial recruitment /survey) ]This was established using a survey to indicate willingness to receive vaccine.
- Uptake of the Vaccine Doses [ Time Frame: at baseline ]Those that actually received the vaccine and each time point.
- Uptake of the Vaccine Doses [ Time Frame: at 3 months ]Those that actually received the vaccine and each time point.
- Uptake of the Vaccine Doses [ Time Frame: at 6 months ]Those that actually received the vaccine and each time point.
- Serum Titers of Vaccine-specific HPV Types [ Time Frame: baseline and 7 months ]Immunogenicity

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Ages Eligible for Study: | 16 Years to 26 Years (Child, Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- postpartum day 0-4 after vaginal or Cesarean delivery at UAB hospital
Exclusion criteria
- Fetal demise or miscarriage, autoimmune disorder, HIV, Hepatitis B/C, chronic steroid use, preeclampsia, non-English speaking

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): NCT03451071
United States, Alabama | |
University of Alabama at Birmingham | |
Birmingham, Alabama, United States, 35233 |
Documents provided by Haller Smith, University of Alabama at Birmingham:
Responsible Party: | Haller Smith, Professor, University of Alabama at Birmingham |
ClinicalTrials.gov Identifier: | NCT03451071 |
Other Study ID Numbers: |
000518236 |
First Posted: | March 1, 2018 Key Record Dates |
Results First Posted: | October 4, 2021 |
Last Update Posted: | October 4, 2021 |
Last Verified: | September 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | Yes |
Neoplasms |