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Crossover Vaccination of Women Previously Randomized Into Protocol 04-C-N191

NCT01086709 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 5444

Last updated 2018-04-05

No results posted yet for this study

Summary

Background:

\- National Cancer Institute Protocol 04-C-N191, also known as the Costa Rica Vaccine Trial, was a double-blind controlled study of the effectiveness of an experimental human papillomavirus (HPV) vaccine in preventing cervical cancer in young women in Costa Rica. Costa Rica was part of the first large study to show the association between HPV and cervical cancer, and the study contributed greatly to the understanding of this association. The women who have participated in the vaccine trial in Costa Rica are reaching the end of the follow-up period offered in the vaccine trial protocol, and as a result they are being offered the chance to have complementary vaccinations against HPV, hepatitis A, and hepatitis B.

Objectives:

* To offer participants in the Costa Rica Vaccine Trial the vaccine that they did not receive during the masked portion of the trial (HPV vaccine or hepatitis A vaccine) and hepatitis B vaccination.
* To collect information about exposure to known and suspected risk factors for HPV infection and cervical cancer from women who are receiving vaccination against HPV at crossover.

Eligibility:

\- Women who participated in National Cancer Institute Protocol 04-C-N191.

Design:

* All participants will be offered vaccination against hepatitis B.
* Women who received the hepatitis A vaccine during the trial will be offered vaccination against HPV.
* Women who received the HPV vaccine during the trial will be offered vaccination against hepatitis A.
* Appropriate vaccinations (including a combined hepatitis A and hepatitis B vaccine) will be available to reduce the number of injections that participants will be asked to receive.
* All vaccines will be given according to the manufacturer's specifications for appropriate length of time between vaccine doses.

Conditions

  • Cervical Neoplasia
  • HPV Infections

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Allan Hildesheim, Ph.D. · National Cancer Institute (NCI)

Eligibility

Min Age
21 Years
Max Age
30 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-01-27
Completion
2015-03-17

Countries

  • Costa Rica

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01086709 on ClinicalTrials.gov