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Post-marketing Study to Assess the Safety of CERVARIX When Used in the United States and in Canada

NCT01290393 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 2

Last updated 2018-07-26

No results posted yet for this study

Summary

This study will assess the risk of spontaneous abortion during weeks 1-19 of gestation, and other pregnancy outcomes, in an Exposed vaccinated cohort, i.e. women with last menstrual period between 30 days before and 90 days after any dose of CERVARIX, when compared to a Non-exposed vaccinated cohort, i.e. women with last menstrual period between 120 days and 18 months after the last CERVARIX or GARDASIL dose.

Conditions

  • Infections, Papillomavirus

Interventions

OTHER

Data collection

Data collection from hard copy interview forms routinely used by the Organization of Teratology Information Specialists (OTIS).

Sponsors & Collaborators

  • The Organization of Teratology Information Specialists

    collaborator OTHER

  • GlaxoSmithKline

    lead INDUSTRY

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Eligibility

Min Age
15 Years
Max Age
25 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-09-26
Primary Completion
2012-12-20
Completion
2012-12-20

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT01290393 on ClinicalTrials.gov