NCT01290393

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

Post-marketing Safety Study to Assess the Risk of Spontaneous Abortion Following Administration of CERVARIX in the United States and Canada

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 2 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Female
• Age: 15 Years – 25 Years
• Healthy volunteers: Accepted

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.

Detailed description

The present study will be conducted by the OTIS (Organization of Teratology Information Specialists) network. OTIS is a non-profit organization specialised to assess exposures during pregnancy and dedicated to providing accurate evidence-based, clinical information to patients and health care professionals about exposures during pregnancy and lactation. OTIS is based on voluntary phone calls. Women call when they have questions and concerns about risks potentially associated with any kind of exposure during pregnancy or breastfeeding, including medications, chemicals, pesticides, diseases, infections, and vaccinations.

Conditions

• Infections, Papillomavirus

Interventions

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

Timeline

• Start date: 2011-09-26
• Primary completion: 2012-12-20
• Completion: 2012-12-20
• First posted: 2011-02-07
• Last updated: 2018-07-26

Locations

1 site across 1 country: United States