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

Terminated

• Conditions: Infections, Papillomavirus
• Interventions: Other: Data collection

• Registration Number: NCT01290393
• Lead Sponsor: GlaxoSmithKline

Brief 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.

Study Timeline

• Study First Submitted: 2011-02-03
• Study First Submitted QC: 2011-02-03
• Study First Posted: 2011-02-07
• Study Start: 2011-09-26
• Primary Completion: 2012-12-20
• Study Completion: 2012-12-20
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-25
• Last Update Posted: 2018-07-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 2

Inclusion Criteria

For Exposed vaccinated cohort:

• Written informed consent, and assent in case of minors, obtained from the subject/from the parent(s)/legally acceptable representative(s) of the subject.
• Aged between, and including, 15 and 25 years of age.
• Residing within the US or Canada.
• Subjects who received at least one dose of CERVARIX.
• Gestational age at inclusion should be 19 completed weeks (i.e. 133 days of gestation) or less.
• Last menstrual period between 30 days before and 90 days after any dose of CERVARIX with a maximum of 20% of subjects with last menstrual period between 46 and 90 days after any dose of CERVARIX.
• Subjects who the Investigator believes can and will comply with the requirements of the protocol (e.g. available for phone interviews). Or subjects who the Investigator believes that parent(s)/legally acceptable representative(s) can and will comply with the requirements of the protocol.

For Non-exposed vaccinated cohort:

• Written informed consent, and assent in case of minors, obtained from the subject/from the parent(s)/legally acceptable representative(s) of the subject.
• Aged between, and including, 15 and 25 years of age.
• Residing within the US or Canada.
• Subjects who received at least one dose of CERVARIX or at least one dose of GARDASIL.
• Gestational age at inclusion should be 19 completed weeks (i.e. 133 days of gestation) or less.
• Last menstrual period between 120 days and 18 months after the last dose of CERVARIX/ GARDASIL.
• Subjects who the Investigator believes can and will comply with the requirements of the protocol (e.g. available for phone interviews). Or subjects who the Investigator believes that parent(s)/legally acceptable representative(s) can and will comply with the requirements of the protocol.

Exclusion Criteria

For Exposed vaccinated cohort:

• Last menstrual period between 30 days before and 90 days after any GARDASIL dose.
• Ongoing pregnancy with foetus known to be non-viable.
• Ongoing pregnancy with pre-enrolment knowledge by prenatal diagnosis of a major structural defect.
• Use of any investigational or non-registered product (drug or vaccine) during the study period.

For Non-exposed vaccinated cohort:

• Ongoing pregnancy with foetus known to be non-viable.
• Ongoing pregnancy with pre-enrolment knowledge by prenatal diagnosis of a major structural defect.
• Use of any investigational or non-registered product (drug or vaccine) during the study period.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Exposed vaccinated cohort	Data collection	Women with last menstrual period between 30 days before and 90 days after any CERVARIX dose. The target sample size of the Exposed vaccinated cohort is 150 subjects.
Non-exposed vaccinated cohort	Data collection	Women with last menstrual period between 120 days and 18 months after the last CERVARIX or GARDASIL dose. The target sample size of the Non-exposed vaccinated cohort is 300 subjects.

Primary Outcome Measures

Name	Time	Method
Occurrence of spontaneous abortion during weeks 1-19 of gestation	This outcome measure will be recorded between zero and six weeks after end of pregnancy

Secondary Outcome Measures

Name	Time	Method
Occurrence of other adverse pregnancy outcomes	This outcome measure will be recorded between zero and six weeks after end of pregnancy

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 San Diego, California, United States