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

NCT ID: NCT01290393

Last Updated: 2018-07-26

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 2 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-09-26
• Study Completion Date: 2012-12-20

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.

Conditions

Infections, Papillomavirus

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Exposed vaccinated cohort

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.

Data collection

Intervention Type: OTHER

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

Non-exposed vaccinated cohort

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.

Data collection

Intervention Type: OTHER

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

Interventions

Data collection

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

The Organization of Teratology Information Specialists

OTHER

Sponsor Role: collaborator

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

San Diego, California, United States

Countries

United States

Other Identifiers

114176

Identifier Type: -

Identifier Source: org_study_id