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

NCT01290393 | Terminated

• 1 other identifier: 114176
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Infections, Papillomavirus

Keywords

vaccine; Spontaneous abortions; Human papillomavirus; HPV; Cervarix; pregnancy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Occurrence of other adverse pregnancy outcomes

  This outcome measure will be recorded between zero and six weeks after end of pregnancy

Study Arms (2)

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.

Other: Data collection

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.

Other: Data collection

Interventions

Data collection OTHER

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

Exposed vaccinated cohort; Non-exposed vaccinated cohort

Eligibility Criteria

• Age: 15 Years - 25 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women aged 15 to 25 years and residing in the United States or in Canada

You may qualify if:

• 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.
• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead
• The Organization of Teratology Information Specialists: collaborator

Study Sites (1)

GSK Investigational Site

San Diego, California, 92123, United States

Location

MeSH Terms

Conditions

Papillomavirus Infections; Abortion, Spontaneous

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2011
• First Posted: February 7, 2011
• Study Start: September 26, 2011
• Primary Completion: December 20, 2012
• Study Completion: December 20, 2012
• Last Updated: July 26, 2018

Record last verified: 2018-07

Locations

US (1)