Infections, Papillomavirus Clinical Trial
Official title:
Post-marketing Safety Study to Assess the Risk of Spontaneous Abortion Following Administration of CERVARIX in the United States and Canada
Verified date | July 2018 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Terminated |
Enrollment | 2 |
Est. completion date | December 20, 2012 |
Est. primary completion date | December 20, 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 15 Years to 25 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | GSK Investigational Site | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline | The Organization of Teratology Information Specialists |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Occurrence of other adverse pregnancy outcomes | This outcome measure will be recorded between zero and six weeks after end of pregnancy |
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