Clinical trial NCT01290393: Post-marketing Study to Assess the Safety of CERVARIX When Used in the United States and in Canada
Official title: Post-marketing Safety Study to Assess the Risk of Spontaneous Abortion Following Administration of CERVARIX in the United States and Canada
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Infections, Papillomavirus
Keywords: vaccine
Spontaneous abortions
Human papillomavirus
HPV
Cervarix
pregnancy
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: The Organization of Teratology Information Specialists
First posted: 2011-02-07
Enrollment: 2
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women aged 15 to 25 years and residing in the United States or in Canada

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.

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.

Primary outcomes:
measure: Occurrence of spontaneous abortion during weeks 1-19 of gestation
timeFrame: This outcome measure will be recorded between zero and six weeks after end of pregnancy
Secondary outcomes:
measure: Occurrence of other adverse pregnancy outcomes
timeFrame: This outcome measure will be recorded between zero and six weeks after end of pregnancy
Other outcomes:
Locations:
city: San Diego
country: United States
facility: GSK Investigational Site
state: California
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: