Clinical trial · Observational
Post-marketing Study to Assess the Safety of CERVARIX When Used in the United States and in Canada
Post-marketing Safety Study to Assess the Risk of Spontaneous Abortion Following Administration of CERVARIX in the United States and Canada
NCT01290393CI-TRIAL-00034000terminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low accrual of subjects primarily attributable to the low uptake of Cervarix in the US and Canada in women aged 15 to 25 years of age.
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Infections, Papillomavirus | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Data collection | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Exposed vaccinated cohort
- description
- 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.
- interventionNames
- Other: Data collection
- label
- Non-exposed vaccinated cohort
- description
- 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.
- interventionNames
- Other: Data collection
Primary outcomes (1)
- 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 (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 15 Years
- Maximum age
- 25 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.