Post-marketing Safety Study to Assess the Risk of Spontan... | NCT01905462

Studies
Post-marketing Safety Study to Assess the Risk of Spontaneous Abortions in Women Exposed to Cervarix Residing in UK

NCT01905462

Sponsor

GlaxoSmithKline

Status

Completed

Last Update Posted

Sep 30, 2013Estimated

Enrollment

1,046Actual

Phase

Not provided

Conditions

Infections, Papillomavirus

Interventions

Data Collection
Cervarix

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2012

Primary Completion Date

Aug 2013Actual

Completion Date

Aug 2013Actual

First Submitted Date

Jul 18, 2013

First Submission Date that Met QC Criteria

Jul 18, 2013

First Posted Date

Jul 23, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 26, 2013

Last Update Posted Date

Sep 30, 2013Estimated

Name	Class
Clinical Practice Research Datalink	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study will assess the risk of spontaneous abortion during weeks 1-23 and weeks 1-19 of gestation, respectively, and other pregnancy outcomes, in an exposed cohort, i.e. women with last menstrual period (LMP) between 30 days before and 45 days after, or 30 days before and 90 days after any dose of Cervarix, when compared to a non-exposed cohort, i.e. women with LMP between 120 days and 18 months after the last Cervarix dose. The data collected in the Clinical Practice Research Datalink General Practitioner OnLine Database (CPRD GOLD) in the UK, will be analysed in this study.

Detailed Description

Convenience sampling will be used in this study. It is planned to include all eligible pregnant women (included in CPRD GOLD and who fulfil to the inclusion/exclusion criteria) in each of the two cohorts.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,046Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Exposed cohort		Women with the first day of LMP between 30 days before and 45 days after any Cervarix dose and between 30 days before and 90 days after any Cervarix dose.	Other: Data Collection Biological: Cervarix
Non-exposed cohort		Women with the first day of LMP between 120 days and 18 months after their last Cervarix dose (and no further Cervarix dose before the outcome).	Other: Data Collection Biological: Cervarix

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Data Collection	Other	Analyses of data collected within the CPRD GOLD database.	Exposed cohort Non-exposed cohort

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Occurrence of spontaneous abortion		Weeks 1-23 of gestation

Secondary Outcomes

Measure	Description	Time Frame
Occurrence of spontaneous abortion		Weeks 1-19 of gestation
Occurrence of other pregnancy outcomes	Induced/therapeutic and other abortions; Stillbirth; Birth defects identified among all pregnancies with known outcome classified as live births, stillbirths and abortions. For live births, birth defects identified within the first 12 weeks of life will be included; Small/large for gestational age at birth; Pre-term and post-term delivery.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

For the exposed cohort:

All subjects must satisfy all of the following criteria at entry into the exposed cohort:

Full date of first day of LMP available in the database or calculated from Estimated date of delivery (EDD).
Female, aged between, and including, 15 and 25 years of age at LMP.
Recorded in the CPRD GOLD for at least 12 months at LMP.
First day of LMP available in the database or calculated from EDD between September 1st 2008 and June 30th 2011.
At least one dose of Cervarix received between September 1st 2008 and June 30th 2011.
Full date of Cervarix vaccination(s) available.
First day of LMP available in the database or calculated from EDD between 30 days before and 90 days after any dose of Cervarix.
Subject defined as acceptable in CPRD GOLD.

For the non-exposed cohort:

All subjects must satisfy all of the following criteria at entry into the non-exposed cohort:

Full date of first day of LMP available in the database or calculated from EDD.
Female, aged between, and including, 15 and 25 years of age at LMP.
Recorded in the CPRD GOLD since at least 12 months at LMP.
First day of LMP available in the database or calculated from EDD between September 1st 2008 and June 30th 2011.
At least one dose of Cervarix received between September 1st 2008 and June 30th 2011.
Full date of Cervarix vaccination(s) available.
First day of LMP available in the database or calculated from EDD between 120 days and 18 months after the last dose of Cervarix.
Subject defined as acceptable in CPRD GOLD.

Exclusion Criteria:

For the exposed cohort:

• Female with the first day LMP between 30 days before and 90 days after at least one dose of unspecified Human Papillomavirus vaccine and/or Gardasil.

For the non-exposed cohort:

Female with the first day LMP between 30 days before and 90 days after at least one dose of unspecified Human Papillomavirus vaccine and/or Gardasil.
Female included for a previous pregnancy in the exposed cohort.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

25 Years

Standard Ages

ChildAdult

Study Population

Pregnant women aged 15 to 25 years, residing in UK, exposed to Cervarix and whose data is recorded in the CPRD GOLD.

Sampling Method

Non-Probability Sample

ID	Term
D030361	Papillomavirus Infections
D000022	Abortion, Spontaneous

ID	Term
D015229	Sexually Transmitted Diseases, Viral
D012749	Sexually Transmitted Diseases
D003141	Communicable Diseases
D007239	Infections

ID	Term
D003625	Data Collection
C510352	human papillomavirus vaccine, L1 type 16, 18

ID	Term
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms
D011787	Quality of Health Care