NCT01551537

Brief Summary

This PMS study aims to collect safety and reactogenicity data of Cervarix in the local population as per the licensing requirement of the Sri Lankan regulatory authority.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2013

Shorter than P25 for all trials

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 12, 2012

Completed
1.1 years until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

September 9, 2013

Status Verified

September 1, 2013

Enrollment Period

1 year

First QC Date

March 8, 2012

Last Update Submit

September 5, 2013

Conditions

Human Papillomavirus Infection

Keywords

Healthy femalesPost-marketing surveillance (PMS)Human papillomavirus vaccineSri LankaCervarix

Outcome Measures

Primary Outcomes (6)

  • Occurrence of solicited local adverse events (AEs).

    During the 7-day period (Days 0-6) following any dose of Cervarix and overall.

  • Occurrence of solicited general AEs.

    During the 7-day period (Days 0-6) following any dose of Cervarix and overall.

  • Occurrence of unsolicited AEs.

    During the 30-day period (Days 0-29) following any dose of Cervarix and overall.

  • Occurrence of any Serious adverse events (SAEs) and SAE(s) causally related to vaccination.

    Throughout the PMS study period (up to six months after the last dose of Cervarix).

  • Occurrence of potential Immune-Mediated Diseases (pIMDs).

    Throughout the PMS study period (up to six months after the last dose of Cervarix).

  • Occurrence of Medically Significant Condition (MSCs).

    Throughout the PMS study period (up to six months after the last dose of Cervarix).

Study Arms (1)

Cohort Group

Healthy females aged 10 years and above will receive 1, 2 or 3 doses of Cervarix as per the Prescribing Information (PI) in Sri Lanka.

Other: Cervarix data collectionOther: Data Collection

Interventions

Cervarix data collectionOTHER

Safety monitoring: recording of all AEs during the study period using diary cards, follow-up visit or telephone contact.

Cohort Group
Data CollectionOTHER

All adverse events will be recorded by diary card, follow-up visit or telephone contact.

Cohort Group

Eligibility Criteria

Age10 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy females aged 10 years and above who will receive Cervarix as a part of routine practice as per the PI in Sri Lanka.

You may qualify if:

  • Subjects who the investigator believes that they and/or their parent(s)/ LAR(s) can and will comply with the requirements of the protocol should be enrolled in the PMS study.
  • A female aged 10 years and above at the time of the first vaccination.
  • Written informed consent obtained from the subject. For subjects below the legal age of consent, written informed consent must be obtained from the parent(s)/LAR(s) of the subject and informed assent must be obtained from the subject. Where subject/subject's parent(s)/LAR(s) are illiterate, the consent form will be countersigned by an impartial witness.
  • Subjects of childbearing potential must not be pregnant. Absence of pregnancy should be verified as per the investigator's clinical judgement.

You may not qualify if:

  • Subjects with contraindication according to the locally approved PI.
  • Child in care.
  • Previous administration of more than two doses of Cervarix.
  • Previous vaccination with a HPV vaccine other than Cervarix.
  • Planned administration of another HPV vaccine other than Cervarix during the PMS study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Papillomavirus Infections

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR
0

Study Design

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

Study Record Dates

First Submitted

March 8, 2012

First Posted

March 12, 2012

Study Start

April 1, 2013

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

September 9, 2013

Record last verified: 2013-09