Post-marketing Surveillance of GSK Biologicals' Cervarix™ When Administered to Healthy Females in Sri Lanka

This study has been withdrawn prior to enrollment.
(Lack of clarity regarding the PMS study requirement from the RA and Ethics committee hence it was concluded GSK will submit local PSURs)
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01551537
First received: March 8, 2012
Last updated: September 5, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Human Papillomavirus Infection
Other: Cervarix data collection
Other: Data Collection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-marketing Surveillance (PMS) of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) -16/18 Vaccine, Cervarix™ When Administered to Healthy Females According to the Prescribing Information in Sri Lanka

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence of solicited local adverse events (AEs). [ Time Frame: During the 7-day period (Days 0-6) following any dose of Cervarix and overall. ] [ Designated as safety issue: No ]
  • Occurrence of solicited general AEs. [ Time Frame: During the 7-day period (Days 0-6) following any dose of Cervarix and overall. ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited AEs. [ Time Frame: During the 30-day period (Days 0-29) following any dose of Cervarix and overall. ] [ Designated as safety issue: No ]
  • Occurrence of any Serious adverse events (SAEs) and SAE(s) causally related to vaccination. [ Time Frame: Throughout the PMS study period (up to six months after the last dose of Cervarix). ] [ Designated as safety issue: No ]
  • Occurrence of potential Immune-Mediated Diseases (pIMDs). [ Time Frame: Throughout the PMS study period (up to six months after the last dose of Cervarix). ] [ Designated as safety issue: No ]
  • Occurrence of Medically Significant Condition (MSCs). [ Time Frame: Throughout the PMS study period (up to six months after the last dose of Cervarix). ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: April 2013
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 collection
Safety monitoring: recording of all AEs during the study period using diary cards, follow-up visit or telephone contact.
Other: Data Collection
All adverse events will be recorded by diary card, follow-up visit or telephone contact.

Detailed Description:

Subjects who received one or two doses of Cervarix prior to the start of this PMS study can also be enrolled in the study. These subjects would receive either 2 doses or 1 dose respectively after being enrolled in the study.

Since there is lack of clarity regarding the PMS study requirement (both from Regulatory agency and Ethics Committee), it was decided that GSK will submit Local PSURs on a regular basis as desired by Local regulatory agency. The same is communicated to Regulatory agency and if they want something more they are requested to revert back with specific requirements.

  Eligibility

Ages Eligible for Study:   10 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-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.

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01551537

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01551537     History of Changes
Other Study ID Numbers: 113763
Study First Received: March 8, 2012
Last Updated: September 5, 2013
Health Authority: Sri Lanka: Cosmetics, Devices and Drug Regulatory Authority

Keywords provided by GlaxoSmithKline:
Healthy females
Post-marketing surveillance (PMS)
Human papillomavirus vaccine
Sri Lanka
Cervarix

Additional relevant MeSH terms:
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections

ClinicalTrials.gov processed this record on August 19, 2014