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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


N/A
10 Years
N/A
Not Enrolling
Female
Human Papillomavirus Infection

Thank you

Trial Information

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


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.


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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Occurrence of solicited local adverse events (AEs).

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

Sri Lanka: Cosmetics, Devices and Drug Regulatory Authority

Study ID:

113763

NCT ID:

NCT01551537

Start Date:

April 2013

Completion Date:

April 2014

Related Keywords:

  • Human Papillomavirus Infection
  • Healthy females
  • Post-marketing surveillance (PMS)
  • Human papillomavirus vaccine
  • Sri Lanka
  • Cervarix
  • Warts
  • Papillomavirus Infections

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