Clinical trial NCT01551537: Post-marketing Surveillance of GSK Biologicals' Cervarix™ When Administered to Healthy Females in Sri Lanka
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
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Human Papillomavirus Infection
Keywords: Healthy females
Post-marketing surveillance (PMS)
Human papillomavirus vaccine
Sri Lanka
Cervarix
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2012-03-12
Enrollment: 0
Sex: FEMALE
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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 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.

Primary outcomes:
measure: Occurrence of solicited local adverse events (AEs).
timeFrame: During the 7-day period (Days 0-6) following any dose of Cervarix and overall.
measure: Occurrence of solicited general AEs.
timeFrame: During the 7-day period (Days 0-6) following any dose of Cervarix and overall.
measure: Occurrence of unsolicited AEs.
timeFrame: During the 30-day period (Days 0-29) following any dose of Cervarix and overall.
measure: Occurrence of any Serious adverse events (SAEs) and SAE(s) causally related to vaccination.
timeFrame: Throughout the PMS study period (up to six months after the last dose of Cervarix).
measure: Occurrence of potential Immune-Mediated Diseases (pIMDs).
timeFrame: Throughout the PMS study period (up to six months after the last dose of Cervarix).
measure: Occurrence of Medically Significant Condition (MSCs).
timeFrame: Throughout the PMS study period (up to six months after the last dose of Cervarix).
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: