Clinical trial · Observational
Post-marketing Surveillance of GSK Biologicals' Cervarix™ When Administered to Healthy Females in Sri Lanka
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of clarity regarding the PMS study requirement from the RA and Ethics committee hence it was concluded GSK will submit local PSURs
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Human Papillomavirus Infection | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cervarix data collection | Other | — | UNRESOLVED |
| Data Collection | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Cohort Group
- description
- 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.
- interventionNames
- Other: Cervarix data collection
- Other: Data Collection
Primary outcomes (6)
- 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
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 10 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available