A Phase 3 interventional study of Cervarix in Infections, Papillomavirus, sponsored by GlaxoSmithKline. Completed at 1 site in Hong Kong. Open to female participants aged 25 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-10-20.
Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Prevention
This study will collect safety data of GlaxoSmithKline Biologicals' human papillomavirus (HPV) vaccine in healthy females of Chinese origin who are unable to receive all three doses of commercially available HPV vaccine before they are 25 years, and were placebo recipients in the primary study (NCT00306241).
GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Biological: Cervarix
Subjects will receive three doses of the HPV vaccine administered intramuscularly according to a 0, 1, 6 month vaccination schedule.
Number of Subjects Reporting Any Serious Adverse Event (SAE) and SAE(s) With a Causal Relationship to Vaccination as Assessed by the Investigator.
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
Time frame: During the entire study period (Day 0 up to the telephone contact at Month 12).
| Milestone | Cervarix Group |
|---|---|
| Started | 92 |
| Completed | 92 |
| Not completed | 0 |
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
| Subjects | Cervarix Group |
|---|---|
| Any | 3 |
| Related | 0 |
Collected over Serious adverse events: Throughout the study period from Day 0 up to Month 12.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cervarix Group | — | 3/92 (3.3%) | — |
| Event | Cervarix Group |
|---|---|
| Abortion missedPregnancy, puerperium and perinatal conditions | 1/92 |
| Benign hydatidiform moleNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/92 |
| Hepatic enzyme increasedInvestigations | 1/92 |
| Age, Continuous(Years) | Cervarix Group |
|---|---|
| Mean | 30.8 ± 4.14 |
| Sex: Female, Male(Participants) | Cervarix Group |
|---|---|
| Female | 92 |
| Male | 0 |
Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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