Trial Outcomes & Findings for Safety Study of GSK Biologicals' HPV Vaccine (GSK-580299) in Healthy Female Subjects. (NCT NCT00811798)
NCT ID: NCT00811798
Last Updated: 2016-10-20
Results Overview
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.
COMPLETED
PHASE3
92 participants
During the entire study period (Day 0 up to the telephone contact at Month 12).
2016-10-20
Participant Flow
Participant milestones
| Measure |
Cervarix Group
Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|
|
Overall Study
STARTED
|
92
|
|
Overall Study
COMPLETED
|
92
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety Study of GSK Biologicals' HPV Vaccine (GSK-580299) in Healthy Female Subjects.
Baseline characteristics by cohort
| Measure |
Cervarix Group
n=92 Participants
Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|
|
Age, Continuous
|
30.8 Years
STANDARD_DEVIATION 4.14 • n=5 Participants
|
|
Sex: Female, Male
Female
|
92 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During the entire study period (Day 0 up to the telephone contact at Month 12).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.
Outcome measures
| Measure |
Cervarix Group
n=92 Participants
Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|
|
Number of Subjects Reporting Any Serious Adverse Event (SAE) and SAE(s) With a Causal Relationship to Vaccination as Assessed by the Investigator.
Any
|
3 Subjects
|
|
Number of Subjects Reporting Any Serious Adverse Event (SAE) and SAE(s) With a Causal Relationship to Vaccination as Assessed by the Investigator.
Related
|
0 Subjects
|
Adverse Events
Cervarix Group
Serious adverse events
| Measure |
Cervarix Group
n=92 participants at risk
Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|
|
Pregnancy, puerperium and perinatal conditions
Abortion missed
|
1.1%
1/92 • Serious adverse events: Throughout the study period from Day 0 up to Month 12.
Only serious advers events have been assessed during the study and no other symptoms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign hydatidiform mole
|
1.1%
1/92 • Serious adverse events: Throughout the study period from Day 0 up to Month 12.
Only serious advers events have been assessed during the study and no other symptoms.
|
|
Investigations
Hepatic enzyme increased
|
1.1%
1/92 • Serious adverse events: Throughout the study period from Day 0 up to Month 12.
Only serious advers events have been assessed during the study and no other symptoms.
|
Other adverse events
Adverse event data not reported
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER