Trial Outcomes & Findings for Safety Study of GSK Biologicals' Human Papillomavirus Vaccine in 580299/008 Subjects From Brazil, Taiwan or Thailand (NCT NCT00849381)
NCT ID: NCT00849381
Last Updated: 2014-09-12
Results Overview
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Note: Results from one center where compliance issues were discovered are presented also separately.
COMPLETED
PHASE3
1239 participants
During the entire study period (up to Month 12)
2014-09-12
Participant Flow
Subjects enrolled in this study were previously enrolled in the Control Group in the primary study (NCT00122681), where they had received Hepatitis A vaccination.
Results from one study center where compliance issues were discovered were presented both separately from the entire study cohort, as well as included in it. Out of the 1239 subjects enrolled in this study, 2 did not receive vaccination and were hence eliminated from the study.
Participant milestones
| Measure |
Cervarix Group
Subjects who received the Hepatitis A control vaccine in the primary study (NCT00122681) and the Cervarix vaccine in the current study.
|
|---|---|
|
Overall Study
STARTED
|
1237
|
|
Overall Study
COMPLETED
|
1092
|
|
Overall Study
NOT COMPLETED
|
145
|
Reasons for withdrawal
| Measure |
Cervarix Group
Subjects who received the Hepatitis A control vaccine in the primary study (NCT00122681) and the Cervarix vaccine in the current study.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Lost to Follow-up
|
129
|
|
Overall Study
Protocol Violation
|
5
|
|
Overall Study
Withdrawal by Subject
|
6
|
|
Overall Study
Other
|
4
|
Baseline Characteristics
Safety Study of GSK Biologicals' Human Papillomavirus Vaccine in 580299/008 Subjects From Brazil, Taiwan or Thailand
Baseline characteristics by cohort
| Measure |
Cervarix Group
n=1237 Participants
Subjects who received the Hepatitis A control vaccine in the primary study (NCT00122681) and the Cervarix vaccine in the current study.
|
|---|---|
|
Age, Continuous
|
28.7 Years
STANDARD_DEVIATION 1.59 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1237 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Gender
Female
|
243 Participants
n=5 Participants
|
|
Gender
Male
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During the entire study period (up to Month 12)SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Note: Results from one center where compliance issues were discovered are presented also separately.
Outcome measures
| Measure |
Cervarix Group
n=1237 Participants
Subjects who received the Hepatitis A control vaccine in the primary study (NCT00122681) and the Cervarix vaccine in the current study.
|
|---|---|
|
Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)
Any SAEs all centers
|
11 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)
Grade 3 SAEs all centers
|
1 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)
Related SAEs all centers
|
0 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)
Any SAEs non-compliant center (n=243)
|
1 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)
Grade 3 SAEs non-compliant center (n=243)
|
0 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)
Related SAEs non-compliant center (n=243)
|
0 Subjects
|
PRIMARY outcome
Timeframe: During the entire study period (up to Month 12)MSCs include adverse events prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
Outcome measures
| Measure |
Cervarix Group
n=1237 Participants
Subjects who received the Hepatitis A control vaccine in the primary study (NCT00122681) and the Cervarix vaccine in the current study.
|
|---|---|
|
Number of Subjects With Any, Grade 3 and Related Medically Significant Conditions (MSCs)
Any MSCs all centers
|
45 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Medically Significant Conditions (MSCs)
Grade 3 MSCs all centers
|
1 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Medically Significant Conditions (MSCs)
Related MSCs all centers
|
0 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Medically Significant Conditions (MSCs)
Any MSCs non-compliant center (n=243)
|
1 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Medically Significant Conditions (MSCs)
Grade 3 MSCs non-compliant center (n=243)
|
0 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Medically Significant Conditions (MSCs)
Related MSCs non-compliant center (n=243)
|
0 Subjects
|
PRIMARY outcome
Timeframe: During the entire study period (up to Month 12)Population: The analysis was based on the subjects with positive pregnancy results in the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of Cervarix vaccine in this study and for whom data were available.
The pregnancy outcomes reported included elective termination, live birth and spontaneous abortion, all of which occurred with no apparent congenital (congenit.) anomalies (anom.) Note: Results from one non-compliant center (NCC) are also presented separately.
Outcome measures
| Measure |
Cervarix Group
n=52 Participants
Subjects who received the Hepatitis A control vaccine in the primary study (NCT00122681) and the Cervarix vaccine in the current study.
|
|---|---|
|
Number of Subjects With Pregnancies and Pregnancy Outcomes
Elective termination NO congenit. anom.
|
5 Subjects
|
|
Number of Subjects With Pregnancies and Pregnancy Outcomes
Live infant NO apparent congenit. anom.
|
40 Subjects
|
|
Number of Subjects With Pregnancies and Pregnancy Outcomes
Lost to follow up
|
2 Subjects
|
|
Number of Subjects With Pregnancies and Pregnancy Outcomes
Spontaneous abortion NO congenit. anom.
|
4 Subjects
|
|
Number of Subjects With Pregnancies and Pregnancy Outcomes
Pregnancy Ongoing
|
1 Subjects
|
|
Number of Subjects With Pregnancies and Pregnancy Outcomes
Elective termination NO congenit. anom.(NCC, n=25)
|
0 Subjects
|
|
Number of Subjects With Pregnancies and Pregnancy Outcomes
Live infant NO apparent congenit. anom.(NCC, n=25)
|
22 Subjects
|
|
Number of Subjects With Pregnancies and Pregnancy Outcomes
Lost to follow up (NCC, n=25)
|
1 Subjects
|
|
Number of Subjects With Pregnancies and Pregnancy Outcomes
Spontaneous abortion NO congenit. anom.(NCC, n=25)
|
1 Subjects
|
|
Number of Subjects With Pregnancies and Pregnancy Outcomes
Pregnancy Ongoing (NCC, n=25)
|
1 Subjects
|
Adverse Events
Cervarix Group
Serious adverse events
| Measure |
Cervarix Group
n=1237 participants at risk
Subjects who received the Hepatitis A control vaccine in the primary study (NCT00122681) and the Cervarix vaccine in the current study.
|
|---|---|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous complete
|
0.24%
3/1237 • SAEs were collected from study start until study end at Month 12.
Other adverse events were not assessed in this study.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous incomplete
|
0.08%
1/1237 • SAEs were collected from study start until study end at Month 12.
Other adverse events were not assessed in this study.
|
|
Renal and urinary disorders
Appendicitis
|
0.08%
1/1237 • SAEs were collected from study start until study end at Month 12.
Other adverse events were not assessed in this study.
|
|
Infections and infestations
Chronic tonsillitis
|
0.08%
1/1237 • SAEs were collected from study start until study end at Month 12.
Other adverse events were not assessed in this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of liver
|
0.08%
1/1237 • SAEs were collected from study start until study end at Month 12.
Other adverse events were not assessed in this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian germ cell teratoma benign
|
0.08%
1/1237 • SAEs were collected from study start until study end at Month 12.
Other adverse events were not assessed in this study.
|
|
Vascular disorders
Thrombophlebitis
|
0.08%
1/1237 • SAEs were collected from study start until study end at Month 12.
Other adverse events were not assessed in this study.
|
|
Endocrine disorders
Thyroid cyst
|
0.08%
1/1237 • SAEs were collected from study start until study end at Month 12.
Other adverse events were not assessed in this study.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.08%
1/1237 • SAEs were collected from study start until study end at Month 12.
Other adverse events were not assessed in this study.
|
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