Trial Outcomes & Findings for Safety Evaluation of a Human Papillomavirus (HPV) Vaccine in Healthy Female Control Subjects From the GSK HPV 023 Study (NCT NCT01418937)
NCT ID: NCT01418937
Last Updated: 2018-07-12
Results Overview
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
COMPLETED
PHASE3
164 participants
Throughout the study period (from Month 0 up to Month 12)
2018-07-12
Participant Flow
During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
Participant milestones
| Measure |
Cervarix Group
Subjects received 3 intramuscular injections of Cervarix™ vaccine according to a 0, 1, 6-month schedule.
|
|---|---|
|
Overall Study
STARTED
|
164
|
|
Overall Study
COMPLETED
|
156
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Cervarix Group
Subjects received 3 intramuscular injections of Cervarix™ vaccine according to a 0, 1, 6-month schedule.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Pregnancy
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Safety Evaluation of a Human Papillomavirus (HPV) Vaccine in Healthy Female Control Subjects From the GSK HPV 023 Study
Baseline characteristics by cohort
| Measure |
Cervarix Group
n=164 Participants
Subjects received 3 intramuscular injections of Cervarix™ vaccine according to a 0, 1, 6-month schedule.
|
|---|---|
|
Age, Continuous
|
30.8 Years
STANDARD_DEVIATION 2.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
164 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Throughout the study period (from Month 0 up to Month 12)Population: The analysis was based on the Total Vaccinated cohort, which included all subjects with the study vaccine administered
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Outcome measures
| Measure |
Cervarix Group
n=164 Participants
Subjects received 3 intramuscular injections of Cervarix™ vaccine according to a 0, 1, 6-month schedule.
|
|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs)
Any SAEs
|
1 Subjects
|
|
Number of Subjects With Serious Adverse Events (SAEs)
Grade 3 SAEs
|
1 Subjects
|
|
Number of Subjects With Serious Adverse Events (SAEs)
Related SAEs
|
0 Subjects
|
PRIMARY outcome
Timeframe: Throughout the study period (from Month 0 up to Month 12)Population: The analysis was based on the Total Vaccinated cohort, which included all subjects with the study vaccine administered
Outcome measures
| Measure |
Cervarix Group
n=164 Participants
Subjects received 3 intramuscular injections of Cervarix™ vaccine according to a 0, 1, 6-month schedule.
|
|---|---|
|
Number of Subjects With Potential Immune-mediated Disease (pIMDs)
Any pIMDs
|
0 Subjects
|
|
Number of Subjects With Potential Immune-mediated Disease (pIMDs)
Grade 3 pIMDs
|
0 Subjects
|
|
Number of Subjects With Potential Immune-mediated Disease (pIMDs)
Related pIMDs
|
0 Subjects
|
PRIMARY outcome
Timeframe: Throughout the study period (from Month 0 up to Month 12)Population: The analysis was based on the Total Vaccinated cohort, which included all subjects with the study vaccine administered
MSCs include AEs 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=164 Participants
Subjects received 3 intramuscular injections of Cervarix™ vaccine according to a 0, 1, 6-month schedule.
|
|---|---|
|
Number of Subjects With Medically Significant Conditions (MSCs)
Any MSCs
|
8 Subjects
|
|
Number of Subjects With Medically Significant Conditions (MSCs)
Grade 3 MSCs
|
1 Subjects
|
|
Number of Subjects With Medically Significant Conditions (MSCs)
Vaccine-related MSCs
|
0 Subjects
|
PRIMARY outcome
Timeframe: Throughout the study period (from Month 0 up to Month 12)Population: The analysis was performed on the number of pregnant subjects participating in the study.
The pregnancy outcomes were based on reports from pregnant subjects in the study population. Pregnancy outcomes are pregnancies resulting in live births.
Outcome measures
| Measure |
Cervarix Group
n=5 Participants
Subjects received 3 intramuscular injections of Cervarix™ vaccine according to a 0, 1, 6-month schedule.
|
|---|---|
|
Number of Pregnant Subjects Reporting Pregnancy Outcomes
|
5 Subjects
|
Adverse Events
Cervarix Group
Serious adverse events
| Measure |
Cervarix Group
n=164 participants at risk
Subjects received 3 intramuscular injections of Cervarix™ vaccine according to a 0, 1, 6-month schedule.
|
|---|---|
|
Psychiatric disorders
Depression suicidal
|
0.61%
1/164 • SAEs were collected throughout the entire study period (from Day 0 to Month 12)
Non-serious solicited and unsolicited adverse events were not collected 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