Trial Outcomes & Findings for Safety Evaluation of the GSK-580299 Vaccine in Women From the Control Group in the Primary NCT00294047 Study (NCT NCT01190189)
NCT ID: NCT01190189
Last Updated: 2019-06-19
Results Overview
Assessed SAEs included medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were congenital anomalies/birth defects in the offspring of a study subject. Any SAE = occurrence of the SAE regardless of intensity grade. Grade 3 SAE = an SAE which prevented normal, everyday activities. Related SAE = an SAE assessed by the investigator as causally related to the study vaccination.
COMPLETED
PHASE3
137 participants
During the entire study period (from Day 0 up to Month 12)
2019-06-19
Participant Flow
This study was conducted by multiple investigators at 28 centers in Canada and the United States.
All subjects enrolled were vaccinated and included in the Total Vaccinated cohort (TVc).
Participant milestones
| Measure |
Cervarix Group
Healthy female subjects who received control vaccine in the primary study HPV-015 (NCT00294047), were administered three doses of Cervarix vaccine intramuscularly, according to a 0,1,6-month schedule.
|
|---|---|
|
Overall Study
STARTED
|
137
|
|
Overall Study
COMPLETED
|
131
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Cervarix Group
Healthy female subjects who received control vaccine in the primary study HPV-015 (NCT00294047), were administered three doses of Cervarix vaccine intramuscularly, according to a 0,1,6-month schedule.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Migrated/moved from study area
|
1
|
Baseline Characteristics
Safety Evaluation of the GSK-580299 Vaccine in Women From the Control Group in the Primary NCT00294047 Study
Baseline characteristics by cohort
| Measure |
Cervarix Group
n=137 Participants
Healthy female subjects who received control vaccine in the primary study HPV-015 (NCT00294047), were administered three doses of Cervarix vaccine intramuscularly, according to a 0,1,6-month schedule.
|
|---|---|
|
Age, Continuous
|
47.9 Years
STANDARD_DEVIATION 7.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
137 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Geographic Ancestry · African Heritage/African American
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Geographic Ancestry · Asian - East Asian Heritage
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Geographic Ancestry · Asian - Japanese Heritage
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Geographic Ancestry · White - Arabic/North African Heritage
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Geographic Ancestry · White - Caucasian/European Heritage
|
119 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Geographic Ancestry · Native Canadian
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Geographic Ancestry · Cuban
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During the entire study period (from Day 0 up to Month 12)Population: The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available.
Assessed SAEs included medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were congenital anomalies/birth defects in the offspring of a study subject. Any SAE = occurrence of the SAE regardless of intensity grade. Grade 3 SAE = an SAE which prevented normal, everyday activities. Related SAE = an SAE assessed by the investigator as causally related to the study vaccination.
Outcome measures
| Measure |
Cervarix Group
n=137 Participants
Healthy female subjects who received control vaccine in the primary study HPV-015 (NCT00294047), were administered three doses of Cervarix vaccine intramuscularly, according to a 0,1,6-month schedule.
|
|---|---|
|
Number of Subjects Reporting Any, Grade 3 and Related Serious Adverse Events (SAEs)
Any SAE(s)
|
1 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Serious Adverse Events (SAEs)
Grade 3 SAE(s)
|
1 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Serious Adverse Events (SAEs)
Related SAE(s)
|
0 Participants
|
PRIMARY outcome
Timeframe: During the entire study period (from Day 0 up to Month 12)Population: The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available.
Medically significant conditions were defined as: AEs prompting emergency room or physician visits that were not (1) related to common diseases, or (2) not related to routine visits for physical examination or vaccination, or as SAEs that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury. Any MSC = occurrence of the MSC regardless of intensity grade. Grade 3 MSC = a MSC which prevented normal, everyday activities. Related MSC = MSC assessed by the investigator as related to the study vaccination.
Outcome measures
| Measure |
Cervarix Group
n=137 Participants
Healthy female subjects who received control vaccine in the primary study HPV-015 (NCT00294047), were administered three doses of Cervarix vaccine intramuscularly, according to a 0,1,6-month schedule.
|
|---|---|
|
Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs)
Any MSC(s)
|
24 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs)
Grade 3 MSC(s)
|
2 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs)
Related MSC(s)
|
1 Participants
|
PRIMARY outcome
Timeframe: During the entire study period (from Day 0 up to Month 12)Population: The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available.
pIMD(s) are a subset of medically significant conditions (MSCs) that included autoimmune diseases and other inflammatory and/or neurological disorders of interest which may or may not have had an autoimmune aetiology. Any pIMD = occurrence of the pIMD regardless of intensity grade. Grade 3 pIMD = a pIMD which prevented normal, everyday activities. Related pIMD = pIMD assessed by the investigator as related to the study vaccination.
Outcome measures
| Measure |
Cervarix Group
n=137 Participants
Healthy female subjects who received control vaccine in the primary study HPV-015 (NCT00294047), were administered three doses of Cervarix vaccine intramuscularly, according to a 0,1,6-month schedule.
|
|---|---|
|
Number of Subjects Reporting Any, Grade 3 and Related Potentially Immune-Mediated Diseases (pIMDs)
Any pIMD(s)
|
1 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Potentially Immune-Mediated Diseases (pIMDs)
Grade 3 pIMD(s)
|
0 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Potentially Immune-Mediated Diseases (pIMDs)
Related pIMD(s)
|
0 Participants
|
PRIMARY outcome
Timeframe: During the entire study period (from Day 0 up to Month 12)Population: The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available.
Pregnancy is the term used to describe the period in which a fetus develops inside a woman's womb or uterus. In this study, the number of subjects with pregnancies was calculated. The subjects with confirmed pregnancies were followed up to determine the outcomes of the reported pregnancies.
Outcome measures
| Measure |
Cervarix Group
n=137 Participants
Healthy female subjects who received control vaccine in the primary study HPV-015 (NCT00294047), were administered three doses of Cervarix vaccine intramuscularly, according to a 0,1,6-month schedule.
|
|---|---|
|
Number of Subjects Reporting Pregnancies and Outcomes of the Reported Pregnancies
|
0 Participants
|
Adverse Events
Cervarix Group
Serious adverse events
| Measure |
Cervarix Group
n=137 participants at risk
Healthy female subjects who received control vaccine in the primary study HPV-015 (NCT00294047), were administered three doses of Cervarix vaccine intramuscularly, according to a 0,1,6-month schedule.
|
|---|---|
|
Reproductive system and breast disorders
Menorrhagia
|
0.73%
1/137 • Number of events 1 • During the entire study period (from Day 0 up to Month 12).
|
Other adverse events
| Measure |
Cervarix Group
n=137 participants at risk
Healthy female subjects who received control vaccine in the primary study HPV-015 (NCT00294047), were administered three doses of Cervarix vaccine intramuscularly, according to a 0,1,6-month schedule.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.5%
2/137 • Number of events 2 • During the entire study period (from Day 0 up to Month 12).
|
|
Psychiatric disorders
Anxiety
|
0.73%
1/137 • Number of events 1 • During the entire study period (from Day 0 up to Month 12).
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.73%
1/137 • Number of events 1 • During the entire study period (from Day 0 up to Month 12).
|
|
Psychiatric disorders
Attention deficit/hyperactivity disorder
|
0.73%
1/137 • Number of events 1 • During the entire study period (from Day 0 up to Month 12).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.73%
1/137 • Number of events 1 • During the entire study period (from Day 0 up to Month 12).
|
|
Infections and infestations
Cellulitis
|
0.73%
1/137 • Number of events 1 • During the entire study period (from Day 0 up to Month 12).
|
|
Skin and subcutaneous tissue disorders
Chloasma
|
0.73%
1/137 • Number of events 1 • During the entire study period (from Day 0 up to Month 12).
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.73%
1/137 • Number of events 1 • During the entire study period (from Day 0 up to Month 12).
|
|
Nervous system disorders
Complex regional pain syndrome
|
0.73%
1/137 • Number of events 1 • During the entire study period (from Day 0 up to Month 12).
|
|
Injury, poisoning and procedural complications
Concussion
|
0.73%
1/137 • Number of events 1 • During the entire study period (from Day 0 up to Month 12).
|
|
Eye disorders
Conjunctivitis allergic
|
0.73%
1/137 • Number of events 1 • During the entire study period (from Day 0 up to Month 12).
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.73%
1/137 • Number of events 1 • During the entire study period (from Day 0 up to Month 12).
|
|
Gastrointestinal disorders
Crohn's disease
|
0.73%
1/137 • Number of events 1 • During the entire study period (from Day 0 up to Month 12).
|
|
Psychiatric disorders
Depression
|
0.73%
1/137 • Number of events 1 • During the entire study period (from Day 0 up to Month 12).
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.73%
1/137 • Number of events 1 • During the entire study period (from Day 0 up to Month 12).
|
|
Infections and infestations
Furuncle
|
0.73%
1/137 • Number of events 1 • During the entire study period (from Day 0 up to Month 12).
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.73%
1/137 • Number of events 1 • During the entire study period (from Day 0 up to Month 12).
|
|
Vascular disorders
Hypertension
|
0.73%
1/137 • Number of events 1 • During the entire study period (from Day 0 up to Month 12).
|
|
Injury, poisoning and procedural complications
Laceration
|
0.73%
1/137 • Number of events 1 • During the entire study period (from Day 0 up to Month 12).
|
|
Infections and infestations
Mastitis
|
0.73%
1/137 • Number of events 1 • During the entire study period (from Day 0 up to Month 12).
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.73%
1/137 • Number of events 1 • During the entire study period (from Day 0 up to Month 12).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.73%
1/137 • Number of events 1 • During the entire study period (from Day 0 up to Month 12).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.73%
1/137 • Number of events 1 • During the entire study period (from Day 0 up to Month 12).
|
|
Infections and infestations
Otitis media
|
0.73%
1/137 • Number of events 1 • During the entire study period (from Day 0 up to Month 12).
|
|
Reproductive system and breast disorders
Ovarian cyst
|
1.5%
2/137 • Number of events 2 • During the entire study period (from Day 0 up to Month 12).
|
|
Infections and infestations
Pneumonia
|
0.73%
1/137 • Number of events 1 • During the entire study period (from Day 0 up to Month 12).
|
|
Renal and urinary disorders
Pollakiuria
|
0.73%
1/137 • Number of events 1 • During the entire study period (from Day 0 up to Month 12).
|
|
Skin and subcutaneous tissue disorders
Skin burning sensation
|
0.73%
1/137 • Number of events 1 • During the entire study period (from Day 0 up to Month 12).
|
|
Infections and infestations
Staphylococcal infection
|
0.73%
1/137 • Number of events 1 • During the entire study period (from Day 0 up to Month 12).
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.73%
1/137 • Number of events 1 • During the entire study period (from Day 0 up to Month 12).
|
|
Infections and infestations
Tooth infection
|
0.73%
1/137 • Number of events 1 • During the entire study period (from Day 0 up to Month 12).
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.73%
1/137 • Number of events 1 • During the entire study period (from Day 0 up to Month 12).
|
|
Injury, poisoning and procedural complications
Ulnar nerve injury
|
0.73%
1/137 • Number of events 1 • During the entire study period (from Day 0 up to Month 12).
|
|
Ear and labyrinth disorders
Vertigo
|
0.73%
1/137 • Number of events 1 • During the entire study period (from Day 0 up to Month 12).
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.73%
1/137 • Number of events 1 • During the entire study period (from Day 0 up to Month 12).
|
Additional Information
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