Trial Outcomes & Findings for The Safety Evaluation of the GSK-580299 Vaccine in Women From the Control Group in the Primary NCT00294047 Study (NCT NCT01249365)
NCT ID: NCT01249365
Last Updated: 2019-11-13
Results Overview
Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as the occurrence of any SAE regardless of intensity grade or relation to vaccination. Grade 3 SAE = SAE which prevented normal, everyday activities (in adults/adolescents, such an SAE, for example, prevented attendance at work/school and necessitated the administration of corrective therapy). Related SAE = SAE assessed by the investigator as causally related to the study vaccination.
COMPLETED
PHASE3
199 participants
Throughout the study (from Month 0 to Month 12)
2019-11-13
Participant Flow
Participant milestones
| Measure |
HPV Vaccine
Healthy female subjects aged 26 years and above, who received control vaccine in the primary study NCT00294047, were administrated 3 intramuscular injections of Cervarix vaccine into the deltoid of the non-dominant arm, according to a 0, 1, 6-month schedule in the current study.
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|---|---|
|
Overall Study
STARTED
|
199
|
|
Overall Study
COMPLETED
|
198
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
HPV Vaccine
Healthy female subjects aged 26 years and above, who received control vaccine in the primary study NCT00294047, were administrated 3 intramuscular injections of Cervarix vaccine into the deltoid of the non-dominant arm, according to a 0, 1, 6-month schedule in the current study.
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|---|---|
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Overall Study
Lost to Follow-up
|
1
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Baseline Characteristics
The Safety Evaluation of the GSK-580299 Vaccine in Women From the Control Group in the Primary NCT00294047 Study
Baseline characteristics by cohort
| Measure |
HPV Vaccine
n=199 Participants
Healthy female subjects aged 26 years and above, who received control vaccine in the primary study NCT00294047, were administrated 3 intramuscular injections of Cervarix vaccine into the deltoid of the non-dominant arm, according to a 0, 1, 6-month schedule in the current study.
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|---|---|
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Age, Continuous
|
46.9 Years
STANDARD_DEVIATION 7.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
199 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · African Heritage/African American
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · Asian - Central/South Asian Heritage
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · Asian - East Asian Heritage
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · Asian - South East Asian Heritage
|
78 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · White - Caucasian/European Heritage
|
116 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Throughout the study (from Month 0 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 resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as the occurrence of any SAE regardless of intensity grade or relation to vaccination. Grade 3 SAE = SAE which prevented normal, everyday activities (in adults/adolescents, such an SAE, for example, prevented attendance at work/school and necessitated the administration of corrective therapy). Related SAE = SAE assessed by the investigator as causally related to the study vaccination.
Outcome measures
| Measure |
HPV Vaccine
n=199 Participants
Healthy female subjects aged 26 years and above, who received control vaccine in the primary study NCT00294047, were administrated 3 intramuscular injections of Cervarix vaccine into the deltoid of the non-dominant arm, according to a 0, 1, 6-month schedule in the current study.
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|---|---|
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Number of Subjects Reporting Serious Adverse Events
Any SAE(s)
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6 Participants
|
|
Number of Subjects Reporting Serious Adverse Events
Grade 3 SAE(s)
|
2 Participants
|
|
Number of Subjects Reporting Serious Adverse Events
Related SAE(s)
|
0 Participants
|
PRIMARY outcome
Timeframe: Throughout the study (from Month 0 to Month 12)Population: The analysis was based on the Total Vaccinated cohort, which included all subjects with the study vaccine administered.
Medically significant conditions (MSCs) are defined as: AEs prompting emergency room or physician visits that were not related to common diseases, or not related to routine visits for physical examination or vaccination; SAEs that were not related to common diseases. Common diseases include: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury. Potential immune-mediated diseases (pIMDs) are a subset of medically significant conditions that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Any was defined as the occurrence of any MSC or pIMD regardless of intensity grade or relation to vaccination. Grade 3 MSC or pIMD = a MSC or pIMD which prevented normal, everyday activities. Related MSC or pIMD = a MSC or pIMD assessed by the investigator as related to the vaccination.
Outcome measures
| Measure |
HPV Vaccine
n=199 Participants
Healthy female subjects aged 26 years and above, who received control vaccine in the primary study NCT00294047, were administrated 3 intramuscular injections of Cervarix vaccine into the deltoid of the non-dominant arm, according to a 0, 1, 6-month schedule in the current study.
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|---|---|
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Number of Subjects Reporting Medically Significant Conditions (MSCs) and Potential Immune-mediated Diseases (pIMDs)
Any MSCs
|
16 Participants
|
|
Number of Subjects Reporting Medically Significant Conditions (MSCs) and Potential Immune-mediated Diseases (pIMDs)
Grade 3 MSCs
|
2 Participants
|
|
Number of Subjects Reporting Medically Significant Conditions (MSCs) and Potential Immune-mediated Diseases (pIMDs)
Related MSCs
|
0 Participants
|
|
Number of Subjects Reporting Medically Significant Conditions (MSCs) and Potential Immune-mediated Diseases (pIMDs)
Any pIMDs
|
1 Participants
|
|
Number of Subjects Reporting Medically Significant Conditions (MSCs) and Potential Immune-mediated Diseases (pIMDs)
Grade 3 pIMDs
|
0 Participants
|
|
Number of Subjects Reporting Medically Significant Conditions (MSCs) and Potential Immune-mediated Diseases (pIMDs)
Related pIMDs
|
0 Participants
|
PRIMARY outcome
Timeframe: Throughout the study (from Month 0 to Month 12)Population: The analysis was based on the Total Vaccinated cohort, which included all subjects with the study vaccine administered and who reported any pregnancies and outcomes of reported pregnancies.
Live infant NO apparent congenital anomaly; Live infant congenital anomaly; Premature live infant NO apparent congenital anomaly; Premature live infant congenital anomaly; Elective termination NO apparent congenital anomaly; Elective termination congenital anomaly; Therapeutic abortion; Ectopic pregnancy; Spontaneous abortion NO apparent congenital anomaly; Spontaneous abortion congenital anomaly; Stillbirth NO apparent congenital anomaly; Stillbirth congenital anomaly; Molar pregnancy; Pregnancy ongoing; Lost to follow up.
Outcome measures
| Measure |
HPV Vaccine
n=1 Participants
Healthy female subjects aged 26 years and above, who received control vaccine in the primary study NCT00294047, were administrated 3 intramuscular injections of Cervarix vaccine into the deltoid of the non-dominant arm, according to a 0, 1, 6-month schedule in the current study.
|
|---|---|
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Number of Subjects Reporting Pregnancies and Outcome of Reported Pregnancies
Live infant NO apparent congenital anomaly
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1 Participants
|
|
Number of Subjects Reporting Pregnancies and Outcome of Reported Pregnancies
Live infant congenital anomaly
|
0 Participants
|
|
Number of Subjects Reporting Pregnancies and Outcome of Reported Pregnancies
Premature live infant NO apparent congen. anomaly
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0 Participants
|
|
Number of Subjects Reporting Pregnancies and Outcome of Reported Pregnancies
Premature live infant congenital anomaly
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0 Participants
|
|
Number of Subjects Reporting Pregnancies and Outcome of Reported Pregnancies
Elective termination NO apparent congen. anomaly
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0 Participants
|
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Number of Subjects Reporting Pregnancies and Outcome of Reported Pregnancies
Elective termination congenital anomaly
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0 Participants
|
|
Number of Subjects Reporting Pregnancies and Outcome of Reported Pregnancies
Therapeutic abortion
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0 Participants
|
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Number of Subjects Reporting Pregnancies and Outcome of Reported Pregnancies
Ectopic pregnancy
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0 Participants
|
|
Number of Subjects Reporting Pregnancies and Outcome of Reported Pregnancies
Spontaneous abortion NO apparent congen. anomaly
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0 Participants
|
|
Number of Subjects Reporting Pregnancies and Outcome of Reported Pregnancies
Spontaneous abortion congenital anomaly
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0 Participants
|
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Number of Subjects Reporting Pregnancies and Outcome of Reported Pregnancies
Stillbirth NO apparent congenital anomaly
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0 Participants
|
|
Number of Subjects Reporting Pregnancies and Outcome of Reported Pregnancies
Stillbirth congenital anomaly
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0 Participants
|
|
Number of Subjects Reporting Pregnancies and Outcome of Reported Pregnancies
Molar pregnancy
|
0 Participants
|
|
Number of Subjects Reporting Pregnancies and Outcome of Reported Pregnancies
Pregnancy ongoing
|
0 Participants
|
|
Number of Subjects Reporting Pregnancies and Outcome of Reported Pregnancies
Lost to follow up
|
0 Participants
|
Adverse Events
HPV Vaccine
Serious adverse events
| Measure |
HPV Vaccine
n=199 participants at risk
Healthy female subjects aged 26 years and above, who received control vaccine in the primary study NCT00294047, were administrated 3 intramuscular injections of Cervarix vaccine into the deltoid of the non-dominant arm, according to a 0, 1, 6-month schedule in the current study.
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|---|---|
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Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.50%
1/199 • Number of events 1 • Adverse Events were reported from the first receipt of study vaccine (Month 0) until 6 months following administration of the last dose of study vaccine (i.e. at study conclusion, Month 12).
Non-serious solicited adverse events were not collected in this study. Non-serious unsolicited events collected in this study did not exceed the threshold of 5%.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.50%
1/199 • Number of events 1 • Adverse Events were reported from the first receipt of study vaccine (Month 0) until 6 months following administration of the last dose of study vaccine (i.e. at study conclusion, Month 12).
Non-serious solicited adverse events were not collected in this study. Non-serious unsolicited events collected in this study did not exceed the threshold of 5%.
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.50%
1/199 • Number of events 1 • Adverse Events were reported from the first receipt of study vaccine (Month 0) until 6 months following administration of the last dose of study vaccine (i.e. at study conclusion, Month 12).
Non-serious solicited adverse events were not collected in this study. Non-serious unsolicited events collected in this study did not exceed the threshold of 5%.
|
|
Nervous system disorders
Migraine
|
0.50%
1/199 • Number of events 1 • Adverse Events were reported from the first receipt of study vaccine (Month 0) until 6 months following administration of the last dose of study vaccine (i.e. at study conclusion, Month 12).
Non-serious solicited adverse events were not collected in this study. Non-serious unsolicited events collected in this study did not exceed the threshold of 5%.
|
|
Nervous system disorders
Nerve root compression
|
0.50%
1/199 • Number of events 1 • Adverse Events were reported from the first receipt of study vaccine (Month 0) until 6 months following administration of the last dose of study vaccine (i.e. at study conclusion, Month 12).
Non-serious solicited adverse events were not collected in this study. Non-serious unsolicited events collected in this study did not exceed the threshold of 5%.
|
|
Psychiatric disorders
Agitated depression
|
0.50%
1/199 • Number of events 2 • Adverse Events were reported from the first receipt of study vaccine (Month 0) until 6 months following administration of the last dose of study vaccine (i.e. at study conclusion, Month 12).
Non-serious solicited adverse events were not collected in this study. Non-serious unsolicited events collected in this study did not exceed the threshold of 5%.
|
|
Psychiatric disorders
Major depression
|
0.50%
1/199 • Number of events 2 • Adverse Events were reported from the first receipt of study vaccine (Month 0) until 6 months following administration of the last dose of study vaccine (i.e. at study conclusion, Month 12).
Non-serious solicited adverse events were not collected in this study. Non-serious unsolicited events collected in this study did not exceed the threshold of 5%.
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
0.50%
1/199 • Number of events 1 • Adverse Events were reported from the first receipt of study vaccine (Month 0) until 6 months following administration of the last dose of study vaccine (i.e. at study conclusion, Month 12).
Non-serious solicited adverse events were not collected in this study. Non-serious unsolicited events collected in this study did not exceed the threshold of 5%.
|
|
Reproductive system and breast disorders
Dysfunctional uterine bleeding
|
0.50%
1/199 • Number of events 1 • Adverse Events were reported from the first receipt of study vaccine (Month 0) until 6 months following administration of the last dose of study vaccine (i.e. at study conclusion, Month 12).
Non-serious solicited adverse events were not collected in this study. Non-serious unsolicited events collected in this study did not exceed the threshold of 5%.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.50%
1/199 • Number of events 1 • Adverse Events were reported from the first receipt of study vaccine (Month 0) until 6 months following administration of the last dose of study vaccine (i.e. at study conclusion, Month 12).
Non-serious solicited adverse events were not collected in this study. Non-serious unsolicited events collected in this study did not exceed the threshold of 5%.
|
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