Trial Outcomes & Findings for A Post-marketing Surveillance Study to Assess the Safety of Cervarix (GlaxoSmithKline [GSK] Biologicals' Human Papillomavirus [HPV] -16/18 Vaccine), When Administered According to the Approved Prescribing Information (PI) in Korea (NCT NCT03671369)
NCT ID: NCT03671369
Last Updated: 2023-02-23
Results Overview
An adverse event (AE) is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. The percentage of subjects with AEs was calculated by dividing the number of subjects with adverse events by the number of subjects in each total number of Cervarix doses vaccinated in Total Safety Cohort, and multiplied by 100.
COMPLETED
670 participants
From Day 1 up to 30 days (post dose 1 vaccination)
2023-02-23
Participant Flow
This study was conducted at 29 centers in Republic of Korea.
Out of 670 subjects enrolled in the study, 1 subject did not receive any vaccine and therefore was not included in any analysis.
Participant milestones
| Measure |
Cervarix Group
The study group comprised of 9-25 year-old male and female subjects who were administered with 3 doses of Cervarix vaccine, according to a 0, 1, and 6 months schedule, as per locally approved prescribing information (PI) in Korea. The 9-14 years old subjects were vaccinated with 2 doses, according to a 0 and 6-12 months schedule. In the 2-dose schedule, if the second dose was administered before 5 months after the first dose, the third dose vaccination was required. In the 3 doses schedule, if the vaccination schedule required flexibility, the second dose was administered between 1 and 2.5 months and the third dose was administered between 5 and 12 months after the first dose.
|
|---|---|
|
Overall Study
STARTED
|
669
|
|
Overall Study
COMPLETED
|
378
|
|
Overall Study
NOT COMPLETED
|
291
|
Reasons for withdrawal
| Measure |
Cervarix Group
The study group comprised of 9-25 year-old male and female subjects who were administered with 3 doses of Cervarix vaccine, according to a 0, 1, and 6 months schedule, as per locally approved prescribing information (PI) in Korea. The 9-14 years old subjects were vaccinated with 2 doses, according to a 0 and 6-12 months schedule. In the 2-dose schedule, if the second dose was administered before 5 months after the first dose, the third dose vaccination was required. In the 3 doses schedule, if the vaccination schedule required flexibility, the second dose was administered between 1 and 2.5 months and the third dose was administered between 5 and 12 months after the first dose.
|
|---|---|
|
Overall Study
Other
|
1
|
|
Overall Study
Withdrawal by Subject
|
289
|
|
Overall Study
Not willing to be vaccinated
|
1
|
Baseline Characteristics
A Post-marketing Surveillance Study to Assess the Safety of Cervarix (GlaxoSmithKline [GSK] Biologicals' Human Papillomavirus [HPV] -16/18 Vaccine), When Administered According to the Approved Prescribing Information (PI) in Korea
Baseline characteristics by cohort
| Measure |
Cervarix Group
n=669 Participants
The study group comprised of 9-25 year-old male and female subjects who were administered with 3 doses of Cervarix vaccine, according to a 0, 1, and 6 months schedule, as per locally approved prescribing information (PI) in Korea. The 9-14 years old subjects were vaccinated with 2 doses, according to a 0 and 6-12 months schedule. In the 2-dose schedule, if the second dose was administered before 5 months after the first dose, the third dose vaccination was required. In the 3 doses schedule, if the vaccination schedule required flexibility, the second dose was administered between 1 and 2.5 months and the third dose was administered between 5 and 12 months after the first dose.
|
|---|---|
|
Age, Continuous
|
12.92 Years
STANDARD_DEVIATION 2.75 • n=85 Participants
|
|
Sex/Gender, Customized
Male
|
23 Participants
n=85 Participants
|
|
Sex/Gender, Customized
Female
|
646 Participants
n=85 Participants
|
|
Race/Ethnicity, Customized
Korean
|
664 Participants
n=85 Participants
|
|
Race/Ethnicity, Customized
Non-Korean
|
5 Participants
n=85 Participants
|
PRIMARY outcome
Timeframe: From Day 1 up to 30 days (post dose 1 vaccination)Population: The analysis was performed on Total Safety cohort, which included all subjects with data available at the specified time point who received at least one dose of vaccine as per the protocol and who reported adverse events even though they have not completed 30-days follow-up period after vaccination.
An adverse event (AE) is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. The percentage of subjects with AEs was calculated by dividing the number of subjects with adverse events by the number of subjects in each total number of Cervarix doses vaccinated in Total Safety Cohort, and multiplied by 100.
Outcome measures
| Measure |
Cervarix Group
n=457 Participants
The study group comprised of 9-25 year-old male and female subjects who were administered with 3 doses of Cervarix vaccine, according to a 0, 1, and 6 months schedule, as per locally approved prescribing information (PI) in Korea. The 9-14 years old subjects were vaccinated with 2 doses, according to a 0 and 6-12 months schedule. In the 2-dose schedule, if the second dose was administered before 5 months after the first dose, the third dose vaccination was required. In the 3 doses schedule, if the vaccination schedule required flexibility, the second dose was administered between 1 and 2.5 months and the third dose was administered between 5 and 12 months after the first dose.
|
|---|---|
|
Percentage (%) of Subjects With Adverse Events (AEs) Post Dose 1
|
17.72 Percentage of subjects
Interval 14.33 to 21.54
|
PRIMARY outcome
Timeframe: From Day 1 up to 30 days (post dose 2 vaccination)Population: The analysis was performed on Total Safety cohort, which included all subjects with data available at the specified time point who received two doses of vaccine as per the protocol and who reported adverse events even though they have not completed 30-days follow-up period after vaccination.
An adverse event (AE) is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. The percentage of subjects with AEs was calculated by dividing the number of subjects with adverse events by the number of subjects in each total number of Cervarix doses vaccinated in Total Safety Cohort, and multiplied by 100.
Outcome measures
| Measure |
Cervarix Group
n=389 Participants
The study group comprised of 9-25 year-old male and female subjects who were administered with 3 doses of Cervarix vaccine, according to a 0, 1, and 6 months schedule, as per locally approved prescribing information (PI) in Korea. The 9-14 years old subjects were vaccinated with 2 doses, according to a 0 and 6-12 months schedule. In the 2-dose schedule, if the second dose was administered before 5 months after the first dose, the third dose vaccination was required. In the 3 doses schedule, if the vaccination schedule required flexibility, the second dose was administered between 1 and 2.5 months and the third dose was administered between 5 and 12 months after the first dose.
|
|---|---|
|
Percentage (%) of Subjects With Adverse Events (AEs) Post Dose 2
|
18.77 Percentage of subjects
Interval 15.01 to 23.01
|
PRIMARY outcome
Timeframe: From Day 1 up to 30 days (post dose 3 vaccination)Population: The analysis was performed on Total Safety cohort, which included all subjects with data available at the specified time point who received three doses of vaccine as per the protocol and who reported adverse events even though they have not completed 30-days follow-up period after vaccination.
An adverse event (AE) is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. The percentage of subjects with AEs was calculated by dividing the number of subjects with adverse events by the number of subjects in each total number of Cervarix doses vaccinated in Total Safety Cohort, and multiplied by 100.
Outcome measures
| Measure |
Cervarix Group
n=35 Participants
The study group comprised of 9-25 year-old male and female subjects who were administered with 3 doses of Cervarix vaccine, according to a 0, 1, and 6 months schedule, as per locally approved prescribing information (PI) in Korea. The 9-14 years old subjects were vaccinated with 2 doses, according to a 0 and 6-12 months schedule. In the 2-dose schedule, if the second dose was administered before 5 months after the first dose, the third dose vaccination was required. In the 3 doses schedule, if the vaccination schedule required flexibility, the second dose was administered between 1 and 2.5 months and the third dose was administered between 5 and 12 months after the first dose.
|
|---|---|
|
Percentage (%) of Subjects With Adverse Events (AEs) Post Dose 3
|
2.86 Percentage of subjects
Interval 0.07 to 14.92
|
PRIMARY outcome
Timeframe: From Day 1 up to 30 days (post dose 1 vaccination)Population: The analysis was performed on Total Safety cohort, which included all participants with data available at the specified time point who received at least one dose of vaccine as per the protocol and who reported adverse events even though they have not completed 30-days follow-up period after vaccination.
An AE with maximum intensity are equivalent to severe AEs category (AEs which prevented normal everyday activities in a young child. Such an AE would, for example, prevent attendance at school/kindergarten/a day-care centre and can cause the parent(s)/Legally Acceptable Representative(s) to seek medical advice). The physician assessed the maximum intensity that occurred over the duration of the event for all AEs recorded during the PMS. The assessment was based on the physician's clinical judgement.
Outcome measures
| Measure |
Cervarix Group
n=457 Participants
The study group comprised of 9-25 year-old male and female subjects who were administered with 3 doses of Cervarix vaccine, according to a 0, 1, and 6 months schedule, as per locally approved prescribing information (PI) in Korea. The 9-14 years old subjects were vaccinated with 2 doses, according to a 0 and 6-12 months schedule. In the 2-dose schedule, if the second dose was administered before 5 months after the first dose, the third dose vaccination was required. In the 3 doses schedule, if the vaccination schedule required flexibility, the second dose was administered between 1 and 2.5 months and the third dose was administered between 5 and 12 months after the first dose.
|
|---|---|
|
Number of Participants With AEs by Maximum Intensity Post Dose 1
|
0 Participants
|
PRIMARY outcome
Timeframe: From Day 1 up to 30 days (post dose 2 vaccination)Population: The analysis was performed on Total Safety cohort, which included all participants with data available at the specified time point who received two doses of vaccine as per the protocol and who reported adverse events even though they have not completed 30-days follow-up period after vaccination.
An AE with maximum intensity are equivalent to severe AEs category (AEs which prevented normal everyday activities in a young child. Such an AE would, for example, prevent attendance at school/kindergarten/a day-care centre and can cause the parent(s)/Legally Acceptable Representative(s) to seek medical advice). The physician assessed the maximum intensity that occurred over the duration of the event for all AEs recorded during the PMS. The assessment was based on the physician's clinical judgement.
Outcome measures
| Measure |
Cervarix Group
n=389 Participants
The study group comprised of 9-25 year-old male and female subjects who were administered with 3 doses of Cervarix vaccine, according to a 0, 1, and 6 months schedule, as per locally approved prescribing information (PI) in Korea. The 9-14 years old subjects were vaccinated with 2 doses, according to a 0 and 6-12 months schedule. In the 2-dose schedule, if the second dose was administered before 5 months after the first dose, the third dose vaccination was required. In the 3 doses schedule, if the vaccination schedule required flexibility, the second dose was administered between 1 and 2.5 months and the third dose was administered between 5 and 12 months after the first dose.
|
|---|---|
|
Number of Participants With AEs by Maximum Intensity Post Dose 2
|
0 Participants
|
PRIMARY outcome
Timeframe: From Day 1 up to 30 days (post dose 3 vaccination)Population: The analysis was performed on Total Safety cohort, which included all participants with data available at the specified time point who received three doses of vaccine as per the protocol and who reported adverse events even though they have not completed 30-days follow-up period after vaccination.
An AE with maximum intensity are equivalent to severe AEs category (AEs which prevented normal everyday activities in a young child. Such an AE would, for example, prevent attendance at school/kindergarten/a day-care centre and can cause the parent(s)/Legally Acceptable Representative(s) to seek medical advice). The physician assessed the maximum intensity that occurred over the duration of the event for all AEs recorded during the PMS. The assessment was based on the physician's clinical judgement.
Outcome measures
| Measure |
Cervarix Group
n=35 Participants
The study group comprised of 9-25 year-old male and female subjects who were administered with 3 doses of Cervarix vaccine, according to a 0, 1, and 6 months schedule, as per locally approved prescribing information (PI) in Korea. The 9-14 years old subjects were vaccinated with 2 doses, according to a 0 and 6-12 months schedule. In the 2-dose schedule, if the second dose was administered before 5 months after the first dose, the third dose vaccination was required. In the 3 doses schedule, if the vaccination schedule required flexibility, the second dose was administered between 1 and 2.5 months and the third dose was administered between 5 and 12 months after the first dose.
|
|---|---|
|
Number of Participants With AEs by Maximum Intensity Post Dose 3
|
0 Participants
|
PRIMARY outcome
Timeframe: From Day 1 to 30 days after the last vaccine dose administered (at Month 0 or Month 2 or Month 6)Population: The analysis was performed on the Total Safety cohort, which included all participants who received at least one dose of vaccine as per the protocol and who reported adverse events even though they have not completed 30 days follow up period after vaccination.
A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject.
Outcome measures
| Measure |
Cervarix Group
n=662 Participants
The study group comprised of 9-25 year-old male and female subjects who were administered with 3 doses of Cervarix vaccine, according to a 0, 1, and 6 months schedule, as per locally approved prescribing information (PI) in Korea. The 9-14 years old subjects were vaccinated with 2 doses, according to a 0 and 6-12 months schedule. In the 2-dose schedule, if the second dose was administered before 5 months after the first dose, the third dose vaccination was required. In the 3 doses schedule, if the vaccination schedule required flexibility, the second dose was administered between 1 and 2.5 months and the third dose was administered between 5 and 12 months after the first dose.
|
|---|---|
|
Number of Participants With Serious Adverse Events (SAEs) and Fatal SAEs
Serious Adverse Events
|
0 Participants
|
|
Number of Participants With Serious Adverse Events (SAEs) and Fatal SAEs
Fatal Serious Adverse Events
|
0 Participants
|
Adverse Events
Cervarix Group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cervarix Group
n=669 participants at risk
The study group comprised of 9-25 year-old male and female subjects who were administered with 3 doses of Cervarix vaccine, according to a 0, 1, and 6 months schedule, as per locally approved prescribing information (PI) in Korea. The 9-14 years old subjects were vaccinated with 2 doses, according to a 0 and 6-12 months schedule. In the 2-dose schedule, if the second dose was administered before 5 months after the first dose, the third dose vaccination was required. In the 3 doses schedule, if the vaccination schedule required flexibility, the second dose was administered between 1 and 2.5 months and the third dose was administered between 5 and 12 months after the first dose.
|
|---|---|
|
General disorders
Injection site pain
|
9.0%
60/669 • Number of events 68 • Non-serious adverse events: From Day 1 up to 30 days (post dose 1, dose 2 and dose 3 vaccination). SAEs: From Day 1 to 30 days after the last vaccine dose administered (at Month 0 or Month 2 or Month 6).
Data was collected based on the Total Vaccinated Cohort.
|
|
General disorders
Injection site erythema
|
4.6%
31/669 • Number of events 34 • Non-serious adverse events: From Day 1 up to 30 days (post dose 1, dose 2 and dose 3 vaccination). SAEs: From Day 1 to 30 days after the last vaccine dose administered (at Month 0 or Month 2 or Month 6).
Data was collected based on the Total Vaccinated Cohort.
|
|
General disorders
Injection site swelling
|
1.9%
13/669 • Number of events 13 • Non-serious adverse events: From Day 1 up to 30 days (post dose 1, dose 2 and dose 3 vaccination). SAEs: From Day 1 to 30 days after the last vaccine dose administered (at Month 0 or Month 2 or Month 6).
Data was collected based on the Total Vaccinated Cohort.
|
|
General disorders
Pyrexia
|
1.8%
12/669 • Number of events 12 • Non-serious adverse events: From Day 1 up to 30 days (post dose 1, dose 2 and dose 3 vaccination). SAEs: From Day 1 to 30 days after the last vaccine dose administered (at Month 0 or Month 2 or Month 6).
Data was collected based on the Total Vaccinated Cohort.
|
|
General disorders
Injection site pruritus
|
0.60%
4/669 • Number of events 4 • Non-serious adverse events: From Day 1 up to 30 days (post dose 1, dose 2 and dose 3 vaccination). SAEs: From Day 1 to 30 days after the last vaccine dose administered (at Month 0 or Month 2 or Month 6).
Data was collected based on the Total Vaccinated Cohort.
|
|
General disorders
Injection site bruising
|
0.30%
2/669 • Number of events 2 • Non-serious adverse events: From Day 1 up to 30 days (post dose 1, dose 2 and dose 3 vaccination). SAEs: From Day 1 to 30 days after the last vaccine dose administered (at Month 0 or Month 2 or Month 6).
Data was collected based on the Total Vaccinated Cohort.
|
|
General disorders
Injection site paraesthesia
|
0.30%
2/669 • Number of events 2 • Non-serious adverse events: From Day 1 up to 30 days (post dose 1, dose 2 and dose 3 vaccination). SAEs: From Day 1 to 30 days after the last vaccine dose administered (at Month 0 or Month 2 or Month 6).
Data was collected based on the Total Vaccinated Cohort.
|
|
General disorders
Pain
|
0.30%
2/669 • Number of events 2 • Non-serious adverse events: From Day 1 up to 30 days (post dose 1, dose 2 and dose 3 vaccination). SAEs: From Day 1 to 30 days after the last vaccine dose administered (at Month 0 or Month 2 or Month 6).
Data was collected based on the Total Vaccinated Cohort.
|
|
General disorders
Fatigue
|
0.15%
1/669 • Number of events 1 • Non-serious adverse events: From Day 1 up to 30 days (post dose 1, dose 2 and dose 3 vaccination). SAEs: From Day 1 to 30 days after the last vaccine dose administered (at Month 0 or Month 2 or Month 6).
Data was collected based on the Total Vaccinated Cohort.
|
|
General disorders
Injection site oedema
|
0.15%
1/669 • Number of events 1 • Non-serious adverse events: From Day 1 up to 30 days (post dose 1, dose 2 and dose 3 vaccination). SAEs: From Day 1 to 30 days after the last vaccine dose administered (at Month 0 or Month 2 or Month 6).
Data was collected based on the Total Vaccinated Cohort.
|
|
General disorders
Injection site rash
|
0.15%
1/669 • Number of events 1 • Non-serious adverse events: From Day 1 up to 30 days (post dose 1, dose 2 and dose 3 vaccination). SAEs: From Day 1 to 30 days after the last vaccine dose administered (at Month 0 or Month 2 or Month 6).
Data was collected based on the Total Vaccinated Cohort.
|
|
General disorders
Injection site warmth
|
0.15%
1/669 • Number of events 1 • Non-serious adverse events: From Day 1 up to 30 days (post dose 1, dose 2 and dose 3 vaccination). SAEs: From Day 1 to 30 days after the last vaccine dose administered (at Month 0 or Month 2 or Month 6).
Data was collected based on the Total Vaccinated Cohort.
|
|
Infections and infestations
Tonsillitis
|
1.0%
7/669 • Number of events 7 • Non-serious adverse events: From Day 1 up to 30 days (post dose 1, dose 2 and dose 3 vaccination). SAEs: From Day 1 to 30 days after the last vaccine dose administered (at Month 0 or Month 2 or Month 6).
Data was collected based on the Total Vaccinated Cohort.
|
|
Infections and infestations
Nasopharyngitis
|
0.75%
5/669 • Number of events 5 • Non-serious adverse events: From Day 1 up to 30 days (post dose 1, dose 2 and dose 3 vaccination). SAEs: From Day 1 to 30 days after the last vaccine dose administered (at Month 0 or Month 2 or Month 6).
Data was collected based on the Total Vaccinated Cohort.
|
|
Infections and infestations
Pharyngitis
|
0.60%
4/669 • Number of events 4 • Non-serious adverse events: From Day 1 up to 30 days (post dose 1, dose 2 and dose 3 vaccination). SAEs: From Day 1 to 30 days after the last vaccine dose administered (at Month 0 or Month 2 or Month 6).
Data was collected based on the Total Vaccinated Cohort.
|
|
Infections and infestations
Bronchitis
|
0.45%
3/669 • Number of events 3 • Non-serious adverse events: From Day 1 up to 30 days (post dose 1, dose 2 and dose 3 vaccination). SAEs: From Day 1 to 30 days after the last vaccine dose administered (at Month 0 or Month 2 or Month 6).
Data was collected based on the Total Vaccinated Cohort.
|
|
Infections and infestations
Rhinitis
|
0.45%
3/669 • Number of events 3 • Non-serious adverse events: From Day 1 up to 30 days (post dose 1, dose 2 and dose 3 vaccination). SAEs: From Day 1 to 30 days after the last vaccine dose administered (at Month 0 or Month 2 or Month 6).
Data was collected based on the Total Vaccinated Cohort.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.45%
3/669 • Number of events 3 • Non-serious adverse events: From Day 1 up to 30 days (post dose 1, dose 2 and dose 3 vaccination). SAEs: From Day 1 to 30 days after the last vaccine dose administered (at Month 0 or Month 2 or Month 6).
Data was collected based on the Total Vaccinated Cohort.
|
|
Infections and infestations
Chronic sinusitis
|
0.30%
2/669 • Number of events 2 • Non-serious adverse events: From Day 1 up to 30 days (post dose 1, dose 2 and dose 3 vaccination). SAEs: From Day 1 to 30 days after the last vaccine dose administered (at Month 0 or Month 2 or Month 6).
Data was collected based on the Total Vaccinated Cohort.
|
|
Infections and infestations
Paronychia
|
0.30%
2/669 • Number of events 2 • Non-serious adverse events: From Day 1 up to 30 days (post dose 1, dose 2 and dose 3 vaccination). SAEs: From Day 1 to 30 days after the last vaccine dose administered (at Month 0 or Month 2 or Month 6).
Data was collected based on the Total Vaccinated Cohort.
|
|
Infections and infestations
Pneumonia
|
0.30%
2/669 • Number of events 2 • Non-serious adverse events: From Day 1 up to 30 days (post dose 1, dose 2 and dose 3 vaccination). SAEs: From Day 1 to 30 days after the last vaccine dose administered (at Month 0 or Month 2 or Month 6).
Data was collected based on the Total Vaccinated Cohort.
|
|
Infections and infestations
Conjunctivitis
|
0.15%
1/669 • Number of events 1 • Non-serious adverse events: From Day 1 up to 30 days (post dose 1, dose 2 and dose 3 vaccination). SAEs: From Day 1 to 30 days after the last vaccine dose administered (at Month 0 or Month 2 or Month 6).
Data was collected based on the Total Vaccinated Cohort.
|
|
Infections and infestations
Impetigo
|
0.15%
1/669 • Number of events 1 • Non-serious adverse events: From Day 1 up to 30 days (post dose 1, dose 2 and dose 3 vaccination). SAEs: From Day 1 to 30 days after the last vaccine dose administered (at Month 0 or Month 2 or Month 6).
Data was collected based on the Total Vaccinated Cohort.
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.30%
2/669 • Number of events 2 • Non-serious adverse events: From Day 1 up to 30 days (post dose 1, dose 2 and dose 3 vaccination). SAEs: From Day 1 to 30 days after the last vaccine dose administered (at Month 0 or Month 2 or Month 6).
Data was collected based on the Total Vaccinated Cohort.
|
|
Gastrointestinal disorders
Nausea
|
0.30%
2/669 • Number of events 2 • Non-serious adverse events: From Day 1 up to 30 days (post dose 1, dose 2 and dose 3 vaccination). SAEs: From Day 1 to 30 days after the last vaccine dose administered (at Month 0 or Month 2 or Month 6).
Data was collected based on the Total Vaccinated Cohort.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.15%
1/669 • Number of events 1 • Non-serious adverse events: From Day 1 up to 30 days (post dose 1, dose 2 and dose 3 vaccination). SAEs: From Day 1 to 30 days after the last vaccine dose administered (at Month 0 or Month 2 or Month 6).
Data was collected based on the Total Vaccinated Cohort.
|
|
Gastrointestinal disorders
Enteritis
|
0.15%
1/669 • Number of events 1 • Non-serious adverse events: From Day 1 up to 30 days (post dose 1, dose 2 and dose 3 vaccination). SAEs: From Day 1 to 30 days after the last vaccine dose administered (at Month 0 or Month 2 or Month 6).
Data was collected based on the Total Vaccinated Cohort.
|
|
Gastrointestinal disorders
Functional gastrointestinal disorder
|
0.15%
1/669 • Number of events 1 • Non-serious adverse events: From Day 1 up to 30 days (post dose 1, dose 2 and dose 3 vaccination). SAEs: From Day 1 to 30 days after the last vaccine dose administered (at Month 0 or Month 2 or Month 6).
Data was collected based on the Total Vaccinated Cohort.
|
|
Gastrointestinal disorders
Gastritis
|
0.15%
1/669 • Number of events 1 • Non-serious adverse events: From Day 1 up to 30 days (post dose 1, dose 2 and dose 3 vaccination). SAEs: From Day 1 to 30 days after the last vaccine dose administered (at Month 0 or Month 2 or Month 6).
Data was collected based on the Total Vaccinated Cohort.
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.15%
1/669 • Number of events 1 • Non-serious adverse events: From Day 1 up to 30 days (post dose 1, dose 2 and dose 3 vaccination). SAEs: From Day 1 to 30 days after the last vaccine dose administered (at Month 0 or Month 2 or Month 6).
Data was collected based on the Total Vaccinated Cohort.
|
|
Gastrointestinal disorders
Vomiting
|
0.15%
1/669 • Number of events 1 • Non-serious adverse events: From Day 1 up to 30 days (post dose 1, dose 2 and dose 3 vaccination). SAEs: From Day 1 to 30 days after the last vaccine dose administered (at Month 0 or Month 2 or Month 6).
Data was collected based on the Total Vaccinated Cohort.
|
|
Nervous system disorders
Headache
|
0.90%
6/669 • Number of events 6 • Non-serious adverse events: From Day 1 up to 30 days (post dose 1, dose 2 and dose 3 vaccination). SAEs: From Day 1 to 30 days after the last vaccine dose administered (at Month 0 or Month 2 or Month 6).
Data was collected based on the Total Vaccinated Cohort.
|
|
Nervous system disorders
Dizziness
|
0.60%
4/669 • Number of events 4 • Non-serious adverse events: From Day 1 up to 30 days (post dose 1, dose 2 and dose 3 vaccination). SAEs: From Day 1 to 30 days after the last vaccine dose administered (at Month 0 or Month 2 or Month 6).
Data was collected based on the Total Vaccinated Cohort.
|
|
Nervous system disorders
Syncope
|
0.15%
1/669 • Number of events 1 • Non-serious adverse events: From Day 1 up to 30 days (post dose 1, dose 2 and dose 3 vaccination). SAEs: From Day 1 to 30 days after the last vaccine dose administered (at Month 0 or Month 2 or Month 6).
Data was collected based on the Total Vaccinated Cohort.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.90%
6/669 • Number of events 6 • Non-serious adverse events: From Day 1 up to 30 days (post dose 1, dose 2 and dose 3 vaccination). SAEs: From Day 1 to 30 days after the last vaccine dose administered (at Month 0 or Month 2 or Month 6).
Data was collected based on the Total Vaccinated Cohort.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.15%
1/669 • Number of events 1 • Non-serious adverse events: From Day 1 up to 30 days (post dose 1, dose 2 and dose 3 vaccination). SAEs: From Day 1 to 30 days after the last vaccine dose administered (at Month 0 or Month 2 or Month 6).
Data was collected based on the Total Vaccinated Cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.75%
5/669 • Number of events 5 • Non-serious adverse events: From Day 1 up to 30 days (post dose 1, dose 2 and dose 3 vaccination). SAEs: From Day 1 to 30 days after the last vaccine dose administered (at Month 0 or Month 2 or Month 6).
Data was collected based on the Total Vaccinated Cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.45%
3/669 • Number of events 3 • Non-serious adverse events: From Day 1 up to 30 days (post dose 1, dose 2 and dose 3 vaccination). SAEs: From Day 1 to 30 days after the last vaccine dose administered (at Month 0 or Month 2 or Month 6).
Data was collected based on the Total Vaccinated Cohort.
|
|
Eye disorders
Chalazion
|
0.15%
1/669 • Number of events 1 • Non-serious adverse events: From Day 1 up to 30 days (post dose 1, dose 2 and dose 3 vaccination). SAEs: From Day 1 to 30 days after the last vaccine dose administered (at Month 0 or Month 2 or Month 6).
Data was collected based on the Total Vaccinated Cohort.
|
|
Eye disorders
Dry eye
|
0.15%
1/669 • Number of events 1 • Non-serious adverse events: From Day 1 up to 30 days (post dose 1, dose 2 and dose 3 vaccination). SAEs: From Day 1 to 30 days after the last vaccine dose administered (at Month 0 or Month 2 or Month 6).
Data was collected based on the Total Vaccinated Cohort.
|
|
Eye disorders
Ocular discomfort
|
0.15%
1/669 • Number of events 1 • Non-serious adverse events: From Day 1 up to 30 days (post dose 1, dose 2 and dose 3 vaccination). SAEs: From Day 1 to 30 days after the last vaccine dose administered (at Month 0 or Month 2 or Month 6).
Data was collected based on the Total Vaccinated Cohort.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.15%
1/669 • Number of events 1 • Non-serious adverse events: From Day 1 up to 30 days (post dose 1, dose 2 and dose 3 vaccination). SAEs: From Day 1 to 30 days after the last vaccine dose administered (at Month 0 or Month 2 or Month 6).
Data was collected based on the Total Vaccinated Cohort.
|
|
Skin and subcutaneous tissue disorders
Keratosis pilaris
|
0.15%
1/669 • Number of events 1 • Non-serious adverse events: From Day 1 up to 30 days (post dose 1, dose 2 and dose 3 vaccination). SAEs: From Day 1 to 30 days after the last vaccine dose administered (at Month 0 or Month 2 or Month 6).
Data was collected based on the Total Vaccinated Cohort.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.15%
1/669 • Number of events 1 • Non-serious adverse events: From Day 1 up to 30 days (post dose 1, dose 2 and dose 3 vaccination). SAEs: From Day 1 to 30 days after the last vaccine dose administered (at Month 0 or Month 2 or Month 6).
Data was collected based on the Total Vaccinated Cohort.
|
|
Immune system disorders
Lip swelling
|
0.15%
1/669 • Number of events 1 • Non-serious adverse events: From Day 1 up to 30 days (post dose 1, dose 2 and dose 3 vaccination). SAEs: From Day 1 to 30 days after the last vaccine dose administered (at Month 0 or Month 2 or Month 6).
Data was collected based on the Total Vaccinated Cohort.
|
|
Immune system disorders
Swelling of eyelid
|
0.15%
1/669 • Number of events 1 • Non-serious adverse events: From Day 1 up to 30 days (post dose 1, dose 2 and dose 3 vaccination). SAEs: From Day 1 to 30 days after the last vaccine dose administered (at Month 0 or Month 2 or Month 6).
Data was collected based on the Total Vaccinated Cohort.
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.15%
1/669 • Number of events 1 • Non-serious adverse events: From Day 1 up to 30 days (post dose 1, dose 2 and dose 3 vaccination). SAEs: From Day 1 to 30 days after the last vaccine dose administered (at Month 0 or Month 2 or Month 6).
Data was collected based on the Total Vaccinated Cohort.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.15%
1/669 • Number of events 1 • Non-serious adverse events: From Day 1 up to 30 days (post dose 1, dose 2 and dose 3 vaccination). SAEs: From Day 1 to 30 days after the last vaccine dose administered (at Month 0 or Month 2 or Month 6).
Data was collected based on the Total Vaccinated Cohort.
|
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