Trial Outcomes & Findings for A Post Marketing Surveillance (PMS) Study to Monitor the Safety of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) Vaccine in Female Chinese Subjects (NCT NCT03438006)
NCT ID: NCT03438006
Last Updated: 2021-09-08
Results Overview
An adverse event following immunisation (AEFI) is defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a vaccine. Medically attended AEFIs are defined as events leading to an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits. Any Medically attended AEFIS are presented for each dose and across doses. Grade 3 Medically attended AEFI = an AEFI which prevented normal, everyday activities. Related Medically Attended AEFI = AEFI assessed by the investigator as related to the vaccination.
Recruitment status
COMPLETED
Target enrollment
3016 participants
Primary outcome timeframe
During the 30-day period following each immunisation with Cervarix (administered on Day 1, Month 1 and Month 6)
Results posted on
2021-09-08
Participant Flow
The study was conducted at 8 centres in China
Out of 3016 participants enrolled in the study, 3 participants did not receive any vaccination and therefore were not included in any analysis.
Participant milestones
| Measure |
Cervarix Group
Healthy female Chinese participants aged between 9 and 45 years, vaccinated according to the Prescribing Information (PI) as per routine practice.
|
|---|---|
|
Overall Study
STARTED
|
3013
|
|
Overall Study
COMPLETED
|
2895
|
|
Overall Study
NOT COMPLETED
|
118
|
Reasons for withdrawal
| Measure |
Cervarix Group
Healthy female Chinese participants aged between 9 and 45 years, vaccinated according to the Prescribing Information (PI) as per routine practice.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Lost to Follow-up
|
67
|
|
Overall Study
CONSENT WITHDRAWAL NOT DUE TO ADV. EVENT
|
47
|
|
Overall Study
NOT WILLING / NOT ABLE TO BE CONTACTED
|
3
|
Baseline Characteristics
A Post Marketing Surveillance (PMS) Study to Monitor the Safety of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) Vaccine in Female Chinese Subjects
Baseline characteristics by cohort
| Measure |
Cervarix Group
n=3013 Participants
Healthy female Chinese participants aged between 9 and 45 years, vaccinated according to the Prescribing Information (PI) as per routine practice.
|
|---|---|
|
Age, Continuous
|
30.6 YEARS
STANDARD_DEVIATION 9.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3013 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - East Asian Heritage
|
3013 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During the 30-day period following each immunisation with Cervarix (administered on Day 1, Month 1 and Month 6)Population: Analysis was based on the Exposed Set (ES) which included all participants exposed to Cervarix and who provided safety data.
An adverse event following immunisation (AEFI) is defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a vaccine. Medically attended AEFIs are defined as events leading to an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits. Any Medically attended AEFIS are presented for each dose and across doses. Grade 3 Medically attended AEFI = an AEFI which prevented normal, everyday activities. Related Medically Attended AEFI = AEFI assessed by the investigator as related to the vaccination.
Outcome measures
| Measure |
Cervarix Group
n=3013 Participants
Healthy female Chinese participants aged between 9 and 45 years, vaccinated according to the Prescribing Information (PI) as per routine practice.
|
|---|---|
|
Number of Participants With Any (Following Each Dose and Across Doses), Grade 3 (Across Doses) and Vaccine Related (Across Doses) Medically Attended Adverse Events Following Immunisation (AEFIs)
Dose 1
|
49 Participants
|
|
Number of Participants With Any (Following Each Dose and Across Doses), Grade 3 (Across Doses) and Vaccine Related (Across Doses) Medically Attended Adverse Events Following Immunisation (AEFIs)
Dose 2
|
55 Participants
|
|
Number of Participants With Any (Following Each Dose and Across Doses), Grade 3 (Across Doses) and Vaccine Related (Across Doses) Medically Attended Adverse Events Following Immunisation (AEFIs)
Dose 3
|
56 Participants
|
|
Number of Participants With Any (Following Each Dose and Across Doses), Grade 3 (Across Doses) and Vaccine Related (Across Doses) Medically Attended Adverse Events Following Immunisation (AEFIs)
Across doses
|
147 Participants
|
|
Number of Participants With Any (Following Each Dose and Across Doses), Grade 3 (Across Doses) and Vaccine Related (Across Doses) Medically Attended Adverse Events Following Immunisation (AEFIs)
Grade 3
|
1 Participants
|
|
Number of Participants With Any (Following Each Dose and Across Doses), Grade 3 (Across Doses) and Vaccine Related (Across Doses) Medically Attended Adverse Events Following Immunisation (AEFIs)
Related
|
2 Participants
|
SECONDARY outcome
Timeframe: Throughout the study period (From Day 1 to either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24) whichever occured first))Population: Analysis was based on the Exposed Set (ES) which included all participants exposed to Cervarix.
Serious AEFIs assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a participant. Any serious AEFI = If a medically attended AEFI led to hospitalisation (or met any other serious AEFI criteria). Fatal Serious AEFIs are those events that resulted in death. Related Serious AEFIs= AEFIs assessed by the investigator as causally related to the study vaccination.
Outcome measures
| Measure |
Cervarix Group
n=3013 Participants
Healthy female Chinese participants aged between 9 and 45 years, vaccinated according to the Prescribing Information (PI) as per routine practice.
|
|---|---|
|
Number of Participants With Any, Fatal and Vaccine Related Serious AEFIs (Across Doses)
Any
|
22 Participants
|
|
Number of Participants With Any, Fatal and Vaccine Related Serious AEFIs (Across Doses)
Fatal
|
0 Participants
|
|
Number of Participants With Any, Fatal and Vaccine Related Serious AEFIs (Across Doses)
Related
|
0 Participants
|
SECONDARY outcome
Timeframe: Throughout the study period (from Day 1 up to either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first))Population: Analysis was based on the Exposed Set (ES) which included all participants exposed to Cervarix.
pIMDs are a subset of AEFIs that included autoimmune diseases and other inflammatory and/or neurologic disorders of interest which might or might not have an autoimmune aetiology. Any was defined as the occurrence of any pIMD regardless of intensity grade or relation to vaccination. Grade 3 pIMDs = pIMDs which prevented normal, everyday activities. Related pIMDs = pIMDs assessed by the investigator as related to the vaccination.
Outcome measures
| Measure |
Cervarix Group
n=3013 Participants
Healthy female Chinese participants aged between 9 and 45 years, vaccinated according to the Prescribing Information (PI) as per routine practice.
|
|---|---|
|
Number of Participants With Any, Grade 3 and Vaccine Related Potential Immune Mediated Diseases (pIMDs) (Across Doses)
Any
|
1 Participants
|
|
Number of Participants With Any, Grade 3 and Vaccine Related Potential Immune Mediated Diseases (pIMDs) (Across Doses)
Grade 3
|
0 Participants
|
|
Number of Participants With Any, Grade 3 and Vaccine Related Potential Immune Mediated Diseases (pIMDs) (Across Doses)
Related
|
0 Participants
|
SECONDARY outcome
Timeframe: Throughout the study period (from Day 1 up to either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first))Population: The analysis was based on the ES, which included all participants exposed to Cervarix and who reported pregnancies and/or outcomes of reported pregnancies.
The number of participants reporting pregnancies and outcomes of reported pregnancies (elective abortion for medical reasons, spontaneous abortion or congenital anomaly) when Cervarix was administered to the participant, inadvertently within 60 days before pregnancy onset, or any time during pregnancy, was reported.
Outcome measures
| Measure |
Cervarix Group
n=65 Participants
Healthy female Chinese participants aged between 9 and 45 years, vaccinated according to the Prescribing Information (PI) as per routine practice.
|
|---|---|
|
Number of Participants Reporting Pregnancies and Outcomes of Reported Pregnancies
Live infant no apparent congenital anomaly
|
34 Participants
|
|
Number of Participants Reporting Pregnancies and Outcomes of Reported Pregnancies
Live infant congenital anomaly
|
1 Participants
|
|
Number of Participants Reporting Pregnancies and Outcomes of Reported Pregnancies
Elective termination no apparent congenital anomaly
|
20 Participants
|
|
Number of Participants Reporting Pregnancies and Outcomes of Reported Pregnancies
Elective termination congenital anomaly
|
0 Participants
|
|
Number of Participants Reporting Pregnancies and Outcomes of Reported Pregnancies
Spontaneous abortion no apparent congenital anomaly
|
1 Participants
|
|
Number of Participants Reporting Pregnancies and Outcomes of Reported Pregnancies
Spontaneous abortion congenital anomaly
|
0 Participants
|
|
Number of Participants Reporting Pregnancies and Outcomes of Reported Pregnancies
Stillbirth no apparent congenital anomaly
|
0 Participants
|
|
Number of Participants Reporting Pregnancies and Outcomes of Reported Pregnancies
Stillbirth congenital anomaly
|
0 Participants
|
|
Number of Participants Reporting Pregnancies and Outcomes of Reported Pregnancies
Ectopic pregnancy
|
4 Participants
|
|
Number of Participants Reporting Pregnancies and Outcomes of Reported Pregnancies
Molar pregnancy
|
0 Participants
|
|
Number of Participants Reporting Pregnancies and Outcomes of Reported Pregnancies
Pregnancies lost to follow-up
|
5 Participants
|
|
Number of Participants Reporting Pregnancies and Outcomes of Reported Pregnancies
Pregnancy ongoing
|
0 Participants
|
Adverse Events
Cervarix Group
Serious events: 22 serious events
Other events: 143 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cervarix Group
n=3013 participants at risk
Healthy female Chinese participants aged between 9 and 45 years, vaccinated according to the Prescribing Information (PI) as per routine practice.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.03%
1/3013 • Number of events 1 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.03%
1/3013 • Number of events 1 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Congenital, familial and genetic disorders
Glycogen storage disease type I
|
0.03%
1/3013 • Number of events 1 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Congenital, familial and genetic disorders
Type V hyperlipidaemia
|
0.03%
1/3013 • Number of events 1 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Gastrointestinal disorders
Gastritis
|
0.03%
1/3013 • Number of events 1 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.03%
1/3013 • Number of events 1 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.03%
1/3013 • Number of events 1 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.03%
1/3013 • Number of events 1 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Infections and infestations
Bronchitis
|
0.07%
2/3013 • Number of events 2 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Infections and infestations
Mastitis
|
0.03%
1/3013 • Number of events 1 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Infections and infestations
Pelvic inflammatory disease
|
0.03%
1/3013 • Number of events 1 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Infections and infestations
Pneumonia
|
0.13%
4/3013 • Number of events 4 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Infections and infestations
Viral hepatitis carrier
|
0.03%
1/3013 • Number of events 1 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.03%
1/3013 • Number of events 1 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.03%
1/3013 • Number of events 1 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
0.03%
1/3013 • Number of events 1 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.03%
1/3013 • Number of events 1 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.03%
1/3013 • Number of events 1 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.03%
1/3013 • Number of events 1 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Nervous system disorders
Diabetic neuropathy
|
0.03%
1/3013 • Number of events 1 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Pregnancy, puerperium and perinatal conditions
Abortion missed
|
0.03%
1/3013 • Number of events 1 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.13%
4/3013 • Number of events 4 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Pregnancy, puerperium and perinatal conditions
Gestational diabetes
|
0.03%
1/3013 • Number of events 1 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Pregnancy, puerperium and perinatal conditions
High risk pregnancy
|
0.03%
1/3013 • Number of events 1 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Pregnancy, puerperium and perinatal conditions
Premature delivery
|
0.03%
1/3013 • Number of events 1 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Psychiatric disorders
Sleep disorder
|
0.03%
1/3013 • Number of events 1 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.03%
1/3013 • Number of events 1 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.03%
1/3013 • Number of events 1 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.03%
1/3013 • Number of events 1 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Reproductive system and breast disorders
Uterine scar
|
0.03%
1/3013 • Number of events 1 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Surgical and medical procedures
Abortion induced
|
0.07%
2/3013 • Number of events 2 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Vascular disorders
Venous thrombosis
|
0.03%
1/3013 • Number of events 1 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
Other adverse events
| Measure |
Cervarix Group
n=3013 participants at risk
Healthy female Chinese participants aged between 9 and 45 years, vaccinated according to the Prescribing Information (PI) as per routine practice.
|
|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.03%
1/3013 • Number of events 1 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Cardiac disorders
Sinus node dysfunction
|
0.03%
1/3013 • Number of events 1 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Cardiac disorders
Tachycardia
|
0.03%
1/3013 • Number of events 1 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Ear and labyrinth disorders
Ear pruritus
|
0.03%
1/3013 • Number of events 1 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Ear and labyrinth disorders
Tinnitus
|
0.03%
1/3013 • Number of events 1 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Endocrine disorders
Hyperthyroidism
|
0.03%
1/3013 • Number of events 1 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Eye disorders
Chalazion
|
0.03%
1/3013 • Number of events 1 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Eye disorders
Conjunctival oedema
|
0.03%
1/3013 • Number of events 1 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Eye disorders
Dry eye
|
0.03%
1/3013 • Number of events 1 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Gastrointestinal disorders
Abdominal pain
|
0.07%
2/3013 • Number of events 2 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.07%
2/3013 • Number of events 2 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Gastrointestinal disorders
Enteritis
|
0.07%
2/3013 • Number of events 2 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Gastrointestinal disorders
Gastritis
|
0.13%
4/3013 • Number of events 4 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.03%
1/3013 • Number of events 1 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.03%
1/3013 • Number of events 1 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Gastrointestinal disorders
Stomatitis
|
0.03%
1/3013 • Number of events 1 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Gastrointestinal disorders
Tooth impacted
|
0.03%
1/3013 • Number of events 1 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
General disorders
Influenza like illness
|
0.13%
4/3013 • Number of events 5 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
General disorders
Pyrexia
|
0.33%
10/3013 • Number of events 10 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Immune system disorders
Hypersensitivity
|
0.03%
1/3013 • Number of events 1 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Infections and infestations
Acute sinusitis
|
0.10%
3/3013 • Number of events 3 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Infections and infestations
Bronchitis
|
0.80%
24/3013 • Number of events 26 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Infections and infestations
Conjunctivitis
|
0.03%
1/3013 • Number of events 1 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Infections and infestations
Gastroenteritis
|
0.17%
5/3013 • Number of events 5 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Infections and infestations
Gingivitis
|
0.03%
1/3013 • Number of events 1 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Infections and infestations
Helicobacter infection
|
0.07%
2/3013 • Number of events 2 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Infections and infestations
Herpangina
|
0.03%
1/3013 • Number of events 1 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Infections and infestations
Influenza
|
0.03%
1/3013 • Number of events 1 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Infections and infestations
Nasopharyngitis
|
0.13%
4/3013 • Number of events 4 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Infections and infestations
Otitis media chronic
|
0.03%
1/3013 • Number of events 1 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Infections and infestations
Paronychia
|
0.03%
1/3013 • Number of events 1 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Infections and infestations
Pelvic inflammatory disease
|
0.07%
2/3013 • Number of events 2 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Infections and infestations
Periodontitis
|
0.03%
1/3013 • Number of events 1 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Infections and infestations
Pharyngitis
|
0.30%
9/3013 • Number of events 9 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Infections and infestations
Pneumonia
|
0.13%
4/3013 • Number of events 4 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Infections and infestations
Tonsillitis
|
0.40%
12/3013 • Number of events 12 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Infections and infestations
Upper respiratory tract infection
|
1.00%
30/3013 • Number of events 32 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Infections and infestations
Urethritis
|
0.03%
1/3013 • Number of events 1 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Infections and infestations
Urinary tract infection
|
0.17%
5/3013 • Number of events 5 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Infections and infestations
Vaginal infection
|
0.07%
2/3013 • Number of events 2 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.03%
1/3013 • Number of events 1 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Injury, poisoning and procedural complications
Animal scratch
|
0.03%
1/3013 • Number of events 1 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.03%
1/3013 • Number of events 1 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.03%
1/3013 • Number of events 1 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.03%
1/3013 • Number of events 1 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.03%
1/3013 • Number of events 1 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.03%
1/3013 • Number of events 1 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.03%
1/3013 • Number of events 1 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Nervous system disorders
Dizziness
|
0.03%
1/3013 • Number of events 1 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Nervous system disorders
Headache
|
0.03%
1/3013 • Number of events 1 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Nervous system disorders
Migraine
|
0.03%
1/3013 • Number of events 1 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Nervous system disorders
Neuritis
|
0.03%
1/3013 • Number of events 1 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Psychiatric disorders
Anxiety
|
0.03%
1/3013 • Number of events 1 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Psychiatric disorders
Insomnia
|
0.07%
2/3013 • Number of events 2 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Psychiatric disorders
Sleep disorder
|
0.03%
1/3013 • Number of events 1 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Renal and urinary disorders
Calculus urinary
|
0.03%
1/3013 • Number of events 1 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.03%
1/3013 • Number of events 1 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Reproductive system and breast disorders
Adenomyosis
|
0.03%
1/3013 • Number of events 1 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Reproductive system and breast disorders
Breast hyperplasia
|
0.03%
1/3013 • Number of events 1 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.10%
3/3013 • Number of events 3 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Reproductive system and breast disorders
Polymenorrhoea
|
0.03%
1/3013 • Number of events 1 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.03%
1/3013 • Number of events 1 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.03%
1/3013 • Number of events 1 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.07%
2/3013 • Number of events 2 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.03%
1/3013 • Number of events 1 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.10%
3/3013 • Number of events 3 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.03%
1/3013 • Number of events 1 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.07%
2/3013 • Number of events 2 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.03%
1/3013 • Number of events 1 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.10%
3/3013 • Number of events 3 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.10%
3/3013 • Number of events 3 • Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].
|
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