Trial Outcomes & Findings for Study to Assess Immune Responses and Safety of the GSK-580299 Vaccine in Healthy Women (26 to 45 Years) (NCT NCT01277042)
NCT ID: NCT01277042
Last Updated: 2018-08-17
Results Overview
A seroconverted subject was defined as a subject seronegative at baseline whose concentration for anti-HPV-16/18 antibodies, as measured by Enzyme-linked Immunosorbent assay (ELISA) , was higher than or equal to (≥) cut-off value. A seronegative subject was defined as a subject whose antibody concentration was below (\<) cut-off value. Cut-off values were 8 ELISA units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1212 participants
Primary outcome timeframe
One month after third vaccination (Month 7)
Results posted on
2018-08-17
Participant Flow
The study comprised a Primary Vaccination Phase from Day 0 to Month 7, followed by a Long-Term Safety Follow-up Phase, up to Month 12.
Participant milestones
| Measure |
Cervarix Group
Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
Engerix Group
Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
Overall Study
STARTED
|
606
|
606
|
|
Overall Study
COMPLETED
|
598
|
601
|
|
Overall Study
NOT COMPLETED
|
8
|
5
|
Reasons for withdrawal
| Measure |
Cervarix Group
Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
Engerix Group
Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
3
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
Study to Assess Immune Responses and Safety of the GSK-580299 Vaccine in Healthy Women (26 to 45 Years)
Baseline characteristics by cohort
| Measure |
Cervarix Group
n=606 Participants
Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
Engerix Group
n=606 Participants
Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
Total
n=1212 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.8 Years
STANDARD_DEVIATION 4.92 • n=5 Participants
|
35.6 Years
STANDARD_DEVIATION 5.06 • n=7 Participants
|
35.7 Years
STANDARD_DEVIATION 4.99 • n=5 Participants
|
|
Sex: Female, Male
Female
|
606 Participants
n=5 Participants
|
606 Participants
n=7 Participants
|
1212 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: One month after third vaccination (Month 7)Population: The analysis was based on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
A seroconverted subject was defined as a subject seronegative at baseline whose concentration for anti-HPV-16/18 antibodies, as measured by Enzyme-linked Immunosorbent assay (ELISA) , was higher than or equal to (≥) cut-off value. A seronegative subject was defined as a subject whose antibody concentration was below (\<) cut-off value. Cut-off values were 8 ELISA units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.
Outcome measures
| Measure |
Cervarix Group
n=365 Participants
Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
Engerix Group
n=401 Participants
Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
Number of Seroconverted Subjects Against Human Papillomavirus-16 (HPV-16) and HPV-18
HPV-16
|
345 Participants
|
67 Participants
|
|
Number of Seroconverted Subjects Against Human Papillomavirus-16 (HPV-16) and HPV-18
HPV-18
|
363 Participants
|
135 Participants
|
SECONDARY outcome
Timeframe: Before vaccination (Month 0) and one month after third vaccination (Month 7)Population: The analysis was based on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
A seropositive subject was defined as a subject whose anti-HPV-16/18 antibody concentration, as measured by ELISA, was higher than or equal to (≥) cut-off value. Cut-off values were 8 ELISA units per milliliter (EL.U/mL) for anti-HPV-16 antibodies, and 7 EL.U/mL for anti-HPV-18 antibodies.
Outcome measures
| Measure |
Cervarix Group
n=596 Participants
Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
Engerix Group
n=601 Participants
Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
Number of Subjects Seropositive Against HPV-16 and HPV-18
HPV-16, Day 0
|
251 Participants
|
257 Participants
|
|
Number of Subjects Seropositive Against HPV-16 and HPV-18
HPV-16, Month 7
|
596 Participants
|
322 Participants
|
|
Number of Subjects Seropositive Against HPV-16 and HPV-18
HPV-18, Day 0
|
231 Participants
|
200 Participants
|
|
Number of Subjects Seropositive Against HPV-16 and HPV-18
HPV-18, Month 7
|
594 Participants
|
312 Participants
|
SECONDARY outcome
Timeframe: Before vaccination (Month 0) and one month after third vaccination (Month 7)Population: The analysis was based on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Concentrations are given as geometric mean titers (GMTs), expressed in ELISA units per milliliter (EL.U/mL). Cut-off values were 8 EL.U/mL for anti-HPV-16 antibodies, and 7 EL.U/mL for anti-HPV-18 antibodies.
Outcome measures
| Measure |
Cervarix Group
n=596 Participants
Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
Engerix Group
n=601 Participants
Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
Concentrations for Anti-HPV-16 and Anti-HPV-18 Antibodies
HPV-16, Day 0
|
9.7 EL.U/mL
Interval 8.8 to 10.6
|
9.3 EL.U/mL
Interval 8.5 to 10.2
|
|
Concentrations for Anti-HPV-16 and Anti-HPV-18 Antibodies
HPV-16, Month 7
|
6439.8 EL.U/mL
Interval 6039.8 to 6866.3
|
12.1 EL.U/mL
Interval 11.0 to 13.4
|
|
Concentrations for Anti-HPV-16 and Anti-HPV-18 Antibodies
HPV-18, Day 0
|
6.4 EL.U/mL
Interval 6.0 to 6.9
|
6.0 EL.U/mL
Interval 5.6 to 6.5
|
|
Concentrations for Anti-HPV-16 and Anti-HPV-18 Antibodies
HPV-18, Month 7
|
3563.3 EL.U/mL
Interval 3310.0 to 3836.0
|
8.7 EL.U/mL
Interval 8.0 to 9.5
|
SECONDARY outcome
Timeframe: During the 7 days (Days 0 - 6) after any vaccinationPopulation: The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and symptom sheet completed.
Solicited local symptoms assessed were pain, redness and swelling. Grade 3 redness and swelling were redness and swelling above 50 millimeters (mm) and grade 3 pain was defined as pain that prevented normal activity. Any was defined as the incidence of a symptom regardless of intensity grade.
Outcome measures
| Measure |
Cervarix Group
n=604 Participants
Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
Engerix Group
n=606 Participants
Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Grade 3 redness
|
2 Participants
|
1 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Any pain
|
470 Participants
|
296 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Grade 3 pain
|
36 Participants
|
5 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Any redness
|
156 Participants
|
88 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Any swelling
|
146 Participants
|
58 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Grade 3 swelling
|
11 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: During the 7 days (Days 0 - 6) after any vaccinationPopulation: The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and symptom sheet completed.
Solicited symptoms were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, urticaria and temperature \[axillary temperature above (\>)37 degrees Celsius(°C)\].Grade 3 temperature= temperature \>39°C. Grade 3 utricaria= distributed on at least 4 body areas. Grade 3 symptom=prevented normal activity. Gastrointestinal symptoms=nausea, vomiting, diarrhoea and/or abdominal pain. Arthralgia (joint pain): in joints distal from injection site. Any=incidence of a symptom regardless of intensity grade or relationship to vaccination. Related = incidence of a symptom assessed by investigator as related to vaccination.
Outcome measures
| Measure |
Cervarix Group
n=604 Participants
Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
Engerix Group
n=606 Participants
Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any arthralgia
|
19 Participants
|
14 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 arthralgia
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related arthralgia
|
17 Participants
|
12 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any fatigue
|
100 Participants
|
68 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 fatigue
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related fatigue
|
93 Participants
|
59 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any gastrointestinal symptoms
|
33 Participants
|
24 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 gastrointestinal symptoms
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related gastrointestinal symptoms
|
24 Participants
|
11 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any headache
|
71 Participants
|
46 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 headache
|
4 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related headache
|
64 Participants
|
38 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any myalgia
|
69 Participants
|
42 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 myalgia
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related myalgia
|
66 Participants
|
39 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any rash
|
2 Participants
|
1 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 rash
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related rash
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Temperature >37.0°C
|
28 Participants
|
24 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Temperature >39.0°C
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related temperature
|
15 Participants
|
13 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any urticaria
|
4 Participants
|
1 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 urticaria
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related urticaria
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Throughout the study (from Month 0 up to Month 12)Population: The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination, grade 3 was a SAE that prevented normal activities, and related was defined as a SAE assessed by the investigator to be causally related to the study vaccination. and related was an event assessed by the investigator as causally related to the study vaccination.
Outcome measures
| Measure |
Cervarix Group
n=606 Participants
Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
Engerix Group
n=606 Participants
Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
Number of Subjects Reporting Any, Grade 3 and Related Serious Adverse Events (SAEs)
Any SAE(s)
|
3 Participants
|
3 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Serious Adverse Events (SAEs)
Grade 3 SAE(s)
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Serious Adverse Events (SAEs)
Related SAE(s)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 30 days (Days 0 - 29) after any vaccinationPopulation: The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.
An unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.
Outcome measures
| Measure |
Cervarix Group
n=606 Participants
Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
Engerix Group
n=606 Participants
Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Any AE(s)
|
32 Participants
|
36 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Grade 3 AE(s)
|
2 Participants
|
2 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Related AE(s)
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Throughout the study (from Month 0 up to Month 12)Population: The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.
MSCs were AEs prompting emergency room or physician visits that were not related to common diseases (upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury), or not related to routine visits for physical examination or vaccination. It also included SAEs not related to common diseases. MSCs included pIMDs, a subset of MSCs that included autoimmune diseases and other inflammatory and/or neurological disorders of interest which might or might not have had an autoimmune etiology.
Outcome measures
| Measure |
Cervarix Group
n=606 Participants
Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
Engerix Group
n=606 Participants
Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
Number of Subjects Reporting Medically Significant Conditions (MSCs) Including Potential Immune Mediated Diseases (pIMDs)
|
5 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Throughout the study (from Month 0 up to Month 12)Population: The analysis was performed on Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented, solely on subjects with outcome of pregnancies.
The sole pregnancy outcome reported was elective termination with no apparent congenital anomaly.
Outcome measures
| Measure |
Cervarix Group
n=4 Participants
Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
Engerix Group
n=1 Participants
Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
Number of Subjects With Outcome of Pregnancies
|
4 Participants
|
1 Participants
|
Adverse Events
Cervarix Group
Serious events: 3 serious events
Other events: 490 other events
Deaths: 0 deaths
Engerix Group
Serious events: 3 serious events
Other events: 318 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cervarix Group
n=606 participants at risk
Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
Engerix Group
n=606 participants at risk
Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
Cardiac disorders
Aortic valve incompetence
|
0.00%
0/606 • Serious adverse events were assessed from Month 0 up to Month 12. Systematically assessed frequent adverse events were assessed during 7 days (Days 0-6) post vaccination period.
For the systematically assessed other (non-serious) adverse events the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
0.17%
1/606 • Serious adverse events were assessed from Month 0 up to Month 12. Systematically assessed frequent adverse events were assessed during 7 days (Days 0-6) post vaccination period.
For the systematically assessed other (non-serious) adverse events the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.00%
0/606 • Serious adverse events were assessed from Month 0 up to Month 12. Systematically assessed frequent adverse events were assessed during 7 days (Days 0-6) post vaccination period.
For the systematically assessed other (non-serious) adverse events the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
0.17%
1/606 • Serious adverse events were assessed from Month 0 up to Month 12. Systematically assessed frequent adverse events were assessed during 7 days (Days 0-6) post vaccination period.
For the systematically assessed other (non-serious) adverse events the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/606 • Serious adverse events were assessed from Month 0 up to Month 12. Systematically assessed frequent adverse events were assessed during 7 days (Days 0-6) post vaccination period.
For the systematically assessed other (non-serious) adverse events the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
0.17%
1/606 • Serious adverse events were assessed from Month 0 up to Month 12. Systematically assessed frequent adverse events were assessed during 7 days (Days 0-6) post vaccination period.
For the systematically assessed other (non-serious) adverse events the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.00%
0/606 • Serious adverse events were assessed from Month 0 up to Month 12. Systematically assessed frequent adverse events were assessed during 7 days (Days 0-6) post vaccination period.
For the systematically assessed other (non-serious) adverse events the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
0.17%
1/606 • Serious adverse events were assessed from Month 0 up to Month 12. Systematically assessed frequent adverse events were assessed during 7 days (Days 0-6) post vaccination period.
For the systematically assessed other (non-serious) adverse events the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
|
Infections and infestations
Gastroenteritis shigella
|
0.00%
0/606 • Serious adverse events were assessed from Month 0 up to Month 12. Systematically assessed frequent adverse events were assessed during 7 days (Days 0-6) post vaccination period.
For the systematically assessed other (non-serious) adverse events the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
0.17%
1/606 • Serious adverse events were assessed from Month 0 up to Month 12. Systematically assessed frequent adverse events were assessed during 7 days (Days 0-6) post vaccination period.
For the systematically assessed other (non-serious) adverse events the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroadenoma of breast
|
0.00%
0/606 • Serious adverse events were assessed from Month 0 up to Month 12. Systematically assessed frequent adverse events were assessed during 7 days (Days 0-6) post vaccination period.
For the systematically assessed other (non-serious) adverse events the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
0.17%
1/606 • Serious adverse events were assessed from Month 0 up to Month 12. Systematically assessed frequent adverse events were assessed during 7 days (Days 0-6) post vaccination period.
For the systematically assessed other (non-serious) adverse events the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.17%
1/606 • Serious adverse events were assessed from Month 0 up to Month 12. Systematically assessed frequent adverse events were assessed during 7 days (Days 0-6) post vaccination period.
For the systematically assessed other (non-serious) adverse events the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
0.00%
0/606 • Serious adverse events were assessed from Month 0 up to Month 12. Systematically assessed frequent adverse events were assessed during 7 days (Days 0-6) post vaccination period.
For the systematically assessed other (non-serious) adverse events the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.17%
1/606 • Serious adverse events were assessed from Month 0 up to Month 12. Systematically assessed frequent adverse events were assessed during 7 days (Days 0-6) post vaccination period.
For the systematically assessed other (non-serious) adverse events the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
0.00%
0/606 • Serious adverse events were assessed from Month 0 up to Month 12. Systematically assessed frequent adverse events were assessed during 7 days (Days 0-6) post vaccination period.
For the systematically assessed other (non-serious) adverse events the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.17%
1/606 • Serious adverse events were assessed from Month 0 up to Month 12. Systematically assessed frequent adverse events were assessed during 7 days (Days 0-6) post vaccination period.
For the systematically assessed other (non-serious) adverse events the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
0.00%
0/606 • Serious adverse events were assessed from Month 0 up to Month 12. Systematically assessed frequent adverse events were assessed during 7 days (Days 0-6) post vaccination period.
For the systematically assessed other (non-serious) adverse events the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.17%
1/606 • Serious adverse events were assessed from Month 0 up to Month 12. Systematically assessed frequent adverse events were assessed during 7 days (Days 0-6) post vaccination period.
For the systematically assessed other (non-serious) adverse events the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
0.00%
0/606 • Serious adverse events were assessed from Month 0 up to Month 12. Systematically assessed frequent adverse events were assessed during 7 days (Days 0-6) post vaccination period.
For the systematically assessed other (non-serious) adverse events the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
Other adverse events
| Measure |
Cervarix Group
n=606 participants at risk
Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
Engerix Group
n=606 participants at risk
Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
General disorders
Pain
|
77.6%
470/606 • Serious adverse events were assessed from Month 0 up to Month 12. Systematically assessed frequent adverse events were assessed during 7 days (Days 0-6) post vaccination period.
For the systematically assessed other (non-serious) adverse events the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
48.8%
296/606 • Serious adverse events were assessed from Month 0 up to Month 12. Systematically assessed frequent adverse events were assessed during 7 days (Days 0-6) post vaccination period.
For the systematically assessed other (non-serious) adverse events the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
|
General disorders
Redness
|
25.7%
156/606 • Serious adverse events were assessed from Month 0 up to Month 12. Systematically assessed frequent adverse events were assessed during 7 days (Days 0-6) post vaccination period.
For the systematically assessed other (non-serious) adverse events the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
14.5%
88/606 • Serious adverse events were assessed from Month 0 up to Month 12. Systematically assessed frequent adverse events were assessed during 7 days (Days 0-6) post vaccination period.
For the systematically assessed other (non-serious) adverse events the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
|
General disorders
Swelling
|
24.1%
146/606 • Serious adverse events were assessed from Month 0 up to Month 12. Systematically assessed frequent adverse events were assessed during 7 days (Days 0-6) post vaccination period.
For the systematically assessed other (non-serious) adverse events the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
9.6%
58/606 • Serious adverse events were assessed from Month 0 up to Month 12. Systematically assessed frequent adverse events were assessed during 7 days (Days 0-6) post vaccination period.
For the systematically assessed other (non-serious) adverse events the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
|
General disorders
Fatigue
|
16.5%
100/606 • Serious adverse events were assessed from Month 0 up to Month 12. Systematically assessed frequent adverse events were assessed during 7 days (Days 0-6) post vaccination period.
For the systematically assessed other (non-serious) adverse events the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
11.2%
68/606 • Serious adverse events were assessed from Month 0 up to Month 12. Systematically assessed frequent adverse events were assessed during 7 days (Days 0-6) post vaccination period.
For the systematically assessed other (non-serious) adverse events the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
|
General disorders
Gastrointestinal
|
5.4%
33/606 • Serious adverse events were assessed from Month 0 up to Month 12. Systematically assessed frequent adverse events were assessed during 7 days (Days 0-6) post vaccination period.
For the systematically assessed other (non-serious) adverse events the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
4.0%
24/606 • Serious adverse events were assessed from Month 0 up to Month 12. Systematically assessed frequent adverse events were assessed during 7 days (Days 0-6) post vaccination period.
For the systematically assessed other (non-serious) adverse events the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
|
General disorders
Headache
|
11.7%
71/606 • Serious adverse events were assessed from Month 0 up to Month 12. Systematically assessed frequent adverse events were assessed during 7 days (Days 0-6) post vaccination period.
For the systematically assessed other (non-serious) adverse events the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
7.6%
46/606 • Serious adverse events were assessed from Month 0 up to Month 12. Systematically assessed frequent adverse events were assessed during 7 days (Days 0-6) post vaccination period.
For the systematically assessed other (non-serious) adverse events the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
|
General disorders
Myalgia
|
11.4%
69/606 • Serious adverse events were assessed from Month 0 up to Month 12. Systematically assessed frequent adverse events were assessed during 7 days (Days 0-6) post vaccination period.
For the systematically assessed other (non-serious) adverse events the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
6.9%
42/606 • Serious adverse events were assessed from Month 0 up to Month 12. Systematically assessed frequent adverse events were assessed during 7 days (Days 0-6) post vaccination period.
For the systematically assessed other (non-serious) adverse events the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
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