Trial Outcomes & Findings for Extension Study of the Efficacy of the GSK 580299 Vaccine in Japanese Women Vaccinated in the Primary NCT00316693 Study (NCT NCT00929526)
NCT ID: NCT00929526
Last Updated: 2016-10-20
Results Overview
Low-grade cervical lesions and higher lesions are defined as CIN1+, i.e. CIN grade 1 (CIN1), CIN grade 2 (CIN2), CIN grade 3 (CIN3), adenocarcinoma in situ (AIS) or invasive cervical cancer (ICC). Detection of vaccine oncogenic Human papillomavirus (HPV) types 16 or 18 was made by polymerase chain reaction (PCR). For single type: Subjects Deoxyribonucleic acid (DNA) negative at Month 0 and Month 6 and seronegative at Month 0 for the corresponding HPV type. For combined types: Subjects DNA negative at Month 0 and Month 6 and seronegative at Month 0 for at least one HPV type.
COMPLETED
PHASE3
752 participants
From Month 0 up to Month 12
2016-10-20
Participant Flow
No vaccines were administered in this extension study. The mean duration of this study was aproximately 12 months for each subjects (from Month 0 up to Month 12). This study began 36 months after the first vaccination in study NCT00316693.
Subjects were randomised in the primary vaccination study NCT00316693 to receive the Cervarix vaccine or the Aimmugen vaccine and were aged 20 - 25 years at the time of first vaccination. Only subjects showing willingness to participate in this long term follow-up study and who had signed the informed consent form entered this study.
Participant milestones
| Measure |
Cervarix Group
subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
|
Aimmugen Group
subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
|
|---|---|---|
|
Overall Study
STARTED
|
375
|
377
|
|
Overall Study
COMPLETED
|
358
|
348
|
|
Overall Study
NOT COMPLETED
|
17
|
29
|
Reasons for withdrawal
| Measure |
Cervarix Group
subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
|
Aimmugen Group
subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
11
|
|
Overall Study
Lost to Follow-up
|
8
|
12
|
|
Overall Study
Other
|
8
|
6
|
Baseline Characteristics
Extension Study of the Efficacy of the GSK 580299 Vaccine in Japanese Women Vaccinated in the Primary NCT00316693 Study
Baseline characteristics by cohort
| Measure |
Cervarix Group
n=375 Participants
subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
|
Aimmugen Group
n=377 Participants
subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
|
Total
n=752 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
25.4 Years
STANDARD_DEVIATION 1.72 • n=5 Participants
|
25.5 Years
STANDARD_DEVIATION 1.72 • n=7 Participants
|
25.5 Years
STANDARD_DEVIATION 1.72 • n=5 Participants
|
|
Sex: Female, Male
Female
|
375 Participants
n=5 Participants
|
377 Participants
n=7 Participants
|
752 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: From Month 0 up to Month 12Population: The analysis was performed in subjects who were seronegative at baseline and negative for human papillomavirus (HPV) desoxyribonucleic acid (DNA) at baseline and Month 6 in the primary study (NCT00316693) for the HPV-type considered and for whom data concerning efficacy outcome measures were available in this follow-up study.
Low-grade cervical lesions and higher lesions are defined as CIN1+, i.e. CIN grade 1 (CIN1), CIN grade 2 (CIN2), CIN grade 3 (CIN3), adenocarcinoma in situ (AIS) or invasive cervical cancer (ICC). Detection of vaccine oncogenic Human papillomavirus (HPV) types 16 or 18 was made by polymerase chain reaction (PCR). For single type: Subjects Deoxyribonucleic acid (DNA) negative at Month 0 and Month 6 and seronegative at Month 0 for the corresponding HPV type. For combined types: Subjects DNA negative at Month 0 and Month 6 and seronegative at Month 0 for at least one HPV type.
Outcome measures
| Measure |
Cervarix Group
n=332 Participants
subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
|
Aimmugen Group
n=335 Participants
subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
|
|---|---|---|
|
Number of Subjects Reporting Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Cases Associated With HPV16 and/or HPV18 Detected Within the Lesional Component of the Cervical Tissue Specimen.
CIN1+ HPV-16/18 (N=332;335)
|
0 Subjects
|
5 Subjects
|
|
Number of Subjects Reporting Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Cases Associated With HPV16 and/or HPV18 Detected Within the Lesional Component of the Cervical Tissue Specimen.
CIN1+ HPV-16 (N=286;289)
|
0 Subjects
|
5 Subjects
|
|
Number of Subjects Reporting Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Cases Associated With HPV16 and/or HPV18 Detected Within the Lesional Component of the Cervical Tissue Specimen.
CIN1+ HPV-18 (N=294;291)
|
0 Subjects
|
0 Subjects
|
SECONDARY outcome
Timeframe: From Month 0 up to Month 12Population: The analysis was performed in subjects who were seronegative at baseline and negative for HPV DNA at baseline and Month 6 in the primary study (NCT00316693) for the HPV-type considered and for whom data concerning efficacy outcome measures were available in this follow-up study.
Cytologically confirmed abnormalities and lesions (ASC-US+) are defined as atypical squamous cell of undetermined significance (ASC-US), low-grade squamous intraepithelial lesions (LSIL), high-grade squamous intraepithelial lesions (HSIL), atypical squamous cell-cannot exclude HSIL (ASC-H) and atypical glandular cells (AGC). For single type: Subjects DNA negative at Month 0 and Month 6 and seronegative at Month 0 for the corresponding HPV type. For combined types: Subjects DNA negative at Month 0 and Month 6 and seronegative at Month 0 for at least one HPV type.
Outcome measures
| Measure |
Cervarix Group
n=332 Participants
subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
|
Aimmugen Group
n=335 Participants
subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
|
|---|---|---|
|
Number of Subjects Reporting Cytological Abnormalities and Lesions Associated With HPV-16 and/or HPV-18.
ASC-US+ HPV-16/18 (N=332;335)
|
3 Subjects
|
11 Subjects
|
|
Number of Subjects Reporting Cytological Abnormalities and Lesions Associated With HPV-16 and/or HPV-18.
ASC-US+ HPV-16 (N=286;289)
|
2 Subjects
|
10 Subjects
|
|
Number of Subjects Reporting Cytological Abnormalities and Lesions Associated With HPV-16 and/or HPV-18.
ASC-US+ HPV-18 (N=294;291)
|
1 Subjects
|
2 Subjects
|
SECONDARY outcome
Timeframe: From Month 0 up to Month 12Population: The analysis was performed in subjects who were DNA negative at baseline and Month 6 in the primary study (NCT00316693) for the HPV-type considered, regardless of their initial serostatus and for whom data concerning efficacy outcome measures were available in this current follow-up study.
Cytologically confirmed abnormalities and lesions (ASC-US+) are defined as ASC-US, LSIL, HSIL, ASC-H and AGC. HR= High-risk HPV-types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Outcome measures
| Measure |
Cervarix Group
n=363 Participants
subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
|
Aimmugen Group
n=359 Participants
subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
|
|---|---|---|
|
Number of Subjects Reporting Cytologically Confirmed Abnormalities and Lesions Concurrently Associated With Any Oncogenic HPV Types.
|
33 Subjects
|
45 Subjects
|
SECONDARY outcome
Timeframe: From Month 0 up to Month 12Population: The analysis was performed in subjects who were DNA negative at baseline and Month 6 in the primary study (NCT00316693) for the HPV-type considered, regardless of their initial serostatus and for whom data concerning efficacy outcome measures were available in this current follow-up study.
Low-grade cervical lesions and higher lesions are defined as CIN1+, i.e. CIN1, CIN2, CIN3, AIS or ICC. HR=High-risk HPV-types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Outcome measures
| Measure |
Cervarix Group
n=363 Participants
subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
|
Aimmugen Group
n=359 Participants
subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
|
|---|---|---|
|
Number of Subjects Reporting CIN1+ Associated With Any Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen.
|
8 Subjects
|
22 Subjects
|
SECONDARY outcome
Timeframe: From Month 0 up to Month 12Population: The analysis was performed in subjects who were seronegative at baseline and negative for HPV DNA at baseline and Month 6 in the primary study (NCT00316693) for the HPV-type considered and for whom data concerning efficacy outcome measures were available in this follow-up study.
For single type: Subjects DNA negative at Month 0 and Month 6 and seronegative at Month 0 for the corresponding HPV type. For combined types: Subjects DNA negative at Month 0 and Month 6 and seronegative at Month 0 for at least one HPV type.
Outcome measures
| Measure |
Cervarix Group
n=332 Participants
subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
|
Aimmugen Group
n=335 Participants
subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
|
|---|---|---|
|
Number of Subjects Reporting Incident Cervical Infection Associated With HPV-16 and/or 18.
Incident infection HPV-18 (N=294;291)
|
5 Subjects
|
13 Subjects
|
|
Number of Subjects Reporting Incident Cervical Infection Associated With HPV-16 and/or 18.
Incident infection HPV-16/18 (N=332;335)
|
7 Subjects
|
28 Subjects
|
|
Number of Subjects Reporting Incident Cervical Infection Associated With HPV-16 and/or 18.
Incident infection HPV-16 (N=286;289)
|
3 Subjects
|
16 Subjects
|
SECONDARY outcome
Timeframe: From Month 0 up to Month 12Population: The analysis was performed in subjects who were negative for HPV DNA at baseline and Month 6 in the primary study (NCT00316693) for the HPV-type considered, regardless of their initial serostatus and for whom data concerning efficacy outcome measures were available in this current follow-up study.
HR=High-risk HPV-types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Outcome measures
| Measure |
Cervarix Group
n=363 Participants
subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
|
Aimmugen Group
n=359 Participants
subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
|
|---|---|---|
|
Number of Subjects Reporting Incident Cervical Infection With Any Oncogenic HPV Types.
|
87 Subjects
|
98 Subjects
|
SECONDARY outcome
Timeframe: From Month 0 up to Month 12Population: The analysis was performed in subjects who were seronegative at baseline and negative for HPV DNA at baseline and Month 6 in the primary study (NCT00316693) for the HPV-type considered and for whom data concerning efficacy outcome measures were available in this follow-up study.
Persistent infection (12-month definition): detection of at least 2 positive HPV DNA PCR assays for the same viral genotype with no negative DNA sample between the 2 positive DNA samples, over an approximate interval of 12 months (\>300 days). For single type: Subjects DNA negative at Month 0 and Month 6 and seronegative at Month 0 for the corresponding HPV type. For combined types: Subjects DNA negative at Month 0 and Month 6 and seronegative at Month 0 for at least one HPV type.
Outcome measures
| Measure |
Cervarix Group
n=257 Participants
subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
|
Aimmugen Group
n=241 Participants
subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
|
|---|---|---|
|
Number of Subjects Reporting Persistent Long-term Cervical Infection (12-month Definition) With HPV-16 and/or 18.
Persistent infection HPV-16/18 (N=257;241)
|
0 Subjects
|
9 Subjects
|
|
Number of Subjects Reporting Persistent Long-term Cervical Infection (12-month Definition) With HPV-16 and/or 18.
Persistent infection HPV-16 (N=225;206)
|
0 Subjects
|
6 Subjects
|
|
Number of Subjects Reporting Persistent Long-term Cervical Infection (12-month Definition) With HPV-16 and/or 18.
Persistent infection HPV-18 (N=227;209)
|
0 Subjects
|
4 Subjects
|
SECONDARY outcome
Timeframe: From Month 0 up to Month 12Population: The analysis was performed in subjects who were negative for HPV DNA at baseline and Month 6 in the primary study (NCT00316693) for the HPV-type considered, regardless of their initial serostatus and for whom data concerning efficacy outcome measures were available in this current follow-up study.
Persistent infection: subjects with at least 2 positive samples (difference \> than 300 days) and no negative samples in between. HR=High-risk HPV-types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Outcome measures
| Measure |
Cervarix Group
n=280 Participants
subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
|
Aimmugen Group
n=261 Participants
subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
|
|---|---|---|
|
Number of Subjects Reporting Persistent Long-term Cervical Infection (12-month Definition) With Any Oncogenic HPV-types.
|
19 Subjects
|
31 Subjects
|
SECONDARY outcome
Timeframe: At Month 0 and at Month 12Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available in this current follow-up study for antibodies against at least one study vaccine antigen component.
Assay cut-off values assessed were 8 Enzyme-linked Immunosorbent Assay (ELISA) units per millilitre (EL.U/mL) for HPV-16 antibodies and 7 ELISA units per millilitre (EL.U/mL) for HPV-18 antibodies in the Cervarix Group.
Outcome measures
| Measure |
Cervarix Group
n=291 Participants
subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
|
Aimmugen Group
subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
|
|---|---|---|
|
Number of Subjects With HPV-16 and HPV-18 Antibodies Titers Equal to or Above the Assay Cut-off Values.
HPV-16 >=8 EL.U/mL [at Month 0] (N=282)
|
282 Subjects
|
—
|
|
Number of Subjects With HPV-16 and HPV-18 Antibodies Titers Equal to or Above the Assay Cut-off Values.
HPV-16 >=8 EL.U/mL [at Month 12] (N=291)
|
291 Subjects
|
—
|
|
Number of Subjects With HPV-16 and HPV-18 Antibodies Titers Equal to or Above the Assay Cut-off Values.
HPV-18 >=7 EL.U/mL [at Month 0] (N=281)
|
281 Subjects
|
—
|
|
Number of Subjects With HPV-16 and HPV-18 Antibodies Titers Equal to or Above the Assay Cut-off Values.
HPV-18 >=7 EL.U/mL [at Month 12] (N=290)
|
290 Subjects
|
—
|
SECONDARY outcome
Timeframe: At Month 0 and at Month 12Population: The According-To-Protocol cohort for immunogenicity M48 EXT- NCT00316693 included all evaluable subjects for whom data concerning immunogenicity outcome measures were available in this current follow-up study for antibodies against at least one study vaccine antigen component.
Titers were expressed as Geometric Mean Titers (GMTs). Geometric mean titres were assessed by ELISA in the Cervarix Group.
Outcome measures
| Measure |
Cervarix Group
n=291 Participants
subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
|
Aimmugen Group
subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
|
|---|---|---|
|
HPV-16 and HPV-18 Antibody Titers
HPV-16 [Month 0] (N=282)
|
1409.9 Titers
Interval 1268.1 to 1567.6
|
—
|
|
HPV-16 and HPV-18 Antibody Titers
HPV-16 [Month 12] (N=291)
|
1294.8 Titers
Interval 1171.4 to 1431.1
|
—
|
|
HPV-16 and HPV-18 Antibody Titers
HPV-18 [Month 0] (N=281)
|
572.3 Titers
Interval 505.6 to 647.7
|
—
|
|
HPV-16 and HPV-18 Antibody Titers
HPV-18 [Month 12] (N=290)
|
470.9 Titers
Interval 419.2 to 528.9
|
—
|
SECONDARY outcome
Timeframe: During the follow-up period from last study visit at Month 24 in the primary vaccination study NCT00316693 until the end of this follow-up study at Month 12Population: The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available.
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
Outcome measures
| Measure |
Cervarix Group
n=375 Participants
subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
|
Aimmugen Group
n=377 Participants
subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
|
|---|---|---|
|
Number of Subjects Reporting Serious Adverse Events (SAEs).
|
11 Subjects
|
16 Subjects
|
SECONDARY outcome
Timeframe: During the follow-up period from last study visit at Month 24 in the primary vaccination study NCT00316693 until the end of this follow-up study at Month 12Population: The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available.
NOCDs included autoimmune diseases, diabetes mellitus.
Outcome measures
| Measure |
Cervarix Group
n=375 Participants
subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
|
Aimmugen Group
n=377 Participants
subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
|
|---|---|---|
|
Number of Subjects With New Onset of Chronic Diseases (NOCDs) Regardless of Causal Relationship to Vaccination and Intensity.
|
2 Subjects
|
2 Subjects
|
SECONDARY outcome
Timeframe: During the follow-up period from last study visit at Month 24 in the primary vaccination study NCT00316693 until the end of this follow-up study at Month 12Population: The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available.
Outcome measures
| Measure |
Cervarix Group
n=375 Participants
subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
|
Aimmugen Group
n=377 Participants
subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
|
|---|---|---|
|
Number of Subjects With New Onset of Autoimmune Diseases (NOADs) Regardless of Causal Relationship to Vaccination and Intensity.
|
2 Subjects
|
1 Subjects
|
SECONDARY outcome
Timeframe: During the follow-up period from last study visit at Month 24 in the primary vaccination study NCT00316693 until the end of this follow-up study at Month 12Population: The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available.
MSCs were defined as adverse events (AEs) prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common disease.
Outcome measures
| Measure |
Cervarix Group
n=375 Participants
subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
|
Aimmugen Group
n=377 Participants
subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
|
|---|---|---|
|
Number of Subjects With Medically Significant Conditions (MSCs).
|
11 Subjects
|
15 Subjects
|
SECONDARY outcome
Timeframe: During the follow-up period from last study visit at Month 24 in the primary vaccination study NCT00316693 until the end of this follow-up study at Month 12 (Month 48 Ext- NCT00316693).Population: The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available.
Pregnancy outcomes are live infant, elective termination, ectopic pregnancy, stillbirth, spontaneous abortion, lost to follow-up and pregnancy ongoing. For each category it was specified if the infant presents congenital anomaly (CA) or no apparent congenital anomaly (No ACA).
Outcome measures
| Measure |
Cervarix Group
n=37 Participants
subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
|
Aimmugen Group
n=41 Participants
subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
|
|---|---|---|
|
Number of Subjects With Pregnancies and Pregnancy Outcomes.
Live infant No ACA
|
28 Subjects
|
30 Subjects
|
|
Number of Subjects With Pregnancies and Pregnancy Outcomes.
Live infant CA
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Pregnancies and Pregnancy Outcomes.
Elective termination No ACA
|
4 Subjects
|
3 Subjects
|
|
Number of Subjects With Pregnancies and Pregnancy Outcomes.
Spontaneous abortion No ACA
|
3 Subjects
|
4 Subjects
|
|
Number of Subjects With Pregnancies and Pregnancy Outcomes.
Stillbirth No ACA
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects With Pregnancies and Pregnancy Outcomes.
Ectopic pregnancy
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Pregnancies and Pregnancy Outcomes.
Lost to follow-up
|
0 Subjects
|
2 Subjects
|
|
Number of Subjects With Pregnancies and Pregnancy Outcomes.
Pregnancy ongoing
|
1 Subjects
|
0 Subjects
|
Adverse Events
Cervarix Group
Aimmugen Group
Serious adverse events
| Measure |
Cervarix Group
n=375 participants at risk
subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
|
Aimmugen Group
n=377 participants at risk
subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Abortion missed
|
0.53%
2/375 • SAEs: from Month 24 (last study visit in the primary vaccination study NCT00316693) until Month 12 in this current follow-up study.
The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available. Other adverse events (solicited and unsolicited) were not assessed and not reported during this study.
|
0.80%
3/377 • SAEs: from Month 24 (last study visit in the primary vaccination study NCT00316693) until Month 12 in this current follow-up study.
The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available. Other adverse events (solicited and unsolicited) were not assessed and not reported during this study.
|
|
Pregnancy, puerperium and perinatal conditions
Foetal distress syndrome
|
0.00%
0/375 • SAEs: from Month 24 (last study visit in the primary vaccination study NCT00316693) until Month 12 in this current follow-up study.
The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available. Other adverse events (solicited and unsolicited) were not assessed and not reported during this study.
|
0.53%
2/377 • SAEs: from Month 24 (last study visit in the primary vaccination study NCT00316693) until Month 12 in this current follow-up study.
The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available. Other adverse events (solicited and unsolicited) were not assessed and not reported during this study.
|
|
Pregnancy, puerperium and perinatal conditions
Premature separation of placenta
|
0.53%
2/375 • SAEs: from Month 24 (last study visit in the primary vaccination study NCT00316693) until Month 12 in this current follow-up study.
The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available. Other adverse events (solicited and unsolicited) were not assessed and not reported during this study.
|
0.00%
0/377 • SAEs: from Month 24 (last study visit in the primary vaccination study NCT00316693) until Month 12 in this current follow-up study.
The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available. Other adverse events (solicited and unsolicited) were not assessed and not reported during this study.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous complete
|
0.27%
1/375 • SAEs: from Month 24 (last study visit in the primary vaccination study NCT00316693) until Month 12 in this current follow-up study.
The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available. Other adverse events (solicited and unsolicited) were not assessed and not reported during this study.
|
0.00%
0/377 • SAEs: from Month 24 (last study visit in the primary vaccination study NCT00316693) until Month 12 in this current follow-up study.
The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available. Other adverse events (solicited and unsolicited) were not assessed and not reported during this study.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous incomplete
|
0.00%
0/375 • SAEs: from Month 24 (last study visit in the primary vaccination study NCT00316693) until Month 12 in this current follow-up study.
The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available. Other adverse events (solicited and unsolicited) were not assessed and not reported during this study.
|
0.27%
1/377 • SAEs: from Month 24 (last study visit in the primary vaccination study NCT00316693) until Month 12 in this current follow-up study.
The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available. Other adverse events (solicited and unsolicited) were not assessed and not reported during this study.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic granulomatous angiitis
|
0.27%
1/375 • SAEs: from Month 24 (last study visit in the primary vaccination study NCT00316693) until Month 12 in this current follow-up study.
The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available. Other adverse events (solicited and unsolicited) were not assessed and not reported during this study.
|
0.00%
0/377 • SAEs: from Month 24 (last study visit in the primary vaccination study NCT00316693) until Month 12 in this current follow-up study.
The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available. Other adverse events (solicited and unsolicited) were not assessed and not reported during this study.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/375 • SAEs: from Month 24 (last study visit in the primary vaccination study NCT00316693) until Month 12 in this current follow-up study.
The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available. Other adverse events (solicited and unsolicited) were not assessed and not reported during this study.
|
0.27%
1/377 • SAEs: from Month 24 (last study visit in the primary vaccination study NCT00316693) until Month 12 in this current follow-up study.
The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available. Other adverse events (solicited and unsolicited) were not assessed and not reported during this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign ovarian tumour
|
0.00%
0/375 • SAEs: from Month 24 (last study visit in the primary vaccination study NCT00316693) until Month 12 in this current follow-up study.
The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available. Other adverse events (solicited and unsolicited) were not assessed and not reported during this study.
|
0.27%
1/377 • SAEs: from Month 24 (last study visit in the primary vaccination study NCT00316693) until Month 12 in this current follow-up study.
The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available. Other adverse events (solicited and unsolicited) were not assessed and not reported during this study.
|
|
Psychiatric disorders
Borderline personality disorder
|
0.27%
1/375 • SAEs: from Month 24 (last study visit in the primary vaccination study NCT00316693) until Month 12 in this current follow-up study.
The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available. Other adverse events (solicited and unsolicited) were not assessed and not reported during this study.
|
0.00%
0/377 • SAEs: from Month 24 (last study visit in the primary vaccination study NCT00316693) until Month 12 in this current follow-up study.
The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available. Other adverse events (solicited and unsolicited) were not assessed and not reported during this study.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/375 • SAEs: from Month 24 (last study visit in the primary vaccination study NCT00316693) until Month 12 in this current follow-up study.
The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available. Other adverse events (solicited and unsolicited) were not assessed and not reported during this study.
|
0.27%
1/377 • SAEs: from Month 24 (last study visit in the primary vaccination study NCT00316693) until Month 12 in this current follow-up study.
The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available. Other adverse events (solicited and unsolicited) were not assessed and not reported during this study.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.27%
1/375 • SAEs: from Month 24 (last study visit in the primary vaccination study NCT00316693) until Month 12 in this current follow-up study.
The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available. Other adverse events (solicited and unsolicited) were not assessed and not reported during this study.
|
0.00%
0/377 • SAEs: from Month 24 (last study visit in the primary vaccination study NCT00316693) until Month 12 in this current follow-up study.
The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available. Other adverse events (solicited and unsolicited) were not assessed and not reported during this study.
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.00%
0/375 • SAEs: from Month 24 (last study visit in the primary vaccination study NCT00316693) until Month 12 in this current follow-up study.
The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available. Other adverse events (solicited and unsolicited) were not assessed and not reported during this study.
|
0.27%
1/377 • SAEs: from Month 24 (last study visit in the primary vaccination study NCT00316693) until Month 12 in this current follow-up study.
The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available. Other adverse events (solicited and unsolicited) were not assessed and not reported during this study.
|
|
Pregnancy, puerperium and perinatal conditions
Foetal growth restriction
|
0.00%
0/375 • SAEs: from Month 24 (last study visit in the primary vaccination study NCT00316693) until Month 12 in this current follow-up study.
The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available. Other adverse events (solicited and unsolicited) were not assessed and not reported during this study.
|
0.27%
1/377 • SAEs: from Month 24 (last study visit in the primary vaccination study NCT00316693) until Month 12 in this current follow-up study.
The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available. Other adverse events (solicited and unsolicited) were not assessed and not reported during this study.
|
|
Pregnancy, puerperium and perinatal conditions
Gestational hypertension
|
0.27%
1/375 • SAEs: from Month 24 (last study visit in the primary vaccination study NCT00316693) until Month 12 in this current follow-up study.
The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available. Other adverse events (solicited and unsolicited) were not assessed and not reported during this study.
|
0.00%
0/377 • SAEs: from Month 24 (last study visit in the primary vaccination study NCT00316693) until Month 12 in this current follow-up study.
The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available. Other adverse events (solicited and unsolicited) were not assessed and not reported during this study.
|
|
Pregnancy, puerperium and perinatal conditions
Intra-uterine death
|
0.27%
1/375 • SAEs: from Month 24 (last study visit in the primary vaccination study NCT00316693) until Month 12 in this current follow-up study.
The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available. Other adverse events (solicited and unsolicited) were not assessed and not reported during this study.
|
0.00%
0/377 • SAEs: from Month 24 (last study visit in the primary vaccination study NCT00316693) until Month 12 in this current follow-up study.
The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available. Other adverse events (solicited and unsolicited) were not assessed and not reported during this study.
|
|
Investigations
Intraocular pressure increased
|
0.27%
1/375 • SAEs: from Month 24 (last study visit in the primary vaccination study NCT00316693) until Month 12 in this current follow-up study.
The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available. Other adverse events (solicited and unsolicited) were not assessed and not reported during this study.
|
0.00%
0/377 • SAEs: from Month 24 (last study visit in the primary vaccination study NCT00316693) until Month 12 in this current follow-up study.
The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available. Other adverse events (solicited and unsolicited) were not assessed and not reported during this study.
|
|
Infections and infestations
Mastitis
|
0.00%
0/375 • SAEs: from Month 24 (last study visit in the primary vaccination study NCT00316693) until Month 12 in this current follow-up study.
The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available. Other adverse events (solicited and unsolicited) were not assessed and not reported during this study.
|
0.27%
1/377 • SAEs: from Month 24 (last study visit in the primary vaccination study NCT00316693) until Month 12 in this current follow-up study.
The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available. Other adverse events (solicited and unsolicited) were not assessed and not reported during this study.
|
|
Nervous system disorders
Multiple sclerosis
|
0.27%
1/375 • SAEs: from Month 24 (last study visit in the primary vaccination study NCT00316693) until Month 12 in this current follow-up study.
The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available. Other adverse events (solicited and unsolicited) were not assessed and not reported during this study.
|
0.00%
0/377 • SAEs: from Month 24 (last study visit in the primary vaccination study NCT00316693) until Month 12 in this current follow-up study.
The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available. Other adverse events (solicited and unsolicited) were not assessed and not reported during this study.
|
|
Infections and infestations
Pneumonia influenzal
|
0.00%
0/375 • SAEs: from Month 24 (last study visit in the primary vaccination study NCT00316693) until Month 12 in this current follow-up study.
The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available. Other adverse events (solicited and unsolicited) were not assessed and not reported during this study.
|
0.27%
1/377 • SAEs: from Month 24 (last study visit in the primary vaccination study NCT00316693) until Month 12 in this current follow-up study.
The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available. Other adverse events (solicited and unsolicited) were not assessed and not reported during this study.
|
|
Infections and infestations
Pneumonia mycoplasmal
|
0.00%
0/375 • SAEs: from Month 24 (last study visit in the primary vaccination study NCT00316693) until Month 12 in this current follow-up study.
The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available. Other adverse events (solicited and unsolicited) were not assessed and not reported during this study.
|
0.27%
1/377 • SAEs: from Month 24 (last study visit in the primary vaccination study NCT00316693) until Month 12 in this current follow-up study.
The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available. Other adverse events (solicited and unsolicited) were not assessed and not reported during this study.
|
|
Pregnancy, puerperium and perinatal conditions
Premature labour
|
0.00%
0/375 • SAEs: from Month 24 (last study visit in the primary vaccination study NCT00316693) until Month 12 in this current follow-up study.
The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available. Other adverse events (solicited and unsolicited) were not assessed and not reported during this study.
|
0.27%
1/377 • SAEs: from Month 24 (last study visit in the primary vaccination study NCT00316693) until Month 12 in this current follow-up study.
The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available. Other adverse events (solicited and unsolicited) were not assessed and not reported during this study.
|
|
Musculoskeletal and connective tissue disorders
Still's disease adult onset
|
0.00%
0/375 • SAEs: from Month 24 (last study visit in the primary vaccination study NCT00316693) until Month 12 in this current follow-up study.
The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available. Other adverse events (solicited and unsolicited) were not assessed and not reported during this study.
|
0.27%
1/377 • SAEs: from Month 24 (last study visit in the primary vaccination study NCT00316693) until Month 12 in this current follow-up study.
The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available. Other adverse events (solicited and unsolicited) were not assessed and not reported during this study.
|
|
Pregnancy, puerperium and perinatal conditions
Threatened labour
|
0.27%
1/375 • SAEs: from Month 24 (last study visit in the primary vaccination study NCT00316693) until Month 12 in this current follow-up study.
The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available. Other adverse events (solicited and unsolicited) were not assessed and not reported during this study.
|
0.00%
0/377 • SAEs: from Month 24 (last study visit in the primary vaccination study NCT00316693) until Month 12 in this current follow-up study.
The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available. Other adverse events (solicited and unsolicited) were not assessed and not reported during this study.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.27%
1/375 • SAEs: from Month 24 (last study visit in the primary vaccination study NCT00316693) until Month 12 in this current follow-up study.
The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available. Other adverse events (solicited and unsolicited) were not assessed and not reported during this study.
|
0.00%
0/377 • SAEs: from Month 24 (last study visit in the primary vaccination study NCT00316693) until Month 12 in this current follow-up study.
The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available. Other adverse events (solicited and unsolicited) were not assessed and not reported during this study.
|
|
Congenital, familial and genetic disorders
Ventricular septal defect
|
0.00%
0/375 • SAEs: from Month 24 (last study visit in the primary vaccination study NCT00316693) until Month 12 in this current follow-up study.
The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available. Other adverse events (solicited and unsolicited) were not assessed and not reported during this study.
|
0.27%
1/377 • SAEs: from Month 24 (last study visit in the primary vaccination study NCT00316693) until Month 12 in this current follow-up study.
The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available. Other adverse events (solicited and unsolicited) were not assessed and not reported during this study.
|
Other adverse events
Adverse event data not reported
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER