Trial Outcomes & Findings for Human Papillomavirus (HPV) Vaccine Consistency and Non-inferiority Trial in Young Adult Women (NCT NCT00337818)
NCT ID: NCT00337818
Last Updated: 2017-05-30
Results Overview
Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL). \*Data for Month 18 outcome variables were incorporated into the Month 24 analyses.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
770 participants
Primary outcome timeframe
At months 18*, 24, 36 and 48
Results posted on
2017-05-30
Participant Flow
Only 8 subjects came to Month 18 whereas most of the subjects came to Month 24. Therefore, no separate analysis at Month 18 was prepared; data for Month 18 outcome variables were incorporated into Month 24 analyses.
Participant milestones
| Measure |
Cervarix New Process
Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus \[HPV\] vaccine) produced with the new manufacturing process.
|
Cervarix Old Process Group
Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus \[HPV\] vaccine) produced with the old manufacturing process.
|
Cervarix Young
Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus \[HPV\] vaccine) produced with the new manufacturing process.
|
|---|---|---|---|
|
Overall Study
STARTED
|
458
|
154
|
158
|
|
Overall Study
COMPLETED
|
169
|
63
|
51
|
|
Overall Study
NOT COMPLETED
|
289
|
91
|
107
|
Reasons for withdrawal
| Measure |
Cervarix New Process
Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus \[HPV\] vaccine) produced with the new manufacturing process.
|
Cervarix Old Process Group
Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus \[HPV\] vaccine) produced with the old manufacturing process.
|
Cervarix Young
Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus \[HPV\] vaccine) produced with the new manufacturing process.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
289
|
91
|
107
|
Baseline Characteristics
Human Papillomavirus (HPV) Vaccine Consistency and Non-inferiority Trial in Young Adult Women
Baseline characteristics by cohort
| Measure |
Cervarix New Process
n=458 Participants
Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus \[HPV\] vaccine) produced with the new manufacturing process.
|
Cervarix Old Process Group
n=154 Participants
Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus \[HPV\] vaccine) produced with the old manufacturing process.
|
Cervarix Young
n=158 Participants
Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus \[HPV\] vaccine) produced with the new manufacturing process.
|
Total
n=770 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
20.2 years
STANDARD_DEVIATION 2.96 • n=5 Participants
|
20.3 years
STANDARD_DEVIATION 2.99 • n=7 Participants
|
12.4 years
STANDARD_DEVIATION 1.37 • n=5 Participants
|
18.6 years
STANDARD_DEVIATION 4.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
458 Participants
n=5 Participants
|
154 Participants
n=7 Participants
|
158 Participants
n=5 Participants
|
770 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: At months 18*, 24, 36 and 48Population: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data for the defined timepoint.
Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL). \*Data for Month 18 outcome variables were incorporated into the Month 24 analyses.
Outcome measures
| Measure |
Cervarix New Process
n=160 Participants
Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus \[HPV\] vaccine) produced with the new manufacturing process.
|
Cervarix Old Process Group
n=51 Participants
Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus \[HPV\] vaccine) produced with the old manufacturing process.
|
Cervarix Young
n=55 Participants
Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus \[HPV\] vaccine) produced with the new manufacturing process.
|
|---|---|---|---|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies
Anti-HPV-18 (Month 48) (n=141, 48, 48)
|
462.4 EL.U/mL
Interval 391.5 to 546.1
|
519.9 EL.U/mL
Interval 374.1 to 722.4
|
935.6 EL.U/mL
Interval 717.9 to 1219.5
|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies
Anti-HPV-16 (Month 24) (n=160, 51, 55)
|
1440.4 EL.U/mL
Interval 1249.3 to 1660.7
|
1903.7 EL.U/mL
Interval 1396.0 to 2596.0
|
3861.7 EL.U/mL
Interval 2947.0 to 5060.4
|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies
Anti-HPV-16 (Month 36) (n=150, 46, 52)
|
1397.5 EL.U/mL
Interval 1207.1 to 1618.1
|
1679.3 EL.U/mL
Interval 1211.5 to 2327.6
|
3353.0 EL.U/mL
Interval 2553.4 to 4403.1
|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies
Anti-HPV-16 (Month 48) (n=141, 49, 49)
|
1140.9 EL.U/mL
Interval 974.9 to 1335.3
|
1427.3 EL.U/mL
Interval 1027.6 to 1982.4
|
2862.2 EL.U/mL
Interval 2129.3 to 3847.3
|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies
Anti-HPV-18 (Month 24) (n=160, 50, 54)
|
649.8 EL.U/mL
Interval 554.3 to 761.8
|
778.8 EL.U/mL
Interval 577.1 to 1050.8
|
1341.8 EL.U/mL
Interval 1053.2 to 1709.6
|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies
Anti-HPV-18 (Month 36) (n=151, 45, 51)
|
574.7 EL.U/mL
Interval 490.2 to 673.7
|
649.6 EL.U/mL
Interval 464.5 to 908.4
|
1111.0 EL.U/mL
Interval 848.5 to 1454.9
|
SECONDARY outcome
Timeframe: At months 24, 36, and 48Population: Analysis was performed on the ATP cohort for analysis of immunogenicity, in post-menarcheal subjects who volunteered for cervicovaginal sampling collection and with cervicovaginal secretion samples having less than 80 erythrocytes per milliliter and with results available for the defined timepoint.
Titers are given as Geometric Mean Titers (GMTs) expressed as EL.U/mL.
Outcome measures
| Measure |
Cervarix New Process
n=78 Participants
Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus \[HPV\] vaccine) produced with the new manufacturing process.
|
Cervarix Old Process Group
n=27 Participants
Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus \[HPV\] vaccine) produced with the old manufacturing process.
|
Cervarix Young
n=4 Participants
Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus \[HPV\] vaccine) produced with the new manufacturing process.
|
|---|---|---|---|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervical Samples
HPV-18 (Month 36) (n= 78, 27, 3)
|
38.9 EL.U/mL
Interval 31.2 to 48.6
|
29.6 EL.U/mL
Interval 19.8 to 44.2
|
19.9 EL.U/mL
Interval 1.1 to 362.2
|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervical Samples
HPV-18 (Month 48) (n= 66, 19, 4)
|
33.9 EL.U/mL
Interval 24.7 to 46.5
|
48.8 EL.U/mL
Interval 26.4 to 90.0
|
97.5 EL.U/mL
Interval 38.7 to 245.4
|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervical Samples
HPV-16 (Month 24) (n= 55, 13, 1)
|
85.4 EL.U/mL
Interval 57.9 to 125.8
|
107.5 EL.U/mL
Interval 47.5 to 242.8
|
198.8 EL.U/mL
Interval 198.8 to 198.8
|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervical Samples
HPV-16 (Month 36) (n= 78, 27, 3)
|
68.2 EL.U/mL
Interval 54.6 to 85.2
|
62.1 EL.U/mL
Interval 40.8 to 94.7
|
63.4 EL.U/mL
Interval 4.8 to 845.9
|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervical Samples
HPV-16 (Month 48) (n=69, 19, 4)
|
56.2 EL.U/mL
Interval 43.4 to 72.8
|
94.5 EL.U/mL
Interval 50.8 to 175.8
|
129.2 EL.U/mL
Interval 12.8 to 1305.0
|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervical Samples
HPV-18 (Month 24) (n= 55, 13, 1)
|
45.9 EL.U/mL
Interval 31.1 to 67.6
|
31.9 EL.U/mL
Interval 15.8 to 64.4
|
107.9 EL.U/mL
Interval 107.9 to 107.9
|
SECONDARY outcome
Timeframe: At Months 24, 36 and 48Population: Analysis was performed on the Total Vaccinated Cohort, on subjects with cervicovaginal secretion sample results available and with cervicovaginal secretion samples having less than 200 erythrocytes per milliliter and with results available for the defined timepoint.
Titers are given as Geometric Mean Titers (GMTs) expressed as EL.U/mL.
Outcome measures
| Measure |
Cervarix New Process
n=78 Participants
Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus \[HPV\] vaccine) produced with the new manufacturing process.
|
Cervarix Old Process Group
n=27 Participants
Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus \[HPV\] vaccine) produced with the old manufacturing process.
|
Cervarix Young
n=4 Participants
Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus \[HPV\] vaccine) produced with the new manufacturing process.
|
|---|---|---|---|
|
Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies in Blood Samples
Anti-HPV-16 [Month 24] (n=74;24;3)
|
1403.1 EL.U/mL
Interval 1126.9 to 1747.0
|
1490.5 EL.U/mL
Interval 1016.1 to 2186.5
|
5399.5 EL.U/mL
Interval 367.9 to 79243.9
|
|
Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies in Blood Samples
Anti-HPV-16 [Month 36] (n=78;27;3)
|
1291.8 EL.U/mL
Interval 1030.9 to 1618.7
|
1435.0 EL.U/mL
Interval 993.0 to 2073.8
|
3733.3 EL.U/mL
Interval 383.1 to 36384.7
|
|
Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies in Blood Samples
Anti-HPV-16 [Month 48] (n=69;19;4)
|
1047.3 EL.U/mL
Interval 854.2 to 1284.0
|
1950.5 EL.U/mL
Interval 1095.1 to 3474.1
|
3332.7 EL.U/mL
Interval 1087.6 to 10212.5
|
|
Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies in Blood Samples
Anti-HPV-18 [Month 24] (n=74;24;3)
|
584.5 EL.U/mL
Interval 461.1 to 741.0
|
648.6 EL.U/mL
Interval 467.7 to 899.6
|
1814.6 EL.U/mL
Interval 240.3 to 13702.9
|
|
Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies in Blood Samples
Anti-HPV-18 [Month 36] (n=78;27;3)
|
555.4 EL.U/mL
Interval 439.3 to 702.1
|
542.1 EL.U/mL
Interval 392.8 to 748.0
|
1163.6 EL.U/mL
Interval 88.8 to 15244.0
|
|
Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies in Blood Samples
Anti-HPV-18 [Month 48] (n=66;19;4)
|
478.4 EL.U/mL
Interval 376.8 to 607.3
|
805.4 EL.U/mL
Interval 491.2 to 1320.5
|
1048.9 EL.U/mL
Interval 250.5 to 4392.8
|
SECONDARY outcome
Timeframe: Throughout the study period (up to Month 48)Population: Analysis was performed on the Total vaccinated cohort for Month 24, Month 36 and Month 48, respectively.
NOCDs assessed include e.g. autoimmune disorders, asthma, type I diabetes. MSCs assessed include adverse events prompting emergency room or physician visits that are not related to common diseases or serious adverse events (SAEs) that are not related to common diseases.
Outcome measures
| Measure |
Cervarix New Process
n=186 Participants
Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus \[HPV\] vaccine) produced with the new manufacturing process.
|
Cervarix Old Process Group
n=65 Participants
Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus \[HPV\] vaccine) produced with the old manufacturing process.
|
Cervarix Young
n=57 Participants
Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus \[HPV\] vaccine) produced with the new manufacturing process.
|
|---|---|---|---|
|
Number of Subjects Reporting Pregnancies, New Onset Chronic Diseases (NOCDs) and Other Medically Significant Conditions (MSCs)
NOCDs from Month 12 to Month 24 (n= 186, 64, 57)
|
1 Subjects
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Pregnancies, New Onset Chronic Diseases (NOCDs) and Other Medically Significant Conditions (MSCs)
NOCDs from Month 24 to Month 36 (n= 184, 65, 53)
|
3 Subjects
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Pregnancies, New Onset Chronic Diseases (NOCDs) and Other Medically Significant Conditions (MSCs)
NOCDs from Month 36 to Month 48 (n= 169, 63, 51)
|
0 Subjects
|
1 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Pregnancies, New Onset Chronic Diseases (NOCDs) and Other Medically Significant Conditions (MSCs)
MSCs from Month 12 to Month 24 (n= 186, 64, 57)
|
12 Subjects
|
4 Subjects
|
2 Subjects
|
|
Number of Subjects Reporting Pregnancies, New Onset Chronic Diseases (NOCDs) and Other Medically Significant Conditions (MSCs)
MSCs from Month 24 to Month 36 (n= 184, 65, 53)
|
35 Subjects
|
10 Subjects
|
6 Subjects
|
|
Number of Subjects Reporting Pregnancies, New Onset Chronic Diseases (NOCDs) and Other Medically Significant Conditions (MSCs)
MSCs from Month 36 to Month 48 (n= 169, 63, 51)
|
19 Subjects
|
5 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Pregnancies, New Onset Chronic Diseases (NOCDs) and Other Medically Significant Conditions (MSCs)
Pregnancies from Month 12 to Month 24(n=186,64,57)
|
4 Subjects
|
2 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Pregnancies, New Onset Chronic Diseases (NOCDs) and Other Medically Significant Conditions (MSCs)
Pregnancies from Month 24 to Month 36(n=184,65,53)
|
20 Subjects
|
7 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Pregnancies, New Onset Chronic Diseases (NOCDs) and Other Medically Significant Conditions (MSCs)
Pregnancies from Month 36 to Month 48(n=169,63,51)
|
15 Subjects
|
6 Subjects
|
1 Subjects
|
SECONDARY outcome
Timeframe: Throughout the study period (up to Month 48)Population: Analysis was performed on the Total vaccinated cohort of each time point.
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.
Outcome measures
| Measure |
Cervarix New Process
n=186 Participants
Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus \[HPV\] vaccine) produced with the new manufacturing process.
|
Cervarix Old Process Group
n=65 Participants
Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus \[HPV\] vaccine) produced with the old manufacturing process.
|
Cervarix Young
n=57 Participants
Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus \[HPV\] vaccine) produced with the new manufacturing process.
|
|---|---|---|---|
|
Number of Subjects Reporting SAEs
From Month 12 to 24 (n=186,64,57)
|
2 Subjects
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting SAEs
From Month 24 to 36 (n=184,65,53)
|
7 Subjects
|
0 Subjects
|
3 Subjects
|
|
Number of Subjects Reporting SAEs
From Month 36 to 48 (n=169,63,51)
|
5 Subjects
|
2 Subjects
|
0 Subjects
|
Adverse Events
Cervarix New Process
Serious events: 11 serious events
Other events: 0 other events
Deaths: 0 deaths
Cervarix Old Process Group
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Cervarix Young
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cervarix New Process
n=186 participants at risk
Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus \[HPV\] vaccine) produced with the new manufacturing process.
|
Cervarix Old Process Group
n=65 participants at risk
Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus \[HPV\] vaccine) produced with the old manufacturing process.
|
Cervarix Young
n=57 participants at risk
Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus \[HPV\] vaccine) produced with the new manufacturing process.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.54%
1/186 • During the entire long-term follow-up of the study: data collected at Month 18, 24, 36 and 48.
Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study. The number of subjects at risk for each individal adverse event corresponds to the total number of subjects included in the total vaccinated cohort of the particular timepoint at which the adverse event was reported.
|
0.00%
0/65 • During the entire long-term follow-up of the study: data collected at Month 18, 24, 36 and 48.
Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study. The number of subjects at risk for each individal adverse event corresponds to the total number of subjects included in the total vaccinated cohort of the particular timepoint at which the adverse event was reported.
|
0.00%
0/57 • During the entire long-term follow-up of the study: data collected at Month 18, 24, 36 and 48.
Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study. The number of subjects at risk for each individal adverse event corresponds to the total number of subjects included in the total vaccinated cohort of the particular timepoint at which the adverse event was reported.
|
|
Infections and infestations
Anogenital warts
|
0.54%
1/186 • During the entire long-term follow-up of the study: data collected at Month 18, 24, 36 and 48.
Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study. The number of subjects at risk for each individal adverse event corresponds to the total number of subjects included in the total vaccinated cohort of the particular timepoint at which the adverse event was reported.
|
0.00%
0/65 • During the entire long-term follow-up of the study: data collected at Month 18, 24, 36 and 48.
Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study. The number of subjects at risk for each individal adverse event corresponds to the total number of subjects included in the total vaccinated cohort of the particular timepoint at which the adverse event was reported.
|
0.00%
0/57 • During the entire long-term follow-up of the study: data collected at Month 18, 24, 36 and 48.
Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study. The number of subjects at risk for each individal adverse event corresponds to the total number of subjects included in the total vaccinated cohort of the particular timepoint at which the adverse event was reported.
|
|
Infections and infestations
Enteritis infectious
|
0.54%
1/186 • During the entire long-term follow-up of the study: data collected at Month 18, 24, 36 and 48.
Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study. The number of subjects at risk for each individal adverse event corresponds to the total number of subjects included in the total vaccinated cohort of the particular timepoint at which the adverse event was reported.
|
0.00%
0/65 • During the entire long-term follow-up of the study: data collected at Month 18, 24, 36 and 48.
Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study. The number of subjects at risk for each individal adverse event corresponds to the total number of subjects included in the total vaccinated cohort of the particular timepoint at which the adverse event was reported.
|
0.00%
0/57 • During the entire long-term follow-up of the study: data collected at Month 18, 24, 36 and 48.
Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study. The number of subjects at risk for each individal adverse event corresponds to the total number of subjects included in the total vaccinated cohort of the particular timepoint at which the adverse event was reported.
|
|
Infections and infestations
Genital herpes
|
0.54%
1/186 • During the entire long-term follow-up of the study: data collected at Month 18, 24, 36 and 48.
Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study. The number of subjects at risk for each individal adverse event corresponds to the total number of subjects included in the total vaccinated cohort of the particular timepoint at which the adverse event was reported.
|
0.00%
0/65 • During the entire long-term follow-up of the study: data collected at Month 18, 24, 36 and 48.
Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study. The number of subjects at risk for each individal adverse event corresponds to the total number of subjects included in the total vaccinated cohort of the particular timepoint at which the adverse event was reported.
|
0.00%
0/57 • During the entire long-term follow-up of the study: data collected at Month 18, 24, 36 and 48.
Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study. The number of subjects at risk for each individal adverse event corresponds to the total number of subjects included in the total vaccinated cohort of the particular timepoint at which the adverse event was reported.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/186 • During the entire long-term follow-up of the study: data collected at Month 18, 24, 36 and 48.
Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study. The number of subjects at risk for each individal adverse event corresponds to the total number of subjects included in the total vaccinated cohort of the particular timepoint at which the adverse event was reported.
|
0.00%
0/65 • During the entire long-term follow-up of the study: data collected at Month 18, 24, 36 and 48.
Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study. The number of subjects at risk for each individal adverse event corresponds to the total number of subjects included in the total vaccinated cohort of the particular timepoint at which the adverse event was reported.
|
1.8%
1/57 • During the entire long-term follow-up of the study: data collected at Month 18, 24, 36 and 48.
Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study. The number of subjects at risk for each individal adverse event corresponds to the total number of subjects included in the total vaccinated cohort of the particular timepoint at which the adverse event was reported.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/186 • During the entire long-term follow-up of the study: data collected at Month 18, 24, 36 and 48.
Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study. The number of subjects at risk for each individal adverse event corresponds to the total number of subjects included in the total vaccinated cohort of the particular timepoint at which the adverse event was reported.
|
0.00%
0/65 • During the entire long-term follow-up of the study: data collected at Month 18, 24, 36 and 48.
Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study. The number of subjects at risk for each individal adverse event corresponds to the total number of subjects included in the total vaccinated cohort of the particular timepoint at which the adverse event was reported.
|
1.8%
1/57 • During the entire long-term follow-up of the study: data collected at Month 18, 24, 36 and 48.
Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study. The number of subjects at risk for each individal adverse event corresponds to the total number of subjects included in the total vaccinated cohort of the particular timepoint at which the adverse event was reported.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/186 • During the entire long-term follow-up of the study: data collected at Month 18, 24, 36 and 48.
Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study. The number of subjects at risk for each individal adverse event corresponds to the total number of subjects included in the total vaccinated cohort of the particular timepoint at which the adverse event was reported.
|
0.00%
0/65 • During the entire long-term follow-up of the study: data collected at Month 18, 24, 36 and 48.
Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study. The number of subjects at risk for each individal adverse event corresponds to the total number of subjects included in the total vaccinated cohort of the particular timepoint at which the adverse event was reported.
|
1.8%
1/57 • During the entire long-term follow-up of the study: data collected at Month 18, 24, 36 and 48.
Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study. The number of subjects at risk for each individal adverse event corresponds to the total number of subjects included in the total vaccinated cohort of the particular timepoint at which the adverse event was reported.
|
|
Pregnancy, puerperium and perinatal conditions
Blighted ovum
|
0.54%
1/186 • During the entire long-term follow-up of the study: data collected at Month 18, 24, 36 and 48.
Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study. The number of subjects at risk for each individal adverse event corresponds to the total number of subjects included in the total vaccinated cohort of the particular timepoint at which the adverse event was reported.
|
0.00%
0/65 • During the entire long-term follow-up of the study: data collected at Month 18, 24, 36 and 48.
Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study. The number of subjects at risk for each individal adverse event corresponds to the total number of subjects included in the total vaccinated cohort of the particular timepoint at which the adverse event was reported.
|
0.00%
0/57 • During the entire long-term follow-up of the study: data collected at Month 18, 24, 36 and 48.
Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study. The number of subjects at risk for each individal adverse event corresponds to the total number of subjects included in the total vaccinated cohort of the particular timepoint at which the adverse event was reported.
|
|
Reproductive system and breast disorders
Endometriosis
|
1.1%
2/186 • During the entire long-term follow-up of the study: data collected at Month 18, 24, 36 and 48.
Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study. The number of subjects at risk for each individal adverse event corresponds to the total number of subjects included in the total vaccinated cohort of the particular timepoint at which the adverse event was reported.
|
0.00%
0/65 • During the entire long-term follow-up of the study: data collected at Month 18, 24, 36 and 48.
Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study. The number of subjects at risk for each individal adverse event corresponds to the total number of subjects included in the total vaccinated cohort of the particular timepoint at which the adverse event was reported.
|
0.00%
0/57 • During the entire long-term follow-up of the study: data collected at Month 18, 24, 36 and 48.
Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study. The number of subjects at risk for each individal adverse event corresponds to the total number of subjects included in the total vaccinated cohort of the particular timepoint at which the adverse event was reported.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.54%
1/186 • During the entire long-term follow-up of the study: data collected at Month 18, 24, 36 and 48.
Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study. The number of subjects at risk for each individal adverse event corresponds to the total number of subjects included in the total vaccinated cohort of the particular timepoint at which the adverse event was reported.
|
0.00%
0/65 • During the entire long-term follow-up of the study: data collected at Month 18, 24, 36 and 48.
Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study. The number of subjects at risk for each individal adverse event corresponds to the total number of subjects included in the total vaccinated cohort of the particular timepoint at which the adverse event was reported.
|
0.00%
0/57 • During the entire long-term follow-up of the study: data collected at Month 18, 24, 36 and 48.
Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study. The number of subjects at risk for each individal adverse event corresponds to the total number of subjects included in the total vaccinated cohort of the particular timepoint at which the adverse event was reported.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/169 • During the entire long-term follow-up of the study: data collected at Month 18, 24, 36 and 48.
Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study. The number of subjects at risk for each individal adverse event corresponds to the total number of subjects included in the total vaccinated cohort of the particular timepoint at which the adverse event was reported.
|
3.2%
2/63 • During the entire long-term follow-up of the study: data collected at Month 18, 24, 36 and 48.
Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study. The number of subjects at risk for each individal adverse event corresponds to the total number of subjects included in the total vaccinated cohort of the particular timepoint at which the adverse event was reported.
|
0.00%
0/51 • During the entire long-term follow-up of the study: data collected at Month 18, 24, 36 and 48.
Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study. The number of subjects at risk for each individal adverse event corresponds to the total number of subjects included in the total vaccinated cohort of the particular timepoint at which the adverse event was reported.
|
|
Pregnancy, puerperium and perinatal conditions
Chorioamnionitis
|
0.59%
1/169 • During the entire long-term follow-up of the study: data collected at Month 18, 24, 36 and 48.
Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study. The number of subjects at risk for each individal adverse event corresponds to the total number of subjects included in the total vaccinated cohort of the particular timepoint at which the adverse event was reported.
|
0.00%
0/63 • During the entire long-term follow-up of the study: data collected at Month 18, 24, 36 and 48.
Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study. The number of subjects at risk for each individal adverse event corresponds to the total number of subjects included in the total vaccinated cohort of the particular timepoint at which the adverse event was reported.
|
0.00%
0/51 • During the entire long-term follow-up of the study: data collected at Month 18, 24, 36 and 48.
Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study. The number of subjects at risk for each individal adverse event corresponds to the total number of subjects included in the total vaccinated cohort of the particular timepoint at which the adverse event was reported.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.59%
1/169 • During the entire long-term follow-up of the study: data collected at Month 18, 24, 36 and 48.
Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study. The number of subjects at risk for each individal adverse event corresponds to the total number of subjects included in the total vaccinated cohort of the particular timepoint at which the adverse event was reported.
|
0.00%
0/63 • During the entire long-term follow-up of the study: data collected at Month 18, 24, 36 and 48.
Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study. The number of subjects at risk for each individal adverse event corresponds to the total number of subjects included in the total vaccinated cohort of the particular timepoint at which the adverse event was reported.
|
0.00%
0/51 • During the entire long-term follow-up of the study: data collected at Month 18, 24, 36 and 48.
Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study. The number of subjects at risk for each individal adverse event corresponds to the total number of subjects included in the total vaccinated cohort of the particular timepoint at which the adverse event was reported.
|
|
Infections and infestations
Enterocolitis infectious
|
0.59%
1/169 • During the entire long-term follow-up of the study: data collected at Month 18, 24, 36 and 48.
Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study. The number of subjects at risk for each individal adverse event corresponds to the total number of subjects included in the total vaccinated cohort of the particular timepoint at which the adverse event was reported.
|
0.00%
0/63 • During the entire long-term follow-up of the study: data collected at Month 18, 24, 36 and 48.
Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study. The number of subjects at risk for each individal adverse event corresponds to the total number of subjects included in the total vaccinated cohort of the particular timepoint at which the adverse event was reported.
|
0.00%
0/51 • During the entire long-term follow-up of the study: data collected at Month 18, 24, 36 and 48.
Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study. The number of subjects at risk for each individal adverse event corresponds to the total number of subjects included in the total vaccinated cohort of the particular timepoint at which the adverse event was reported.
|
|
Pregnancy, puerperium and perinatal conditions
Stillbirth
|
0.59%
1/169 • During the entire long-term follow-up of the study: data collected at Month 18, 24, 36 and 48.
Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study. The number of subjects at risk for each individal adverse event corresponds to the total number of subjects included in the total vaccinated cohort of the particular timepoint at which the adverse event was reported.
|
0.00%
0/63 • During the entire long-term follow-up of the study: data collected at Month 18, 24, 36 and 48.
Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study. The number of subjects at risk for each individal adverse event corresponds to the total number of subjects included in the total vaccinated cohort of the particular timepoint at which the adverse event was reported.
|
0.00%
0/51 • During the entire long-term follow-up of the study: data collected at Month 18, 24, 36 and 48.
Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study. The number of subjects at risk for each individal adverse event corresponds to the total number of subjects included in the total vaccinated cohort of the particular timepoint at which the adverse event was reported.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/186 • During the entire long-term follow-up of the study: data collected at Month 18, 24, 36 and 48.
Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study. The number of subjects at risk for each individal adverse event corresponds to the total number of subjects included in the total vaccinated cohort of the particular timepoint at which the adverse event was reported.
|
1.6%
1/64 • During the entire long-term follow-up of the study: data collected at Month 18, 24, 36 and 48.
Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study. The number of subjects at risk for each individal adverse event corresponds to the total number of subjects included in the total vaccinated cohort of the particular timepoint at which the adverse event was reported.
|
0.00%
0/57 • During the entire long-term follow-up of the study: data collected at Month 18, 24, 36 and 48.
Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study. The number of subjects at risk for each individal adverse event corresponds to the total number of subjects included in the total vaccinated cohort of the particular timepoint at which the adverse event was reported.
|
|
Pregnancy, puerperium and perinatal conditions
Premature separation of placenta
|
0.54%
1/186 • During the entire long-term follow-up of the study: data collected at Month 18, 24, 36 and 48.
Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study. The number of subjects at risk for each individal adverse event corresponds to the total number of subjects included in the total vaccinated cohort of the particular timepoint at which the adverse event was reported.
|
0.00%
0/64 • During the entire long-term follow-up of the study: data collected at Month 18, 24, 36 and 48.
Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study. The number of subjects at risk for each individal adverse event corresponds to the total number of subjects included in the total vaccinated cohort of the particular timepoint at which the adverse event was reported.
|
0.00%
0/57 • During the entire long-term follow-up of the study: data collected at Month 18, 24, 36 and 48.
Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study. The number of subjects at risk for each individal adverse event corresponds to the total number of subjects included in the total vaccinated cohort of the particular timepoint at which the adverse event was reported.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.54%
1/186 • During the entire long-term follow-up of the study: data collected at Month 18, 24, 36 and 48.
Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study. The number of subjects at risk for each individal adverse event corresponds to the total number of subjects included in the total vaccinated cohort of the particular timepoint at which the adverse event was reported.
|
0.00%
0/64 • During the entire long-term follow-up of the study: data collected at Month 18, 24, 36 and 48.
Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study. The number of subjects at risk for each individal adverse event corresponds to the total number of subjects included in the total vaccinated cohort of the particular timepoint at which the adverse event was reported.
|
0.00%
0/57 • During the entire long-term follow-up of the study: data collected at Month 18, 24, 36 and 48.
Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study. The number of subjects at risk for each individal adverse event corresponds to the total number of subjects included in the total vaccinated cohort of the particular timepoint at which the adverse event was reported.
|
Other adverse events
Adverse event data not reported
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