Trial Outcomes & Findings for Follow-up Study to Evaluate the Safety and Immunogenicity of a HPV Vaccine (580299) in North America (NCT NCT00546078)
NCT ID: NCT00546078
Last Updated: 2018-06-26
Results Overview
Cut-off values assessed include 8 Enzyme-linked immunosorbent assay 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
PHASE2
Target enrollment
116 participants
Primary outcome timeframe
At Day 7 and Month 1 (Day 30)
Results posted on
2018-06-26
Participant Flow
One subject that enrolled into the study was not vaccinated and as such not reported as started in the participant flow.
Participant milestones
| Measure |
Cervarix™ 4-Dose Group
Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
|
Cervarix™ 3-Dose Group
Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
|
|---|---|---|
|
Overall Study
STARTED
|
65
|
50
|
|
Overall Study
Month 18
|
61
|
45
|
|
Overall Study
COMPLETED
|
61
|
43
|
|
Overall Study
NOT COMPLETED
|
4
|
7
|
Reasons for withdrawal
| Measure |
Cervarix™ 4-Dose Group
Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
|
Cervarix™ 3-Dose Group
Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
|
Overall Study
Other reason
|
1
|
1
|
Baseline Characteristics
Follow-up Study to Evaluate the Safety and Immunogenicity of a HPV Vaccine (580299) in North America
Baseline characteristics by cohort
| Measure |
Cervarix™ 4-Dose Group
n=65 Participants
Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
|
Cervarix™ 3-Dose Group
n=50 Participants
Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
|
Total
n=115 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27.8 years
STANDARD_DEVIATION 2.82 • n=5 Participants
|
27.0 years
STANDARD_DEVIATION 2.89 • n=7 Participants
|
27.5 years
STANDARD_DEVIATION 2.87 • n=5 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
115 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: At Day 7 and Month 1 (Day 30)Population: Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity.
Cut-off values assessed include 8 Enzyme-linked immunosorbent assay 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™ 4-Dose Group
n=61 Participants
Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
|
Cervarix™ 3-Dose Group
n=45 Participants
Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
|
|---|---|---|
|
Number of Subjects With Anti-human Papilloma Virus-16 (Anti-HPV-16) and Anti-HPV-18 Antibody Titers Greater Than or Equal to Pre-defined Cut-off Values
Anti-HPV-16 at Day 7
|
61 Participants
|
30 Participants
|
|
Number of Subjects With Anti-human Papilloma Virus-16 (Anti-HPV-16) and Anti-HPV-18 Antibody Titers Greater Than or Equal to Pre-defined Cut-off Values
Anti-HPV-16 at Month 1
|
57 Participants
|
45 Participants
|
|
Number of Subjects With Anti-human Papilloma Virus-16 (Anti-HPV-16) and Anti-HPV-18 Antibody Titers Greater Than or Equal to Pre-defined Cut-off Values
Anti-HPV-18 at Day 7
|
61 Participants
|
26 Participants
|
|
Number of Subjects With Anti-human Papilloma Virus-16 (Anti-HPV-16) and Anti-HPV-18 Antibody Titers Greater Than or Equal to Pre-defined Cut-off Values
Anti-HPV-18 at Month 1
|
57 Participants
|
45 Participants
|
PRIMARY outcome
Timeframe: At Day 7 and at Month 1 (Day 30)Population: Analysis was performed on the ATP cohort for immunogenicity.
Titers are given as geometric mean titers (GMTs) calculated on all subjects.
Outcome measures
| Measure |
Cervarix™ 4-Dose Group
n=61 Participants
Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
|
Cervarix™ 3-Dose Group
n=45 Participants
Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
|
|---|---|---|
|
Anti-HPV-16 and Anti-HPV-18 Antibody Titers
anti-HPV-16 Day 7
|
5894.9 titer
Interval 4734.0 to 7340.7
|
67.9 titer
Interval 27.2 to 169.7
|
|
Anti-HPV-16 and Anti-HPV-18 Antibody Titers
anti-HPV-16 Month 1
|
15410.7 titer
Interval 12807.9 to 18542.4
|
1231.1 titer
Interval 709.6 to 2135.9
|
|
Anti-HPV-16 and Anti-HPV-18 Antibody Titers
anti-HPV-18 Day 7
|
3916.2 titer
Interval 3087.7 to 4967.0
|
20.7 titer
Interval 10.2 to 42.2
|
|
Anti-HPV-16 and Anti-HPV-18 Antibody Titers
anti-HPV-18 Month 1
|
8362.7 titer
Interval 6930.4 to 10091.1
|
442.0 titer
Interval 269.8 to 724.3
|
SECONDARY outcome
Timeframe: At Month 7 and Month 18Population: Analysis was performed on the ATP cohort for immunogenicity.
Cut-off values assessed include 8 EL.U/mL for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.
Outcome measures
| Measure |
Cervarix™ 4-Dose Group
n=55 Participants
Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
|
Cervarix™ 3-Dose Group
n=43 Participants
Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
|
|---|---|---|
|
Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Greater Than or Equal to Pre-defined Cut-off Values
Anti-HPV-16 at Month 7
|
55 Participants
|
43 Participants
|
|
Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Greater Than or Equal to Pre-defined Cut-off Values
Anti-HPV-16 at Month 18
|
49 Participants
|
40 Participants
|
|
Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Greater Than or Equal to Pre-defined Cut-off Values
Anti-HPV-18 at Month 7
|
55 Participants
|
43 Participants
|
|
Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Greater Than or Equal to Pre-defined Cut-off Values
Anti-HPV-18 at Month 18
|
49 Participants
|
40 Participants
|
SECONDARY outcome
Timeframe: At Month 7 and Month 18Population: Analysis was performed on the APT cohort for immunogenicity
Titers are given as GMTs calculated on all subjects.
Outcome measures
| Measure |
Cervarix™ 4-Dose Group
n=55 Participants
Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
|
Cervarix™ 3-Dose Group
n=43 Participants
Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
|
|---|---|---|
|
Anti-HPV-16 and Anti-HPV-18 Antibody Titers
Anti-HPV-16 at Month 7
|
5826.9 titer
Interval 4742.4 to 7159.5
|
7166.5 titer
Interval 5954.3 to 8625.5
|
|
Anti-HPV-16 and Anti-HPV-18 Antibody Titers
Ant-HPV-16 at Month 18
|
3936.6 titer
Interval 3128.7 to 4953.1
|
1626.9 titer
Interval 1252.4 to 2113.5
|
|
Anti-HPV-16 and Anti-HPV-18 Antibody Titers
Anti-HPV-18 at Month 7
|
2940.3 titer
Interval 2385.0 to 3625.0
|
3584.3 titer
Interval 2913.9 to 4408.9
|
|
Anti-HPV-16 and Anti-HPV-18 Antibody Titers
Ant-HPV-18 at Month 18
|
1802.5 titer
Interval 1407.9 to 2307.6
|
520.1 titer
Interval 382.9 to 706.4
|
SECONDARY outcome
Timeframe: Day 0, Month 1 (Day 30), Month 7 and Month 18Population: Analysis was performed on the ATP cohort for immunogenicity.
Outcome measures
| Measure |
Cervarix™ 4-Dose Group
n=61 Participants
Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
|
Cervarix™ 3-Dose Group
n=45 Participants
Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
|
|---|---|---|
|
Number of Subjects With Antibody Titers Against Other Oncogenic HPV Types (HPV-31 & HPV-45) Greater Than or Equal to 59 EL.U/mL
anti-HPV-31 Day 7
|
61 Participants
|
20 Participants
|
|
Number of Subjects With Antibody Titers Against Other Oncogenic HPV Types (HPV-31 & HPV-45) Greater Than or Equal to 59 EL.U/mL
anti-HPV-31 Month 1
|
58 Participants
|
31 Participants
|
|
Number of Subjects With Antibody Titers Against Other Oncogenic HPV Types (HPV-31 & HPV-45) Greater Than or Equal to 59 EL.U/mL
anti-HPV-31 Month 7
|
55 Participants
|
43 Participants
|
|
Number of Subjects With Antibody Titers Against Other Oncogenic HPV Types (HPV-31 & HPV-45) Greater Than or Equal to 59 EL.U/mL
anti-HPV-31 Month 18
|
48 Participants
|
35 Participants
|
|
Number of Subjects With Antibody Titers Against Other Oncogenic HPV Types (HPV-31 & HPV-45) Greater Than or Equal to 59 EL.U/mL
anti-HPV-45 Day 7
|
61 Participants
|
18 Participants
|
|
Number of Subjects With Antibody Titers Against Other Oncogenic HPV Types (HPV-31 & HPV-45) Greater Than or Equal to 59 EL.U/mL
anti-HPV-45 Month 1
|
58 Participants
|
32 Participants
|
|
Number of Subjects With Antibody Titers Against Other Oncogenic HPV Types (HPV-31 & HPV-45) Greater Than or Equal to 59 EL.U/mL
anti-HPV-45 Month 7
|
55 Participants
|
43 Participants
|
|
Number of Subjects With Antibody Titers Against Other Oncogenic HPV Types (HPV-31 & HPV-45) Greater Than or Equal to 59 EL.U/mL
anti-HPV-45 Month 18
|
49 Participants
|
35 Participants
|
SECONDARY outcome
Timeframe: Day 7, Month 1 (Day 30), Month 7 and Month 18Population: Analysis was performed on the ATP cohort for immunogenicity
Titers are given as geometric mean titers (GMTs) calculated on all subjects.
Outcome measures
| Measure |
Cervarix™ 4-Dose Group
n=61 Participants
Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
|
Cervarix™ 3-Dose Group
n=45 Participants
Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
|
|---|---|---|
|
Anti-HPV-31 and Anti-HPV-45 Antibody Titers
anti-HPV-31 Day 7
|
2075.3 titer
Interval 1635.4 to 2633.6
|
90.7 titer
Interval 55.8 to 147.4
|
|
Anti-HPV-31 and Anti-HPV-45 Antibody Titers
anti-HPV-31 Month 1
|
3705.8 titer
Interval 2902.4 to 4731.5
|
192.1 titer
Interval 110.7 to 333.4
|
|
Anti-HPV-31 and Anti-HPV-45 Antibody Titers
anti-HPV-31 Month 7
|
1193.8 titer
Interval 879.6 to 1620.2
|
878.3 titer
Interval 641.2 to 1202.9
|
|
Anti-HPV-31 and Anti-HPV-45 Antibody Titers
anti-HPV-31 Month 18
|
667.0 titer
Interval 470.2 to 946.3
|
225.4 titer
Interval 147.9 to 343.6
|
|
Anti-HPV-31 and Anti-HPV-45 Antibody Titers
anti-HPV-45 Day 7
|
2347.7 titer
Interval 1869.9 to 2905.6
|
76.4 titer
Interval 49.9 to 116.9
|
|
Anti-HPV-31 and Anti-HPV-45 Antibody Titers
anti-HPV-45 Month 1
|
4491.5 titer
Interval 3655.6 to 5518.5
|
189.9 titer
Interval 113.6 to 317.4
|
|
Anti-HPV-31 and Anti-HPV-45 Antibody Titers
anti-HPV-45 Month 7
|
1503.1 titer
Interval 1149.7 to 1965.0
|
981.0 titer
Interval 778.6 to 1236.0
|
|
Anti-HPV-31 and Anti-HPV-45 Antibody Titers
anti-HPV-45 Month 18
|
890.2 titer
Interval 663.6 to 1194.1
|
185.1 titer
Interval 129.5 to 264.5
|
SECONDARY outcome
Timeframe: Day 0, Month 1 [Day 30], Month 7 and Month 18Population: Analyses were performed on a subset (from pre-defined study sites) of subjects from the ATP cohort for immunogenicity.
CD4 T cell-mediated immune responses against the antigens HPV-16, HPV-18, HPV-31 and HPV-45 were analyzed for cells expressing at least 2 of the following immune markers: CD40 Ligand, Interleukin-2, Tumor Necrosis Factor alpha or Interferon-gamma. An immune response is defined as 500 or more antigen-specific CD4 T-cells per million CD4 T-cells.
Outcome measures
| Measure |
Cervarix™ 4-Dose Group
n=34 Participants
Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
|
Cervarix™ 3-Dose Group
n=26 Participants
Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
|
|---|---|---|
|
Number of Subjects With Cluster of Differentiation 4 (CD4) T Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types
HPV-16, Day 0
|
24 Participants
|
0 Participants
|
|
Number of Subjects With Cluster of Differentiation 4 (CD4) T Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types
HPV-16, Month 1
|
25 Participants
|
5 Participants
|
|
Number of Subjects With Cluster of Differentiation 4 (CD4) T Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types
HPV-16, Month 7
|
22 Participants
|
16 Participants
|
|
Number of Subjects With Cluster of Differentiation 4 (CD4) T Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types
HPV-16, Month 18
|
23 Participants
|
13 Participants
|
|
Number of Subjects With Cluster of Differentiation 4 (CD4) T Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types
HPV-18, Day 0
|
17 Participants
|
1 Participants
|
|
Number of Subjects With Cluster of Differentiation 4 (CD4) T Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types
HPV-18, Month 1
|
24 Participants
|
3 Participants
|
|
Number of Subjects With Cluster of Differentiation 4 (CD4) T Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types
HPV-18, Month 7
|
21 Participants
|
13 Participants
|
|
Number of Subjects With Cluster of Differentiation 4 (CD4) T Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types
HPV-18, Month 18
|
20 Participants
|
8 Participants
|
|
Number of Subjects With Cluster of Differentiation 4 (CD4) T Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types
HPV-31, Day 0
|
20 Participants
|
1 Participants
|
|
Number of Subjects With Cluster of Differentiation 4 (CD4) T Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types
HPV-31, Month 1
|
24 Participants
|
3 Participants
|
|
Number of Subjects With Cluster of Differentiation 4 (CD4) T Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types
HPV-31, Month 7
|
19 Participants
|
12 Participants
|
|
Number of Subjects With Cluster of Differentiation 4 (CD4) T Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types
HPV-31, Month 18
|
22 Participants
|
10 Participants
|
|
Number of Subjects With Cluster of Differentiation 4 (CD4) T Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types
HPV-45, Day 0
|
15 Participants
|
1 Participants
|
|
Number of Subjects With Cluster of Differentiation 4 (CD4) T Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types
HPV-45, Month 1
|
24 Participants
|
2 Participants
|
|
Number of Subjects With Cluster of Differentiation 4 (CD4) T Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types
HPV-45, Month 7
|
16 Participants
|
11 Participants
|
|
Number of Subjects With Cluster of Differentiation 4 (CD4) T Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types
HPV-45, Month 18
|
20 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Day 0, Month 1 [Day 30], Month 7 and Month 18Population: Analyses were performed on a subset (from pre-defined study sites) of subjects from the ATP cohort for immunogenicity.
CD8 T cell-mediated immune responses against the antigens HPV-16, HPV-18, HPV-31 and HPV-45 were analyzed for cells expressing at least 2 of the following immune markers: CD40 Ligand, Interleukin-2, Tumor Necrosis Factor alpha or Interferon-gamma. An immune response is defined as 200 or more antigen-specific CD8 T-cells per million CD8 T-cells.
Outcome measures
| Measure |
Cervarix™ 4-Dose Group
n=34 Participants
Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
|
Cervarix™ 3-Dose Group
n=25 Participants
Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
|
|---|---|---|
|
Number of Subjects With Cluster of Differentiation 8 (CD8) T Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types
HPV-16, Day 0
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Cluster of Differentiation 8 (CD8) T Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types
HPV-16, Month 1
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Cluster of Differentiation 8 (CD8) T Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types
HPV-16, Month 7
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Cluster of Differentiation 8 (CD8) T Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types
HPV-16, Month 18
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Cluster of Differentiation 8 (CD8) T Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types
HPV-18, Day 0
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Cluster of Differentiation 8 (CD8) T Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types
HPV-18, Month 1
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Cluster of Differentiation 8 (CD8) T Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types
HPV-18, Month 7
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Cluster of Differentiation 8 (CD8) T Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types
HPV-18, Month 18
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Cluster of Differentiation 8 (CD8) T Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types
HPV-31, Day 0
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Cluster of Differentiation 8 (CD8) T Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types
HPV-31, Month 1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Cluster of Differentiation 8 (CD8) T Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types
HPV-31, Month 7
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Cluster of Differentiation 8 (CD8) T Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types
HPV-31, Month 18
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Cluster of Differentiation 8 (CD8) T Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types
HPV-045, Day 0
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Cluster of Differentiation 8 (CD8) T Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types
HPV-45, Month 1
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Cluster of Differentiation 8 (CD8) T Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types
HPV-45, Month 7
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Cluster of Differentiation 8 (CD8) T Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types
HPV-45, Month 18
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 0, Month 1 [Day 30], Month 7 and Month 18Population: Analyses were performed on a subset (from pre-defined study sites) of subjects from the ATP cohort for immunogenicity.
B-cell-mediated immune responses against the antigens HPV-16, HPV-18, HPV-31 and HPV-45 were measured by Enzyme-linked immunosorbent spot (ELISPOT) assay. A memory B-cell immune response was defined as presence of any antigen-specific memory B-cells per million B-cells.
Outcome measures
| Measure |
Cervarix™ 4-Dose Group
n=34 Participants
Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
|
Cervarix™ 3-Dose Group
n=26 Participants
Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
|
|---|---|---|
|
Number of Subjects With B Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types
HPV-16, Day 0
|
20 Participants
|
1 Participants
|
|
Number of Subjects With B Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types
HPV-16, Month 1
|
27 Participants
|
21 Participants
|
|
Number of Subjects With B Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types
HPV-16, Month 7
|
26 Participants
|
20 Participants
|
|
Number of Subjects With B Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types
HPV-16, Month 18
|
17 Participants
|
11 Participants
|
|
Number of Subjects With B Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types
HPV-18, Day 0
|
21 Participants
|
3 Participants
|
|
Number of Subjects With B Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types
HPV-18, Month 1
|
27 Participants
|
18 Participants
|
|
Number of Subjects With B Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types
HPV-18, Month 7
|
26 Participants
|
20 Participants
|
|
Number of Subjects With B Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types
HPV-18, Month 18
|
18 Participants
|
15 Participants
|
|
Number of Subjects With B Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types
HPV-31, Day 0
|
20 Participants
|
1 Participants
|
|
Number of Subjects With B Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types
HPV-31, Month 1
|
24 Participants
|
3 Participants
|
|
Number of Subjects With B Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types
HPV-31, Month 7
|
21 Participants
|
15 Participants
|
|
Number of Subjects With B Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types
HPV-31, Month 18
|
11 Participants
|
6 Participants
|
|
Number of Subjects With B Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types
HPV-45, Day 0
|
15 Participants
|
1 Participants
|
|
Number of Subjects With B Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types
HPV-45, Month 1
|
24 Participants
|
2 Participants
|
|
Number of Subjects With B Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types
HPV-45, Month 7
|
18 Participants
|
11 Participants
|
|
Number of Subjects With B Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types
HPV-45, Month 18
|
14 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Day 0, Month 1 (Day 30), Month 7 and Month 18Population: Analysis was performed on the subset of subjects from the ATP cohort for immunogenicity for whom cervical secretion samples were collected.
Seropositivity was defined as the detection of antibody titers above the limit of quantification by Enzyme-Linked Immunosorbant Assay. Defining a cut-off is technically not possible for this assay. Analyses were done in all collected samples from the evaluable subjects who provided cervical samples, with \< 200 erythrocytes per microliter.
Outcome measures
| Measure |
Cervarix™ 4-Dose Group
n=15 Participants
Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
|
Cervarix™ 3-Dose Group
n=17 Participants
Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
|
|---|---|---|
|
Number of Subjects Seropositive for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervico-vaginal Secretion Samples
Anti-HPV-16 Day 0
|
8 Participants
|
2 Participants
|
|
Number of Subjects Seropositive for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervico-vaginal Secretion Samples
Anti-HPV-16 Month 1
|
13 Participants
|
5 Participants
|
|
Number of Subjects Seropositive for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervico-vaginal Secretion Samples
Anti-HPV-16 Month 7
|
12 Participants
|
11 Participants
|
|
Number of Subjects Seropositive for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervico-vaginal Secretion Samples
Anti-HPV-16 Month 18
|
15 Participants
|
14 Participants
|
|
Number of Subjects Seropositive for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervico-vaginal Secretion Samples
Anti-HPV-18 Day 0
|
9 Participants
|
1 Participants
|
|
Number of Subjects Seropositive for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervico-vaginal Secretion Samples
Anti-HPV-18 Month 1
|
13 Participants
|
6 Participants
|
|
Number of Subjects Seropositive for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervico-vaginal Secretion Samples
Anti-HPV-18 Month 7
|
12 Participants
|
11 Participants
|
|
Number of Subjects Seropositive for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervico-vaginal Secretion Samples
Anti-HPV-18 Month 18
|
13 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Day 0, Month 1 (Day 30), Month 7 and Month 18Population: Analysis was performed on the subset of subjects from the ATP cohort for immunogenicity for whom cervical secretion samples were collected.
Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL). Analyses were done in all collected samples from the evaluable subjects who provided cervical samples with \< 200 erythrocytes per microliter.
Outcome measures
| Measure |
Cervarix™ 4-Dose Group
n=15 Participants
Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
|
Cervarix™ 3-Dose Group
n=17 Participants
Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
|
|---|---|---|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervico-vaginal Secretion Samples
Anti-HPV-18, Month 7
|
111.5 EL.U/mL
Interval 57.1 to 217.7
|
178.0 EL.U/mL
Interval 88.0 to 359.9
|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervico-vaginal Secretion Samples
Anti-HPV-18, Month 18
|
73.6 EL.U/mL
Interval 31.2 to 173.4
|
29.6 EL.U/mL
Interval 16.0 to 54.8
|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervico-vaginal Secretion Samples
Anti-HPV-16, Day 0
|
323.8 EL.U/mL
Interval 84.0 to 1247.3
|
147.0 EL.U/mL
Interval 93.3 to 231.6
|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervico-vaginal Secretion Samples
Anti-HPV-16, Month 1
|
562.1 EL.U/mL
Interval 312.8 to 1010.3
|
331.2 EL.U/mL
Interval 100.3 to 1093.6
|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervico-vaginal Secretion Samples
Anti-HPV-16, Month 7
|
220.5 EL.U/mL
Interval 104.7 to 464.7
|
299.2 EL.U/mL
Interval 153.4 to 583.3
|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervico-vaginal Secretion Samples
Anti-HPV-16, Month 18
|
110.9 EL.U/mL
Interval 46.2 to 266.0
|
52.8 EL.U/mL
Interval 34.3 to 81.4
|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervico-vaginal Secretion Samples
Anti-HPV-18, Day 0
|
177.1 EL.U/mL
Interval 43.6 to 719.0
|
58.6 EL.U/mL
Interval 58.6 to 58.6
|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervico-vaginal Secretion Samples
Anti-HPV-18, Month 1
|
375.1 EL.U/mL
Interval 257.8 to 545.8
|
54.0 EL.U/mL
Interval 10.1 to 288.5
|
SECONDARY outcome
Timeframe: Within 7 days after vaccinationPopulation: Analysis was performed on those subjects from the Total Vaccinated Cohort with available results.
Solicited local symptoms assessed include pain, redness and swelling at the injection site. Solicited symptoms reported after the 4th vaccine dose in the 4-dose Group and across the 3 doses administered during this study in the 3-dose Group are disclosed.
Outcome measures
| Measure |
Cervarix™ 4-Dose Group
n=64 Participants
Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
|
Cervarix™ 3-Dose Group
n=48 Participants
Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
|
|---|---|---|
|
Number of Subjects Reporting Solicited Local Symptoms
Pain
|
61 Participants
|
45 Participants
|
|
Number of Subjects Reporting Solicited Local Symptoms
Redness
|
24 Participants
|
18 Participants
|
|
Number of Subjects Reporting Solicited Local Symptoms
Swelling
|
22 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Within 7 days of vaccinationPopulation: Analysis was performed on those subjects from the Total Vaccinated Cohort with available results.
Solicited general symptoms assessed include arthralgia, fatigue, fever, gastrointestinal discomfort, headache, myalgia, rash and urticaria. Solicited symptoms reported after the 4th vaccine dose in the 4-dose Group and across the 3 doses administered during this study in the 3-dose Group are disclosed.
Outcome measures
| Measure |
Cervarix™ 4-Dose Group
n=64 Participants
Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
|
Cervarix™ 3-Dose Group
n=48 Participants
Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
|
|---|---|---|
|
Number of Subjects Reporting Solicited General Symptoms
Arthralgia
|
10 Participants
|
4 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Fatigue
|
33 Participants
|
33 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Fever (Oral or Axillary) ≥ 37.5 degrees Celsius
|
4 Participants
|
5 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Gastrointestinal
|
16 Participants
|
16 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Headache
|
32 Participants
|
31 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Myalgia
|
30 Participants
|
21 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Rash
|
0 Participants
|
2 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Urticaria
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Within 30 days of vaccinationAn unsolicited adverse event is defined as any adverse event (AE) reported in addition to those solicited during the clinical study. Also any "solicited" symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. AEs reported after the 4th vaccine dose in the 4-dose Group and after the 3 doses administered in this study in the 3-dose Group are disclosed.
Outcome measures
| Measure |
Cervarix™ 4-Dose Group
n=65 Participants
Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
|
Cervarix™ 3-Dose Group
n=50 Participants
Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
|
|---|---|---|
|
Number of Subjects Reporting Unsolicited Adverse Events (AE)
|
24 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: From Day 0 up to Month 18Population: Analysis was performed on those subjects reporting pregnancy during the study period.
Information on any subject who became pregnant while participating in this study was collected. The outcomes of the pregnancies are reported below.
Outcome measures
| Measure |
Cervarix™ 4-Dose Group
n=11 Participants
Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
|
Cervarix™ 3-Dose Group
n=6 Participants
Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
|
|---|---|---|
|
Outcome of Any Reported Pregnancies
Pregnancy ongoing
|
1 Participants
|
0 Participants
|
|
Outcome of Any Reported Pregnancies
Total number of pregnancies
|
11 Participants
|
6 Participants
|
|
Outcome of Any Reported Pregnancies
Elective termination
|
0 Participants
|
2 Participants
|
|
Outcome of Any Reported Pregnancies
Premature birth
|
2 Participants
|
0 Participants
|
|
Outcome of Any Reported Pregnancies
Live infant
|
8 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: From Day 0 up to Month 18NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. MSC include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
Outcome measures
| Measure |
Cervarix™ 4-Dose Group
n=65 Participants
Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
|
Cervarix™ 3-Dose Group
n=50 Participants
Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
|
|---|---|---|
|
Number of Subjects With New Onset of Chronic Diseases (NOCDs), New Onset of Autoimmune Diseases (NOADs) and Medically Significant Conditions (MSCs)
NOCDs
|
2 Participants
|
4 Participants
|
|
Number of Subjects With New Onset of Chronic Diseases (NOCDs), New Onset of Autoimmune Diseases (NOADs) and Medically Significant Conditions (MSCs)
NOADs
|
0 Participants
|
2 Participants
|
|
Number of Subjects With New Onset of Chronic Diseases (NOCDs), New Onset of Autoimmune Diseases (NOADs) and Medically Significant Conditions (MSCs)
MSCs
|
16 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: From Day 0 up to Month 18SAEs 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™ 4-Dose Group
n=65 Participants
Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
|
Cervarix™ 3-Dose Group
n=50 Participants
Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
|
|---|---|---|
|
Number of Subjects Reporting Serious Adverse Events (SAEs)
|
1 Participants
|
1 Participants
|
Adverse Events
Cervarix™ 4-Dose Group
Serious events: 1 serious events
Other events: 62 other events
Deaths: 0 deaths
Cervarix™ 3-Dose Group
Serious events: 1 serious events
Other events: 47 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cervarix™ 4-Dose Group
n=65 participants at risk
Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
|
Cervarix™ 3-Dose Group
n=50 participants at risk
Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
|
|---|---|---|
|
Hepatobiliary disorders
Cholecystitis
|
1.5%
1/65 • Solicited adverse events: from Day 0 to Day 6. Unsolicited adverse events: from Day 0 to Day 29. NOCDs, NOADs and MSCs: from Day 0 to Month 18.
Events collected by systematic assessment are reported for subjects with a symptom diary card available.Events collected by non-systematic method are reported for the Total Vaccinated Cohort
|
0.00%
0/50 • Solicited adverse events: from Day 0 to Day 6. Unsolicited adverse events: from Day 0 to Day 29. NOCDs, NOADs and MSCs: from Day 0 to Month 18.
Events collected by systematic assessment are reported for subjects with a symptom diary card available.Events collected by non-systematic method are reported for the Total Vaccinated Cohort
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/65 • Solicited adverse events: from Day 0 to Day 6. Unsolicited adverse events: from Day 0 to Day 29. NOCDs, NOADs and MSCs: from Day 0 to Month 18.
Events collected by systematic assessment are reported for subjects with a symptom diary card available.Events collected by non-systematic method are reported for the Total Vaccinated Cohort
|
2.0%
1/50 • Solicited adverse events: from Day 0 to Day 6. Unsolicited adverse events: from Day 0 to Day 29. NOCDs, NOADs and MSCs: from Day 0 to Month 18.
Events collected by systematic assessment are reported for subjects with a symptom diary card available.Events collected by non-systematic method are reported for the Total Vaccinated Cohort
|
Other adverse events
| Measure |
Cervarix™ 4-Dose Group
n=65 participants at risk
Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
|
Cervarix™ 3-Dose Group
n=50 participants at risk
Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
|
|---|---|---|
|
Nervous system disorders
Dizziness
|
6.2%
4/65 • Solicited adverse events: from Day 0 to Day 6. Unsolicited adverse events: from Day 0 to Day 29. NOCDs, NOADs and MSCs: from Day 0 to Month 18.
Events collected by systematic assessment are reported for subjects with a symptom diary card available.Events collected by non-systematic method are reported for the Total Vaccinated Cohort
|
0.00%
0/50 • Solicited adverse events: from Day 0 to Day 6. Unsolicited adverse events: from Day 0 to Day 29. NOCDs, NOADs and MSCs: from Day 0 to Month 18.
Events collected by systematic assessment are reported for subjects with a symptom diary card available.Events collected by non-systematic method are reported for the Total Vaccinated Cohort
|
|
Infections and infestations
Upper respiratory tract infection
|
1.5%
1/65 • Solicited adverse events: from Day 0 to Day 6. Unsolicited adverse events: from Day 0 to Day 29. NOCDs, NOADs and MSCs: from Day 0 to Month 18.
Events collected by systematic assessment are reported for subjects with a symptom diary card available.Events collected by non-systematic method are reported for the Total Vaccinated Cohort
|
8.0%
4/50 • Solicited adverse events: from Day 0 to Day 6. Unsolicited adverse events: from Day 0 to Day 29. NOCDs, NOADs and MSCs: from Day 0 to Month 18.
Events collected by systematic assessment are reported for subjects with a symptom diary card available.Events collected by non-systematic method are reported for the Total Vaccinated Cohort
|
|
General disorders
Arthralgia
|
15.6%
10/64 • Solicited adverse events: from Day 0 to Day 6. Unsolicited adverse events: from Day 0 to Day 29. NOCDs, NOADs and MSCs: from Day 0 to Month 18.
Events collected by systematic assessment are reported for subjects with a symptom diary card available.Events collected by non-systematic method are reported for the Total Vaccinated Cohort
|
8.3%
4/48 • Solicited adverse events: from Day 0 to Day 6. Unsolicited adverse events: from Day 0 to Day 29. NOCDs, NOADs and MSCs: from Day 0 to Month 18.
Events collected by systematic assessment are reported for subjects with a symptom diary card available.Events collected by non-systematic method are reported for the Total Vaccinated Cohort
|
|
General disorders
Fatigue
|
51.6%
33/64 • Solicited adverse events: from Day 0 to Day 6. Unsolicited adverse events: from Day 0 to Day 29. NOCDs, NOADs and MSCs: from Day 0 to Month 18.
Events collected by systematic assessment are reported for subjects with a symptom diary card available.Events collected by non-systematic method are reported for the Total Vaccinated Cohort
|
68.8%
33/48 • Solicited adverse events: from Day 0 to Day 6. Unsolicited adverse events: from Day 0 to Day 29. NOCDs, NOADs and MSCs: from Day 0 to Month 18.
Events collected by systematic assessment are reported for subjects with a symptom diary card available.Events collected by non-systematic method are reported for the Total Vaccinated Cohort
|
|
General disorders
Fever
|
6.2%
4/64 • Solicited adverse events: from Day 0 to Day 6. Unsolicited adverse events: from Day 0 to Day 29. NOCDs, NOADs and MSCs: from Day 0 to Month 18.
Events collected by systematic assessment are reported for subjects with a symptom diary card available.Events collected by non-systematic method are reported for the Total Vaccinated Cohort
|
10.4%
5/48 • Solicited adverse events: from Day 0 to Day 6. Unsolicited adverse events: from Day 0 to Day 29. NOCDs, NOADs and MSCs: from Day 0 to Month 18.
Events collected by systematic assessment are reported for subjects with a symptom diary card available.Events collected by non-systematic method are reported for the Total Vaccinated Cohort
|
|
General disorders
Gastrointestinal symptoms
|
25.0%
16/64 • Solicited adverse events: from Day 0 to Day 6. Unsolicited adverse events: from Day 0 to Day 29. NOCDs, NOADs and MSCs: from Day 0 to Month 18.
Events collected by systematic assessment are reported for subjects with a symptom diary card available.Events collected by non-systematic method are reported for the Total Vaccinated Cohort
|
33.3%
16/48 • Solicited adverse events: from Day 0 to Day 6. Unsolicited adverse events: from Day 0 to Day 29. NOCDs, NOADs and MSCs: from Day 0 to Month 18.
Events collected by systematic assessment are reported for subjects with a symptom diary card available.Events collected by non-systematic method are reported for the Total Vaccinated Cohort
|
|
General disorders
Headache
|
49.2%
32/65 • Solicited adverse events: from Day 0 to Day 6. Unsolicited adverse events: from Day 0 to Day 29. NOCDs, NOADs and MSCs: from Day 0 to Month 18.
Events collected by systematic assessment are reported for subjects with a symptom diary card available.Events collected by non-systematic method are reported for the Total Vaccinated Cohort
|
64.6%
31/48 • Solicited adverse events: from Day 0 to Day 6. Unsolicited adverse events: from Day 0 to Day 29. NOCDs, NOADs and MSCs: from Day 0 to Month 18.
Events collected by systematic assessment are reported for subjects with a symptom diary card available.Events collected by non-systematic method are reported for the Total Vaccinated Cohort
|
|
General disorders
Myalgia
|
46.2%
30/65 • Solicited adverse events: from Day 0 to Day 6. Unsolicited adverse events: from Day 0 to Day 29. NOCDs, NOADs and MSCs: from Day 0 to Month 18.
Events collected by systematic assessment are reported for subjects with a symptom diary card available.Events collected by non-systematic method are reported for the Total Vaccinated Cohort
|
43.8%
21/48 • Solicited adverse events: from Day 0 to Day 6. Unsolicited adverse events: from Day 0 to Day 29. NOCDs, NOADs and MSCs: from Day 0 to Month 18.
Events collected by systematic assessment are reported for subjects with a symptom diary card available.Events collected by non-systematic method are reported for the Total Vaccinated Cohort
|
|
General disorders
Pain
|
95.3%
61/64 • Solicited adverse events: from Day 0 to Day 6. Unsolicited adverse events: from Day 0 to Day 29. NOCDs, NOADs and MSCs: from Day 0 to Month 18.
Events collected by systematic assessment are reported for subjects with a symptom diary card available.Events collected by non-systematic method are reported for the Total Vaccinated Cohort
|
93.8%
45/48 • Solicited adverse events: from Day 0 to Day 6. Unsolicited adverse events: from Day 0 to Day 29. NOCDs, NOADs and MSCs: from Day 0 to Month 18.
Events collected by systematic assessment are reported for subjects with a symptom diary card available.Events collected by non-systematic method are reported for the Total Vaccinated Cohort
|
|
General disorders
Redness
|
37.5%
24/64 • Solicited adverse events: from Day 0 to Day 6. Unsolicited adverse events: from Day 0 to Day 29. NOCDs, NOADs and MSCs: from Day 0 to Month 18.
Events collected by systematic assessment are reported for subjects with a symptom diary card available.Events collected by non-systematic method are reported for the Total Vaccinated Cohort
|
37.5%
18/48 • Solicited adverse events: from Day 0 to Day 6. Unsolicited adverse events: from Day 0 to Day 29. NOCDs, NOADs and MSCs: from Day 0 to Month 18.
Events collected by systematic assessment are reported for subjects with a symptom diary card available.Events collected by non-systematic method are reported for the Total Vaccinated Cohort
|
|
General disorders
Swelling
|
34.4%
22/64 • Solicited adverse events: from Day 0 to Day 6. Unsolicited adverse events: from Day 0 to Day 29. NOCDs, NOADs and MSCs: from Day 0 to Month 18.
Events collected by systematic assessment are reported for subjects with a symptom diary card available.Events collected by non-systematic method are reported for the Total Vaccinated Cohort
|
33.3%
16/48 • Solicited adverse events: from Day 0 to Day 6. Unsolicited adverse events: from Day 0 to Day 29. NOCDs, NOADs and MSCs: from Day 0 to Month 18.
Events collected by systematic assessment are reported for subjects with a symptom diary card available.Events collected by non-systematic method are reported for the Total Vaccinated Cohort
|
|
Infections and infestations
Chlamydial infection
|
0.00%
0/65 • Solicited adverse events: from Day 0 to Day 6. Unsolicited adverse events: from Day 0 to Day 29. NOCDs, NOADs and MSCs: from Day 0 to Month 18.
Events collected by systematic assessment are reported for subjects with a symptom diary card available.Events collected by non-systematic method are reported for the Total Vaccinated Cohort
|
8.0%
4/50 • Solicited adverse events: from Day 0 to Day 6. Unsolicited adverse events: from Day 0 to Day 29. NOCDs, NOADs and MSCs: from Day 0 to Month 18.
Events collected by systematic assessment are reported for subjects with a symptom diary card available.Events collected by non-systematic method are reported for the Total Vaccinated Cohort
|
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