Trial Outcomes & Findings for Evaluation of Safety and Immunogenicity of Co-administering Human Papillomavirus Vaccine With Another Vaccine in Healthy Female Subjects (NCT NCT00578227)
NCT ID: NCT00578227
Last Updated: 2018-08-17
Results Overview
Seroconversion is defined as the appearance of anti-HAV antibodies \[i.e., antibody titer greater than or equal to 15 milli-international units/milliliter (mIU/mL)\] in the sera of subjects seronegative (antibody titer below 15 mIU/mL) before vaccination.
COMPLETED
PHASE3
814 participants
At Month 7
2018-08-17
Participant Flow
Although the total number of enrolled subjects for this study was 814, one subject did not receive any study vaccine and was therefore not considered as started in the 'Participant Flow' section.
Participant milestones
| Measure |
Cervarix™ & Twinrix™ Group
Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A \& Hepatitis B (HAB) vaccine (Months 0, 1 \& 6).
|
Cervarix™ Group
Subjects received 3 doses of HPV vaccine (Months 0, 1 \& 6).
|
Twinrix™ Group
Subjects received 3 doses of HAB vaccine (Months 0, 1 \& 6).
|
|---|---|---|---|
|
Overall Study
STARTED
|
272
|
270
|
271
|
|
Overall Study
COMPLETED
|
267
|
268
|
267
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
4
|
Reasons for withdrawal
| Measure |
Cervarix™ & Twinrix™ Group
Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A \& Hepatitis B (HAB) vaccine (Months 0, 1 \& 6).
|
Cervarix™ Group
Subjects received 3 doses of HPV vaccine (Months 0, 1 \& 6).
|
Twinrix™ Group
Subjects received 3 doses of HAB vaccine (Months 0, 1 \& 6).
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
5
|
1
|
3
|
Baseline Characteristics
Evaluation of Safety and Immunogenicity of Co-administering Human Papillomavirus Vaccine With Another Vaccine in Healthy Female Subjects
Baseline characteristics by cohort
| Measure |
Cervarix™ & Twinrix™ Group
n=272 Participants
Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A \& Hepatitis B (HAB) vaccine (Months 0, 1 \& 6).
|
Cervarix™ Group
n=270 Participants
Subjects received 3 doses of HPV vaccine (Months 0, 1 \& 6).
|
Twinrix™ Group
n=271 Participants
Subjects received 3 doses of HAB vaccine (Months 0, 1 \& 6).
|
Total
n=813 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
11.2 years
STANDARD_DEVIATION 2.04 • n=5 Participants
|
11.2 years
STANDARD_DEVIATION 2.02 • n=7 Participants
|
11.2 years
STANDARD_DEVIATION 1.99 • n=5 Participants
|
11.2 years
STANDARD_DEVIATION 2.01 • n=4 Participants
|
|
Sex: Female, Male
Female
|
272 Participants
n=5 Participants
|
270 Participants
n=7 Participants
|
271 Participants
n=5 Participants
|
813 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 Month 7Population: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, in subjects seronegative for anti-HAV before vaccination (i.e. with antibody titer below 15 mIU/mL).
Seroconversion is defined as the appearance of anti-HAV antibodies \[i.e., antibody titer greater than or equal to 15 milli-international units/milliliter (mIU/mL)\] in the sera of subjects seronegative (antibody titer below 15 mIU/mL) before vaccination.
Outcome measures
| Measure |
Cervarix™ & Twinrix™ Group
n=240 Participants
Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A \& Hepatitis B (HAB) vaccine (Months 0, 1 \& 6).
|
Cervarix™ Group
Subjects received 3 doses of HPV vaccine (Months 0, 1 \& 6).
|
Twinrix™ Group
n=242 Participants
Subjects received 3 doses of HAB vaccine (Months 0, 1 \& 6).
|
9-Year Old Cervarix Vaccine Recipients
All 9-year subjects who received 3 doses of HPV vaccine alone or co-administered with HAB vaccine.
|
|---|---|---|---|---|
|
Number of Subjects Seroconverted for Anti-hepatitis A (Anti-HAV) Antibodies
|
240 Participants
|
—
|
242 Participants
|
—
|
PRIMARY outcome
Timeframe: At Month 7Population: Analysis was performed on the ATP cohort for analysis of immunogenicity, in subjects seronegative for anti-HAV before vaccination (i.e. with antibody titer below 15 mIU/mL).
Titers are given as Geometric Mean Titers (GMTs) expressed as mIU/mL.
Outcome measures
| Measure |
Cervarix™ & Twinrix™ Group
n=240 Participants
Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A \& Hepatitis B (HAB) vaccine (Months 0, 1 \& 6).
|
Cervarix™ Group
Subjects received 3 doses of HPV vaccine (Months 0, 1 \& 6).
|
Twinrix™ Group
n=242 Participants
Subjects received 3 doses of HAB vaccine (Months 0, 1 \& 6).
|
9-Year Old Cervarix Vaccine Recipients
All 9-year subjects who received 3 doses of HPV vaccine alone or co-administered with HAB vaccine.
|
|---|---|---|---|---|
|
Anti-Heptatis A (HAV) Antibody Titers.
|
4504.2 mIU/mL
Interval 3993.0 to 5080.8
|
—
|
5288.4 mIU/mL
Interval 4713.3 to 5933.7
|
—
|
PRIMARY outcome
Timeframe: At Month 7Population: Analysis was performed on the ATP cohort for analysis of immunogenicity, in subjects seronegative for anti-HBs before vaccination, i.e. with anti-HBs antibody titer greater than or equal to 3.3 mIU/mL.
A subject seroprotected against HBs is a subject with antibody titers greater than or equal to 10 mIU/mL.
Outcome measures
| Measure |
Cervarix™ & Twinrix™ Group
n=178 Participants
Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A \& Hepatitis B (HAB) vaccine (Months 0, 1 \& 6).
|
Cervarix™ Group
Subjects received 3 doses of HPV vaccine (Months 0, 1 \& 6).
|
Twinrix™ Group
n=161 Participants
Subjects received 3 doses of HAB vaccine (Months 0, 1 \& 6).
|
9-Year Old Cervarix Vaccine Recipients
All 9-year subjects who received 3 doses of HPV vaccine alone or co-administered with HAB vaccine.
|
|---|---|---|---|---|
|
Number of Subjects Seroprotected for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies
|
175 Participants
|
—
|
161 Participants
|
—
|
PRIMARY outcome
Timeframe: At Month 7Population: Analysis was performed on the ATP cohort for analysis of immunogenicity, in subjects seronegative for the corresponding HPV type before vaccination, i.e. with antibody titers below 8 EL.U/mL for anti-HPV-16 antibodies and below 7 EL.U/mL for anti-HPV-18 antibodies.
Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subject seronegative before vaccination. Cut-off values = 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™ & Twinrix™ Group
n=239 Participants
Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A \& Hepatitis B (HAB) vaccine (Months 0, 1 \& 6).
|
Cervarix™ Group
n=241 Participants
Subjects received 3 doses of HPV vaccine (Months 0, 1 \& 6).
|
Twinrix™ Group
Subjects received 3 doses of HAB vaccine (Months 0, 1 \& 6).
|
9-Year Old Cervarix Vaccine Recipients
All 9-year subjects who received 3 doses of HPV vaccine alone or co-administered with HAB vaccine.
|
|---|---|---|---|---|
|
Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies
Anti-HPV-16
|
228 Participants
|
233 Participants
|
—
|
—
|
|
Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies
Anti-HPV-18
|
238 Participants
|
241 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: At Month 7Population: Analysis was performed on the ATP cohort for analysis of immunogenicity, in subjects seronegative for the corresponding HPV type before vaccination, i.e. with antibody titers below 8 EL.U/mL for anti-HPV-16 antibodies and below 7 EL.U/mL for anti-HPV-18 antibodies.
Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).
Outcome measures
| Measure |
Cervarix™ & Twinrix™ Group
n=239 Participants
Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A \& Hepatitis B (HAB) vaccine (Months 0, 1 \& 6).
|
Cervarix™ Group
n=241 Participants
Subjects received 3 doses of HPV vaccine (Months 0, 1 \& 6).
|
Twinrix™ Group
Subjects received 3 doses of HAB vaccine (Months 0, 1 \& 6).
|
9-Year Old Cervarix Vaccine Recipients
All 9-year subjects who received 3 doses of HPV vaccine alone or co-administered with HAB vaccine.
|
|---|---|---|---|---|
|
Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibody Titers
Anti-HPV-16 GMTs
|
22993.5 EL.U/mL
Interval 20093.4 to 26312.0
|
26981.9 EL.U/mL
Interval 23909.5 to 30449.1
|
—
|
—
|
|
Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibody Titers
Anti-HPV-18 GMTs
|
8671.2 EL.U/mL
Interval 7651.7 to 9826.6
|
11182.7 EL.U/mL
Interval 9924.8 to 12600.1
|
—
|
—
|
SECONDARY outcome
Timeframe: At Month 7Population: Analysis was performed on the ATP cohort for analysis of immunogenicity, in subjects seronegative for anti-HBs before vaccination, i.e. with anti-HBs antibody titers below 3.3 mIU/mL.
Titers are given as Geometric Mean Titers (GMTs)expressed as mIU/mL.
Outcome measures
| Measure |
Cervarix™ & Twinrix™ Group
n=178 Participants
Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A \& Hepatitis B (HAB) vaccine (Months 0, 1 \& 6).
|
Cervarix™ Group
Subjects received 3 doses of HPV vaccine (Months 0, 1 \& 6).
|
Twinrix™ Group
n=161 Participants
Subjects received 3 doses of HAB vaccine (Months 0, 1 \& 6).
|
9-Year Old Cervarix Vaccine Recipients
All 9-year subjects who received 3 doses of HPV vaccine alone or co-administered with HAB vaccine.
|
|---|---|---|---|---|
|
Anti-HBs Antibody Titers
|
3136.5 mIU/mL
Interval 2436.0 to 4038.4
|
—
|
5646.5 mIU/mL
Interval 4481.3 to 7114.6
|
—
|
SECONDARY outcome
Timeframe: At month 7Population: Analysis was performed on the ATP cohort for analysis of immunogenicity, in subjects seronegative for anti-HBs before vaccination.
Seroconversion is defined as the appearance of anti-HBs antibodies (i.e., antibody titer greater than or equal to 3.3 mIU/mL) in the sera of subjects seronegative (with antibody titers below 3.3 mIU/mL) before vaccination.
Outcome measures
| Measure |
Cervarix™ & Twinrix™ Group
n=178 Participants
Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A \& Hepatitis B (HAB) vaccine (Months 0, 1 \& 6).
|
Cervarix™ Group
Subjects received 3 doses of HPV vaccine (Months 0, 1 \& 6).
|
Twinrix™ Group
n=161 Participants
Subjects received 3 doses of HAB vaccine (Months 0, 1 \& 6).
|
9-Year Old Cervarix Vaccine Recipients
All 9-year subjects who received 3 doses of HPV vaccine alone or co-administered with HAB vaccine.
|
|---|---|---|---|---|
|
Number of Subjects Seroconverted for Anti-HBs Antibodies
|
175 Participants
|
—
|
161 Participants
|
—
|
SECONDARY outcome
Timeframe: At Month 7Population: Analysis was performed in 9-year old subjects from the ATP cohort for analysis of immunogenicity, who were seronegative for the corresponding HPV type before vaccination, i.e. with antibody titers below 8 EL.U/mL for anti-HPV-16 antibodies and below 7 EL.U/mL for anti-HPV-18 antibodies.
Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subject seronegative before vaccination. Cut-off values = 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™ & Twinrix™ Group
Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A \& Hepatitis B (HAB) vaccine (Months 0, 1 \& 6).
|
Cervarix™ Group
Subjects received 3 doses of HPV vaccine (Months 0, 1 \& 6).
|
Twinrix™ Group
Subjects received 3 doses of HAB vaccine (Months 0, 1 \& 6).
|
9-Year Old Cervarix Vaccine Recipients
n=161 Participants
All 9-year subjects who received 3 doses of HPV vaccine alone or co-administered with HAB vaccine.
|
|---|---|---|---|---|
|
Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Vaccine Recipients Aged 9 Years
Anti-HPV-16
|
—
|
—
|
—
|
156 Participants
|
|
Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Vaccine Recipients Aged 9 Years
Anti-HPV-18
|
—
|
—
|
—
|
161 Participants
|
SECONDARY outcome
Timeframe: At Month 7Population: Analysis was performed in 9-year old subjects from the ATP cohort for analysis of immunogenicity, who were seronegative for the corresponding HPV type before vaccination, i.e. with antibody titers below 8 EL.U/mL for anti-HPV-16 antibodies and below 7 EL.U/mL for anti-HPV-18 antibodies.
Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).
Outcome measures
| Measure |
Cervarix™ & Twinrix™ Group
Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A \& Hepatitis B (HAB) vaccine (Months 0, 1 \& 6).
|
Cervarix™ Group
Subjects received 3 doses of HPV vaccine (Months 0, 1 \& 6).
|
Twinrix™ Group
Subjects received 3 doses of HAB vaccine (Months 0, 1 \& 6).
|
9-Year Old Cervarix Vaccine Recipients
n=161 Participants
All 9-year subjects who received 3 doses of HPV vaccine alone or co-administered with HAB vaccine.
|
|---|---|---|---|---|
|
Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibody Titers in Vaccine Recipients Aged 9 Years
Anti-HPV-16 GMTs
|
—
|
—
|
—
|
32170.2 EL.U/mL
Interval 27985.5 to 36980.7
|
|
Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibody Titers in Vaccine Recipients Aged 9 Years
Anti-HPV-18 GMTs
|
—
|
—
|
—
|
12257.1 EL.U/mL
Interval 10644.6 to 14113.9
|
SECONDARY outcome
Timeframe: One month after the second dose of vaccinePopulation: Analysis was performed on a subset from the ATP cohort for analysis of immunogenicity, in subjects for which a blood sample was taken at Month 2 and were seronegative for anti-HAV before vaccination, i.e. with anti-HAV antibody titers below 15 mIU/mL.
Seroconversion is defined as the appearance of anti-HAV antibodies (i.e., antibody titer greater than or equal to 15 mIU/mL) in the sera of subjects seronegative (antibody titer below 15 mIU/mL) before vaccination.
Outcome measures
| Measure |
Cervarix™ & Twinrix™ Group
n=113 Participants
Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A \& Hepatitis B (HAB) vaccine (Months 0, 1 \& 6).
|
Cervarix™ Group
Subjects received 3 doses of HPV vaccine (Months 0, 1 \& 6).
|
Twinrix™ Group
n=113 Participants
Subjects received 3 doses of HAB vaccine (Months 0, 1 \& 6).
|
9-Year Old Cervarix Vaccine Recipients
All 9-year subjects who received 3 doses of HPV vaccine alone or co-administered with HAB vaccine.
|
|---|---|---|---|---|
|
Number of Subjects Seroconverted for Anti-HAV Antibodies
|
112 Participants
|
—
|
112 Participants
|
—
|
SECONDARY outcome
Timeframe: One month after the second dose of vaccinePopulation: Analysis was performed on a subset from the ATP cohort for analysis of immunogenicity, in subjects for which a blood sample was taken at Month 2 and were seronegative for anti-HAV before vaccination, i.e. with anti-HAV antibody titers below 15 mIU/mL.
Titers are given as geometric mean titers (GMTs) expressed as mIU/mL.
Outcome measures
| Measure |
Cervarix™ & Twinrix™ Group
n=113 Participants
Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A \& Hepatitis B (HAB) vaccine (Months 0, 1 \& 6).
|
Cervarix™ Group
Subjects received 3 doses of HPV vaccine (Months 0, 1 \& 6).
|
Twinrix™ Group
n=113 Participants
Subjects received 3 doses of HAB vaccine (Months 0, 1 \& 6).
|
9-Year Old Cervarix Vaccine Recipients
All 9-year subjects who received 3 doses of HPV vaccine alone or co-administered with HAB vaccine.
|
|---|---|---|---|---|
|
Anti-HAV Antibody Titers
|
467.0 mIU/mL
Interval 374.4 to 582.5
|
—
|
513.9 mIU/mL
Interval 418.7 to 630.6
|
—
|
SECONDARY outcome
Timeframe: One month after the second dose of vaccinePopulation: Analysis was performed on a subset from the ATP cohort for analysis of immunogenicity, in subjects for which a blood sample was taken at Month 2 and were seronegative for anti-HBs with antibody titers below 3.3 mIU/mL.
Seroconversion is defined as the appearance of anti-HBs antibodies (i.e., antibody titer greater than or equal to 3.3 mIU/mL) in the sera of subjects seronegative (with antibody titers below 3.3 mIU/mL) before vaccination. A seroprotected subject against HBs is a subject with antibody titers greater than or equal to 10 mIU/mL.
Outcome measures
| Measure |
Cervarix™ & Twinrix™ Group
n=70 Participants
Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A \& Hepatitis B (HAB) vaccine (Months 0, 1 \& 6).
|
Cervarix™ Group
Subjects received 3 doses of HPV vaccine (Months 0, 1 \& 6).
|
Twinrix™ Group
n=58 Participants
Subjects received 3 doses of HAB vaccine (Months 0, 1 \& 6).
|
9-Year Old Cervarix Vaccine Recipients
All 9-year subjects who received 3 doses of HPV vaccine alone or co-administered with HAB vaccine.
|
|---|---|---|---|---|
|
Number of Subjects Seroconverted and Number of Subjects Seroprotected for Anti-HBs Antibodies
Seroconverted
|
68 Participants
|
—
|
56 Participants
|
—
|
|
Number of Subjects Seroconverted and Number of Subjects Seroprotected for Anti-HBs Antibodies
Seroprotected
|
60 Participants
|
—
|
53 Participants
|
—
|
SECONDARY outcome
Timeframe: One month after the second dose of vaccinePopulation: Analysis was performed on a subset from the ATP cohort for analysis of immunogenicity, in subjects for which a blood sample was taken at Month 2 and were seronegative for anti-HBs before vaccination, i.e. with antibody titers below 3.3 mIU/mL.
Titers are given as geometric mean titers (GMTs) expressed as mIU/mL.
Outcome measures
| Measure |
Cervarix™ & Twinrix™ Group
n=70 Participants
Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A \& Hepatitis B (HAB) vaccine (Months 0, 1 \& 6).
|
Cervarix™ Group
Subjects received 3 doses of HPV vaccine (Months 0, 1 \& 6).
|
Twinrix™ Group
n=58 Participants
Subjects received 3 doses of HAB vaccine (Months 0, 1 \& 6).
|
9-Year Old Cervarix Vaccine Recipients
All 9-year subjects who received 3 doses of HPV vaccine alone or co-administered with HAB vaccine.
|
|---|---|---|---|---|
|
Anti-HBs Antibody Titers
|
33.7 mIU/mL
Interval 24.9 to 45.8
|
—
|
43.0 mIU/mL
Interval 30.1 to 61.3
|
—
|
SECONDARY outcome
Timeframe: One month after the second dose of vaccinePopulation: Analysis was performed on a subset from the ATP cohort for analysis of immunogenicity, in subjects for which a blood sample was taken at Month 2 and were seronegative for the corresponding HPV type before vaccination, i.e. with antibody titers below 8 EL.U/mL for anti-HPV-16 antibodies and below 7 EL.U/mL for anti-HPV-18 antibodies.
Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subject seronegative before vaccination. 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™ & Twinrix™ Group
n=112 Participants
Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A \& Hepatitis B (HAB) vaccine (Months 0, 1 \& 6).
|
Cervarix™ Group
n=112 Participants
Subjects received 3 doses of HPV vaccine (Months 0, 1 \& 6).
|
Twinrix™ Group
Subjects received 3 doses of HAB vaccine (Months 0, 1 \& 6).
|
9-Year Old Cervarix Vaccine Recipients
All 9-year subjects who received 3 doses of HPV vaccine alone or co-administered with HAB vaccine.
|
|---|---|---|---|---|
|
Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies
Anti-HPV-16
|
105 Participants
|
106 Participants
|
—
|
—
|
|
Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies
Anti-HPV-18
|
112 Participants
|
111 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: One month after the second dose of vaccinePopulation: Analysis was performed on a subset from the ATP cohort for analysis of immunogenicity, in subjects for which a blood sample was taken at Month 2 and were seronegative for the corresponding HPV type before vaccination, i.e. with antibody titers below 8 EL.U/mL for anti-HPV-16 antibodies and below 7 EL.U/mL for anti-HPV-18 antibodies.
Titers are given as Geometric Mean Titers (GMTs) expressed as EL.U/mL.
Outcome measures
| Measure |
Cervarix™ & Twinrix™ Group
n=112 Participants
Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A \& Hepatitis B (HAB) vaccine (Months 0, 1 \& 6).
|
Cervarix™ Group
n=112 Participants
Subjects received 3 doses of HPV vaccine (Months 0, 1 \& 6).
|
Twinrix™ Group
Subjects received 3 doses of HAB vaccine (Months 0, 1 \& 6).
|
9-Year Old Cervarix Vaccine Recipients
All 9-year subjects who received 3 doses of HPV vaccine alone or co-administered with HAB vaccine.
|
|---|---|---|---|---|
|
Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibody Titers
Anti-HPV-16 GMTs
|
5215.2 EL.U/mL
Interval 4598.2 to 5915.0
|
4967.2 EL.U/mL
Interval 4142.5 to 5956.1
|
—
|
—
|
|
Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibody Titers
Anti-HPV-18 GMTs
|
4496.8 EL.U/mL
Interval 3899.4 to 5185.8
|
4266.5 EL.U/mL
Interval 3562.9 to 5109.0
|
—
|
—
|
SECONDARY outcome
Timeframe: During the 7-day period (Day 0-6) following vaccinationPopulation: Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.
Solicited local symptoms assessed include injection site pain, redness and swelling. Data are presented across doses.
Outcome measures
| Measure |
Cervarix™ & Twinrix™ Group
n=269 Participants
Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A \& Hepatitis B (HAB) vaccine (Months 0, 1 \& 6).
|
Cervarix™ Group
n=270 Participants
Subjects received 3 doses of HPV vaccine (Months 0, 1 \& 6).
|
Twinrix™ Group
n=271 Participants
Subjects received 3 doses of HAB vaccine (Months 0, 1 \& 6).
|
9-Year Old Cervarix Vaccine Recipients
All 9-year subjects who received 3 doses of HPV vaccine alone or co-administered with HAB vaccine.
|
|---|---|---|---|---|
|
Number of Subjects Reporting Solicited Local Symptoms
Pain
|
251 Participants
|
250 Participants
|
202 Participants
|
—
|
|
Number of Subjects Reporting Solicited Local Symptoms
Redness
|
155 Participants
|
170 Participants
|
74 Participants
|
—
|
|
Number of Subjects Reporting Solicited Local Symptoms
Swelling
|
146 Participants
|
137 Participants
|
56 Participants
|
—
|
SECONDARY outcome
Timeframe: During the 7-day period following vaccinationPopulation: Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.
Solicited general symptoms assessed include arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, rash, temperature \[axillary route, greater than or equal to 37.5 degree Celsius (°C)\] and urticaria.
Outcome measures
| Measure |
Cervarix™ & Twinrix™ Group
n=269 Participants
Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A \& Hepatitis B (HAB) vaccine (Months 0, 1 \& 6).
|
Cervarix™ Group
n=270 Participants
Subjects received 3 doses of HPV vaccine (Months 0, 1 \& 6).
|
Twinrix™ Group
n=271 Participants
Subjects received 3 doses of HAB vaccine (Months 0, 1 \& 6).
|
9-Year Old Cervarix Vaccine Recipients
All 9-year subjects who received 3 doses of HPV vaccine alone or co-administered with HAB vaccine.
|
|---|---|---|---|---|
|
Number of Subjects Reporting Solicited General Symptoms
Rash
|
18 Participants
|
21 Participants
|
12 Participants
|
—
|
|
Number of Subjects Reporting Solicited General Symptoms
Arthralgia
|
50 Participants
|
45 Participants
|
40 Participants
|
—
|
|
Number of Subjects Reporting Solicited General Symptoms
Fatigue
|
122 Participants
|
133 Participants
|
119 Participants
|
—
|
|
Number of Subjects Reporting Solicited General Symptoms
Fever
|
24 Participants
|
28 Participants
|
14 Participants
|
—
|
|
Number of Subjects Reporting Solicited General Symptoms
Gastrointestinal
|
70 Participants
|
65 Participants
|
72 Participants
|
—
|
|
Number of Subjects Reporting Solicited General Symptoms
Headache
|
125 Participants
|
124 Participants
|
110 Participants
|
—
|
|
Number of Subjects Reporting Solicited General Symptoms
Myalgia
|
103 Participants
|
99 Participants
|
75 Participants
|
—
|
|
Number of Subjects Reporting Solicited General Symptoms
Urticaria
|
6 Participants
|
11 Participants
|
9 Participants
|
—
|
SECONDARY outcome
Timeframe: Throughout the active phase of the study (up to Month 7)Population: Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.
Medically significant conditions include adverse events (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™ & Twinrix™ Group
n=272 Participants
Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A \& Hepatitis B (HAB) vaccine (Months 0, 1 \& 6).
|
Cervarix™ Group
n=270 Participants
Subjects received 3 doses of HPV vaccine (Months 0, 1 \& 6).
|
Twinrix™ Group
n=271 Participants
Subjects received 3 doses of HAB vaccine (Months 0, 1 \& 6).
|
9-Year Old Cervarix Vaccine Recipients
All 9-year subjects who received 3 doses of HPV vaccine alone or co-administered with HAB vaccine.
|
|---|---|---|---|---|
|
Number of Subjects Reporting Medically Significant Conditions
|
22 Participants
|
23 Participants
|
31 Participants
|
—
|
SECONDARY outcome
Timeframe: Throughout the safety follow-up (from Month 7 up to Month 12)Population: Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.
Medically significant conditions include adverse events (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™ & Twinrix™ Group
n=272 Participants
Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A \& Hepatitis B (HAB) vaccine (Months 0, 1 \& 6).
|
Cervarix™ Group
n=270 Participants
Subjects received 3 doses of HPV vaccine (Months 0, 1 \& 6).
|
Twinrix™ Group
n=271 Participants
Subjects received 3 doses of HAB vaccine (Months 0, 1 \& 6).
|
9-Year Old Cervarix Vaccine Recipients
All 9-year subjects who received 3 doses of HPV vaccine alone or co-administered with HAB vaccine.
|
|---|---|---|---|---|
|
Number of Subjects Reporting Medically Significant Conditions
|
2 Participants
|
2 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: During the 30-day period following any vaccinationPopulation: Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.
Unsolicited adverse events include any adverse event reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Outcome measures
| Measure |
Cervarix™ & Twinrix™ Group
n=272 Participants
Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A \& Hepatitis B (HAB) vaccine (Months 0, 1 \& 6).
|
Cervarix™ Group
n=270 Participants
Subjects received 3 doses of HPV vaccine (Months 0, 1 \& 6).
|
Twinrix™ Group
n=271 Participants
Subjects received 3 doses of HAB vaccine (Months 0, 1 \& 6).
|
9-Year Old Cervarix Vaccine Recipients
All 9-year subjects who received 3 doses of HPV vaccine alone or co-administered with HAB vaccine.
|
|---|---|---|---|---|
|
Number of Subjects Reporting Unsolicited Adverse Events
|
83 Participants
|
96 Participants
|
83 Participants
|
—
|
SECONDARY outcome
Timeframe: Throughout the study (up to Month 12)Population: Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.
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™ & Twinrix™ Group
n=272 Participants
Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A \& Hepatitis B (HAB) vaccine (Months 0, 1 \& 6).
|
Cervarix™ Group
n=270 Participants
Subjects received 3 doses of HPV vaccine (Months 0, 1 \& 6).
|
Twinrix™ Group
n=271 Participants
Subjects received 3 doses of HAB vaccine (Months 0, 1 \& 6).
|
9-Year Old Cervarix Vaccine Recipients
All 9-year subjects who received 3 doses of HPV vaccine alone or co-administered with HAB vaccine.
|
|---|---|---|---|---|
|
Number of Subjects Reporting Serious Adverse Events (SAE)
|
2 Participants
|
4 Participants
|
4 Participants
|
—
|
Adverse Events
Cervarix™ & Twinrix™ Group
Cervarix™ Group
Twinrix™ Group
Serious adverse events
| Measure |
Cervarix™ & Twinrix™ Group
n=272 participants at risk
Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A \& Hepatitis B (HAB) vaccine (Months 0, 1 \& 6).
|
Cervarix™ Group
n=270 participants at risk
Subjects received 3 doses of HPV vaccine (Months 0, 1 \& 6).
|
Twinrix™ Group
n=271 participants at risk
Subjects received 3 doses of HAB vaccine (Months 0, 1 \& 6).
|
|---|---|---|---|
|
Infections and infestations
Anal abscess
|
0.00%
0/272 • From Day 0 up to Month 12
|
0.37%
1/270 • From Day 0 up to Month 12
|
0.00%
0/271 • From Day 0 up to Month 12
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/272 • From Day 0 up to Month 12
|
0.37%
1/270 • From Day 0 up to Month 12
|
0.00%
0/271 • From Day 0 up to Month 12
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/272 • From Day 0 up to Month 12
|
0.37%
1/270 • From Day 0 up to Month 12
|
0.00%
0/271 • From Day 0 up to Month 12
|
|
Injury, poisoning and procedural complications
Concussion
|
0.37%
1/272 • From Day 0 up to Month 12
|
0.00%
0/270 • From Day 0 up to Month 12
|
0.00%
0/271 • From Day 0 up to Month 12
|
|
Psychiatric disorders
Depression
|
0.00%
0/272 • From Day 0 up to Month 12
|
0.00%
0/270 • From Day 0 up to Month 12
|
0.37%
1/271 • From Day 0 up to Month 12
|
|
Nervous system disorders
Epilepsy
|
0.37%
1/272 • From Day 0 up to Month 12
|
0.00%
0/270 • From Day 0 up to Month 12
|
0.00%
0/271 • From Day 0 up to Month 12
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/272 • From Day 0 up to Month 12
|
0.00%
0/270 • From Day 0 up to Month 12
|
0.37%
1/271 • From Day 0 up to Month 12
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/272 • From Day 0 up to Month 12
|
0.00%
0/270 • From Day 0 up to Month 12
|
0.37%
1/271 • From Day 0 up to Month 12
|
|
Nervous system disorders
Syncope
|
0.00%
0/272 • From Day 0 up to Month 12
|
0.37%
1/270 • From Day 0 up to Month 12
|
0.00%
0/271 • From Day 0 up to Month 12
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/272 • From Day 0 up to Month 12
|
0.00%
0/270 • From Day 0 up to Month 12
|
0.37%
1/271 • From Day 0 up to Month 12
|
|
Injury, poisoning and procedural complications
Venous injury
|
0.00%
0/272 • From Day 0 up to Month 12
|
0.00%
0/270 • From Day 0 up to Month 12
|
0.37%
1/271 • From Day 0 up to Month 12
|
Other adverse events
| Measure |
Cervarix™ & Twinrix™ Group
n=272 participants at risk
Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A \& Hepatitis B (HAB) vaccine (Months 0, 1 \& 6).
|
Cervarix™ Group
n=270 participants at risk
Subjects received 3 doses of HPV vaccine (Months 0, 1 \& 6).
|
Twinrix™ Group
n=271 participants at risk
Subjects received 3 doses of HAB vaccine (Months 0, 1 \& 6).
|
|---|---|---|---|
|
General disorders
Pain at injection site
|
92.3%
251/272 • From Day 0 up to Month 12
|
92.6%
250/270 • From Day 0 up to Month 12
|
74.5%
202/271 • From Day 0 up to Month 12
|
|
General disorders
Redness at injection site
|
57.0%
155/272 • From Day 0 up to Month 12
|
63.0%
170/270 • From Day 0 up to Month 12
|
27.3%
74/271 • From Day 0 up to Month 12
|
|
General disorders
Swelling at injection site
|
53.7%
146/272 • From Day 0 up to Month 12
|
50.7%
137/270 • From Day 0 up to Month 12
|
20.7%
56/271 • From Day 0 up to Month 12
|
|
General disorders
Arthralgia
|
18.4%
50/272 • From Day 0 up to Month 12
|
16.7%
45/270 • From Day 0 up to Month 12
|
14.8%
40/271 • From Day 0 up to Month 12
|
|
General disorders
Fever
|
8.8%
24/272 • From Day 0 up to Month 12
|
10.4%
28/270 • From Day 0 up to Month 12
|
5.2%
14/271 • From Day 0 up to Month 12
|
|
General disorders
Gastrointestinal symptoms
|
25.7%
70/272 • From Day 0 up to Month 12
|
24.1%
65/270 • From Day 0 up to Month 12
|
26.6%
72/271 • From Day 0 up to Month 12
|
|
General disorders
Headache
|
46.0%
125/272 • From Day 0 up to Month 12
|
45.9%
124/270 • From Day 0 up to Month 12
|
40.6%
110/271 • From Day 0 up to Month 12
|
|
General disorders
Myalgia
|
37.9%
103/272 • From Day 0 up to Month 12
|
36.7%
99/270 • From Day 0 up to Month 12
|
27.7%
75/271 • From Day 0 up to Month 12
|
|
General disorders
Rash
|
6.6%
18/272 • From Day 0 up to Month 12
|
7.8%
21/270 • From Day 0 up to Month 12
|
4.4%
12/271 • From Day 0 up to Month 12
|
|
Infections and infestations
Nasopharyngitis
|
2.2%
6/272 • From Day 0 up to Month 12
|
7.8%
21/270 • From Day 0 up to Month 12
|
4.8%
13/271 • From Day 0 up to Month 12
|
|
General disorders
Fatigue
|
44.9%
122/272 • From Day 0 up to Month 12
|
49.3%
133/270 • From Day 0 up to Month 12
|
43.9%
119/271 • From Day 0 up to Month 12
|
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