Trial Outcomes & Findings for Evaluation of Safety and Immunogenicity of Co-administering Human Papillomavirus (HPV) Vaccine With Other Vaccines in Healthy Female Subjects (NCT NCT00426361)
NCT ID: NCT00426361
Last Updated: 2018-07-20
Results Overview
Seroprotection against diphtheria and tetanus is defined as anti-diphtheria and anti-tetanus antibody titres greater than or equal to 0.1 International Units per Milliliter (≥ 0.1 IU/mL).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
751 participants
Primary outcome timeframe
One month after vaccination with Boostrix Polio
Results posted on
2018-07-20
Participant Flow
Participant milestones
| Measure |
Cervarix Group
Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
|
Cervarix + Boostrix Polio Group
Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
|
Boostrix Polio → Cervarix Group
Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
|
|---|---|---|---|
|
Overall Study
STARTED
|
248
|
255
|
248
|
|
Overall Study
COMPLETED
|
244
|
250
|
243
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
5
|
Reasons for withdrawal
| Measure |
Cervarix Group
Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
|
Cervarix + Boostrix Polio Group
Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
|
Boostrix Polio → Cervarix Group
Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
5
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
0
|
Baseline Characteristics
Evaluation of Safety and Immunogenicity of Co-administering Human Papillomavirus (HPV) Vaccine With Other Vaccines in Healthy Female Subjects
Baseline characteristics by cohort
| Measure |
Cervarix Group
n=248 Participants
Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
|
Cervarix + Boostrix Polio Group
n=255 Participants
Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
|
Boostrix Polio → Cervarix Group
n=248 Participants
Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
|
Total
n=751 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
Active phase (up to Month 7/8)
|
13.9 years
STANDARD_DEVIATION 2.59 • n=99 Participants
|
14.0 years
STANDARD_DEVIATION 2.43 • n=107 Participants
|
13.9 years
STANDARD_DEVIATION 2.47 • n=206 Participants
|
13.9 years
STANDARD_DEVIATION 2.50 • n=7 Participants
|
|
Age, Continuous
Safety follow-up (up to Month 12/13)
|
13.9 years
STANDARD_DEVIATION 2.58 • n=99 Participants
|
13.9 years
STANDARD_DEVIATION 2.41 • n=107 Participants
|
13.8 years
STANDARD_DEVIATION 2.46 • n=206 Participants
|
13.9 years
STANDARD_DEVIATION 2.48 • n=7 Participants
|
|
Sex: Female, Male
Female
|
248 Participants
n=99 Participants
|
255 Participants
n=107 Participants
|
248 Participants
n=206 Participants
|
751 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: One month after vaccination with Boostrix PolioPopulation: Analysis was performed on the Month 1 According-to-Protocol (ATP) cohort for analysis of immunogenicity and only on those subjects vaccinated with Boostrix Polio.
Seroprotection against diphtheria and tetanus is defined as anti-diphtheria and anti-tetanus antibody titres greater than or equal to 0.1 International Units per Milliliter (≥ 0.1 IU/mL).
Outcome measures
| Measure |
Cervarix Group
Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
|
Cervarix + Boostrix Polio Group
n=240 Participants
Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
|
Boostrix Polio → Cervarix Group
n=233 Participants
Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
|
|---|---|---|---|
|
Number of Subjects Seroprotected Against Diphtheria and Tetanus
Diphtheria
|
—
|
238 Participants
|
233 Participants
|
|
Number of Subjects Seroprotected Against Diphtheria and Tetanus
Tetanus
|
—
|
240 Participants
|
233 Participants
|
PRIMARY outcome
Timeframe: One month after vaccination with Boostrix PolioPopulation: Analysis was performed on the Month 1 According-to-Protocol (ATP) cohort for analysis of immunogenicity and only on those subjects vaccinated with Boostrix Polio.
Titers are given as geometric mean titers (GMTs) calculated on all subjects and expressed as Enzyme-linked Immunosorbent Assay Units per Milliliter (EL.U/mL).
Outcome measures
| Measure |
Cervarix Group
Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
|
Cervarix + Boostrix Polio Group
n=240 Participants
Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
|
Boostrix Polio → Cervarix Group
n=233 Participants
Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
|
|---|---|---|---|
|
Titers of Anti-pertussis Toxoid (Anti-PT), Anti-pertactin Toxoid (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibodies
Anti-PT
|
—
|
84.2 EL.U/mL
Interval 73.6 to 96.4
|
75.4 EL.U/mL
Interval 65.6 to 86.8
|
|
Titers of Anti-pertussis Toxoid (Anti-PT), Anti-pertactin Toxoid (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibodies
Anti-FHA
|
—
|
611.7 EL.U/mL
Interval 553.6 to 675.9
|
615.2 EL.U/mL
Interval 552.3 to 685.2
|
|
Titers of Anti-pertussis Toxoid (Anti-PT), Anti-pertactin Toxoid (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibodies
Anti-PRN
|
—
|
426.2 EL.U/mL
Interval 368.1 to 493.4
|
360.0 EL.U/mL
Interval 299.3 to 433.1
|
PRIMARY outcome
Timeframe: One month after vaccination with Boostrix PolioPopulation: Analysis was performed on the Month 1 According-to-Protocol (ATP) cohort for analysis of immunogenicity and only on those subjects vaccinated with Boostrix Polio and with available results for the defined antigen.
Seroprotection against polio 1, 2 and 3 is defined as anti-polio 1, 2 and 3 antibody titers greater than or equal to 8 Effective Dose 50% (≥ 8 ED50).
Outcome measures
| Measure |
Cervarix Group
Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
|
Cervarix + Boostrix Polio Group
n=240 Participants
Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
|
Boostrix Polio → Cervarix Group
n=232 Participants
Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
|
|---|---|---|---|
|
Number of Subjects Seroprotected Against Poliovirus Type 1 (Polio 1), Polio 2 and Polio 3
Polio 1
|
—
|
239 Participants
|
231 Participants
|
|
Number of Subjects Seroprotected Against Poliovirus Type 1 (Polio 1), Polio 2 and Polio 3
Polio 2
|
—
|
240 Participants
|
232 Participants
|
|
Number of Subjects Seroprotected Against Poliovirus Type 1 (Polio 1), Polio 2 and Polio 3
Polio 3
|
—
|
239 Participants
|
232 Participants
|
SECONDARY outcome
Timeframe: One month post Cervarix Dose 3 (Month 7/8)Population: Analysis was performed on the Month 7/8 According-to-Protocol (ATP) cohort for analysis of immunogenicity on subjects with available results for the defined antibody.
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 Group
n=198 Participants
Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
|
Cervarix + Boostrix Polio Group
n=204 Participants
Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
|
Boostrix Polio → Cervarix Group
n=204 Participants
Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
|
|---|---|---|---|
|
Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-HPV-18 Antibodies After Completing the Cervarix Vaccination Course
Anti-HPV-16
|
198 Participants
|
201 Participants
|
204 Participants
|
|
Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-HPV-18 Antibodies After Completing the Cervarix Vaccination Course
Anti-HPV-18
|
191 Participants
|
203 Participants
|
203 Participants
|
SECONDARY outcome
Timeframe: One month post Dose 1Population: Analysis was performed on the Month 1 According-to-Protocol (ATP) cohort for analysis of immunogenicity and only on subjects from the Cervarix and Cervarix + Boostrix Polio groups with available results for the defined antibody.
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 Group
n=198 Participants
Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
|
Cervarix + Boostrix Polio Group
n=204 Participants
Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
|
Boostrix Polio → Cervarix Group
Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
|
|---|---|---|---|
|
Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies After Incomplete Cervarix Vaccination Course
Anti-HPV-16
|
198 Participants
|
201 Participants
|
—
|
|
Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies After Incomplete Cervarix Vaccination Course
Anti-HPV-18
|
191 Participants
|
203 Participants
|
—
|
SECONDARY outcome
Timeframe: One month post Cervarix Dose 3 (Month 7/8)]Population: Analysis was performed on the Month 7/8 According-to-Protocol (ATP) cohort for analysis of immunogenicity on subjects with available results for the defined antibody.
Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).
Outcome measures
| Measure |
Cervarix Group
n=213 Participants
Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
|
Cervarix + Boostrix Polio Group
n=222 Participants
Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
|
Boostrix Polio → Cervarix Group
n=218 Participants
Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
|
|---|---|---|---|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies After Completing the Cervarix Vaccination Course
Anti-HPV-16
|
18363.6 EL.U/mL
Interval 16243.0 to 20761.0
|
15370.2 EL.U/mL
Interval 13350.9 to 17694.8
|
14089.5 EL.U/mL
Interval 12460.9 to 15930.9
|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies After Completing the Cervarix Vaccination Course
Anti-HPV-18
|
7032.8 EL.U/mL
Interval 6220.7 to 7950.9
|
6630.4 EL.U/mL
Interval 5768.0 to 7621.6
|
5135.0 EL.U/mL
Interval 4537.3 to 5811.5
|
SECONDARY outcome
Timeframe: One month after vaccination with Boostrix-PolioPopulation: Analysis was performed on the Month 1 According-to-Protocol (ATP) cohort for analysis of immunogenicity and only on those subjects vaccinated with Boostrix Polio.
Titers are given as Geometric Mean Titers (GMTs) and expressed as IU/mL.
Outcome measures
| Measure |
Cervarix Group
Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
|
Cervarix + Boostrix Polio Group
n=240 Participants
Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
|
Boostrix Polio → Cervarix Group
n=233 Participants
Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
|
|---|---|---|---|
|
Titers of Anti-diphtheria and Anti-tetanus Antibodies
Anti-diphtheria
|
—
|
5.085 IU/mL
Interval 4.551 to 5.681
|
5.466 IU/mL
Interval 4.896 to 6.103
|
|
Titers of Anti-diphtheria and Anti-tetanus Antibodies
Anti-tetanus
|
—
|
8.552 IU/mL
Interval 7.889 to 9.272
|
9.039 IU/mL
Interval 8.321 to 9.818
|
SECONDARY outcome
Timeframe: One month after vaccination with Boostrix PolioPopulation: Analysis was performed on the Month 1 According-to-Protocol (ATP) cohort for analysis of immunogenicity and only on those subjects vaccinated with Boostrix Polio.
Anti-diphtheria and anti-tetanus antibodies cut-off value assessed include 1.0 IU/mL.
Outcome measures
| Measure |
Cervarix Group
Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
|
Cervarix + Boostrix Polio Group
n=240 Participants
Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
|
Boostrix Polio → Cervarix Group
n=233 Participants
Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
|
|---|---|---|---|
|
Number of Subjects With Anti-diphtheria and Anti-tetanus Antibody Titers Above 1.0 International Units Per Milliliter (IU/mL)
Anti-tetanus
|
—
|
239 Participants
|
233 Participants
|
|
Number of Subjects With Anti-diphtheria and Anti-tetanus Antibody Titers Above 1.0 International Units Per Milliliter (IU/mL)
Anti-diphtheria
|
—
|
231 Participants
|
226 Participants
|
SECONDARY outcome
Timeframe: One month after vaccination with Boostrix PolioPopulation: Analysis was performed on the Month 1 According-to-Protocol (ATP) cohort for analysis of immunogenicity and only on those subjects vaccinated with Boostrix Polio.
Titers are given as Geometric Mean Titers (GMTs). The titer is a serum dilution giving 50 percent reduction of signal compared to control without serum.
Outcome measures
| Measure |
Cervarix Group
Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
|
Cervarix + Boostrix Polio Group
n=240 Participants
Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
|
Boostrix Polio → Cervarix Group
n=232 Participants
Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
|
|---|---|---|---|
|
Anti-poliovirus Type 1 (Anti-polio 1), Anti-polio 2 and Anti-polio 3 Antibody Titers
Anti-polio 1
|
—
|
2045.1 titer
Interval 1714.7 to 2439.2
|
2390.5 titer
Interval 2021.4 to 2826.9
|
|
Anti-poliovirus Type 1 (Anti-polio 1), Anti-polio 2 and Anti-polio 3 Antibody Titers
Anti-polio 2
|
—
|
2151.1 titer
Interval 1806.5 to 2561.6
|
2158.1 titer
Interval 1821.3 to 2557.1
|
|
Anti-poliovirus Type 1 (Anti-polio 1), Anti-polio 2 and Anti-polio 3 Antibody Titers
Anti-polio 3
|
—
|
2777.2 titer
Interval 2376.5 to 3245.4
|
2732.5 titer
Interval 2318.0 to 3221.2
|
SECONDARY outcome
Timeframe: One month after vaccination with Boostrix PolioPopulation: Analysis was performed on the Month 1 According-to-Protocol (ATP) cohort for analysis of immunogenicity and only on those subjects vaccinated with Boostrix Polio.
Booster responses to diphtheria and tetanus were defined as: * For initially seronegative subjects (pre-vaccination titer below cut-off value of 0.1 International Units per Milliliter): antibody titers at least four times the cut-off (post-vaccination titer greater than or equal to 0.4 IU/mL), and * For initially seropositive subjects (pre-vaccination titer greater than or equal to 0.1 IU/mL): an increase in antibody titers of at least four times the pre-vaccination titer.
Outcome measures
| Measure |
Cervarix Group
Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
|
Cervarix + Boostrix Polio Group
n=240 Participants
Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
|
Boostrix Polio → Cervarix Group
n=232 Participants
Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
|
|---|---|---|---|
|
Number of Subjects With Booster Response to Diphtheria and Tetanus
Diphtheria
|
—
|
160 Participants
|
159 Participants
|
|
Number of Subjects With Booster Response to Diphtheria and Tetanus
Tetanus
|
—
|
167 Participants
|
161 Participants
|
SECONDARY outcome
Timeframe: One month after vaccination with Boostrix PolioPopulation: Analysis was performed on the Month 1 According-to-Protocol (ATP) cohort for analysis of immunogenicity and only on those subjects vaccinated with Boostrix Polio.
Booster response to PT, FHA and PRN were defined as: * For initially seronegative subjects \[pre-vaccination titer below cut-off value of 5 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL)\]: antibody titers at least 4 times the cut-off, * For initially seropositive subjects with pre-vaccination titer above 5 EL.U/mL and \< 20 EL.U/mL: an increase in antibody titers of at least 4 times the pre-vaccination titer, * For initially seropositive subjects with pre-vaccination titer above 20 EL.U/mL: an increase in antibody titers of at least 2 times the pre-vaccination titer.
Outcome measures
| Measure |
Cervarix Group
Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
|
Cervarix + Boostrix Polio Group
n=238 Participants
Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
|
Boostrix Polio → Cervarix Group
n=230 Participants
Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
|
|---|---|---|---|
|
Number of Subjects With Booster Response to Pertussis Toxoid (PT), Pertactin Toxoid (PRN) and Filamentous Hemagglutinin (FHA)
PT
|
—
|
199 Participants
|
182 Participants
|
|
Number of Subjects With Booster Response to Pertussis Toxoid (PT), Pertactin Toxoid (PRN) and Filamentous Hemagglutinin (FHA)
FHA
|
—
|
210 Participants
|
205 Participants
|
|
Number of Subjects With Booster Response to Pertussis Toxoid (PT), Pertactin Toxoid (PRN) and Filamentous Hemagglutinin (FHA)
PRN
|
—
|
222 Participants
|
207 Participants
|
SECONDARY outcome
Timeframe: During the 7-day period (Day 0-6) following each vaccinationPopulation: Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.
Solicited local symptoms assessed include pain, redness and swelling at the injection site. Solicited general symptoms assessed include arthralgia, fatigue, fever (above 37.5 degree Celsius), gastrointestinal symptoms, headache, myalgia, rash and urticaria.
Outcome measures
| Measure |
Cervarix Group
n=246 Participants
Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
|
Cervarix + Boostrix Polio Group
n=253 Participants
Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
|
Boostrix Polio → Cervarix Group
n=247 Participants
Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
|
|---|---|---|---|
|
Number of Subjects Reporting Solicited Symptoms
Pain
|
225 Participants
|
237 Participants
|
233 Participants
|
|
Number of Subjects Reporting Solicited Symptoms
Redness
|
110 Participants
|
128 Participants
|
140 Participants
|
|
Number of Subjects Reporting Solicited Symptoms
Swelling
|
124 Participants
|
125 Participants
|
123 Participants
|
|
Number of Subjects Reporting Solicited Symptoms
Arthralgia
|
58 Participants
|
71 Participants
|
77 Participants
|
|
Number of Subjects Reporting Solicited Symptoms
Fatigue
|
109 Participants
|
135 Participants
|
121 Participants
|
|
Number of Subjects Reporting Solicited Symptoms
Fever
|
30 Participants
|
46 Participants
|
37 Participants
|
|
Number of Subjects Reporting Solicited Symptoms
Gastrointestinal symptoms
|
51 Participants
|
63 Participants
|
61 Participants
|
|
Number of Subjects Reporting Solicited Symptoms
Headache
|
111 Participants
|
138 Participants
|
122 Participants
|
|
Number of Subjects Reporting Solicited Symptoms
Myalgia
|
107 Participants
|
144 Participants
|
127 Participants
|
|
Number of Subjects Reporting Solicited Symptoms
Rash
|
20 Participants
|
27 Participants
|
17 Participants
|
|
Number of Subjects Reporting Solicited Symptoms
Urticaria
|
12 Participants
|
11 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: During the 30-day period (Day 0-29) following vaccinationUnsolicited adverse event = 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.
Outcome measures
| Measure |
Cervarix Group
n=248 Participants
Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
|
Cervarix + Boostrix Polio Group
n=255 Participants
Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
|
Boostrix Polio → Cervarix Group
n=248 Participants
Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
|
|---|---|---|---|
|
Number of Subjects Reporting Unsolicited Adverse Events
|
85 Participants
|
74 Participants
|
99 Participants
|
SECONDARY outcome
Timeframe: During the active phase of the study (up to Month 7/8) and during the safety follow-up (up to Month 12/13)Population: Analysis was performed on the Total Vaccinated Cohort (for the active phase) and on the Extended Safety Follow-up Vaccinated Cohort (for the safety follow-up).
NOCDs assessed include e.g. autoimmune disorders, asthma, type I diabetes. MSAEs assessed include AEs prompting emergency room or physician visits that are not related to common diseases or SAEs that are not related to common diseases.
Outcome measures
| Measure |
Cervarix Group
n=248 Participants
Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
|
Cervarix + Boostrix Polio Group
n=255 Participants
Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
|
Boostrix Polio → Cervarix Group
n=248 Participants
Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
|
|---|---|---|---|
|
Number of Subjects Reporting Unsolicited Adverse Events as New Onset Chronic Diseases (NOCDs) and Other Medically Significant Adverse Events (MSAEs)
MSAEs [Safety follow-up]
|
7 Participants
|
3 Participants
|
5 Participants
|
|
Number of Subjects Reporting Unsolicited Adverse Events as New Onset Chronic Diseases (NOCDs) and Other Medically Significant Adverse Events (MSAEs)
NOCDs [Active phase]
|
5 Participants
|
9 Participants
|
9 Participants
|
|
Number of Subjects Reporting Unsolicited Adverse Events as New Onset Chronic Diseases (NOCDs) and Other Medically Significant Adverse Events (MSAEs)
NOCDs [Safety follow-up]
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Unsolicited Adverse Events as New Onset Chronic Diseases (NOCDs) and Other Medically Significant Adverse Events (MSAEs)
MSAEs [Active phase]
|
35 Participants
|
27 Participants
|
49 Participants
|
SECONDARY outcome
Timeframe: During the active phase of the study (up to Month 7/8) and during the safety follow-up (up to Month 12/13)Population: Analysis was performed on the Total Vaccinated Cohort (for the active phase) and on the Extended Safety Follow-up Vaccinated Cohort (for the safety follow-up).
Serious adverse events assessed include medical occurrences that results 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 Group
n=248 Participants
Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
|
Cervarix + Boostrix Polio Group
n=255 Participants
Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
|
Boostrix Polio → Cervarix Group
n=248 Participants
Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
|
|---|---|---|---|
|
Number of Subjects Reporting Serious Adverse Events (SAEs)
Active phase
|
2 Participants
|
4 Participants
|
2 Participants
|
|
Number of Subjects Reporting Serious Adverse Events (SAEs)
Safety follow-up
|
1 Participants
|
0 Participants
|
1 Participants
|
Adverse Events
Cervarix Group
Serious events: 3 serious events
Other events: 232 other events
Deaths: 0 deaths
Cervarix + Boostrix Polio Group
Serious events: 4 serious events
Other events: 245 other events
Deaths: 0 deaths
Boostrix Polio → Cervarix Group
Serious events: 3 serious events
Other events: 242 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cervarix Group
n=248 participants at risk
Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
|
Cervarix + Boostrix Polio Group
n=255 participants at risk
Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
|
Boostrix Polio → Cervarix Group
n=248 participants at risk
Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
|
|---|---|---|---|
|
Psychiatric disorders
Suicide attempt
|
0.40%
1/248 • During the 7 day follow-up period after any vaccination for other (non-serious) adverse events. During the entire study period (12 months for Cervarix and Cervarix + Boostrix groups and 13 months for Cervarix → Boostrix group) for serious adverse events.
For other (non-serious) adverse events collected by systematic assessment, the number of subjects at risk corresponds to the number of subjects from the Total Vaccinated Cohort with a documented dose.
|
0.00%
0/255 • During the 7 day follow-up period after any vaccination for other (non-serious) adverse events. During the entire study period (12 months for Cervarix and Cervarix + Boostrix groups and 13 months for Cervarix → Boostrix group) for serious adverse events.
For other (non-serious) adverse events collected by systematic assessment, the number of subjects at risk corresponds to the number of subjects from the Total Vaccinated Cohort with a documented dose.
|
0.00%
0/248 • During the 7 day follow-up period after any vaccination for other (non-serious) adverse events. During the entire study period (12 months for Cervarix and Cervarix + Boostrix groups and 13 months for Cervarix → Boostrix group) for serious adverse events.
For other (non-serious) adverse events collected by systematic assessment, the number of subjects at risk corresponds to the number of subjects from the Total Vaccinated Cohort with a documented dose.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/248 • During the 7 day follow-up period after any vaccination for other (non-serious) adverse events. During the entire study period (12 months for Cervarix and Cervarix + Boostrix groups and 13 months for Cervarix → Boostrix group) for serious adverse events.
For other (non-serious) adverse events collected by systematic assessment, the number of subjects at risk corresponds to the number of subjects from the Total Vaccinated Cohort with a documented dose.
|
0.39%
1/255 • During the 7 day follow-up period after any vaccination for other (non-serious) adverse events. During the entire study period (12 months for Cervarix and Cervarix + Boostrix groups and 13 months for Cervarix → Boostrix group) for serious adverse events.
For other (non-serious) adverse events collected by systematic assessment, the number of subjects at risk corresponds to the number of subjects from the Total Vaccinated Cohort with a documented dose.
|
0.00%
0/248 • During the 7 day follow-up period after any vaccination for other (non-serious) adverse events. During the entire study period (12 months for Cervarix and Cervarix + Boostrix groups and 13 months for Cervarix → Boostrix group) for serious adverse events.
For other (non-serious) adverse events collected by systematic assessment, the number of subjects at risk corresponds to the number of subjects from the Total Vaccinated Cohort with a documented dose.
|
|
Infections and infestations
Gastroenteritis
|
0.40%
1/248 • During the 7 day follow-up period after any vaccination for other (non-serious) adverse events. During the entire study period (12 months for Cervarix and Cervarix + Boostrix groups and 13 months for Cervarix → Boostrix group) for serious adverse events.
For other (non-serious) adverse events collected by systematic assessment, the number of subjects at risk corresponds to the number of subjects from the Total Vaccinated Cohort with a documented dose.
|
0.00%
0/255 • During the 7 day follow-up period after any vaccination for other (non-serious) adverse events. During the entire study period (12 months for Cervarix and Cervarix + Boostrix groups and 13 months for Cervarix → Boostrix group) for serious adverse events.
For other (non-serious) adverse events collected by systematic assessment, the number of subjects at risk corresponds to the number of subjects from the Total Vaccinated Cohort with a documented dose.
|
0.00%
0/248 • During the 7 day follow-up period after any vaccination for other (non-serious) adverse events. During the entire study period (12 months for Cervarix and Cervarix + Boostrix groups and 13 months for Cervarix → Boostrix group) for serious adverse events.
For other (non-serious) adverse events collected by systematic assessment, the number of subjects at risk corresponds to the number of subjects from the Total Vaccinated Cohort with a documented dose.
|
|
Pregnancy, puerperium and perinatal conditions
Imminent abortion
|
0.00%
0/248 • During the 7 day follow-up period after any vaccination for other (non-serious) adverse events. During the entire study period (12 months for Cervarix and Cervarix + Boostrix groups and 13 months for Cervarix → Boostrix group) for serious adverse events.
For other (non-serious) adverse events collected by systematic assessment, the number of subjects at risk corresponds to the number of subjects from the Total Vaccinated Cohort with a documented dose.
|
0.39%
1/255 • During the 7 day follow-up period after any vaccination for other (non-serious) adverse events. During the entire study period (12 months for Cervarix and Cervarix + Boostrix groups and 13 months for Cervarix → Boostrix group) for serious adverse events.
For other (non-serious) adverse events collected by systematic assessment, the number of subjects at risk corresponds to the number of subjects from the Total Vaccinated Cohort with a documented dose.
|
0.00%
0/248 • During the 7 day follow-up period after any vaccination for other (non-serious) adverse events. During the entire study period (12 months for Cervarix and Cervarix + Boostrix groups and 13 months for Cervarix → Boostrix group) for serious adverse events.
For other (non-serious) adverse events collected by systematic assessment, the number of subjects at risk corresponds to the number of subjects from the Total Vaccinated Cohort with a documented dose.
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.00%
0/248 • During the 7 day follow-up period after any vaccination for other (non-serious) adverse events. During the entire study period (12 months for Cervarix and Cervarix + Boostrix groups and 13 months for Cervarix → Boostrix group) for serious adverse events.
For other (non-serious) adverse events collected by systematic assessment, the number of subjects at risk corresponds to the number of subjects from the Total Vaccinated Cohort with a documented dose.
|
0.39%
1/255 • During the 7 day follow-up period after any vaccination for other (non-serious) adverse events. During the entire study period (12 months for Cervarix and Cervarix + Boostrix groups and 13 months for Cervarix → Boostrix group) for serious adverse events.
For other (non-serious) adverse events collected by systematic assessment, the number of subjects at risk corresponds to the number of subjects from the Total Vaccinated Cohort with a documented dose.
|
0.00%
0/248 • During the 7 day follow-up period after any vaccination for other (non-serious) adverse events. During the entire study period (12 months for Cervarix and Cervarix + Boostrix groups and 13 months for Cervarix → Boostrix group) for serious adverse events.
For other (non-serious) adverse events collected by systematic assessment, the number of subjects at risk corresponds to the number of subjects from the Total Vaccinated Cohort with a documented dose.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/248 • During the 7 day follow-up period after any vaccination for other (non-serious) adverse events. During the entire study period (12 months for Cervarix and Cervarix + Boostrix groups and 13 months for Cervarix → Boostrix group) for serious adverse events.
For other (non-serious) adverse events collected by systematic assessment, the number of subjects at risk corresponds to the number of subjects from the Total Vaccinated Cohort with a documented dose.
|
0.00%
0/255 • During the 7 day follow-up period after any vaccination for other (non-serious) adverse events. During the entire study period (12 months for Cervarix and Cervarix + Boostrix groups and 13 months for Cervarix → Boostrix group) for serious adverse events.
For other (non-serious) adverse events collected by systematic assessment, the number of subjects at risk corresponds to the number of subjects from the Total Vaccinated Cohort with a documented dose.
|
0.40%
1/248 • During the 7 day follow-up period after any vaccination for other (non-serious) adverse events. During the entire study period (12 months for Cervarix and Cervarix + Boostrix groups and 13 months for Cervarix → Boostrix group) for serious adverse events.
For other (non-serious) adverse events collected by systematic assessment, the number of subjects at risk corresponds to the number of subjects from the Total Vaccinated Cohort with a documented dose.
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.00%
0/248 • During the 7 day follow-up period after any vaccination for other (non-serious) adverse events. During the entire study period (12 months for Cervarix and Cervarix + Boostrix groups and 13 months for Cervarix → Boostrix group) for serious adverse events.
For other (non-serious) adverse events collected by systematic assessment, the number of subjects at risk corresponds to the number of subjects from the Total Vaccinated Cohort with a documented dose.
|
0.39%
1/255 • During the 7 day follow-up period after any vaccination for other (non-serious) adverse events. During the entire study period (12 months for Cervarix and Cervarix + Boostrix groups and 13 months for Cervarix → Boostrix group) for serious adverse events.
For other (non-serious) adverse events collected by systematic assessment, the number of subjects at risk corresponds to the number of subjects from the Total Vaccinated Cohort with a documented dose.
|
0.00%
0/248 • During the 7 day follow-up period after any vaccination for other (non-serious) adverse events. During the entire study period (12 months for Cervarix and Cervarix + Boostrix groups and 13 months for Cervarix → Boostrix group) for serious adverse events.
For other (non-serious) adverse events collected by systematic assessment, the number of subjects at risk corresponds to the number of subjects from the Total Vaccinated Cohort with a documented dose.
|
|
Infections and infestations
Tonsillitis streptococcal
|
0.00%
0/248 • During the 7 day follow-up period after any vaccination for other (non-serious) adverse events. During the entire study period (12 months for Cervarix and Cervarix + Boostrix groups and 13 months for Cervarix → Boostrix group) for serious adverse events.
For other (non-serious) adverse events collected by systematic assessment, the number of subjects at risk corresponds to the number of subjects from the Total Vaccinated Cohort with a documented dose.
|
0.00%
0/255 • During the 7 day follow-up period after any vaccination for other (non-serious) adverse events. During the entire study period (12 months for Cervarix and Cervarix + Boostrix groups and 13 months for Cervarix → Boostrix group) for serious adverse events.
For other (non-serious) adverse events collected by systematic assessment, the number of subjects at risk corresponds to the number of subjects from the Total Vaccinated Cohort with a documented dose.
|
0.40%
1/248 • During the 7 day follow-up period after any vaccination for other (non-serious) adverse events. During the entire study period (12 months for Cervarix and Cervarix + Boostrix groups and 13 months for Cervarix → Boostrix group) for serious adverse events.
For other (non-serious) adverse events collected by systematic assessment, the number of subjects at risk corresponds to the number of subjects from the Total Vaccinated Cohort with a documented dose.
|
|
Reproductive system and breast disorders
Ovarian cyst ruptured
|
0.40%
1/248 • During the 7 day follow-up period after any vaccination for other (non-serious) adverse events. During the entire study period (12 months for Cervarix and Cervarix + Boostrix groups and 13 months for Cervarix → Boostrix group) for serious adverse events.
For other (non-serious) adverse events collected by systematic assessment, the number of subjects at risk corresponds to the number of subjects from the Total Vaccinated Cohort with a documented dose.
|
0.00%
0/255 • During the 7 day follow-up period after any vaccination for other (non-serious) adverse events. During the entire study period (12 months for Cervarix and Cervarix + Boostrix groups and 13 months for Cervarix → Boostrix group) for serious adverse events.
For other (non-serious) adverse events collected by systematic assessment, the number of subjects at risk corresponds to the number of subjects from the Total Vaccinated Cohort with a documented dose.
|
0.00%
0/248 • During the 7 day follow-up period after any vaccination for other (non-serious) adverse events. During the entire study period (12 months for Cervarix and Cervarix + Boostrix groups and 13 months for Cervarix → Boostrix group) for serious adverse events.
For other (non-serious) adverse events collected by systematic assessment, the number of subjects at risk corresponds to the number of subjects from the Total Vaccinated Cohort with a documented dose.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/248 • During the 7 day follow-up period after any vaccination for other (non-serious) adverse events. During the entire study period (12 months for Cervarix and Cervarix + Boostrix groups and 13 months for Cervarix → Boostrix group) for serious adverse events.
For other (non-serious) adverse events collected by systematic assessment, the number of subjects at risk corresponds to the number of subjects from the Total Vaccinated Cohort with a documented dose.
|
0.00%
0/255 • During the 7 day follow-up period after any vaccination for other (non-serious) adverse events. During the entire study period (12 months for Cervarix and Cervarix + Boostrix groups and 13 months for Cervarix → Boostrix group) for serious adverse events.
For other (non-serious) adverse events collected by systematic assessment, the number of subjects at risk corresponds to the number of subjects from the Total Vaccinated Cohort with a documented dose.
|
0.40%
1/248 • During the 7 day follow-up period after any vaccination for other (non-serious) adverse events. During the entire study period (12 months for Cervarix and Cervarix + Boostrix groups and 13 months for Cervarix → Boostrix group) for serious adverse events.
For other (non-serious) adverse events collected by systematic assessment, the number of subjects at risk corresponds to the number of subjects from the Total Vaccinated Cohort with a documented dose.
|
Other adverse events
| Measure |
Cervarix Group
n=248 participants at risk
Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
|
Cervarix + Boostrix Polio Group
n=255 participants at risk
Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
|
Boostrix Polio → Cervarix Group
n=248 participants at risk
Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
|
|---|---|---|---|
|
General disorders
Pain
|
91.5%
225/246 • During the 7 day follow-up period after any vaccination for other (non-serious) adverse events. During the entire study period (12 months for Cervarix and Cervarix + Boostrix groups and 13 months for Cervarix → Boostrix group) for serious adverse events.
For other (non-serious) adverse events collected by systematic assessment, the number of subjects at risk corresponds to the number of subjects from the Total Vaccinated Cohort with a documented dose.
|
93.7%
237/253 • During the 7 day follow-up period after any vaccination for other (non-serious) adverse events. During the entire study period (12 months for Cervarix and Cervarix + Boostrix groups and 13 months for Cervarix → Boostrix group) for serious adverse events.
For other (non-serious) adverse events collected by systematic assessment, the number of subjects at risk corresponds to the number of subjects from the Total Vaccinated Cohort with a documented dose.
|
94.3%
233/247 • During the 7 day follow-up period after any vaccination for other (non-serious) adverse events. During the entire study period (12 months for Cervarix and Cervarix + Boostrix groups and 13 months for Cervarix → Boostrix group) for serious adverse events.
For other (non-serious) adverse events collected by systematic assessment, the number of subjects at risk corresponds to the number of subjects from the Total Vaccinated Cohort with a documented dose.
|
|
General disorders
Redness
|
44.7%
110/246 • During the 7 day follow-up period after any vaccination for other (non-serious) adverse events. During the entire study period (12 months for Cervarix and Cervarix + Boostrix groups and 13 months for Cervarix → Boostrix group) for serious adverse events.
For other (non-serious) adverse events collected by systematic assessment, the number of subjects at risk corresponds to the number of subjects from the Total Vaccinated Cohort with a documented dose.
|
50.6%
128/253 • During the 7 day follow-up period after any vaccination for other (non-serious) adverse events. During the entire study period (12 months for Cervarix and Cervarix + Boostrix groups and 13 months for Cervarix → Boostrix group) for serious adverse events.
For other (non-serious) adverse events collected by systematic assessment, the number of subjects at risk corresponds to the number of subjects from the Total Vaccinated Cohort with a documented dose.
|
56.7%
140/247 • During the 7 day follow-up period after any vaccination for other (non-serious) adverse events. During the entire study period (12 months for Cervarix and Cervarix + Boostrix groups and 13 months for Cervarix → Boostrix group) for serious adverse events.
For other (non-serious) adverse events collected by systematic assessment, the number of subjects at risk corresponds to the number of subjects from the Total Vaccinated Cohort with a documented dose.
|
|
General disorders
Swelling
|
50.4%
124/246 • During the 7 day follow-up period after any vaccination for other (non-serious) adverse events. During the entire study period (12 months for Cervarix and Cervarix + Boostrix groups and 13 months for Cervarix → Boostrix group) for serious adverse events.
For other (non-serious) adverse events collected by systematic assessment, the number of subjects at risk corresponds to the number of subjects from the Total Vaccinated Cohort with a documented dose.
|
49.4%
125/253 • During the 7 day follow-up period after any vaccination for other (non-serious) adverse events. During the entire study period (12 months for Cervarix and Cervarix + Boostrix groups and 13 months for Cervarix → Boostrix group) for serious adverse events.
For other (non-serious) adverse events collected by systematic assessment, the number of subjects at risk corresponds to the number of subjects from the Total Vaccinated Cohort with a documented dose.
|
49.8%
123/247 • During the 7 day follow-up period after any vaccination for other (non-serious) adverse events. During the entire study period (12 months for Cervarix and Cervarix + Boostrix groups and 13 months for Cervarix → Boostrix group) for serious adverse events.
For other (non-serious) adverse events collected by systematic assessment, the number of subjects at risk corresponds to the number of subjects from the Total Vaccinated Cohort with a documented dose.
|
|
General disorders
Arthralgia
|
23.6%
58/246 • During the 7 day follow-up period after any vaccination for other (non-serious) adverse events. During the entire study period (12 months for Cervarix and Cervarix + Boostrix groups and 13 months for Cervarix → Boostrix group) for serious adverse events.
For other (non-serious) adverse events collected by systematic assessment, the number of subjects at risk corresponds to the number of subjects from the Total Vaccinated Cohort with a documented dose.
|
28.1%
71/253 • During the 7 day follow-up period after any vaccination for other (non-serious) adverse events. During the entire study period (12 months for Cervarix and Cervarix + Boostrix groups and 13 months for Cervarix → Boostrix group) for serious adverse events.
For other (non-serious) adverse events collected by systematic assessment, the number of subjects at risk corresponds to the number of subjects from the Total Vaccinated Cohort with a documented dose.
|
31.2%
77/247 • During the 7 day follow-up period after any vaccination for other (non-serious) adverse events. During the entire study period (12 months for Cervarix and Cervarix + Boostrix groups and 13 months for Cervarix → Boostrix group) for serious adverse events.
For other (non-serious) adverse events collected by systematic assessment, the number of subjects at risk corresponds to the number of subjects from the Total Vaccinated Cohort with a documented dose.
|
|
General disorders
Fatigue
|
44.3%
109/246 • During the 7 day follow-up period after any vaccination for other (non-serious) adverse events. During the entire study period (12 months for Cervarix and Cervarix + Boostrix groups and 13 months for Cervarix → Boostrix group) for serious adverse events.
For other (non-serious) adverse events collected by systematic assessment, the number of subjects at risk corresponds to the number of subjects from the Total Vaccinated Cohort with a documented dose.
|
53.4%
135/253 • During the 7 day follow-up period after any vaccination for other (non-serious) adverse events. During the entire study period (12 months for Cervarix and Cervarix + Boostrix groups and 13 months for Cervarix → Boostrix group) for serious adverse events.
For other (non-serious) adverse events collected by systematic assessment, the number of subjects at risk corresponds to the number of subjects from the Total Vaccinated Cohort with a documented dose.
|
49.0%
121/247 • During the 7 day follow-up period after any vaccination for other (non-serious) adverse events. During the entire study period (12 months for Cervarix and Cervarix + Boostrix groups and 13 months for Cervarix → Boostrix group) for serious adverse events.
For other (non-serious) adverse events collected by systematic assessment, the number of subjects at risk corresponds to the number of subjects from the Total Vaccinated Cohort with a documented dose.
|
|
General disorders
Fever (above 37.5 degree Celsius)
|
12.2%
30/246 • During the 7 day follow-up period after any vaccination for other (non-serious) adverse events. During the entire study period (12 months for Cervarix and Cervarix + Boostrix groups and 13 months for Cervarix → Boostrix group) for serious adverse events.
For other (non-serious) adverse events collected by systematic assessment, the number of subjects at risk corresponds to the number of subjects from the Total Vaccinated Cohort with a documented dose.
|
18.2%
46/253 • During the 7 day follow-up period after any vaccination for other (non-serious) adverse events. During the entire study period (12 months for Cervarix and Cervarix + Boostrix groups and 13 months for Cervarix → Boostrix group) for serious adverse events.
For other (non-serious) adverse events collected by systematic assessment, the number of subjects at risk corresponds to the number of subjects from the Total Vaccinated Cohort with a documented dose.
|
15.0%
37/247 • During the 7 day follow-up period after any vaccination for other (non-serious) adverse events. During the entire study period (12 months for Cervarix and Cervarix + Boostrix groups and 13 months for Cervarix → Boostrix group) for serious adverse events.
For other (non-serious) adverse events collected by systematic assessment, the number of subjects at risk corresponds to the number of subjects from the Total Vaccinated Cohort with a documented dose.
|
|
General disorders
Gastrointestinal symptoms
|
20.7%
51/246 • During the 7 day follow-up period after any vaccination for other (non-serious) adverse events. During the entire study period (12 months for Cervarix and Cervarix + Boostrix groups and 13 months for Cervarix → Boostrix group) for serious adverse events.
For other (non-serious) adverse events collected by systematic assessment, the number of subjects at risk corresponds to the number of subjects from the Total Vaccinated Cohort with a documented dose.
|
24.9%
63/253 • During the 7 day follow-up period after any vaccination for other (non-serious) adverse events. During the entire study period (12 months for Cervarix and Cervarix + Boostrix groups and 13 months for Cervarix → Boostrix group) for serious adverse events.
For other (non-serious) adverse events collected by systematic assessment, the number of subjects at risk corresponds to the number of subjects from the Total Vaccinated Cohort with a documented dose.
|
24.7%
61/247 • During the 7 day follow-up period after any vaccination for other (non-serious) adverse events. During the entire study period (12 months for Cervarix and Cervarix + Boostrix groups and 13 months for Cervarix → Boostrix group) for serious adverse events.
For other (non-serious) adverse events collected by systematic assessment, the number of subjects at risk corresponds to the number of subjects from the Total Vaccinated Cohort with a documented dose.
|
|
General disorders
Headache
|
45.1%
111/246 • During the 7 day follow-up period after any vaccination for other (non-serious) adverse events. During the entire study period (12 months for Cervarix and Cervarix + Boostrix groups and 13 months for Cervarix → Boostrix group) for serious adverse events.
For other (non-serious) adverse events collected by systematic assessment, the number of subjects at risk corresponds to the number of subjects from the Total Vaccinated Cohort with a documented dose.
|
54.5%
138/253 • During the 7 day follow-up period after any vaccination for other (non-serious) adverse events. During the entire study period (12 months for Cervarix and Cervarix + Boostrix groups and 13 months for Cervarix → Boostrix group) for serious adverse events.
For other (non-serious) adverse events collected by systematic assessment, the number of subjects at risk corresponds to the number of subjects from the Total Vaccinated Cohort with a documented dose.
|
49.4%
122/247 • During the 7 day follow-up period after any vaccination for other (non-serious) adverse events. During the entire study period (12 months for Cervarix and Cervarix + Boostrix groups and 13 months for Cervarix → Boostrix group) for serious adverse events.
For other (non-serious) adverse events collected by systematic assessment, the number of subjects at risk corresponds to the number of subjects from the Total Vaccinated Cohort with a documented dose.
|
|
General disorders
Myalgia
|
43.5%
107/246 • During the 7 day follow-up period after any vaccination for other (non-serious) adverse events. During the entire study period (12 months for Cervarix and Cervarix + Boostrix groups and 13 months for Cervarix → Boostrix group) for serious adverse events.
For other (non-serious) adverse events collected by systematic assessment, the number of subjects at risk corresponds to the number of subjects from the Total Vaccinated Cohort with a documented dose.
|
56.9%
144/253 • During the 7 day follow-up period after any vaccination for other (non-serious) adverse events. During the entire study period (12 months for Cervarix and Cervarix + Boostrix groups and 13 months for Cervarix → Boostrix group) for serious adverse events.
For other (non-serious) adverse events collected by systematic assessment, the number of subjects at risk corresponds to the number of subjects from the Total Vaccinated Cohort with a documented dose.
|
51.4%
127/247 • During the 7 day follow-up period after any vaccination for other (non-serious) adverse events. During the entire study period (12 months for Cervarix and Cervarix + Boostrix groups and 13 months for Cervarix → Boostrix group) for serious adverse events.
For other (non-serious) adverse events collected by systematic assessment, the number of subjects at risk corresponds to the number of subjects from the Total Vaccinated Cohort with a documented dose.
|
|
General disorders
Rash
|
8.1%
20/246 • During the 7 day follow-up period after any vaccination for other (non-serious) adverse events. During the entire study period (12 months for Cervarix and Cervarix + Boostrix groups and 13 months for Cervarix → Boostrix group) for serious adverse events.
For other (non-serious) adverse events collected by systematic assessment, the number of subjects at risk corresponds to the number of subjects from the Total Vaccinated Cohort with a documented dose.
|
10.7%
27/253 • During the 7 day follow-up period after any vaccination for other (non-serious) adverse events. During the entire study period (12 months for Cervarix and Cervarix + Boostrix groups and 13 months for Cervarix → Boostrix group) for serious adverse events.
For other (non-serious) adverse events collected by systematic assessment, the number of subjects at risk corresponds to the number of subjects from the Total Vaccinated Cohort with a documented dose.
|
6.9%
17/247 • During the 7 day follow-up period after any vaccination for other (non-serious) adverse events. During the entire study period (12 months for Cervarix and Cervarix + Boostrix groups and 13 months for Cervarix → Boostrix group) for serious adverse events.
For other (non-serious) adverse events collected by systematic assessment, the number of subjects at risk corresponds to the number of subjects from the Total Vaccinated Cohort with a documented dose.
|
|
General disorders
Urticaria
|
4.9%
12/246 • During the 7 day follow-up period after any vaccination for other (non-serious) adverse events. During the entire study period (12 months for Cervarix and Cervarix + Boostrix groups and 13 months for Cervarix → Boostrix group) for serious adverse events.
For other (non-serious) adverse events collected by systematic assessment, the number of subjects at risk corresponds to the number of subjects from the Total Vaccinated Cohort with a documented dose.
|
4.3%
11/253 • During the 7 day follow-up period after any vaccination for other (non-serious) adverse events. During the entire study period (12 months for Cervarix and Cervarix + Boostrix groups and 13 months for Cervarix → Boostrix group) for serious adverse events.
For other (non-serious) adverse events collected by systematic assessment, the number of subjects at risk corresponds to the number of subjects from the Total Vaccinated Cohort with a documented dose.
|
6.1%
15/247 • During the 7 day follow-up period after any vaccination for other (non-serious) adverse events. During the entire study period (12 months for Cervarix and Cervarix + Boostrix groups and 13 months for Cervarix → Boostrix group) for serious adverse events.
For other (non-serious) adverse events collected by systematic assessment, the number of subjects at risk corresponds to the number of subjects from the Total Vaccinated Cohort with a documented dose.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.6%
14/248 • During the 7 day follow-up period after any vaccination for other (non-serious) adverse events. During the entire study period (12 months for Cervarix and Cervarix + Boostrix groups and 13 months for Cervarix → Boostrix group) for serious adverse events.
For other (non-serious) adverse events collected by systematic assessment, the number of subjects at risk corresponds to the number of subjects from the Total Vaccinated Cohort with a documented dose.
|
1.6%
4/255 • During the 7 day follow-up period after any vaccination for other (non-serious) adverse events. During the entire study period (12 months for Cervarix and Cervarix + Boostrix groups and 13 months for Cervarix → Boostrix group) for serious adverse events.
For other (non-serious) adverse events collected by systematic assessment, the number of subjects at risk corresponds to the number of subjects from the Total Vaccinated Cohort with a documented dose.
|
4.0%
10/248 • During the 7 day follow-up period after any vaccination for other (non-serious) adverse events. During the entire study period (12 months for Cervarix and Cervarix + Boostrix groups and 13 months for Cervarix → Boostrix group) for serious adverse events.
For other (non-serious) adverse events collected by systematic assessment, the number of subjects at risk corresponds to the number of subjects from the Total Vaccinated Cohort with a documented dose.
|
|
Nervous system disorders
Headache
|
1.6%
4/248 • During the 7 day follow-up period after any vaccination for other (non-serious) adverse events. During the entire study period (12 months for Cervarix and Cervarix + Boostrix groups and 13 months for Cervarix → Boostrix group) for serious adverse events.
For other (non-serious) adverse events collected by systematic assessment, the number of subjects at risk corresponds to the number of subjects from the Total Vaccinated Cohort with a documented dose.
|
2.4%
6/255 • During the 7 day follow-up period after any vaccination for other (non-serious) adverse events. During the entire study period (12 months for Cervarix and Cervarix + Boostrix groups and 13 months for Cervarix → Boostrix group) for serious adverse events.
For other (non-serious) adverse events collected by systematic assessment, the number of subjects at risk corresponds to the number of subjects from the Total Vaccinated Cohort with a documented dose.
|
5.6%
14/248 • During the 7 day follow-up period after any vaccination for other (non-serious) adverse events. During the entire study period (12 months for Cervarix and Cervarix + Boostrix groups and 13 months for Cervarix → Boostrix group) for serious adverse events.
For other (non-serious) adverse events collected by systematic assessment, the number of subjects at risk corresponds to the number of subjects from the Total Vaccinated Cohort with a documented dose.
|
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