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Trial record 38 of 91 for:    cervarix

Evaluation of the Immune Responses of GSK Biologicals' HPV Vaccine Following Manufacturing Process Adaptation.

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ClinicalTrials.gov Identifier: NCT00250276
Recruitment Status : Completed
First Posted : November 8, 2005
Results First Posted : March 17, 2017
Last Update Posted : July 20, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Infections, Papillomavirus
Intervention Biological: Cervarix™
Enrollment 798
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cervarix Lot1 Group Cervarix Lot2 Group Cervarix Lot3 Group Cervarix Low Group
Hide Arm/Group Description Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm. Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm. Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm. Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Period Title: Overall Study
Started 199 198 201 200
Completed 182 177 182 181
Not Completed 17 21 19 19
Reason Not Completed
Serious Adverse Event             0             0             1             0
Non-serious Adverse Event             2             0             0             2
Protocol Violation             0             1             0             0
Withdrawal by Subject             1             2             3             2
Migrated/moved from study area             3             0             2             7
Lost to Follow-up             11             18             13             8
Arm/Group Title Cervarix Lot1 Group Cervarix Lot2 Group Cervarix Lot3 Group Cervarix Low Group Total
Hide Arm/Group Description Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm. Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm. Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm. Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm. Total of all reporting groups
Overall Number of Baseline Participants 199 198 201 200 798
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 199 participants 198 participants 201 participants 200 participants 798 participants
21.8  (2.08) 21.8  (2.08) 21.9  (2.00) 22.0  (1.96) 21.88  (2.03)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 199 participants 198 participants 201 participants 200 participants 798 participants
Female
199
 100.0%
198
 100.0%
201
 100.0%
200
 100.0%
798
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Number of Seroconverted (SCR) Subjects for Anti-Human Papillomavirus Type 16 (Anti-HPV-16) and Anti-Human Papillomavirus Type 18 (Anti-HPV-18)
Hide Description Seroconversion was defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (anti-HPV-16 concentrations ≥8 Enzyme-Linked Immunosorbent Assay [ELISA] units per milliliter [EL.U/mL] and anti-HPV-18 concentrations ≥7 EL.U/mL) in the serum of subjects seronegative before vaccination.
Time Frame At Month 7
Hide Outcome Measure Data
Hide Analysis Population Description
The According-to-Protocol cohort for immunogenicity included all evaluable subjects from whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine component at Month 7.
Arm/Group Title Cervarix Lot1 Group Cervarix Lot2 Group Cervarix Lot3 Group Pooled Group Cervarix Low Group
Hide Arm/Group Description:
Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis.
Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 129 143 135 407 117
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-HPV-16 Number Analyzed 118 participants 127 participants 126 participants 371 participants 102 participants
118
 100.0%
127
 100.0%
126
 100.0%
371
 100.0%
102
 100.0%
Anti-HPV-18 Number Analyzed 129 participants 143 participants 135 participants 407 participants 117 participants
129
 100.0%
143
 100.0%
135
 100.0%
407
 100.0%
117
 100.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cervarix Lot1 Group, Cervarix Lot2 Group
Comments To demonstrate lot-to-lot consistency in terms of immunogenicity between the 3 industrial production lots (600L scale) of the Cervarix™ vaccine, one month post dose 3 (Month 7). If consistency was demonstrated the 3 lots would be pooled and non-inferiority of the 600L scale lot vaccine versus the 80L scale would be evaluated as a second primary objective.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The first primary objective was reached as the 95% Confidence Interval (CI) of the GMC ratio between lots was within [0.5;2] for the anti-HPV-16 antibodies.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments The ANOVA model on the logarithm (log)10 transformation of the concentrations. The ANOVA model included the vaccine group as fixed effect.
Method of Estimation Estimation Parameter GMC ratio for anti-HPV-16 antibody
Estimated Value 1.04
Confidence Interval (2-Sided) 95%
0.81 to 1.34
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cervarix Lot1 Group, Cervarix Lot2 Group
Comments To demonstrate lot-to-lot consistency in terms of immunogenicity between the 3 industrial production lots (600L scale) of the Cervarix™ vaccine, one month post dose 3 (Month 7). If consistency was demonstrated the 3 lots would be pooled and non-inferiority of the 600L scale lot vaccine versus the 80L scale would be evaluated as a second primary objective.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The first primary objective was reached as the 95% CIs of the GMC ratio between lots were within [0.5;2] for the anti-HPV-18 antibodies.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments The ANOVA model on the log10 transformation of theconcentrations. The ANOVA model included the vaccine group as fixed effect.
Method of Estimation Estimation Parameter GMC ratio for anti-HPV-18 antibody
Estimated Value 1.19
Confidence Interval (2-Sided) 95%
0.95 to 1.49
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Cervarix Lot1 Group, Cervarix Lot3 Group
Comments To demonstrate lot-to-lot consistency in terms of immunogenicity between the 3 industrial production lots (600L scale) of the Cervarix™ vaccine, one month post dose 3 (Month 7). If consistency was demonstrated the 3 lots would be pooled and non-inferiority of the 600L scale lot vaccine versus the 80L scale would be evaluated as a second primary objective.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The first primary objective was reached as the 95% CIs of the GMC ratio between lots were within [0.5;2] for the anti-HPV-16 antibodies.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments The ANOVA model on the log10 transformation of the concnetration. The ANOVA model included the vaccine group as fixed effect.
Method of Estimation Estimation Parameter GMC ratio for anti-HPV-16 antibody
Estimated Value 1.26
Confidence Interval (2-Sided) 95%
0.98 to 1.63
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Cervarix Lot1 Group, Cervarix Lot3 Group
Comments To demonstrate lot-to-lot consistency in terms of immunogenicity between the 3 industrial production lots (600L scale) of the Cervarix™ vaccine, one month post dose 3 (Month 7). If consistency was demonstrated the 3 lots would be pooled and non-inferiority of the 600L scale lot vaccine versus the 80L scale would be evaluated as a second primary objective.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The first primary objective was reached as the 95% CIs of the GMC ratio between lots were within [0.5;2] for the anti-HPV-18 antibodies.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments The ANOVA model on the log10 transformation of the concnetration. The ANOVA model included the vaccine group as fixed effect.
Method of Estimation Estimation Parameter GMC ratio for anti-HPV-18 antibody
Estimated Value 1.48
Confidence Interval (2-Sided) 95%
1.18 to 1.85
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Cervarix Lot2 Group, Cervarix Lot3 Group
Comments To demonstrate lot-to-lot consistency in terms of immunogenicity between the 3 industrial production lots (600L scale) of the Cervarix™ vaccine, one month post dose 3 (Month 7). If consistency was demonstrated the 3 lots would be pooled and non-inferiority of the 600L scale lot vaccine versus the 80L scale would be evaluated as a second primary objective.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The first primary objective was reached as the 95% CIs of the GMC ratio between lots were within [0.5;2] for the anti-HPV-16 antibodies.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments The ANOVA model on the log10 transformation of the concentration. The ANOVA model included the vaccine group as fixed effect.
Method of Estimation Estimation Parameter GMT ratio for anti-HPV-16 antibody
Estimated Value 1.21
Confidence Interval (2-Sided) 95%
0.94 to 1.55
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Cervarix Lot2 Group, Cervarix Lot3 Group
Comments To demonstrate lot-to-lot consistency in terms of immunogenicity between the 3 industrial production lots (600L scale) of the Cervarix™ vaccine, one month post dose 3 (Month 7). If consistency was demonstrated the 3 lots would be pooled and non-inferiority of the 600L scale lot vaccine versus the 80L scale would be evaluated as a second primary objective.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The first primary objective was reached as the 95% CIs of the GMC ratio between lots were within [0.5;2] for the anti-HPV-18 antibodies.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments The ANOVA model on the log10 transformation of the concentration. The ANOVA model included the vaccine group as fixed effect.
Method of Estimation Estimation Parameter GMC ratio for anti-HPV-18 antibody
Estimated Value 1.24
Confidence Interval (2-Sided) 95%
1.00 to 1.55
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Pooled Group, Cervarix Low Group
Comments To demonstrate that the Cervarix™ vaccine produced at 600L manufacturing scale was non-inferior in terms of immunogenicity to the Cervarix™ vaccine produced at 80L scale, one month after the third dose (Month 7).
Type of Statistical Test Non-Inferiority or Equivalence
Comments The second primary objective was reached as the upper limit of the 95% CI of the difference in seroconversion rates for anti-HPV-16 antibodies was below 5%.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Proc StatXact 5.0
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in seroconversion rate
Estimated Value 0.00
Confidence Interval (2-Sided) 95%
-3.63 to 1.02
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Pooled Group, Cervarix Low Group
Comments To demonstrate that the Cervarix™ vaccine produced at 600L manufacturing scale was non-inferior in terms of immunogenicity to the Cervarix™ vaccine produced at 80L scale, on month after the third dose (Month 7).
Type of Statistical Test Non-Inferiority or Equivalence
Comments The second primary objective was reached as the upper limit of the 95% CI of the difference in seroconversion rates for anti-HPV-18 antibodies was below 5%.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Proc StatXact 5.0
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in seroconversion rate
Estimated Value 0.00
Confidence Interval (2-Sided) 95%
-3.18 to 0.94
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Pooled Group, Cervarix Low Group
Comments To demonstrate that the Cervarix™ vaccine produced at 600L manufacturing scale was non-inferior in terms of immunogenicity to the Cervarix™ vaccine produced at 80L scale, on month after the third dose (Month 7).
Type of Statistical Test Non-Inferiority or Equivalence
Comments The second primary objective was reached as the upper limit of the 95% CI of the GMC rates for anti-HPV-16 was below 2%.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments The ANOVA model on the log10 transformation of the concentration, included the vaccine groups as fixed effect (pooled 600L lot versus 80L lot).
Method of Estimation Estimation Parameter GMC ratio for anti-HPV-16 antibody
Estimated Value 0.87
Confidence Interval (2-Sided) 95%
0.70 to 1.08
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Pooled Group, Cervarix Low Group
Comments To demonstrate that the Cervarix™ vaccine produced at 600L manufacturing scale was non-inferior in terms of immunogenicity to the Cervarix™ vaccine produced at 80L scale, on month after the third dose (Month 7).
Type of Statistical Test Non-Inferiority or Equivalence
Comments The second primary objective was reached as the upper limit of the 95% CI of the GMC rates anti-HPV-18 antibodies was below 2%.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments The ANOVA model on the log10 transformation of the concentration, included the vaccine groups as fixed effect (pooled 600L lot versus 80L lot).
Method of Estimation Estimation Parameter GMC ratio for anti-HPV-18 antibody
Estimated Value 0.80
Confidence Interval (2-Sided) 95%
0.66 to 0.97
Estimation Comments [Not Specified]
2.Primary Outcome
Title Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18
Hide Description Seropositivity defined subjects with anti-HPV-16 antibody concentration ≥ 8 EL.U/mL and/or anti-HPV-18 antibody concentration ≥ 7 EL.U/mL.
Time Frame At Month 7
Hide Outcome Measure Data
Hide Analysis Population Description
The According-to-Protocol cohort for immunogenicity included all evaluable subjects from whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine component at Month 7.
Arm/Group Title Cervarix Lot1 Group Cervarix Lot2 Group Cervarix Lot3 Group Cervarix Low Group
Hide Arm/Group Description:
Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 54 38 43 57
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-HPV-16 Number Analyzed 54 participants 38 participants 43 participants 57 participants
54
 100.0%
38
 100.0%
43
 100.0%
57
 100.0%
Anti-HPV-18 Number Analyzed 43 participants 22 participants 34 participants 41 participants
43
 100.0%
22
 100.0%
34
 100.0%
41
 100.0%
3.Secondary Outcome
Title Number of SCR Subjects for Anti-HPV-16 and Anti-HPV-18
Hide Description Seroconversion was defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (anti-HPV-16 concentrations ≥8 ELISA units per milliliter [EL.U/mL] and anti-HPV-18 concentrations ≥7 EL.U/mL) in the serum of subjects seronegative before vaccination.
Time Frame At Month 2
Hide Outcome Measure Data
Hide Analysis Population Description
The According-to-Protocol cohort for immunogenicity included all evaluable subjects from whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine component at Month 2.
Arm/Group Title Cervarix Lot1 Group Cervarix Lot2 Group Cervarix Lot3 Group Cervarix Low Group
Hide Arm/Group Description:
Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 128 142 134 116
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-HPV-16 Number Analyzed 117 participants 126 participants 125 participants 102 participants
117
 100.0%
126
 100.0%
125
 100.0%
102
 100.0%
Anti-HPV-18 Number Analyzed 128 participants 142 participants 134 participants 116 participants
128
 100.0%
142
 100.0%
134
 100.0%
116
 100.0%
4.Secondary Outcome
Title Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18
Hide Description Seropositivity defined subjects with anti-HPV-16 antibody concentration ≥ 8 EL.U/mL and/or anti-HPV-18 antibody concentration ≥ 7 EL.U/mL .
Time Frame At Month 2
Hide Outcome Measure Data
Hide Analysis Population Description
The According-to-Protocol cohort for immunogenicity included all evaluable subjects from whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine component at Month 2.
Arm/Group Title Cervarix Lot1 Group Cervarix Lot2 Group Cervarix Lot3 Group Cervarix Low Group
Hide Arm/Group Description:
Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 54 38 43 56
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-HPV-16 Number Analyzed 54 participants 38 participants 43 participants 56 participants
54
 100.0%
38
 100.0%
43
 100.0%
56
 100.0%
Anti-HPV-18 Number Analyzed 43 participants 22 participants 34 participants 41 participants
43
 100.0%
22
 100.0%
34
 100.0%
41
 100.0%
5.Secondary Outcome
Title Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Hide Description Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) diameter of injection site.
Time Frame During the 7-days (Day 0-6) post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at least one vaccine administration documented.
Arm/Group Title Cervarix Lot1 Group Cervarix Lot2 Group Cervarix Lot3 Group Pooled Group Cervarix Low Group
Hide Arm/Group Description:
Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis.
Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 198 197 199 594 197
Measure Type: Count of Participants
Unit of Measure: Participants
Any Pain Dose 1 Number Analyzed 198 participants 197 participants 199 participants 594 participants 196 participants
188
  94.9%
190
  96.4%
178
  89.4%
556
  93.6%
185
  94.4%
Grade 3 Pain Dose 1 Number Analyzed 198 participants 197 participants 199 participants 594 participants 196 participants
20
  10.1%
16
   8.1%
17
   8.5%
53
   8.9%
12
   6.1%
Any Redness Dose 1 Number Analyzed 198 participants 197 participants 199 participants 594 participants 196 participants
74
  37.4%
71
  36.0%
77
  38.7%
222
  37.4%
75
  38.3%
Grade 3 Redness Dose 1 Number Analyzed 198 participants 197 participants 199 participants 594 participants 196 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Any Swelling Dose 1 Number Analyzed 198 participants 197 participants 199 participants 594 participants 196 participants
58
  29.3%
57
  28.9%
57
  28.6%
172
  29.0%
54
  27.6%
Grade 3 Swelling Dose 1 Number Analyzed 198 participants 197 participants 199 participants 594 participants 196 participants
9
   4.5%
2
   1.0%
2
   1.0%
13
   2.2%
4
   2.0%
Any Pain Dose 2 Number Analyzed 196 participants 195 participants 198 participants 589 participants 194 participants
167
  85.2%
166
  85.1%
170
  85.9%
503
  85.4%
161
  83.0%
Grade 3 Pain Dose 2 Number Analyzed 196 participants 195 participants 198 participants 589 participants 194 participants
17
   8.7%
10
   5.1%
19
   9.6%
46
   7.8%
12
   6.2%
Any Redness Dose 2 Number Analyzed 196 participants 195 participants 198 participants 589 participants 194 participants
78
  39.8%
85
  43.6%
79
  39.9%
242
  41.1%
62
  32.0%
Grade 3 Redness Dose 2 Number Analyzed 196 participants 195 participants 198 participants 589 participants 194 participants
3
   1.5%
6
   3.1%
0
   0.0%
9
   1.5%
1
   0.5%
Any Swelling Dose 2 Number Analyzed 196 participants 195 participants 198 participants 589 participants 194 participants
64
  32.7%
59
  30.3%
56
  28.3%
179
  30.4%
53
  27.3%
Grade 3 Swelling Dose 2 Number Analyzed 196 participants 195 participants 198 participants 589 participants 194 participants
7
   3.6%
2
   1.0%
2
   1.0%
11
   1.9%
5
   2.6%
Any Pain Dose 3 Number Analyzed 181 participants 178 participants 184 participants 543 participants 181 participants
164
  90.6%
151
  84.8%
162
  88.0%
477
  87.8%
156
  86.2%
Grade 3 Pain Dose 3 Number Analyzed 181 participants 178 participants 184 participants 543 participants 181 participants
21
  11.6%
14
   7.9%
11
   6.0%
46
   8.5%
15
   8.3%
Any Redness Dose 3 Number Analyzed 181 participants 178 participants 184 participants 543 participants 181 participants
94
  51.9%
102
  57.3%
96
  52.2%
292
  53.8%
92
  50.8%
Grade 3 Redness Dose 3 Number Analyzed 181 participants 178 participants 184 participants 543 participants 181 participants
5
   2.8%
6
   3.4%
4
   2.2%
15
   2.8%
5
   2.8%
Any Swelling Dose 3 Number Analyzed 181 participants 178 participants 184 participants 543 participants 181 participants
92
  50.8%
84
  47.2%
85
  46.2%
261
  48.1%
82
  45.3%
Grade 3 Swelling Dose 3 Number Analyzed 181 participants 178 participants 184 participants 543 participants 181 participants
8
   4.4%
3
   1.7%
2
   1.1%
13
   2.4%
3
   1.7%
Any Pain Across Number Analyzed 198 participants 197 participants 199 participants 594 participants 197 participants
194
  98.0%
192
  97.5%
190
  95.5%
576
  97.0%
192
  97.5%
Grade 3 Pain Across Number Analyzed 198 participants 197 participants 199 participants 594 participants 197 participants
45
  22.7%
29
  14.7%
34
  17.1%
108
  18.2%
30
  15.2%
Any Redness Across Number Analyzed 198 participants 197 participants 199 participants 594 participants 197 participants
118
  59.6%
128
  65.0%
127
  63.8%
373
  62.8%
126
  64.0%
Grade 3 Redness Across Number Analyzed 198 participants 197 participants 199 participants 594 participants 197 participants
8
   4.0%
9
   4.6%
4
   2.0%
21
   3.5%
6
   3.0%
Any Swelling Across Number Analyzed 198 participants 197 participants 199 participants 594 participants 197 participants
116
  58.6%
112
  56.9%
113
  56.8%
341
  57.4%
107
  54.3%
Grade 3 Swelling Across Number Analyzed 198 participants 197 participants 199 participants 594 participants 197 participants
15
   7.6%
6
   3.0%
6
   3.0%
27
   4.5%
10
   5.1%
6.Secondary Outcome
Title Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Hide Description Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], gastro-intestinal, headache, myalgia, rash and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. Arthralgia (joint pain) = pain occurring in joints that were distal from the injection site. This outcome presents solicited general symptoms post dose 1 of vaccination.
Time Frame During the 7-days (Day 0-6) post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at least one vaccine administration documented.
Arm/Group Title Cervarix Lot1 Group Cervarix Lot2 Group Cervarix Lot3 Group Pooled Group Cervarix Low Group
Hide Arm/Group Description:
Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis.
Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 198 197 199 594 196
Measure Type: Count of Participants
Unit of Measure: Participants
Any Arthralgia
19
   9.6%
19
   9.6%
13
   6.5%
51
   8.6%
17
   8.7%
Grade 3 Arthralgia
1
   0.5%
0
   0.0%
2
   1.0%
3
   0.5%
0
   0.0%
Related Arthralgia
14
   7.1%
17
   8.6%
8
   4.0%
39
   6.6%
14
   7.1%
Any Fatigue
81
  40.9%
84
  42.6%
73
  36.7%
238
  40.1%
80
  40.8%
Grade 3 Fatigue
4
   2.0%
1
   0.5%
4
   2.0%
9
   1.5%
5
   2.6%
Related Fatigue
60
  30.3%
62
  31.5%
48
  24.1%
170
  28.6%
61
  31.1%
Any Fever
4
   2.0%
7
   3.6%
4
   2.0%
15
   2.5%
5
   2.6%
Grade 3 Fever
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Related Fever
1
   0.5%
5
   2.5%
3
   1.5%
9
   1.5%
3
   1.5%
Any Gastro-intestinal
32
  16.2%
39
  19.8%
34
  17.1%
105
  17.7%
30
  15.3%
Grade 3 Gastro-intestinal
1
   0.5%
2
   1.0%
0
   0.0%
3
   0.5%
1
   0.5%
Related Gastro-intestinal
17
   8.6%
24
  12.2%
19
   9.5%
60
  10.1%
19
   9.7%
Any Headache
69
  34.8%
70
  35.5%
60
  30.2%
199
  33.5%
65
  33.2%
Grade 3 Headache
8
   4.0%
4
   2.0%
2
   1.0%
14
   2.4%
4
   2.0%
Related Headache
44
  22.2%
49
  24.9%
38
  19.1%
131
  22.1%
46
  23.5%
Any Myalgia
45
  22.7%
55
  27.9%
50
  25.1%
150
  25.3%
42
  21.4%
Grade 3 Myalgia
3
   1.5%
2
   1.0%
3
   1.5%
8
   1.3%
0
   0.0%
Related Myalgia
36
  18.2%
44
  22.3%
41
  20.6%
121
  20.4%
30
  15.3%
Any Rash
4
   2.0%
4
   2.0%
6
   3.0%
14
   2.4%
5
   2.6%
Grade 3 Rash
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Related Rash
2
   1.0%
3
   1.5%
4
   2.0%
9
   1.5%
4
   2.0%
Any Urticaria
5
   2.5%
3
   1.5%
3
   1.5%
11
   1.9%
4
   2.0%
Grade 3 Urticaria
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Related Urticaria
2
   1.0%
2
   1.0%
2
   1.0%
6
   1.0%
4
   2.0%
7.Secondary Outcome
Title Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Hide Description Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], gastro-intestinal, headache, myalgia, rash and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. Arthralgia (joint pain) = pain occurring in joints that were distal from the injection site. This outcome presents solicited general symptoms post dose 2 of vaccination.
Time Frame During the 7-days (Day 0-6) post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at last one vaccine administration documented.
Arm/Group Title Cervarix Lot1 Group Cervarix Lot2 Group Cervarix Lot3 Group Pooled Group Cervarix Low Group
Hide Arm/Group Description:
Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis.
Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 195 195 198 588 193
Measure Type: Count of Participants
Unit of Measure: Participants
Any Arthralgia
14
   7.2%
14
   7.2%
14
   7.1%
42
   7.1%
17
   8.8%
Grade 3 Arthralgia
0
   0.0%
0
   0.0%
1
   0.5%
1
   0.2%
0
   0.0%
Related Arthralgia
12
   6.2%
11
   5.6%
10
   5.1%
33
   5.6%
14
   7.3%
Any Fatigue
63
  32.3%
73
  37.4%
69
  34.8%
205
  34.9%
58
  30.1%
Grade 3 Fatigue
2
   1.0%
4
   2.1%
3
   1.5%
9
   1.5%
5
   2.6%
Related Fatigue
39
  20.0%
55
  28.2%
38
  19.2%
132
  22.4%
40
  20.7%
Any Fever
7
   3.6%
5
   2.6%
7
   3.5%
19
   3.2%
5
   2.6%
Grade 3 Fever
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Related Fever
5
   2.6%
2
   1.0%
2
   1.0%
9
   1.5%
3
   1.6%
Any Gastro-intestinal
22
  11.3%
21
  10.8%
28
  14.1%
71
  12.1%
24
  12.4%
Grade 3 Gastro-intestinal
1
   0.5%
0
   0.0%
1
   0.5%
2
   0.3%
1
   0.5%
Related Gastro-intestinal
14
   7.2%
14
   7.2%
12
   6.1%
40
   6.8%
9
   4.7%
Any Headache
47
  24.1%
51
  26.2%
46
  23.2%
144
  24.5%
41
  21.2%
Grade 3 Headache
2
   1.0%
4
   2.1%
2
   1.0%
8
   1.4%
1
   0.5%
Related Headache
27
  13.8%
33
  16.9%
29
  14.6%
89
  15.1%
24
  12.4%
Any Myalgia
30
  15.4%
37
  19.0%
39
  19.7%
106
  18.0%
31
  16.1%
Grade 3 Myalgia
0
   0.0%
1
   0.5%
3
   1.5%
4
   0.7%
1
   0.5%
Related Myalgia
22
  11.3%
30
  15.4%
31
  15.7%
83
  14.1%
21
  10.9%
Any Rash
1
   0.5%
3
   1.5%
8
   4.0%
12
   2.0%
5
   2.6%
Grade 3 Rash
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Related Rash
1
   0.5%
3
   1.5%
5
   2.5%
9
   1.5%
3
   1.6%
Any Urticaria
2
   1.0%
2
   1.0%
2
   1.0%
6
   1.0%
5
   2.6%
Grade 3 Urticaria
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Related Urticaria
0
   0.0%
1
   0.5%
2
   1.0%
3
   0.5%
3
   1.6%
8.Secondary Outcome
Title Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Hide Description Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], gastro-intestinal, headache, myalgia, rash and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. Arthralgia (joint pain) = pain occurring in joints that were distal from the injection site. This outcome presents solicited general symptoms post dose 3 of vaccination.
Time Frame During the 7-days (Day 0-6) post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at last one vaccine administration documented.
Arm/Group Title Cervarix Lot1 Group Cervarix Lot2 Group Cervarix Lot3 Group Pooled Group Cervarix Low Group
Hide Arm/Group Description:
Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis.
Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 181 178 184 543 181
Measure Type: Count of Participants
Unit of Measure: Participants
Any Arthralgia
18
   9.9%
19
  10.7%
18
   9.8%
55
  10.1%
13
   7.2%
Grade 3 Arthralgia
1
   0.6%
1
   0.6%
0
   0.0%
2
   0.4%
0
   0.0%
Related Arthralgia
15
   8.3%
16
   9.0%
12
   6.5%
43
   7.9%
11
   6.1%
Any Fatigue
76
  42.0%
67
  37.6%
64
  34.8%
207
  38.1%
60
  33.1%
Grade 3 Fatigue
9
   5.0%
1
   0.6%
2
   1.1%
12
   2.2%
6
   3.3%
Related Fatigue
58
  32.0%
50
  28.1%
49
  26.6%
157
  28.9%
49
  27.1%
Any Fever
7
   3.9%
6
   3.4%
4
   2.2%
17
   3.1%
8
   4.4%
Grade 3 Fever
0
   0.0%
0
   0.0%
1
   0.5%
1
   0.2%
0
   0.0%
Related Fever
1
   0.6%
4
   2.2%
1
   0.5%
6
   1.1%
4
   2.2%
Any Gastro-intestinal
17
   9.4%
19
  10.7%
25
  13.6%
61
  11.2%
15
   8.3%
Grade 3 Gastro-intestinal
2
   1.1%
1
   0.6%
1
   0.5%
4
   0.7%
3
   1.7%
Related Gastro-intestinal
8
   4.4%
9
   5.1%
14
   7.6%
31
   5.7%
7
   3.9%
Any Headache
53
  29.3%
44
  24.7%
49
  26.6%
146
  26.9%
39
  21.5%
Grade 3 Headache
5
   2.8%
2
   1.1%
4
   2.2%
11
   2.0%
1
   0.6%
Related Headache
34
  18.8%
31
  17.4%
29
  15.8%
94
  17.3%
30
  16.6%
Any Myalgia
44
  24.3%
38
  21.3%
39
  21.2%
121
  22.3%
29
  16.0%
Grade 3 Myalgia
3
   1.7%
2
   1.1%
1
   0.5%
6
   1.1%
1
   0.6%
Related Myalgia
35
  19.3%
35
  19.7%
32
  17.4%
102
  18.8%
24
  13.3%
Any Rash
7
   3.9%
4
   2.2%
9
   4.9%
20
   3.7%
9
   5.0%
Grade 3 Rash
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Related Rash
5
   2.8%
2
   1.1%
6
   3.3%
13
   2.4%
6
   3.3%
Any Urticaria
3
   1.7%
0
   0.0%
5
   2.7%
8
   1.5%
6
   3.3%
Grade 3 Urticaria
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Related Urticaria
1
   0.6%
0
   0.0%
2
   1.1%
3
   0.6%
4
   2.2%
9.Secondary Outcome
Title Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Hide Description Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], gastro-intestinal, headache, myalgia, rash and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. Arthralgia (joint pain) = pain occurring in joints that were distal from the injection site. This outcome presents results across vaccination doses for solicited general symptoms.
Time Frame During the 7-days (Day 0-6) post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at last one vaccine administration documented.
Arm/Group Title Cervarix Lot1 Group Cervarix Lot2 Group Cervarix Lot3 Group Pooled Group Cervarix Low Group
Hide Arm/Group Description:
Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis.
Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 198 197 199 594 197
Measure Type: Count of Participants
Unit of Measure: Participants
Any Arthralgia
38
  19.2%
40
  20.3%
32
  16.1%
110
  18.5%
35
  17.8%
Grade 3 Arthralgia
2
   1.0%
1
   0.5%
2
   1.0%
5
   0.8%
0
   0.0%
Related Arthralgia
31
  15.7%
32
  16.2%
22
  11.1%
85
  14.3%
31
  15.7%
Any Fatigue
117
  59.1%
117
  59.4%
106
  53.3%
340
  57.2%
105
  53.3%
Grade 3 Fatigue
13
   6.6%
6
   3.0%
8
   4.0%
27
   4.5%
12
   6.1%
Related Fatigue
90
  45.5%
95
  48.2%
78
  39.2%
263
  44.3%
90
  45.7%
Any Fever
16
   8.1%
18
   9.1%
14
   7.0%
48
   8.1%
15
   7.6%
Grade 3 Fever
0
   0.0%
0
   0.0%
1
   0.5%
1
   0.2%
0
   0.0%
Related Fever
6
   3.0%
11
   5.6%
5
   2.5%
22
   3.7%
7
   3.6%
Any Gastro-intestinal
55
  27.8%
61
  31.0%
57
  28.6%
173
  29.1%
49
  24.9%
Grade 3 Gastro-intestinal
4
   2.0%
3
   1.5%
2
   1.0%
9
   1.5%
5
   2.5%
Related Gastro-intestinal
32
  16.2%
38
  19.3%
33
  16.6%
103
  17.3%
25
  12.7%
Any Headache
99
  50.0%
103
  52.3%
95
  47.7%
297
  50.0%
93
  47.2%
Grade 3 Headache
14
   7.1%
9
   4.6%
8
   4.0%
31
   5.2%
5
   2.5%
Related Headache
68
  34.3%
77
  39.1%
57
  28.6%
202
  34.0%
68
  34.5%
Any Myalgia
75
  37.9%
82
  41.6%
73
  36.7%
230
  38.7%
66
  33.5%
Grade 3 Myalgia
6
   3.0%
5
   2.5%
6
   3.0%
17
   2.9%
2
   1.0%
Related Myalgia
62
  31.3%
70
  35.5%
62
  31.2%
194
  32.7%
48
  24.4%
Any Rash
11
   5.6%
10
   5.1%
19
   9.5%
40
   6.7%
15
   7.6%
Grade 3 Rash
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Related Rash
7
   3.5%
7
   3.6%
13
   6.5%
27
   4.5%
11
   5.6%
Any Urticaria
7
   3.5%
5
   2.5%
7
   3.5%
19
   3.2%
10
   5.1%
Grade 3 Urticaria
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Related Urticaria
3
   1.5%
3
   1.5%
4
   2.0%
10
   1.7%
8
   4.1%
10.Secondary Outcome
Title Number of Subjects With New Onset Chronic Diseases (NOCDs)
Hide Description NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.
Time Frame From Month 0 to Month 7
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at last one vaccine administration documented.
Arm/Group Title Cervarix Lot1 Group Cervarix Lot2 Group Cervarix Lot3 Group Pooled Group Cervarix Low Group
Hide Arm/Group Description:
Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis.
Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 199 198 201 598 200
Measure Type: Count of Participants
Unit of Measure: Participants
3
   1.5%
4
   2.0%
7
   3.5%
14
   2.3%
3
   1.5%
11.Secondary Outcome
Title Number of Subjects With Medically Significant Adverse Events (MSAEs)
Hide Description MSAEs 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.
Time Frame From Month 0 to Month 7
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at last one vaccine administration documented.
Arm/Group Title Pooled Group Cervarix Low Group
Hide Arm/Group Description:
The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis.
Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured at lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 598 200
Measure Type: Count of Participants
Unit of Measure: Participants
71
  11.9%
23
  11.5%
12.Secondary Outcome
Title Number of Subjects With (NOCDs)
Hide Description NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.
Time Frame From Month 0 to Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at last one vaccine administration documented.
Arm/Group Title Cervarix Lot1 Group Cervarix Lot2 Group Cervarix Lot3 Group Pooled Group Cervarix Low Group
Hide Arm/Group Description:
Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis.
Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 199 198 201 598 200
Measure Type: Count of Participants
Unit of Measure: Participants
4
   2.0%
4
   2.0%
7
   3.5%
15
   2.5%
3
   1.5%
13.Secondary Outcome
Title Number of Subjects With MSAEs
Hide Description MSAEs 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.
Time Frame From Month 0 to Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at last one vaccine administration documented.
Arm/Group Title Pooled Group Cervarix Low Group
Hide Arm/Group Description:
The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis.
Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured at lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 598 200
Measure Type: Count of Participants
Unit of Measure: Participants
78
  13.0%
23
  11.5%
14.Secondary Outcome
Title Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Hide Description An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Time Frame Within 30 days (Day 0-29) post vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at last one vaccine administration documented.
Arm/Group Title Cervarix Lot1 Group Cervarix Lot2 Group Cervarix Lot3 Group Pooled Group Cervarix Low Group
Hide Arm/Group Description:
Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis.
Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 199 198 201 598 200
Measure Type: Count of Participants
Unit of Measure: Participants
Any (AEs)
58
  29.1%
56
  28.3%
76
  37.8%
190
  31.8%
67
  33.5%
Grade 3 (AEs)
5
   2.5%
6
   3.0%
14
   7.0%
25
   4.2%
7
   3.5%
Related (AEs)
22
  11.1%
23
  11.6%
30
  14.9%
75
  12.5%
32
  16.0%
15.Secondary Outcome
Title Number of Subjects With Serious Adverse Events (SAEs)
Hide Description Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time Frame From Month 0 to Month 7
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at least one vaccine administration documented.
Arm/Group Title Cervarix Lot1 Group Cervarix Lot2 Group Cervarix Lot3 Group Pooled Group Cervarix Low Group
Hide Arm/Group Description:
Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis.
Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 199 198 201 598 200
Measure Type: Count of Participants
Unit of Measure: Participants
2
   1.0%
0
   0.0%
2
   1.0%
4
   0.7%
3
   1.5%
16.Secondary Outcome
Title Number of Subjects With Serious Adverse Events (SAEs)
Hide Description Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time Frame From Month 0 to Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at least one vaccine administration documented.
Arm/Group Title Cervarix Lot1 Group Cervarix Lot2 Group Cervarix Lot3 Group Pooled Group Cervarix Low Group
Hide Arm/Group Description:
Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis.
Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 199 198 201 598 200
Measure Type: Count of Participants
Unit of Measure: Participants
6
   3.0%
1
   0.5%
2
   1.0%
9
   1.5%
3
   1.5%
Time Frame Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cervarix Lot1 Group Cervarix Lot2 Group Cervarix Lot3 Group Pooled Group Cervarix Low Group
Hide Arm/Group Description Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm. Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm. Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm. The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis. Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
All-Cause Mortality
Cervarix Lot1 Group Cervarix Lot2 Group Cervarix Lot3 Group Pooled Group Cervarix Low Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cervarix Lot1 Group Cervarix Lot2 Group Cervarix Lot3 Group Pooled Group Cervarix Low Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/199 (3.02%)   1/198 (0.51%)   2/201 (1.00%)   9/598 (1.51%)   3/200 (1.50%) 
Cardiac disorders           
Supraventricular tachycardia  1  0/199 (0.00%)  0/198 (0.00%)  0/201 (0.00%)  0/598 (0.00%)  1/200 (0.50%) 
Endocrine disorders           
Basedow’s disease  1  1/199 (0.50%)  0/198 (0.00%)  0/201 (0.00%)  1/598 (0.17%)  0/200 (0.00%) 
Infections and infestations           
Appendicitis  1  0/199 (0.00%)  0/198 (0.00%)  0/201 (0.00%)  0/598 (0.00%)  2/200 (1.00%) 
Cerebral malaria  1  1/199 (0.50%)  0/198 (0.00%)  0/201 (0.00%)  1/598 (0.17%)  0/200 (0.00%) 
Pelvic inflammatory disease  1  1/199 (0.50%)  0/198 (0.00%)  0/201 (0.00%)  1/598 (0.17%)  0/200 (0.00%) 
Tuberculosis  1  1/199 (0.50%)  0/198 (0.00%)  0/201 (0.00%)  1/598 (0.17%)  0/200 (0.00%) 
Injury, poisoning and procedural complications           
Femur fracture  1  1/199 (0.50%)  0/198 (0.00%)  0/201 (0.00%)  1/598 (0.17%)  0/200 (0.00%) 
Road traffic accident  1  0/199 (0.00%)  0/198 (0.00%)  1/201 (0.50%)  1/598 (0.17%)  0/200 (0.00%) 
Musculoskeletal and connective tissue disorders           
Intervertebral disc protrusion  1  0/199 (0.00%)  0/198 (0.00%)  1/201 (0.50%)  1/598 (0.17%)  0/200 (0.00%) 
Nervous system disorders           
Syncope  1  0/199 (0.00%)  0/198 (0.00%)  0/201 (0.00%)  0/598 (0.00%)  1/200 (0.50%) 
Pregnancy, puerperium and perinatal conditions           
Abortion missed  1  0/199 (0.00%)  1/198 (0.51%)  0/201 (0.00%)  1/598 (0.17%)  0/200 (0.00%) 
Abortion spontaneous  1  1/199 (0.50%)  0/198 (0.00%)  0/201 (0.00%)  1/598 (0.17%)  0/200 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 9.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4.9%
Cervarix Lot1 Group Cervarix Lot2 Group Cervarix Lot3 Group Pooled Group Cervarix Low Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   196/199 (98.49%)   194/198 (97.98%)   191/201 (95.02%)   581/598 (97.16%)   194/200 (97.00%) 
General disorders           
Pain  1  194/198 (97.98%)  192/197 (97.46%)  190/199 (95.48%)  576/594 (96.97%)  192/197 (97.46%) 
Redness  1  118/198 (59.60%)  128/197 (64.97%)  127/199 (63.82%)  373/594 (62.79%)  126/197 (63.96%) 
Swelling  1  116/198 (58.59%)  112/197 (56.85%)  113/199 (56.78%)  341/594 (57.41%)  107/197 (54.31%) 
Arthralgia  1  38/198 (19.19%)  40/197 (20.30%)  32/199 (16.08%)  110/594 (18.52%)  35/197 (17.77%) 
Fatigue  1  117/198 (59.09%)  117/197 (59.39%)  106/199 (53.27%)  340/594 (57.24%)  105/197 (53.30%) 
Fever/(Axillary) (°C)  1  16/198 (8.08%)  18/197 (9.14%)  14/199 (7.04%)  48/594 (8.08%)  15/197 (7.61%) 
Gastrointestinal  1  55/198 (27.78%)  61/197 (30.96%)  57/199 (28.64%)  173/594 (29.12%)  49/197 (24.87%) 
Headache  1  99/198 (50.00%)  103/197 (52.28%)  95/199 (47.74%)  297/594 (50.00%)  93/197 (47.21%) 
Myalgia  1  75/198 (37.88%)  82/197 (41.62%)  73/199 (36.68%)  230/594 (38.72%)  66/197 (33.50%) 
Rash  1  11/198 (5.56%)  10/197 (5.08%)  19/199 (9.55%)  40/594 (6.73%)  15/197 (7.61%) 
Urticaria  1  7/198 (3.54%)  5/197 (2.54%)  7/199 (3.52%)  19/594 (3.20%)  10/197 (5.08%) 
Injection site pruritus  1  7/199 (3.52%)  3/198 (1.52%)  4/201 (1.99%)  14/598 (2.34%)  10/200 (5.00%) 
Infections and infestations           
Nasopharyngitis  1  8/199 (4.02%)  8/198 (4.04%)  10/201 (4.98%)  26/598 (4.35%)  7/200 (3.50%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 9.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00250276     History of Changes
Other Study ID Numbers: 104772
First Submitted: November 7, 2005
First Posted: November 8, 2005
Results First Submitted: January 31, 2017
Results First Posted: March 17, 2017
Last Update Posted: July 20, 2018