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Vaccine To Prevent Cervical Intraepithelial Neoplasia or Cervical Cancer in Younger Healthy Participants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00128661
First received: August 8, 2005
Last updated: May 24, 2012
Last verified: May 2012
Results First Received: December 15, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Cervical Cancer
Precancerous Condition
Interventions: Biological: human papillomavirus 16/18 L1 virus-like particle/AS04 vaccine
Biological: hepatitis A inactivated virus vaccine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Solicited symptoms were collected for 3730 and 3740 subjects instead of the 3727 and 3739 subjects who were randomized in the study in the Cervarix and the Havrix groups, respectively. These 4 sujects received both vaccines and were included in the denominator of both arm based on the actual vaccine type administered.

Reporting Groups
  Description
Cervarix Group Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
Havrix Group Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.

Participant Flow:   Overall Study
    Cervarix Group   Havrix Group
STARTED   3727   3739 
COMPLETED   3453   3481 
NOT COMPLETED   274   258 
Adverse Event                14                11 
Lost to Follow-up                10                7 
Withdrawal by Subject                243                232 
Unspecified                7                8 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Cervarix Group Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
Havrix Group Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
Total Total of all reporting groups

Baseline Measures
   Cervarix Group   Havrix Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 3727   3739   7466 
Age 
[Units: Years]
Mean (Standard Deviation)
     
Years   21.1  (2.3)   21.1  (2.3)   21.1  (2.3) 
Gender 
[Units: Subjects]
     
Female   3727   3739   7466 
Male   0   0   0 


  Outcome Measures
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1.  Primary:   Number of Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Cases Associated With HPV16 and/or HPV18 Infection Detected in the Preceding Cervical Cytology Specimen.   [ Time Frame: From Month 6 up to Month 48 ]

Measure Type Primary
Measure Title Number of Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Cases Associated With HPV16 and/or HPV18 Infection Detected in the Preceding Cervical Cytology Specimen.
Measure Description

CIN2+ was defined as CIN grade 2 (CIN2), CIN grade 3 (CIN3), adenocarcinoma in situ (AIS) or invasive cervical cancer.

Preceding cervical cytology means the last cervical cytology specimen collected before the histopathology specimen was obtained.

Subjects were human papillomavirus (HPV) deoxyribonucleic acid (DNA) negative (DNA-) by polymerase chain reaction (PCR) at Month 0 and Month 6 for the corresponding HPV-type.

Time Frame From Month 6 up to Month 48  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The According-To-Protocol (ATP) cohort for efficacy included subjects with efficacy data available, who received 3 doses of vaccine, who were HPV DNA- for the corresponding type at enrollment and at the time of administration of the 3rd dose (Month 6) and who did not have a biopsy or treatment during the vaccination phase (prior to the Month 6).

Reporting Groups
  Description
Cervarix Group Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
Havrix Group Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.

Measured Values
   Cervarix Group   Havrix Group 
Participants Analyzed 
[Units: Participants]
 2635   2677 
Number of Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Cases Associated With HPV16 and/or HPV18 Infection Detected in the Preceding Cervical Cytology Specimen. 
[Units: Events]
   
HPV16 Associated CIN2+ (N=2464;2452)   1   9 
HPV18 Associated CIN2+ (N=2567; 2593)   0   2 
HPV16 and/or 18 Associated CIN2+ (N=2635;2677)   1   10 

No statistical analysis provided for Number of Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Cases Associated With HPV16 and/or HPV18 Infection Detected in the Preceding Cervical Cytology Specimen.



2.  Secondary:   Number of Cervical Infection With HPV16 or HPV18.   [ Time Frame: From Month 6 up to Month 48 ]

Measure Type Secondary
Measure Title Number of Cervical Infection With HPV16 or HPV18.
Measure Description Subjects were human papillomavirus (HPV) deoxyribonucleic acid (DNA) negative (DNA-) (by PCR) at Month 0 and Month 6 for the corresponding HPV-type
Time Frame From Month 6 up to Month 48  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The According-To-Protocol (ATP) cohort for efficacy included subjects with efficacy data available, who received 3 doses of vaccine, who were HPV DNA- for the corresponding type at enrollment and at the time of administration of the 3rd dose (Month 6) and who did not have a biopsy or treatment during the vaccination phase (prior to the Month 6).

Reporting Groups
  Description
Cervarix Group Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
Havrix Group Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.

Measured Values
   Cervarix Group   Havrix Group 
Participants Analyzed 
[Units: Participants]
 2635   2677 
Number of Cervical Infection With HPV16 or HPV18. 
[Units: Events]
   
HPV16 Cervical Infection (N=2464;2452)   50   251 
HPV18 Cervical Infection (N=2567;2593)   32   177 
HPV16 and/or 18 Cervical Infection (N=2635;2677)   78   387 

No statistical analysis provided for Number of Cervical Infection With HPV16 or HPV18.



3.  Secondary:   Number of Histopathologically Confirmed CIN2+ Cases Associated With Infection by Any Oncogenic HPV Type   [ Time Frame: From Month 6 up to Month 48 ]

Measure Type Secondary
Measure Title Number of Histopathologically Confirmed CIN2+ Cases Associated With Infection by Any Oncogenic HPV Type
Measure Description

Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59 and 68 detected by polymerase chain reaction (PRC) in the preceding cervical cytology specimen.

Note: The assay did not distinguish between HPV types 68 and 73.

CIN2+ was defined as CIN grade 2 (CIN2), CIN grade 3 (CIN3), adenocarcinoma in situ (AIS) or invasive cervical cancer

Subjects were human papillomavirus (HPV) deoxyribonucleic acid (DNA) negative (DNA-) (by PCR) at Month 0 and Month 6 for the corresponding HPV-type

Time Frame From Month 6 up to Month 48  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The According-To-Protocol (ATP) cohort for efficacy included subjects with efficacy data available, who received 3 doses of vaccine, who were HPV DNA- for the corresponding type at enrollment and at the time of administration of the 3rd dose (Month 6) and who did not have a biopsy or treatment during the vaccination phase (prior to the Month 6).

Reporting Groups
  Description
Cervarix Group Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
Havrix Group Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.

Measured Values
   Cervarix Group   Havrix Group 
Participants Analyzed 
[Units: Participants]
 2643   2697 
Number of Histopathologically Confirmed CIN2+ Cases Associated With Infection by Any Oncogenic HPV Type 
[Units: Events]
   
HPV16 Associated CIN2+ (N=2464;2452)   1   9 
HPV18 Associated CIN2+ (N=2567,2593)   0   2 
HPV31 Associated CIN2+ (N=2525;2546)   1   6 
HPV33 Associated CIN2+ (N=2596;2645)   0   3 
HPV35 Associated CIN2+ (N=2593;2631)   0   4 
HPV39 Associated CIN2+ (N=2528;2581)   0   0 
HPV45 Associated CIN2+ (N=2573;2622)   1   1 
HPV51 Associated CIN2+ (N=2453;2539)   1   6 
HPV52 Associated CIN2+ (N=2456;2505)   5   10 
HPV56 Associated CIN2+ (N=2524;2564)   1   5 
HPV58 Associated CIN2+ (N=2551;2595)   2   5 
HPV59 Associated CIN2+ (N=2576;2637)   3   3 
HPV68 and/or 73 Associated CIN2+ (N=2519;2576)   1   4 
Non 16/18 Onco HPV Associated CIN2+ (N=2643;2697)   11   28 
Any Oncogenic HPV Associated CIN2+ (N=2643;2697)   11   33 

No statistical analysis provided for Number of Histopathologically Confirmed CIN2+ Cases Associated With Infection by Any Oncogenic HPV Type



4.  Secondary:   Number of Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 Cases   [ Time Frame: From Month 6 up to Month 48 ]

Measure Type Secondary
Measure Title Number of Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 Cases
Measure Description

Persistent incident HPV-16 and /or HPV-18 cervical infection had to fulfil the following criteria: first detection after the 6-month visit, 2 same type HPV positive (by PCR) test results 10+ months apart, and no intervening HPV negative tests for the corresponding type.

Persistent HPV16 or HPV18 cervical infection = detection of the same HPV type by polymerase chain reaction (PCR) in cervical samples from all consecutive evaluations over approximately 12 months.

Subjects were HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type.

Time Frame From Month 6 up to Month 48  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The According-To-Protocol (ATP) cohort for efficacy included subjects with efficacy data available, who received 3 doses of vaccine, who were HPV DNA- for the corresponding type at enrollment and at the time of administration of the 3rd dose (Month 6) and who did not have a biopsy or treatment during the vaccination phase (prior to the Month 6).

Reporting Groups
  Description
Cervarix Group Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
Havrix Group Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.

Measured Values
   Cervarix Group   Havrix Group 
Participants Analyzed 
[Units: Participants]
 2635   2677 
Number of Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 Cases 
[Units: Events]
   
Persistent HPV16 Infection (N=2464,2452)   10   71 
Persistent HPV18 Infection (N=2567;2593)   0   37 
Persistent HPV16 and/or 18 Infection (N=2635;2677)   10   104 

No statistical analysis provided for Number of Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 Cases



5.  Secondary:   Geometric Mean Titers (GMTs) for HPV-16 Antibody in the Immunogenicity Subcohort.   [ Time Frame: Before vaccination and at Month 1, 6, 7, 12, 18, 24, 30, 36, 42 and 48 ]

Measure Type Secondary
Measure Title Geometric Mean Titers (GMTs) for HPV-16 Antibody in the Immunogenicity Subcohort.
Measure Description

Titers were assessed for the 600 subjects enrolled into the immunogenicity subcohort by Enzyme linked immunosorbent assay (ELISA) and expressed as geometric mean titers (GMTs).

Seronegative subjects = antibody concentration below 8 ELISA Units per millilitre (EL.U/mL) prior to vaccination.

Seropositive subjects=antibody concentration equal to or above 8 EL.U/mL prior to vaccination.

Immunogenicity subcohort = subset of 600 subjects from the 2 groups of the ATP cohort: subjects attended 1 extra clinic visit approximately 1 month (30 to 60 days) after the last dose was administered (Month 7)

Time Frame Before vaccination and at Month 1, 6, 7, 12, 18, 24, 30, 36, 42 and 48  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The ATP cohort for immunogenicity included subjects who received 3 doses of vaccine, who were HPV DNA- for the corresponding type at enrollment and during the 48-month follow-up period, who did not have a biopsy or treatment during the vaccination phase (prior to the Month 6) and for whom immunogenicity results were available.

Reporting Groups
  Description
Cervarix Group Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
Havrix Group Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.

Measured Values
   Cervarix Group   Havrix Group 
Participants Analyzed 
[Units: Participants]
 196   157 
Geometric Mean Titers (GMTs) for HPV-16 Antibody in the Immunogenicity Subcohort. 
[Units: Titers]
Geometric Mean (95% Confidence Interval)
   
HPV-16 [before vaccination] (N=194;156)   6.7 
 (5.7 to 7.8) 
 8.2 
 (6.7 to 10.0) 
HPV-16 [at Month 1] (N=196,157)   646.6 
 (549.3 to 761.1) 
 7.9 
 (6.5 to 9.6) 
HPV-16 [at Month 6] (N=195,156)   771.5 
 (668.3 to 890.7) 
 8.4 
 (6.9 to 10.3) 
HPV-16 [at Month 7] (N=195,157)   3261 
 (2959 to 3595) 
 8.5 
 (6.9 to 10.3) 
HPV-16 [at Month 12] (N=182,146)   2090 
 (1822 to 2398) 
 8.3 
 (6.7 to 10.4) 
HPV-16 [at Month 18] (N=25,17)   1045 
 (776.0 to 1408) 
 10.4 
 (4.8 to 22.7) 
HPV-16 [at Month 24] (N=175,137)   1486 
 (1293 to 1709) 
 8.6 
 (6.9 to 10.7) 
HPV-16 [at Month 30] (N=19,15)   1070 
 (747.5 to 1532) 
 11.9 
 (5.1 to 28.0) 
HPV-16 [at Month 36] (N=163,132)   1256 
 (1080 to 1461) 
 9.0 
 (7.4 to 11.0) 
HPV-16 [at Month 42] (N=22,18)   1259 
 (879.4 to 1802) 
 6.1 
 (4.0 to 9.4) 
HPV-16 [at Month 48] (N=172,131)   1155 
 (1009 to 1322) 
 9.5 
 (7.7 to 11.7) 

No statistical analysis provided for Geometric Mean Titers (GMTs) for HPV-16 Antibody in the Immunogenicity Subcohort.



6.  Secondary:   Geometric Mean Titers (GMTs) for HPV-18 Antibody in the Immunogenicity Subcohort   [ Time Frame: Before vaccination and at Month 1, 6, 7, 12, 18, 24, 30, 36, 42 and 48 ]

Measure Type Secondary
Measure Title Geometric Mean Titers (GMTs) for HPV-18 Antibody in the Immunogenicity Subcohort
Measure Description

Titers were assessed for the 600 subjects enrolled into the immunogenicity subcohortby Enzyme linked immunosorbent assay (ELISA) and expressed as geometric mean titers (GMTs).

Seronegative (Sero-) subjects=antibody concentration below 7 EL.U/mL prior to vaccination.

Seropositive (Sero+) subjects=antibody concentration equal to or above 7 EL.U/mL prior to vaccination.

Immunogenicity subcohort=subset of 600 subjects from the 2 groups of the ATP cohort: subjects attended 1 extra clinic visit approximately 1 month (30 to 60 days) after the last dose was administered (Month 7).

Time Frame Before vaccination and at Month 1, 6, 7, 12, 18, 24, 30, 36, 42 and 48  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The ATP cohort for immunogenicity included subjects who received 3 doses of vaccine, who were HPV DNA- for the corresponding type at enrollment and during the 48-month follow-up period, who did not have a biopsy or treatment during the vaccination phase (prior to the Month 6) and for whom immunogenicity results were available.

Reporting Groups
  Description
Cervarix Group Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
Havrix Group Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.

Measured Values
   Cervarix Group   Havrix Group 
Participants Analyzed 
[Units: Participants]
 203   175 
Geometric Mean Titers (GMTs) for HPV-18 Antibody in the Immunogenicity Subcohort 
[Units: Titers]
Geometric Mean (95% Confidence Interval)
   
HPV-18 [before vaccination] (N=200;173)   5.4 
 (4.8 to 6.1) 
 6.2 
 (5.2 to 7.4) 
HPV-18 [at Month 1] (N=203;170)   372.7 
 (322.8 to 430.3) 
 6.4 
 (5.4 to 7.6) 
HPV-18 [at Month 6] (N=203;175)   532.2 
 (467.5 to 605.9) 
 6.7 
 (5.6 to 7.9) 
HPV-18 [at Month 7] (N=202;175)   3276 
 (3001 to 3576) 
 6.8 
 (5.7 to 8.1) 
HPV-18 [at Month 12] (N=190;166)   1082 
 (942.0 to 1242) 
 7.0 
 (5.7 to 8.5) 
HPV-18 [at Month 18] (N=28;20)   502.4 
 (339.1 to 744.5) 
 6.7 
 (3.8 to 12.1) 
HPV-18 [at Month 24] (N=178;150)   633.0 
 (551.5 to 726.6) 
 6.9 
 (5.6 to 8.4) 
HPV-18 [at Month 30] (N=17;19)   403.8 
 (257.8 to 632.5) 
 6.4 
 (3.8 to 10.5) 
HPV-18 [at Month 36] (N=168;145)   519.7 
 (449.3 to 601.1) 
 6.0 
 (5.0 to 7.2) 
HPV-18 [at Month 42] (N=25;19)   582.4 
 (422.9 to 801.9) 
 5.5 
 (3.6 to 8.4) 
HPV-18 [at Month 48] (N=179;149)   470.1 
 (411.2 to 537.4) 
 6.6 
 (5.5 to 8.0) 

No statistical analysis provided for Geometric Mean Titers (GMTs) for HPV-18 Antibody in the Immunogenicity Subcohort



7.  Secondary:   HPV-16 Geometric Mean Titers (GMTs) (V5 Monoclonal Antibody Inhibition Test)   [ Time Frame: Before vaccination and at Month 1, 6, 7, 12, 18, 24, 30, 36, 42 and 48 ]

Measure Type Secondary
Measure Title HPV-16 Geometric Mean Titers (GMTs) (V5 Monoclonal Antibody Inhibition Test)
Measure Description

Titers were assessed for the 600 subjects enrolled into the immunogenicity subcohort by Inhibition Enzyme Immunoassay (EIA) and expressed as geometric mean antibody titers (GMTs).

Seronegative (Sero-) subjects=antibody concentration below 41 EL.U/mL prior to vaccination.

Seropositive (Sero+) subjects=antibody concentration equal to or above 41 EL.U/mL prior to vaccination.

Immunogenicity subcohort=subset of 600 subjects from the 2 groups of the ATP cohort: subjects attended 1 extra clinic visit approximately 1 month (30 to 60 days) after the last dose was administered (Month 7).

Time Frame Before vaccination and at Month 1, 6, 7, 12, 18, 24, 30, 36, 42 and 48  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The ATP cohort for immunogenicity included subjects who received 3 doses of vaccine, who were HPV DNA- for the corresponding type at enrollment and during the 48-month follow-up period, who did not have a biopsy or treatment during the vaccination phase (prior to the Month 6) and for whom immunogenicity results were available.

Reporting Groups
  Description
Cervarix Group Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
Havrix Group Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.

Measured Values
   Cervarix Group   Havrix Group 
Participants Analyzed 
[Units: Participants]
 196   158 
HPV-16 Geometric Mean Titers (GMTs) (V5 Monoclonal Antibody Inhibition Test) 
[Units: Titers]
Geometric Mean (95% Confidence Interval)
   
HPV-16 [before vaccination] (N=196;158)   21.1 
 (20.5 to 21.8) 
 21.4 
 (20.6 to 22.3) 
HPV-16 [at Month 1] (N=182;155)   58.5 
 (48.3 to 70.8) 
 21.5 
 (20.7 to 22.3) 
HPV-16 [at Month 6] (N=189;156)   80.9 
 (70.3 to 93.1) 
 21.5 
 (20.6 to 22.4) 
HPV-16 [at Month 7] (N=193;158)   1047 
 (926.3 to 1183) 
 21.4 
 (20.6 to 22.3) 
HPV-16 [at Month 12] (N=175;146)   291.4 
 (253.7 to 334.8) 
 22.6 
 (20.8 to 24.5) 
HPV-16 [at Month 18] (N=24;17)   116.6 
 (83.2 to 163.3) 
 20.5 
 (20.5 to 20.5) 
HPV-16 [at Month 24] (N=169;138)   184.6 
 (163.0 to 209.1) 
 21.4 
 (20.6 to 22.3) 
HPV-16 [at Month 30] (N=18;15)   112.4 
 (78.7 to 160.6) 
 20.5 
 (20.5 to 20.5) 
HPV-16 [at Month 36] (N=162;132)   139.7 
 (122.5 to 159.5) 
 20.8 
 (20.2 to 21.3) 
HPV-16 [at Month 42] (N=22;18)   126.9 
 (89.9 to 179.1) 
 20.5 
 (20.5 to 20.5) 
HPV-16 [at Month 48] (N=168;133)   131.8 
 (115.5 to 150.5) 
 21.0 
 (20.4 to 21.7) 

No statistical analysis provided for HPV-16 Geometric Mean Titers (GMTs) (V5 Monoclonal Antibody Inhibition Test)



8.  Secondary:   HPV-18 Geometric Mean Titers (GMTs) (J4 Monoclonal Antibody Inhibition Test)   [ Time Frame: Before vaccination and at Month 1, 6, 7, 12, 18, 24, 30, 36, 42 and 48 ]

Measure Type Secondary
Measure Title HPV-18 Geometric Mean Titers (GMTs) (J4 Monoclonal Antibody Inhibition Test)
Measure Description

Titers were assessed for the 600 subjects enrolled into the immunogenicity subcohort by Inhibition Enzyme Immunoassay (EIA) and expressed as geometric mean antibody titers (GMTs).

Seronegative (Sero-) subjects=antibody concentration below 110 EL.U/mL prior to vaccination.

Seropositive (Sero+) subjects=antibody concentration equal to or above 110 EL.U/mL prior to vaccination.

Immunogenicity subcohort=subset of 600 subjects from the 2 groups of the ATP cohort: subjects attended 1 extra clinic visit approximately 1 month (30 to 60 days) after the last dose was administered (Month 7).

Time Frame Before vaccination and at Month 1, 6, 7, 12, 18, 24, 30, 36, 42 and 48  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The ATP cohort for immunogenicity included subjects who received 3 doses of vaccine, who were HPV DNA- for the corresponding type at enrollment and during the 48-month follow-up period, who did not have a biopsy or treatment during the vaccination phase (prior to the Month 6) and for whom immunogenicity results were available.

Reporting Groups
  Description
Cervarix Group Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
Havrix Group Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.

Measured Values
   Cervarix Group   Havrix Group 
Participants Analyzed 
[Units: Participants]
 203   176 
HPV-18 Geometric Mean Titers (GMTs) (J4 Monoclonal Antibody Inhibition Test) 
[Units: Titers]
Geometric Mean (95% Confidence Interval)
   
HPV-18 [before vaccination] (N=203;176)   55.0 
 (55.0 to 55.0) 
 55.7 
 (54.7 to 56.7) 
HPV-18 [at Month 1] (N=197;173)   99.1 
 (88.0 to 111.5) 
 55.3 
 (54.7 to 55.8) 
HPV-18 [at Month 6] (N=195;175)   111.4 
 (100.2 to 123.9) 
 55.4 
 (54.6 to 56.3) 
HPV-18 [at Month 7] (N=198;176)   823.6 
 (737.7 to 919.5) 
 55.0 
 (55.0 to 55.0) 
HPV-18 [at Month 12] (N=182;166)   231.1 
 (203.2 to 262.7) 
 56.7 
 (54.7 to 58.8) 
HPV-18 [at Month 18] (N=28;20)   121.8 
 (89.5 to 165.8) 
 55.0 
 (55.0 to 55.0) 
HPV-18 [at Month 24] (N=170;154)   140.8 
 (123.8 to 160.2) 
 55.0 
 (55.0 to 55.0) 
HPV-18 [at Month 30] (N=17;19)   89.5 
 (67.6 to 118.7) 
 55.0 
 (55.0 to 55.0) 
HPV-18 [at Month 36] (N=167;145)   107.9 
 (96.0 to 121.2) 
 55.0 
 (55.0 to 55.0) 
HPV-18 [at Month 42] (N=25;19)   103.3 
 (80.3 to 132.9) 
 55.0 
 (55.0 to 55.0) 
HPV-18 [at Month 48 (N=179;150)   96.9 
 (87.7 to 107.0) 
 56.7 
 (54.0 to 59.6) 

No statistical analysis provided for HPV-18 Geometric Mean Titers (GMTs) (J4 Monoclonal Antibody Inhibition Test)



9.  Secondary:   Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.   [ Time Frame: Within 60 minutes after vaccination ]

Measure Type Secondary
Measure Title Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
Measure Description Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal everyday activities as assessed by inability to attend work or school and which necessitated the administration of corrective therapy. Grade 3 redness and swelling was defined as redness/swelling above 50 millimeter (mm).
Time Frame Within 60 minutes after vaccination  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Total Vaccinated cohort included all vaccinated subjects with at least 1 vaccine administration documented.

Reporting Groups
  Description
Cervarix Group Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
Havrix Group Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.

Measured Values
   Cervarix Group   Havrix Group 
Participants Analyzed 
[Units: Participants]
 3730   3740 
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. 
[Units: Subjects]
   
Any pain   1627   1610 
Grade 3 pain   25   20 
Any redness   544   501 
Grade 3 redness > 50 mm   0   2 
Any swelling   207   201 
Grade 3 swelling > 50 mm   0   1 

No statistical analysis provided for Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.



10.  Secondary:   Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms.   [ Time Frame: Within 60 minutes after vaccination ]

Measure Type Secondary
Measure Title Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms.
Measure Description Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, urticaria and fever (Fever = oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)). Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal everyday activities as assessed by inability to attend work or school and which necessitated the administration of corrective therapy.Grade 3 urticaria = urticaria distributed on at least 4 body areas. Grade 3 fever = oral temperature > 39.0°C.
Time Frame Within 60 minutes after vaccination  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Total Vaccinated cohort included all vaccinated subjects with at least 1 vaccine administration documented.

Reporting Groups
  Description
Cervarix Group Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
Havrix Group Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.

Measured Values
   Cervarix Group   Havrix Group 
Participants Analyzed 
[Units: Participants]
 3730   3740 
Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms. 
[Units: Subjects]
   
Any fatigue   512   502 
Grade 3 fatigue   6   5 
Any myalgia   257   232 
Grade 3 myalgia   0   1 
Any arthralgia   58   64 
Grade 3 arthralgia   0   1 
Any gastrointestinal   191   171 
Grade 3 gastrointestinal   0   0 
Any headache   714   718 
Grade 3 headache   2   0 
Any rash   15   17 
Grade 3 rash   0   0 
Any urticaria   19   21 
Grade 3 urticaria   0   0 
Fever (oral) >= 37.5°C   472   477 
Fever (oral) > 39.0°C   0   0 

No statistical analysis provided for Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms.



11.  Secondary:   Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms on a 10% Random Subset of Participants.   [ Time Frame: From Day 3 to Day 6 after vaccination ]

Measure Type Secondary
Measure Title Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms on a 10% Random Subset of Participants.
Measure Description Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal everyday activities as assessed by inability to attend work or school and which necessitated the administration of corrective therapy. Grade 3 redness and swelling was defined as redness/swelling above 50 millimeter (mm).
Time Frame From Day 3 to Day 6 after vaccination  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Total Vaccinated cohort included all vaccinated subjects with at least 1 vaccine administration documented.

Reporting Groups
  Description
Cervarix Group Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
Havrix Group Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.

Measured Values
   Cervarix Group   Havrix Group 
Participants Analyzed 
[Units: Participants]
 380   376 
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms on a 10% Random Subset of Participants. 
[Units: Subjects]
   
Any pain   202   74 
Grade 3 pain   0   0 
Any redness   6   1 
Grade 3 redness   1   0 
Any swelling   23   1 
Grade 3 swelling   7   0 

No statistical analysis provided for Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms on a 10% Random Subset of Participants.



12.  Secondary:   Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms on a 10% Random Subset of Participants.   [ Time Frame: From Day 3 to Day 6 after vaccination ]

Measure Type Secondary
Measure Title Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms on a 10% Random Subset of Participants.
Measure Description Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, urticaria and fever (Fever = oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)). Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal everyday activities as assessed by inability to attend work or school and which necessitated the administration of corrective therapy.Grade 3 urticaria = urticaria distributed on at least 4 body areas. Grade 3 fever = oral temperature > 39.0°C.
Time Frame From Day 3 to Day 6 after vaccination  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Total Vaccinated cohort included all vaccinated subjects with at least 1 vaccine administration documented.

Reporting Groups
  Description
Cervarix Group Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
Havrix Group Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.

Measured Values
   Cervarix Group   Havrix Group 
Participants Analyzed 
[Units: Participants]
 380   376 
Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms on a 10% Random Subset of Participants. 
[Units: Subjects]
   
Any pain   214   189 
Grade 3 pain   2   0 
Any myalgia   250   211 
Grade 3 myalgia   1   0 
Any arthralgia   44   32 
Grade 3 arthralgia   0   0 
Any gastrointestinal   157   119 
Grade 3 gastrointestinal   0   1 
Any headache   247   242 
Grade 3 headache   1   2 
Any rash   31   26 
Grade 3 rash   0   0 
Any urticaria   3   1 
Grade 3 urticaria   0   0 
Fever (oral) >= 37.5°C   43   37 
Fever (oral) > 39.0°C   0   0 

No statistical analysis provided for Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms on a 10% Random Subset of Participants.



13.  Secondary:   Number of Subjects Reporting Serious Adverse Events (SAEs).   [ Time Frame: During the entire study period (From Month 0 up to Month 48). ]

Measure Type Secondary
Measure Title Number of Subjects Reporting Serious Adverse Events (SAEs).
Measure Description SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
Time Frame During the entire study period (From Month 0 up to Month 48).  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Total Vaccinated cohort included all vaccinated subjects with at least 1 vaccine administration documented.

Reporting Groups
  Description
Cervarix Group Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
Havrix Group Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.

Measured Values
   Cervarix Group   Havrix Group 
Participants Analyzed 
[Units: Participants]
 3727   3739 
Number of Subjects Reporting Serious Adverse Events (SAEs). 
[Units: Subjects]
 912   891 

No statistical analysis provided for Number of Subjects Reporting Serious Adverse Events (SAEs).



14.  Secondary:   Number of Subjects Reporting Unsolicited Adverse Events (AEs).   [ Time Frame: During the entire study period (From Month 0 up to Month 48). ]

Measure Type Secondary
Measure Title Number of Subjects Reporting Unsolicited Adverse Events (AEs).
Measure Description An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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.
Time Frame During the entire study period (From Month 0 up to Month 48).  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Total Vaccinated cohort included all vaccinated subjects with at least 1 vaccine administration documented.

Reporting Groups
  Description
Cervarix Group Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
Havrix Group Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.

Measured Values
   Cervarix Group   Havrix Group 
Participants Analyzed 
[Units: Participants]
 3727   3739 
Number of Subjects Reporting Unsolicited Adverse Events (AEs). 
[Units: Subjects]
 3228   3254 

No statistical analysis provided for Number of Subjects Reporting Unsolicited Adverse Events (AEs).



15.  Secondary:   Number of Subjects With All Possible Pregnancy Outcomes   [ Time Frame: During the entire study period (From Month 0 up to Month 48). ]

Measure Type Secondary
Measure Title Number of Subjects With All Possible Pregnancy Outcomes
Measure Description The range of possible pregnancy outcomes was: Pregnancy loss, Pregnancy resolved alive, and Unresolved pregnancy.
Time Frame During the entire study period (From Month 0 up to Month 48).  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The analysis was performed on the Total Vaccinated Cohort, on all pregnant subjects.

Reporting Groups
  Description
Cervarix Group Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
Havrix Group Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.

Measured Values
   Cervarix Group   Havrix Group 
Participants Analyzed 
[Units: Participants]
 2123   2129 
Number of Subjects With All Possible Pregnancy Outcomes 
[Units: Subjects]
   
Pregnancy loss   317   294 
Pregnancy resolved alive   1756   1766 
Unresolved pregnancy   50   69 

No statistical analysis provided for Number of Subjects With All Possible Pregnancy Outcomes



16.  Secondary:   Number of Cervical Infection With HPV16 or HPV18.   [ Time Frame: During the first year of follow-up period ]

Measure Type Secondary
Measure Title Number of Cervical Infection With HPV16 or HPV18.
Measure Description Subjects were human papillomavirus (HPV) deoxyribonucleic acid (DNA) negative (DNA-) (by PCR) at Month 0 and Month 6 for the corresponding HPV-type
Time Frame During the first year of follow-up period  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The According-To-Protocol (ATP) cohort for efficacy included subjects with efficacy data available, who received 3 doses of vaccine, who were HPV DNA- for the corresponding type at enrollment and at the time of administration of the 3rd dose (Month 6) and who did not have a biopsy or treatment during the vaccination phase (prior to the Month 6).

Reporting Groups
  Description
Cervarix Group Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
Havrix Group Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.

Measured Values
   Cervarix Group   Havrix Group 
Participants Analyzed 
[Units: Participants]
 2380   2420 
Number of Cervical Infection With HPV16 or HPV18. 
[Units: Events]
   
HPV16 Cervical Infection (N=2242;2232)   21   37 
HPV18 Cervical Infection (N=2330;2347)   7   29 
HPV16 and/or 18 Cervical Infection (N=2380;2420)   27   64 

No statistical analysis provided for Number of Cervical Infection With HPV16 or HPV18.



17.  Secondary:   Number of Cervical Infection With HPV16 or HPV18.   [ Time Frame: During the second year of follow-up period ]

Measure Type Secondary
Measure Title Number of Cervical Infection With HPV16 or HPV18.
Measure Description Subjects were human papillomavirus (HPV) deoxyribonucleic acid (DNA) negative (DNA-) (by PCR) at Month 0 and Month 6 for the corresponding HPV-type
Time Frame During the second year of follow-up period  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The According-To-Protocol (ATP) cohort for efficacy included subjects with efficacy data available, who received 3 doses of vaccine, who were HPV DNA- for the corresponding type at enrollment and at the time of administration of the 3rd dose (Month 6) and who did not have a biopsy or treatment during the vaccination phase (prior to the Month 6).

Reporting Groups
  Description
Cervarix Group Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
Havrix Group Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.

Measured Values
   Cervarix Group   Havrix Group 
Participants Analyzed 
[Units: Participants]
 2313   2349 
Number of Cervical Infection With HPV16 or HPV18. 
[Units: Events]
   
HPV16 Cervical Infection (N=2170;2176)   10   77 
HPV18 Cervical Infection (N=2269;2307)   9   47 
HPV16 and/or 18 Cervical Infection (N=2313;2349)   18   117 

No statistical analysis provided for Number of Cervical Infection With HPV16 or HPV18.



18.  Secondary:   Number of Cervical Infection With HPV16 or HPV18.   [ Time Frame: During the third year of follow-up period ]

Measure Type Secondary
Measure Title Number of Cervical Infection With HPV16 or HPV18.
Measure Description Subjects were human papillomavirus (HPV) deoxyribonucleic acid (DNA) negative (DNA-) (by PCR) at Month 0 and Month 6 for the corresponding HPV-type
Time Frame During the third year of follow-up period  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The According-To-Protocol (ATP) cohort for efficacy included subjects with efficacy data available, who received 3 doses of vaccine, who were HPV DNA- for the corresponding type at enrollment and at the time of administration of the 3rd dose (Month 6) and who did not have a biopsy or treatment during the vaccination phase (prior to the Month 6).

Reporting Groups
  Description
Cervarix Group Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
Havrix Group Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.

Measured Values
   Cervarix Group   Havrix Group 
Participants Analyzed 
[Units: Participants]
 2232   2196 
Number of Cervical Infection With HPV16 or HPV18. 
[Units: Events]
   
HPV16 Cervical Infection (N=2097;2026)   6   60 
HPV18 Cervical Infection (N=2200;2196)   6   44 
HPV16 and/or 18 Cervical Infection (N=2236;2166)   11   88 

No statistical analysis provided for Number of Cervical Infection With HPV16 or HPV18.



19.  Secondary:   Number of Cervical Infection With HPV16 or HPV18.   [ Time Frame: From the fourth year follow-up period ]

Measure Type Secondary
Measure Title Number of Cervical Infection With HPV16 or HPV18.
Measure Description Subjects were human papillomavirus (HPV) deoxyribonucleic acid (DNA) negative (DNA-) (by PCR) at Month 0 and Month 6 for the corresponding HPV-type
Time Frame From the fourth year follow-up period  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The According-To-Protocol (ATP) cohort for efficacy included subjects with efficacy data available, who received 3 doses of vaccine, who were HPV DNA- for the corresponding type at enrollment and at the time of administration of the 3rd dose (Month 6) and who did not have a biopsy or treatment during the vaccination phase (prior to the Month 6).

Reporting Groups
  Description
Cervarix Group Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
Havrix Group Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.

Measured Values
   Cervarix Group   Havrix Group 
Participants Analyzed 
[Units: Participants]
 2421   2325 
Number of Cervical Infection With HPV16 or HPV18. 
[Units: Events]
   
HPV16 Cervical Infection (N=2277;2139)   13   77 
HPV18 Cervical Infection (N=2389;2325)   10   57 
HPV16 and/or 18 Cervical Infection (N=2421;2261)   22   118 

No statistical analysis provided for Number of Cervical Infection With HPV16 or HPV18.



20.  Secondary:   Number of Subjects Reporting Unsolicited Adverse Events (AEs).   [ Time Frame: within 30 days (Days 0-29) after vaccination ]

Measure Type Secondary
Measure Title Number of Subjects Reporting Unsolicited Adverse Events (AEs).
Measure Description An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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.
Time Frame within 30 days (Days 0-29) after vaccination  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Total Vaccinated cohort included all vaccinated subjects with at least 1 vaccine administration documented.

Reporting Groups
  Description
Cervarix Group Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
Havrix Group Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.

Measured Values
   Cervarix Group   Havrix Group 
Participants Analyzed 
[Units: Participants]
 3727   3739 
Number of Subjects Reporting Unsolicited Adverse Events (AEs). 
[Units: Subjects]
 1638   1536 

No statistical analysis provided for Number of Subjects Reporting Unsolicited Adverse Events (AEs).




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The following analysis "occurence of histopathologically confirmed CIN2+ cases associated with HPV16 or HPV18 infection was not performed, in accordance with the Statistical Analysis Plan submitted to the FDA.


  More Information