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Trial record 54 of 91 for:    cervarix

Partially Blind Study to Evaluate Immunogenicity & Safety of GSK Bio's HPV Vaccine 580299 in Healthy Women Aged 9-25 Yrs

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ClinicalTrials.gov Identifier: NCT00541970
Recruitment Status : Completed
First Posted : October 10, 2007
Results First Posted : April 17, 2014
Last Update Posted : August 17, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Prevention
Condition Infections, Papillomavirus
Interventions Biological: Cervarix
Drug: Placebo
Enrollment 961
Recruitment Details The study included two phases, an active vaccination phase (Months 0-7) followed by a safety follow-up phase (up to the end of the study at Month 60).
Pre-assignment Details The study was run in an open manner for subjects in the groups receiving the Cervarix vaccine on a 3-dose vaccination schedule. For subjects in the group receiving the Cervarix vaccine on a 2-dose vaccination schedule, the study was run in an observer-blind manner until Month 24, and then in an open manner.
Arm/Group Title Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 2 Group
Hide Arm/Group Description Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm. Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm. Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm. Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
Period Title: Month 7
Started 240 241 240 239
Completed 231 228 229 234
Not Completed 9 13 11 5
Reason Not Completed
Protocol Violation             9             13             11             5
Period Title: Month 12
Started 240 241 240 239
Completed 228 219 219 223
Not Completed 12 22 21 16
Reason Not Completed
Adverse Event             0             1             1             1
Protocol Violation             12             21             20             15
Period Title: Month 18
Started 240 241 240 239
Completed 226 217 215 222
Not Completed 14 24 25 17
Reason Not Completed
Adverse Event             0             1             1             1
Protocol Violation             14             23             24             16
Period Title: Month 24
Started 240 241 240 239
Completed 211 209 208 217
Not Completed 29 32 32 22
Reason Not Completed
Adverse Event             0             1             1             1
Protocol Violation             29             31             31             21
Period Title: Month 36
Started 240 241 240 239
Completed 179 175 174 179
Not Completed 61 66 66 60
Reason Not Completed
Protocol Violation             61             66             66             60
Period Title: Month 48
Started 240 241 240 239
Completed 169 168 167 164
Not Completed 71 73 73 75
Reason Not Completed
Withdrawal by Subject             2             4             4             2
Other             3             1             1             0
Lost to Follow-up             66             68             68             73
Period Title: Month 60
Started 240 241 240 239
Completed 162 164 158 167
Not Completed 78 77 82 72
Reason Not Completed
Protocol Violation             78             77             82             72
Arm/Group Title Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 2 Group Total
Hide Arm/Group Description Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm. Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm. Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm. Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm. Total of all reporting groups
Overall Number of Baseline Participants 240 241 240 239 960
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 240 participants 241 participants 240 participants 239 participants 960 participants
17.1  (4.30) 17.2  (4.30) 17.3  (4.25) 17.2  (4.38) 17.2  (4.31)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 240 participants 241 participants 240 participants 239 participants 960 participants
Female
240
 100.0%
241
 100.0%
240
 100.0%
239
 100.0%
960
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies
Hide Description Titers are given as Geometric Mean Titers (GMTs) expressed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Time Frame One month after vaccination with the last dose of the Cervarix vaccine (Cervarix 1/Placebo Group: Month 3; Other groups: Month 7).
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Arm/Group Title Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 2 Group
Hide Arm/Group Description:
Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
Overall Number of Participants Analyzed 224 206 204 208
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Anti-HPV-16 Number Analyzed 224 participants 204 participants 204 participants 208 participants
5844.6
(5259.6 to 6494.7)
10500.9
(9356.9 to 11784.8)
7741.6
(6868.2 to 8726.1)
13045.3
(11211.4 to 15179.2)
Anti-HPV-18 Number Analyzed 223 participants 206 participants 204 participants 208 participants
3543.2
(3126.6 to 4015.3)
5997.5
(5310.9 to 6772.8)
4811.4
(4282.7 to 5405.3)
5087.1
(4460.2 to 5802.1)
2.Primary Outcome
Title Number of Subjects With Report of Any, and Grade 3 Solicited Local Symptoms
Hide Description Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the solicited local symptom irrespective of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling larger than (>) 50 millimeters (mm).
Time Frame Within 7 days (Day 0-6) after vaccination.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Analysis for this outcome was done on subjects with available results for this outcome measure.
Arm/Group Title Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 2 Group
Hide Arm/Group Description:
Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
Overall Number of Participants Analyzed 238 239 238 238
Measure Type: Count of Participants
Unit of Measure: Participants
Any Pain
222
  93.3%
225
  94.1%
222
  93.3%
225
  94.5%
Grade 3 Pain
18
   7.6%
27
  11.3%
26
  10.9%
35
  14.7%
Any Redness
109
  45.8%
112
  46.9%
123
  51.7%
145
  60.9%
Redness > 50 mm
3
   1.3%
4
   1.7%
1
   0.4%
3
   1.3%
Any Swelling
92
  38.7%
88
  36.8%
83
  34.9%
118
  49.6%
Swelling > 50 mm
4
   1.7%
3
   1.3%
1
   0.4%
5
   2.1%
3.Primary 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 or above (≥) 37.5 degrees Celsius (°C), gastrointestinal symptoms, which included nausea, vomiting, diarrhoea and/or abdominal pain, headache, myalgia, rash and urticaria. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature ≥ 39 °C. Grade 3 urticaria = urticaria distributed on at least 4 body areas. Related symptom = symptom assessed by the investigator to be causally related to vaccination.
Time Frame Within 7 days (Day 0-6) after vaccination.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Analysis for this outcome was done on subjects with available results for this outcome measure.
Arm/Group Title Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 2 Group
Hide Arm/Group Description:
Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
Overall Number of Participants Analyzed 238 239 238 238
Measure Type: Count of Participants
Unit of Measure: Participants
Any Arthralgia
45
  18.9%
57
  23.8%
39
  16.4%
43
  18.1%
Related Arthralgia
39
  16.4%
43
  18.0%
35
  14.7%
35
  14.7%
Grade 3 Arthralgia
0
   0.0%
3
   1.3%
4
   1.7%
3
   1.3%
Any Fatigue
100
  42.0%
109
  45.6%
104
  43.7%
107
  45.0%
Related Fatigue
76
  31.9%
82
  34.3%
87
  36.6%
83
  34.9%
Grade 3 Fatigue
11
   4.6%
4
   1.7%
5
   2.1%
8
   3.4%
Any Fever (Axillary Temperature >= 37.5°C)
23
   9.7%
20
   8.4%
22
   9.2%
39
  16.4%
Related Fever
18
   7.6%
15
   6.3%
16
   6.7%
27
  11.3%
Grade 3 Fever (Axillary Temperature >= 39.0°C)
1
   0.4%
0
   0.0%
1
   0.4%
0
   0.0%
Any Gastrointestinal Symptoms
48
  20.2%
48
  20.1%
36
  15.1%
68
  28.6%
Related Gastrointestinal Symptoms
36
  15.1%
43
  18.0%
27
  11.3%
50
  21.0%
Grade 3 Gastrointestinal Symptoms
3
   1.3%
7
   2.9%
2
   0.8%
7
   2.9%
Any Headache
101
  42.4%
116
  48.5%
112
  47.1%
125
  52.5%
Related Headache
79
  33.2%
81
  33.9%
91
  38.2%
95
  39.9%
Grade 3 Headache
9
   3.8%
9
   3.8%
7
   2.9%
12
   5.0%
Any Myalgia
79
  33.2%
109
  45.6%
98
  41.2%
99
  41.6%
Related Myalgia
62
  26.1%
87
  36.4%
75
  31.5%
77
  32.4%
Grade 3 Myalgia
3
   1.3%
9
   3.8%
6
   2.5%
7
   2.9%
Any Rash
12
   5.0%
12
   5.0%
10
   4.2%
15
   6.3%
Related Rash
8
   3.4%
9
   3.8%
8
   3.4%
9
   3.8%
Grade 3 Rash
0
   0.0%
0
   0.0%
1
   0.4%
1
   0.4%
Any Urticaria
2
   0.8%
4
   1.7%
4
   1.7%
5
   2.1%
Related Urticaria
1
   0.4%
3
   1.3%
4
   1.7%
3
   1.3%
Grade 3 Urticaria
0
   0.0%
0
   0.0%
1
   0.4%
0
   0.0%
4.Secondary Outcome
Title Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies .
Hide Description Titers are given as Geometric Mean Titers (GMTs) expressed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). The analysis was performed on the subjects who were administered a 2-dose vaccination schedule.
Time Frame At Month 3, 1 month after the second dose of vaccine or placebo
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Arm/Group Title Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group
Hide Arm/Group Description:
Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Overall Number of Participants Analyzed 224 206 203
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Anti-HPV-16 Number Analyzed 224 participants 204 participants 203 participants
5844.6
(5259.6 to 6494.7)
397.9
(337.4 to 469.2)
266.4
(227.2 to 312.4)
Anti-HPV-18 Number Analyzed 223 participants 206 participants 203 participants
3543.2
(3126.6 to 4015.3)
228.3
(196.7 to 265.0)
181.9
(156.8 to 211.1)
5.Secondary Outcome
Title Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies
Hide Description Titers are given as Geometric Mean Titers (GMTs) expressed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). Groups were stratified into 3 age strata: 9-14, 15-19 and 20-25 years of age at the time of first vaccination. The 15-19 years age stratum in the group receiving the Cervarix vaccine on a 3-dose vaccination schedule was considered an active comparator.
Time Frame At Month 7, 1 month after the last dose of vaccine or placebo.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Arm/Group Title Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 2 Group
Hide Arm/Group Description:
Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
Overall Number of Participants Analyzed 221 206 204 208
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
9-14 years, Anti-HPV-16 Number Analyzed 76 participants 62 participants 69 participants 75 participants
2003.9
(1635.7 to 2455.0)
15028.4
(12611.3 to 17908.6)
11058.6
(9273.8 to 13186.7)
22066.3
(18140.7 to 26841.2)
15-19 years, Anti-HPV-16 Number Analyzed 72 participants 74 participants 70 participants 66 participants
1168.5
(957.4 to 1426.2)
10818.7
(8979.8 to 13034.2)
7869.6
(6488.9 to 9543.9)
12817.4
(9723.2 to 16896.2)
20-25 years, Anti-HPV-16 Number Analyzed 73 participants 68 participants 65 participants 67 participants
1371.2
(1092.2 to 1721.6)
7331.4
(5965.2 to 9010.4)
5209.2
(4166.5 to 6512.7)
7370.0
(5673.6 to 9573.6)
9-14 years, Anti-HPV-18 Number Analyzed 76 participants 64 participants 69 participants 75 participants
1134.3
(922.8 to 1394.3)
8085.8
(6654.5 to 9825.0)
5630.7
(4772.1 to 6643.7)
7192.9
(5952.6 to 8691.6)
15-19 years, Anti-HPV-18 Number Analyzed 72 participants 74 participants 69 participants 66 participants
719.8
(571.2 to 907.0)
6170.1
(5046.8 to 7543.5)
5039.3
(4283.4 to 5928.5)
4907.0
(3780.8 to 6368.7)
20-25 years, Anti-HPV-18 Number Analyzed 72 participants 68 participants 66 participants 67 participants
656.5
(514.6 to 837.5)
4389.6
(3525.6 to 5465.4)
3889.2
(2980.9 to 5074.3)
3576.8
(2886.5 to 4432.2)
6.Secondary Outcome
Title Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies
Hide Description Titers are given as Geometric Mean Titers (GMTs) expressed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Time Frame At Month 12, at Month 18, at Month 24, at Month 36, and at Month 48 during the safety follow-up phase.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects eligible for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Arm/Group Title Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 2 Group
Hide Arm/Group Description:
Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
Overall Number of Participants Analyzed 216 198 195 198
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Anti-HPV-16 at Month 12 Number Analyzed 216 participants 191 participants 195 participants 198 participants
1064.7
(937.5 to 1209.1)
3256.0
(2918.8 to 3632.1)
2438.7
(2167.2 to 2744.2)
4726.7
(4036.8 to 5534.6)
Anti-HPV-16 at Month 18 Number Analyzed 212 participants 196 participants 194 participants 197 participants
968.1
(845.2 to 1109.0)
2229.4
(1983.2 to 2506.2)
1659.1
(1466.9 to 1876.4)
3185.1
(2735.1 to 3709.2)
Anti-HPV-16 at Month 24 Number Analyzed 199 participants 184 participants 186 participants 190 participants
821.2
(718.5 to 938.5)
1756.4
(1556.6 to 1981.9)
1285.1
(1139.6 to 1449.2)
2425.9
(2071.1 to 2841.5)
Anti-HPV-16 at Month 36 Number Analyzed 166 participants 158 participants 162 participants 153 participants
688.3
(592.2 to 799.9)
1462.2
(1288.8 to 1658.8)
1094.0
(961.1 to 1245.1)
2195.4
(1850.8 to 2604.1)
Anti-HPV-16 at Month 48 Number Analyzed 160 participants 151 participants 157 participants 148 participants
649.5
(556.0 to 758.8)
1261.2
(1106.4 to 1437.7)
953.5
(835.5 to 1088.2)
1892.3
(1594.2 to 2246.0)
Anti-HPV-18 at Month 12 Number Analyzed 215 participants 193 participants 194 participants 198 participants
472.9
(410.5 to 544.8)
1760.1
(1531.5 to 2022.8)
1426.2
(1250.8 to 1626.1)
1714.5
(1469.7 to 2000.0)
Anti-HPV-18 at Month 18 Number Analyzed 211 participants 198 participants 193 participants 197 participants
389.2
(338.7 to 447.2)
1025.2
(889.0 to 1182.2)
883.1
(774.7 to 1006.8)
1096.6
(939.4 to 1280.1)
Anti-HPV-18 at Month 24 Number Analyzed 198 participants 186 participants 185 participants 190 participants
345.9
(299.3 to 399.8)
818.2
(706.5 to 947.5)
674.6
(591.8 to 769.0)
866.8
(741.2 to 1013.6)
Anti-HPV-18 at Month 36 Number Analyzed 166 participants 160 participants 162 participants 153 participants
302.2
(254.9 to 358.2)
712.8
(605.4 to 839.3)
617.9
(532.3 to 717.2)
874.2
(734.9 to 1040.0)
Anti-HPV-18 at Month 48 Number Analyzed 160 participants 153 participants 157 participants 148 participants
260.4
(218.5 to 310.2)
626.3
(531.0 to 738.7)
517.0
(446.2 to 599.1)
723.2
(607.2 to 861.4)
7.Secondary Outcome
Title Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies
Hide Description Titers are given as Geometric Mean Titers (GMTs) expressed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Time Frame At Month 7, 1 month after the last dose of vaccine or placebo.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Arm/Group Title Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 2 Group
Hide Arm/Group Description:
Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
Overall Number of Participants Analyzed 221 206 204 208
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Anti-HPV-16 Number Analyzed 221 participants 204 participants 204 participants 208 participants
1677.5
(1677.5 to 1677.5)
11784.8
(11784.8 to 11784.8)
8726.1
(8726.1 to 8726.1)
15179.2
(15179.2 to 15179.2)
Anti-HPV-18 Number Analyzed 220 participants 206 participants 204 participants 208 participants
817.3
(715.6 to 933.4)
5997.5
(5310.9 to 6772.8)
4811.4
(4282.7 to 5405.3)
5087.1
(4460.2 to 5802.1)
8.Secondary Outcome
Title Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.
Hide Description Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents BAS results.
Time Frame At Month 7 (M7)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Analysis for this outcome was done on subjects with available results for this outcome measure.
Arm/Group Title Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 2 Group
Hide Arm/Group Description:
Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
Overall Number of Participants Analyzed 223 221 221 225
Measure Type: Count of Participants
Unit of Measure: Participants
BAS, PRE NORMAL, M7 NORMAL Number Analyzed 222 participants 219 participants 218 participants 220 participants
219
  98.6%
214
  97.7%
208
  95.4%
214
  97.3%
BAS, PRE NORMAL, M7 BELOW Number Analyzed 222 participants 219 participants 218 participants 220 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
BAS, PRE NORMAL, M7 ABOVE Number Analyzed 222 participants 219 participants 218 participants 220 participants
2
   0.9%
3
   1.4%
6
   2.8%
3
   1.4%
BAS, PRE NORMAL, M7 MISSING Number Analyzed 222 participants 219 participants 218 participants 220 participants
1
   0.5%
2
   0.9%
4
   1.8%
3
   1.4%
BAS, PRE BELOW, M7 NORMAL Number Analyzed 0 participants 0 participants 1 participants 1 participants
0 0
1
 100.0%
0
   0.0%
BAS, PRE BELOW, M7 BELOW Number Analyzed 0 participants 0 participants 1 participants 1 participants
0 0
0
   0.0%
1
 100.0%
BAS, PRE BELOW, M7 ABOVE Number Analyzed 0 participants 0 participants 1 participants 1 participants
0 0
0
   0.0%
0
   0.0%
BAS, PRE ABOVE, M7 NORMAL Number Analyzed 1 participants 2 participants 2 participants 4 participants
1
 100.0%
2
 100.0%
2
 100.0%
4
 100.0%
BAS, PRE ABOVE, M7 BELOW Number Analyzed 1 participants 2 participants 2 participants 4 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
BAS, PRE ABOVE, M7 ABOVE Number Analyzed 1 participants 2 participants 2 participants 4 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
9.Secondary Outcome
Title Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.
Hide Description Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range.This outcome presents CREA results.
Time Frame At Month 7 (M7)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Analysis for this outcome was done on subjects with available results for this outcome measure.
Arm/Group Title Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 2 Group
Hide Arm/Group Description:
Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
Overall Number of Participants Analyzed 226 225 228 229
Measure Type: Count of Participants
Unit of Measure: Participants
CREA, PRE NORMAL, M7 NORMAL Number Analyzed 215 participants 211 participants 215 participants 218 participants
202
  94.0%
200
  94.8%
210
  97.7%
206
  94.5%
CREA, PRE NORMAL, M7 BELOW Number Analyzed 215 participants 211 participants 215 participants 218 participants
7
   3.3%
4
   1.9%
3
   1.4%
6
   2.8%
CREA, PRE NORMAL, M7 ABOVE Number Analyzed 215 participants 211 participants 215 participants 218 participants
5
   2.3%
7
   3.3%
1
   0.5%
4
   1.8%
CREA, PRE NORMAL, M7 MISSING Number Analyzed 215 participants 211 participants 215 participants 218 participants
1
   0.5%
0
   0.0%
1
   0.5%
2
   0.9%
CREA, PRE BELOW, M7 NORMAL Number Analyzed 8 participants 7 participants 7 participants 6 participants
6
  75.0%
3
  42.9%
3
  42.9%
2
  33.3%
CREA, PRE BELOW, M7 BELOW Number Analyzed 8 participants 7 participants 7 participants 6 participants
2
  25.0%
4
  57.1%
4
  57.1%
3
  50.0%
CREA, PRE BELOW, M7 ABOVE Number Analyzed 8 participants 7 participants 7 participants 6 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
CREA, PRE BELOW, M7 MISSING Number Analyzed 8 participants 7 participants 7 participants 6 participants
0
   0.0%
0
   0.0%
0
   0.0%
1
  16.7%
CREA, PRE ABOVE, M7 NORMAL Number Analyzed 3 participants 7 participants 6 participants 5 participants
2
  66.7%
4
  57.1%
4
  66.7%
2
  40.0%
CREA, PRE ABOVE, M7 BELOW Number Analyzed 3 participants 7 participants 6 participants 5 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
CREA, PRE ABOVE, M7 ABOVE Number Analyzed 3 participants 7 participants 6 participants 5 participants
1
  33.3%
3
  42.9%
2
  33.3%
3
  60.0%
10.Secondary Outcome
Title Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.
Hide Description Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents EOS results.
Time Frame At Month 7 (M7)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Analysis for this outcome was done on subjects with available results for this outcome measure.
Arm/Group Title Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 2 Group
Hide Arm/Group Description:
Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
Overall Number of Participants Analyzed 226 223 223 226
Measure Type: Count of Participants
Unit of Measure: Participants
EOS, PRE NORMAL, M7 NORMAL Number Analyzed 209 participants 214 participants 212 participants 214 participants
203
  97.1%
207
  96.7%
200
  94.3%
205
  95.8%
EOS, PRE NORMAL, M7 BELOW Number Analyzed 226 participants 214 participants 212 participants 214 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
EOS, PRE NORMAL, M7 ABOVE Number Analyzed 209 participants 214 participants 212 participants 214 participants
5
   2.4%
6
   2.8%
8
   3.8%
6
   2.8%
EOS, PRE NORMAL, M7 MISSING Number Analyzed 209 participants 214 participants 212 participants 214 participants
1
   0.5%
1
   0.5%
4
   1.9%
3
   1.4%
EOS, PRE BELOW, M7 NORMAL Number Analyzed 1 participants 2 participants 1 participants 0 participants
0
   0.0%
1
  50.0%
0
   0.0%
0
EOS, PRE BELOW, M7 BELOW Number Analyzed 1 participants 2 participants 1 participants 0 participants
0
   0.0%
1
  50.0%
1
 100.0%
0
EOS, PRE BELOW, M7 ABOVE Number Analyzed 1 participants 2 participants 1 participants 0 participants
1
 100.0%
0
   0.0%
0
   0.0%
0
EOS, PRE ABOVE, M7 NORMAL Number Analyzed 16 participants 7 participants 10 participants 12 participants
8
  50.0%
3
  42.9%
3
  30.0%
7
  58.3%
EOS, PRE ABOVE, M7 BELOW Number Analyzed 16 participants 7 participants 10 participants 12 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
EOS, PRE ABOVE, M7 ABOVE Number Analyzed 16 participants 7 participants 10 participants 12 participants
8
  50.0%
3
  42.9%
7
  70.0%
5
  41.7%
EOS, PRE ABOVE, M7 MISSING Number Analyzed 16 participants 7 participants 10 participants 12 participants
0
   0.0%
1
  14.3%
0
   0.0%
0
   0.0%
11.Secondary Outcome
Title Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.
Hide Description Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents Hct results.
Time Frame At Month 7 (M7)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Analysis for this outcome was done on subjects with available results for this outcome measure.
Arm/Group Title Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 2 Group
Hide Arm/Group Description:
Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
Overall Number of Participants Analyzed 229 228 227 233
Measure Type: Count of Participants
Unit of Measure: Participants
Hct, PRE NORMAL, M7 NORMAL Number Analyzed 215 participants 208 participants 208 participants 217 participants
196
  91.2%
193
  92.8%
189
  90.9%
208
  95.9%
Hct, PRE NORMAL, M7 BELOW Number Analyzed 215 participants 208 participants 208 participants 217 participants
6
   2.8%
5
   2.4%
8
   3.8%
2
   0.9%
Hct, PRE NORMAL, M7 ABOVE Number Analyzed 215 participants 208 participants 208 participants 217 participants
11
   5.1%
8
   3.8%
7
   3.4%
6
   2.8%
Hct, PRE NORMAL, M7 MISSING Number Analyzed 215 participants 208 participants 208 participants 217 participants
2
   0.9%
2
   1.0%
4
   1.9%
1
   0.5%
Hct, PRE BELOW, M7 NORMAL Number Analyzed 6 participants 7 participants 7 participants 3 participants
3
  50.0%
5
  71.4%
4
  57.1%
2
  66.7%
Hct, PRE BELOW, M7 BELOW Number Analyzed 6 participants 7 participants 7 participants 3 participants
3
  50.0%
2
  28.6%
3
  42.9%
1
  33.3%
Hct, PRE BELOW, M7 ABOVE Number Analyzed 6 participants 7 participants 7 participants 3 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hct, PRE ABOVE, M7 NORMAL Number Analyzed 8 participants 13 participants 12 participants 13 participants
7
  87.5%
8
  61.5%
10
  83.3%
7
  53.8%
Hct, PRE ABOVE, M7 BELOW Number Analyzed 8 participants 13 participants 12 participants 13 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hct, PRE ABOVE, M7 ABOVE Number Analyzed 8 participants 13 participants 12 participants 13 participants
1
  12.5%
5
  38.5%
2
  16.7%
6
  46.2%
12.Secondary Outcome
Title Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.
Hide Description Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents ALT results.
Time Frame At Month 7 (M7)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Analysis for this outcome was done on subjects with available results for this outcome measure.
Arm/Group Title Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 2 Group
Hide Arm/Group Description:
Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
Overall Number of Participants Analyzed 229 227 229 233
Measure Type: Count of Participants
Unit of Measure: Participants
ALT, PRE NORMAL, M7 NORMAL Number Analyzed 215 participants 219 participants 225 participants 218 participants
211
  98.1%
211
  96.3%
213
  94.7%
209
  95.9%
ALT, PRE NORMAL, M7 BELOW Number Analyzed 215 participants 219 participants 225 participants 218 participants
3
   1.4%
2
   0.9%
4
   1.8%
4
   1.8%
ALT, PRE NORMAL, M7 ABOVE Number Analyzed 215 participants 219 participants 225 participants 218 participants
1
   0.5%
6
   2.7%
7
   3.1%
5
   2.3%
ALT, PRE NORMAL, M7 MISSING Number Analyzed 215 participants 219 participants 225 participants 218 participants
0
   0.0%
0
   0.0%
1
   0.4%
0
   0.0%
ALT, PRE BELOW, M7 NORMAL Number Analyzed 1 participants 3 participants 1 participants 4 participants
0
   0.0%
2
  66.7%
0
   0.0%
2
  50.0%
ALT, PRE BELOW, M7 BELOW Number Analyzed 1 participants 3 participants 1 participants 4 participants
1
 100.0%
1
  33.3%
1
 100.0%
2
  50.0%
ALT, PRE BELOW, M7 ABOVE Number Analyzed 1 participants 3 participants 1 participants 4 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
ALT, PRE ABOVE, M7 NORMAL Number Analyzed 13 participants 5 participants 3 participants 11 participants
9
  69.2%
4
  80.0%
1
  33.3%
7
  63.6%
ALT, PRE ABOVE, M7 BELOW Number Analyzed 13 participants 5 participants 3 participants 11 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
ALT, PRE ABOVE, M7 ABOVE Number Analyzed 13 participants 5 participants 3 participants 11 participants
4
  30.8%
1
  20.0%
2
  66.7%
3
  27.3%
ALT, PRE ABOVE, M7 MISSING Number Analyzed 13 participants 5 participants 3 participants 11 participants
0
   0.0%
0
   0.0%
0
   0.0%
1
   9.1%
13.Secondary Outcome
Title Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.
Hide Description Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents LYM results.
Time Frame At Month 7 (M7)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Analysis for this outcome was done on subjects with available results for this outcome measure.
Arm/Group Title Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 2 Group
Hide Arm/Group Description:
Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
Overall Number of Participants Analyzed 226 223 223 227
Measure Type: Count of Participants
Unit of Measure: Participants
LYM, PRE NORMAL, M7 NORMAL Number Analyzed 211 participants 211 participants 204 participants 213 participants
201
  95.3%
202
  95.7%
192
  94.1%
202
  94.8%
LYM, PRE NORMAL, M7 BELOW Number Analyzed 211 participants 211 participants 204 participants 213 participants
3
   1.4%
0
   0.0%
3
   1.5%
1
   0.5%
LYM, PRE NORMAL, M7 ABOVE Number Analyzed 211 participants 211 participants 204 participants 213 participants
6
   2.8%
7
   3.3%
5
   2.5%
7
   3.3%
LYM, PRE NORMAL, M7 MISSING Number Analyzed 211 participants 211 participants 204 participants 213 participants
1
   0.5%
2
   0.9%
4
   2.0%
3
   1.4%
LYM, PRE BELOW, M7 NORMAL Number Analyzed 6 participants 3 participants 5 participants 5 participants
4
  66.7%
3
 100.0%
3
  60.0%
1
  20.0%
LYM, PRE BELOW, M7 BELOW Number Analyzed 6 participants 3 participants 5 participants 5 participants
2
  33.3%
0
   0.0%
2
  40.0%
2
  40.0%
LYM, PRE BELOW, M7 ABOVE Number Analyzed 6 participants 3 participants 5 participants 5 participants
0
   0.0%
0
   0.0%
0
   0.0%
2
  40.0%
LYM, PRE ABOVE, M7 NORMAL Number Analyzed 9 participants 9 participants 14 participants 9 participants
5
  55.6%
7
  77.8%
8
  57.1%
5
  55.6%
LYM, PRE ABOVE, M7 BELOW Number Analyzed 9 participants 9 participants 14 participants 9 participants
0
   0.0%
0
   0.0%
1
   7.1%
0
   0.0%
LYM, PRE ABOVE, M7 ABOVE Number Analyzed 9 participants 9 participants 14 participants 9 participants
4
  44.4%
2
  22.2%
5
  35.7%
4
  44.4%
14.Secondary Outcome
Title Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.
Hide Description Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents MON results.
Time Frame At Month 7 (M7)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Analysis for this outcome was done on subjects with available results for this outcome measure.
Arm/Group Title Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 2 Group
Hide Arm/Group Description:
Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
Overall Number of Participants Analyzed 226 223 223 227
Measure Type: Count of Participants
Unit of Measure: Participants
MON, PRE NORMAL, M7 NORMAL Number Analyzed 217 participants 211 participants 211 participants 219 participants
212
  97.7%
202
  95.7%
197
  93.4%
208
  95.0%
MON, PRE NORMAL, M7 BELOW Number Analyzed 217 participants 211 participants 211 participants 219 participants
0
   0.0%
1
   0.5%
2
   0.9%
2
   0.9%
MON, PRE NORMAL, M7 ABOVE Number Analyzed 217 participants 211 participants 211 participants 219 participants
4
   1.8%
6
   2.8%
9
   4.3%
6
   2.7%
MON, PRE NORMAL, M7 MISSING Number Analyzed 217 participants 211 participants 211 participants 219 participants
1
   0.5%
2
   0.9%
3
   1.4%
3
   1.4%
MON, PRE BELOW, M7 NORMAL Number Analyzed 3 participants 2 participants 0 participants 2 participants
1
  33.3%
1
  50.0%
0
2
 100.0%
MON, PRE BELOW, M7 BELOW Number Analyzed 3 participants 2 participants 0 participants 2 participants
2
  66.7%
1
  50.0%
0
0
   0.0%
MON, PRE BELOW, M7 ABOVE Number Analyzed 3 participants 2 participants 0 participants 2 participants
0
   0.0%
0
   0.0%
0
0
   0.0%
MON, PRE ABOVE, M7 NORMAL Number Analyzed 6 participants 10 participants 12 participants 6 participants
5
  83.3%
6
  60.0%
6
  50.0%
4
  66.7%
MON, PRE ABOVE], M7 BELOW Number Analyzed 6 participants 10 participants 12 participants 6 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
MON, PRE ABOVE, M7 ABOVE Number Analyzed 6 participants 10 participants 12 participants 6 participants
1
  16.7%
4
  40.0%
5
  41.7%
2
  33.3%
MON, PRE ABOVE, M7 MISSING Number Analyzed 6 participants 10 participants 12 participants 6 participants
0
   0.0%
0
   0.0%
1
   8.3%
0
   0.0%
15.Secondary Outcome
Title Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.
Hide Description Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents NEU results.
Time Frame At Month 7 (M7)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Analysis for this outcome was done on subjects with available results for this outcome measure.
Arm/Group Title Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 2 Group
Hide Arm/Group Description:
Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
Overall Number of Participants Analyzed 224 223 223 226
Measure Type: Count of Participants
Unit of Measure: Participants
NEU, PRE NORMAL, M7 NORMAL Number Analyzed 206 participants 207 participants 202 participants 204 participants
184
  89.3%
188
  90.8%
185
  91.6%
186
  91.2%
NEU, PRE NORMAL, M7 BELOW Number Analyzed 206 participants 207 participants 202 participants 204 participants
16
   7.8%
16
   7.7%
9
   4.5%
9
   4.4%
NEU, PRE NORMAL, M7 ABOVE Number Analyzed 206 participants 207 participants 202 participants 204 participants
5
   2.4%
1
   0.5%
1
   0.5%
3
   1.5%
NEU, PRE NORMAL, M7 MISSING Number Analyzed 206 participants 207 participants 202 participants 204 participants
1
   0.5%
2
   1.0%
7
   3.5%
6
   2.9%
NEU, PRE BELOW, M7 NORMAL Number Analyzed 11 participants 11 participants 16 participants 19 participants
8
  72.7%
6
  54.5%
9
  56.3%
15
  78.9%
NEU, PRE BELOW, M7 BELOW Number Analyzed 11 participants 11 participants 16 participants 19 participants
2
  18.2%
4
  36.4%
7
  43.8%
3
  15.8%
NEU, PRE BELOW, M7 ABOVE Number Analyzed 11 participants 11 participants 16 participants 19 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
NEU, PRE ABOVE, M7 NORMAL Number Analyzed 7 participants 5 participants 5 participants 3 participants
6
  85.7%
5
 100.0%
5
 100.0%
1
  33.3%
NEU, PRE ABOVE, M7 BELOW Number Analyzed 7 participants 5 participants 5 participants 3 participants
0
   0.0%
0
   0.0%
0
   0.0%
2
  66.7%
NEU, PRE ABOVE, M7 ABOVE Number Analyzed 7 participants 5 participants 5 participants 3 participants
1
  14.3%
0
   0.0%
0
   0.0%
0
   0.0%
NEU, PRE BELOW, M7 MISSING Number Analyzed 11 participants 11 participants 16 participants 19 participants
1
   9.1%
1
   9.1%
0
   0.0%
1
   5.3%
16.Secondary Outcome
Title Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.
Hide Description Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents RBC results.
Time Frame At Month 7 (M7)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Analysis for this outcome was done on subjects with available results for this outcome measure.
Arm/Group Title Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 2 Group
Hide Arm/Group Description:
Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
Overall Number of Participants Analyzed 229 228 228 233
Measure Type: Count of Participants
Unit of Measure: Participants
RBC, PRE NORMAL, M7 NORMAL Number Analyzed 214 participants 215 participants 204 participants 225 participants
204
  95.3%
204
  94.9%
196
  96.1%
213
  94.7%
RBC, PRE NORMAL, M7 BELOW Number Analyzed 214 participants 215 participants 204 participants 225 participants
7
   3.3%
7
   3.3%
2
   1.0%
7
   3.1%
RBC, PRE NORMAL, M7 ABOVE Number Analyzed 214 participants 215 participants 204 participants 225 participants
2
   0.9%
3
   1.4%
2
   1.0%
3
   1.3%
RBC, PRE NORMAL, M7 MISSING Number Analyzed 214 participants 215 participants 204 participants 225 participants
1
   0.5%
1
   0.5%
4
   2.0%
2
   0.9%
RBC, PRE BELOW, M7 NORMAL Number Analyzed 6 participants 6 participants 12 participants 4 participants
4
  66.7%
3
  50.0%
2
  16.7%
1
  25.0%
RBC, PRE BELOW, M7 BELOW Number Analyzed 6 participants 6 participants 12 participants 4 participants
2
  33.3%
3
  50.0%
10
  83.3%
3
  75.0%
RBC, PRE BELOW, M7 ABOVE Number Analyzed 6 participants 6 participants 12 participants 4 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
RBC, PRE ABOVE, M7 NORMAL Number Analyzed 9 participants 7 participants 12 participants 4 participants
5
  55.6%
4
  57.1%
6
  50.0%
3
  75.0%
RBC, PRE ABOVE, M7 BELOW Number Analyzed 9 participants 7 participants 12 participants 4 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
RBC, PRE ABOVE, M7 ABOVE Number Analyzed 9 participants 7 participants 12 participants 4 participants
4
  44.4%
3
  42.9%
6
  50.0%
1
  25.0%
17.Secondary Outcome
Title Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.
Hide Description Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents WBC results.
Time Frame At Month 7 (M7)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented, on subjects with available results.
Arm/Group Title Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 2 Group
Hide Arm/Group Description:
Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
Overall Number of Participants Analyzed 229 228 229 233
Measure Type: Count of Participants
Unit of Measure: Participants
WBC, PRE NORMAL, M7 NORMAL Number Analyzed 207 participants 213 participants 211 participants 225 participants
197
  95.2%
199
  93.4%
194
  91.9%
212
  94.2%
WBC, PRE NORMAL, M7 BELOW Number Analyzed 207 participants 213 participants 211 participants 225 participants
4
   1.9%
9
   4.2%
5
   2.4%
9
   4.0%
WBC, PRE NORMAL, M7 ABOVE Number Analyzed 207 participants 213 participants 211 participants 225 participants
5
   2.4%
4
   1.9%
8
   3.8%
3
   1.3%
WBC, PRE NORMAL, M7 MISSING Number Analyzed 207 participants 213 participants 211 participants 225 participants
1
   0.5%
1
   0.5%
4
   1.9%
1
   0.4%
WBC, PRE BELOW, M7 NORMAL Number Analyzed 8 participants 9 participants 6 participants 4 participants
4
  50.0%
5
  55.6%
3
  50.0%
3
  75.0%
WBC, PRE BELOW, M7 BELOW Number Analyzed 8 participants 9 participants 6 participants 4 participants
4
  50.0%
4
  44.4%
3
  50.0%
1
  25.0%
WBC, PRE BELOW, M7 ABOVE Number Analyzed 8 participants 9 participants 6 participants 4 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
WBC, PRE ABOVE, M7 NORMAL Number Analyzed 14 participants 6 participants 12 participants 4 participants
10
  71.4%
4
  66.7%
9
  75.0%
4
 100.0%
WBC, PRE ABOVE, M7 BELOW Number Analyzed 14 participants 6 participants 12 participants 4 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
WBC, PRE ABOVE, M7 ABOVE Number Analyzed 14 participants 6 participants 12 participants 4 participants
4
  28.6%
2
  33.3%
3
  25.0%
0
   0.0%
18.Secondary Outcome
Title Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.
Hide Description Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents PLA results.
Time Frame At Month 7 (M7)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Analysis for this outcome was done on subjects with available results for this outcome measure.
Arm/Group Title Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 2 Group
Hide Arm/Group Description:
Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
Overall Number of Participants Analyzed 226 227 228 232
Measure Type: Count of Participants
Unit of Measure: Participants
PLA, PRE NORMAL, M7 NORMAL Number Analyzed 211 participants 210 participants 215 participants 221 participants
204
  96.7%
204
  97.1%
206
  95.8%
218
  98.6%
PLA, PRE NORMAL, M7 BELOW Number Analyzed 211 participants 210 participants 215 participants 221 participants
1
   0.5%
2
   1.0%
3
   1.4%
0
   0.0%
PLA, PRE NORMAL, M7 ABOVE Number Analyzed 211 participants 210 participants 215 participants 221 participants
5
   2.4%
2
   1.0%
2
   0.9%
1
   0.5%
PLA, PRE NORMAL, M7 MISSING Number Analyzed 211 participants 210 participants 215 participants 221 participants
1
   0.5%
2
   1.0%
4
   1.9%
2
   0.9%
PLA, PRE BELOW, M7 NORMAL Number Analyzed 0 participants 3 participants 0 participants 3 participants
0
0
   0.0%
0
1
  33.3%
PLA, PRE BELOW, M7 BELOW Number Analyzed 0 participants 3 participants 0 participants 3 participants
0
3
 100.0%
0
2
  66.7%
PLA, PRE BELOW, M7 ABOVE Number Analyzed 0 participants 3 participants 0 participants 3 participants
0
0
   0.0%
0
0
   0.0%
PLA, PRE ABOVE, M7 NORMAL Number Analyzed 15 participants 14 participants 13 participants 8 participants
9
  60.0%
11
  78.6%
8
  61.5%
4
  50.0%
PLA, PRE ABOVE, M7 BELOW Number Analyzed 15 participants 14 participants 13 participants 8 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
PLA, PRE ABOVE, M7 ABOVE Number Analyzed 15 participants 14 participants 13 participants 8 participants
6
  40.0%
3
  21.4%
5
  38.5%
4
  50.0%
19.Secondary Outcome
Title Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18)
Hide Description Seroconversion was defined as the appearance of antibodies (i.e.titers greater than or equal to (≥) cut-off value) in the serum of subjects seronegative before vaccination. Assay cut-off was defined as ≥ 8 ELISA units per milliliter (EL.U/mL) for HPV-16, and 7 EL.U/mL for HPV-18. Seronegative subjects are subjects who had an antibody concentration below cut-off value. Cut-off values were 8 EL.U/mL for antibody concentrations against HPV-16, and 7 EL.U/mL for antibody concentrations against HPV-18.
Time Frame At Month 12, at Month 18, at Month 24, at Month 36, and at Month 48 during the safety follow-up phase.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Arm/Group Title Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 2 Group
Hide Arm/Group Description:
Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
Overall Number of Participants Analyzed 216 198 195 198
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-HPV-16 at Month 12 Number Analyzed 216 participants 191 participants 195 participants 198 participants
194
  89.8%
162
  84.8%
172
  88.2%
169
  85.4%
Anti-HPV-16 at Month 18 Number Analyzed 212 participants 196 participants 194 participants 197 participants
192
  90.6%
166
  84.7%
172
  88.7%
168
  85.3%
Anti-HPV-16 at Month 24 Number Analyzed 199 participants 184 participants 186 participants 190 participants
185
  93.0%
155
  84.2%
165
  88.7%
162
  85.3%
Anti-HPV-16 at Month 36 Number Analyzed 166 participants 158 participants 162 participants 153 participants
156
  94.0%
135
  85.4%
146
  90.1%
135
  88.2%
Anti-HPV-16 at Month 48 Number Analyzed 160 participants 151 participants 157 participants 148 participants
149
  93.1%
130
  86.1%
139
  88.5%
129
  87.2%
Anti-HPV-18 at Month 12 Number Analyzed 215 participants 193 participants 194 participants 198 participants
187
  87.0%
173
  89.6%
166
  85.6%
173
  87.4%
Anti-HPV-18 at Month 18 Number Analyzed 211 participants 198 participants 193 participants 197 participants
184
  87.2%
177
  89.4%
166
  86.0%
173
  87.8%
Anti-HPV-18 at Month 24 Number Analyzed 198 participants 186 participants 185 participants 190 participants
173
  87.4%
165
  88.7%
159
  85.9%
166
  87.4%
Anti-HPV-18 at Month 36 Number Analyzed 166 participants 160 participants 162 participants 153 participants
144
  86.7%
145
  90.6%
139
  85.8%
132
  86.3%
Anti-HPV-18 at Month 48 Number Analyzed 160 participants 153 participants 157 participants 148 participants
138
  86.3%
139
  90.8%
135
  86.0%
129
  87.2%
20.Secondary Outcome
Title Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies
Hide Description Titers are given as Geometric Mean Titers (GMTs) expressed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). The assay cut-off for Month 60 was defined as ≥ 19 ELISA units per milliliter (EL.U/mL).
Time Frame At Month 60 of the safety follow-up phase
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Arm/Group Title Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 2 Group
Hide Arm/Group Description:
Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
Overall Number of Participants Analyzed 137 134 131 146
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Anti-HPV-16 at Month 60 Number Analyzed 137 participants 132 participants 131 participants 146 participants
658.0
(560.4 to 772.5)
1254.0
(1088.5 to 1444.8)
976.1
(846.1 to 1126.1)
1858.5
(1586.2 to 2177.6)
Anti-HPV-18 at Month 60 Number Analyzed 137 participants 134 participants 131 participants 146 participants
269.4
(223.0 to 325.5)
622.2
(519.0 to 745.9)
557.9
(473.7 to 657.0)
745.3
(629.3 to 882.7)
21.Secondary Outcome
Title Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18)
Hide Description Seroconversion was defined as the appearance of antibodies (i.e. titers greater than or equal to (≥) cut-off value) in the serum of subjects seronegative before vaccination. Assay cut-off was defined as ≥ 19 ELISA units per milliliter (EL.U/mL). Seronegative subjects are subjects who had an antibody concentration below cut-off value.
Time Frame At Month 60 of the safety follow-up phase
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Arm/Group Title Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 2 Group
Hide Arm/Group Description:
Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
Overall Number of Participants Analyzed 130 122 119 127
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-HPV-16 at Month 60 Number Analyzed 130 participants 114 participants 119 participants 127 participants
130
 100.0%
114
 100.0%
119
 100.0%
127
 100.0%
Anti-HPV-18 at Month 60 Number Analyzed 117 participants 122 participants 116 participants 125 participants
116
  99.1%
122
 100.0%
116
 100.0%
125
 100.0%
22.Secondary Outcome
Title Number of Subjects With Pregnancy Outcomes.
Hide Description Pregnancy outcomes were ectopic pregnancy, elective termination with no apparent congenital anomaly (ACA), elective termination with congenital anomaly (CA), lost to follow up, pregnancy ongoing, spontaneous abortion with no ACA and live infant with no ACA.
Time Frame From Month 0 to Month 48.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on pregnant subjects in the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 2 Group
Hide Arm/Group Description:
Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
Overall Number of Participants Analyzed 23 16 24 20
Measure Type: Count of Participants
Unit of Measure: Participants
Ectopic pregnancy
1
   4.3%
0
   0.0%
0
   0.0%
0
   0.0%
Elective termination with NO ACA
5
  21.7%
3
  18.8%
3
  12.5%
5
  25.0%
Elective termination with CA
0
   0.0%
0
   0.0%
1
   4.2%
0
   0.0%
Live infant with NO ACA
15
  65.2%
12
  75.0%
15
  62.5%
12
  60.0%
Lost to follow up
1
   4.3%
0
   0.0%
0
   0.0%
0
   0.0%
Pregnancy ongoing
0
   0.0%
1
   6.3%
2
   8.3%
2
  10.0%
Spontaneous abortion with NO ACA
1
   4.3%
0
   0.0%
3
  12.5%
1
   5.0%
23.Secondary Outcome
Title Number of Subjects With Pregnancy Outcomes.
Hide Description Pregnancy outcomes were ectopic pregnancy, elective termination with no apparent congenital anomaly (ACA), elective termination with congenital anomaly (CA), lost to follow up, pregnancy ongoing, spontaneous abortion with no ACA and live infant with no ACA.
Time Frame Throughout the study period, from Month 0 to Month 60.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on pregnant subjects in the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 2 Group
Hide Arm/Group Description:
Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
Overall Number of Participants Analyzed 32 23 30 26
Measure Type: Count of Participants
Unit of Measure: Participants
Ectopic pregnancy
1
   3.1%
0
   0.0%
0
   0.0%
1
   3.8%
Elective termination NO apparent congenital anom.
5
  15.6%
6
  26.1%
4
  13.3%
6
  23.1%
Elective termination congenital anomaly
0
   0.0%
0
   0.0%
1
   3.3%
0
   0.0%
Live infant NO apparent congenital anomaly
22
  68.8%
16
  69.6%
22
  73.3%
18
  69.2%
Lost to follow up
1
   3.1%
0
   0.0%
0
   0.0%
0
   0.0%
Molar pregnancy
1
   3.1%
0
   0.0%
0
   0.0%
0
   0.0%
Spontaneous abortion NO apparent congenital anom.
2
   6.3%
1
   4.3%
3
  10.0%
1
   3.8%
24.Secondary Outcome
Title Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
Hide Description An unsolicited adverse event (AE) 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. Grade 3 = an event that prevented normal activity. Related = an event assessed by the investigator as causally related to the study vaccination.
Time Frame Within 30 days (Day 0-29) after vaccination.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 2 Group
Hide Arm/Group Description:
Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
Overall Number of Participants Analyzed 240 241 240 239
Measure Type: Count of Participants
Unit of Measure: Participants
Any unsolicited AE(s)
83
  34.6%
85
  35.3%
76
  31.7%
107
  44.8%
Grade 3 unsolicited AE(s)
11
   4.6%
8
   3.3%
6
   2.5%
14
   5.9%
Related unsolicited AE(s)
26
  10.8%
20
   8.3%
16
   6.7%
27
  11.3%
25.Secondary Outcome
Title Number of Subjects With Medically Significant Conditions (MSCs).
Hide Description MSCs were defined as: AEs prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. The following did not require reporting as long as they were not considered SAEs and occurred more than 30 days after each vaccination: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities, injury, visits for routine physical examination or visits for vaccination.
Time Frame From Month 0 to Month 7.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 2 Group
Hide Arm/Group Description:
Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
Overall Number of Participants Analyzed 240 241 240 239
Measure Type: Count of Participants
Unit of Measure: Participants
40
  16.7%
48
  19.9%
45
  18.8%
42
  17.6%
26.Secondary Outcome
Title Number of Subjects With Medically Significant Conditions (MSCs).
Hide Description MSCs were defined as: AEs prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. The following did not require reporting as long as they were not considered SAEs and occurred more than 30 days after each vaccination: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities, injury, visits for routine physical examination or visits for vaccination.
Time Frame From Month 0 to Month 48.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 2 Group
Hide Arm/Group Description:
Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
Overall Number of Participants Analyzed 240 241 240 239
Measure Type: Count of Participants
Unit of Measure: Participants
79
  32.9%
94
  39.0%
88
  36.7%
82
  34.3%
27.Secondary Outcome
Title Number of Subjects With Medically Significant Conditions (MSCs).
Hide Description MSCs were defined as: AEs prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. The following did not require reporting as long as they were not considered SAEs and occurred more than 30 days after each vaccination: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities, injury, visits for routine physical examination or visits for vaccination.
Time Frame Throughout the study period, from Month 0 to Month 60.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 2 Group
Hide Arm/Group Description:
Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
Overall Number of Participants Analyzed 240 241 240 239
Measure Type: Count of Participants
Unit of Measure: Participants
85
  35.4%
97
  40.2%
92
  38.3%
89
  37.2%
28.Secondary Outcome
Title Number of Subjects With New Onset of Autoimmune Diseases (NOADs)
Hide Description NOADs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.
Time Frame From Month 0 to Month 7.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 2 Group
Hide Arm/Group Description:
Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
Overall Number of Participants Analyzed 240 241 240 239
Measure Type: Count of Participants
Unit of Measure: Participants
1
   0.4%
1
   0.4%
2
   0.8%
1
   0.4%
29.Secondary Outcome
Title Number of Subjects With New Onset of Autoimune Diseases (NOADs)
Hide Description NOADs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.
Time Frame From Month 0 to Month 48.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 2 Group
Hide Arm/Group Description:
Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
Overall Number of Participants Analyzed 240 241 240 239
Measure Type: Count of Participants
Unit of Measure: Participants
3
   1.3%
4
   1.7%
5
   2.1%
4
   1.7%
30.Secondary Outcome
Title Number of Subjects With New Onset of Autoimmune Diseases (NOADs)
Hide Description NOADs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.
Time Frame Throughout the study period, from Month 0 to Month 60.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 2 Group
Hide Arm/Group Description:
Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
Overall Number of Participants Analyzed 240 241 240 239
Measure Type: Count of Participants
Unit of Measure: Participants
4
   1.7%
4
   1.7%
5
   2.1%
6
   2.5%
31.Secondary Outcome
Title Number of Subjects With New Onset of Chronic Diseases (NOCDs)
Hide Description NOCDs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.
Time Frame From Month 0 to Month 7.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 2 Group
Hide Arm/Group Description:
Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
Overall Number of Participants Analyzed 240 241 240 239
Measure Type: Count of Participants
Unit of Measure: Participants
4
   1.7%
2
   0.8%
6
   2.5%
3
   1.3%
32.Secondary Outcome
Title Number of Subjects With New Onset of Chronic Diseases (NOCDs)
Hide Description NOCDs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.
Time Frame From Month 0 to Month 48.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 2 Group
Hide Arm/Group Description:
Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
Overall Number of Participants Analyzed 240 241 240 239
Measure Type: Count of Participants
Unit of Measure: Participants
8
   3.3%
11
   4.6%
13
   5.4%
6
   2.5%
33.Secondary Outcome
Title Number of Subjects With New Onset of Chronic Diseases (NOCDs)
Hide Description NOCDs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.
Time Frame Throughout the study period, from Month 0 to Month 60.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 2 Group
Hide Arm/Group Description:
Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
Overall Number of Participants Analyzed 240 241 240 239
Measure Type: Count of Participants
Unit of Measure: Participants
8
   3.3%
11
   4.6%
14
   5.8%
7
   2.9%
34.Secondary Outcome
Title Number of Subjects With Serious Adverse Events (SAEs).
Hide Description SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity, or are a congenital anomaly/birth defect in the offspring of a study subject.
Time Frame From Month 0 to Month 7.
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Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 2 Group
Hide Arm/Group Description:
Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
Overall Number of Participants Analyzed 240 241 240 239
Measure Type: Count of Participants
Unit of Measure: Participants
4
   1.7%
4
   1.7%
4
   1.7%
2
   0.8%
35.Secondary Outcome
Title Number of Subjects With Serious Adverse Events (SAEs).
Hide Description SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Time Frame From Month 0 to Month 48.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 2 Group
Hide Arm/Group Description:
Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
Overall Number of Participants Analyzed 240 241 240 239
Measure Type: Count of Participants
Unit of Measure: Participants
10
   4.2%
13
   5.4%
19
   7.9%
13
   5.4%
36.Secondary Outcome
Title Number of Subjects With Serious Adverse Events (SAEs)
Hide Description SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Time Frame Throughout the study period, from Month 0 to Month 60.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 2 Group
Hide Arm/Group Description:
Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
Overall Number of Participants Analyzed 240 241 240 239
Measure Type: Count of Participants
Unit of Measure: Participants
14
   5.8%
16
   6.6%
19
   7.9%
15
   6.3%
<
Time Frame Serious adverse events: From Month 0 to Month 60. Unsolicited adverse events: Within the 30-day (Days 0-29) follow-up period after vaccination. Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination.
Adverse Event Reporting Description 3 among the serious adverse events (SAEs) listed below are SAEs reported for the subject’s offsprings (Spina bifida, Foetal distress syndrome and Premature baby).
 
Arm/Group Title Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 2 Group
Hide Arm/Group Description Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm. Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm. Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm. Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
All-Cause Mortality
Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 2 Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 2 Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   14/240 (5.83%)   16/241 (6.64%)   19/240 (7.92%)   15/239 (6.28%) 
Congenital, familial and genetic disorders         
Atrial septal defect *  0/240 (0.00%)  0/241 (0.00%)  1/240 (0.42%)  0/239 (0.00%) 
Spina bifida * [1]  0/240 (0.00%)  0/241 (0.00%)  1/240 (0.42%)  0/239 (0.00%) 
Endocrine disorders         
Basedow’s disease *  0/240 (0.00%)  0/241 (0.00%)  0/240 (0.00%)  1/239 (0.42%) 
Gastrointestinal disorders         
Abdominal pain *  3/240 (1.25%)  1/241 (0.41%)  0/240 (0.00%)  1/239 (0.42%) 
Appendix disorder *  0/240 (0.00%)  0/241 (0.00%)  0/240 (0.00%)  1/239 (0.42%) 
Umbilical hernia, obstructive *  0/240 (0.00%)  2/241 (0.83%)  0/240 (0.00%)  0/239 (0.00%) 
Vomiting *  0/240 (0.00%)  1/241 (0.41%)  0/240 (0.00%)  0/239 (0.00%) 
Gastroenteritis *  0/240 (0.00%)  0/241 (0.00%)  0/240 (0.00%)  1/239 (0.42%) 
Gastroenteritis viral *  0/240 (0.00%)  1/241 (0.41%)  0/240 (0.00%)  0/239 (0.00%) 
Hepatobiliary disorders         
Bile duct stone *  0/240 (0.00%)  0/241 (0.00%)  1/240 (0.42%)  0/239 (0.00%) 
Cholecystitis acute *  0/240 (0.00%)  1/241 (0.41%)  0/240 (0.00%)  0/239 (0.00%) 
Hepatomegaly *  1/240 (0.42%)  0/241 (0.00%)  0/240 (0.00%)  0/239 (0.00%) 
Infections and infestations         
Acute tonsillitis *  0/240 (0.00%)  1/241 (0.41%)  0/240 (0.00%)  0/239 (0.00%) 
Appendicitis *  0/240 (0.00%)  2/241 (0.83%)  4/240 (1.67%)  1/239 (0.42%) 
Endometritis decidual *  0/240 (0.00%)  1/241 (0.41%)  0/240 (0.00%)  0/239 (0.00%) 
Pharyngitis streptococcal *  0/240 (0.00%)  0/241 (0.00%)  0/240 (0.00%)  1/239 (0.42%) 
Pilonidal cyst *  1/240 (0.42%)  0/241 (0.00%)  0/240 (0.00%)  0/239 (0.00%) 
Tonsillitis *  0/240 (0.00%)  0/241 (0.00%)  0/240 (0.00%)  2/239 (0.84%) 
Tonsillitis bacterial *  0/240 (0.00%)  0/241 (0.00%)  1/240 (0.42%)  0/239 (0.00%) 
Urinary tract infection *  1/240 (0.42%)  0/241 (0.00%)  0/240 (0.00%)  1/239 (0.42%) 
Vestibular neuronitis *  1/240 (0.42%)  1/241 (0.41%)  0/240 (0.00%)  0/239 (0.00%) 
Injury, poisoning and procedural complications         
Concussion *  1/240 (0.42%)  0/241 (0.00%)  0/240 (0.00%)  0/239 (0.00%) 
Humerus fracture *  0/240 (0.00%)  0/241 (0.00%)  1/240 (0.42%)  0/239 (0.00%) 
Ligament rupture *  0/240 (0.00%)  0/241 (0.00%)  0/240 (0.00%)  1/239 (0.42%) 
Multiple injuries *  0/240 (0.00%)  0/241 (0.00%)  0/240 (0.00%)  1/239 (0.42%) 
Road traffic accident *  0/240 (0.00%)  0/241 (0.00%)  1/240 (0.42%)  0/239 (0.00%) 
Tibia fracture *  0/240 (0.00%)  1/241 (0.41%)  1/240 (0.42%)  0/239 (0.00%) 
Upper limb fracture *  0/240 (0.00%)  0/241 (0.00%)  1/240 (0.42%)  0/239 (0.00%) 
Contusion *  0/240 (0.00%)  1/241 (0.41%)  0/240 (0.00%)  0/239 (0.00%) 
Fall *  0/240 (0.00%)  1/241 (0.41%)  0/240 (0.00%)  0/239 (0.00%) 
Stab wound *  1/240 (0.42%)  0/241 (0.00%)  0/240 (0.00%)  0/239 (0.00%) 
Musculoskeletal and connective tissue disorders         
Coccydynia *  1/240 (0.42%)  0/241 (0.00%)  0/240 (0.00%)  0/239 (0.00%) 
Ligament laxity *  0/240 (0.00%)  0/241 (0.00%)  0/240 (0.00%)  1/239 (0.42%) 
Polyarthritis *  0/240 (0.00%)  0/241 (0.00%)  0/240 (0.00%)  1/239 (0.42%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Fibroma *  0/240 (0.00%)  1/241 (0.41%)  0/240 (0.00%)  0/239 (0.00%) 
Fibrosarcoma *  0/240 (0.00%)  1/241 (0.41%)  0/240 (0.00%)  0/239 (0.00%) 
Malignant melanoma stage IV *  0/240 (0.00%)  0/241 (0.00%)  1/240 (0.42%)  0/239 (0.00%) 
Uterine leiomyoma *  1/240 (0.42%)  0/241 (0.00%)  0/240 (0.00%)  0/239 (0.00%) 
Benign hydatidiform mole *  1/240 (0.42%)  0/241 (0.00%)  0/240 (0.00%)  0/239 (0.00%) 
Nervous system disorders         
Basilar artery thrombosis *  0/240 (0.00%)  0/241 (0.00%)  1/240 (0.42%)  0/239 (0.00%) 
Cerebrovascular accident *  0/240 (0.00%)  0/241 (0.00%)  1/240 (0.42%)  0/239 (0.00%) 
Migraine with aura *  0/240 (0.00%)  0/241 (0.00%)  0/240 (0.00%)  1/239 (0.42%) 
Pregnancy, puerperium and perinatal conditions         
Abortion spontaneous *  1/240 (0.42%)  0/241 (0.00%)  1/240 (0.42%)  0/239 (0.00%) 
Abortion spontaneous incomplete *  0/240 (0.00%)  0/241 (0.00%)  2/240 (0.83%)  1/239 (0.42%) 
Ectopic pregnancy *  1/240 (0.42%)  0/241 (0.00%)  0/240 (0.00%)  0/239 (0.00%) 
Foetal distress syndrome * [1]  0/240 (0.00%)  0/241 (0.00%)  1/240 (0.42%)  0/239 (0.00%) 
Pre-eclampsia *  0/240 (0.00%)  1/241 (0.41%)  0/240 (0.00%)  0/239 (0.00%) 
Premature baby * [1]  0/240 (0.00%)  1/241 (0.41%)  0/240 (0.00%)  0/239 (0.00%) 
Abortion missed *  0/240 (0.00%)  1/241 (0.41%)  0/240 (0.00%)  0/239 (0.00%) 
Psychiatric disorders         
Abnormal behaviour *  0/240 (0.00%)  0/241 (0.00%)  0/240 (0.00%)  1/239 (0.42%) 
Anorexia nervosa *  0/240 (0.00%)  0/241 (0.00%)  1/240 (0.42%)  0/239 (0.00%) 
Bulimia nervosa *  0/240 (0.00%)  0/241 (0.00%)  1/240 (0.42%)  0/239 (0.00%) 
Depression *  0/240 (0.00%)  1/241 (0.41%)  1/240 (0.42%)  1/239 (0.42%) 
Major depression *  0/240 (0.00%)  1/241 (0.41%)  0/240 (0.00%)  0/239 (0.00%) 
Psychotic disorder *  0/240 (0.00%)  1/241 (0.41%)  0/240 (0.00%)  0/239 (0.00%) 
Suicide attempt *  0/240 (0.00%)  1/241 (0.41%)  0/240 (0.00%)  0/239 (0.00%) 
Renal and urinary disorders         
Cystitis haemorrhagic *  0/240 (0.00%)  1/241 (0.41%)  0/240 (0.00%)  0/239 (0.00%) 
Renal colic *  0/240 (0.00%)  0/241 (0.00%)  0/240 (0.00%)  1/239 (0.42%) 
Renal disorder *  0/240 (0.00%)  0/241 (0.00%)  0/240 (0.00%)  1/239 (0.42%) 
Reproductive system and breast disorders         
Adenomyosis *  1/240 (0.42%)  0/241 (0.00%)  0/240 (0.00%)  0/239 (0.00%) 
Ovarian cyst *  1/240 (0.42%)  0/241 (0.00%)  0/240 (0.00%)  0/239 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Hyperventilation *  0/240 (0.00%)  1/241 (0.41%)  0/240 (0.00%)  0/239 (0.00%) 
Skin and subcutaneous tissue disorders         
Erythema multiforme *  0/240 (0.00%)  0/241 (0.00%)  0/240 (0.00%)  1/239 (0.42%) 
Vascular disorders         
Circulatory collapse *  0/240 (0.00%)  1/241 (0.41%)  1/240 (0.42%)  0/239 (0.00%) 
*
Indicates events were collected by non-systematic assessment
[1]
SAE reported for the subject’s offspring
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 2 Group
Affected / at Risk (%) Affected / at Risk (%)