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

Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT00250276
Collaborator
(none)
798
Enrollment
8
Locations
4
Arms
16.1
Actual Duration (Months)
99.8
Patients Per Site
6.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Human papillomavirus infection has clearly been recognized as the cause of cervical cancer. Indeed, the infection of the cervix by certain oncogenic types of HPV, if not cleared , can lead over time to cervical cancer in women . This study will compare the immune response induced by different lots of the HPV-16/18 L1/AS04 vaccine, following adjustments to the manufacturing process.

Condition or Disease Intervention/Treatment Phase
  • Biological: Cervarix™
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
798 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Assess Lot-to-lot Consistency of GSK Biologicals' HPV-16/18 L1/AS04 Vaccine Following Manufacturing Adjustments Administered Intramuscularly According to a 0,1,6-mth Schedule in Healthy Female Subjects (18-25 y)
Actual Study Start Date :
Oct 28, 2005
Actual Primary Completion Date :
Mar 1, 2007
Actual Study Completion Date :
Mar 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cervarix Lot1 Group

Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.

Biological: Cervarix™
GSK Biologicals' vaccine against human papillomaviruses 16 and 18.
Experimental: Cervarix Lot2 Group

Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.

Biological: Cervarix™
GSK Biologicals' vaccine against human papillomaviruses 16 and 18.
Experimental: Cervarix Lot3 Group

Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.

Biological: Cervarix™
GSK Biologicals' vaccine against human papillomaviruses 16 and 18.
Experimental: Cervarix Low Group

Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.

Biological: Cervarix™
GSK Biologicals' vaccine against human papillomaviruses 16 and 18.

Outcome Measures

Primary Outcome Measures

  1. Number of Seroconverted (SCR) Subjects for Anti-Human Papillomavirus Type 16 (Anti-HPV-16) and Anti-Human Papillomavirus Type 18 (Anti-HPV-18) [At Month 7]

    Seroconversion was defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (anti-HPV-16 concentrations ≥8 Enzyme-Linked Immunosorbent Assay [ELISA] units per milliliter [EL.U/mL] and anti-HPV-18 concentrations ≥7 EL.U/mL) in the serum of subjects seronegative before vaccination.

  2. Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 [At Month 7]

    Seropositivity defined subjects with anti-HPV-16 antibody concentration ≥ 8 EL.U/mL and/or anti-HPV-18 antibody concentration ≥ 7 EL.U/mL.

Secondary Outcome Measures

  1. Number of SCR Subjects for Anti-HPV-16 and Anti-HPV-18 [At Month 2]

    Seroconversion was defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (anti-HPV-16 concentrations ≥8 ELISA units per milliliter [EL.U/mL] and anti-HPV-18 concentrations ≥7 EL.U/mL) in the serum of subjects seronegative before vaccination.

  2. Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 [At Month 2]

    Seropositivity defined subjects with anti-HPV-16 antibody concentration ≥ 8 EL.U/mL and/or anti-HPV-18 antibody concentration ≥ 7 EL.U/mL .

  3. Number of Subjects With Any and Grade 3 Solicited Local Symptoms [During the 7-days (Day 0-6) post-vaccination]

    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) diameter of injection site.

  4. Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms [During the 7-days (Day 0-6) post-vaccination]

    Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], gastro-intestinal, headache, myalgia, rash and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. Arthralgia (joint pain) = pain occurring in joints that were distal from the injection site. This outcome presents solicited general symptoms post dose 1 of vaccination.

  5. Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms [During the 7-days (Day 0-6) post-vaccination]

    Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], gastro-intestinal, headache, myalgia, rash and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. Arthralgia (joint pain) = pain occurring in joints that were distal from the injection site. This outcome presents solicited general symptoms post dose 2 of vaccination.

  6. Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms [During the 7-days (Day 0-6) post-vaccination]

    Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], gastro-intestinal, headache, myalgia, rash and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. Arthralgia (joint pain) = pain occurring in joints that were distal from the injection site. This outcome presents solicited general symptoms post dose 3 of vaccination.

  7. Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms [During the 7-days (Day 0-6) post-vaccination]

    Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], gastro-intestinal, headache, myalgia, rash and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. Arthralgia (joint pain) = pain occurring in joints that were distal from the injection site. This outcome presents results across vaccination doses for solicited general symptoms.

  8. Number of Subjects With New Onset Chronic Diseases (NOCDs) [From Month 0 to Month 7]

    NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.

  9. Number of Subjects With Medically Significant Adverse Events (MSAEs) [From Month 0 to Month 7]

    MSAEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.

  10. Number of Subjects With (NOCDs) [From Month 0 to Month 12]

    NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.

  11. Number of Subjects With MSAEs [From Month 0 to Month 12]

    MSAEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.

  12. Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) [Within 30 days (Day 0-29) post vaccination]

    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.

  13. Number of Subjects With Serious Adverse Events (SAEs) [From Month 0 to Month 7]

    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

  14. Number of Subjects With Serious Adverse Events (SAEs) [From Month 0 to Month 12]

    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 25 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • A female subject between, and including, 18 and 25 years of age at the time of the first vaccination.

  • Written informed consent obtained from the subject prior to enrolment.

  • Subject must have a negative urine pregnancy test.

  • Healthy subject before entering the study entry as established by medical history and physical examination.

  • Subject must be of non-childbearing potential.

Exclusion Criteria:

  • pregnant or breastfeeding subject.

  • previous vaccination against human papillomavirus (HPV).

  • Known acute or chronic, clinically significant neurologic, hepatic or renal functional abnormality.

  • History of chronic condition(s) requiring treatment such as cancer, chronic hepatic or kidney disease(s), diabetes or autoimmune disease.

Contacts and Locations

Locations

Site City State Country Postal Code
1 GSK Investigational Site Hvidovre Denmark DK-2650
2 GSK Investigational Site Kaunas Lithuania LT-50009
3 GSK Investigational Site Klaipeda Lithuania LT-93200
4 GSK Investigational Site Vilnius Lithuania LT-07156
5 GSK Investigational Site Vilnius Lithuania LT-10207
6 GSK Investigational Site Krakow Poland 31-501
7 GSK Investigational Site Poznan Poland 60-533
8 GSK Investigational Site Warszawa Poland 01-211

Sponsors and Collaborators

  • GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00250276
Other Study ID Numbers:
  • 104772
  • 2005-001667-58
First Posted:
Nov 8, 2005
Last Update Posted:
Jan 2, 2020
Last Verified:
Dec 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title Cervarix Lot1 Group Cervarix Lot2 Group Cervarix Lot3 Group Cervarix Low Group
Arm/Group Description Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm. Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm. Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm. Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Period Title: Overall Study
STARTED 199 198 201 200
COMPLETED 182 177 182 181
NOT COMPLETED 17 21 19 19

Baseline Characteristics

Arm/Group Title Cervarix Lot1 Group Cervarix Lot2 Group Cervarix Lot3 Group Cervarix Low Group Total
Arm/Group Description Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm. Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm. Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm. Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm. Total of all reporting groups
Overall Participants 199 198 201 200 798
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]
21.8
(2.08)
21.8
(2.08)
21.9
(2.00)
22.0
(1.96)
21.88
(2.03)
Sex: Female, Male (Count of Participants)
Female
199
100%
198
100%
201
100%
200
100%
798
100%
Male
0
0%
0
0%
0
0%
0
0%
0
0%

Outcome Measures

1. Primary Outcome
Title Number of Seroconverted (SCR) Subjects for Anti-Human Papillomavirus Type 16 (Anti-HPV-16) and Anti-Human Papillomavirus Type 18 (Anti-HPV-18)
Description Seroconversion was defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (anti-HPV-16 concentrations ≥8 Enzyme-Linked Immunosorbent Assay [ELISA] units per milliliter [EL.U/mL] and anti-HPV-18 concentrations ≥7 EL.U/mL) in the serum of subjects seronegative before vaccination.
Time Frame At Month 7

Outcome Measure Data

Analysis Population Description
The According-to-Protocol cohort for immunogenicity included all evaluable subjects from whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine component at Month 7.
Arm/Group Title Cervarix Lot1 Group Cervarix Lot2 Group Cervarix Lot3 Group Pooled Group Cervarix Low Group
Arm/Group Description Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm. Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm. Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm. The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis. Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Measure Participants 129 143 135 407 117
Anti-HPV-16
118
59.3%
127
64.1%
126
62.7%
371
185.5%
102
12.8%
Anti-HPV-18
129
64.8%
143
72.2%
135
67.2%
407
203.5%
117
14.7%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cervarix Lot1 Group, Cervarix Lot2 Group
Comments To demonstrate lot-to-lot consistency in terms of immunogenicity between the 3 industrial production lots (600L scale) of the Cervarix™ vaccine, one month post dose 3 (Month 7). If consistency was demonstrated the 3 lots would be pooled and non-inferiority of the 600L scale lot vaccine versus the 80L scale would be evaluated as a second primary objective.
Type of Statistical Test Non-Inferiority or Equivalence (legacy)
Comments The first primary objective was reached as the 95% Confidence Interval (CI) of the GMC ratio between lots was within [0.5;2] for the anti-HPV-16 antibodies.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter GMC ratio for anti-HPV-16 antibody
Estimated Value 1.04
Confidence Interval (2-Sided) 95%
0.81 to 1.34
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cervarix Lot1 Group, Cervarix Lot2 Group
Comments To demonstrate lot-to-lot consistency in terms of immunogenicity between the 3 industrial production lots (600L scale) of the Cervarix™ vaccine, one month post dose 3 (Month 7). If consistency was demonstrated the 3 lots would be pooled and non-inferiority of the 600L scale lot vaccine versus the 80L scale would be evaluated as a second primary objective.
Type of Statistical Test Non-Inferiority or Equivalence (legacy)
Comments The first primary objective was reached as the 95% CIs of the GMC ratio between lots were within [0.5;2] for the anti-HPV-18 antibodies.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter GMC ratio for anti-HPV-18 antibody
Estimated Value 1.19
Confidence Interval (2-Sided) 95%
0.95 to 1.49
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Cervarix Lot1 Group, Cervarix Lot3 Group
Comments To demonstrate lot-to-lot consistency in terms of immunogenicity between the 3 industrial production lots (600L scale) of the Cervarix™ vaccine, one month post dose 3 (Month 7). If consistency was demonstrated the 3 lots would be pooled and non-inferiority of the 600L scale lot vaccine versus the 80L scale would be evaluated as a second primary objective.
Type of Statistical Test Non-Inferiority or Equivalence (legacy)
Comments The first primary objective was reached as the 95% CIs of the GMC ratio between lots were within [0.5;2] for the anti-HPV-16 antibodies.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter GMC ratio for anti-HPV-16 antibody
Estimated Value 1.26
Confidence Interval (2-Sided) 95%
0.98 to 1.63
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Cervarix Lot1 Group, Cervarix Lot3 Group
Comments To demonstrate lot-to-lot consistency in terms of immunogenicity between the 3 industrial production lots (600L scale) of the Cervarix™ vaccine, one month post dose 3 (Month 7). If consistency was demonstrated the 3 lots would be pooled and non-inferiority of the 600L scale lot vaccine versus the 80L scale would be evaluated as a second primary objective.
Type of Statistical Test Non-Inferiority or Equivalence (legacy)
Comments The first primary objective was reached as the 95% CIs of the GMC ratio between lots were within [0.5;2] for the anti-HPV-18 antibodies.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter GMC ratio for anti-HPV-18 antibody
Estimated Value 1.48
Confidence Interval (2-Sided) 95%
1.18 to 1.85
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Cervarix Lot2 Group, Cervarix Lot3 Group
Comments To demonstrate lot-to-lot consistency in terms of immunogenicity between the 3 industrial production lots (600L scale) of the Cervarix™ vaccine, one month post dose 3 (Month 7). If consistency was demonstrated the 3 lots would be pooled and non-inferiority of the 600L scale lot vaccine versus the 80L scale would be evaluated as a second primary objective.
Type of Statistical Test Non-Inferiority or Equivalence (legacy)
Comments The first primary objective was reached as the 95% CIs of the GMC ratio between lots were within [0.5;2] for the anti-HPV-16 antibodies.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter GMT ratio for anti-HPV-16 antibody
Estimated Value 1.21
Confidence Interval (2-Sided) 95%
0.94 to 1.55
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Cervarix Lot2 Group, Cervarix Lot3 Group
Comments To demonstrate lot-to-lot consistency in terms of immunogenicity between the 3 industrial production lots (600L scale) of the Cervarix™ vaccine, one month post dose 3 (Month 7). If consistency was demonstrated the 3 lots would be pooled and non-inferiority of the 600L scale lot vaccine versus the 80L scale would be evaluated as a second primary objective.
Type of Statistical Test Non-Inferiority or Equivalence (legacy)
Comments The first primary objective was reached as the 95% CIs of the GMC ratio between lots were within [0.5;2] for the anti-HPV-18 antibodies.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter GMC ratio for anti-HPV-18 antibody
Estimated Value 1.24
Confidence Interval (2-Sided) 95%
1.00 to 1.55
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Pooled Group, Cervarix Low Group
Comments To demonstrate that the Cervarix™ vaccine produced at 600L manufacturing scale was non-inferior in terms of immunogenicity to the Cervarix™ vaccine produced at 80L scale, one month after the third dose (Month 7).
Type of Statistical Test Non-Inferiority or Equivalence (legacy)
Comments The second primary objective was reached as the upper limit of the 95% CI of the difference in seroconversion rates for anti-HPV-16 antibodies was below 5%.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Difference in seroconversion rate
Estimated Value 0.00
Confidence Interval (2-Sided) 95%
-3.63 to 1.02
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Pooled Group, Cervarix Low Group
Comments To demonstrate that the Cervarix™ vaccine produced at 600L manufacturing scale was non-inferior in terms of immunogenicity to the Cervarix™ vaccine produced at 80L scale, on month after the third dose (Month 7).
Type of Statistical Test Non-Inferiority or Equivalence (legacy)
Comments The second primary objective was reached as the upper limit of the 95% CI of the difference in seroconversion rates for anti-HPV-18 antibodies was below 5%.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Difference in seroconversion rate
Estimated Value 0.00
Confidence Interval (2-Sided) 95%
-3.18 to 0.94
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Pooled Group, Cervarix Low Group
Comments To demonstrate that the Cervarix™ vaccine produced at 600L manufacturing scale was non-inferior in terms of immunogenicity to the Cervarix™ vaccine produced at 80L scale, on month after the third dose (Month 7).
Type of Statistical Test Non-Inferiority or Equivalence (legacy)
Comments The second primary objective was reached as the upper limit of the 95% CI of the GMC rates for anti-HPV-16 was below 2%.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter GMC ratio for anti-HPV-16 antibody
Estimated Value 0.87
Confidence Interval (2-Sided) 95%
0.70 to 1.08
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Pooled Group, Cervarix Low Group
Comments To demonstrate that the Cervarix™ vaccine produced at 600L manufacturing scale was non-inferior in terms of immunogenicity to the Cervarix™ vaccine produced at 80L scale, on month after the third dose (Month 7).
Type of Statistical Test Non-Inferiority or Equivalence (legacy)
Comments The second primary objective was reached as the upper limit of the 95% CI of the GMC rates anti-HPV-18 antibodies was below 2%.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter GMC ratio for anti-HPV-18 antibody
Estimated Value 0.80
Confidence Interval (2-Sided) 95%
0.66 to 0.97
Parameter Dispersion Type:
Value:
Estimation Comments
2. Primary Outcome
Title Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18
Description Seropositivity defined subjects with anti-HPV-16 antibody concentration ≥ 8 EL.U/mL and/or anti-HPV-18 antibody concentration ≥ 7 EL.U/mL.
Time Frame At Month 7

Outcome Measure Data

Analysis Population Description
The According-to-Protocol cohort for immunogenicity included all evaluable subjects from whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine component at Month 7.
Arm/Group Title Cervarix Lot1 Group Cervarix Lot2 Group Cervarix Lot3 Group Cervarix Low Group
Arm/Group Description Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm. Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm. Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm. Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Measure Participants 54 38 43 57
Anti-HPV-16
54
27.1%
38
19.2%
43
21.4%
57
28.5%
Anti-HPV-18
43
21.6%
22
11.1%
34
16.9%
41
20.5%
3. Secondary Outcome
Title Number of SCR Subjects for Anti-HPV-16 and Anti-HPV-18
Description Seroconversion was defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (anti-HPV-16 concentrations ≥8 ELISA units per milliliter [EL.U/mL] and anti-HPV-18 concentrations ≥7 EL.U/mL) in the serum of subjects seronegative before vaccination.
Time Frame At Month 2

Outcome Measure Data

Analysis Population Description
The According-to-Protocol cohort for immunogenicity included all evaluable subjects from whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine component at Month 2.
Arm/Group Title Cervarix Lot1 Group Cervarix Lot2 Group Cervarix Lot3 Group Cervarix Low Group
Arm/Group Description Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm. Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm. Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm. Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Measure Participants 128 142 134 116
Anti-HPV-16
117
58.8%
126
63.6%
125
62.2%
102
51%
Anti-HPV-18
128
64.3%
142
71.7%
134
66.7%
116
58%
4. Secondary Outcome
Title Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18
Description Seropositivity defined subjects with anti-HPV-16 antibody concentration ≥ 8 EL.U/mL and/or anti-HPV-18 antibody concentration ≥ 7 EL.U/mL .
Time Frame At Month 2

Outcome Measure Data

Analysis Population Description
The According-to-Protocol cohort for immunogenicity included all evaluable subjects from whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine component at Month 2.
Arm/Group Title Cervarix Lot1 Group Cervarix Lot2 Group Cervarix Lot3 Group Cervarix Low Group
Arm/Group Description Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm. Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm. Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm. Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Measure Participants 54 38 43 56
Anti-HPV-16
54
27.1%
38
19.2%
43
21.4%
56
28%
Anti-HPV-18
43
21.6%
22
11.1%
34
16.9%
41
20.5%
5. Secondary Outcome
Title Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Description Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) diameter of injection site.
Time Frame During the 7-days (Day 0-6) post-vaccination

Outcome Measure Data

Analysis Population Description
The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at least one vaccine administration documented.
Arm/Group Title Cervarix Lot1 Group Cervarix Lot2 Group Cervarix Lot3 Group Pooled Group Cervarix Low Group
Arm/Group Description Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm. Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm. Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm. The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis. Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Measure Participants 198 197 199 594 197
Any Pain Dose 1
188
94.5%
190
96%
178
88.6%
556
278%
185
23.2%
Grade 3 Pain Dose 1
20
10.1%
16
8.1%
17
8.5%
53
26.5%
12
1.5%
Any Redness Dose 1
74
37.2%
71
35.9%
77
38.3%
222
111%
75
9.4%
Grade 3 Redness Dose 1
0
0%
0
0%
0
0%
0
0%
0
0%
Any Swelling Dose 1
58
29.1%
57
28.8%
57
28.4%
172
86%
54
6.8%
Grade 3 Swelling Dose 1
9
4.5%
2
1%
2
1%
13
6.5%
4
0.5%
Any Pain Dose 2
167
83.9%
166
83.8%
170
84.6%
503
251.5%
161
20.2%
Grade 3 Pain Dose 2
17
8.5%
10
5.1%
19
9.5%
46
23%
12
1.5%
Any Redness Dose 2
78
39.2%
85
42.9%
79
39.3%
242
121%
62
7.8%
Grade 3 Redness Dose 2
3
1.5%
6
3%
0
0%
9
4.5%
1
0.1%
Any Swelling Dose 2
64
32.2%
59
29.8%
56
27.9%
179
89.5%
53
6.6%
Grade 3 Swelling Dose 2
7
3.5%
2
1%
2
1%
11
5.5%
5
0.6%
Any Pain Dose 3
164
82.4%
151
76.3%
162
80.6%
477
238.5%
156
19.5%
Grade 3 Pain Dose 3
21
10.6%
14
7.1%
11
5.5%
46
23%
15
1.9%
Any Redness Dose 3
94
47.2%
102
51.5%
96
47.8%
292
146%
92
11.5%
Grade 3 Redness Dose 3
5
2.5%
6
3%
4
2%
15
7.5%
5
0.6%
Any Swelling Dose 3
92
46.2%
84
42.4%
85
42.3%
261
130.5%
82
10.3%
Grade 3 Swelling Dose 3
8
4%
3
1.5%
2
1%
13
6.5%
3
0.4%
Any Pain Across
194
97.5%
192
97%
190
94.5%
576
288%
192
24.1%
Grade 3 Pain Across
45
22.6%
29
14.6%
34
16.9%
108
54%
30
3.8%
Any Redness Across
118
59.3%
128
64.6%
127
63.2%
373
186.5%
126
15.8%
Grade 3 Redness Across
8
4%
9
4.5%
4
2%
21
10.5%
6
0.8%
Any Swelling Across
116
58.3%
112
56.6%
113
56.2%
341
170.5%
107
13.4%
Grade 3 Swelling Across
15
7.5%
6
3%
6
3%
27
13.5%
10
1.3%
6. Secondary Outcome
Title Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Description Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], gastro-intestinal, headache, myalgia, rash and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. Arthralgia (joint pain) = pain occurring in joints that were distal from the injection site. This outcome presents solicited general symptoms post dose 1 of vaccination.
Time Frame During the 7-days (Day 0-6) post-vaccination

Outcome Measure Data

Analysis Population Description
The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at least one vaccine administration documented.
Arm/Group Title Cervarix Lot1 Group Cervarix Lot2 Group Cervarix Lot3 Group Pooled Group Cervarix Low Group
Arm/Group Description Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm. Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm. Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm. The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis. Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Measure Participants 198 197 199 594 196
Any Arthralgia
19
9.5%
19
9.6%
13
6.5%
51
25.5%
17
2.1%
Grade 3 Arthralgia
1
0.5%
0
0%
2
1%
3
1.5%
0
0%
Related Arthralgia
14
7%
17
8.6%
8
4%
39
19.5%
14
1.8%
Any Fatigue
81
40.7%
84
42.4%
73
36.3%
238
119%
80
10%
Grade 3 Fatigue
4
2%
1
0.5%
4
2%
9
4.5%
5
0.6%
Related Fatigue
60
30.2%
62
31.3%
48
23.9%
170
85%
61
7.6%
Any Fever
4
2%
7
3.5%
4
2%
15
7.5%
5
0.6%
Grade 3 Fever
0
0%
0
0%
0
0%
0
0%
0
0%
Related Fever
1
0.5%
5
2.5%
3
1.5%
9
4.5%
3
0.4%
Any Gastro-intestinal
32
16.1%
39
19.7%
34
16.9%
105
52.5%
30
3.8%
Grade 3 Gastro-intestinal
1
0.5%
2
1%
0
0%
3
1.5%
1
0.1%
Related Gastro-intestinal
17
8.5%
24
12.1%
19
9.5%
60
30%
19
2.4%
Any Headache
69
34.7%
70
35.4%
60
29.9%
199
99.5%
65
8.1%
Grade 3 Headache
8
4%
4
2%
2
1%
14
7%
4
0.5%
Related Headache
44
22.1%
49
24.7%
38
18.9%
131
65.5%
46
5.8%
Any Myalgia
45
22.6%
55
27.8%
50
24.9%
150
75%
42
5.3%
Grade 3 Myalgia
3
1.5%
2
1%
3
1.5%
8
4%
0
0%
Related Myalgia
36
18.1%
44
22.2%
41
20.4%
121
60.5%
30
3.8%
Any Rash
4
2%
4
2%
6
3%
14
7%
5
0.6%
Grade 3 Rash
0
0%
0
0%
0
0%
0
0%
0
0%
Related Rash
2
1%
3
1.5%
4
2%
9
4.5%
4
0.5%
Any Urticaria
5
2.5%
3
1.5%
3
1.5%
11
5.5%
4
0.5%
Grade 3 Urticaria
0
0%
0
0%
0
0%
0
0%
0
0%
Related Urticaria
2
1%
2
1%
2
1%
6
3%
4
0.5%
7. Secondary Outcome
Title Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Description Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], gastro-intestinal, headache, myalgia, rash and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. Arthralgia (joint pain) = pain occurring in joints that were distal from the injection site. This outcome presents solicited general symptoms post dose 2 of vaccination.
Time Frame During the 7-days (Day 0-6) post-vaccination

Outcome Measure Data

Analysis Population Description
The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at last one vaccine administration documented.
Arm/Group Title Cervarix Lot1 Group Cervarix Lot2 Group Cervarix Lot3 Group Pooled Group Cervarix Low Group
Arm/Group Description Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm. Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm. Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm. The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis. Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Measure Participants 195 195 198 588 193
Any Arthralgia
14
7%
14
7.1%
14
7%
42
21%
17
2.1%
Grade 3 Arthralgia
0
0%
0
0%
1
0.5%
1
0.5%
0
0%
Related Arthralgia
12
6%
11
5.6%
10
5%
33
16.5%
14
1.8%
Any Fatigue
63
31.7%
73
36.9%
69
34.3%
205
102.5%
58
7.3%
Grade 3 Fatigue
2
1%
4
2%
3
1.5%
9
4.5%
5
0.6%
Related Fatigue
39
19.6%
55
27.8%
38
18.9%
132
66%
40
5%
Any Fever
7
3.5%
5
2.5%
7
3.5%
19
9.5%
5
0.6%
Grade 3 Fever
0
0%
0
0%
0
0%
0
0%
0
0%
Related Fever
5
2.5%
2
1%
2
1%
9
4.5%
3
0.4%
Any Gastro-intestinal
22
11.1%
21
10.6%
28
13.9%
71
35.5%
24
3%
Grade 3 Gastro-intestinal
1
0.5%
0
0%
1
0.5%
2
1%
1
0.1%
Related Gastro-intestinal
14
7%
14
7.1%
12
6%
40
20%
9
1.1%
Any Headache
47
23.6%
51
25.8%
46
22.9%
144
72%
41
5.1%
Grade 3 Headache
2
1%
4
2%
2
1%
8
4%
1
0.1%
Related Headache
27
13.6%
33
16.7%
29
14.4%
89
44.5%
24
3%
Any Myalgia
30
15.1%
37
18.7%
39
19.4%
106
53%
31
3.9%
Grade 3 Myalgia
0
0%
1
0.5%
3
1.5%
4
2%
1
0.1%
Related Myalgia
22
11.1%
30
15.2%
31
15.4%
83
41.5%
21
2.6%
Any Rash
1
0.5%
3
1.5%
8
4%
12
6%
5
0.6%
Grade 3 Rash
0
0%
0
0%
0
0%
0
0%
0
0%
Related Rash
1
0.5%
3
1.5%
5
2.5%
9
4.5%
3
0.4%
Any Urticaria
2
1%
2
1%
2
1%
6
3%
5
0.6%
Grade 3 Urticaria
0
0%
0
0%
0
0%
0
0%
0
0%
Related Urticaria
0
0%
1
0.5%
2
1%
3
1.5%
3
0.4%
8. Secondary Outcome
Title Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Description Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], gastro-intestinal, headache, myalgia, rash and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. Arthralgia (joint pain) = pain occurring in joints that were distal from the injection site. This outcome presents solicited general symptoms post dose 3 of vaccination.
Time Frame During the 7-days (Day 0-6) post-vaccination

Outcome Measure Data

Analysis Population Description
The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at last one vaccine administration documented.
Arm/Group Title Cervarix Lot1 Group Cervarix Lot2 Group Cervarix Lot3 Group Pooled Group Cervarix Low Group
Arm/Group Description Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm. Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm. Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm. The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis. Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Measure Participants 181 178 184 543 181
Any Arthralgia
18
9%
19
9.6%
18
9%
55
27.5%
13
1.6%
Grade 3 Arthralgia
1
0.5%
1
0.5%
0
0%
2
1%
0
0%
Related Arthralgia
15
7.5%
16
8.1%
12
6%
43
21.5%
11
1.4%
Any Fatigue
76
38.2%
67
33.8%
64
31.8%
207
103.5%
60
7.5%
Grade 3 Fatigue
9
4.5%
1
0.5%
2
1%
12
6%
6
0.8%
Related Fatigue
58
29.1%
50
25.3%
49
24.4%
157
78.5%
49
6.1%
Any Fever
7
3.5%
6
3%
4
2%
17
8.5%
8
1%
Grade 3 Fever
0
0%
0
0%
1
0.5%
1
0.5%
0
0%
Related Fever
1
0.5%
4
2%
1
0.5%
6
3%
4
0.5%
Any Gastro-intestinal
17
8.5%
19
9.6%
25
12.4%
61
30.5%
15
1.9%
Grade 3 Gastro-intestinal
2
1%
1
0.5%
1
0.5%
4
2%
3
0.4%
Related Gastro-intestinal
8
4%
9
4.5%
14
7%
31
15.5%
7
0.9%
Any Headache
53
26.6%
44
22.2%
49
24.4%
146
73%
39
4.9%
Grade 3 Headache
5
2.5%
2
1%
4
2%
11
5.5%
1
0.1%
Related Headache
34
17.1%
31
15.7%
29
14.4%
94
47%
30
3.8%
Any Myalgia
44
22.1%
38
19.2%
39
19.4%
121
60.5%
29
3.6%
Grade 3 Myalgia
3
1.5%
2
1%
1
0.5%
6
3%
1
0.1%
Related Myalgia
35
17.6%
35
17.7%
32
15.9%
102
51%
24
3%
Any Rash
7
3.5%
4
2%
9
4.5%
20
10%
9
1.1%
Grade 3 Rash
0
0%
0
0%
0
0%
0
0%
0
0%
Related Rash
5
2.5%
2
1%
6
3%
13
6.5%
6
0.8%
Any Urticaria
3
1.5%
0
0%
5
2.5%
8
4%
6
0.8%
Grade 3 Urticaria
0
0%
0
0%
0
0%
0
0%
0
0%
Related Urticaria
1
0.5%
0
0%
2
1%
3
1.5%
4
0.5%
9. Secondary Outcome
Title Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Description Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], gastro-intestinal, headache, myalgia, rash and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. Arthralgia (joint pain) = pain occurring in joints that were distal from the injection site. This outcome presents results across vaccination doses for solicited general symptoms.
Time Frame During the 7-days (Day 0-6) post-vaccination

Outcome Measure Data

Analysis Population Description
The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at last one vaccine administration documented.
Arm/Group Title Cervarix Lot1 Group Cervarix Lot2 Group Cervarix Lot3 Group Pooled Group Cervarix Low Group
Arm/Group Description Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm. Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm. Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm. The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis. Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Measure Participants 198 197 199 594 197
Any Arthralgia
38
19.1%
40
20.2%
32
15.9%
110
55%
35
4.4%
Grade 3 Arthralgia
2
1%
1
0.5%
2
1%
5
2.5%
0
0%
Related Arthralgia
31
15.6%
32
16.2%
22
10.9%
85
42.5%
31
3.9%
Any Fatigue
117
58.8%
117
59.1%
106
52.7%
340
170%
105
13.2%
Grade 3 Fatigue
13
6.5%
6
3%
8
4%
27
13.5%
12
1.5%
Related Fatigue
90
45.2%
95
48%
78
38.8%
263
131.5%
90
11.3%
Any Fever
16
8%
18
9.1%
14
7%
48
24%
15
1.9%
Grade 3 Fever
0
0%
0
0%
1
0.5%
1
0.5%
0
0%
Related Fever
6
3%
11
5.6%
5
2.5%
22
11%
7
0.9%
Any Gastro-intestinal
55
27.6%
61
30.8%
57
28.4%
173
86.5%
49
6.1%
Grade 3 Gastro-intestinal
4
2%
3
1.5%
2
1%
9
4.5%
5
0.6%
Related Gastro-intestinal
32
16.1%
38
19.2%
33
16.4%
103
51.5%
25
3.1%
Any Headache
99
49.7%
103
52%
95
47.3%
297
148.5%
93
11.7%
Grade 3 Headache
14
7%
9
4.5%
8
4%
31
15.5%
5
0.6%
Related Headache
68
34.2%
77
38.9%
57
28.4%
202
101%
68
8.5%
Any Myalgia
75
37.7%
82
41.4%
73
36.3%
230
115%
66
8.3%
Grade 3 Myalgia
6
3%
5
2.5%
6
3%
17
8.5%
2
0.3%
Related Myalgia
62
31.2%
70
35.4%
62
30.8%
194
97%
48
6%
Any Rash
11
5.5%
10
5.1%
19
9.5%
40
20%
15
1.9%
Grade 3 Rash
0
0%
0
0%
0
0%
0
0%
0
0%
Related Rash
7
3.5%
7
3.5%
13
6.5%
27
13.5%
11
1.4%
Any Urticaria
7
3.5%
5
2.5%
7
3.5%
19
9.5%
10
1.3%
Grade 3 Urticaria
0
0%
0
0%
0
0%
0
0%
0
0%
Related Urticaria
3
1.5%
3
1.5%
4
2%
10
5%
8
1%
10. Secondary Outcome
Title Number of Subjects With New Onset Chronic Diseases (NOCDs)
Description NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.
Time Frame From Month 0 to Month 7

Outcome Measure Data

Analysis Population Description
The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at last one vaccine administration documented.
Arm/Group Title Cervarix Lot1 Group Cervarix Lot2 Group Cervarix Lot3 Group Pooled Group Cervarix Low Group
Arm/Group Description Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm. Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm. Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm. The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis. Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Measure Participants 199 198 201 598 200
Count of Participants [Participants]
3
1.5%
4
2%
7
3.5%
14
7%
3
0.4%
11. Secondary Outcome
Title Number of Subjects With Medically Significant Adverse Events (MSAEs)
Description MSAEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
Time Frame From Month 0 to Month 7

Outcome Measure Data

Analysis Population Description
The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at last one vaccine administration documented.
Arm/Group Title Pooled Group Cervarix Low Group
Arm/Group Description The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis. Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured at lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Measure Participants 598 200
Count of Participants [Participants]
71
35.7%
23
11.6%
12. Secondary Outcome
Title Number of Subjects With (NOCDs)
Description NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.
Time Frame From Month 0 to Month 12

Outcome Measure Data

Analysis Population Description
The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at last one vaccine administration documented.
Arm/Group Title Cervarix Lot1 Group Cervarix Lot2 Group Cervarix Lot3 Group Pooled Group Cervarix Low Group
Arm/Group Description Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm. Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm. Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm. The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis. Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Measure Participants 199 198 201 598 200
Count of Participants [Participants]
4
2%
4
2%
7
3.5%
15
7.5%
3
0.4%
13. Secondary Outcome
Title Number of Subjects With MSAEs
Description MSAEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
Time Frame From Month 0 to Month 12

Outcome Measure Data

Analysis Population Description
The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at last one vaccine administration documented.
Arm/Group Title Pooled Group Cervarix Low Group
Arm/Group Description The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis. Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured at lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Measure Participants 598 200
Count of Participants [Participants]
78
39.2%
23
11.6%
14. Secondary Outcome
Title Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Description An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Time Frame Within 30 days (Day 0-29) post vaccination

Outcome Measure Data

Analysis Population Description
The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at last one vaccine administration documented.
Arm/Group Title Cervarix Lot1 Group Cervarix Lot2 Group Cervarix Lot3 Group Pooled Group Cervarix Low Group
Arm/Group Description Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm. Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm. Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm. The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis. Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Measure Participants 199 198 201 598 200
Any (AEs)
58
29.1%
56
28.3%
76
37.8%
190
95%
67
8.4%
Grade 3 (AEs)
5
2.5%
6
3%
14
7%
25
12.5%
7
0.9%
Related (AEs)
22
11.1%
23
11.6%
30
14.9%
75
37.5%
32
4%
15. Secondary Outcome
Title Number of Subjects With Serious Adverse Events (SAEs)
Description Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time Frame From Month 0 to Month 7

Outcome Measure Data

Analysis Population Description
The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at least one vaccine administration documented.
Arm/Group Title Cervarix Lot1 Group Cervarix Lot2 Group Cervarix Lot3 Group Pooled Group Cervarix Low Group
Arm/Group Description Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm. Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm. Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm. The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis. Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Measure Participants 199 198 201 598 200
Count of Participants [Participants]
2
1%
0
0%
2
1%
4
2%
3
0.4%
16. Secondary Outcome
Title Number of Subjects With Serious Adverse Events (SAEs)
Description Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time Frame From Month 0 to Month 12

Outcome Measure Data

Analysis Population Description
The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at least one vaccine administration documented.
Arm/Group Title Cervarix Lot1 Group Cervarix Lot2 Group Cervarix Lot3 Group Pooled Group Cervarix Low Group
Arm/Group Description Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm. Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm. Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm. The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis. Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Measure Participants 199 198 201 598 200
Count of Participants [Participants]
6
3%
1
0.5%
2
1%
9
4.5%
3
0.4%

Adverse Events

Time Frame Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).
Adverse Event Reporting Description
Arm/Group Title Cervarix Lot1 Group Cervarix Lot2 Group Cervarix Lot3 Group Pooled Group Cervarix Low Group
Arm/Group Description Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm. Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm. Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm. The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis. Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
All Cause Mortality
Cervarix Lot1 Group Cervarix Lot2 Group Cervarix Lot3 Group Pooled Group Cervarix Low Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total / (NaN) / (NaN) / (NaN) / (NaN) / (NaN)
Serious Adverse Events
Cervarix Lot1 Group Cervarix Lot2 Group Cervarix Lot3 Group Pooled Group Cervarix Low Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 6/199 (3%) 1/198 (0.5%) 2/201 (1%) 9/598 (1.5%) 3/200 (1.5%)
Cardiac disorders
Supraventricular tachycardia 0/199 (0%) 0/198 (0%) 0/201 (0%) 0/598 (0%) 1/200 (0.5%)
Endocrine disorders
Basedow's disease 1/199 (0.5%) 0/198 (0%) 0/201 (0%) 1/598 (0.2%) 0/200 (0%)
Infections and infestations
Appendicitis 0/199 (0%) 0/198 (0%) 0/201 (0%) 0/598 (0%) 2/200 (1%)
Cerebral malaria 1/199 (0.5%) 0/198 (0%) 0/201 (0%) 1/598 (0.2%) 0/200 (0%)
Pelvic inflammatory disease 1/199 (0.5%) 0/198 (0%) 0/201 (0%) 1/598 (0.2%) 0/200 (0%)
Tuberculosis 1/199 (0.5%) 0/198 (0%) 0/201 (0%) 1/598 (0.2%) 0/200 (0%)
Injury, poisoning and procedural complications
Femur fracture 1/199 (0.5%) 0/198 (0%) 0/201 (0%) 1/598 (0.2%) 0/200 (0%)
Road traffic accident 0/199 (0%) 0/198 (0%) 1/201 (0.5%) 1/598 (0.2%) 0/200 (0%)
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion 0/199 (0%) 0/198 (0%) 1/201 (0.5%) 1/598 (0.2%) 0/200 (0%)
Nervous system disorders
Syncope 0/199 (0%) 0/198 (0%) 0/201 (0%) 0/598 (0%) 1/200 (0.5%)
Pregnancy, puerperium and perinatal conditions
Abortion missed 0/199 (0%) 1/198 (0.5%) 0/201 (0%) 1/598 (0.2%) 0/200 (0%)
Abortion spontaneous 1/199 (0.5%) 0/198 (0%) 0/201 (0%) 1/598 (0.2%) 0/200 (0%)
Other (Not Including Serious) Adverse Events
Cervarix Lot1 Group Cervarix Lot2 Group Cervarix Lot3 Group Pooled Group Cervarix Low Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 196/199 (98.5%) 194/198 (98%) 191/201 (95%) 581/598 (97.2%) 194/200 (97%)
General disorders
Pain 194/198 (98%) 192/197 (97.5%) 190/199 (95.5%) 576/594 (97%) 192/197 (97.5%)
Redness 118/198 (59.6%) 128/197 (65%) 127/199 (63.8%) 373/594 (62.8%) 126/197 (64%)
Swelling 116/198 (58.6%) 112/197 (56.9%) 113/199 (56.8%) 341/594 (57.4%) 107/197 (54.3%)
Arthralgia 38/198 (19.2%) 40/197 (20.3%) 32/199 (16.1%) 110/594 (18.5%) 35/197 (17.8%)
Fatigue 117/198 (59.1%) 117/197 (59.4%) 106/199 (53.3%) 340/594 (57.2%) 105/197 (53.3%)
Fever/(Axillary) (°C) 16/198 (8.1%) 18/197 (9.1%) 14/199 (7%) 48/594 (8.1%) 15/197 (7.6%)
Gastrointestinal 55/198 (27.8%) 61/197 (31%) 57/199 (28.6%) 173/594 (29.1%) 49/197 (24.9%)
Headache 99/198 (50%) 103/197 (52.3%) 95/199 (47.7%) 297/594 (50%) 93/197 (47.2%)
Myalgia 75/198 (37.9%) 82/197 (41.6%) 73/199 (36.7%) 230/594 (38.7%) 66/197 (33.5%)
Rash 11/198 (5.6%) 10/197 (5.1%) 19/199 (9.5%) 40/594 (6.7%) 15/197 (7.6%)
Urticaria 7/198 (3.5%) 5/197 (2.5%) 7/199 (3.5%) 19/594 (3.2%) 10/197 (5.1%)
Injection site pruritus 7/199 (3.5%) 3/198 (1.5%) 4/201 (2%) 14/598 (2.3%) 10/200 (5%)
Infections and infestations
Nasopharyngitis 8/199 (4%) 8/198 (4%) 10/201 (5%) 26/598 (4.3%) 7/200 (3.5%)

Limitations/Caveats

None reported.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

Results Point of Contact

Name/Title GSK Response Center
Organization GlaxoSmithKline
Phone 866-435-7343
Email
Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00250276
Other Study ID Numbers:
  • 104772
  • 2005-001667-58
First Posted:
Nov 8, 2005
Last Update Posted:
Jan 2, 2020
Last Verified:
Dec 1, 2019