Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 13 of 91 for:    cervarix

Follow-up Study to Evaluate the Safety and Immunogenicity of a HPV Vaccine (580299) in North America

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00546078
Recruitment Status : Completed
First Posted : October 18, 2007
Results First Posted : December 15, 2009
Last Update Posted : June 25, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Infections, Papillomavirus
Intervention Biological: Cervarix™
Enrollment 116
Recruitment Details  
Pre-assignment Details One subject that enrolled into the study was not vaccinated and as such not reported as started in the participant flow.
Arm/Group Title Cervarix™ 4-Dose Group Cervarix™ 3-Dose Group
Hide Arm/Group Description Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study. Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
Period Title: Overall Study
Started 65 50
Month 18 61 45
Completed 61 43
Not Completed 4 7
Reason Not Completed
Lost to Follow-up             1             3
Withdrawal by Subject             2             3
Other reason             1             1
Arm/Group Title Cervarix™ 4-Dose Group Cervarix™ 3-Dose Group Total
Hide Arm/Group Description Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study. Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study. Total of all reporting groups
Overall Number of Baseline Participants 65 50 115
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 65 participants 50 participants 115 participants
27.8  (2.82) 27.0  (2.89) 27.5  (2.87)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants 50 participants 115 participants
Female
65
 100.0%
50
 100.0%
115
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Number of Subjects With Anti-human Papilloma Virus-16 (Anti-HPV-16) and Anti-HPV-18 Antibody Titers Greater Than or Equal to Pre-defined Cut-off Values
Hide Description Cut-off values assessed include 8 Enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.
Time Frame At Day 7 and Month 1 (Day 30)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity.
Arm/Group Title Cervarix™ 4-Dose Group Cervarix™ 3-Dose Group
Hide Arm/Group Description:
Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
Overall Number of Participants Analyzed 61 45
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-HPV-16 at Day 7 Number Analyzed 61 participants 45 participants
61
 100.0%
30
  66.7%
Anti-HPV-16 at Month 1 Number Analyzed 57 participants 45 participants
57
 100.0%
45
 100.0%
Anti-HPV-18 at Day 7 Number Analyzed 61 participants 45 participants
61
 100.0%
26
  57.8%
Anti-HPV-18 at Month 1 Number Analyzed 57 participants 45 participants
57
 100.0%
45
 100.0%
2.Primary Outcome
Title Anti-HPV-16 and Anti-HPV-18 Antibody Titers
Hide Description Titers are given as geometric mean titers (GMTs) calculated on all subjects.
Time Frame At Day 7 and at Month 1 (Day 30)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the ATP cohort for immunogenicity.
Arm/Group Title Cervarix™ 4-Dose Group Cervarix™ 3-Dose Group
Hide Arm/Group Description:
Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
Overall Number of Participants Analyzed 61 45
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
anti-HPV-16 Day 7 Number Analyzed 61 participants 45 participants
5894.9
(4734.0 to 7340.7)
67.9
(27.2 to 169.7)
anti-HPV-16 Month 1 Number Analyzed 57 participants 45 participants
15410.7
(12807.9 to 18542.4)
1231.1
(709.6 to 2135.9)
anti-HPV-18 Day 7 Number Analyzed 61 participants 45 participants
3916.2
(3087.7 to 4967.0)
20.7
(10.2 to 42.2)
anti-HPV-18 Month 1 Number Analyzed 57 participants 45 participants
8362.7
(6930.4 to 10091.1)
442.0
(269.8 to 724.3)
3.Secondary Outcome
Title Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Greater Than or Equal to Pre-defined Cut-off Values
Hide Description Cut-off values assessed include 8 EL.U/mL for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.
Time Frame At Month 7 and Month 18
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the ATP cohort for immunogenicity.
Arm/Group Title Cervarix™ 4-Dose Group Cervarix™ 3-Dose Group
Hide Arm/Group Description:
Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
Overall Number of Participants Analyzed 55 43
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-HPV-16 at Month 7 Number Analyzed 55 participants 43 participants
55
 100.0%
43
 100.0%
Anti-HPV-16 at Month 18 Number Analyzed 49 participants 40 participants
49
 100.0%
40
 100.0%
Anti-HPV-18 at Month 7 Number Analyzed 55 participants 43 participants
55
 100.0%
43
 100.0%
Anti-HPV-18 at Month 18 Number Analyzed 49 participants 40 participants
49
 100.0%
40
 100.0%
4.Secondary Outcome
Title Anti-HPV-16 and Anti-HPV-18 Antibody Titers
Hide Description Titers are given as GMTs calculated on all subjects.
Time Frame At Month 7 and Month 18
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the APT cohort for immunogenicity
Arm/Group Title Cervarix™ 4-Dose Group Cervarix™ 3-Dose Group
Hide Arm/Group Description:
Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
Overall Number of Participants Analyzed 55 43
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
Anti-HPV-16 at Month 7 Number Analyzed 55 participants 43 participants
5826.9
(4742.4 to 7159.5)
7166.5
(5954.3 to 8625.5)
Ant-HPV-16 at Month 18 Number Analyzed 49 participants 40 participants
3936.6
(3128.7 to 4953.1)
1626.9
(1252.4 to 2113.5)
Anti-HPV-18 at Month 7 Number Analyzed 55 participants 43 participants
2940.3
(2385.0 to 3625.0)
3584.3
(2913.9 to 4408.9)
Ant-HPV-18 at Month 18 Number Analyzed 49 participants 40 participants
1802.5
(1407.9 to 2307.6)
520.1
(382.9 to 706.4)
5.Secondary Outcome
Title Number of Subjects With Antibody Titers Against Other Oncogenic HPV Types (HPV-31 & HPV-45) Greater Than or Equal to 59 EL.U/mL
Hide Description [Not Specified]
Time Frame Day 0, Month 1 (Day 30), Month 7 and Month 18
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the ATP cohort for immunogenicity.
Arm/Group Title Cervarix™ 4-Dose Group Cervarix™ 3-Dose Group
Hide Arm/Group Description:
Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
Overall Number of Participants Analyzed 61 45
Measure Type: Count of Participants
Unit of Measure: Participants
anti-HPV-31 Day 7 Number Analyzed 61 participants 45 participants
61
 100.0%
20
  44.4%
anti-HPV-31 Month 1 Number Analyzed 58 participants 45 participants
58
 100.0%
31
  68.9%
anti-HPV-31 Month 7 Number Analyzed 55 participants 43 participants
55
 100.0%
43
 100.0%
anti-HPV-31 Month 18 Number Analyzed 49 participants 40 participants
48
  98.0%
35
  87.5%
anti-HPV-45 Day 7 Number Analyzed 61 participants 45 participants
61
 100.0%
18
  40.0%
anti-HPV-45 Month 1 Number Analyzed 58 participants 45 participants
58
 100.0%
32
  71.1%
anti-HPV-45 Month 7 Number Analyzed 55 participants 43 participants
55
 100.0%
43
 100.0%
anti-HPV-45 Month 18 Number Analyzed 49 participants 40 participants
49
 100.0%
35
  87.5%
6.Secondary Outcome
Title Anti-HPV-31 and Anti-HPV-45 Antibody Titers
Hide Description Titers are given as geometric mean titers (GMTs) calculated on all subjects.
Time Frame Day 7, Month 1 (Day 30), Month 7 and Month 18
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the ATP cohort for immunogenicity
Arm/Group Title Cervarix™ 4-Dose Group Cervarix™ 3-Dose Group
Hide Arm/Group Description:
Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
Overall Number of Participants Analyzed 61 45
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
anti-HPV-31 Day 7 Number Analyzed 61 participants 45 participants
2075.3
(1635.4 to 2633.6)
90.7
(55.8 to 147.4)
anti-HPV-31 Month 1 Number Analyzed 58 participants 45 participants
3705.8
(2902.4 to 4731.5)
192.1
(110.7 to 333.4)
anti-HPV-31 Month 7 Number Analyzed 55 participants 43 participants
1193.8
(879.6 to 1620.2)
878.3
(641.2 to 1202.9)
anti-HPV-31 Month 18 Number Analyzed 49 participants 40 participants
667.0
(470.2 to 946.3)
225.4
(147.9 to 343.6)
anti-HPV-45 Day 7 Number Analyzed 61 participants 45 participants
2347.7
(1869.9 to 2905.6)
76.4
(49.9 to 116.9)
anti-HPV-45 Month 1 Number Analyzed 58 participants 45 participants
4491.5
(3655.6 to 5518.5)
189.9
(113.6 to 317.4)
anti-HPV-45 Month 7 Number Analyzed 55 participants 43 participants
1503.1
(1149.7 to 1965.0)
981.0
(778.6 to 1236.0)
anti-HPV-45 Month 18 Number Analyzed 49 participants 40 participants
890.2
(663.6 to 1194.1)
185.1
(129.5 to 264.5)
7.Secondary Outcome
Title Number of Subjects With Cluster of Differentiation 4 (CD4) T Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types
Hide Description

CD4 T cell-mediated immune responses against the antigens HPV-16, HPV-18, HPV-31 and HPV-45 were analyzed for cells expressing at least 2 of the following immune markers: CD40 Ligand, Interleukin-2, Tumor Necrosis Factor alpha or Interferon-gamma.

An immune response is defined as 500 or more antigen-specific CD4 T-cells per million CD4 T-cells.

Time Frame Day 0, Month 1 [Day 30], Month 7 and Month 18
Hide Outcome Measure Data
Hide Analysis Population Description
Analyses were performed on a subset (from pre-defined study sites) of subjects from the ATP cohort for immunogenicity.
Arm/Group Title Cervarix™ 4-Dose Group Cervarix™ 3-Dose Group
Hide Arm/Group Description:
Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
Overall Number of Participants Analyzed 34 26
Measure Type: Count of Participants
Unit of Measure: Participants
HPV-16, Day 0 Number Analyzed 33 participants 25 participants
24
  72.7%
0
   0.0%
HPV-16, Month 1 Number Analyzed 34 participants 24 participants
25
  73.5%
5
  20.8%
HPV-16, Month 7 Number Analyzed 30 participants 26 participants
22
  73.3%
16
  61.5%
HPV-16, Month 18 Number Analyzed 34 participants 25 participants
23
  67.6%
13
  52.0%
HPV-18, Day 0 Number Analyzed 33 participants 25 participants
17
  51.5%
1
   4.0%
HPV-18, Month 1 Number Analyzed 34 participants 24 participants
24
  70.6%
3
  12.5%
HPV-18, Month 7 Number Analyzed 30 participants 26 participants
21
  70.0%
13
  50.0%
HPV-18, Month 18 Number Analyzed 34 participants 25 participants
20
  58.8%
8
  32.0%
HPV-31, Day 0 Number Analyzed 33 participants 25 participants
20
  60.6%
1
   4.0%
HPV-31, Month 1 Number Analyzed 34 participants 24 participants
24
  70.6%
3
  12.5%
HPV-31, Month 7 Number Analyzed 30 participants 26 participants
19
  63.3%
12
  46.2%
HPV-31, Month 18 Number Analyzed 34 participants 25 participants
22
  64.7%
10
  40.0%
HPV-45, Day 0 Number Analyzed 33 participants 25 participants
15
  45.5%
1
   4.0%
HPV-45, Month 1 Number Analyzed 34 participants 24 participants
24
  70.6%
2
   8.3%
HPV-45, Month 7 Number Analyzed 30 participants 26 participants
16
  53.3%
11
  42.3%
HPV-45, Month 18 Number Analyzed 34 participants 25 participants
20
  58.8%
5
  20.0%
8.Secondary Outcome
Title Number of Subjects With Cluster of Differentiation 8 (CD8) T Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types
Hide Description

CD8 T cell-mediated immune responses against the antigens HPV-16, HPV-18, HPV-31 and HPV-45 were analyzed for cells expressing at least 2 of the following immune markers: CD40 Ligand, Interleukin-2, Tumor Necrosis Factor alpha or Interferon-gamma.

An immune response is defined as 200 or more antigen-specific CD8 T-cells per million CD8 T-cells.

Time Frame Day 0, Month 1 [Day 30], Month 7 and Month 18
Hide Outcome Measure Data
Hide Analysis Population Description
Analyses were performed on a subset (from pre-defined study sites) of subjects from the ATP cohort for immunogenicity.
Arm/Group Title Cervarix™ 4-Dose Group Cervarix™ 3-Dose Group
Hide Arm/Group Description:
Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
Overall Number of Participants Analyzed 34 25
Measure Type: Count of Participants
Unit of Measure: Participants
HPV-16, Day 0
0
   0.0%
0
   0.0%
HPV-16, Month 1
1
   2.9%
0
   0.0%
HPV-16, Month 7
0
   0.0%
2
   8.0%
HPV-16, Month 18
1
   2.9%
0
   0.0%
HPV-18, Day 0
0
   0.0%
0
   0.0%
HPV-18, Month 1
0
   0.0%
1
   4.0%
HPV-18, Month 7
0
   0.0%
1
   4.0%
HPV-18, Month 18
1
   2.9%
0
   0.0%
HPV-31, Day 0
0
   0.0%
0
   0.0%
HPV-31, Month 1
0
   0.0%
0
   0.0%
HPV-31, Month 7
2
   5.9%
1
   4.0%
HPV-31, Month 18
1
   2.9%
0
   0.0%
HPV-045, Day 0
0
   0.0%
0
   0.0%
HPV-45, Month 1
0
   0.0%
1
   4.0%
HPV-45, Month 7
2
   5.9%
0
   0.0%
HPV-45, Month 18
0
   0.0%
0
   0.0%
9.Secondary Outcome
Title Number of Subjects With B Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types
Hide Description

B-cell-mediated immune responses against the antigens HPV-16, HPV-18, HPV-31 and HPV-45 were measured by Enzyme-linked immunosorbent spot (ELISPOT) assay.

A memory B-cell immune response was defined as presence of any antigen-specific memory B-cells per million B-cells.

Time Frame Day 0, Month 1 [Day 30], Month 7 and Month 18
Hide Outcome Measure Data
Hide Analysis Population Description
Analyses were performed on a subset (from pre-defined study sites) of subjects from the ATP cohort for immunogenicity.
Arm/Group Title Cervarix™ 4-Dose Group Cervarix™ 3-Dose Group
Hide Arm/Group Description:
Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
Overall Number of Participants Analyzed 34 26
Measure Type: Count of Participants
Unit of Measure: Participants
HPV-16, Day 0 Number Analyzed 33 participants 25 participants
20
  60.6%
1
   4.0%
HPV-16, Month 1 Number Analyzed 34 participants 24 participants
27
  79.4%
21
  87.5%
HPV-16, Month 7 Number Analyzed 30 participants 26 participants
26
  86.7%
20
  76.9%
HPV-16, Month 18 Number Analyzed 34 participants 25 participants
17
  50.0%
11
  44.0%
HPV-18, Day 0 Number Analyzed 33 participants 25 participants
21
  63.6%
3
  12.0%
HPV-18, Month 1 Number Analyzed 34 participants 24 participants
27
  79.4%
18
  75.0%
HPV-18, Month 7 Number Analyzed 30 participants 26 participants
26
  86.7%
20
  76.9%
HPV-18, Month 18 Number Analyzed 34 participants 25 participants
18
  52.9%
15
  60.0%
HPV-31, Day 0 Number Analyzed 33 participants 25 participants
20
  60.6%
1
   4.0%
HPV-31, Month 1 Number Analyzed 34 participants 24 participants
24
  70.6%
3
  12.5%
HPV-31, Month 7 Number Analyzed 30 participants 26 participants
21
  70.0%
15
  57.7%
HPV-31, Month 18 Number Analyzed 34 participants 25 participants
11
  32.4%
6
  24.0%
HPV-45, Day 0 Number Analyzed 33 participants 25 participants
15
  45.5%
1
   4.0%
HPV-45, Month 1 Number Analyzed 34 participants 24 participants
24
  70.6%
2
   8.3%
HPV-45, Month 7 Number Analyzed 30 participants 26 participants
18
  60.0%
11
  42.3%
HPV-45, Month 18 Number Analyzed 34 participants 25 participants
14
  41.2%
6
  24.0%
10.Secondary Outcome
Title Number of Subjects Seropositive for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervico-vaginal Secretion Samples
Hide Description

Seropositivity was defined as the detection of antibody titers above the limit of quantification by Enzyme-Linked Immunosorbant Assay. Defining a cut-off is technically not possible for this assay.

Analyses were done in all collected samples from the evaluable subjects who provided cervical samples, with < 200 erythrocytes per microliter.

Time Frame Day 0, Month 1 (Day 30), Month 7 and Month 18
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the subset of subjects from the ATP cohort for immunogenicity for whom cervical secretion samples were collected.
Arm/Group Title Cervarix™ 4-Dose Group Cervarix™ 3-Dose Group
Hide Arm/Group Description:
Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
Overall Number of Participants Analyzed 15 17
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-HPV-16 Day 0 Number Analyzed 12 participants 10 participants
8
  66.7%
2
  20.0%
Anti-HPV-16 Month 1 Number Analyzed 13 participants 11 participants
13
 100.0%
5
  45.5%
Anti-HPV-16 Month 7 Number Analyzed 12 participants 11 participants
12
 100.0%
11
 100.0%
Anti-HPV-16 Month 18 Number Analyzed 15 participants 17 participants
15
 100.0%
14
  82.4%
Anti-HPV-18 Day 0 Number Analyzed 12 participants 10 participants
9
  75.0%
1
  10.0%
Anti-HPV-18 Month 1 Number Analyzed 13 participants 11 participants
13
 100.0%
6
  54.5%
Anti-HPV-18 Month 7 Number Analyzed 12 participants 11 participants
12
 100.0%
11
 100.0%
Anti-HPV-18 Month 18 Number Analyzed 15 participants 17 participants
13
  86.7%
13
  76.5%
11.Secondary Outcome
Title Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervico-vaginal Secretion Samples
Hide Description

Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).

Analyses were done in all collected samples from the evaluable subjects who provided cervical samples with < 200 erythrocytes per microliter.

Time Frame Day 0, Month 1 (Day 30), Month 7 and Month 18
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the subset of subjects from the ATP cohort for immunogenicity for whom cervical secretion samples were collected.
Arm/Group Title Cervarix™ 4-Dose Group Cervarix™ 3-Dose Group
Hide Arm/Group Description:
Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
Overall Number of Participants Analyzed 15 17
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Anti-HPV-16, Day 0 Number Analyzed 12 participants 10 participants
323.8
(84.0 to 1247.3)
147.0
(93.3 to 231.6)
Anti-HPV-16, Month 1 Number Analyzed 13 participants 11 participants
562.1
(312.8 to 1010.3)
331.2
(100.3 to 1093.6)
Anti-HPV-16, Month 7 Number Analyzed 12 participants 11 participants
220.5
(104.7 to 464.7)
299.2
(153.4 to 583.3)
Anti-HPV-16, Month 18 Number Analyzed 15 participants 17 participants
110.9
(46.2 to 266.0)
52.8
(34.3 to 81.4)
Anti-HPV-18, Day 0 Number Analyzed 12 participants 10 participants
177.1
(43.6 to 719.0)
58.6
(58.6 to 58.6)
Anti-HPV-18, Month 1 Number Analyzed 13 participants 11 participants
375.1
(257.8 to 545.8)
54.0
(10.1 to 288.5)
Anti-HPV-18, Month 7 Number Analyzed 12 participants 11 participants
111.5
(57.1 to 217.7)
178.0
(88.0 to 359.9)
Anti-HPV-18, Month 18 Number Analyzed 15 participants 17 participants
73.6
(31.2 to 173.4)
29.6
(16.0 to 54.8)
12.Secondary Outcome
Title Number of Subjects Reporting Solicited Local Symptoms
Hide Description

Solicited local symptoms assessed include pain, redness and swelling at the injection site.

Solicited symptoms reported after the 4th vaccine dose in the 4-dose Group and across the 3 doses administered during this study in the 3-dose Group are disclosed.

Time Frame Within 7 days after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on those subjects from the Total Vaccinated Cohort with available results.
Arm/Group Title Cervarix™ 4-Dose Group Cervarix™ 3-Dose Group
Hide Arm/Group Description:
Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
Overall Number of Participants Analyzed 64 48
Measure Type: Count of Participants
Unit of Measure: Participants
Pain
61
  95.3%
45
  93.8%
Redness
24
  37.5%
18
  37.5%
Swelling
22
  34.4%
16
  33.3%
13.Secondary Outcome
Title Number of Subjects Reporting Solicited General Symptoms
Hide Description

Solicited general symptoms assessed include arthralgia, fatigue, fever, gastrointestinal discomfort, headache, myalgia, rash and urticaria.

Solicited symptoms reported after the 4th vaccine dose in the 4-dose Group and across the 3 doses administered during this study in the 3-dose Group are disclosed.

Time Frame Within 7 days of vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on those subjects from the Total Vaccinated Cohort with available results.
Arm/Group Title Cervarix™ 4-Dose Group Cervarix™ 3-Dose Group
Hide Arm/Group Description:
Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
Overall Number of Participants Analyzed 64 48
Measure Type: Count of Participants
Unit of Measure: Participants
Arthralgia
10
  15.6%
4
   8.3%
Fatigue
33
  51.6%
33
  68.8%
Fever (Oral or Axillary) ≥ 37.5 degrees Celsius
4
   6.3%
5
  10.4%
Gastrointestinal
16
  25.0%
16
  33.3%
Headache
32
  50.0%
31
  64.6%
Myalgia
30
  46.9%
21
  43.8%
Rash
0
   0.0%
2
   4.2%
Urticaria
2
   3.1%
2
   4.2%
14.Secondary Outcome
Title Number of Subjects Reporting Unsolicited Adverse Events (AE)
Hide Description

An unsolicited adverse event is defined as any adverse event (AE) reported in addition to those solicited during the clinical study. Also any "solicited" symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.

AEs reported after the 4th vaccine dose in the 4-dose Group and after the 3 doses administered in this study in the 3-dose Group are disclosed.

Time Frame Within 30 days of vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cervarix™ 4-Dose Group Cervarix™ 3-Dose Group
Hide Arm/Group Description:
Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
Overall Number of Participants Analyzed 65 50
Measure Type: Count of Participants
Unit of Measure: Participants
24
  36.9%
25
  50.0%
15.Secondary Outcome
Title Outcome of Any Reported Pregnancies
Hide Description Information on any subject who became pregnant while participating in this study was collected. The outcomes of the pregnancies are reported below.
Time Frame From Day 0 up to Month 18
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on those subjects reporting pregnancy during the study period.
Arm/Group Title Cervarix™ 4-Dose Group Cervarix™ 3-Dose Group
Hide Arm/Group Description:
Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
Overall Number of Participants Analyzed 11 6
Measure Type: Count of Participants
Unit of Measure: Participants
Total number of pregnancies
11
 100.0%
6
 100.0%
Elective termination
0
   0.0%
2
  33.3%
Premature birth
2
  18.2%
0
   0.0%
Live infant
8
  72.7%
4
  66.7%
Pregnancy ongoing
1
   9.1%
0
   0.0%
16.Secondary Outcome
Title Number of Subjects With New Onset of Chronic Diseases (NOCDs), New Onset of Autoimmune Diseases (NOADs) and Medically Significant Conditions (MSCs)
Hide Description NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. MSC include AEs 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 Day 0 up to Month 18
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cervarix™ 4-Dose Group Cervarix™ 3-Dose Group
Hide Arm/Group Description:
Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
Overall Number of Participants Analyzed 65 50
Measure Type: Count of Participants
Unit of Measure: Participants
NOCDs
2
   3.1%
4
   8.0%
NOADs
0
   0.0%
2
   4.0%
MSCs
16
  24.6%
19
  38.0%
17.Secondary Outcome
Title Number of Subjects Reporting 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 Day 0 up to Month 18
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cervarix™ 4-Dose Group Cervarix™ 3-Dose Group
Hide Arm/Group Description:
Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
Overall Number of Participants Analyzed 65 50
Measure Type: Count of Participants
Unit of Measure: Participants
1
   1.5%
1
   2.0%
Time Frame Solicited adverse events: from Day 0 to Day 6. Unsolicited adverse events: from Day 0 to Day 29. NOCDs, NOADs and MSCs: from Day 0 to Month 18.
Adverse Event Reporting Description Events collected by systematic assessment are reported for subjects with a symptom diary card available.Events collected by non-systematic method are reported for the Total Vaccinated Cohort
 
Arm/Group Title Cervarix™ 4-Dose Group Cervarix™ 3-Dose Group
Hide Arm/Group Description Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study. Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
All-Cause Mortality
Cervarix™ 4-Dose Group Cervarix™ 3-Dose Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cervarix™ 4-Dose Group Cervarix™ 3-Dose Group
Affected / at Risk (%) Affected / at Risk (%)
Total   1/65 (1.54%)   1/50 (2.00%) 
Hepatobiliary disorders     
Cholecystitis * 1  1/65 (1.54%)  0/50 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism * 1  0/65 (0.00%)  1/50 (2.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 10.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cervarix™ 4-Dose Group Cervarix™ 3-Dose Group
Affected / at Risk (%) Affected / at Risk (%)
Total   62/65 (95.38%)   47/50 (94.00%) 
General disorders     
Arthralgia  1  10/64 (15.63%)  4/48 (8.33%) 
Fatigue  1  33/64 (51.56%)  33/48 (68.75%) 
Fever  1  4/64 (6.25%)  5/48 (10.42%) 
Gastrointestinal symptoms  1  16/64 (25.00%)  16/48 (33.33%) 
Headache  1  32/65 (49.23%)  31/48 (64.58%) 
Myalgia  1  30/65 (46.15%)  21/48 (43.75%) 
Pain  1  61/64 (95.31%)  45/48 (93.75%) 
Redness  1  24/64 (37.50%)  18/48 (37.50%) 
Swelling  1  22/64 (34.38%)  16/48 (33.33%) 
Infections and infestations     
Upper respiratory tract infection * 1  1/65 (1.54%)  4/50 (8.00%) 
Chlamydial infection * 1  0/65 (0.00%)  4/50 (8.00%) 
Nervous system disorders     
Dizziness * 1  4/65 (6.15%)  0/50 (0.00%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 10.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Publications:
Moscicki B et al. Anamnestic response elicited by a fourth dose of the HPV-16/18 ASO4-adjuvanted vaccine in young women. Abstract presented at European Research Organization on Genital Infection and Neoplasia 2010 (EUROGIN). Monte Carlo, Monaco, 17-20 February 2010.
Moscicki B et al. Anamnestic response to non-vaccine types elicited by a fourth dose of the HPV-16/18 ASO4-adjuvanted vaccine in young women. Abstract presented at European Research Organization on Genital Infection and Neoplasia 2010 (EUROGIN). Monte Carlo, Monaco, 17-20 February 2010.
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00546078     History of Changes
Other Study ID Numbers: 109628
First Submitted: October 17, 2007
First Posted: October 18, 2007
Results First Submitted: November 12, 2009
Results First Posted: December 15, 2009
Last Update Posted: June 25, 2018