Long-Term Immune Persistence of GlaxoSmithKline Biologicals' Inactivated Hepatitis A Vaccine Injected According to a 0, 12-month Schedule

Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT00291876
Collaborator
(none)
135
1
1
110
1.2

Study Details

Study Description

Brief Summary

The aim of this study is to evaluate the persistence of hepatitis A antibodies at 138, 150, 162, 174,186, 198, 210, 222, 234 and 246 months after subjects received their first dose of a 2 dose vaccination schedule of hepatitis A vaccine.

This protocol posting deals with objectives & outcome measures of the extension phase at year 11 to 20.

No additional subjects will be recruited during this long-term follow-up.

Condition or Disease Intervention/Treatment Phase
  • Biological: Havrix™
Phase 4

Detailed Description

This is a long-term follow-up study at Years 11, 12, 13, 14, 15, 16, 17, 18, 19 and 20 after primary vaccination with GSK Biologicals' hepatitis A vaccine (two-dose schedule). To evaluate the long-term antibody persistence, volunteers will donate a blood sample at Years 11, 12, 13, 14, 15, 16, 17, 18, 19 and 20 after the first vaccine dose of the primary vaccination course to determine their anti-hepatitis A (anti-HAV) antibody concentrations.

If a subject has become seronegative for anti-HAV antibodies during any of the long-term blood sampling time point (i.e. Months 138, 150, 162, 174,186, 198, 210, 222, 234 and 246), he/ she will be offered an additional vaccine dose. A blood sample will be taken on the day of the additional vaccination 14 days and one month after additional vaccination to evaluate the immune response following this vaccination.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007 and to extend the follow up until Year 20.

The study has 10 phases: 100571, 100572, 100573, 100574, 100575, 110677, 110678, 110679, 110680, 110681.

Study Design

Study Type:
Interventional
Actual Enrollment :
135 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Double-blind Randomized Study to Evaluate the Immunogenicity and Reactogenicity of Two Different Lots of GlaxoSmithKline Biologicals' Inactivated Hepatitis A Vaccine Containing 1440 EL.U of Antigen Per mL and Injected According to a 0, 12 Month Schedule in Healthy Adult Volunteers
Study Start Date :
Jan 1, 2004
Actual Primary Completion Date :
Mar 1, 2013
Actual Study Completion Date :
Mar 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: Havrix Group

Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12.

Biological: Havrix™
2 doses at 12 months interval

Outcome Measures

Primary Outcome Measures

  1. Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration [At Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246]

    Concentrations given as geometric mean concentration (GMC) expressed as milli-international unit per millilitre (mIU/mL). ** = Regarding Month 234 data, please note that there were 5 subjects for whom serum sample tube was broken and thus due to risk of contamination the test were not performed. Hence these subjects were not included in the LT-ATP cohort for immunogenicity analysis at Month 234. $ = Regarding Month 246 data, please note there was 1 subject for whom serum sample tube was broken and hence scrapped by laboratory. Hence this subject was not included in the LT-ATP cohort for immunogenicity analysis at Month 246.

  2. Number of Seropositive Subjects Against Hepatitis A Virus [At Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246]

    A seropositive subject was a vaccinated subject whose concentrations for antibodies against hepatitis A virus (anti-HAV) were equal or above (>=) the assay cut-off for seropositivity of 15 milli-international units per milliliter (mIU/mL). ** = Regarding Month 234 data, please note that there were 5 subjects for whom serum sample tube was broken and thus due to risk of contamination the test were not performed. Hence these subjects were not included in the LT-ATP cohort for immunogenicity analysis at Month 234. $ = Regarding Month 246 data, please note there was 1 subject for whom serum sample tube was broken and hence scrapped by laboratory. Hence this subject was not included in the LT-ATP cohort for immunogenicity analysis at Month 246.

Secondary Outcome Measures

  1. Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration [Before additional vaccination, 14 days after additional vaccination and 30 days after additional vaccination]

    Concentrations given as GMC expressed as mIU/mL. 4 subjects received additional vaccination at Month 186 and 1 subject at Month 198. Please note that value 14.9 means <15.

  2. Number of Subjects Reporting Solicited Local Symptoms [During the 4-day (Days 0-3) follow-up period after additional vaccination]

    Solicited local symptoms assessed include pain, redness and swelling. Additional vaccination was given to 4 subjects at the Month 186 timepoint and to 1 subject at the Month 198 timepoint.

  3. Number of Subjects Reporting Solicited General Symptoms [During the 4-day (Days 0-3) follow-up period after additional vaccination]

    Solicited general symptoms assessed include fatigue, fever, gastrointestinal symptoms and headache. 4 subjects received additional vaccination at Month 186 and 1 subject at Month 198.

  4. Number of Subjects Reporting Unsolicited Adverse Events (AE) [During the 30-day follow-up period after additional vaccination]

    An AE is 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. 4 subjects received additional vaccination at Month 186 and 1 at Month 198.

  5. Number of Subjects Reporting Serious Adverse Events (SAE) Assessed by the Investigator as Related to Primary Study Vaccination, Procedures or Lack of Vaccine Efficacy [At Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246]

    An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above

  6. Number of Subjects Reporting Serious Adverse Events (SAE) After Additional Vaccination [During the 30-day follow-up period after additional vaccination]

    An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above. 4 subjects received additional vaccination at Month 186 and 1 at Month 198.

  7. Number of Subjects Reporting Pregnancies After Additional Vaccination [At Months 186 and 198]

    The number of subjects with outcome of pregnancies reported among subjects who had received the additional vaccination was tabulated. 4 subjects received additional vaccination at Month 186 and 1 subject at Month 198.

Eligibility Criteria

Criteria

Ages Eligible for Study:
29 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Subjects who had received at least one dose of the study vaccine in the primary study

  • Written informed consent will have been obtained from the subjects before the blood sampling visit of each year.

Contacts and Locations

Locations

Site City State Country Postal Code
1 GSK Investigational Site Wilrijk Belgium 2610

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:
NCT00291876
Other Study ID Numbers:
  • 100571 (M138)
  • 100572 (M150)
  • 100573 (M162)
  • 100574 (M174)
  • 100575 (M186)
  • 110677 (M198)
  • 110678 (M210)
  • 110679
  • 110680
  • 110681
First Posted:
Feb 15, 2006
Last Update Posted:
Nov 29, 2017
Last Verified:
Jan 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by GlaxoSmithKline
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details Participant Flow and Baseline Measures are given for each of the follow-up time points- Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246. Note that not all subjects returned and participated in each of the intermediate follow-up time points.
Pre-assignment Detail The Long-Term (LT) Total Cohort included all subjects who returned for the follow-up and who belonged to the Total Cohort in the primary study. The Long Term According-to-Protocol (LT-ATP) cohort for immunogenicity included subjects who returned for the follow-up and who were included in the ATP cohort for immunogenicity of the primary study.
Arm/Group Title Havrix Group
Arm/Group Description Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12.
Period Title: Month 138
STARTED 107
COMPLETED 107
NOT COMPLETED 0
Period Title: Month 138
STARTED 117
COMPLETED 117
NOT COMPLETED 0
Period Title: Month 138
STARTED 127
COMPLETED 127
NOT COMPLETED 0
Period Title: Month 138
STARTED 127
COMPLETED 127
NOT COMPLETED 0
Period Title: Month 138
STARTED 129
COMPLETED 129
NOT COMPLETED 0
Period Title: Month 138
STARTED 135
COMPLETED 135
NOT COMPLETED 0
Period Title: Month 138
STARTED 124
COMPLETED 124
NOT COMPLETED 0
Period Title: Month 138
STARTED 114
COMPLETED 114
NOT COMPLETED 0
Period Title: Month 138
STARTED 110
COMPLETED 110
NOT COMPLETED 0
Period Title: Month 138
STARTED 116
COMPLETED 116
NOT COMPLETED 0

Baseline Characteristics

Arm/Group Title Havrix Group
Arm/Group Description Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12.
Overall Participants 135
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]
42.2
(5.44)
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]
42.9
(5.35)
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]
43.4
(5.34)
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]
44.5
(5.37)
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]
45.4
(5.39)
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]
46.3
(5.35)
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]
47.6
(5.39)
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]
48.5
(5.39)
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]
49.6
(5.42)
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]
50.8
(5.34)
Sex: Female, Male (Count of Participants)
Female
77
57%
Male
30
22.2%
Sex: Female, Male (Count of Participants)
Female
87
64.4%
Male
30
22.2%
Sex: Female, Male (Count of Participants)
Female
93
68.9%
Male
34
25.2%
Sex: Female, Male (Count of Participants)
Female
94
69.6%
Male
33
24.4%
Sex: Female, Male (Count of Participants)
Female
98
72.6%
Male
31
23%
Sex: Female, Male (Count of Participants)
Female
103
76.3%
Male
32
23.7%
Sex: Female, Male (Count of Participants)
Female
93
68.9%
Male
31
23%
Sex: Female, Male (Count of Participants)
Female
83
61.5%
Male
31
23%
Sex: Female, Male (Count of Participants)
Female
81
60%
Male
29
21.5%
Sex: Female, Male (Count of Participants)
Female
86
63.7%
Male
30
22.2%

Outcome Measures

1. Primary Outcome
Title Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration
Description Concentrations given as geometric mean concentration (GMC) expressed as milli-international unit per millilitre (mIU/mL). ** = Regarding Month 234 data, please note that there were 5 subjects for whom serum sample tube was broken and thus due to risk of contamination the test were not performed. Hence these subjects were not included in the LT-ATP cohort for immunogenicity analysis at Month 234. $ = Regarding Month 246 data, please note there was 1 subject for whom serum sample tube was broken and hence scrapped by laboratory. Hence this subject was not included in the LT-ATP cohort for immunogenicity analysis at Month 246.
Time Frame At Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246

Outcome Measure Data

Analysis Population Description
Analysis was performed on the Long Term According-to-Protocol (LT-ATP) cohort for analysis of immunogenicity, on subjects with available data for the defined timepoint. * The laboratory assay was changed at Month 138, thus the blood samples were re-tested with the old assay for the sake of bridging.
Arm/Group Title Havrix Group
Arm/Group Description Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12.
Measure Participants 102
Month 138 (N=79)
748.1
Month 138 (N=85)*
378.6
Month 150 (N=93)
419.3
Month 162 (N=101)
342.2
Month 174 (N=102)
318.9
Month 186 (N=98)
353.1
Month 198 (N=101)
339.9
Month 210 (N=91)
369.3
Month 222 (N=86)
340.1
Month 234 (N=79)**
283.3
Month 246 (N=85)$
317.3
2. Primary Outcome
Title Number of Seropositive Subjects Against Hepatitis A Virus
Description A seropositive subject was a vaccinated subject whose concentrations for antibodies against hepatitis A virus (anti-HAV) were equal or above (>=) the assay cut-off for seropositivity of 15 milli-international units per milliliter (mIU/mL). ** = Regarding Month 234 data, please note that there were 5 subjects for whom serum sample tube was broken and thus due to risk of contamination the test were not performed. Hence these subjects were not included in the LT-ATP cohort for immunogenicity analysis at Month 234. $ = Regarding Month 246 data, please note there was 1 subject for whom serum sample tube was broken and hence scrapped by laboratory. Hence this subject was not included in the LT-ATP cohort for immunogenicity analysis at Month 246.
Time Frame At Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246

Outcome Measure Data

Analysis Population Description
Analysis was performed on the Long Term According-to-Protocol (LT-ATP) cohort for analysis of immunogenicity, on subjects with available data for the defined timepoint. *The laboratory assay was changed at Month 138, thus the blood samples were re-tested with the old assay for the sake of bridging.
Arm/Group Title Havrix Group
Arm/Group Description Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12.
Measure Participants 102
Month 138 (N=79)
77
Month 138 (N=85)*
82
Month 150 (N=93)
90
Month 162 (N=101)
98
Month 174 (N=102)
100
Month 186 (N=98)
95
Month 198 (N=101)
97
Month 210 (N=91)
88
Month 222 (N=86)
86
Month 234 (N=79)**
79
Month 246 (N=85)$
85
3. Secondary Outcome
Title Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration
Description Concentrations given as GMC expressed as mIU/mL. 4 subjects received additional vaccination at Month 186 and 1 subject at Month 198. Please note that value 14.9 means <15.
Time Frame Before additional vaccination, 14 days after additional vaccination and 30 days after additional vaccination

Outcome Measure Data

Analysis Population Description
Analysis was performed on the Long Term Total cohort, only on subjects who received an additional vaccine dose during the current long-term follow-up study. If a subject became seronegative (< 15 mIU/mL) at any of the long-term blood sampling timepoint, he/she was offered an additional vaccine dose.
Arm/Group Title Havrix Group
Arm/Group Description Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12.
Measure Participants 5
Subject 1 Month 186 before
14.9
Subject 1 Month 186 day 14
15
Subject 1 Month 186 day 30
26
Subject 2 Month 186 before
14.9
Subject 2 Month 186 day 14
453
Subject 2 Month 186 day 30
787
Subject 3 Month 186 before
15
Subject 3 Month 186 day 14
3102
Subject 3 Month 186 day 30
3819
Subject 4 Month 186 before
16
Subject 4 Month 186 day 14
1636
Subject 4 Month 186 day 30
2051
Subject 5 Month 198 before
16
Subject 5 Month 198 day 14
3222
Subject 5 Month 198 day 30
4894
4. Secondary Outcome
Title Number of Subjects Reporting Solicited Local Symptoms
Description Solicited local symptoms assessed include pain, redness and swelling. Additional vaccination was given to 4 subjects at the Month 186 timepoint and to 1 subject at the Month 198 timepoint.
Time Frame During the 4-day (Days 0-3) follow-up period after additional vaccination

Outcome Measure Data

Analysis Population Description
Analysis was performed on the Long Term Total cohort, only on subjects who received an additional vaccine dose during the current long-term follow-up study. If a subject became seronegative (< 15 mIU/mL) at any of the long-term blood sampling timepoint, he/she was offered an additional vaccine dose.
Arm/Group Title Havrix Group
Arm/Group Description Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12.
Measure Participants 5
Pain Month 186 (N=4)
2
Redness Month 186 (N=4)
0
Swelling Month 186 (N=4)
0
Pain Month 198 (N=1)
1
Redness Month 198 (N=1)
0
Swelling Month 198 (N=1)
0
5. Secondary Outcome
Title Number of Subjects Reporting Solicited General Symptoms
Description Solicited general symptoms assessed include fatigue, fever, gastrointestinal symptoms and headache. 4 subjects received additional vaccination at Month 186 and 1 subject at Month 198.
Time Frame During the 4-day (Days 0-3) follow-up period after additional vaccination

Outcome Measure Data

Analysis Population Description
Analysis was performed on the Long Term Total cohort, only on subjects who received an additional vaccine dose during the current long-term follow-up study. If a subject became seronegative (< 15 mIU/mL) at any of the long-term blood sampling timepoint, he/she was offered an additional vaccine dose.
Arm/Group Title Havrix Group
Arm/Group Description Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12.
Measure Participants 5
Fatigue Month 186 (N=4)
2
Fever Month 186 (N=4)
0
Gastrointestinal Month 186 (N=4)
1
Headache Month 186 (N=4)
1
Fatigue Month 198 (N=1)
0
Fever Month 198 (N=1)
0
Gastrointestinal Month 198 (N=1)
0
Headache Month 198 (N=1)
0
6. Secondary Outcome
Title Number of Subjects Reporting Unsolicited Adverse Events (AE)
Description An AE is 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. 4 subjects received additional vaccination at Month 186 and 1 at Month 198.
Time Frame During the 30-day follow-up period after additional vaccination

Outcome Measure Data

Analysis Population Description
Analysis was performed on the Long Term Total cohort, only on subjects who received an additional vaccine dose during the current long-term follow-up study. If a subject became seronegative (< 15 mIU/mL) at any of the long-term blood sampling timepoint, he/she was offered an additional vaccine dose.
Arm/Group Title Havrix Group
Arm/Group Description Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12.
Measure Participants 5
Month 186 (N=4)
0
Month 198 (N=1)
0
7. Secondary Outcome
Title Number of Subjects Reporting Serious Adverse Events (SAE) Assessed by the Investigator as Related to Primary Study Vaccination, Procedures or Lack of Vaccine Efficacy
Description An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above
Time Frame At Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246

Outcome Measure Data

Analysis Population Description
Analysis was performed on the Long Term Total cohort, on subjects with available data for the defined timepoint.
Arm/Group Title Havrix Group
Arm/Group Description Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12.
Measure Participants 135
Month 138 (N=107)
0
Month 150 (N=117)
0
Month 162 (N=127)
0
Month 174 (N=127)
0
Month 186 (N=129)
0
Month 198 (N=135)
0
Month 210 (N=124)
0
Month 222 (N=114)
0
Month 234 (N=110)
0
Month 246 (N=116)
0
8. Secondary Outcome
Title Number of Subjects Reporting Serious Adverse Events (SAE) After Additional Vaccination
Description An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above. 4 subjects received additional vaccination at Month 186 and 1 at Month 198.
Time Frame During the 30-day follow-up period after additional vaccination

Outcome Measure Data

Analysis Population Description
Analysis was performed on the Long Term Total cohort, only on subjects who received an additional vaccine dose during the current long-term follow-up study. If a subject became seronegative (< 15 mIU/mL) at any of the long-term blood sampling timepoint, he/she was offered an additional vaccine dose.
Arm/Group Title Havrix Group
Arm/Group Description Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12.
Measure Participants 5
Month 186 (N=4)
0
Month 198 (N=1)
0
9. Secondary Outcome
Title Number of Subjects Reporting Pregnancies After Additional Vaccination
Description The number of subjects with outcome of pregnancies reported among subjects who had received the additional vaccination was tabulated. 4 subjects received additional vaccination at Month 186 and 1 subject at Month 198.
Time Frame At Months 186 and 198

Outcome Measure Data

Analysis Population Description
Analysis was performed on the Long Term Total cohort, only on subjects who received an additional vaccine dose during the current long-term follow-up study. If a subject became seronegative (< 15 mIU/mL) at any of the long-term blood sampling timepoint, he/she was offered an additional vaccine dose.
Arm/Group Title Havrix Group
Arm/Group Description Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12.
Measure Participants 5
Subjects with pregnancy - At Month 186 (N=4)
0
Subjects with pregnancy - At Month 198 (N=1)
0

Adverse Events

Time Frame SAEs: At Months 138, 150, 162, 174, 186, 198, 210, 222 234 and 246. Other adverse events: within the 4-day periods after additional vaccination (at Month 186 or 198), only in subjects who received additional vaccination at the specified time point.
Adverse Event Reporting Description Analyses were performed on the Long-Term (LT) Total Cohort which included all subjects who returned for the follow-up and who belonged to the Total Cohort in the primary study. Maximum amount of subjects which participated at Month 198 has been taken as the number of subjects at risk for SAEs.
Arm/Group Title Havrix Group
Arm/Group Description Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12.
All Cause Mortality
Havrix Group
Affected / at Risk (%) # Events
Total / (NaN)
Serious Adverse Events
Havrix Group
Affected / at Risk (%) # Events
Total 0/135 (0%)
Other (Not Including Serious) Adverse Events
Havrix Group
Affected / at Risk (%) # Events
Total 2/5 (40%)
General disorders
Pain 2/4 (50%)
Pain 1/1 (100%)
Fatigue 2/4 (50%)
Gastrointestinal 1/4 (25%)
Headache 1/4 (25%)

Limitations/Caveats

For 5 subjects at Month 234, serum sample tubes were broken. Due to risk of contamination, anti-HAV concentrations analyses were not performed for these subjects, who were excluded in the LT-ATP cohort for immunogenicity analysis at Month 234.

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:
NCT00291876
Other Study ID Numbers:
  • 100571 (M138)
  • 100572 (M150)
  • 100573 (M162)
  • 100574 (M174)
  • 100575 (M186)
  • 110677 (M198)
  • 110678 (M210)
  • 110679
  • 110680
  • 110681
First Posted:
Feb 15, 2006
Last Update Posted:
Nov 29, 2017
Last Verified:
Jan 1, 2017