Study in Toddlers to Demonstrate Non-inferiority of GSK Biologicals' Hib-MenC & to Evaluate Persistence up to 5 Years.
Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT00326118
Collaborator
(none)
433
7
2
17.2
61.9
3.6
Study Details
Study Description
Brief Summary
The purpose of the primary phase of the study is to demonstrate the non-inferiority of a single dose of GSK Biologicals' Haemophilus influenzae type b and meningococcal C (Hib-MenC) conjugate vaccine when given in the second year of life to subjects primed in infancy with a Hib vaccine, but not with a meningococcal serogroup C vaccine, versus commercially available Hib and MenC vaccines.
In the extension phase, at Years 1, 2, 3, 4 & 5, one blood sample is taken at each year to follow the antibody persistence up to 5 years after vaccination. No additional vaccine is administered during the extension phase. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
This multicenter study is open and has 2 treatment groups with Hiberix™ + a commercially available MenC vaccine as active controls. Priorix™ is given concomitantly in both groups. In the primary phase, two blood samples are taken from all subjects for immunogenicity analyses: before and one month after vaccination. In the extension phase, at Year 1, 2, 3, 4 & 5, one blood sample is taken at each year to follow the antibody persistence up to 5 years after vaccination. No additional vaccine is administered during the extension phase.
Study Design
Study Type:
Interventional
Actual Enrollment
:
433 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Study to Demonstrate Non-inferiority of GSK Biologicals' Hib-MenC With Priorix™, Versus MenC-CRM197 Vaccine With Hiberix™ & Priorix™ in Toddlers Primed With Hib But Not MenC & to Evaluate Persistence up to 5 Years After Vaccination.
Study Start Date
:
Jun 1, 2006
Actual Primary Completion Date
:
Nov 1, 2007
Actual Study Completion Date
:
Nov 6, 2007
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Meningitec + Hiberix Group Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm. |
Biological: Priorix™
One subcutaneous dose at 12-18 months of age
Biological: Hiberix™
One intramuscular dose at 12-18 months of age.
Biological: Meningitec™
One intramuscular dose at 12-18 months of age
|
| Experimental: Menitorix Group Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm. |
Biological: Haemophilus influenzae type b and meningococcal serogroup C (vaccine)
One intramuscular dose at 12-18 months of age
Other Names:
Biological: Priorix™
One subcutaneous dose at 12-18 months of age
|
Outcome Measures
Primary Outcome Measures
- Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 0.15 Micrograms Per Milliliter (µg/mL) [1 month after vaccination]
Anti-PRP antibody concentration greater than or equal to 0.15 µg/mL is indicative of short-term protection.
- Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Greater Than or Equal to 1:8 Titer [1 month after vaccination]
rSBA-MenC titers greater than or equal to 1:8 titer are indicative of seroprotection.
Secondary Outcome Measures
- Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Above the Cut-off Values [Prior to, 1 month, 1 year, 2 years, 3 years and 4 years after vaccination]
rSBA-MenC titers cut-off values assessed were greater than or equal to (≥) 1:8 (indicative of seroprotection) and ≥ 1:128 titers. Functional anti-meningococcal serogroup C activity (SBA-MenC) was determined by a serum bactericidal test using rabbit complement. For SBA testing at a GlaxoSmithKline (GSK) laboratory up to Year 3 after vaccination, titres were expressed as the reciprocal of the dilution resulting in 50% inhibition. For SBA testing at the Public Health England (PHE), formerly known as Health Protection Agency (HPA), at Year 4, titres were expressed as the reciprocal of the last dilution resulting in at least 50% inhibition.
- Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Above the Cut-off Values [5 years after vaccination]
rSBA-MenC titers cut-off values assessed were greater than or equal to (≥)1:8 (indicative of seroprotection) and 1:128 titers. For SBA testing at the PHE at Year 5, titres were expressed as the reciprocal of the last dilution resulting in at least 50% inhibition.
- Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers [Prior to, 1 month, 1 year, 2 years, 3 years and 4 years after vaccination.]
Titers are given as Geometric Mean Titers (GMTs). Functional anti-meningococcal serogroup C activity (SBA-MenC) was determined by a serum bactericidal test using rabbit complement. For SBA testing at a GlaxoSmithKline (GSK) laboratory up to Year 3 after vaccination, titres were expressed as the reciprocal of the dilution resulting in 50% inhibition. For SBA testing at the PHE at year 4 after vaccination, titres were expressed as the reciprocal of the last dilution resulting in at least 50% inhibition.
- Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers [5 years after vaccination]
Titers are given as Geometric Mean Titers (GMTs). Functional anti-meningococcal serogroup C activity (SBA-MenC) was determined by a serum bactericidal test using rabbit complement. For SBA testing at the PHE at Year 5, titres were expressed as the reciprocal of the last dilution resulting in at least 50% inhibition.
- Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Above Cut-off Values [Prior to, 1 month, 1 year, 2 years, 3 years and 4 years after vaccination]
Anti-PRP antibody concentration cut-off values assessed include 0.15 µg/mL (indicative of short-term protection) and 1.0 µg/mL (indicative of long-term protection).
- Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Above Cut-off Values [5 years after vaccination]
Anti-PRP antibody concentration cut-off values assessed include 0.15 µg/mL (indicative of short-term protection) and 1.0 µg/mL (indicative of long-term protection).
- Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations [Prior to, 1 month , 1 year, 2 years, 3 years and 4 years after vaccination]
Concentrations are given as Geometric Mean Concentrations (GMCs).
- Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations [5 years after vaccination]
Concentrations are given as Geometric Mean Concentrations (GMCs).
- Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Above the Cut-off Values [Prior to, 1 month, 1 year, 2 years and 3 years after vaccination]
Anti-PSC antibody concentration cut-off values assessed include greater than or equal to (≥) 0.30 µg/mL and ≥ 2.0 µg/mL.
- Anti-polysaccharide C (Anti-PSC) Antibody Concentrations [Prior to, 1 month, 1 year, 2 years and 3 years after vaccination]
Concentrations given as Geometric Mean Concentrations (GMCs).
- Number of Subjects Reporting Solicited Local and General Symptoms [Within 4 days (Day 0 -Day 3) after vaccination]
Solicited local symptoms assessed include pain, redness and swelling at the injection site. Solicited general symptoms assessed include drowsiness, fever (≥ 38°C), irritability and loss of appetite.
- Number of Subjects Reporting Unsolicited Symptoms [Within 31 days (Day 0 - Day 30) after vaccination]
Unsolicited symptom: 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 will be reported as an unsolicited adverse event.
- Number of Subjects Reporting Serious Adverse Events (SAEs) [Throughout the entire study period (up to year 5)]
A serious adverse event (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject. For the long-term persistence phase (Years 1 through 5), only those SAEs that are determined by the investigator to have a causal relationship to the vaccination will be described individually.
Eligibility Criteria
Criteria
Ages Eligible for Study:
12 Months
to 18 Months
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
Primary phase:
-
Subjects whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
-
A male or female between, and including, 12 and 18 months of age at the time of vaccination.
-
Written informed consent obtained from the parent or guardian of the subject.
-
Free of obvious health problems as established by medical history and clinical examination before entering into the study.
-
Previously completed routine childhood vaccinations to the best of his/her parents'/guardians knowledge.
-
Having completed primary vaccination with two doses of Haemophilus influenzae type b outer membrane protein (Hib-OMP) containing vaccine OR three doses of diphtheria, tetanus, acellular pertussis and Haemophilus influenzae type b (DTPa/Hib) containing vaccine at least 6 months before the study start.
Long-term persistence phase:
- Having participated in the vaccination study 106445
Exclusion Criteria:
For the primary vaccination phase:
-
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
-
Chronic administration (defined as more than 14 days) or planned administration of immuno-suppressants or other immune-modifying drugs within six months prior to vaccination.
-
Planned administration/administration of a vaccine not foreseen by the protocol during the period starting from 30 days before vaccination and ending 30 days after vaccination.
-
Administration of a meningococcal vaccine not foreseen by the study protocol during the period starting at birth and ending at first dose.
-
Previous administration of a booster dose of Hib vaccine.
-
Previous vaccination against measles, mumps, rubella.
-
History of H. influenzae type b, meningococcal serogroup C and/or confirmed measles, mumps or rubella diseases.
-
Known exposure to measles, mumps or rubella within 30 days prior to the start of the study.
-
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection.
-
A family history of congenital or hereditary immunodeficiency.
-
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
-
Major congenital defects or serious chronic illness.
-
History of neurological disorders or more than one episode of febrile convulsion.
-
Acute disease at the time of enrolment.
-
Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Additional exclusion criteria for the long-term persistence phase: to be checked each year.
-
Previous administration of a booster dose of Hib, meningococcal serogroup C vaccines.
-
History of H. influenzae type b, meningococcal serogroup C diseases.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | GSK Investigational Site | Garran | Australian Capital Territory | Australia | 2606 |
| 2 | GSK Investigational Site | Randwick | New South Wales | Australia | 2031 |
| 3 | GSK Investigational Site | Westmead | New South Wales | Australia | 2145 |
| 4 | GSK Investigational Site | Herston | Queensland | Australia | 4029 |
| 5 | GSK Investigational Site | North Adelaide | South Australia | Australia | 5006 |
| 6 | GSK Investigational Site | Carlton | Victoria | Australia | 3053 |
| 7 | GSK Investigational Site | Perth | Western Australia | Australia |
Sponsors and Collaborators
- GlaxoSmithKline
Investigators
- Study Director: GSK Clinical Trials, GlaxoSmithKline
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- Booy R et al. Immunogenicity and safety of the Hib-MenC-TT conjugate vaccine in Hib-primed toddlers: 3 year follow-up. Abstract presented at the 7th World Congress for World Society for Pediatric Infectious Diseases (WSPID). Melbourne, Australia, 16-19 November 2011.
- Booy R et al. Immunogenicity and safety of the Hib-MenC-TT conjugate vaccine in Hib-primed toddlers: 4 year follow-up. Abstract presented at the Communicable Diseases Network Australia - Communicable Diseases Control Conference 2013, Canberra, Australia, 19-20 March 2013.
- Booy R et al. Prolonged immunogenicity and safety of the HibMenC-TT conjugate vaccine in Hib-Primed toddlers. Abstract presented at the PHAA Communicable Disease Conference. Canberra, Australia, 4-6 April 2011.
- Booy R, Richmond P, Nolan T, McVernon J, Marshall H, Nissen M, Reynolds G, Ziegler JB, Heron L, Lambert S, Caubet M, Mesaros N, Boutriau D. Immediate and longer term immunogenicity of a single dose of the combined haemophilus influenzae type B-Neisseria meningitidis serogroup C-tetanus toxoid conjugate vaccine in primed toddlers 12 to 18 months of age. Pediatr Infect Dis J. 2011 Apr;30(4):340-2. doi: 10.1097/INF.0b013e31820013d2.
- Booy R, Richmond P, Nolan T, McVernon J, Marshall H, Nissen M, Reynolds G, Ziegler JB, Stoney T, Heron L, Lambert S, Mesaros N, Peddiraju K, Miller JM. Three-year antibody persistence and safety after a single dose of combined haemophilus influenzae type b (Hib)-Neisseria meningitidis serogroup C-tetanus toxoid conjugate vaccine in Hib-primed toddlers. Pediatr Infect Dis J. 2013 Feb;32(2):169-74. doi: 10.1097/INF.0b013e3182787bff.
Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00326118
Other Study ID Numbers:
- 106445
- 106446
- 106449
- 106450
- 106452
- 106454
First Posted:
May 16, 2006
Last Update Posted:
Aug 24, 2018
Last Verified:
Sep 1, 2016
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by GlaxoSmithKline
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | Total of subjects completed in the previous period does not necessarily correspond to the amount of subjects who came back for the follow-up. These subjects were considered lost-to-follow-up. |
| Arm/Group Title | Menitorix Group | Meningitec + Hiberix Group |
|---|---|---|
| Arm/Group Description | Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm. | Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm. |
| Period Title: Active Phase | ||
| STARTED | 324 | 109 |
| COMPLETED | 320 | 108 |
| NOT COMPLETED | 4 | 1 |
| Period Title: Active Phase | ||
| STARTED | 295 | 100 |
| COMPLETED | 295 | 100 |
| NOT COMPLETED | 0 | 0 |
| Period Title: Active Phase | ||
| STARTED | 270 | 92 |
| COMPLETED | 270 | 92 |
| NOT COMPLETED | 0 | 0 |
| Period Title: Active Phase | ||
| STARTED | 256 | 89 |
| COMPLETED | 256 | 89 |
| NOT COMPLETED | 0 | 0 |
| Period Title: Active Phase | ||
| STARTED | 228 | 80 |
| COMPLETED | 228 | 80 |
| NOT COMPLETED | 0 | 0 |
| Period Title: Active Phase | ||
| STARTED | 217 | 78 |
| COMPLETED | 217 | 78 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Menitorix Group | Meningitec + Hiberix Group | Total |
|---|---|---|---|
| Arm/Group Description | Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm. | Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm. | Total of all reporting groups |
| Overall Participants | 324 | 109 | 433 |
| Age (Months) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Months] |
12.5
(0.94)
|
12.5
(0.75)
|
12.5
(0.90)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
150
46.3%
|
42
38.5%
|
192
44.3%
|
| Male |
174
53.7%
|
67
61.5%
|
241
55.7%
|
Outcome Measures
| Title | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 0.15 Micrograms Per Milliliter (µg/mL) |
|---|---|
| Description | Anti-PRP antibody concentration greater than or equal to 0.15 µg/mL is indicative of short-term protection. |
| Time Frame | 1 month after vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity which included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component for the blood sample taken 1 month after vaccination. |
| Arm/Group Title | Menitorix Group | Meningitec + Hiberix Group |
|---|---|---|
| Arm/Group Description | Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm. | Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm. |
| Measure Participants | 292 | 100 |
| Number [Subjects] |
292
|
100
|
| Title | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Greater Than or Equal to 1:8 Titer |
|---|---|
| Description | rSBA-MenC titers greater than or equal to 1:8 titer are indicative of seroprotection. |
| Time Frame | 1 month after vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity which included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component for the blood sample taken 1 month after vaccination. |
| Arm/Group Title | Menitorix Group | Meningitec + Hiberix Group |
|---|---|---|
| Arm/Group Description | Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm. | Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm. |
| Measure Participants | 281 | 98 |
| Number [Subjects] |
280
|
98
|
| Title | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Above the Cut-off Values |
|---|---|
| Description | rSBA-MenC titers cut-off values assessed were greater than or equal to (≥) 1:8 (indicative of seroprotection) and ≥ 1:128 titers. Functional anti-meningococcal serogroup C activity (SBA-MenC) was determined by a serum bactericidal test using rabbit complement. For SBA testing at a GlaxoSmithKline (GSK) laboratory up to Year 3 after vaccination, titres were expressed as the reciprocal of the dilution resulting in 50% inhibition. For SBA testing at the Public Health England (PHE), formerly known as Health Protection Agency (HPA), at Year 4, titres were expressed as the reciprocal of the last dilution resulting in at least 50% inhibition. |
| Time Frame | Prior to, 1 month, 1 year, 2 years, 3 years and 4 years after vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity (prior to and 1 month after vaccination) and the ATP cohort for analysis of persistence for Year 1, 2, 3 and 4 (1, 2, 3 and 4 years after vaccination), on subjects with available data for at least one tested antigen at the considered time point. |
| Arm/Group Title | Menitorix Group | Meningitec + Hiberix Group |
|---|---|---|
| Arm/Group Description | Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm. | Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm. |
| Measure Participants | 281 | 98 |
| ≥ 1:8 [Prior to vaccination] (N=255, 83) |
37
|
7
|
| ≥ 1:8 [1 year after vaccination] (N=249, 89) |
216
|
68
|
| ≥ 1:8 [2 years after vaccination] (N= 235, 86) |
164
|
52
|
| ≥ 1:8 [3 years after vaccination] (N= 226, 77) |
145
|
41
|
| ≥ 1:8 [4 years after vaccination] (N= 208, 73) |
26
|
9
|
| ≥ 1:128 [Prior to vaccination] (N=255, 83) |
15
|
3
|
| ≥ 1:128 [1 month after vaccination] (N=281, 98) |
247
|
89
|
| ≥ 1:128 [1 year after vaccination] (N=249, 89) |
117
|
37
|
| ≥ 1:128 [2 years after vaccination] (N= 235, 86) |
76
|
26
|
| ≥ 1:128 [3 years after vaccination] (N= 226, 77) |
58
|
22
|
| ≥ 1:128 [4 years after vaccination] (N= 208, 73) |
7
|
4
|
| Title | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Above the Cut-off Values |
|---|---|
| Description | rSBA-MenC titers cut-off values assessed were greater than or equal to (≥)1:8 (indicative of seroprotection) and 1:128 titers. For SBA testing at the PHE at Year 5, titres were expressed as the reciprocal of the last dilution resulting in at least 50% inhibition. |
| Time Frame | 5 years after vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 5, on subjects with available data for at least one tested antigen at the considered time point. |
| Arm/Group Title | Menitorix Group | Meningitec + Hiberix Group |
|---|---|---|
| Arm/Group Description | Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm. | Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm |
| Measure Participants | 195 | 68 |
| ≥ 1:8 [5 years after vaccination] |
37
|
17
|
| ≥ 1:128 [5 years after vaccination ] |
12
|
7
|
| Title | Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers |
|---|---|
| Description | Titers are given as Geometric Mean Titers (GMTs). Functional anti-meningococcal serogroup C activity (SBA-MenC) was determined by a serum bactericidal test using rabbit complement. For SBA testing at a GlaxoSmithKline (GSK) laboratory up to Year 3 after vaccination, titres were expressed as the reciprocal of the dilution resulting in 50% inhibition. For SBA testing at the PHE at year 4 after vaccination, titres were expressed as the reciprocal of the last dilution resulting in at least 50% inhibition. |
| Time Frame | Prior to, 1 month, 1 year, 2 years, 3 years and 4 years after vaccination. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity (prior to and 1 month after vaccination) and the ATP cohort for analysis of persistence for Year 1, 2, 3 and 4 (1, 2, 3 and 4 years after vaccination), on subjects with available data for at least one tested antigen at the considered time point. |
| Arm/Group Title | Menitorix Group | Meningitec + Hiberix Group |
|---|---|---|
| Arm/Group Description | Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm. | Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm. |
| Measure Participants | 281 | 98 |
| Prior to vaccination (N= 255; 83) |
6.3
|
5.5
|
| 1 month after vaccination (N= 281; 98) |
482.8
|
621.0
|
| 1 year after vaccination (N= 249; 89) |
91.7
|
63.8
|
| 2 years after vaccination (N= 235; 86) |
39.3
|
30.6
|
| 3 years after vaccination (N= 226; 77) |
29.8
|
21.8
|
| 4 years after vaccination (N=208;73) |
5.3
|
6.0
|
| Title | Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers |
|---|---|
| Description | Titers are given as Geometric Mean Titers (GMTs). Functional anti-meningococcal serogroup C activity (SBA-MenC) was determined by a serum bactericidal test using rabbit complement. For SBA testing at the PHE at Year 5, titres were expressed as the reciprocal of the last dilution resulting in at least 50% inhibition. |
| Time Frame | 5 years after vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 5, on subjects with available data for at least one tested antigen at the considered time point. |
| Arm/Group Title | Menitorix Group | Meningitec + Hiberix Group |
|---|---|---|
| Arm/Group Description | Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm. | Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm. |
| Measure Participants | 195 | 68 |
| Geometric Mean (95% Confidence Interval) [Titer] |
6.6
|
8.5
|
| Title | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Above Cut-off Values |
|---|---|
| Description | Anti-PRP antibody concentration cut-off values assessed include 0.15 µg/mL (indicative of short-term protection) and 1.0 µg/mL (indicative of long-term protection). |
| Time Frame | Prior to, 1 month, 1 year, 2 years, 3 years and 4 years after vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity (prior to and 1 month after vaccination) and the ATP cohort for analysis of persistence for Year 1, 2, 3 and 4 (1, 2, 3 and 4 years after vaccination), on subjects with available data for at least one tested antigen at the considered time point. |
| Arm/Group Title | Menitorix Group | Meningitec + Hiberix Group |
|---|---|---|
| Arm/Group Description | Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm. | Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm. |
| Measure Participants | 292 | 100 |
| ≥ 0.15 µg/mL [Prior to vaccination] (N=285,98) |
219
|
82
|
| ≥ 0.15 µg/mL [1 year post-vaccination] (N=255,91) |
252
|
91
|
| ≥ 0.15 µg/mL [2 years post-vaccination] (N=237,84) |
235
|
84
|
| ≥ 0.15 µg/mL [3 years post-vaccination] (N=233,78) |
231
|
77
|
| ≥ 0.15 µg/mL [4 years post-vaccination] (N=204,73) |
202
|
73
|
| ≥ 1.0 µg/mL [Prior to vaccination] (N=285,98) |
77
|
22
|
| ≥ 1.0 µg/mL [1 month post-vaccination] (N=292,100) |
286
|
100
|
| ≥ 1.0 µg/mL [1 year post-vaccination] (N=255,91) |
209
|
80
|
| ≥ 1.0 µg/mL [2 years post-vaccination] (N=237,84) |
174
|
72
|
| ≥ 1.0 µg/mL [3 years post-vaccination] (N=233,78) |
164
|
64
|
| ≥ 1.0 µg/mL [4 years post-vaccination] (N=204,73) |
144
|
57
|
| Title | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Above Cut-off Values |
|---|---|
| Description | Anti-PRP antibody concentration cut-off values assessed include 0.15 µg/mL (indicative of short-term protection) and 1.0 µg/mL (indicative of long-term protection). |
| Time Frame | 5 years after vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 5, on subjects with available data for at least one tested antigen at the considered time point. |
| Arm/Group Title | Menitorix Group | Meningitec + Hiberix Group |
|---|---|---|
| Arm/Group Description | Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm. | Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm. |
| Measure Participants | 191 | 67 |
| ≥ 0.15 µg/mL [5 years post-vaccination] |
191
|
67
|
| ≥ 1.0 µg/mL [5 years post-vaccination] |
129
|
47
|
| Title | Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations |
|---|---|
| Description | Concentrations are given as Geometric Mean Concentrations (GMCs). |
| Time Frame | Prior to, 1 month , 1 year, 2 years, 3 years and 4 years after vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity (prior to and 1 month after vaccination) and the ATP cohort for analysis of persistence for Year 1, 2, 3 and 4 (1, 2, 3 and 4 years after vaccination), on subjects with available data for at least one tested antigen at the considered time point. |
| Arm/Group Title | Menitorix Group | Meningitec + Hiberix Group |
|---|---|---|
| Arm/Group Description | Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm. | Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm. |
| Measure Participants | 292 | 100 |
| Prior to vaccination (N=285, 98) |
0.438
|
0.472
|
| 1 month after vaccination (N=292, 100) |
46.652
|
73.976
|
| 1 year after vaccination (N=255, 91) |
3.550
|
4.802
|
| 2 years after vaccination (N= 237, 84) |
2.5
|
3.3
|
| 3 years after vaccination (N= 233, 78) |
2.234
|
2.751
|
| 4 years after vaccination (N= 204, 73) |
2.116
|
2.964
|
| Title | Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations |
|---|---|
| Description | Concentrations are given as Geometric Mean Concentrations (GMCs). |
| Time Frame | 5 years after vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 5, on subjects with available data for at least one tested antigen at the considered time point. |
| Arm/Group Title | Menitorix Group | Meningitec + Hiberix Group |
|---|---|---|
| Arm/Group Description | Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm. | Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm. |
| Measure Participants | 191 | 67 |
| Geometric Mean (95% Confidence Interval) [microgram per milliliter (µg/mL)] |
2.131
|
2.537
|
| Title | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Above the Cut-off Values |
|---|---|
| Description | Anti-PSC antibody concentration cut-off values assessed include greater than or equal to (≥) 0.30 µg/mL and ≥ 2.0 µg/mL. |
| Time Frame | Prior to, 1 month, 1 year, 2 years and 3 years after vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity (prior to and 1 month after vaccination) and the ATP cohort for analysis of persistence for Year 1, 2, 3 (1, 2, 3 years after vaccination), on subjects with available data for at least one tested antigen at the considered time point. |
| Arm/Group Title | Menitorix Group | Meningitec + Hiberix Group |
|---|---|---|
| Arm/Group Description | Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm. | Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm. |
| Measure Participants | 290 | 100 |
| ≥ 0.3 µg/mL [prior to vaccination] (N=283, 96) |
2
|
1
|
| ≥ 0.3 µg/mL [1 month post-vaccination] (N=290,100) |
290
|
100
|
| ≥ 0.3 µg/mL [1 year post-vaccination] (N=250, 91) |
95
|
33
|
| ≥ 0.3 µg/mL [2 years post-vaccination] (N=233,84) |
47
|
17
|
| ≥ 0.3 µg/mL [3 years post-vaccination] (N=230,79) |
24
|
8
|
| ≥ 2.0 µg/mL [prior to vaccination] (N=283, 96) |
0
|
0
|
| ≥ 2.0 µg/mL [1 month post-vaccination] (N=290,100) |
289
|
96
|
| ≥ 2.0 µg/mL [1 year post-vaccination] (N=250, 91) |
6
|
0
|
| ≥ 2.0 µg/mL [2 years post-vaccination] (N=233,84) |
1
|
1
|
| ≥ 2.0 µg/mL [3 years post-vaccination] (N=230,79) |
1
|
1
|
| Title | Anti-polysaccharide C (Anti-PSC) Antibody Concentrations |
|---|---|
| Description | Concentrations given as Geometric Mean Concentrations (GMCs). |
| Time Frame | Prior to, 1 month, 1 year, 2 years and 3 years after vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity (prior to and 1 month after vaccination) and the ATP cohort for analysis of persistence for Year 1, 2, 3 (1, 2, 3 years after vaccination), on subjects with available data for at least one tested antigen at the considered time point. |
| Arm/Group Title | Menitorix Group | Meningitec + Hiberix Group |
|---|---|---|
| Arm/Group Description | Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm. | Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm. |
| Measure Participants | 290 | 100 |
| Prior to vaccination (N=283, 96) |
NA
|
NA
|
| 1 month after vaccination (N=290,100) |
18.69
|
7.95
|
| 1 year after vaccination (N=250, 91) |
NA
|
NA
|
| 2 years after vaccination (N= 233, 84) |
0.2
|
0.2
|
| 3 years after vaccination (N= 230, 79) |
NA
|
NA
|
| Title | Number of Subjects Reporting Solicited Local and General Symptoms |
|---|---|
| Description | Solicited local symptoms assessed include pain, redness and swelling at the injection site. Solicited general symptoms assessed include drowsiness, fever (≥ 38°C), irritability and loss of appetite. |
| Time Frame | Within 4 days (Day 0 -Day 3) after vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on the Total Vaccinated Cohort, on vaccinated subjects with available data for the vaccination phase. |
| Arm/Group Title | Menitorix Group | Meningitec + Hiberix Group |
|---|---|---|
| Arm/Group Description | Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm. | Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm. |
| Measure Participants | 324 | 109 |
| Pain |
91
|
42
|
| Redness |
146
|
64
|
| Swelling |
78
|
41
|
| Drowsiness |
102
|
40
|
| Fever |
76
|
30
|
| Irritabily |
154
|
69
|
| Loss of appetite |
102
|
40
|
| Title | Number of Subjects Reporting Unsolicited Symptoms |
|---|---|
| Description | Unsolicited symptom: 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 will be reported as an unsolicited adverse event. |
| Time Frame | Within 31 days (Day 0 - Day 30) after vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on the Total Vaccinated Cohort, on vaccinated subjects with available data for the vaccination phase. |
| Arm/Group Title | Menitorix Group | Meningitec + Hiberix Group |
|---|---|---|
| Arm/Group Description | Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm. | Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm. |
| Measure Participants | 324 | 109 |
| Number [Subjects] |
217
|
81
|
| Title | Number of Subjects Reporting Serious Adverse Events (SAEs) |
|---|---|
| Description | A serious adverse event (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject. For the long-term persistence phase (Years 1 through 5), only those SAEs that are determined by the investigator to have a causal relationship to the vaccination will be described individually. |
| Time Frame | Throughout the entire study period (up to year 5) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on vaccinated subjects from the Total Vaccinated Cohort for the Vaccination Phase of the study (up to Month 1) and on the Total Enrolled Cohort up to Year 5, which included all vaccinated subjects in the vaccination phase who came back for the Year 1, Year 2, Year 3 ,Year 4 and/or Year 5 persistence phases of the study. |
| Arm/Group Title | Menitorix Group | Meningitec + Hiberix Group |
|---|---|---|
| Arm/Group Description | Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm. | Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm. |
| Measure Participants | 324 | 109 |
| Vaccination Phase (N=324, 109) |
4
|
2
|
| Until year 5 (N=295, 100) |
0
|
0
|
Adverse Events
| Time Frame | Up to Year 5 for Serious Adverse Events. Within 31 days after vaccination for Other Adverse Events that were not systematically assessed. Within 4 days after vaccination for Other Adverse Events that were systematically assessed. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | For long-term persistence (Years 1 to 5), only SAEs that are determined by the investigator as causally related to vaccination will be described individually. No SAEs related to vaccination were reported between the end of the vaccination phase up to Year 5. | |||
| Arm/Group Title | Menitorix Group | Meningitec + Hiberix Group | ||
| Arm/Group Description | Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm. | Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm. | ||
All Cause Mortality |
||||
| Menitorix Group | Meningitec + Hiberix Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Menitorix Group | Meningitec + Hiberix Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 4/324 (1.2%) | 2/109 (1.8%) | ||
| General disorders | ||||
| Pyrexia | 0/324 (0%) | 1/109 (0.9%) | ||
| Infections and infestations | ||||
| Croup infectious | 1/324 (0.3%) | 0/109 (0%) | ||
| Gastroenteritis | 1/324 (0.3%) | 0/109 (0%) | ||
| Pneumonia | 0/324 (0%) | 1/109 (0.9%) | ||
| Injury, poisoning and procedural complications | ||||
| Traumatic brain injury | 1/324 (0.3%) | 0/109 (0%) | ||
| Nervous system disorders | ||||
| Convulsion | 1/324 (0.3%) | 0/109 (0%) | ||
| Psychiatric disorders | ||||
| Breath holding | 1/324 (0.3%) | 0/109 (0%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Asthma | 0/324 (0%) | 1/109 (0.9%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Rash | 0/324 (0%) | 1/109 (0.9%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Menitorix Group | Meningitec + Hiberix Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 293/324 (90.4%) | 104/109 (95.4%) | ||
| Gastrointestinal disorders | ||||
| Teething | 40/324 (12.3%) | 15/109 (13.8%) | ||
| Diarrhea | 25/324 (7.7%) | 8/109 (7.3%) | ||
| Vomiting | 22/324 (6.8%) | 9/109 (8.3%) | ||
| General disorders | ||||
| Pyrexia | 37/324 (11.4%) | 13/109 (11.9%) | ||
| Injection site reaction | 7/324 (2.2%) | 10/109 (9.2%) | ||
| Irritability | 0/324 (0%) | 9/109 (8.3%) | ||
| Pain | 91/324 (28.1%) | 42/109 (38.5%) | ||
| Redness | 146/324 (45.1%) | 64/109 (58.7%) | ||
| Swelling | 78/324 (24.1%) | 41/109 (37.6%) | ||
| Drowsiness | 102/324 (31.5%) | 40/109 (36.7%) | ||
| Fever (above or equal to 38 degrees Celsius) | 76/324 (23.5%) | 30/109 (27.5%) | ||
| Irritability | 154/324 (47.5%) | 69/109 (63.3%) | ||
| Loss of appetite | 102/324 (31.5%) | 40/109 (36.7%) | ||
| Infections and infestations | ||||
| Upper respiratory tract infection | 54/324 (16.7%) | 13/109 (11.9%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Rhinorrhoea | 17/324 (5.2%) | 3/109 (2.8%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Rash | 24/324 (7.4%) | 17/109 (15.6%) | ||
| Dermatitis diaper | 9/324 (2.8%) | 9/109 (8.3%) | ||
Limitations/Caveats
[Not Specified]
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 |
Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00326118
Other Study ID Numbers:
- 106445
- 106446
- 106449
- 106450
- 106452
- 106454
First Posted:
May 16, 2006
Last Update Posted:
Aug 24, 2018
Last Verified:
Sep 1, 2016