Last updated: 11/02/2018 23:41:47

Comparison of GSKBiologicals' Hib-MenCY-TT vaccine vs Licensed Hib Conjugate or Meningococcal Vaccine

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GSK study ID
101858
See study documents
Clinicaltrials.gov ID
NCT00129129
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Evaluate Immuno and Safety of GSKBiologicals' HibMenCYTT vs Licensed Hib Conjugate Vaccine, Each Coadministered With Pediarix® and Prevnar®, in Healthy Infants. An Exploratory Control Group Will Receive Licensed Menomune® at 3 to 5 years
Trial description: This study is evaluating the safety and immunogenicity of GSK Biologicals’ Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine, each administered at 2, 4, and 6 months of age, and compared to licensed meningococcal serogroups A, C, Y, and W-135 polysaccharide vaccine administered at 3 to 5 years of age.
The safety and immunogenicity of a booster dose of Hib-MenCY-TT vaccine will be compared to a booster dose of licensed Hib conjugate vaccine, each administered at 12 to 15 months of age. The group primed with the Hib conjugate vaccine will re-randomized at 12-15 months of age to receive a booster dose of Hib-MenCY-TT or a booster dose of the Hib conjugate vaccine.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Single (Participant)
Allocation:
Randomized
Primary outcomes:

Number of subjects with anti-polyribosyl-ribitol-phosphate (anti-PRP) antibody concentration equal to or above (≥) cut-off value.

Timeframe: One month after the 3-dose primary vaccination course (at Month 5)

Concentration of antibodies against Streptococcus pneumoniae serotypes

Timeframe: One month after the 3-dose primary vaccination course (at Month 5)

Anti-pertussis toxoid (PT), anti-filamentous haemagglutinin (FHA) and anti-pertactin (PRN) antibody concentrations

Timeframe: One month after the 3-dose primary vaccination course (at Month 5)

Number of subjects reporting any Grade 3 symptoms

Timeframe: During the 4-day follow-up period after each primary vaccine dose

Number of subjects with anti-polyribosyl-ribitol-phosphate (anti-PRP) antibody concentration equal to or above (≥) cut-off value

Timeframe: One month after the fourth dose (at Month 11-14)

Secondary outcomes:

Number of subjects with Neisseria meningitidis serogroup C serum bacterial assay using rabbit complement (rSBA-MenC) antibody titers ≥ the cut-off values

Timeframe: Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)

Neisseria meningitidis serogroup C serum bacterial assay using rabbit complement (rSBA-MenC) antibody titers

Timeframe: Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)

Number of subjects with Neisseria meningitidis serogroup Y serum bacterial assay using rabbit complement (rSBA-MenY) antibody titers ≥ the cut-off values

Timeframe: Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)

Neisseria meningitidis serogroup Y serum bacterial assay using rabbit complement (rSBA-MenY) antibody titers

Timeframe: Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)

Number of subjects with Neisseria meningitidis serogroup C serum bacterial assay using human complement (hSBA-MenC) antibody titers ≥ 1:4

Timeframe: One month after the primary vaccination course (at Month 5 for the MenHibrix and ActHIB groups)/one month after vaccination (at Month 1 for the Menomune Group)

Number of subjects with Neisseria meningitidis serogroup Y serum bacterial assay using human complement (hSBA-MenC) antibody titers ≥ 1:4

Timeframe: One month after the primary vaccination course (at Month 5 for the MenHibrix and ActHIB groups)/one month after vaccination (at Month 1 for the Menomune Group)

Number of subjects with anti-polysaccharide C (anti-PSC) antibody concentrations above ≥ the cut-off values

Timeframe: Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)

Anti-polysaccharide C (anti-PSC) antibody concentrations

Timeframe: Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)

Number of subjects with anti-polysaccharide Y (anti-PSY) antibody concentrations equal to or above ≥ the cut-off values

Timeframe: Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)

Anti-polysaccharide Y (anti-PSY) antibody concentrations

Timeframe: Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)

Number of subjects reporting medically attended visits

Timeframe: During the 31-day follow-up period after vaccination with Menomune vaccine at Day 0

Number of subjects reporting rash

Timeframe: During the 31-day follow-up period after vaccination with Menomune vaccine at Day 0

Number of subjects reporting serious adverse events (SAEs)

Timeframe: During the 31-day follow-up period after vaccination with Menomune vaccine at Day 0

Number of subjects with anti-PRP antibody concentrations ≥ the cut-off values

Timeframe: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)

Anti-PRP antibody concentrations

Timeframe: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)

Number of subjects with Streptococcus pneumoniae serotypes antibody concentrations ≥ cut-off

Timeframe: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)

Number of subjects with Streptococcus pneumoniae serotypes antibody concentrations ≥ cut-off

Timeframe: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)

Number of subjects with Streptococcus pneumoniae serotypes antibody concentrations ≥ cut-off

Timeframe: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)

Number of subjects with anti-diphtheria and anti-tetanus antibody concentration ≥ 0.1 international units per milliliter (IU/mL)

Timeframe: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)

Anti-diphtheria and anti-tetanus antibody concentrations

Timeframe: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)

Number of subjects with anti-hepatitis-B surface antigen (anti-HBs) antibody concentration ≥ 10.0 milli-international units per milliliter (mIU/mL)

Timeframe: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)

Anti-hepatitis-B surface antigen (anti-HBs) antibody concentrations

Timeframe: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)

Number of subjects with anti-PT, anti-FHA and anti-PRN antibody concentration ≥ 5.0 EL.U/mL

Timeframe: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)

Anti PT, anti-FHA and anti-PRN antibody concentrations

Timeframe: Prior to the primary vaccination course (at Day 0)

Number of subjects with anti-poliovirus types 1, 2 and 3 antibody titer ≥ 1:8

Timeframe: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)

Anti-poliovirus types 1, 2 and 3 antibody titers

Timeframe: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)

Number of subjects with vaccine response to PT, FHA and PRN

Timeframe: One month after the 3-dose primary vaccination course (at Month 5)

Number of subjects reporting any, Grade 2 or 3 and Grade 3 solicited local symptoms

Timeframe: Within 4 days (Day 0-3) after the 3-dose primary vaccination

Number of subjects reporting any, Grade 2 or 3 and Grade 3 solicited local symptoms

Timeframe: Within 8 days (Day 0-7) after the 3-dose primary vaccination

Number of subjects reporting any, Grade 2 or 3 and Grade 3 solicited general symptoms

Timeframe: Within 4 days (Day 0-3) after the 3-dose primary vaccination

Number of subjects reporting any, Grade 2 or 3 and Grade 3 solicited general symptoms

Timeframe: Within 8 days (Day 0-7) after the 3-dose primary vaccination

Number of subjects reporting unsolicited adverse events (AEs)

Timeframe: From Dose 1 (at Day 0) through Day 30 following the last vaccine dose administered (Day 30 post Month 4 vaccination for MenHibrix and ActHIB groups, Day 30 post Month 1 for Menomune Group).

Number of subjects reporting serious adverse events (SAEs)

Timeframe: During the entire Primary Phase of the study, from Day 0 up to the end of Primary Phase safety follow-up period (6 months after the last vaccination).

Number of subjects reporting serious adverse events (SAEs)

Timeframe: From Day 0 following Dose 1 throughout the study up to the day preceding the administration of the fourth dose of vaccine.

Number of subjects reporting new onset of chronic illness(es) (NOCIs)

Timeframe: From Day 0 following Dose 1 throughout the study up to the day preceding the administration of the fourth dose of vaccine

Number of subjects reporting rash

Timeframe: From Day 0 following Dose 1 throughout the study up to the day preceding the administration of the fourth dose of vaccine.

Number of subjects reporting emergency room (ER) visits or visits to physicians’ office, related or not to common illnesses

Timeframe: From Day 0 following Dose 1 throughout the study up to the day preceding the administration of the fourth dose of vaccine.

Number of subjects with fourth dose response for Neisseria meningitidis serogroup C and Y serum bacterial assay using rabbit complement (rSBA-MenC and Y)

Timeframe: One month post fourth dose vaccination (at Month 11-14)

Number of subjects with fourth dose response for Neisseria meningitidis serogroup C and Y serum bacterial assay using rabbit complement (rSBA-MenC and Y)

Timeframe: One month post fourth dose vaccination (at Month 11-14)

Number of subjects with fourth dose response for Neisseria meningitidis serogroup C and Y serum bacterial assay using human complement (hSBA-MenC and Y)

Timeframe: One month post fourth dose vaccination (at Month 11-14)

Number of subjects with fourth dose response for Neisseria meningitidis serogroup C and Y serum bacterial assay using human complement (hSBA-MenC and Y)

Timeframe: One month post fourth dose vaccination (at Month 11-14)

Number of subjects with Streptococcus pneumoniae serotypes antibody concentrations equal to or above 0.05 microgram per milliliter (µg/mL)

Timeframe: One month after fourth dose vaccination (at Month 11-14)

Number of subjects with Streptococcus pneumoniae serotypes antibody concentrations equal to or above 0.2 microgram per milliliter (µg/mL)

Timeframe: One month after fourth dose vaccination (at Month 11-14)

Number of subjects with Streptococcus pneumoniae serotypes antibody concentrations equal to or above 0.5 microgram per milliliter (µg/mL)

Timeframe: One month after fourth dose vaccination (at Month 11-14)

Concentration of antibodies against Streptococcus pneumonia serotypes

Timeframe: One month post fourth dose vaccination (at Month 11-14)

Number of subjects with anti-polyribosyl-ribitol-phosphate (anti-PRP) antibody concentrations equal to or above the cut-off values

Timeframe: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)

Anti-PRP antibody concentrations

Timeframe: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)

Number of subjects with Neisseria meningitidis serogroup C serum bacterial assay using rabbit complement (rSBA-MenC) antibody titers equal to or above the cut-off values

Timeframe: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)

rSBA-MenC antibody titers

Timeframe: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)

Number of subjects with Neisseria meningitidis serogroup Y serum bacterial assay using rabbit complement (rSBA-MenY) antibody titers equal to or above the cut-off values

Timeframe: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)

rSBA-MenY antibody titers

Timeframe: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)

Number of subjects with Neisseria meningitidis serogroup C serum bacterial assay using human complement (hSBA-MenC) antibody titers equal to or above the cut-off values

Timeframe: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)

hSBA-MenC antibody titers

Timeframe: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)

Number of subjects with Neisseria meningitidis serogroup Y serum bacterial assay using human complement (hSBA-MenY) antibody titers equal to or above the cut-off values

Timeframe: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)

hSBA-MenY antibody titers

Timeframe: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)

Number of subjects with anti-polysaccharide C (anti-PSC) antibody concentrations equal to or above the cut-off values

Timeframe: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)

Anti-PSC antibody concentrations

Timeframe: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)

Number of subjects with anti-polysaccharide Y (anti-PSY) antibody concentrations equal to or above the cut-off values

Timeframe: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)

Anti-PSY antibody concentrations

Timeframe: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)

Number of subjects with anti-tetanus antibody concentration equal to or above 0.1 international units per milliliter (IU/mL)

Timeframe: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)

Anti-tetanus antibody concentrations

Timeframe: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)

Number of subjects reporting any, Grade 2 or 3 and Grade 3 solicited local symptoms

Timeframe: Within 4 days (Day 0-3) after fourth dose vaccination

Number of subjects reporting any, Grade 2 or 3 and Grade 3 solicited local symptoms

Timeframe: Within 8 days (Day 0-7) after fourth dose vaccination

Number of subjects reporting any, Grade 2 or 3 and Grade 3 solicited general symptoms

Timeframe: Within 4 days (Day 0-3) after fourth dose vaccination

Number of subjects reporting any, Grade 2 or 3 and Grade 3 solicited general symptoms

Timeframe: Within 8 days (Day 0-7) after fourth dose vaccination

Number of subjects reporting unsolicited adverse events (AEs)

Timeframe: During the 31-day follow-up period following the fourth dose

Number of subjects reporting serious adverse events (SAEs)

Timeframe: During the entire Primary Phase of the study, from Day 0 up to the end of Primary Phase safety follow-up period (6 months after the last vaccination).

Number of subjects reporting new onset of chronic illness(es)

Timeframe: From receipt of the fourth dose (at Month 10-13) through the end of the 6-month safety follow-up

Number of subjects reporting rash

Timeframe: From receipt of the fourth dose (at Month 10-13) through the end of the 6-month safety follow-up

Number of subjects reporting emergency room (ER) visits or physicians office visits related or not to common illnesses

Timeframe: From receipt of the fourth dose (at Month 10-13) through the end of the 6-month safety follow-up

Number of subjects reporting large swelling reactions of the injected limb(s)

Timeframe: Within 4 days (Day 0-3) and within 8 days (Day 0-7) following the fourth dose

Interventions:
Biological/vaccine: GSK Biologicals' Haemophilus influenza type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine 792014 vaccine
Biological/vaccine: ActHIB
Biological/vaccine: Pediarix
Biological/vaccine: Prevnar
Biological/vaccine: Menomune
Enrollment:
756
Observational study model:
Not applicable
Primary completion date:
2005-15-09
Time perspective:
Not applicable
Clinical publications:
Bryant KA et al. (2011) Haemophilus influenzae type b–Neisseria meningitidis serogroups C and Y tetanus toxoid conjugate vaccine for infants and toddlers. Expert Rev Vaccines. 10(7):941-950.
Marchant CD et al. (2010) Randomized trial to assess immunogenicity and safety of Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y–tetanus toxoid conjugate vaccine in infants. Pediatr Infect Dis J. 29(1):48-52.
Marshall GS et al. (2010) Immune response and one year antibody persistence after a fourth dose of a novel Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y–tetanus toxoid conjugate vaccine (HibMenCY) at 12 to 15 months of age. Pediatr Infect Dis J. 29(5): 469-471.
Marshall GS et al. (2011) Co-administration of a novel Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine does not interfere with the immune response to antigens contained in infant vaccines routinely used in the United States. Human Vaccines. 7(2):258-264.
Medical condition
Haemophilus influenzae type b, Neisseria Meningitidis
Product
SB792014
Collaborators
Not applicable
Study date(s)
August 2004 to March 2006
Type
Interventional
Phase
2

Participation criteria

Sex
Female & Male
Age
6 weeks - 15 months
Accepts healthy volunteers
Yes
  • For Groups A and B
  • -Subjects for whom the investigator believes that parents/guardians can and will comply with the requirements of the protocol.
  • For Groups A and B
  • -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.
Inclusion and exclusion criteria
Inclusion criteria:
  • For Groups A and B --Subjects for whom the investigator believes that parents/guardians can and will comply with the requirements of the protocol. --Healthy male or female between, and including, 6 and 12 weeks of age at the time of the first 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 the study. --Born after a gestation period between 36 and 42 weeks. --Infants who have not received a previous dose of hepatitis B vaccine or those who have received only 1 dose of hepatitis B vaccine administered at least 30 days prior to enrollment. -For Group C --Subjects for whom the investigator believes that parents/guardians can and will comply with the requirements of the protocol. --Healthy male or female between, and including, 3 and 5 years of age at the time of the first 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 the study.
Exclusion criteria:
  • For Groups A and B --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) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. --Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of study vaccine(s). --Previous vaccination against Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, poliovirus, and/or Streptococcus pneumoniae; more than one previous dose of hepatitis B vaccine. --History of Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, hepatitis B, poliovirus, and/or Streptococcus pneumoniae disease. --Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination --History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s), including dry natural latex rubber. --Major congenital defects or serious chronic illness. --History of any neurologic disorders or seizures. --Acute disease at time of enrollment. --Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. For Group C --Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the dose of study vaccine, or planned use during the study period. --Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose. --Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the dose of study vaccine. --Previous vaccination against Neisseria meningitidis. --History of Neisseria meningitidis disease. --Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination --History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, including dry natural latex rubber --Major congenital defects or serious chronic illness. --Acute disease at time of enrollment. --Administration of immunoglobulins and/or any blood products within the 3 months preceding vaccination or planned administration during the study period.

Trial location(s)

Location
Status
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Location
GSK Investigational Site
Louisville, Kentucky, United States, 40202
Status
Study Complete
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Location
GSK Investigational Site
Marietta, Georgia, United States, 30062
Status
Study Complete
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Location
GSK Investigational Site
Boston, Massachusetts, United States, 02118
Status
Study Complete
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Location
GSK Investigational Site
Rochester, New York, United States, 14620
Status
Study Complete
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Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15227
Status
Study Complete
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Location
GSK Investigational Site
Norristown, Pennsylvania, United States, 19401
Status
Study Complete
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Location
GSK Investigational Site
Beaver Falls, Pennsylvania, United States, 15010
Status
Study Complete
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Location
GSK Investigational Site
University Heights, Ohio, United States, 44118
Status
Study Complete
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Location
GSK Investigational Site
Greenville, Pennsylvania, United States, 16125
Status
Study Complete
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Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15241
Status
Study Complete
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Location
GSK Investigational Site
Rydal, Pennsylvania, United States, 19046
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Fountain Valley, California, United States, 92708
Status
Study Complete
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Location
GSK Investigational Site
Centennial, Colorado, United States, 80112
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Boston, Massachusetts, United States, 02115
Status
Study Complete
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Location
GSK Investigational Site
Warwick, Rhode Island, United States, 02886
Status
Study Complete
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Location
GSK Investigational Site
West Desmoines, Iowa, United States, 50266
Status
Study Complete
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Location
GSK Investigational Site
Erie, Pennsylvania, United States, 16505
Status
Study Complete
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Location
GSK Investigational Site
New Bedford, Massachusetts, United States, 02740
Status
Study Complete
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Location
GSK Investigational Site
Bardstown, Kentucky, United States, 40004
Status
Study Complete
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Location
GSK Investigational Site
Norwich, Connecticut, United States, 06360
Status
Study Complete
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Location
GSK Investigational Site
Bronx, New York, United States, 10467
Status
Study Complete
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Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15217
Status
Study Complete
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Location
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
Status
Study Complete
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Location
GSK Investigational Site
Boardman, Ohio, United States, 44512
Status
Study Complete
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Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15236
Status
Study Complete
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Location
GSK Investigational Site
Louisville, Kentucky, United States, 40272
Status
Study Complete
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Location
GSK Investigational Site
Bossier City, Louisiana, United States, 71111
Status
Study Complete
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Study documents

Clinical study report
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Results posted on ClinicalTrials.gov

Recruitment status
Completed
Actual primary completion date
2005-15-09
Actual study completion date
2006-29-03

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

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