3 Formulations of Hib-MenCY-TT Vaccine & 1 Formulation of Hib-MenC-TT Vaccine Compared to Licensed Meningococcal Serogroup C Conjugate Vaccine, Each Administered at 2,3,4 Mths of Age

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00129116
First received: August 10, 2005
Last updated: June 26, 2014
Last verified: June 2014
  Purpose

This study evaluated the safety and immunogenicity of 3 formulations of Hib-MenCY-TT vaccine and 1 formulation of Hib-MenC-TT vaccine compared to a control group receiving licensed meningococcal serogroup C conjugate vaccine, each administered at 2, 3, and 4 months of age. Antibody persistence and immune responses to booster vaccinations were additionally assessed at 12 to 18 months of age.


Condition Intervention Phase
Haemophilus Influenzae Type b
Neisseria Meningitidis
Biological: Hib-MenCY-TT vaccine
Biological: Hib-MenC-TT vaccine
Biological: Menjugate ®
Biological: Infanrix penta ®
Biological: Infanrix hexa ®
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: A Phase II, Open (Partially Double-blind), Randomised, Controlled, Multicentre, Primary Vaccination Study to Evaluate the Immunogenicity, Reactogenicity and Safety of Three Different Formulations of GSK Biologicals' Combined Haemophilus Influenzae Type B-meningococcal Serogroups C and Y- Conjugate Vaccine and One Formulation of GSK Biologicals' Haemophilus Influenzae Type B-meningococcal Serogroup C Conjugate Vaccine Each Given Concomitantly With InfanrixTM Penta, Versus MeningitecTM, Given Concomitantly With InfanrixTM Hexa in Infants According to a 2-3-4 Month Schedule

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL). [ Time Frame: One month after dose 3 (at study Month 3 - primary phase) ] [ Designated as safety issue: No ]
    Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 1 microgram per millilitre (µg/mL)

  • Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8 [ Time Frame: One month after dose 3 (at study Month 3 - primary phase) ] [ Designated as safety issue: No ]
    rSBA-MenC antibody titre cut-off value assessed was ≥1:8

  • Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8 [ Time Frame: One month after dose 3 (at study Month 3 - primary phase) ] [ Designated as safety issue: No ]
    rSBA-MenY antibody titre cut-off value assessed was ≥1:8

  • Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL). [ Time Frame: One month after the booster vaccination (at study Month 1 - booster phase) ] [ Designated as safety issue: No ]
    Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 1 microgram per millilitre (µg/mL)

  • Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8 [ Time Frame: One month after the booster vaccination (at study Month 1 - booster phase) ] [ Designated as safety issue: No ]
    rSBA-MenC antibody titre cut-off value assessed was ≥1:8

  • Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8 [ Time Frame: One month after the booster vaccination (at study Month 1 - booster phase) ] [ Designated as safety issue: No ]
    rSBA-MenY antibody titre cut-off value assessed was ≥1:8


Secondary Outcome Measures:
  • Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8 [ Time Frame: Before the administration of the first dose (at pre-vaccination = study Month 0 - primary phase) ] [ Designated as safety issue: No ]
    rSBA-MenC antibody titre cut-off value assessed was ≥1:8

  • Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8 [ Time Frame: Before the administration of the first dose (at pre-vaccination = study Month 0 - primary phase) ] [ Designated as safety issue: No ]
    rSBA-MenY antibody titre cut-off value assessed was ≥1:8

  • Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL). [ Time Frame: Before the administration of the first dose (at pre-vaccination = study Month 0 - primary phase) ] [ Designated as safety issue: No ]
    Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 1 microgram per millilitre (µg/mL)

  • Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL). [ Time Frame: Prior to the booster vaccination (at study Month 0 - booster phase) ] [ Designated as safety issue: No ]
    Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 1 microgram per millilitre (µg/mL)

  • Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8 [ Time Frame: Prior to the booster vaccination (at study Month 0 - booster phase) ] [ Designated as safety issue: No ]
    rSBA-MenC antibody titre cut-off value assessed was ≥1:8

  • Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8 [ Time Frame: Prior to the booster vaccination (at study Month 0 - booster phase) ] [ Designated as safety issue: No ]
    rSBA-MenY antibody titre cut-off value assessed was ≥1:8

  • rSBA-MenC Antibody Titres [ Time Frame: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase) ] [ Designated as safety issue: No ]
    Titres are expressed as geometric mean titres (GMTs)

  • rSBA-MenY Antibody Titres [ Time Frame: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase) ] [ Designated as safety issue: No ]
    Titres are expressed as geometric mean titres (GMTs)

  • Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 0.15 Microgram Per Millilitre (µg/mL). [ Time Frame: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase) ] [ Designated as safety issue: No ]
    Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 0.15 microgram per millilitre (µg/mL)

  • Anti-PRP Antibody Concentrations [ Time Frame: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase) ] [ Designated as safety issue: No ]
    Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.

  • Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL) [ Time Frame: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase) ] [ Designated as safety issue: No ]
    Anti-PSC antibody concentration cut-off value assessed was ≥0.30 µg/mL

  • Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL) [ Time Frame: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase) ] [ Designated as safety issue: No ]
    Anti-PSY antibody concentration cut-off value assessed was ≥0.30 µg/mL

  • Anti-PSC Antibody Concentrations [ Time Frame: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase) ] [ Designated as safety issue: No ]
    Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.

  • Anti-PSY Antibody Concentrations [ Time Frame: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase) ] [ Designated as safety issue: No ]
    Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.

  • Anti-tetanus Antibody Concentrations [ Time Frame: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase) ] [ Designated as safety issue: No ]
    Antibody concentrations are expressed as geometric mean concentrations (GMCs) in International Units per millilitre (IU/mL).

  • Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN), Anti-pertussis Toxoid (Anti-PT) Antibody Concentrations [ Time Frame: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase) ] [ Designated as safety issue: No ]
    Antibody concentrations are expressed as geometric mean concentrations (GMCs) in Enzyme-Linked Immunosorbent Assay (ELISA) Units per millilitre.

  • Number of Seroprotected Subjects for Anti-tetanus Antibodies [ Time Frame: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase) ] [ Designated as safety issue: No ]
    Seroprotection status is defined as anti-tetanus toxoid antibody concentration ≥ 0.1 International Units per millilitre (IU/mL)

  • Number of Subjects With Anti-FHA, Anti-PRN and Anti-PT Antibody Concentration Equal to or Above 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units Per Millilitre (EL.U/mL) [ Time Frame: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase) ] [ Designated as safety issue: No ]
    Anti-FHA, anti-PRN and anti-PT antibody concentration cut-off value assessed was ≥ 5 ELISA units per millilitre.

  • Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 0.15 Microgram Per Millilitre (µg/mL). [ Time Frame: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase) ] [ Designated as safety issue: No ]
    Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 0.15 microgram per millilitre (µg/mL)

  • Anti-PRP Antibody Concentrations [ Time Frame: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase) ] [ Designated as safety issue: No ]
    Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.

  • Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:128 [ Time Frame: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase) ] [ Designated as safety issue: No ]
    rSBA-MenC antibody titre cut-off value assessed was ≥1:128

  • Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:128 [ Time Frame: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase) ] [ Designated as safety issue: No ]
    rSBA-MenY antibody titre cut-off value assessed was ≥1:128

  • rSBA-MenC Antibody Titres [ Time Frame: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase) ] [ Designated as safety issue: No ]
    Titres are expressed as geometric mean titres (GMTs)

  • rSBA-MenY Antibody Titres [ Time Frame: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase) ] [ Designated as safety issue: No ]
    Titres are expressed as geometric mean titres (GMTs)

  • Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL) [ Time Frame: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase) ] [ Designated as safety issue: No ]
    Anti-PSC antibody concentration cut-off value assessed was ≥0.30 µg/mL

  • Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 2.0 Microgram Per Millilitre (µg/mL) [ Time Frame: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase) ] [ Designated as safety issue: No ]
    Anti-PSC antibody concentration cut-off value assessed was ≥2.0 µg/mL

  • Anti-PSC Antibody Concentrations [ Time Frame: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase) ] [ Designated as safety issue: No ]
    Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.

  • Anti-PSY Antibody Concentrations [ Time Frame: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase) ] [ Designated as safety issue: No ]
    Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.

  • Number of Subjects With Anti-tetanus Toxoid (Anti-T) Antibody Concentration Equal to or Above 0.1 International Units Per Millilitre (IU/mL). [ Time Frame: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase) ] [ Designated as safety issue: No ]
    Anti-tetanus toxoid antibody concentration cut-off value assessed was ≥ 0.1 IU/mL

  • Anti-T Antibody Concentrations [ Time Frame: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase) ] [ Designated as safety issue: No ]
    Antibody concentrations are expressed as geometric mean concentrations (GMCs) in International Units per millilitre (IU/mL).

  • Anti-diphtheria Antibody Concentrations [ Time Frame: One month after the third dose (at study Month 3 - primary phase) ] [ Designated as safety issue: No ]
    Antibody concentrations are expressed as geometric mean concentrations (GMCs) in IU/mL.

  • Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations [ Time Frame: One month after the third dose (at study Month 3 - primary phase) ] [ Designated as safety issue: No ]
    Antibody concentrations are expressed as geometric mean concentrations (GMCs) in milli-International Units per millilitre (mIU/mL).

  • Anti-poliovirus Types 1, 2, 3 Antibody Titres [ Time Frame: One month after the third dose (at study Month 3 - primary phase) ] [ Designated as safety issue: No ]
    Titres are expressed as geometric mean titres (GMTs)

  • Number of Seroprotected Subjects for Anti-diphtheria Antibodies [ Time Frame: One month after the third dose (at study Month 3 - primary phase) ] [ Designated as safety issue: No ]
    Seroprotection status is defined as anti-diphtheria antibody concentrations ≥ 0.1 IU/mL

  • Number of Seroprotected Subjects for Anti-hepatitis B Antibodies [ Time Frame: One month after the third dose (at study Month 3 - primary phase) ] [ Designated as safety issue: No ]
    Seroprotection status is defined as anti-HBs antibody concentrations ≥ 10 mIU/mL

  • Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3 Antibodies [ Time Frame: One month after the third dose (at study Month 3 - primary phase) ] [ Designated as safety issue: No ]
    Seroprotection status is defined as anti-polio 1, 2 and 3 antibody titres ≥ 1:8

  • Number of Subjects With Vaccine Response to PT, FHA and PRN [ Time Frame: One month after the third dose (at study Month 3 - primary phase) ] [ Designated as safety issue: No ]
    Vaccine response rates are defined as appearance of antibodies in subjects who were initially seronegative (i.e., with concentrations < cut-off value) or at least maintenance of pre-vaccination antibody concentrations in subjects who were initially seropositive (i.e., with concentrations ≥ cut-off value), taking into consideration the decreasing maternal antibodies.

  • Number of Subjects With Solicited Local Symptoms [ Time Frame: During the 8-day (Day 0-7) follow-up period (during the primary phase) ] [ Designated as safety issue: No ]
    Solicited local symptoms assessed were pain, redness and swelling.

  • Number of Subjects With Solicited General Symptoms [ Time Frame: During the 8-day (Day 0-7) follow-up period (during the primary phase) ] [ Designated as safety issue: No ]
    Solicited general symptoms assessed were drowsiness, irritability, loss of appetite and fever (fever is defined as rectal temperature ≥ 38.0 degrees Celsius (°C)).

  • Number of Subjects With Unsolicited Adverse Events (AEs) [ Time Frame: During the 31-day (Day 0-30) follow-up period (during the primary phase) ] [ Designated as safety issue: No ]
    An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.

  • Number of Subjects Reporting Serious Adverse Events (SAEs) [ Time Frame: Over the full course of the primary phase (up to study Month 3 - primary phase) ] [ Designated as safety issue: No ]
    SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.

  • Number of Subjects With Solicited Local Symptoms [ Time Frame: During the 8-day (Day 0-7) follow-up period (during the booster phase) ] [ Designated as safety issue: No ]
    Solicited local symptoms assessed were pain, redness and swelling.

  • Number of Subjects With Solicited General Symptoms [ Time Frame: During the 8-day (Day 0-7) follow-up period (during the booster phase) ] [ Designated as safety issue: No ]
    Solicited general symptoms assessed were drowsiness, irritability, loss of appetite and fever (fever is defined as rectal temperature ≥ 38.0 degrees Celsius (°C)).

  • Number of Subjects With Unsolicited Adverse Events (AEs) [ Time Frame: During the 31-day (Day 0-30) follow-up period (during the booster phase) ] [ Designated as safety issue: No ]
    An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.

  • Number of Subjects Reporting Serious Adverse Events (SAEs) [ Time Frame: Over the full course of the booster phase (up to study Month 1 - booster phase) ] [ Designated as safety issue: No ]
    SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.


Enrollment: 388
Study Start Date: March 2003
Study Completion Date: October 2004
Primary Completion Date: December 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Menhibrix F1/Infanrix-penta Group
Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
Biological: Hib-MenCY-TT vaccine
Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh.
Biological: Infanrix penta ®
Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in right thigh.
Other Name: DTPa-HBV-IPV vaccine
Experimental: Menhibrix F2/Infanrix-penta Group
Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
Biological: Hib-MenCY-TT vaccine
Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh.
Biological: Infanrix penta ®
Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in right thigh.
Other Name: DTPa-HBV-IPV vaccine
Experimental: Menhibrix F3/Infanrix-penta Group
Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
Biological: Hib-MenCY-TT vaccine
Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh.
Biological: Infanrix penta ®
Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in right thigh.
Other Name: DTPa-HBV-IPV vaccine
Experimental: Menitorix/Infanrix-penta Group
Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
Biological: Hib-MenC-TT vaccine
Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh.
Biological: Infanrix penta ®
Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in right thigh.
Other Name: DTPa-HBV-IPV vaccine
Active Comparator: Menjugate/Infanrix-hexa Group
Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
Biological: Menjugate ®
Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh.
Biological: Infanrix hexa ®
Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in right thigh.
Other Name: DTPa-HBV-IPV/Hib vaccine

Detailed Description:

Primary & booster vaccination study to evaluate the immuno,reacto & safety of 3 diff. formulations of GSKBio'combined Haemophilus influenzae typeb-meningococcal serogroups C & Y-conjugate vaccine & one formulation of GSKBio' Haemophilus influenzae typeb-meningococcal serogroup C conjugate vaccine each given concomitantly With Infanrix penta (DTaP-IPV-HepB vaccine), vs Meningitec meningococcal SerogroupC conj.vaccine) given concomitantly With Infanrix hexa (DTaP-IPV-HepB-Hib vaccine) in infants according a 2-3-4 mth schedule

  Eligibility

Ages Eligible for Study:   6 Weeks to 12 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy infants without major congenital illness, immunosuppression, or chronic disease born at 36 to 42 weeks of gestation, between 6 and 12 weeks of age at enrollment, and vaccinated against hepatitis B at birth.

Exclusion Criteria:

  • Infants should not have received any investigational drug, vaccine, chronic immunosuppressants, or immunoglobulin or blood products.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00129116

Locations
Belgium
GSK Investigational Site
Asse, Belgium, 1730
GSK Investigational Site
Drongen, Belgium, 9031
GSK Investigational Site
Gent, Belgium, 9000
GSK Investigational Site
Maldegem, Belgium, 9990
GSK Investigational Site
Merelbeke, Belgium, 9820
GSK Investigational Site
Oudenaerde, Belgium, 9700
GSK Investigational Site
Sint-Amandsberg, Belgium, 9040
Germany
GSK Investigational Site
Cham, Bayern, Germany, 93413
GSK Investigational Site
Kaufering, Bayern, Germany, 86916
GSK Investigational Site
Muenchen, Bayern, Germany, 80939
GSK Investigational Site
Muenchen, Bayern, Germany, 81675
GSK Investigational Site
Noerdlingen, Bayern, Germany, 86720
GSK Investigational Site
Olching, Bayern, Germany, 82140
GSK Investigational Site
Niedernhausen, Hessen, Germany, 65527
GSK Investigational Site
Detmold, Nordrhein-Westfalen, Germany, 32756
GSK Investigational Site
Kirchlengern, Nordrhein-Westfalen, Germany, 32278
GSK Investigational Site
Loehne, Nordrhein-Westfalen, Germany, 32584
GSK Investigational Site
Leipzig, Sachsen, Germany, 04178
GSK Investigational Site
Bredstedt, Schleswig-Holstein, Germany, 25821
GSK Investigational Site
Flensburg, Schleswig-Holstein, Germany, 24943
GSK Investigational Site
Flensburg, Schleswig-Holstein, Germany, 24937
GSK Investigational Site
Berlin, Germany, 13355
GSK Investigational Site
Berlin, Germany, 10315
GSK Investigational Site
Berlin, Germany, 12627
GSK Investigational Site
Berlin, Germany, 14197
GSK Investigational Site
Hamburg, Germany, 22307
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00129116     History of Changes
Other Study ID Numbers: 792014/003, 100381
Study First Received: August 10, 2005
Results First Received: June 15, 2012
Last Updated: June 26, 2014
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by GlaxoSmithKline:
Invasive bacterial disease caused by Hib
Neisseria meningitidis serogroups C & Y

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
Respiratory Tract Diseases
Respiratory Tract Infections
RNA Virus Infections
Virus Diseases
PENTA
Anticoagulants
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014