Dose Ranging Study of Combined Haemophilus Influenzae Type B-Meningococcal Serogroups CY (Hib-MenCY-TT) Vaccine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00127855
First received: August 8, 2005
Last updated: June 15, 2012
Last verified: October 2011
  Purpose

This study evaluated the safety and immunogenicity of 3 formulations of Hib-MenCY-TT vaccine compared to 2 control groups receiving licensed meningococcal serogroup C conjugate vaccine and/or licensed Hib conjugate vaccine administered at 2, 4, and 6 months of age. Antibody persistence and immune responses to polysaccharide vaccine boosters were additionally assessed at 11 to 14 months of age.


Condition Intervention Phase
Meningococcal Infection
Haemophilus Infection
Biological: Hib-MenCY-TT vaccine (MenHibrix)
Biological: Meningitec®
Biological: ActHIB®
Biological: Infanrix® Penta
Biological: Prevenar®
Biological: Mencevax® ACWY
Biological: PRP (Polyribosyl Ribitol Phosphate)
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 (Including Immune Memory), Reactogenicity and Safety of Three Different Formulations of the GSK Biologicals' Combined Haemophilus Influenzae Type B-meningococcal Serogroups CY Conjugate Vaccine Given Concomitantly With Infanrix® Penta and Prevenar®, Versus ActHIB® and Meningitec® Given Concomitantly With Infanrix® Penta and Versus ActHIB® Given Concomitantly With Infanrix® Penta and Prevenar® in Infants According to a 2-4-6 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 Concentrations Greater Than or Equal to 1 Milligram Per Milliliter [ Time Frame: One month after primary vaccination (Month 5) ] [ Designated as safety issue: No ]
    The cut-off concentration assessed was 1 milligram per milliliter (mg/mL).

  • Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers Greater Than or Equal to 1:8 [ Time Frame: One month after primary vaccination (Month 5) ] [ Designated as safety issue: No ]
    The cut-off titer assessed was a dilution of 1:8. Titers were expressed as the reciprocal of the dilution resulting in 50 percent inhibition.

  • Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup Y (MenY) Titers Greater Than or Equal to 1:8 [ Time Frame: One month after primary vaccination (Month 5) ] [ Designated as safety issue: No ]
    The cut-off titer assessed was a dilution of 1:8. Titers were expressed as the reciprocal of the dilution resulting in 50 percent inhibition.


Secondary Outcome Measures:
  • Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers Greater Than or Equal to 1:8 [ Time Frame: Prior to vaccination (Day 0), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11) ] [ Designated as safety issue: No ]
    The cut-off titer assessed was a dilution of 1:8. Titers were expressed as the reciprocal of the dilution resulting in 50 percent inhibition.

  • Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers [ Time Frame: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11) ] [ Designated as safety issue: No ]
    Titers were presented as geometric mean titers (GMTs) expressed as the reciprocal of the dilution resulting in 50 percent inhibition.

  • Number of Subjects With rSBA-MenY Titers Greater Than or Equal to 1:8 [ Time Frame: Prior to vaccination (Day 0), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11) ] [ Designated as safety issue: No ]
    The cut-off titer assessed was a dilution of 1:8. Titers were expressed as the reciprocal of the dilution resulting in 50 percent inhibition.

  • Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup Y (MenY) Titers [ Time Frame: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11) ] [ Designated as safety issue: No ]
    Titers were presented as geometric mean titers (GMTs) expressed as the reciprocal of the dilution resulting in 50 percent inhibition.

  • Number of Subjects With Anti-polysaccharide C (PSC) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL) [ Time Frame: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11) ] [ Designated as safety issue: No ]
    The cut-off concentration assessed was 30 micrograms per milliliter (µg/mL).

  • Anti-polysaccharide C (PSC) Antibody Concentration [ Time Frame: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11) ] [ Designated as safety issue: No ]
    Titers are presented as Geometric Mean Titers (GMTs) expressed as micrograms per milliliter (µg/mL).

  • Number of Subjects With Anti-polysaccharide Y (PSY) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL) [ Time Frame: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11) ] [ Designated as safety issue: No ]
    The cut-off concentration assessed was 30 micrograms per milliliter (µg/mL).

  • Anti-polysaccharide Y (PSY) Antibody Concentration [ Time Frame: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11) ] [ Designated as safety issue: No ]
    Titers are presented as Geometric Mean Titers (GMTs) expressed as micrograms per milliliter (µg/mL).

  • Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values [ Time Frame: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11) ] [ Designated as safety issue: No ]
    The cut-off concentrations assessed were 0.15 micrograms per milliliter (µg/mL) and 1 µg/mL.

  • Anti-PRP Antibody Concentration [ Time Frame: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11) ] [ Designated as safety issue: No ]
    Concentrations are presented as GMCs and expressed as µg/mL.

  • Number of Subjects Seroprotected for Anti-diphtheria Antibodies [ Time Frame: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10) ] [ Designated as safety issue: No ]
    Seroprotection is defined as anti-diphtheria toxoid antibody concentration greater than or equal to 0.1 International Units per Milliliter (IU/mL).

  • Anti-diphtheria Antibody Concentrations [ Time Frame: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10) ] [ Designated as safety issue: No ]
    Concentrations are presented as GMCs and expressed as International Units per Milliliter (IU/mL).

  • Number of Subjects Seroprotected for Anti-tetanus Antibodies [ Time Frame: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10) ] [ Designated as safety issue: No ]
    Seroprotection is defined as anti-tetanus toxoid antibody concentration greater than or equal to 0.1 International Units per Milliliter (IU/mL).

  • Anti-tetanus Antibody Concentrations [ Time Frame: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10) ] [ Designated as safety issue: No ]
    Concentrations are presented as GMCs and expressed as International Units per Milliliter (IU/mL).

  • Number of Subjects Seroseropositive for Anti-filamentus Haemagglutinin (FHA) Antibodies [ Time Frame: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10) ] [ Designated as safety issue: No ]
    Seropositivity is defined as anti-FHA antibody concentration greater than or equal to 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).

  • Anti- FHA Antibody Concentrations [ Time Frame: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10) ] [ Designated as safety issue: No ]
    Concentrations are presented as GMCs and expressed as Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).

  • Number of Subjects Seroseropositive for Anti-pertactin (PRN) Antibodies [ Time Frame: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10) ] [ Designated as safety issue: No ]
    Seropositivity is defined as anti-PRN antibody concentration greater than or equal to 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).

  • Anti-PRN Antibody Concentrations [ Time Frame: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10) ] [ Designated as safety issue: No ]
    Concentrations are presented as GMCs and expressed as Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).

  • Number of Subjects Seroseropositive for Anti-pertussis Toxoid (PT) Antibodies [ Time Frame: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10) ] [ Designated as safety issue: No ]
    Seropositivity is defined as anti-PT antibody concentration greater than or equal to 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).

  • Anti- PT Antibody Concentrations [ Time Frame: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10) ] [ Designated as safety issue: No ]
    Concentrations are presented as GMCs and expressed as Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).

  • Number of Subjects Seroprotected for Anti-hepatitis B (HBs) Antibodies [ Time Frame: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10) ] [ Designated as safety issue: No ]
    Seroprotection is defined as anti-HBs antibody concentration greater than or equal to 10 Milli-International Units per Milliliter (mIU/mL).

  • Anti- HBs Antibody Concentrations [ Time Frame: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10) ] [ Designated as safety issue: No ]
    Concentrations are presented as GMCs and expressed as Milli-International Units per Milliliter (mIU/mL).

  • Number of Subjects Seroprotected for Anti-poliovirus Types 1, 2 and 3 Antibodies [ Time Frame: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10) ] [ Designated as safety issue: No ]
    Seroprotection is defined as anti-polio antibody titer greater than or equal to 1:8 dilution.

  • Anti-poliovirus Types 1, 2 and 3 Antibody Titers [ Time Frame: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10) ] [ Designated as safety issue: No ]
    Titers are presented as GMTs and expressed in terms of the 50 % inhibitory dilution.

  • Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values [ Time Frame: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10) ] [ Designated as safety issue: No ]
    Pneumococcal antibodies assessed included anti-4, anti-6B, anti-9V, anti-14, anti-18C, anti-19F and anti-23F antibodies. The cut-off values assessed were 0.05 and 0.2 micrograms per milliliter (µg/mL).

  • Anti-pneumococcal Antibody Concentrations [ Time Frame: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10) ] [ Designated as safety issue: No ]
    Pneumococcal antibodies assessed included anti-4, anti-6B, anti-9V, anti-14, anti-18C, anti-19F and anti-23F antibodies. Concentrations are presented as GMCs and expressed as micrograms per milliliter (µg/mL).

  • Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Course [ Time Frame: During the 8-Day (Day 0-7) follow-up period after any vaccine dose during the primary vaccination course ] [ Designated as safety issue: No ]
    Solicited local symptoms assessed include pain, redness and swelling at the injection site. Solicited general symptoms assessed include drowsiness, irritability, loss of appetite and fever (rectal temperature greater than or equal to 38 degrees Celcius).

  • Number of Subjects Reporting Solicited Local and General Symptoms After Administration of the Polysaccharide Challenge Dose [ Time Frame: During the 8-Day (Day 0-7) follow-up period after the polysaccharide challenge dose ] [ Designated as safety issue: No ]
    Solicited local symptoms assessed include pain, redness and swelling at the injection site. Solicited general symptoms assessed include drowsiness, irritability, loss of appetite and fever (rectal temperature greater than or equal to 38 degrees Celcius).

  • Number of Subjects Reporting Unsolicited Adverse Events During the Primary Vaccination Course [ Time Frame: During the 31-Day (Day 0-30) follow-up period after any vaccine dose during the primary vaccination course ] [ Designated as safety issue: No ]
    Unsolicited adverse event covers any adverse event 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 Unsolicited Adverse Events After Administration of the Polysaccharide Challenge Dose [ Time Frame: During the 31-Day (Day 0-30) follow-up period after administration of the polysaccharide challenge dose ] [ Designated as safety issue: No ]
    Unsolicited adverse event covers any adverse event 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 During the Primary Vaccination Course [ Time Frame: Up to one month after the 3-dose primary vaccination course (Month 5) ] [ Designated as safety issue: No ]
    Serious adverse events cover all medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.

  • Number of Subjects Reporting Serious Adverse Events After Administration of the Polysaccharide Challenge Dose [ Time Frame: Up to one month following administration of the polysaccharide challenge dose (Month 11) ] [ Designated as safety issue: No ]
    Serious adverse events cover all medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.


Enrollment: 409
Study Start Date: March 2003
Study Completion Date: August 2004
Primary Completion Date: February 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MenHibrix Formulation 1 Group
Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
Biological: Hib-MenCY-TT vaccine (MenHibrix)
Three doses were administered intramuscularly (IM) in left thigh at Months 0,2 and 4 respectively
Biological: Infanrix® Penta
Three doses were administered IM in right upper thigh at Months 0,2 and 4 respectively.
Other Name: DTPa-HBV-IPV vaccine
Biological: Prevenar®
Three doses were administered IM in right lower thigh at Months 0,2 and 4 respectively.
Biological: Mencevax® ACWY
One fifth of one dose was administered IM in deltoid region of right arm at Month 10 as booster.
Biological: PRP (Polyribosyl Ribitol Phosphate)
One dose was administered IM in deltoid region of left arm at Month 10 as booster.
Experimental: MenHibrix Formulation 2 Group
Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
Biological: Hib-MenCY-TT vaccine (MenHibrix)
Three doses were administered intramuscularly (IM) in left thigh at Months 0,2 and 4 respectively
Biological: Infanrix® Penta
Three doses were administered IM in right upper thigh at Months 0,2 and 4 respectively.
Other Name: DTPa-HBV-IPV vaccine
Biological: Prevenar®
Three doses were administered IM in right lower thigh at Months 0,2 and 4 respectively.
Biological: Mencevax® ACWY
One fifth of one dose was administered IM in deltoid region of right arm at Month 10 as booster.
Biological: PRP (Polyribosyl Ribitol Phosphate)
One dose was administered IM in deltoid region of left arm at Month 10 as booster.
Experimental: MenHibrix Formulation 3 Group
Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
Biological: Hib-MenCY-TT vaccine (MenHibrix)
Three doses were administered intramuscularly (IM) in left thigh at Months 0,2 and 4 respectively
Biological: Infanrix® Penta
Three doses were administered IM in right upper thigh at Months 0,2 and 4 respectively.
Other Name: DTPa-HBV-IPV vaccine
Biological: Prevenar®
Three doses were administered IM in right lower thigh at Months 0,2 and 4 respectively.
Biological: Mencevax® ACWY
One fifth of one dose was administered IM in deltoid region of right arm at Month 10 as booster.
Biological: PRP (Polyribosyl Ribitol Phosphate)
One dose was administered IM in deltoid region of left arm at Month 10 as booster.
Active Comparator: Menjugate Group
Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
Biological: Meningitec®
Three doses were administered IM in right lower thigh at Months 0,2 and 4.
Biological: ActHIB®
Three doses were administered IM in left thigh at Months 0,2 and 4.
Biological: Infanrix® Penta
Three doses were administered IM in right upper thigh at Months 0,2 and 4 respectively.
Other Name: DTPa-HBV-IPV vaccine
Biological: Mencevax® ACWY
One fifth of one dose was administered IM in deltoid region of right arm at Month 10 as booster.
Biological: PRP (Polyribosyl Ribitol Phosphate)
One dose was administered IM in deltoid region of left arm at Month 10 as booster.
Active Comparator: ActHIB Group
Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
Biological: ActHIB®
Three doses were administered IM in left thigh at Months 0,2 and 4.
Biological: Infanrix® Penta
Three doses were administered IM in right upper thigh at Months 0,2 and 4 respectively.
Other Name: DTPa-HBV-IPV vaccine
Biological: Prevenar®
Three doses were administered IM in right lower thigh at Months 0,2 and 4 respectively.
Biological: Mencevax® ACWY
One fifth of one dose was administered IM in deltoid region of right arm at Month 10 as booster.
Biological: PRP (Polyribosyl Ribitol Phosphate)
One dose was administered IM in deltoid region of left arm at Month 10 as booster.

Detailed Description:

Evaluate immuno. (incl. immune memory),reacto & safety of 3 diff. formul. of GSKBio combined Haemophilus influenzae typeb-meningococcal serogroups CY conjugate vaccine given concomitantly with Infanrix®penta DTaP-IPV-HepB vaccine) & Prevenar® (7-valent pneumo. vaccine) vs ActHIB® (Hibvaccine) & Meningitec® (meningococcal serogroupC vaccine) given concomitantly with Infanrix®penta (DTaP-IPV-HepB vaccine) & Prevenar® (7-valent pneumococcal vaccine)in infants according to a 2-4-6 mth schedule

  Eligibility

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

Inclusion criteria:

  • A male or female between, and including, 6 and 12 weeks (42-90 days) 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 into the study.
  • Vaccinated against hepatitis B at birth.
  • Born after a gestation period of 36 - 42 weeks.

Exclusion criteria:

  • Use of any investigational or non-registered 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 of immunosuppressants or other immune-modifying drugs since birth
  • Any chronic drug therapy to be continued during the study period.
  • Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the first dose of vaccine(s).
  • Previous vaccination against diphtheria, tetanus, pertussis, polio, N. meningitidis of serogroups C and Y, Haemophilus influenzae type b or Streptococcus pneumoniae.
  • History of or known exposure to diphtheria, tetanus, pertussis, polio, or invasive diseases due to N. meningitidis of serogroups C and Y, Haemophilus influenzae type b or Streptococcus pneumoniae.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
  • A family history of congenital or hereditary immunodeficiency.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
  • Major congenital defects or serious chronic illness.
  • History of any neurologic disorders or seizures.
  • Acute disease at the time of enrolment.
  • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
  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: NCT00127855

Locations
Australia, South Australia
GSK Investigational Site
North Adelaide, South Australia, Australia, 5006
Australia, Victoria
GSK Investigational Site
Carlton, Victoria, Australia, 3053
Australia, Western Australia
GSK Investigational Site
Subiaco, Western Australia, Australia, 6018
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00127855     History of Changes
Other Study ID Numbers: 792014/001, 792014/002
Study First Received: August 8, 2005
Results First Received: June 15, 2012
Last Updated: June 15, 2012
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

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

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

ClinicalTrials.gov processed this record on July 20, 2014