Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

August 10, 2005
June 26, 2014
March 2003
December 2003   (final data collection date for primary outcome measure)
  • 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
Evaluate antibody responses to Hib and meningococcal serogroups C an Y in 3 different Hib-MenCY-TT formulations and one Hib-MenC-TT formulation as compared to licensed Hib and meningococcal serogroup C conjugate vaccines.
Complete list of historical versions of study NCT00129116 on ClinicalTrials.gov Archive Site
  • 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.
Evaluate the safety and reactogenicity of the 3 Hib-MenCY-TT formulations and the Hib-MenC-TT formulation. Evaluate antibody persistence, immune memory, and booster vaccine responses induced by Hib-MenCY-TT and Hib-MenC-TT. Evaluate immune responses to
Not Provided
Not Provided
 
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
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

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.

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

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
  • Haemophilus Influenzae Type b
  • Neisseria Meningitidis
  • Biological: Hib-MenCY-TT vaccine
    Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh.
  • Biological: Hib-MenC-TT vaccine
    Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh.
  • Biological: Menjugate ®
    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
  • 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
  • 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.
    Interventions:
    • Biological: Hib-MenCY-TT vaccine
    • Biological: Infanrix penta ®
  • 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.
    Interventions:
    • Biological: Hib-MenCY-TT vaccine
    • Biological: Infanrix penta ®
  • 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.
    Interventions:
    • Biological: Hib-MenCY-TT vaccine
    • Biological: Infanrix penta ®
  • 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.
    Interventions:
    • Biological: Hib-MenC-TT vaccine
    • Biological: Infanrix penta ®
  • 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.
    Interventions:
    • Biological: Menjugate ®
    • Biological: Infanrix hexa ®
Habermehl P, Leroux-Roels G, Sänger R, Mächler G, Boutriau D. Combined Haemophilus influenzae type b and Neisseria meningitidis serogroup C (HibMenC) or serogroup C and Y-tetanus toxoid conjugate (and HibMenCY) vaccines are well-tolerated and immunogenic when administered according to the 2,3,4 months schedule with a fourth dose at 12-18 months of age. Hum Vaccin. 2010 Aug;6(8):640-51.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
388
October 2004
December 2003   (final data collection date for primary outcome measure)

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.
Both
6 Weeks to 12 Weeks
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium,   Germany
 
NCT00129116
792014/003, 100381
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP