- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00127855
Dose Ranging Study of Combined Haemophilus Influenzae Type B-Meningococcal Serogroups CY (Hib-MenCY-TT) Vaccine
July 26, 2018 updated by: GlaxoSmithKline
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.
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.
Study Overview
Status
Completed
Study Type
Interventional
Enrollment (Actual)
409
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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South Australia
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North Adelaide, South Australia, Australia, 5006
- GSK Investigational Site
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Victoria
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Carlton, Victoria, Australia, 3053
- GSK Investigational Site
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Western Australia
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Subiaco, Western Australia, Australia, 6018
- GSK Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 month to 2 months (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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Three doses were administered intramuscularly (IM) in left thigh at Months 0,2 and 4 respectively
Three doses were administered IM in right upper thigh at Months 0,2 and 4 respectively.
Other Names:
Three doses were administered IM in right lower thigh at Months 0,2 and 4 respectively.
One fifth of one dose was administered IM in deltoid region of right arm at Month 10 as booster.
One dose was administered IM in deltoid region of left arm at Month 10 as booster.
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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.
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Three doses were administered intramuscularly (IM) in left thigh at Months 0,2 and 4 respectively
Three doses were administered IM in right upper thigh at Months 0,2 and 4 respectively.
Other Names:
Three doses were administered IM in right lower thigh at Months 0,2 and 4 respectively.
One fifth of one dose was administered IM in deltoid region of right arm at Month 10 as booster.
One dose was administered IM in deltoid region of left arm at Month 10 as booster.
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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.
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Three doses were administered intramuscularly (IM) in left thigh at Months 0,2 and 4 respectively
Three doses were administered IM in right upper thigh at Months 0,2 and 4 respectively.
Other Names:
Three doses were administered IM in right lower thigh at Months 0,2 and 4 respectively.
One fifth of one dose was administered IM in deltoid region of right arm at Month 10 as booster.
One dose was administered IM in deltoid region of left arm at Month 10 as booster.
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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.
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Three doses were administered IM in right upper thigh at Months 0,2 and 4 respectively.
Other Names:
One fifth of one dose was administered IM in deltoid region of right arm at Month 10 as booster.
One dose was administered IM in deltoid region of left arm at Month 10 as booster.
Three doses were administered IM in right lower thigh at Months 0,2 and 4.
Three doses were administered IM in left thigh at Months 0,2 and 4.
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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.
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Three doses were administered IM in right upper thigh at Months 0,2 and 4 respectively.
Other Names:
Three doses were administered IM in right lower thigh at Months 0,2 and 4 respectively.
One fifth of one dose was administered IM in deltoid region of right arm at Month 10 as booster.
One dose was administered IM in deltoid region of left arm at Month 10 as booster.
Three doses were administered IM in left thigh at Months 0,2 and 4.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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The cut-off concentration assessed was 1 milligram per milliliter (mg/mL).
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One month after primary vaccination (Month 5)
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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)
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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.
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One month after primary vaccination (Month 5)
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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)
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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.
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One month after primary vaccination (Month 5)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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)
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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.
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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)
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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)
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Titers were presented as geometric mean titers (GMTs) expressed as the reciprocal of the dilution resulting in 50 percent inhibition.
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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)
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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)
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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.
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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)
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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)
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Titers were presented as geometric mean titers (GMTs) expressed as the reciprocal of the dilution resulting in 50 percent inhibition.
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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)
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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)
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The cut-off concentration assessed was 30 micrograms per milliliter (µg/mL).
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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)
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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)
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Titers are presented as Geometric Mean Titers (GMTs) expressed as micrograms per milliliter (µg/mL).
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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)
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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)
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The cut-off concentration assessed was 30 micrograms per milliliter (µg/mL).
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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)
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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)
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Titers are presented as Geometric Mean Titers (GMTs) expressed as micrograms per milliliter (µg/mL).
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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)
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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)
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The cut-off concentrations assessed were 0.15 micrograms per milliliter (µg/mL) and 1 µg/mL.
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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)
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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)
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Concentrations are presented as GMCs and expressed as µg/mL.
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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)
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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)
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Seroprotection is defined as anti-diphtheria toxoid antibody concentration greater than or equal to 0.1 International Units per Milliliter (IU/mL).
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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)
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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)
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Concentrations are presented as GMCs and expressed as International Units per Milliliter (IU/mL).
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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)
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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)
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Seroprotection is defined as anti-tetanus toxoid antibody concentration greater than or equal to 0.1 International Units per Milliliter (IU/mL).
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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)
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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)
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Concentrations are presented as GMCs and expressed as International Units per Milliliter (IU/mL).
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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)
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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)
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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).
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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)
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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)
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Concentrations are presented as GMCs and expressed as Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).
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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)
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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)
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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).
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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)
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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)
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Concentrations are presented as GMCs and expressed as Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).
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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)
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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)
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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).
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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)
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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)
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Concentrations are presented as GMCs and expressed as Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).
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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)
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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)
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Seroprotection is defined as anti-HBs antibody concentration greater than or equal to 10 Milli-International Units per Milliliter (mIU/mL).
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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)
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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)
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Concentrations are presented as GMCs and expressed as Milli-International Units per Milliliter (mIU/mL).
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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)
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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)
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Seroprotection is defined as anti-polio antibody titer greater than or equal to 1:8 dilution.
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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)
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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)
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Titers are presented as GMTs and expressed in terms of the 50 % inhibitory dilution.
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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)
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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)
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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).
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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)
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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)
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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).
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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)
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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
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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).
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During the 8-Day (Day 0-7) follow-up period after any vaccine dose during the primary vaccination course
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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
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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).
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During the 8-Day (Day 0-7) follow-up period after the polysaccharide challenge dose
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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
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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.
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During the 31-Day (Day 0-30) follow-up period after any vaccine dose during the primary vaccination course
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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
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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.
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During the 31-Day (Day 0-30) follow-up period after administration of the polysaccharide challenge dose
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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)
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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.
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Up to one month after the 3-dose primary vaccination course (Month 5)
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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)
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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.
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Up to one month following administration of the polysaccharide challenge dose (Month 11)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Bryant KA, Marshall GS. Haemophilus influenzae type b-Neisseria meningitidis serogroups C and Y tetanus toxoid conjugate vaccine for infants and toddlers. Expert Rev Vaccines. 2011 Jul;10(7):941-50. doi: 10.1586/erv.11.90.
- Nolan T, Lambert S, Roberton D, Marshall H, Richmond P, Streeton C, Poolman J, Boutriau D. A novel combined Haemophilus influenzae type b-Neisseria meningitidis serogroups C and Y-tetanus-toxoid conjugate vaccine is immunogenic and induces immune memory when co-administered with DTPa-HBV-IPV and conjugate pneumococcal vaccines in infants. Vaccine. 2007 Dec 12;25(51):8487-99. doi: 10.1016/j.vaccine.2007.10.013. Epub 2007 Oct 25.
- T Nolan et al. A novel Haemophilus influenzae type b - meningococcal serogroups C and Y conjugate (Hib-MenCY-TT) vaccine induces persistent immune responses and immune memory. Abstract presented at Pediatric Academic Societies' (PAS) Annual meeting. San Francisco, California, US, 29 April to 2 May 2006.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2003
Primary Completion (Actual)
February 1, 2004
Study Completion (Actual)
February 12, 2004
Study Registration Dates
First Submitted
August 8, 2005
First Submitted That Met QC Criteria
August 8, 2005
First Posted (Estimate)
August 9, 2005
Study Record Updates
Last Update Posted (Actual)
August 27, 2018
Last Update Submitted That Met QC Criteria
July 26, 2018
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Gram-Negative Bacterial Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Orthomyxoviridae Infections
- Pasteurellaceae Infections
- Influenza, Human
- Haemophilus Infections
- Physiological Effects of Drugs
- Immunologic Factors
- Vaccines
- Heptavalent Pneumococcal Conjugate Vaccine
Other Study ID Numbers
- 792014/001
- 792014/002 (Other Identifier: GSK)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study Data/Documents
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Study Protocol
Information identifier: 792014/001Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Dataset Specification
Information identifier: 792014/001Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Clinical Study Report
Information identifier: 792014/001Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Individual Participant Data Set
Information identifier: 792014/001Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Informed Consent Form
Information identifier: 792014/001Information comments: For additional information about this study please refer to the GSK Clinical Study Register
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Neisseria Meningitidis
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Public Health EnglandCompleted
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University Hospital, RouenInstitut Pasteur; Direction Générale de la Santé, FranceCompleted
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Public Health EnglandCompletedNeisseria Meningitidis Serogroup BUnited Kingdom
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University of AdelaideCompletedNeisseria MeningitidisAustralia
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GlaxoSmithKlineCompletedNeisseria Meningitidis | Haemophilus Influenzae Type bUnited States
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GlaxoSmithKlineCompletedNeisseria Meningitidis | Haemophilus Influenzae Type bAustralia
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GlaxoSmithKlineCompletedNeisseria Meningitidis | Haemophilus Influenzae Type bUnited States
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GlaxoSmithKlineCompletedNeisseria Meningitidis | Haemophilus Influenzae Type bUnited States
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GlaxoSmithKlineCompletedNeisseria Meningitidis | Haemophilus Influenzae Type bSpain
Clinical Trials on Hib-MenCY-TT vaccine (MenHibrix)
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GlaxoSmithKlineCompletedNeisseria Meningitidis | Haemophilus Influenzae Type bUnited States
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GlaxoSmithKlineCompletedNeisseria Meningitidis | Haemophilus Influenzae Type bUnited States
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GlaxoSmithKlineCompletedNeisseria Meningitidis | Haemophilus Influenzae Type bBelgium, Germany
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GlaxoSmithKlineCompletedHib-MenCY-TT Vaccine Study Compared to Licensed Hib and Meningococcal Serogroup C Conjugate VaccinesNeisseria Meningitidis | Haemophilus Influenzae Type bAustralia
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GlaxoSmithKlineCompletedInfections, MeningococcalUnited States
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Novartis VaccinesCompletedMeningitis, Epiglottitis, Pneumonia, Arthritis Caused by Haemophilus Influenzae Type bChina
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GlaxoSmithKlineCompleted
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GlaxoSmithKlineCompletedInfections, Meningococcal
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Eunice Kennedy Shriver National Institute of Child...CompletedTyphoid FeverVietnam
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Public Health EnglandDepartment of Health, United Kingdom; Institute of Child Health, London, EnglandCompletedPneumococcal Disease | Meningococcal Disease | Diphtheria, Tetanus and Pertussis | Haemophilus Influenzae Serotype b Disease | Hepatitis bUnited Kingdom