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Immuno,Safety of GSK Vaccine 134612 Given at Age of 12-15 Months 15-18 Months Post-Priming With GSK Vaccine 792014
This study is ongoing, but not recruiting participants.
First Received: January 31, 2008   Last Updated: April 2, 2009   History of Changes
Sponsor: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00614614
  Purpose

The purpose of the study is to characterize the immunogenicity & safety of a booster dose of GSK Biologicals' meningococcal vaccine 134612 given at 12-15 months of age or at 15-18 months of age (co-administered with Infanrix®) in healthy toddlers primed with GSK Biological's Hib-meningococcal vaccine 792014. This study is single-blinded for the primary phase and open-label for the booster phase.


Condition Intervention Phase
Invasive Disease Caused by Neisseria Meningitidis Due to Serogroups A, C, W-135, Y
 Biological: GSK Biologicals' Meningococcal vaccine GSK134612
Biological: GSK Biologicals' Hib-meningococcal vaccine GSK 792014
Biological: Infanrix®
Biological: ActHIB®
Biological: Pediarix®
 Phase III

Study Type: Interventional
Study Design: Prevention, Randomized, Single Blind (Caregiver), Parallel Assignment, Efficacy Study
Official Title: Immunogenicity & Safety Study of a Booster Dose of GSK Biologicals' Meningococcal Vaccine 134612 Given at 12-15 or 15-18 Months of Age (co-Administered With Infanrix®) in Primed Healthy Toddlers

Resource links provided by NLM:

Drug Information available for: Meningococcal Vaccines
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • hSBA-MenA, hSBA-MenW-135, hSBA-MenC, and hSBA-MenY titers above protocol specified cut-off in groups A and C [ Time Frame: One month post vaccination at 12-15 months of age (Group A), one month post vaccination at 15-18 months of age (Group C) ] [ Designated as safety issue: No ]
  • hSBA-MenC and hSBA-MenY GMTs in groups A, B and C [ Time Frame: One month post vaccination at 12-15 months of age (Groups A and B), one month post vaccination at 15-18 months of age (Group C) ] [ Designated as safety issue: No ]
  • hSBA-MenC and hSBA-MenY titers above protocol-specified cut-off in group B [ Time Frame: One month post vaccination at 12-15 months of age ] [ Designated as safety issue: No ]
  • Anti-diphtheria antibody concentrations above protocol-specified cut-off in groups C and D [ Time Frame: One month post vaccination at 15-18 months of age ] [ Designated as safety issue: No ]
  • Anti-tetanus antibody concentrations above protocol-specified cut-off in groups C and D [ Time Frame: One month post vaccination at 15-18 months of age ] [ Designated as safety issue: No ]
  • Anti-PT, anti-FHA and anti-PRN GMCs in groups C and D [ Time Frame: One month post vaccination at 15-18 months of age ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • hSBA-MenC and hSBA-MenY antibody titers in groups A and B [ Time Frame: One month after vaccination at 12-15 months of age ] [ Designated as safety issue: No ]
  • hSBA-MenA and hSBA MenW-135 GMTs and antibody titers in group A [ Time Frame: One month after vaccination at 12-15 months of age ] [ Designated as safety issue: No ]
  • hSBA-MenC, and hSBA-MenY GMTs and titers in group C [ Time Frame: Prior to vaccination at 15-18 months of age ] [ Designated as safety issue: No ]
  • Anti-D and anti-T GMCs [ Time Frame: One month after vaccination with Infanrix® at 15-18 months of age ] [ Designated as safety issue: No ]
  • Anti-PT, anti-FHA and anti-PRN concentrations [ Time Frame: One month after vaccination with Infanrix® at 15-18 months of age ] [ Designated as safety issue: No ]
  • hSBA-MenA, hSBA-MenW-135 GMTs in group C [ Time Frame: One month after vaccination with Infanrix® at 15-18 months of age ] [ Designated as safety issue: No ]
  • Anti-D concentrations in groups A and B [ Time Frame: One month after vaccination at 15-18 months of age ] [ Designated as safety issue: No ]
  • Anti-T concentrations in groups A and B [ Time Frame: One month after vaccination at 15-18 months of age ] [ Designated as safety issue: No ]
  • Anti-PT, anti-FHA and anti-PRN GMCs in groups A and B [ Time Frame: One month after vaccination at 15-18 months of age ] [ Designated as safety issue: No ]
  • Occurrence of solicited local and general symptoms [ Time Frame: 8 days following each booster vaccination. ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited symptoms [ Time Frame: 31 days following each booster vaccination. ] [ Designated as safety issue: No ]
  • Serious adverse events (SAEs) [ Time Frame: From the first primary study dose up to/excluding the first booster study dose ] [ Designated as safety issue: No ]
  • Specific AEs of: new onset of chronic illness(es), conditions prompting ER visits. [ Time Frame: From the first primary study dose up to/excluding the first booster study dose ] [ Designated as safety issue: No ]
  • Serious adverse events (SAEs) [ Time Frame: From the first booster phase visit up to six months after the last vaccination ] [ Designated as safety issue: No ]
  • Specific AEs of:new onset of chronic illness(es), rash and/or conditions prompting emergency room (ER) visits [ Time Frame: From the first booster phase visit up to six months after the last vaccination ] [ Designated as safety issue: No ]
  • Anti-D and anti-T seroprotection rates [ Time Frame: One month after vaccination with Infanrix® at 15-18 months of age ] [ Designated as safety issue: No ]

Enrollment: 1548
Study Start Date: February 2008
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Group A: Experimental
Subjects who were primed with 3 doses of GSK792014 and Pediarix® at 2, 4 and 6 months of age and vaccinated with one dose of GSK134612 at 12-15 months of age followed by Infanrix® three months later
Biological: GSK Biologicals' Meningococcal vaccine GSK134612
One dose in the booster phase as intramuscular injection
Biological: GSK Biologicals' Hib-meningococcal vaccine GSK 792014
Three doses in the priming phase and, for Group B, one dose in the booster phase as intramuscular injection
Biological: Infanrix®
one dose as intramuscular injection
Biological: Pediarix®
three doses in the priming phase as intramuscular injection
Group B: Experimental
Subjects who were primed with 3 doses of GSK792014 and Pediarix® at 2, 4 and 6 months of age and vaccinated with one dose of GSK792014 at 12-15 months of age followed by Infanrix® three months later
Biological: GSK Biologicals' Hib-meningococcal vaccine GSK 792014
Three doses in the priming phase and, for Group B, one dose in the booster phase as intramuscular injection
Biological: Infanrix®
one dose as intramuscular injection
Biological: Pediarix®
three doses in the priming phase as intramuscular injection
Group D: Active Comparator
Subjects were primed with 3 doses of ActHIB® and Pediarix® at 2, 4 and 6 months of age and vaccinated with Infanrix® at 15-18 months of age
Biological: Infanrix®
one dose as intramuscular injection
Biological: ActHIB®
three doses in the priming phase as intramuscular injection
Biological: Pediarix®
three doses in the priming phase as intramuscular injection
Group C: Experimental
Subjects who were primed with 3 doses of GSK792014 and Pediarix® at 2, 4 and 6 months of age and vaccinated with one dose of GSK134612 and Infanrix® at 15-18 months of age
Biological: GSK Biologicals' Meningococcal vaccine GSK134612
One dose in the booster phase as intramuscular injection
Biological: GSK Biologicals' Hib-meningococcal vaccine GSK 792014
Three doses in the priming phase and, for Group B, one dose in the booster phase as intramuscular injection
Biological: Infanrix®
one dose as intramuscular injection
Biological: Pediarix®
three doses in the priming phase as intramuscular injection

Detailed Description:

The purpose of this study is to evaluate the titer of antibody for serogroups A, C, Y and W-135 and the safety of a booster dose of GSK Biologicals' meningococcal vaccine 134612 given to toddlers who were primed with GSK Biological's Hib-meningococcal vaccine 792014. In addition, this study will provide immunogenicity and safety data on the co-administration of Infanrix with meningococcal vaccine 134612 as compared to Infanrix administered alone.

Depending on the group the subject is assigned to, one or two blood samples will be taken out of the subject's arm during the study.

The protocol posting has been updated following a protocol amendment.

  Eligibility

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

Inclusion Criteria:

  • Subjects for whom the investigator believes that parents/guardians can and will comply with the requirements of the protocol.
  • A male or female between, and including, 6 and 12 weeks of age (+ 6 days) at the time of the first vaccination.
  • Written informed consent obtained from the parent or guardian of the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Born after 36 weeks gestation.
  • For inclusion in the booster phase, subjects must have received all three doses in the primary phase.

Exclusion Criteria:

Exclusion criteria for enrolment (primary phase)

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
  • Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of study vaccine(s).
  • Previous vaccination against Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, and/or poliovirus; more than one previous dose of hepatitis B vaccine.
  • History of Neisseria meningitidis, hepatitis B, Haemophilus influenzae type b, diphtheria, tetanus, polio or pertussis diseases.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, or by dry natural latex rubber.
  • Major congenital defects or serious chronic illness.
  • History of any neurologic disorders or seizures.
  • Acute disease at time of enrollment.
  • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
  • Concurrent participation in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).

Exclusion criteria for enrolment (booster phase)

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding entry into the booster phase (Visit 4), or planned use during the study period.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
  • Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of entry into the booster phase (Visit 4) with the exception of Prevnar® and Hib (see the following three criteria) (Note; licensed influenza vaccine is allowed throughout the study)
  • Planned administration/administration of a fourth dose of Prevnar® within 30 days of a booster dose of Infanrix®
  • Previous administration of a booster dose of Hib prior to entry to the booster phase.
  • Previous administration of a primary dose of Hib vaccine that is not part of the study protocol.
  • Previous vaccination against Neisseria meningitidis that is not part of the study protocol.
  • Previous vaccination with diphtheria, tetanus and pertussis antigens outside of the primary phase of the study.
  • History of Neisseria meningitidis, Hib, diphtheria, tetanus or pertussis diseases.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, or by dry natural latex rubber.
  • Major congenital defects or serious chronic illness.
  • History of any neurologic disorders or seizures.
  • Acute disease at time of enrollment.
  • Administration of immunoglobulins and/or any blood products within the past 3 months or planned administration during the study period.
  • Concurrent participation in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00614614

  Show 56 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GSK ( Study Director )
Study ID Numbers: 110870, 110871
Study First Received: January 31, 2008
Last Updated: April 2, 2009
ClinicalTrials.gov Identifier: NCT00614614     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Human serum bactericidal assay
Meningococcal vaccines
Neisseria meningitidis
Vaccines, conjugate
Toddlers
 Immunogenicity
Safety
Meningococcal disease
Booster vaccination

ClinicalTrials.gov processed this record on November 09, 2009



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