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Safety & Immunogenicity Study of Meningococcal Vaccine GSK134612 Given With Priorix-Tetra™ to 12-23 Month-Old Children

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00474266
First Posted: May 16, 2007
Last Update Posted: December 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose

The purpose of this study is to demonstrate, in 12-23 month old children, the non-inferiority of the meningococcal vaccine 134612 given with Priorix-Tetra™.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.


Condition Intervention Phase
Infections, Meningococcal Biological: Meningococcal vaccine GSK134612 Biological: Priorix-Tetra™ Biological: Meningitec™ Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Immunogenicity & Safety Study of GSK Biologicals' Meningococcal Vaccine GSK134612 When Co-Administered With GSK Biologicals' MMRV Vaccine (Priorix-Tetra™) in Healthy 12 to 23-Month-Old Children

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Subjects With rSBA-MenC, rSBA-MenA, rSBA-MenW-135, rSBA-MenY Titers Greater Than or Equal to (≥) the Cut-off Values [ Time Frame: 42 days after the first vaccine dose (Day 42) ]
    The cut-off values for the rSBA titers were ≥ 1:8. The analysis was performed only on subjects receiving meningitis vaccination (Nimenrix) at Day 0.

  • Number of Subjects With Anti-measles Antibody Concentrations ≥ the Cut-off Values [ Time Frame: 42 days after the first vaccine dose (Day 42) ]
    The cut-off values for anti-measles antibody concentrations were ≥ 150 milli-international units per milliliter (mIU/mL).

  • Number of Subjects With Anti-mumps Antibody Concentrations ≥ the Cut-off Values [ Time Frame: 42 days after the first vaccine dose (Day 42) ]
    The cut-off values for anti-mumps antibody concentrations were ≥ 231 units per milliliter (U/mL).

  • Number of Subjects With Anti-rubella Antibody Concentrations ≥ the Cut-off Values. [ Time Frame: 42 days after the first vaccine dose (Day 42) ]
    The cut-off values for anti-rubella antibody concentrations were ≥ 4 international units per milliliter (IU/mL).

  • Number of Subjects With Anti-varicella Antibody Concentrations ≥ the Cut-off Values [ Time Frame: 42 days after the first vaccine dose (Day 42) ]
    The cut-off values for anti-varicella antibody concentrations were ≥ 1:4.


Secondary Outcome Measures:
  • Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values [ Time Frame: Prior to vaccination (Day 0) and after the first vaccination dose (Day 42) ]
    The cut-off values for the rSBA titers were ≥ 1:8 and ≥ 1:128 respectively. At pre-vaccination for all groups, half of the subjects were sera tested for rSBA-MenC while the other half was tested for rSBA-MenA, rSBA-MenW-135 and rSBA-MenY. At Post vaccination I (Day 42), all subjects from Nimenrix + Priorix-Tetra and Nimenrix groups were sera tested for each rSBA. For Meningitec and Priorix-Tetra groups, all subjects were tested for rSBA-MenC while half of subjects were tested for rSBA-MenA, rSBA-MenW-135 and rSBA-MenY.

  • rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers [ Time Frame: Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42) ]
    Antibody titers were expressed as geometric mean titers (GMTs). At pre-vaccination for all groups, half of the subjects were sera tested for rSBA-MenC while the other half were tested for rSBA-MenA, rSBA-MenW-135 and rSBA-MenY. At Post vaccination I (Day 42), all subjects from Nimenrix + Priorix-Tetra and Nimenrix groups were sera tested for each rSBA. For Meningitec and Priorix-Tetra groups, all subjects were tested for rSBA-MenC while half of subjects were tested for rSBA-MenA, rSBA-MenW-135 and rSBA-MenY.

  • Anti-PSA (Anti-polysaccharide A), Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values [ Time Frame: Prior to the first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42) ]
    Anti-PS antibody concentrations were given as geometric mean concentrations (GMCs) and expressed as microgram per milliliter (μg/mL). At pre-vaccination (Day 0) and Post-vaccination I (Day 42), a quarter of the subjects were tested for anti-PSC and another quarter for anti-PSA, anti-PSW-135 and anti-PSY.

  • Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values [ Time Frame: Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42) ]
    The cut-off values for anti-PS antibody concentrations were ≥ 0.3 μg/mL and ≥ 2.0 μg/mL respectively. At pre-vaccination (Day 0) and Post-vaccination I (Day 42), a quarter of the subjects were tested for anti-PSC and another quarter for anti-PSA, anti-PSW-135 and anti-PSY.

  • Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values [ Time Frame: Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42) ]
    The cut-off values for hSBA antibody titers were ≥ 1:4 and ≥ 1:8 for Nimenrix + Priorix-Tetra group, Nimenrix group, Meningitec group and Pooled group (Nimenrix + Priorix-Tetra and Nimenrix groups), respectively. The analysis was performed only on subjects receiving meningitis vaccination (Nimenrix) at Day 0.

  • hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers [ Time Frame: Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42) ]
    Anti-hSBA antibody titers were expressed as geometric mean titers (GMTs) for Nimenrix + Priorix-Tetra group, Nimenrix group, Meningitec group and Pooled group (Nimenrix + Priorix-Tetra and Nimenrix groups), respectively. The analysis was performed only on subjects receiving meningitis vaccination (Nimenrix) at Day 0.

  • Anti-measles Antibody Concentrations [ Time Frame: 42 days after the first vaccine dose (Day 42) ]
    Anti-measles antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL) in all groups.

  • Anti-measles Antibody Concentrations [ Time Frame: 42 days after the second Priorix-Tetra vaccine dose (Day 126) ]
    Anti-measles antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in mIU/mL in a subset (30%) of the Nimenrix + Priorix-Tetra and Priorix-Tetra groups only. The analysis was performed only on subjects receiving varicella vaccination (Priorix-Tetra) at Day 0.

  • Anti-mumps Antibody Concentrations [ Time Frame: 42 days after the first vaccine dose (Day 42) ]
    Anti-mumps antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in units per milliliter (U/mL) in all groups.

  • Anti-mumps Antibody Concentrations [ Time Frame: 42 days after the second Priorix-Tetra vaccine dose (Day 126) ]
    Anti-mumps antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in U/mL in a subset (30%) of the Nimenrix + Priorix-Tetra and Priorix-Tetra groups only. The analysis was performed only on subjects receiving varicella vaccination ( Priorix-Tetra) at Day 0.

  • Anti-rubella Antibody Concentrations [ Time Frame: 42 days after the first vaccine dose (Day 42) ]
    Anti-rubella antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in international units per millilier (IU/mL) in all groups.

  • Anti-rubella Antibody Concentrations [ Time Frame: 42 days after the second Priorix-Tetra vaccine dose (Day 126) ]
    Anti-rubella antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in IU/mL in a subset (30%) of the Nimenrix + Priorix-Tetra and Priorix-Tetra groups only. The analysis was performed only on subjects receiving varicella vaccination (Priorix-Tetra) at Day 0.

  • Anti-varicella Antibody Titers [ Time Frame: 42 days after the first vaccine dose (Day 42) ]
    Anti-varicella antibody titers were given as geometric mean titers (GMTs) for all groups.

  • Anti-varicella Antibody Titers [ Time Frame: 42 days after the second Priorix-Tetra vaccine dose (Day 126) ]
    Anti-varicella antibody titers were given as geometric mean titers (GMTs) in a subset (30%) of the Nimenrix + Priorix-Tetra and Priorix-Tetra groups only. The analysis was performed only on subjects receiving varicella vaccination ( Priorix-Tetra) at Day 0.

  • Number of Subjects Reporting Solicited Local Symptoms Specific for Priorix-Tetra Vaccination [ Time Frame: During the 4-day (Days 0-3) after vaccination with first dose of Priorix-Tetra vaccine at Day 0 ]
    Solicited local symptoms assessed were pain, redness and swelling for the Nimenrix + Priorix-Tetra Group and Priorix-Tetra Group, respectively. The analysis was performed only on subjects receiving varicella vaccination (Priorix-Tetra) at Day 0.

  • Number of Subjects Reporting Solicited Local Symptoms After Nimenrix or Meningitec Vaccination at Day 0 [ Time Frame: During the 4-day (Days 0-3) after vaccination with Nimenrix or Meningitec at Day 0 ]
    Solicited local symptoms assessed were pain, redness and swelling for the Nimenrix + Priorix-Tetra Group, Nimenrix Group and Meningitec Group, respectively. The analysis was performed only on subjects receiving meningitis vaccination (Priorix-Tetra) at Day 0.

  • Number of Subjects Reporting Solicited General Symptoms [ Time Frame: During the 4-day (Days 0-3) follow-up period after first vaccination dose in all groups ]
    Solicited general symptoms assessed were drowsiness, fever (measured rectally and temperature ≥ 38.0°C ), irritability and loss of appetite, Meningismus, Parotiditis and Rash.

  • Number of Subjects With Priorix-Tetra - Specific Solicited General Symptoms [ Time Frame: During the 43-day (Days 0-42) after first vaccination dose ]
    Solicited general symptoms assessed were fever (measured rectally and temperature ≥ 38.0°C ), Meningismus, Parotiditis and Rash.

  • Number of Subjects Reporting Specific Adverse Events (AEs) [ Time Frame: From Day 0 up to Month 6 after first vaccine dose ]
    Specific AEs include: rash, New Onset of Chronic Illness(es) (NOCI), and/or conditions prompting emergency room (ER) visits or non-routine physician office visits.

  • Number of Subjects Reporting Unsolicited Symptoms [ Time Frame: During the 43-day (Days 0-42) post Dose 1 vaccination period ]
    Unsolicited symptom covers any symptom 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 Symptoms [ Time Frame: During the 43-day (Days 0-42) follow-up period after each vaccination ]
    Unsolicited symptom covers any symptom 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: From Day 0 up to Month 6 after vaccination ]
    SAEs assessed include 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: 1000
Study Start Date: June 5, 2007
Study Completion Date: March 26, 2008
Primary Completion Date: February 26, 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Meningococcal vaccine GSK134612 + Priorix-Tetra™, followed by the second dose of Priorix-Tetra™ 84 days later
Biological: Meningococcal vaccine GSK134612
Single dose intramuscular injection
Biological: Priorix-Tetra™
2-dose subcutaneous injection
Experimental: Group B
Meningococcal vaccine GSK134612, followed by 2 doses of Priorix-Tetra™, respectively 42 and 84 days later
Biological: Meningococcal vaccine GSK134612
Single dose intramuscular injection
Biological: Priorix-Tetra™
2-dose subcutaneous injection
Active Comparator: Group C
Priorix-Tetra™, followed by Meningitec™ 42 days later and the second dose of Priorix-Tetra™ 84 days later
Biological: Priorix-Tetra™
2-dose subcutaneous injection
Biological: Meningitec™
Single dose intramuscular injection
Active Comparator: Group D
Meningitec™, followed by 2 doses of Priorix-Tetra™, respectively 42 and 84 days later
Biological: Priorix-Tetra™
2-dose subcutaneous injection
Biological: Meningitec™
Single dose intramuscular injection

Detailed Description:

Open multicentre study with 4 treatment groups. Two groups will receive the 134612 vaccine with Priorix-Tetra™ either at the same or different visits followed by a second Priorix-Tetra™ vaccination at 84 days.

Two control groups will receive Priorix-Tetra™ and Meningitec™ at different visits followed by a second Priorix-Tetra™ vaccination at 84 days.

For all subjects, two blood samples will be taken: prior to and 42 days after the first vaccination. In a subset (30% of subjects in Groups A en C) from selected study centres: additional sample 42 days after second Priorix-Tetra™ dose.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   12 Months to 23 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
  • A male or female between, and including, 12 and 23 months of age at the time of the 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.
  • Previously completed routine childhood vaccinations to the best of parents' or legal guardians' knowledge.

Exclusion Criteria:

  • 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 within six months prior to the vaccine dose.
  • Planned administration/ administration of a vaccine not foreseen by the study protocol within one month before and 42 days after the first dose of vaccine(s).
  • Previous vaccination with meningococcal vaccine of serogroup A, C W and/or Y.
  • History of meningococcal disease.
  • Previous vaccination against measles, mumps, rubella, and/or varicella.
  • History of measles, mumps, rubella and/or varicella.
  • Known exposure to measles, mumps, rubella, varicella or zoster within 30 days prior to vaccination.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including human immunodeficiency virus (HIV) infection, based on medical history and physical examination.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, including neomycin.
  • Major congenital defects or serious chronic illness.
  • Acute disease at the time of enrolment.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00474266


Locations
Finland
GSK Investigational Site
Espoo, Finland, 02100
GSK Investigational Site
Helsinki, Finland, 00100
GSK Investigational Site
Helsinki, Finland, 00930
GSK Investigational Site
Jarvenpaa, Finland, 04400
GSK Investigational Site
Kotka, Finland, 48600
GSK Investigational Site
Kuopio, Finland, 70100
GSK Investigational Site
Lahti, Finland, 15140
GSK Investigational Site
Oulu, Finland, 90100
GSK Investigational Site
Pori, Finland, 28100
GSK Investigational Site
Seinajoki, Finland, 60100
GSK Investigational Site
Tampere, Finland, 33100
GSK Investigational Site
Turku, Finland, 20520
GSK Investigational Site
Vantaa, Finland, 01300
GSK Investigational Site
Vantaa, Finland, 01600
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Study Data/Documents: Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 109670
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 109670
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 109670
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 109670
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 109670
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 109670
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 109670
For additional information about this study please refer to the GSK Clinical Study Register

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00474266     History of Changes
Other Study ID Numbers: 109670
First Submitted: May 15, 2007
First Posted: May 16, 2007
Results First Submitted: May 17, 2017
Results First Posted: December 15, 2017
Last Update Posted: December 15, 2017
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

Keywords provided by GlaxoSmithKline:
MMRV vaccine
co-administration
immunogenicity
meningococcal vaccine
conjugate vaccine

Additional relevant MeSH terms:
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Vaccines
Tetracycline
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action