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Co-Administration of Meningococcal Vaccine GSK134612 With Infanrix Hexa™ Versus Individual Administration of Each Vaccine

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00508261
First Posted: July 27, 2007
Last Update Posted: October 19, 2016
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 months old subjects, the non-inferiority of meningococcal vaccine GSK134612 co-administered with Infanrix hexa™, compared to each vaccine administered individually and to licensed meningococcal vaccine Meningitec™.

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: Infanrix™ hexa Biological: Meningitec™ Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Co-Administration of GSK Biologicals' Meningococcal Vaccine GSK134612 With Infanrix Hexa™, Compared to Individual Administration of Each Vaccine, in Healthy 12- Through 23-Month-Old Children

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Meningococcal rSBA titres in Groups A and B [ Time Frame: One month after first vaccine dose ]
  • Pertussis antigens antibody concentrations, hepatitis B and Hib seroprotection in Groups A and C. [ Time Frame: One month after first vaccine dose ]

Secondary Outcome Measures:
  • Meningococcal rSBA titres [ Time Frame: Prior to and one month after meningococcal vaccine administration for Groups A, B, C and in a subset of subjects for Group D ]
  • Anti-meningococcal polysaccharide concentrations [ Time Frame: Prior to and one month after meningococcal vaccine administration in a subset of subjects for Groups A, B, C and D ]
  • Anti-tetanus toxoid seroprotection and antibody concentrations [ Time Frame: Prior to and one month after each vaccination for Groups A, B and C ]
  • Anti-diphtheria, anti-HBs, anti-polio type 1, 2 & 3, and anti-PRP seroprotection [ Time Frame: Prior to and one month after Infanrix hexa™ vaccination for Groups A, B and C ]
  • Vaccine response and antibody concentrations to pertussis antigens. [ Time Frame: Prior to and one month after Infanrix hexa™ vaccination for Groups A, B and C ]
  • Occurrence of any grade 3 systemic symptoms [ Time Frame: During the 4-day follow-up period after each vaccination ]
  • Occurrence of solicited local and general symptoms [ Time Frame: During the 4-day follow-up period after each vaccination ]
  • Occurrence of unsolicited symptoms [ Time Frame: During the 31-day follow-up period after each vaccination ]
  • Occurrence of serious adverse events [ Time Frame: Throughout the entire study duration (from Day 0 to Month 7) ]
  • Occurrence of specific adverse events of rash, new onset of chronic illness(es) and conditions prompting emergency room visits and physician office visits not related to common illnesses [ Time Frame: Throughout the entire study duration ]
  • Anti-diphtheria, anti-HBs, anti-polio type 1, 2 & 3, and anti-PRP antibody concentrations [ Time Frame: Prior to and one month after Infanrix hexa™ vaccination for Groups A, B and C ]

Enrollment: 793
Study Start Date: August 2007
Study Completion Date: October 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Meningococcal vaccine GSK134612 co-administered with Infanrix hexa™
Biological: Meningococcal vaccine GSK134612
Single dose intramuscular injection
Biological: Infanrix™ hexa
Single dose intramuscular injection
Experimental: Group B
Meningococcal vaccine GSK134612 followed one month later by Infanrix hexa™
Biological: Meningococcal vaccine GSK134612
Single dose intramuscular injection
Biological: Infanrix™ hexa
Single dose intramuscular injection
Active Comparator: Group C
Infanrix hexa™ followed one month later by Meningococcal vaccine GSK134612
Biological: Meningococcal vaccine GSK134612
Single dose intramuscular injection
Biological: Infanrix™ hexa
Single dose intramuscular injection
Active Comparator: Group D
Meningitec™ vaccination
Biological: Meningitec™
Single dose intramuscular injection

Detailed Description:

Multicentre study with 4 parallel groups. One group will receive GSK134612 co-administered with Infanrix hexa™, two groups will receive sequential administration of GSK134612 and Infanrix hexa™ and the final group will receive Meningitec™.

For subjects in Groups B and C, three blood samples will be taken: prior to first vaccination and 1 month after each vaccination.

For subjects in Groups A and D, two blood samples will be taken: prior to and 1 month after vaccination.

  Eligibility

Information from the National Library of Medicine

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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 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.
  • Documented three-dose primary vaccination with DTPa, hepatitis B, inactivated polio and Haemophilus influenzae type b conjugate vaccines, completed at least 180 days before administration of the first study vaccination.

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines 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 first vaccine dose.
  • Planned administration/ administration of any vaccine not foreseen by the study protocol, including measles, mumps, rubella, varicella and pneumococcal vaccines, within 30 days before the first dose of vaccine(s) and 30 days after the last dose of vaccine(s).
  • Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C, W and/or Y.
  • Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroup A, C, W and/or Y.
  • Previous booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis or Haemophilus influenzae type b.
  • History of meningococcal disease.
  • 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 reactions or allergic disease likely to be exacerbated by any component of the vaccine(s).
  • 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.

Additional criteria for subjects receiving Infanrix hexa™

  • Hypersensitivity reaction due to previous vaccination with Infanrix hexa™.
  • Encephalopathy defined as an acute, severe central nervous system disorder occurring within 7 days following vaccination and generally consisting of major alterations in consciousness, unresponsiveness, generalised or focal seizures that persist more than a few hours, with failure to recover within 24 hours.
  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): NCT00508261


  Show 89 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Publications:
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 109835
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 109835
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: 109835
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 109835
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: 109835
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: 109835
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: 109835
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00508261     History of Changes
Other Study ID Numbers: 109835
First Submitted: July 26, 2007
First Posted: July 27, 2007
Last Update Posted: October 19, 2016
Last Verified: October 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:
Meningococcal vaccine
Immunogenicity
Routine infancy vaccination
Safety

Additional relevant MeSH terms:
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs