Immunogenicity and Safety of Meningococcal Vaccine GSK134612 Given as 1 or 2 Doses to Healthy 9-12 Months Old Toddlers.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00471081
First received: May 8, 2007
Last updated: May 24, 2012
Last verified: January 2012
  Purpose

The purpose of the study is to characterize the safety and immunogenicity of 1 dose of GSK134612 vaccine at 12 months of age and of GSK134612 vaccine administered as 2 doses at 9 and 12 months of age.


Condition Intervention Phase
Invasive Neisseria Meningitidis Serogroup Diseases
Biological: Meningococcal vaccine GSK134612
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Study to Assess Immunogenicity, Reactogenicity and Safety of Primary Vaccination With GSK Biologicals' MenACWY Vaccine (GSK134612) Given as 1 or 2 Doses to Healthy Toddlers 9-12 Months of Age

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Meningococcal serum bactericidal assay using human complement (hSBA) titres [ Time Frame: One month after the last dose of vaccine. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Meningococcal hSBA titres. [ Time Frame: At all blood sampling time points (Month 1 and Month 4) ] [ Designated as safety issue: No ]
  • Meningococcal rSBA titres in a randomized subset. [ Time Frame: At all blood sampling time points (Month 1 and Month 4) ] [ Designated as safety issue: No ]
  • Anti-meningococcal polysaccharide antibody concentrations in a randomized subset of subjects [ Time Frame: At all blood sampling time points (Month 1 and Month 4) ] [ Designated as safety issue: No ]
  • Occurrence of solicited local and general symptoms. [ Time Frame: On Days 0-3 and Days 0-7 after each vaccination. ] [ Designated as safety issue: Yes ]
  • Occurrence of unsolicited symptoms. [ Time Frame: Up to 1 month after each vaccination. ] [ Designated as safety issue: Yes ]
  • Occurrence of serious adverse events and specific adverse events [ Time Frame: Up to six months after the last vaccination. ] [ Designated as safety issue: Yes ]

Enrollment: 385
Study Start Date: July 2007
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Single dose GSK134612.
Biological: Meningococcal vaccine GSK134612
One or 2 intramuscular injections.
Experimental: Group B
Two doses of GSK134612.
Biological: Meningococcal vaccine GSK134612
One or 2 intramuscular injections.

Detailed Description:

The protocol posting has been amended to reflect changes as a consequence of an amendment to the protocol and also to comply with the FDA amendment Act, Sep 2007. Sections impacted are Brief Title, Official Title of the study, Brief Summary, Key Inclusion & Exclusion criteria.

  Eligibility

Ages Eligible for Study:   9 Months to 9 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects whose parents/guardians the investigator believes can and will comply with the requirements of the protocol
  • A male or female of 9 months of age (has not attained 10 months of age) at the time of enrollment.
  • Up to date on vaccinations based on ACIP recommendations and the standard practice at the investigational site.
  • Written informed consent obtained from parents/guardian of the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding enrollment, 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 1 month of a dose of study vaccine(s), with the exception of influenza vaccine.
  • Planned administration of a tetanus toxoid (TT) containing vaccine throughout the active phase of the study (through one month after the last vaccination).
  • Previous vaccination with meningococcal polysaccharide or conjugate vaccine of serogroup A, C W and/or Y.
  • History of meningococcal diseases.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including human immunodeficiency virus (HIV) infection, based on medical history and physical examination (no laboratory testing is required).
  • A family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated.
  • History of reactions or allergic disease likely to be exacerbated by any component of the vaccine.
  • Major congenital defects or serious chronic illness.
  • History of any neurologic disorders or seizures.
  • Acute disease at the time of enrollment.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the active phase of the study (through one month after the last dose of study vaccine).
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00471081

Locations
United States, Arkansas
GSK Investigational Site
Benton, Arkansas, United States, 72015
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
United States, California
GSK Investigational Site
Antioch, California, United States, 94509
GSK Investigational Site
Fremont, California, United States, 94538
GSK Investigational Site
Hayward, California, United States, 94545
GSK Investigational Site
Madera, California, United States, 93637
GSK Investigational Site
Santa Rosa, California, United States, 95403
GSK Investigational Site
Vacaville, California, United States, 95688
United States, Colorado
GSK Investigational Site
Lakewood, Colorado, United States, 80226
GSK Investigational Site
Littleton, Colorado, United States, 80122
GSK Investigational Site
Littleton, Colorado, United States, 80234
GSK Investigational Site
Westminster, Colorado, United States, 80234
GSK Investigational Site
Wheat Ridge, Colorado, United States, 80033
United States, Ohio
GSK Investigational Site
Canton, Ohio, United States, 44718
United States, Pennsylvania
GSK Investigational Site
Erie, Pennsylvania, United States, 16501
United States, Texas
GSK Investigational Site
Amarillo, Texas, United States, 79124
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
Klein N et al. Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal ACWY Tetanus Toxoid Conjugate Vaccine in Healthy Toddlers: 1-year Persistence. Abstract presented at the 51st Annual Interscience Conference on Antimicrobial Agents & Chemotherapy. Chicago, US, 17-20 September 2011.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00471081     History of Changes
Other Study ID Numbers: 109375
Study First Received: May 8, 2007
Last Updated: May 24, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Neisseria meningitidis;
Humans;
Meningococcal vaccines;
Safety
Vaccines, conjugate;
Toddlers;
Immunogenicity;

ClinicalTrials.gov processed this record on September 18, 2014