Immunogenicity and Safety of Meningococcal Vaccine GSK134612 vs. Menactra® in Healthy Adolescent/Adults Aged 10-25 Years.

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00454909
First received: March 30, 2007
Last updated: September 3, 2009
Last verified: September 2009
  Purpose

The purpose of the study is to characterize the safety and immunogenicity of 1 dose of GSK Biologicals' meningococcal vaccine GSK134612 as compared to Menactra® in adolescents/adults 11-25 years of age.

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

The protocol posting has been updated following a protocol amendment.


Condition Intervention Phase
Meningococcal Infections
Biological: Menactra®
Biological: Meningococcal vaccine 134612
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Study to Assess Immunogenicity, Reactogenicity and Safety of 1 Dose of GSK Biologicals' Meningococcal Vaccine GSK134612 vs. 1 Dose of Sanofi-Pasteur's Menactra® in Healthy Subjects 10-25 Years.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY antibody titers above protocol-specified cut-off [ Time Frame: One month after vaccination. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY antibody titers and GMTs. [ Time Frame: One month after vaccination. ] [ Designated as safety issue: No ]
  • hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY antibody titers above protocol-specified cut-off in subjects 10 years of age. [ Time Frame: One month after vaccination ] [ Designated as safety issue: No ]
  • Occurrence of solicited local and general symptoms. [ Time Frame: On Days 0-3 and Days 0-7 after vaccination. ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited symptoms. [ Time Frame: Up to one month after vaccination. ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events and/or specific adverse events. [ Time Frame: Up to six months after vaccination. ] [ Designated as safety issue: No ]

Enrollment: 873
Study Start Date: April 2007
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Subjects aged 10 years (< 11 years) vaccinated with meningococcal vaccine GSK134612.
Biological: Meningococcal vaccine 134612
Single dose intramuscular injection.
Experimental: Group B
Subjects aged 11 to 25 years vaccinated with meningococcal vaccine GSK134612.
Biological: Meningococcal vaccine 134612
Single dose intramuscular injection.
Active Comparator: Group C
Subjects aged 11 to 25 years vaccinated with Menactra®.
Biological: Menactra®
Single dose intramuscular injection.

Detailed Description:

Subjects 11-25 years of age will be randomized to receive either the meningococcal vaccine GSK134612 or Menactra®. An additional non-randomized group of subjects aged 10 years (< 11 years of age) will be enrolled to receive meningococcal vaccine GSK134612 only (At the time the study begun, Menactra® was only licensed in the United States for individuals above 11 years of age and therefore could not be used as a control vaccine in subjects less than 11 years old).

This study will be single-blind for the subjects 11 to 25 years of age and open for the subjects 10 to < 11 years of age.

  Eligibility

Ages Eligible for Study:   10 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects whom the investigator believes can and will comply with the requirements of the protocol.
  • A male or female between, and including, 10 and 25 years of age (has not attained his/her 26th birthday) at the time of the vaccination.
  • Written informed consent obtained from parents/guardian of the subject and written informed assent obtained from the subject if the subject is less than 18 years of age, or written informed consent obtained from the subject if the subject has achieved the 18th birthday.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • If the subject is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception (including abstinence) for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after vaccination.

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the 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 of the dose of vaccine(s).
  • Previous vaccination with meningococcal polysaccharide or conjugate vaccine of serogroup A, C W-135, and/or Y.
  • Previous vaccination with tetanus and diphtheria toxoids within the last month (i.e., Tdap, Td, and TT-containing vaccine within the last month).
  • History of meningococcal disease due to serogroup A, C, W-135, or Y.
  • 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 allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • Hypersensitivity to latex.
  • Major congenital defects or serious chronic illness.
  • History of any neurologic disorders or seizures.
  • Previous history of Guillain-Barré Syndrome.
  • Bleeding disorders, such as hemophilia or thrombocytopenia, or subjects on anti-coagulant therapy.
  • 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 study period.
  • Pregnant or lactating female.
  • History of chronic alcohol consumption and/or drug abuse.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions.
  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: NCT00454909

Locations
United States, California
GSK Investigational Site
Daly City, California, United States, 94015
GSK Investigational Site
Fairfield, California, United States, 94533
GSK Investigational Site
Redwood City, California, United States, 94063
GSK Investigational Site
Sacramento, California, United States, 95815
GSK Investigational Site
Vallejo, California, United States, 94589
GSK Investigational Site
Walnut Creek, California, United States, 94596
United States, Hawaii
GSK Investigational Site
Honolulu, Hawaii, United States, 96819
GSK Investigational Site
Honolulu, Hawaii, United States, 96814
GSK Investigational Site
Waianae, Hawaii, United States, 96792
GSK Investigational Site
Waipio, Hawaii, United States, 96797
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00454909     History of Changes
Other Study ID Numbers: 109377
Study First Received: March 30, 2007
Last Updated: September 3, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Meningococcal Serogroups A, C, W-135 and/or Y Disease

Additional relevant MeSH terms:
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on July 26, 2014