Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Vaccine Given as One Dose to Healthy Subjects Above 56 Years

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01235975
First received: November 4, 2010
Last updated: July 23, 2012
Last verified: August 2011
  Purpose

This study evaluates the immunogenicity and safety of the meningococcal conjugate vaccine GSK 134612 given as single dose to healthy adults 56 years or older compared to the meningococcal polysaccharide vaccine MencevaxACWYTM.


Condition Intervention Phase
Meningococcal Serogroups A, C, W, or Y Infections
Biological: Meningococcal vaccine GSK 134612
Biological: MencevaxACWY TM
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Phase IIIb Immunogenicity, Safety and Reactogenicity Study of GSK Biologicals' Meningococcal Vaccine [GSK 134612] When Given as One Dose to Healthy Subjects Aged 56 Years or Older

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Immunogenicity in all subjects with respect to components of the investigational vaccine [ Time Frame: One month after vaccination (Month 1) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Immunogenicity in all subjects with respect to components of the investigational vaccine on secondary readouts [ Time Frame: Pre-vaccination and one month after vaccination ] [ Designated as safety issue: No ]
  • Occurrence of solicited local and general symptoms [ Time Frame: Within 4 days (Day 0 to 3) after vaccination ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited adverse events [ Time Frame: Within 31 days (Day 0 to 30) after vaccination ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events [ Time Frame: Within 31 days (Day 0 to 30) after vaccination ] [ Designated as safety issue: No ]
  • Occurrence of new onset of chronic illness(ss) [ Time Frame: Within 31 days (Day 0 to 30) after vaccination ] [ Designated as safety issue: No ]

Enrollment: 400
Study Start Date: November 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A Biological: Meningococcal vaccine GSK 134612
Intramuscular injection
Active Comparator: Group B Biological: MencevaxACWY TM
Subcutaneous injection

  Eligibility

Ages Eligible for Study:   56 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who the investigator believes can and will comply with the requirements of the protocol
  • A male or female 56 years of age or older at the time of the vaccination.
  • Written informed consent obtained from the subject.
  • Female subjects of non-childbearing potential may be enrolled in the study.
  • Non-child-bearing potential is defined as current tubal ligation, hysterectomy, ovariectomy or post-menopause.

Exclusion Criteria:

  • Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use 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 non-investigational product.
  • Extended administration of immunosuppressants or other immune-modifying drugs within six months prior to the vaccination. Inhaled and topical steroids are allowed.
  • Any contra-indication to intramuscular and /or subcutaneous injection.
  • Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination and ending 30 days after vaccination. (Vaccination with inactivated influenza vaccines, including H1N1, is allowed at any time during the study as per local recommendations).
  • Previous vaccination with meningococcal serogroups A, C, W-135 and Y polysaccharide vaccine within 5 years prior to vaccination.
  • Previous vaccination at any time with meningococcal serogroups A, C, W-135 and Y polysaccharide conjugate vaccine.
  • Previous vaccination with tetanus toxoid containing vaccine within 5 years prior to vaccination.
  • History of meningococcal disease due to serogroups A, C, W-135 or Y.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • Family history of congenital or hereditary immunodeficiency.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
  • History of neurological disorders and seizures
  • History of Guillain-Barre syndrome.
  • Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or pre-existing laboratory screening tests.
  • Acute disease and/or fever at the time of enrolment.
  • Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine/product or planned administration during the study period.
  • Pregnant or lactating female.
  • Current chronic alcohol consumption and/or drug abuse.
  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: NCT01235975

Locations
Lebanon
GSK Investigational Site
Beirut, Lebanon, 1107-2020
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01235975     History of Changes
Other Study ID Numbers: 113807
Study First Received: November 4, 2010
Last Updated: July 23, 2012
Health Authority: Lebanon: Ministry of Health of Lebanon
Saudi Arabia: Saudi Food & Drug Authority (SFDA)

Keywords provided by GlaxoSmithKline:
Neisseria meningitidis
Meningococcal Vaccines
serogroups A,C, W-135 or Y
meningococcal diseases
meningococcal conjugate vaccine
Immunogenicity

ClinicalTrials.gov processed this record on July 24, 2014