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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:
ClinicalTrials.gov Identifier:
NCT01235975
First Posted: November 8, 2010
Last Update Posted: April 28, 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
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
Infections, Meningococcal Biological: Meningococcal vaccine GSK 134612 Biological: MencevaxACWY TM Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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:
  • Vaccine Response to Meningococcal Antigens (MenA, MenC, MenW-135 and MenY) [ Time Frame: One month after vaccination (Month 1) ]
    Vaccine response for serum bactericidal assay using rabbit complement (rSBA) antibodies against Neisseria meningitides serogroups A, C , W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) was defined as: for initially seronegative subjects [rSBA titer below (<) 1:8], post-vaccination rSBA titer greater than or equal to (≥) 1: 32; for initially seropositive subjects with rSBA titer between 1:8 and 1:128, at least four-fold increase in rSBA titer from pre to post vaccination; and for initially seropositive subjects with rSBA titer ≥1:128, at least two-fold increase in rSBA titer from pre to post vaccination.


Secondary Outcome Measures:
  • Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value [ Time Frame: At Day 0 (PRE) and Month 1 ]
    The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8.

  • Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value [ Time Frame: At Day 0 (PRE) and Month 1 ]
    The cut-off value for the rSBA titers was greater than or equal to (≥) 1:128.

  • rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers [ Time Frame: At Day 0 (PRE) and Month 1 ]
    Antibody titers were presented as geometric mean titers (GMTs).

  • Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations ≥ the Cut-off Value [ Time Frame: At Day 0 (PRE) and Month 1 ]
    The cut-off value for the anti-polysaccharide concentrations was greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL).

  • Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations ≥ the Cut-off Value [ Time Frame: At Day 0 (PRE) and Month 1 ]
    The cut-off value for the anti-polysaccharide concentrations was greater than or equal to (≥) 2.0 micrograms per milliliter (μg/mL).

  • Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations [ Time Frame: At Day 0 (PRE) and Month 1 ]
    Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (μg/mL).

  • Number of Subjects With Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations ≥ the Cut-off Value [ Time Frame: At Day 0 (PRE) and Month 1 ]
    The cut-off value for the anti-TT concentrations was greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).

  • Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations [ Time Frame: At Day 0 (PRE) and Month 1 ]
    Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).

  • Number of Subjects With Any and Grade 3 Solicited Local Symptoms [ Time Frame: Within 4 days (Day 0 to 3) post-vaccination ]
    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest or pain that prevented normal every day activities. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.

  • Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms [ Time Frame: Within 4 days (Day 0 to 3) post-vaccination ]
    Assessed solicited general symptoms were fatigue,gastrointestinal symptoms, headache and temperature [defined as orally temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of any general symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature = temperature above (>) 39.5 °C. Related = symptom assessed by the investigator as causally related to the study vaccination.

  • Number of Subjects With Any Unsolicited Adverse Events (AEs) [ Time Frame: Within 31 days (Day 0 to 30) after vaccination ]
    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

  • Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: Within 31 days (Day 0 to 30) after vaccination ]
    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

  • Number of Subjects With New Onset Chronic Illnesses (NOCI) [ Time Frame: Within 31 days (Day 0 to 30) after vaccination ]
    NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.


Enrollment: 440
Study Start Date: November 2010
Study Completion Date: August 2011
Primary Completion Date: July 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

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:   56 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): NCT01235975


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

Additional Information:
Publications:
Study Data/Documents: Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 113807
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 113807
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: 113807
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 113807
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: 113807
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: 113807
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01235975     History of Changes
Other Study ID Numbers: 113807
First Submitted: November 4, 2010
First Posted: November 8, 2010
Results First Submitted: March 20, 2017
Results First Posted: April 28, 2017
Last Update Posted: April 28, 2017
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:
Neisseria meningitidis
Meningococcal Vaccines
serogroups A,C, W-135 or Y
meningococcal diseases
meningococcal conjugate vaccine
Immunogenicity

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