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

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

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.

Study Overview

• Status: Completed
• Conditions: Infections, Meningococcal
• Intervention / Treatment: Biological: Meningococcal vaccine GSK 134612; Biological: MencevaxACWY TM

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Phase 3

Contacts and Locations

Study Locations

• Lebanon
  • Beirut, Lebanon, 1107-2020
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 56 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A	Biological: Meningococcal vaccine GSK 134612; Intramuscular injection
Active Comparator: Group B	Biological: MencevaxACWY TM; Subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vaccine Response to Meningococcal Antigens (MenA, MenC, MenW-135 and MenY)	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.	One month after vaccination (Month 1)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value	The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8.	At Day 0 and Month 1
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value	The cut-off value for the rSBA titers was greater than or equal to (≥) 1:128.	At Day 0 and Month 1
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers	Antibody titers were presented as geometric mean titers (GMTs).	At Day 0 and Month 1
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	The cut-off value for the anti-polysaccharide concentrations was greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL).	At Day 0 and Month 1
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations ≥ the Cut-off Value	The cut-off value for the anti-polysaccharide concentrations was greater than or equal to (≥) 2.0 micrograms per milliliter (μg/mL).	At Day 0 and Month 1
Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations	Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (μg/mL).	At Day 0 and Month 1
Number of Subjects With Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations ≥ the Cut-off Value	The cut-off value for the anti-TT concentrations was greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).	At Day 0 and Month 1
Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations	Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).	At Day 0 and Month 1
Number of Subjects With Any and Grade 3 Solicited Local Symptoms	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.	Within 4 days (Day 0 to 3) post-vaccination
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	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.	Within 4 days (Day 0 to 3) post-vaccination
Number of Subjects With Any Unsolicited Adverse Events (AEs)	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.	Within 31 days (Day 0 to 30) after vaccination
Number of Subjects With Serious Adverse Events (SAEs)	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.	Within 31 days (Day 0 to 30) after vaccination
Number of Subjects With New Onset Chronic Illnesses (NOCI)	NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.	Within 31 days (Day 0 to 30) after vaccination

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• Dbaibo G, El-Ayoubi N, Ghanem S, Hajar F, Bianco V, Miller JM, Mesaros N. Immunogenicity and safety of a quadrivalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine (MenACWY-TT) administered to adults aged 56 Years and older: results of an open-label, randomized, controlled trial. Drugs Aging. 2013 May;30(5):309-19. doi: 10.1007/s40266-013-0065-0.

Helpful Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2010
• Primary Completion (Actual): July 29, 2011
• Study Completion (Actual): August 3, 2011

Study Registration Dates

• First Submitted: November 4, 2010
• First Submitted That Met QC Criteria: November 4, 2010
• First Posted (Estimate): November 7, 2010

Study Record Updates

• Last Update Posted (Actual): August 20, 2018
• Last Update Submitted That Met QC Criteria: July 19, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Immunogenicity; Neisseria meningitidis; Meningococcal Vaccines; serogroups A,C, W-135 or Y; meningococcal diseases; meningococcal conjugate vaccine
• Additional Relevant MeSH Terms: Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Neisseriaceae Infections; Meningococcal Infections
• Other Study ID Numbers: 113807

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.

Study Data/Documents

1. Clinical Study Report
   Information identifier: 113807
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Dataset Specification
   Information identifier: 113807
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Statistical Analysis Plan
   Information identifier: 113807
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Study Protocol
   Information identifier: 113807
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Individual Participant Data Set
   Information identifier: 113807
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Informed Consent Form
   Information identifier: 113807
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register