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

NCT ID: NCT01235975

Last Updated: 2018-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2011-08-03

Brief Summary

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.

Conditions

Infections, Meningococcal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Group A

Group Type: EXPERIMENTAL

Meningococcal vaccine GSK 134612

Intervention Type: BIOLOGICAL

Intramuscular injection

Group B

Group Type: ACTIVE_COMPARATOR

MencevaxACWY TM

Intervention Type: BIOLOGICAL

Subcutaneous injection

Interventions

Meningococcal vaccine GSK 134612

Intramuscular injection

Intervention Type: BIOLOGICAL

MencevaxACWY TM

Subcutaneous injection

Intervention Type: BIOLOGICAL

Eligibility 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.

• Minimum Eligible Age: 56 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Beirut, , Lebanon

Countries

Lebanon

References

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.

Reference Type: BACKGROUND

PMID: 23494214 (View on PubMed)

Study Documents

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

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

Other Identifiers

113807

Identifier Type: -

Identifier Source: org_study_id