Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza Vaccine for the Elderly

NCT00938392 | Completed Phase 3 Results

• 1 other identifier: 112662
• Study Type: interventional
• Target: 726
• Locations: 2 countries
• Sites: 6

Brief Summary

The objective of the study is to evaluate immunogenicity between different formulations of GSK Biologicals' investigational vaccine GSK2186877A.

Conditions

Influenza

Keywords

influenza infection; GSK Bio's influenza vaccine GSK2186877A

Outcome Measures

Primary Outcomes (1)

• Serum Haemagglutination-Inhibition (HI) Antibody Titers Against the 3 Vaccine Strains

  Titers are presented as Geometric Mean Titers. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane.

  At Days 0 and 21

Secondary Outcomes (9)

• Number of Subjects Seropositive Against the 3 Vaccine Strains

  At Days 0 and 21

• Number of Subjects Seroconverted for the 3 Vaccine Strains

  At Day 21

• Seroconversion Factor for the 3 Vaccine Strains

  At Day 21

• Number of Subjects Seroprotected for the 3 Vaccine Strains

  At Days 0 and 21

• Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms

  During the 7-day post-vaccination period

Study Arms (2)

FluNG Aged Group

EXPERIMENTAL

Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).

Biological: GSK investigational FluNG vaccine GSK2186877A, aged lot

FluNG Fresh Group

EXPERIMENTAL

Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).

Biological: GSK investigational FluNG vaccine GSK2186877A, fresh lot

Interventions

GSK investigational FluNG vaccine GSK2186877A, aged lot BIOLOGICAL

Single dose, intramuscular injection

FluNG Aged Group

GSK investigational FluNG vaccine GSK2186877A, fresh lot BIOLOGICAL

Single dose, intramuscular injection

FluNG Fresh Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study. Specific attention should be given to the compliance potential of subjects with suspected or known drug or alcohol abuse.
• A man or woman 65 years of age or older at the time of vaccination.
• Written informed consent obtained from the subject.
• Free of an acute aggravation of the health status as established by clinical evaluation before entering into the study.

You may not qualify if:

• Any confirmed or suspected influenza illness within the last 6 months.
• Previous vaccination against influenza with any seasonal vaccine since December 2008.
• Planned administration of an influenza vaccine other than the study vaccines during the entire study period.
• 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.
• Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol up to Visit 2.
• Administration of immunoglobulins and/or any blood products within the 3 months preceding the dose of study vaccine or planned administration during the study period.
• Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose. For corticosteroids, this will mean prednisone \>= 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s) including egg and chicken protein, included history of hypersensitivity to a previous dose of influenza vaccine.
• Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
• Acute disease and/or fever at the time of enrolment.
• Fever is defined as temperature \>= 37.5°C on oral setting.
• Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.
• Any medical conditions in which intramuscular injections are contraindicated.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (6)

GSK Investigational Site

Tallinn, Estonia

Location

GSK Investigational Site

Tartu, 50106, Estonia

Location

GSK Investigational Site

Bratislava, 811 03, Slovakia

Location

GSK Investigational Site

Bratislava, 814 66, Slovakia

Location

GSK Investigational Site

Bratislava, 841 04, Slovakia

Location

GSK Investigational Site

Veľký Biel, 900 24, Slovakia

Location

Related 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.

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2009
• First Posted: July 13, 2009
• Study Start: July 30, 2009
• Primary Completion: October 5, 2009
• Study Completion: October 5, 2009
• Last Updated: August 20, 2018
• Results First Posted: May 17, 2012

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will share

Locations

ES (2); SL (4)