Study to Evaluate the Immunogenicity and the Safety of an Adjuvanted Influenza Vaccine Candidate

NCT00363077 | Completed Phase 2 Results

• 1 other identifier: 107975
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the immunogenicity and the safety of the candidate vaccine compared to Fluarix™ administered intramuscularly in elderly aged 60 years and above

Conditions

Influenza

Keywords

Influenza vaccine; Prophylaxis Influenza vaccine

Outcome Measures

Primary Outcomes (4)

• Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.

  Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia. The seropositivity cut-off assay was 1:10.

  At Days 0 and 21

• Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.

  A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer \<1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.

  At Day 21

• Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.

  A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.

  At Day 0 and Day 21

• Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.

  The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.

  At Day 21

Secondary Outcomes (6)

• Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.

  At Days 0 and 21

• Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.

  At Days 0 and 21

• Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms.

  During the 7-day (Days 0-6) post-vaccination period

• Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.

  During the 7-day (Days 0-6) post-vaccination period

• Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).

  During the 30-day (Days 0-29) post vaccination period

Study Arms (2)

GSK1247446A Group

EXPERIMENTAL

Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.

Biological: GSK1247446A Group

Fluarix Group

ACTIVE COMPARATOR

Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.

Biological: Fluarix™

Interventions

GSK1247446A Group BIOLOGICAL

Low dose influenza vaccine adjuvanted with AS03 compared

Also known as: Low dose adjuvanted influenza vaccine

GSK1247446A Group

Fluarix™ BIOLOGICAL

GlaxoSmithKline (GSK) Biologicals' inactivated influenza split vaccine.

Fluarix Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who the investigator believes that they can and wil comply with the requirements of the protocol should be enrolled in the study.
• A male or female 60 years or older at the time of the first vaccination.
• Free of obvious health problems

You may not qualify if:

• Use of non-registered products
• Administration of immune-modifying drugs.
• Administration of vaccine 30 days before enrolment in study.
• Immunosuppressive or immunodeficient condition.
• Hypersensitivity to a previous dose of influenza vaccine
• Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality.
• History of confirmed influenza infection within the last 12 Months.
• Acute disease at the time of enrolment/vaccination.
• History of allergy or reactions likely to be exacerbated by any component of the vaccine

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Ghent, 9000, Belgium

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

Interventions

fluarix

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 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2006
• First Posted: August 15, 2006
• Study Start: October 2, 2006
• Primary Completion: November 1, 2006
• Study Completion: November 17, 2006
• Last Updated: June 8, 2018
• Results First Posted: May 7, 2013

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

BE (1)