Non-inferiority Study of GSK Biologicals' Influenza Vaccine GSK576389A Using Different Formulations

NCT00633074 | Completed Phase 2 Results

• 1 other identifier: 111454
• Study Type: interventional
• Target: 720
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to show the non-inferiority of different formulations of GlaxoSmithKline Biologicials' influenza vaccine.

Conditions

Influenza

Keywords

Influenza

Outcome Measures

Primary Outcomes (1)

• Serum Haemagglutination-inhibition (HI) Antibody Titer Against the Three Vaccine Strains

  Titers were expressed as Geometric Mean Titers (GMTs). The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.

  Days 0 and 21

Secondary Outcomes (11)

• Number of Subjects Seropositive for HI Antibodies Against the Three Vaccine Strains

  Days 0 and 21

• Number of Subjects Seroconverted for HI Antibodies Against the Three Vaccine Strains

  Day 21

• HI Antibody Seroconversion Factors

  Day 21

• Number of Subjects Seroprotected for HI Antibodies Against the Three Vaccine Strains

  Days 0 and 21

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

  During a 7-day period after vaccination

Study Arms (2)

Thiomersal-free FluAS25 adjuvanted vaccine group

EXPERIMENTAL

Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine

Biological: Thiomersal-free FluAS25 adjuvanted vaccine (GSK576389A)

Thiomersal reduced FluAS25 adjuvanted vaccine group

EXPERIMENTAL

Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine

Biological: Thiomersal reduced FluAS25 adjuvanted vaccine (GSK576389A)

Interventions

Thiomersal-free FluAS25 adjuvanted vaccine (GSK576389A) BIOLOGICAL

Intramuscular administration, 1 dose

Thiomersal-free FluAS25 adjuvanted vaccine group

Thiomersal reduced FluAS25 adjuvanted vaccine (GSK576389A) BIOLOGICAL

Intramuscular administration, 1 dose

Thiomersal reduced FluAS25 adjuvanted vaccine 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.
• A male or female 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 (medical history and medical history directed examination) before entering into the study.

You may not qualify if:

• Suspected (based on clinical symptoms) or confirmed (based on laboratory results) influenza infection within the last 6 months.
• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first 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 21 days after vaccination.
• Planned administration of an influenza vaccine other than the study vaccines during the entire study period.
• Previous vaccination against influenza with any seasonal vaccine since July 2007.
• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• History of hypersensitivity to a previous dose of influenza vaccine.
• History of allergy or reactions likely to be exacerbated by any component of the vaccine(s) including egg and chicken protein.
• Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by clinical evaluation (medical history and medical history directed physical examination) or pre-existing laboratory screening tests.
• Acute disease at the time of enrolment.
• Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
• Any medical conditions in which IM injections are contraindicated

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (3)

GSK Investigational Site

Saku, 75501, Estonia

Location

GSK Investigational Site

Tallinn, 13419, Estonia

Location

GSK Investigational Site

Tartu, 50417, Estonia

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 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 29, 2008
• First Posted: March 11, 2008
• Study Start: March 3, 2008
• Primary Completion: April 11, 2008
• Study Completion: April 11, 2008
• Last Updated: June 8, 2018
• Results First Posted: May 28, 2012

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will share

Locations

ES (3)