Study to Evaluate the Immunogenicity and Safety of 2 Formulations of GlaxoSmithKline (GSK) Biologicals' GSK1247446A Low Dose Influenza Vaccine Candidate

NCT00374842 | Completed Phase 2 Results

• 1 other identifier: 108656
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the immunogenicity and the safety of candidate vaccines compared to Fluarix™ administered intramuscularly in subjects aged 18-59 years

Conditions

Influenza

Keywords

Influenza vaccine; Prophylaxis Influenza vaccine

Outcome Measures

Primary Outcomes (4)

• Titers of Serum Haemagglutination-inhibition (HI) Antibodies Against Each of the 3 Influenza Strains Assessed.

  Influenza strains assessed were the A/New Caledonia (A/CAL), A/Wisconsin (A/WIS), B/Malaysia (B/MAL) strains. Titers were presented as geometric mean titers (GMTs) calculated on subjects with available results, and expressed in haemagglutination-inhibition unit (HIU), e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenzae antigen. The seropositivity cut-off value of the assay was 10 HIU.

  At Day 0 and at Day 21.

• Number of Seroprotected Subjects Against Each of the 3 Influenza Strains Assessed.

  A seroprotected subject was a subject whose antibody titer against each of the influenza strains assessed (A/New Caledonia (A/CAL), A/Wisconsin (A/WIS) and B/Malaysia (B/MAL) strains) was equal to or higher than (\>=) the assay seroprotection cut-off value of 40 haemagglutination-inhibition units (HIU) (e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenzae antigen).

  At Day 0 and at Day 21.

• Number of Seroconverted Subjects Against Each of the 3 Influenza Strains Assessed

  Influenza strains assessed were the A/New Caledonia (A/CAL), A/Wisconsin (A/WIS), and B/Malaysia (B/MAL) strains. A seroconverted subject was a subject who had either a pre-vaccination serum HI antibody titer lower than 10 haemagglutination-inhibition units (HIU) (e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenzae antigen) and a post-vaccination titer higher than or equal to 40 HIU, or a pre-vaccination titer \>= 10 and at least a four-fold increase in post- vaccination titer.

  At Day 21.

• Seroconversion Factor Against Each of the 3 Influenza Strains Assessed.

  Influenza strains assessed were the A/New Caledonia (A/CAL), A/Wisconsin (A/WIS), and B/Malaysia (B/MAL) strains. The seroconversion factor (SCF) was defined as a ratio, as the fold increase in serum haemagglutination-inhibition geometric mean titers (GMTs) post-vaccination compared to Day 0 (with GMTs in the above calculation expressed in haemagglutination-inhibition units (HIU) \[e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenza antigen\]).

  At Day 21.

Secondary Outcomes (4)

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

  Within the 7-day follow-up period (Days 0-6) after vaccination

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

  Within the 7-day follow-up period (Days 0-6) after vaccination

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

  Within the 30-day follow-up period (Days 0-29) after vaccination

• Number of Subjects With Any and Related Serious Adverse Events (SAEs)

  From study start to study end, from Day 0 to Day 30

Study Arms (3)

GSK1247446A Formulation 1 Group

EXPERIMENTAL

Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Biological: GSK1247446A

GSK1247446A Formulation 2 Group

EXPERIMENTAL

Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Biological: GSK1247446A

Fluarix Group

ACTIVE COMPARATOR

Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Biological: Fluarix™

Interventions

Fluarix™ BIOLOGICAL

GlaxoSmithKline Biologicals' licensed influenza vaccine

Fluarix Group

GSK1247446A BIOLOGICAL

Low-dose GlaxoSmithKline Biologicals' GSK1247446A influenza vaccine

GSK1247446A Formulation 1 Group; GSK1247446A Formulation 2 Group

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• A male or female aged 18-59 years 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
• Previous vaccination against influenza in 2006
• Acute or chronic 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

Wilrijk, 2610, 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: September 8, 2006
• First Posted: September 12, 2006
• Study Start: October 3, 2006
• Primary Completion: November 1, 2006
• Study Completion: November 30, 2006
• Last Updated: June 8, 2018
• Results First Posted: April 22, 2013

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

BE (1)