Immunogenicity and Safety Study of a GSK Influenza Vaccine Candidate in Adults.

NCT00714285 | Completed Phase 1 Results

• 1 other identifier: 111295
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and immunogenicity of GSK influenza vaccine candidate compared to a licensed trivalent influenza vaccine in adults.

Conditions

Influenza

Keywords

Primary study; immunogenicity; safety

Outcome Measures

Primary Outcomes (1)

• Serum Haemagglutination-inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains.

  Antibody titers were expressed as Geometric mean titers (GMTs).The vaccine influenza strains included A/Solomon Islands,A/Wisconsin,B/Malaysia and B/Jiangsu antigens.

  At Day 0 and Day 21

Secondary Outcomes (10)

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

  At Day 21

• HI Antibody Seroconversion Factors Against the Vaccine Influenza Strains

  Day 21

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

  At Days 0 and 21

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

  During a 7 day (Days 0-6) follow-up period after vaccination

• Number of Subjects With Any and Grade 3 Solicited Local Symptoms Reported by the Former GSK Rules of Grading.

  During a 7-day follow-up period (Days 0-6) after vaccination

Study Arms (4)

Quadrivalent influenza vaccine GSK 2115160A Group 1

EXPERIMENTAL

Subjects in this group received 1 full dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0

Biological: GSK Biologicals' quadrivalent influenza vaccine

Quadrivalent influenza vaccine GSK 2115160A Group 2

EXPERIMENTAL

Subjects in this group received 1 low dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0

Biological: GSK Biologicals' quadrivalent influenza vaccine

Trivalent influenza vaccine GSK 2115160A Group 1

ACTIVE COMPARATOR

Subjects in this group received 1 low dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0

Biological: GSK Biologicals' trivalent influenza vaccine

Trivalent influenza vaccine GSK 2115160A Group 2

ACTIVE COMPARATOR

Subjects in this group received 1 full dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0

Biological: GSK Biologicals' trivalent influenza vaccine

Interventions

GSK Biologicals' quadrivalent influenza vaccine BIOLOGICAL

Single intramuscular dose on Day 0.

Quadrivalent influenza vaccine GSK 2115160A Group 1; Quadrivalent influenza vaccine GSK 2115160A Group 2

GSK Biologicals' trivalent influenza vaccine BIOLOGICAL

Single intramuscular dose on Day 0.

Trivalent influenza vaccine GSK 2115160A Group 1; Trivalent influenza vaccine GSK 2115160A Group 2

Eligibility Criteria

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

You may qualify if:

• Healthy subjects as established by medical history and clinical examination before entering into the study.
• Subjects who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study.
• A male or female between, and including, 18 and 60 years of age at the time of the vaccination.
• Written informed consent obtained from the subject.
• If the subject is female, she must be of non-childbearing potential, if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.

You may not qualify if:

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the administration of study vaccine, or planned use during the study period.
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 3 months prior to administration of the vaccine.
• Administration of a vaccine not foreseen in the study protocol from 30 days before vaccination up to 21 days post vaccination.
• Confirmed influenza infection within a year preceding the study start.
• Administration of an influenza vaccine during Northern Hemisphere season 2007-2008.
• Concurrently participating 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 a non-investigational product (pharmaceutical product or device).
• History of hypersensitivity to a previous dose of influenza vaccine
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
• Acute disease at the time of enrolment.
• Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
• Administration of immunoglobulins and/or any blood products within the three months preceding the administration of study vaccine or planned administration during the study period.
• Pregnant or lactating female.
• Female planning to become pregnant or planning to discontinue contraceptive precautions.
• History of chronic alcohol consumption and/or drug abuse.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Hradec Králové, 500 03, Czechia

Location

Related Publications (1)

• Beran J, Peeters M, Dewe W, Raupachova J, Hobzova L, Devaster JM. Immunogenicity and safety of quadrivalent versus trivalent inactivated influenza vaccine: a randomized, controlled trial in adults. BMC Infect Dis. 2013 May 20;13:224. doi: 10.1186/1471-2334-13-224.

  PMID: 23688546 DERIVED

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 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2008
• First Posted: July 14, 2008
• Study Start: July 14, 2008
• Primary Completion: January 28, 2009
• Study Completion: January 28, 2009
• Last Updated: June 8, 2018
• Results First Posted: September 16, 2013

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share

Locations

CZ (1)