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

NCT ID: NCT00714285

Last Updated: 2018-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 420 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-14
• Study Completion Date: 2009-01-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Quadrivalent influenza vaccine GSK 2115160A Group 1

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

Group Type: EXPERIMENTAL

GSK Biologicals' quadrivalent influenza vaccine

Intervention Type: BIOLOGICAL

Single intramuscular dose on Day 0.

Quadrivalent influenza vaccine GSK 2115160A Group 2

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

Group Type: EXPERIMENTAL

GSK Biologicals' quadrivalent influenza vaccine

Intervention Type: BIOLOGICAL

Single intramuscular dose on Day 0.

Trivalent influenza vaccine GSK 2115160A Group 1

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

Group Type: ACTIVE_COMPARATOR

GSK Biologicals' trivalent influenza vaccine

Intervention Type: BIOLOGICAL

Single intramuscular dose on Day 0.

Trivalent influenza vaccine GSK 2115160A Group 2

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

Group Type: ACTIVE_COMPARATOR

GSK Biologicals' trivalent influenza vaccine

Intervention Type: BIOLOGICAL

Single intramuscular dose on Day 0.

Interventions

GSK Biologicals' quadrivalent influenza vaccine

Single intramuscular dose on Day 0.

Intervention Type: BIOLOGICAL

GSK Biologicals' trivalent influenza vaccine

Single intramuscular dose on Day 0.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.
• Any condition which, in the opinion of the investigator, prevents the subject from participating in the study.
• History of administration of experimental/licensed vaccine.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Hradec Králové, , Czechia

Countries

Czechia

References

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.

Reference Type: DERIVED

PMID: 23688546 (View on PubMed)

Study Documents

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

111295

Identifier Type: -

Identifier Source: org_study_id