Study to Evaluate Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1)

NCT ID: NCT00989612

Last Updated: 2019-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-01
• Study Completion Date: 2010-04-19

Brief Summary

This trial will assess the immunogenicity and safety elicited by the adjuvanted GSK Biologicals' influenza investigational vaccine GSK2340274A in healthy Japanese adults aged 20-64 years.

Detailed Description

This Protocol Posting has been updated following Protocol amendment 1& 2, October 2009. The sections impacted are study design and outcome measures

Conditions

Influenza

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

GSK2340274A GROUP

Healthy subjects, aged 20 to 64 years, male and female, received 2 doses of GSK2340274A vaccine, injected intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.

Group Type: EXPERIMENTAL

Influenza investigational vaccine GSK2340274A

Intervention Type: BIOLOGICAL

Two intramuscular injections on Day 0 and Day 21, respectively

Interventions

Influenza investigational vaccine GSK2340274A

Two intramuscular injections on Day 0 and Day 21, respectively

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Japanese male and female adults 20 to 64 years of age at time of the first vaccination, inclusive.
• Good general health as assessed by medical history and physical examination
• Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
• Written informed consent obtained from the subject.
• Access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line or mobile, but NOT a pay phone or other multiple-user device.
• Females of non-childbearing potential may be enrolled in the study.
• Female of childbearing potential may be enrolled in the study, if she:
• has practiced adequate contraception for 30 days prior to vaccination, and
• has a negative pregnancy test on the day of vaccination, and
• has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.

Exclusion Criteria

• Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• History of previous administration of a novel [H1N1]v vaccine.
• Previous participation in study NCT00742885.
• Presence of significant acute or chronic, uncontrolled medical or psychiatric illness.
• Presence or evidence of substance abuse or of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
• Presence of an axillary temperature >= 37.5 °C, or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.
• Diagnosed with cancer, or treatment for cancer within 3 years.
• Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection.
• Chronic administration of immunosuppressants or other immune modifying drugs within 6 months of study enrolment or planned administration during the study period.
• Receipt of any immunoglobulins and/or any blood products within 3 months of study enrolment or planned administration of any of these products during the study period.
• Any significant disorder of coagulation or treatment with warfarin derivatives or heparin.
• An acute evolving neurological disorder or history of Guillain-Barré syndrome.
• Administration of any vaccines within 30 days before vaccination or planned administration within the first vaccination up to blood sampling at Day 42 and within 30 days prior to blood sampling at Day 182, with the exception of seasonal influenza vaccine.
• Administration of any seasonal influenza vaccine within 14 days before vaccination on Day 0, or planned administration within the first vaccination up to blood sampling at Day 42 and within 14 days prior to blood sampling at Day 182.
• Any known or suspected allergy to any constituent of influenza vaccines or component used in the manufacturing process of the study vaccine; a history of anaphylactic-type reaction to any constituent of influenza vaccines; or a history of severe adverse reaction to a previous influenza vaccine.
• Known pregnancy or a positive urine test result prior to the time of first vaccination.
• Lactating or nursing female.
• Excessive underweight (Body Mass Index [BMI] < 18.5) or excessive obesity (BMI >= 30).
• Any conditions which, in the opinion of the investigator, prevents the subjects from participating in the study.
• Clinically or virologically confirmed influenza infection within 6 months preceding the study start.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 64 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

Fukuoka, , Japan

GSK Investigational Site

Tokyo, , Japan

Countries

Japan

References

Ikematsu H, Nagai H, Kawashima M, Kawakami Y, Tenjinbaru K, Li P, Walravens K, Gillard P, Roman F. Characterization and long-term persistence of immune response following two doses of an AS03A-adjuvanted H1N1 influenza vaccine in healthy Japanese adults. Hum Vaccin Immunother. 2012 Feb;8(2):260-6. doi: 10.4161/hv.18469. Epub 2012 Feb 1.

Reference Type: DERIVED

PMID: 22426369 (View on PubMed)

Ikematsu H, Nagai H, Kawashima M, Kawakami Y, Tenjinbaru K, Maeda A, Li P, Gillard P, Roman F. Immunogenicity and safety of a novel AS03(A)-adjuvanted H1N1 2009 pandemic influenza vaccine in adults in Japan. Hum Vaccin. 2010 Nov;6(11):888-93. doi: 10.4161/hv.6.11.12851. Epub 2010 Nov 1.

Reference Type: DERIVED

PMID: 20980795 (View on PubMed)

Study Documents

Document Type: Clinical Study Report

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

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Document Type: Statistical Analysis Plan

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

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Document Type: Informed Consent Form

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: Study Protocol

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: Dataset Specification

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

View Document

Related Links

https://www.clinicalstudydatarequest.com

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Other Identifiers

113519

Identifier Type: -

Identifier Source: org_study_id