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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00989612
First received: October 1, 2009
Last updated: March 10, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention Phase
Influenza A Virus, H1N1 Subtype
Influenza Infection
Biological: Influenza investigational vaccine GSK2340274A
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety Study of GSK Biologicals' Influenza Candidate Vaccine GSK2340274A

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Humoral immune response in terms of Haemagglutination Inhibition (HI) antibodies [ Time Frame: At Day 0, 21 and 42 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Humoral immune response in terms of HI antibodies antibodies (will also be performed in each age stratum) [ Time Frame: At Day 0, 21, 42 and 182 ] [ Designated as safety issue: No ]
  • Humoral immune response in terms of neutralizing antibodies [ Time Frame: At Day 0, 21, 42 and 182 ] [ Designated as safety issue: No ]
  • Solicited local and general symptoms [ Time Frame: During a 7-day (Day 0-6) follow-up after each vaccination ] [ Designated as safety issue: No ]
  • Unsolicited adverse events [ Time Frame: During a 21-day (Day 0-20) follow-up period after the first vaccination and during a 63-day (Day 21-84) follow-up after the second vaccination ] [ Designated as safety issue: No ]
  • Serious adverse events [ Time Frame: During the entire study period (Day 0-182) ] [ Designated as safety issue: No ]
  • Adverse events of specific interest [ Time Frame: During the entire study period (Day 0-182) ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: October 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Subjects receiving GSK2340274A vaccine
Biological: Influenza investigational vaccine GSK2340274A
Two intramuscular injections on Day 0 and Day 21, respectively

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   20 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00989612

Locations
Japan
GSK Investigational Site
Fukuoka, Japan, 813-8588
GSK Investigational Site
Tokyo, Japan, 204-8585
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00989612     History of Changes
Other Study ID Numbers: 113519
Study First Received: October 1, 2009
Last Updated: March 10, 2011
Health Authority: Japan: Pharmaceutical and Medical Device Agency

Keywords provided by GlaxoSmithKline:
influenza infection
GSK Biologicals' influenza vaccine GSK2340272A

Additional relevant MeSH terms:
Infection
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 24, 2014