Study to Evaluate Immunological Equivalence Between Two Investigational Influenza Vaccines in Adults (H1N1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00979407
First received: September 17, 2009
Last updated: November 1, 2012
Last verified: March 2012
  Purpose

The primary purpose of the study is to assess the equivalence of the immune response elicited by two GSK Biologicals' adjuvanted influenza investigational vaccines (GSK2340272A and GSK2340274A) in adults aged 18 to 60 years. The second purpose of the study is to evaluate the safety and reactogenicity of these two vaccines.


Condition Intervention Phase
Influenza Infection
Biological: Influenza vaccine GSK2340272A
Biological: Influenza vaccine GSK2340274A
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Immunological Equivalence Between GSK2340272A and GSK2340274A Influenza Vaccines in Adults Aged 18 to 60 Years

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 21 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Humoral immune response in terms of HI antibodies [ Time Frame: At Day 0, 21, 42, 182 and 364 ] [ 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 0-364) ] [ Designated as safety issue: No ]
  • Adverse events of specific interest or potential immune-mediated disease [ Time Frame: During the entire study period (Day 0-364) ] [ Designated as safety issue: No ]

Enrollment: 336
Study Start Date: October 2009
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Subjects receiving influenza vaccine GSK2340272A
Biological: Influenza vaccine GSK2340272A
Two intramuscular injections at Day 0 and Day 21
Experimental: Group B
Subjects receiving influenza vaccine GSK2340274A
Biological: Influenza vaccine GSK2340274A
Two intramuscular injections at Day 0 and Day 21

Detailed Description:

This Protocol Posting has been updated following Protocol Amendment 4, July 2010, leading to removal of one of the secondary outcome measures.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female aged 18 to 60 years inclusive, at the time of the first vaccination.
  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
  • Written informed consent obtained from the subject.
  • Satisfactory baseline medical assessment by history and physical examination.
  • 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 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 within 30 days preceding the first dose of the study vaccine or planned use during the study period.
  • Presence of 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 (99.5°F), or acute symptoms greater than "mild" severity on the scheduled date of first vaccination. NOTE: The subject may be vaccinated at a later date, provided symptoms have resolved, vaccination occurs within the window specified by the protocol, and all other eligibility criteria continue to be satisfied.
  • Clinically or virologically confirmed influenza infection within 6 months preceding the study start.
  • 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.
  • Clinically or virologically confirmed influenza infection within 6 months preceding the study start.
  • 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.
  • Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to any constituent of influenza vaccines; or a history of severe adverse reaction to a previous influenza vaccine.
  • Pregnant or lactating female
  • Female planning to become pregnant or planning to discontinue contraceptive precautions.
  • Any conditions which, in the opinion of the investigator, prevents the subjects from participating in the study.
  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: NCT00979407

Locations
France
GSK Investigational Site
Caen cedex 9, France, 14033
GSK Investigational Site
Paris, France, 75679
GSK Investigational Site
Paris Cedex 18, France, 75877
GSK Investigational Site
Poitiers, France, 86000
Germany
GSK Investigational Site
Regensburg, Bayern, Germany, 93053
GSK Investigational Site
Wuerzburg, Bayern, Germany, 97070
GSK Investigational Site
Schmiedeberg, Sachsen, Germany, 01762
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: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00979407     History of Changes
Other Study ID Numbers: 113535
Study First Received: September 17, 2009
Last Updated: November 1, 2012
Health Authority: France: Agence Française de Sécurité Sanitaire des Produits de Santé

Keywords provided by GlaxoSmithKline:
influenza infection
GSK Biologicals' influenza vaccine GSK2340272A and GSK2340274A

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

ClinicalTrials.gov processed this record on July 09, 2014