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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

September 17, 2009
November 1, 2012
October 2009
November 2010   (final data collection date for primary outcome measure)
Humoral immune response in terms of Haemagglutination Inhibition (HI) antibodies [ Time Frame: At Day 21 ] [ Designated as safety issue: No ]
Humoral immune response in terms of Haemagglutination Inhibition (HI) antibodies [ Time Frame: At Day 42 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00979407 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Humoral immune response in terms of HI antibodies [ Time Frame: At Day 0, 21, 42, 182 and 364 ] [ Designated as safety issue: No ]
  • Humoral immune response in terms of neutralizing antibodies [ Time Frame: At Day 0 and 42 ] [ 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 [ Time Frame: During the entire study period (Day 0-364) ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study to Evaluate Immunological Equivalence Between Two Investigational Influenza Vaccines in Adults (H1N1)
Immunological Equivalence Between GSK2340272A and GSK2340274A Influenza Vaccines in Adults Aged 18 to 60 Years

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.

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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Influenza Infection
  • Biological: Influenza vaccine GSK2340272A
    Two intramuscular injections at Day 0 and Day 21
  • Biological: Influenza vaccine GSK2340274A
    Two intramuscular injections at Day 0 and Day 21
  • Experimental: Group A
    Subjects receiving influenza vaccine GSK2340272A
    Intervention: Biological: Influenza vaccine GSK2340272A
  • Experimental: Group B
    Subjects receiving influenza vaccine GSK2340274A
    Intervention: Biological: Influenza vaccine GSK2340274A
Launay O, Duval X, Fitoussi S, Jilg W, Kerdpanich A, Montellano M, Schwarz TF, Watanveerade V, Wenzel JJ, Zalcman G, Bambure V, Li P, Caplanusi A, Madan A, Gillard P, Vaughn DW. Extended antigen sparing potential of AS03-adjuvanted pandemic H1N1 vaccines in children, and immunological equivalence of two formulations of AS03-adjuvanted H1N1 vaccines: results from two randomised trials. BMC Infect Dis. 2013 Sep 16;13:435. doi: 10.1186/1471-2334-13-435.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
336
November 2010
November 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
France,   Germany
 
NCT00979407
113535
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP