Mode
Text Size
Log in / Sign up
Phase 1 N=420 Randomized Single-blind Prevention

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

Influenza

Enrolled (actual)
420
Serious AEs
0.2%
Results posted
Sep 2013
Primary outcome: Primary: Serum Haemagglutination-inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains. — 21.4; 22.2; 23.3; 18.4 Titer

Study Design & Population

Study type
Interventional
Phase
Phase 1
Interventions
GSK Biologicals' quadrivalent influenza vaccine (Biological); GSK Biologicals' trivalent influenza vaccine (Biological)
Age
Adult · 18+ yrs
Sex
All
Sponsor
GlaxoSmithKline
Primary completion
Jan 2009

Outcome Measures

OutcomeResultp-value
PRIMARY
Serum Haemagglutination-inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains.
21.4; 22.2; 23.3; 18.4; 130.0; 150.6
SECONDARY
Number of Subjects Seroconverted for HI Antibodies Against the Vaccine Influenza Strains.
59; 60; 57; 63; 63; 69
SECONDARY
HI Antibody Seroconversion Factors Against the Vaccine Influenza Strains
6.1; 6.8; 6.9; 7.3; 5.5; 7.4
SECONDARY
Number of Subjects Seroprotected for HI Antibodies Against the Vaccine Influenza Strains.
39; 44; 42; 37; 96; 92
SECONDARY
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
76; 79; 74; 52; 0; 2
SECONDARY
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Reported by the Former GSK Rules of Grading.
76; 79; 74; 52; 0; 2
SECONDARY
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
6; 25; 13; 12; 1; 3
SECONDARY
Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading.
6; 25; 13; 12; 1; 3
SECONDARY
Number of Subjects Reporting Any Medically Significant Conditions (MSCs) and Auto-immune Diseases (AIDs).
1; 4; 5; 5; 0; 0
SECONDARY
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AE(s).
7; 7; 16; 11; 0; 1
SECONDARY
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
0; 0; 0; 1.0; 0; 0

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.

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00714285). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search