Clinical trial NCT00693706: Safety and Immune Response Study of GSK Biologicals' Influenza Virus Vaccine 1388442A Compared With Fluarix
Official title: Safety and Immunogenicity Study of GSK Biologicals' Cell Culture-based Influenza Virus Vaccine 1388442A Compared With US Licensed TIV in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Influenza
Keywords: cell culture
Safety
Influenza
Humans
Adults
Immunogenicity
Influenza vaccine
Vaccine
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-06-09
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to compare the safety of \& immune response to a single dose of GSK Biologicals' cell-culture based influenza vaccine 138842A with that of a US licensed, egg-based trivalent influenza vaccine \[Fluarix\] in healthy adults.


Eligibility criteria: Inclusion Criteria:

* Subjects who the investigator believes can and will comply with the requirements of the protocol
* A male or non-pregnant, non-lactating female between 18 and 49 years of age at the time of vaccination
* Access to a telephone for scheduled follow-up telephone contacts
* Ability to provide written informed consent
* Healthy subjects as established by medical history and physical examination before entering into the study
* If the subject is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination and continue such precautions for 2 months after receipt of the study vaccine. All women will have a pregnancy test on the day of vaccination.

Exclusion Criteria:

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period
* Receipt of systemic glucocorticoids within 30 days of study enrollment
* Administration of immunosuppressant, cytotoxic, or other immune-modifying drugs (other than glucocorticoids) or irradiation within 6 months prior to study enrollment or planned administration during the study period
* Administration of immunoglobulins and/or blood products within 3 months prior to study enrollment or planned administration during the study period
* Previous vaccination against influenza (2007-2008 influenza season)
* History of anaphylactic or other allergic reaction to influenza vaccine, any other vaccine, or any vaccine component or excipient
* History of Guillain-Barre Syndrome (GBS)
* Acute disease, febrile illness, or upper respiratory infection at screening.
* History of splenectomy
* Any confirmed or suspected, acquired, congenital, or hereditary immunodeficiency or immunosuppressive condition (including human immunodeficiency virus \[HIV\]) based on medical history and physical examination
* Acquired or congenital coagulation disorders or known thrombocytopenia
* Current treatment with warfarin or heparin derivatives
* Known use of an analgesic or antipyretic medication within 12 hours prior to treatment for the purposes of prophylaxis of adverse events
* Any medical condition for which the US Advisory Committee on Immunization Practices recommends vaccination against influenza

Primary outcomes:
measure: Number of Subjects With Solicited Local Symptoms.
timeFrame: During the 7-day (Days 0-6) post vaccination period
measure: Number of Subjects With Solicited General Symptoms.
timeFrame: During the 7-day (Days 0-6) post vaccination period
measure: Number of Subjects With Medically Attended Adverse Events (MAEs).
timeFrame: During the entire study period (Days 0-182)
measure: Number of Subjects With New Onset of Chronic Diseases (NOCDs).
timeFrame: During the entire study period (Days 0-182)
measure: Number of Subjects With Unsolicited Adverse Events (AEs).
timeFrame: During the 90-day (Days 0-89) post-vaccination period
measure: Number of Subjects With Serious Adverse Events (SAEs).
timeFrame: During the entire study period (Days 0-182)
measure: Titers for Serum Hemagglutination Inhibition (HI) Antibodies for 3 Strains of Influenza Disease.
timeFrame: At Day 21
measure: Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.
timeFrame: At Day 21
measure: Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.
timeFrame: At Day 21
measure: Geometric Mean Fold-rise (GMFR) in 3 Strains of Influenza Disease.
timeFrame: At Day 0 and Day 21
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Lenexa
country: United States
facility: GSK Investigational Site
state: Kansas
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: