Influenza Clinical Trial
Official title:
Safety and Immunogenicity Study of GSK Biologicals' Cell Culture-based Influenza Virus Vaccine 1388442A Compared With US Licensed TIV in Healthy Adults
NCT number | NCT00693706 |
Other study ID # | 110127 |
Secondary ID | |
Status | Completed |
Phase | Phase 1 |
First received | |
Last updated | |
Start date | June 2, 2008 |
Est. completion date | March 26, 2009 |
Verified date | October 2016 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 200 |
Est. completion date | March 26, 2009 |
Est. primary completion date | March 1, 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 49 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | GSK Investigational Site | Lenexa | Kansas |
United States | GSK Investigational Site | Miami | Florida |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Subjects With Solicited Local Symptoms. | Solicited local symptoms were pain, redness and swelling at the injection site. Any = occurrence of a symptom regardless of intensity. | During the 7-day (Days 0-6) post vaccination period | |
Primary | Number of Subjects With Solicited General Symptoms. | Solicited general symptoms were arthralgia, fatigue, headache, muscle aches, shivering and temperature, assessed as oral temperature above or equal (=) 38.0 degrees Celsius (°C). Any = occurrence of a symptom regardless of intensity or relationship to vaccination. | During the 7-day (Days 0-6) post vaccination period | |
Primary | Number of Subjects With Medically Attended Adverse Events (MAEs). | Medically-attended events (MAEs) refer to non-serious and serious events leading to an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits and hospitalization. Related MAE = MAE assessed by the investigator as related to the vaccination. | During the entire study period (Days 0-182) | |
Primary | Number of Subjects With New Onset of Chronic Diseases (NOCDs). | NOCDs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies. | During the entire study period (Days 0-182) | |
Primary | Number of Subjects With Unsolicited Adverse Events (AEs). | Unsolicited AEs cover any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any unsolicited AE = any unsolicited AE regardless of intensity or relationship to vaccination. | During the 90-day (Days 0-89) post-vaccination period | |
Primary | Number of Subjects With Serious Adverse Events (SAEs). | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE = any SAE regardless of intensity or relationship to vaccination. | During the entire study period (Days 0-182) | |
Primary | Titers for Serum Hemagglutination Inhibition (HI) Antibodies for 3 Strains of Influenza Disease. | Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2) and B/Malaysia/2506/2004 (MALAY.) | At Day 21 | |
Primary | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | A seroprotected subject was defined as a vaccinated subject with a serum HI antibody titer = 1:40, a level of HI antibody that has been viewed as correlating with protection against influenza. The 3 influenza strains assessed were A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2) and B/Malaysia/2506/2004 (MALAY.) | At Day 21 | |
Primary | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. | A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer =1:40 or a pre-vaccination titer =1:10 and at least a four-fold increase in post-vaccination titer. The 3 influenza strains assessed were A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2) and B/Malaysia/2506/2004 (MALAY.) | At Day 21 | |
Primary | Geometric Mean Fold-rise (GMFR) in 3 Strains of Influenza Disease. | GMFR was defined as the geometric mean of the ratio of the post-vaccination inverse HI titer to the Day 0 inverse HI titer. The 3 influenza strains assessed were A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2) and B/Malaysia/2506/2004 (MALAY.) | At Day 0 and Day 21 |
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