Phase 1
Completed N=200
Safety and Immune Response Study of GSK Biologicals' Influenza Virus Vaccine 1388442A Compared With Fluarix
Source: ClinicalTrials.gov NCT00693706 ↗Enrolled (actual)
200
Serious AEs
0.5%
Results posted
Mar 2013
Primary outcomePrimary: Number of Subjects With Solicited Local Symptoms. — 48; 48; 1; 0 subjects
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Solicited Local Symptoms. |
48; 48; 1; 0; 1; 0 | — |
| PRIMARY Number of Subjects With Solicited General Symptoms. |
2; 4; 19; 15; 24; 21 | — |
| PRIMARY Number of Subjects With Medically Attended Adverse Events (MAEs). |
4; 7 | — |
| PRIMARY Number of Subjects With New Onset of Chronic Diseases (NOCDs). |
0; 0 | — |
| PRIMARY Number of Subjects With Unsolicited Adverse Events (AEs). |
28; 21 | — |
| PRIMARY Number of Subjects With Serious Adverse Events (SAEs). |
1; 0 | — |
| PRIMARY Titers for Serum Hemagglutination Inhibition (HI) Antibodies for 3 Strains of Influenza Disease. |
183.7; 501.4; 333.5; 315.5; 316.6; 326.8 | — |
| PRIMARY Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. |
90; 97; 98; 98; 99; 96 | — |
| PRIMARY Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. |
72; 79; 68; 66; 74; 67 | — |
| PRIMARY Geometric Mean Fold-rise (GMFR) in 3 Strains of Influenza Disease. |
10.9; 17.8; 10.1; 7.5; 12.3; 10.5 | — |
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
Data sourced from ClinicalTrials.gov (NCT00693706). 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. Informational only — not medical advice.