Phase 2
Completed N=243
Revaccination With Influenza Vaccine GSK1247446A
Influenza · Influenza, Human
Source: ClinicalTrials.gov NCT00545025 ↗
Enrolled (actual)
243
Serious AEs
0.4%
Results posted
May 2013
Primary outcomePrimary: Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms — 8; 5; 1; 2 Subjects
Summary
The protocol is designed to demonstrate the safety of influenza vaccine GSK1247446A after revaccination.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms |
8; 5; 1; 2; 143; 57 | — |
| PRIMARY Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. |
28; 5; 3; 0; 26; 5 | — |
| PRIMARY Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) |
69; 31; 16; 10; 35; 8 | — |
| PRIMARY Number of Subjects With Any and Related Serious Adverse Events (SAEs) |
0; 1; 0; 0 | — |
| SECONDARY Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. |
41.0; 43.0; 162.4; 127.2; 83.2; 78.9 | — |
| SECONDARY Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. |
73; 30; 40; 13; 61; 23 | — |
| SECONDARY Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. |
87; 45; 155; 75; 139; 69 | — |
| SECONDARY Seroconversion Factor for HI Antibodies Against 3 Strains of Influenza Disease. |
3.9; 3.0; 2.3; 1.9; 3.1; 2.6 | — |
Eligibility Criteria
Inclusion Criteria
- A male or female aged 18-60 years old at the time of vaccination, who previously participated in 108656 clinical trial.
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
- Written informed consent obtained from the subject.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- If the subject is female, she must be of non-childbearing potential or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two 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 within 30 days preceding the administration of the study vaccine, or planned use during the study period.
- Planned administration of an influenza vaccine other than the study vaccines during the entire study period
- Previous vaccination against influenza since January 2007.
- Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- Chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to the first vaccine dose.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
- Administration of immunoglobulins and/or any blood products within three months preceding the dose of study vaccine or planned administration during the study period.
- History of hypersensitivity to a previous dose of influenza vaccine.
- History of confirmed influenza infection within the last 12 months.
- Pregnancy.
- History of allergy or reactions likely to be exacerbated by any component of the vaccine(s)
- Acute disease at the time of enrolment.
Data sourced from ClinicalTrials.gov (NCT00545025). 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.