Phase 2
Completed N=300
Study to Evaluate the Immunogenicity and Safety of 2 Formulations of GlaxoSmithKline (GSK) Biologicals' GSK1247446A Low Dose Influenza Vaccine Candidate
Source: ClinicalTrials.gov NCT00374842 ↗Enrolled (actual)
300
Serious AEs
0.3%
Results posted
Apr 2013
Primary outcomePrimary: Titers of Serum Haemagglutination-inhibition (HI) Antibodies Against Each of the 3 Influenza Strains Assessed. — 31.9; 36.1; 26.1; 475.4 HIU
Summary
The purpose of this study is to evaluate the immunogenicity and the safety of candidate vaccines compared to Fluarix™ administered intramuscularly in subjects aged 18-59 years
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Titers of Serum Haemagglutination-inhibition (HI) Antibodies Against Each of the 3 Influenza Strains Assessed. |
31.9; 36.1; 26.1; 475.4; 399.0; 380.6 | — |
| PRIMARY Number of Seroprotected Subjects Against Each of the 3 Influenza Strains Assessed. |
41; 55; 35; 95; 97; 93 | — |
| PRIMARY Number of Seroconverted Subjects Against Each of the 3 Influenza Strains Assessed |
69; 64; 66; 88; 79; 73 | — |
| PRIMARY Seroconversion Factor Against Each of the 3 Influenza Strains Assessed. |
14.9; 11.0; 14.6; 16.5; 12.2; 11.7 | — |
| SECONDARY Number of Subjects With Any and Grade 3 Solicited Local Symptoms |
6; 11; 6; 0; 0; 0 | — |
| SECONDARY Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms |
32; 14; 7; 3; 1; 0 | — |
| SECONDARY Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) |
55; 47; 35; 11; 5; 6 | — |
| SECONDARY Number of Subjects With Any and Related Serious Adverse Events (SAEs) |
1; 0; 0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- A male or female aged 18-59 years at the time of the first vaccination.
- Free of obvious health problems
Exclusion Criteria
- Use of non-registered products
- Administration of immune-modifying drugs.
- Administration of vaccine 30 days before enrolment in study.
- Immunosuppressive or immunodeficient condition.
- Hypersensitivity to a previous dose of influenza vaccine
- Previous vaccination against influenza in 2006
- Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality.
- History of confirmed influenza infection within the last 12 Months.
- Acute disease at the time of enrolment/vaccination.
- History of allergy or reactions likely to be exacerbated by any component of the vaccine
Data sourced from ClinicalTrials.gov (NCT00374842). 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.