Phase 2
Completed N=150
Study to Evaluate the Immunogenicity and the Safety of an Adjuvanted Influenza Vaccine Candidate
Source: ClinicalTrials.gov NCT00363077 ↗Enrolled (actual)
150
Serious AEs
0.7%
Results posted
May 2013
Primary outcomePrimary: Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. — 45.3; 81.1; 116.4; 170.9 titers
Summary
The purpose of this study is to evaluate the immunogenicity and the safety of the candidate vaccine compared to Fluarix™ administered intramuscularly in elderly aged 60 years and above
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. |
45.3; 81.1; 116.4; 170.9; 28.8; 41.3 | — |
| PRIMARY Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. |
21; 12; 52; 40; 46; 31 | — |
| PRIMARY Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. |
40; 54; 68; 73; 35; 44 | — |
| PRIMARY Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. |
2.6; 2.1; 8.7; 5.5; 6.0; 4.2 | — |
| SECONDARY Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. |
436.58; 451.35; 1555.92; 736.15; 322.57; 370.36 | — |
| SECONDARY Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. |
7.91; 4.17; 7.82; 3.74; 6.22; 7.31 | — |
| SECONDARY Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. |
1; 1; 1; 0; 57; 25 | — |
| SECONDARY Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. |
12; 8; 0; 0; 10; 4 | — |
| SECONDARY Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). |
31; 22; 1; 0; 11; 7 | — |
| SECONDARY Number of Subjects With Any and Related Serious Adverse Events (SAEs). |
0; 1; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects who the investigator believes that they can and wil comply with the requirements of the protocol should be enrolled in the study.
- A male or female 60 years or older 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
- Acute 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 (NCT00363077). 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.