Phase 4
Completed N=1,268
A Study to Determine the Immunogenicity and Safety Profile of CSL Limited's Influenza Virus Vaccine Compared to a US Licensed Comparator Influenza Virus Vaccine
Source: ClinicalTrials.gov NCT00735475 ↗Enrolled (actual)
1,268
Serious AEs
3.8%
Results posted
Sep 2011
Primary outcomePrimary: Geometric Mean Titer 21 Days After the Study Vaccination — 58.60; 58.45; 377.94; 337.23 Titers
Summary
The purpose of this study is to determine the immunogenicity and safety profile of CSL Limited's Influenza Virus Vaccine compared to a US Licensed Comparator Influenza Virus Vaccine.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Geometric Mean Titer 21 Days After the Study Vaccination |
58.60; 58.45; 377.94; 337.23; 30.16; 33.31 | — |
| PRIMARY Percentage of Participants With Seroconversion 21 Days After the Study Vaccination |
38.6; 43.2; 69.0; 68.7; 28.9; 33.8 | — |
| SECONDARY Frequency and Intensity of Local and Systemic Solicited Symptoms |
40.2; 35.7; 36.2; 31.4; 15.1; 13.8 | — |
| SECONDARY Duration of Local and Systemic Solicited Symptoms |
1.62; 1.70; 2.04; 1.90; 1.42; 2.67 | — |
| SECONDARY Frequency and Intensity of Unsolicited Adverse Events (UAEs) |
169; 171; 77; 68; 57; 68 | — |
| SECONDARY Serious Adverse Events |
22; 26; 0; 0 | — |
| SECONDARY New Onsets of Chronic Illness |
14; 11; 0; 0; 2; 3 | — |
Eligibility Criteria
Inclusion Criteria
- Males aged ≥ 65 years or females of non-childbearing potential aged ≥ 65 years ;
- Written informed consent ;
- Willingness to provide a blood sample.
Exclusion Criteria
- Known hypersensitivity to a previous dose of influenza vaccine or allergy to eggs, chicken protein, neomycin, polymyxin, or any components of the Study Vaccines;
- Previous vaccination against influenza in 2008 or 2009 with seasonal trivalent inactivated influenza vaccine;
- Known history of Guillain-Barré Syndrome;
- Clinical signs of active infection and/or an oral temperature of greater than or equal to 100 degrees F (37.8 degrees C).
- Have active or recent and clinically significant gastrointestinal/hepatic, renal, neurological, cardiovascular, respiratory, endocrine disorders or other medical disorders;
- History of seizures;
- Confirmed or suspected immunosuppressive condition, or a previously diagnosed immunodeficiency disorder;
- Clinically significant history of malignancy
- Current treatment, or treatment with radiotherapy or cytotoxic drugs at any time during the six months prior to administration of the Study Vaccine;
- Current immunosuppressive or immunomodulative therapy;
- Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the Study Vaccine;
- Participation in a clinical trial or use of an investigational compound within 30 days prior to receiving the Study Vaccine ;
- Vaccination with a registered vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to receiving the Study Vaccine.
- Current treatment with warfarin or other anticoagulants;
- Major congenital defects;
- Evidence, or history (within the previous 12 months) of drug or alcohol abuse;
- Unwillingness or inability to comply with the study protocol including completion of adverse event diary cards;
- History of psychiatric disorders;
- Resident of long term care facility.
Data sourced from ClinicalTrials.gov (NCT00735475). 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.