Phase 2
Completed N=1,220
Study to Evaluate an Influenza Vaccine Candidate
Source: ClinicalTrials.gov NCT00321373 ↗Enrolled (actual)
1,220
Serious AEs
2.8%
Results posted
May 2013
Primary outcomePrimary: Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Virus — 13.4; 13.9; 14.2; 10.8 titer
Summary
The purpose of this study is to evaluate the immune response and safety of influenza vaccine candidate with or without adjuvant compared to Fluarix™ administered intramuscularly in elderly aged 60 years old and above.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Virus |
64.3; 54.3; 84.4; 56.8; 35.8; 42.4 | — |
| SECONDARY Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Virus |
64.3; 54.3; 84.4; 56.8; 35.8; 42.4 | — |
| SECONDARY Number of Subjects With Any and Grade 3 Solicited Local Symptoms. |
246; 32; 86; 12; 0; 1 | — |
| SECONDARY Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. |
80; 17; 21; 6; 0; 1 | — |
| SECONDARY Number of Subjects With Unsolicited Adverse Events (AEs). |
114; 82; 95; 13; 11; 16 | — |
| SECONDARY Number of Subjects With Any and Related Serious Adverse Events (SAEs) |
8; 13; 13; 2; 1; 0 | — |
Eligibility Criteria
Inclusion criteria
- A male or female age 60 years or older at the time of the vaccination.
- Subjects who the investigator believes can and will comply with the requirements of the protocol
- Written informed consent obtained from the subject.
- Free of an acute aggravation of the health status as established by clinical examination before entering into the study.
Exclusion criteria
- Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the administration of the study vaccine, or planned use during the study period.
- Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- Chronic administration (defined as more than 14 days) 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 the 3 months preceding the first dose of study vaccine or planned administration during the study period.
- Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol up to 30 days after vaccination.
- History of hypersensivity to a previous dose of influenza vaccine.
- Previous vaccination against influenza within the 9 months prior to enrollment.
- History of confirmed influenza infection within the last 12 months.
- 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 (NCT00321373). 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.