Phase 2
Completed N=678
Study to Evaluate the Immunogenicity and Safety of a Second Vaccination With the Adjuvanted Influenza Vaccine Candidate
Source: ClinicalTrials.gov NCT00385840 ↗Enrolled (actual)
678
Serious AEs
0.4%
Results posted
Apr 2013
Primary outcomePrimary: Number of Subjects With Any and Grade 3 Solicited Local Symptoms. — 2; 14; 0; 1 subjects
Summary
The purpose of this study is to evaluate the immunogenicity and the safety of a second vaccination with candidate vaccine compared to Fluarix™ administered intramuscularly in elderly aged 60 years and above
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Any and Grade 3 Solicited Local Symptoms. |
2; 14; 0; 1; 27; 282 | — |
| PRIMARY Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. |
10; 96; 0; 3; 7; 78 | — |
| PRIMARY Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). |
31; 121; 1; 9; 4; 34 | — |
| PRIMARY Number of Subjects With Any and Related Serious Adverse Events (SAEs). |
1; 2; 0; 0 | — |
| SECONDARY Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. |
65.9; 61.8; 111.6; 114.4; 59.4; 82.0 | — |
| SECONDARY Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. |
21; 78; 52; 271; 10; 99 | — |
| SECONDARY Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. |
100; 381; 119; 483; 81; 397 | — |
| SECONDARY Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. |
1.7; 1.9; 3.2; 4.5; 1.6; 2.1 | — |
Eligibility Criteria
Inclusion Criteria
- A male or female age 60 years or older at the time of the revaccination, who previously participated in 107192 & 107214 clinical trials.
- 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 3 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 hypersensitivity to a previous dose of influenza vaccine.
- 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 (NCT00385840). 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.