Phase 2
Completed N=3,124
Study to Demonstrate the Lot-to-lot Consistency and to Evaluate the Safety of an Adjuvanted Influenza Vaccine Candidate
Source: ClinicalTrials.gov NCT00321763 ↗Enrolled (actual)
3,124
Serious AEs
3.1%
Results posted
Jun 2013
Primary outcomePrimary: Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. — 26.7; 28.5; 28.6; 27.9 titers
Summary
The purpose of this phase IIb study is to demonstrate the consistency of three lots of an adjuvanted influenza vaccine candidate and to evaluate the safety of this vaccine 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 Disease. |
26.7; 28.5; 28.6; 27.9; 25.7; 121.4 | — |
| PRIMARY Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. |
214; 205; 233; 652; 47; 308 | — |
| PRIMARY Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. |
221; 220; 229; 670; 46; 439 | — |
| PRIMARY Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. |
4.6; 4.2; 4.7; 4.5; 5.1; 7.9 | — |
| PRIMARY Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. |
22; 34; 30; 86; 17; 1 | — |
| PRIMARY Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. |
130; 133; 133; 396; 47; 9 | — |
| PRIMARY Number of Subjects With New Onset of Chronic Diseases (NOCDs). |
3; 3; 2; 8; 1 | — |
| PRIMARY Number of Subjects With Medically Significant Conditions (MSCs). |
70; 69; 72; 211; 52 | — |
| PRIMARY Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). |
133; 150; 162; 445; 109; 11 | — |
| PRIMARY Number of Subjects With Any and Related Serious Adverse Events (SAEs). |
4; 4; 3; 11; 4; 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 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 (NCT00321763). 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.