Phase 2
N=729
Immunogenicity of a Split, Cell-Based, Inactivated, Trivalent Influenza Vaccine in Healthy Adult Subjects
Influenza · Orthomyxoviruses · Myxovirus Infection
Bottom Line
View on ClinicalTrials.gov: NCT00845429 ↗Enrolled (actual)
729
Serious AEs
1.8%
Results posted
Dec 2012
Primary outcome: Primary: Summary of the Pre- and Post-Vaccination Geometric Mean Titers (GMTs) for Each of the Influenza Vaccine Antigens. — 25.9; 26.4; 26.6; 184.8 Titers
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Influenza virus vaccine - cell based (2007-2008 Formulation) (Biological); Influenza virus vaccine - cell-based (2007-2008 Formulation) (Biological); Influenza virus vaccine (2007-2008 Formulation) (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sanofi
- Primary completion
- Aug 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Summary of the Pre- and Post-Vaccination Geometric Mean Titers (GMTs) for Each of the Influenza Vaccine Antigens. |
25.9; 26.4; 26.6; 184.8; 226.6; 425.1 | — |
| PRIMARY Percentage of Participants With Seroprotection to Each of the Influenza Vaccine Antigen Before and Post-vaccination. |
40; 39; 41; 86; 90; 98 | — |
| PRIMARY Percentage of Participants Achieving Seroconversion or Significant Increase at Day 21 Following Vaccination With Influenza Vaccine. |
54; 63; 74; 50; 53; 71 | — |
| SECONDARY Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. |
117; 156; 184; 103; 144; 175 | — |
Summary
Primary Objective:
To describe the immune response to a single administration of 2 formulations of the investigational cell-based influenza vaccines in healthy adult subjects.
Secondary Objective:
To describe the safety following a single administration of 2 formulations of the investigational cell-based influenza vaccines in healthy adult subjects.
Eligibility Criteria
Inclusion Criteria
- Healthy male or female subject, aged ≥ 18 to < 50 years on the day of inclusion
- Informed consent form signed
- Able to attend all scheduled visits and to comply with all trial procedures
- For a woman of childbearing potential: a negative urine pregnancy test and documented use of an effective method of contraception or abstinence for at least four weeks pre vaccination and up until three weeks post-vaccination
Exclusion Criteria
- Subject currently breast-feeding.
- Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the trial vaccination.
- Planned participation in another clinical trial during the present trial period.
- Prior participation in the Phase I trial of FLU INTERPAN (PER.C6) vaccine (study GCE01).
- Congenital or history of acquired immunodeficiency, or immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months.
- Systemic corticosteroid therapy as except the use of topical or inhalant corticosteroids
- Systemic hypersensitivity to egg proteins, chicken proteins, or to any of the vaccine components, or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances.
- Chronic illness at a stage that could interfere with trial conduct or completion (chronic illness may include, but is not limited to, cardiac, renal or auto-immune disorders, or diabetes).
- Receipt of blood or blood-derived products in the 3 months preceding vaccination.
- Receipt of any vaccination in the 4 weeks preceding vaccination, or planned receipt of any vaccination in the 4 weeks following the trial vaccination.
- History of influenza infection (confirmed either clinically, serologically or microbiologically) within the 6 months preceding vaccination.
- Previous vaccination against influenza (in the 6 months preceding the trial vaccination).
- Planned receipt of any other 2007-2008 influenza vaccine.
- Thrombocytopenia or bleeding disorder contraindicating intramuscular (IM) vaccination.
- Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
- History of Guillain-Barré syndrome
- Current abuse of alcohol or drug addiction that may interfere with the subject's ability to comply with trial procedures
- Any other condition which in the opinion of the investigator would pose a health risk to the participant or interfere with the evaluation of the vaccine.
Data sourced from ClinicalTrials.gov (NCT00845429). 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.