Phase 2
N=601
Safety and Immunogenicity of Two Doses of a Tetravalent Influenza Vaccine in Adults Aged 18 Years and Above
Influenza
Bottom Line
View on ClinicalTrials.gov: NCT00620815 ↗Enrolled (actual)
601
Serious AEs
1.5%
Results posted
Sep 2012
Primary outcome: Primary: To Demonstrate the Equivalence of Antibody Response Against A/H5N1 Strain Elicited by the Three Different Immunization Schedules on Day 43. — 4.64; 4.10; 4.61; 14 Area (mm^2)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- MF59-eTIV-H5N1+ placebo /pandemic influenza vaccine (Biological); Pandemic influenza vaccine + placebo /MF59-eTIV-H5N1 (Biological); Pandemic influenza vaccine + seasonal influenza vaccine /pandemic influenza vaccine (Biological); Pandemic influenza vaccine + placebo / MF59-eTIV-H5N1 (Biological); Pandemic influenza vaccine + seasonal influenza vaccine / pandemic influenza vaccine (Biological); MF59-eTIV-H5N1 + Placebo/pandemic influenza vaccine (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Vaccines
- Primary completion
- Jan 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY To Demonstrate the Equivalence of Antibody Response Against A/H5N1 Strain Elicited by the Three Different Immunization Schedules on Day 43. |
4.64; 4.10; 4.61; 14; 12; 16 | — |
| SECONDARY Number of Subjects (Subjects ≤ 60 Years) With Reported Local Reactions After First Vaccination |
10; 0; 5; 0; 6; 5 | — |
| SECONDARY Number of Subjects (Subjects ≤60 Years) With Reported Local Reactions After Second Vaccination |
2; 7; 5; 7; 10; 7 | — |
| SECONDARY Number of Subjects (Subjects ≤ 60 Years) With Reported Systemic Reactions After 1st and 2nd Vaccinations. |
24; 8; 9; 6; 11; 3 | — |
| SECONDARY Percentages of Subjects Achieving Seroconversion/Significant Increase in Antibody Titre/ Area as Measured by SRH and (HI) and at Least 4 Fold Rise in Titres by Micro-neutralization (MN) Assay-H5N1 Strain |
90; 86; 86; 69; 67; 75 | — |
| SECONDARY Percentages of Subjects Achieving HI/MN ≥ 1:40 and SRH Area ≥ 25^mm2 |
4; 0; 4; 93; 86; 89 | — |
| SECONDARY Antibody Response Determined by HI and MN Assay. |
5.93; 5.58; 5.85; 8.36; 6.76; 9.66 | — |
| SECONDARY Percentages of B-cell Antibodies Against H5N1 and H1N1 After Each Vaccination. |
0.7; 0.42; 0.53; 5.39; 6.08; 7.58 | — |
| SECONDARY Mean T-Cells Per Million Total Cells (95% CI) in Response to H5 Peptides and H5N1 Subunit |
162; 175; 167; 273; 358; 365 | — |
Summary
Evaluate the immune response and reactogenicity of H5N1 vaccination in adults aged 18 years and above (as part of a tetravalent vaccine)
Eligibility Criteria
Inclusion Criteria
- Healthy subjects (aged 18 years and above) who have signed an informed consent form
Exclusion Criteria
- Any acute or chronic illness
- Receipt of seasonal influenza vaccine for the current season 2007/2008
- Known or suspected impairment/alteration of immune function
- Receipt of another vaccine within 3 weeks prior to Visit 1 or planned vaccination within 3 weeks following the last study vaccination
- Any serious disease
- Hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein,neomycin or kanamycin or any other component of the study vaccine
- Receipt of blood, blood products or immunoglobulins 3 months prior to vaccination
Data sourced from ClinicalTrials.gov (NCT00620815). 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.