Phase 2
N=405
Immunogenicity, Safety and Tolerability of Prepandemic Influenza and Seasonal Influenza Vaccine in Adult Subjects
Pandemic · Avian Influenza
Bottom Line
View on ClinicalTrials.gov: NCT00481065 ↗Enrolled (actual)
405
Serious AEs
3.5%
Results posted
Feb 2013
Primary outcome: Primary: Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine — 0; 1; 0; 2 Subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- MF59-eH5N1 (Biological); eTIV_a (Biological); MF59-eH5N1 + eTIV_a (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine |
0; 1; 0; 2; 1; 0 | — |
| PRIMARY Geometric Mean Ratio After Two or Three Vaccinations of the MF59-eH5N1 Influenza Vaccine |
2.11; 12; 23; 2.16; 9.52; 14 | — |
| PRIMARY Number of Subjects Who Responded to Two Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H1N1) |
13; 18; 16; 23; 15; 19 | — |
| PRIMARY Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H3N2) |
20; 22; 14; 23; 26; 22 | — |
| PRIMARY Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain B) |
5; 4; 6; 10; 2; 9 | — |
| PRIMARY Geometric Mean Ratio After Two Doses of the Seasonal eTIV_a Influenza Vaccine (Strain H1N1) |
15; 13; 14; 6.77; 12; 10 | — |
| PRIMARY Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain H3N1) |
6.01; 9.72; 9.34; 11; 11; 10 | — |
| PRIMARY Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain B) |
11; 13; 10; 10; 17; 8.77 | — |
| SECONDARY Number of Subjects Reporting Local and Systemic Reactions by Vaccination |
0; 8; 8; 0; 8; 8 | — |
| SECONDARY Number of Subjects With Immunogenicity Results After the Booster Vaccination Against the MF59-eH5N1 Influenza Vaccine Mixed Extemporaneously With the Seasonal eTIV_a Influenza Vaccine |
26; 16; 25; 15; 50; 7 | — |
| SECONDARY Geometric Mean Ratio After the Booster Vaccination Against the MF59-eH5N1 Influenza Vaccine Mixed Extemporaneously With the Seasonal eTIV_a Influenza Vaccine |
13; 7.14; 4.88; 2.77; 4.82; 2.61 | — |
Summary
This study evaluates the immunogenicity, safety and tolerability of an H5N1 vaccine with a seasonal trivalent influenza vaccine, containing the strains recommended by WHO for the 2007 influenza season in the Southern Hemisphere.
Eligibility Criteria
Inclusion Criteria
- Healthy subjects
Data sourced from ClinicalTrials.gov (NCT00481065). 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.