Phase 4
Completed N=1,952
Comparative Study of Influenza Vaccines in Adults, FLUVACS-year 4
Source: ClinicalTrials.gov NCT00538512 ↗Enrolled (actual)
1,952
Serious AEs
0.8%
Results posted
Sep 2011
Primary outcomePrimary: Laboratory-confirmed (Culture and/or PCR) Symptomatic Influenza — 28; 56; 35 participants
Summary
The purpose of this study is to evaluate the absolute (versus placebo) and relative (one vaccine compared to the other) efficacies of the live attenuated and inactivated influenza vaccines in preventing laboratory confirmed symptomatic influenza caused by circulating strains whether similar or dissimilar to strains included in the vaccines.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Laboratory-confirmed (Culture and/or PCR) Symptomatic Influenza |
28; 56; 35 | — |
| SECONDARY Measure Immune Response Induced by the Vaccines and Identify Serologic Correlates of Immune Protection |
137; 48; 92; 65; 14; 5 | — |
| SECONDARY Immune Response to Vaccination and Infection |
4; 40; 28; 9; 33; 22 | — |
| SECONDARY Identify Serologic Correlates of Immune Protection. Suggest Changing to: Number of Participants Demonstrating Postvaccination Seroconversion. |
20; 13; 0; 178; 48; 3 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy adult men and women
- Age 18-49 years
- Who reside geographically close to one of the four study sites in Michigan
Exclusion Criteria
- Persons with any of the health conditions for which the inactivated vaccine is recommended
- Persons for whom either vaccine is contraindicated
Data sourced from ClinicalTrials.gov (NCT00538512). 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.