N/A
Completed N=255
Studies of Pandemic Influenza (H1N1) 2009 Vaccine in Bergen
Healthy
Source: ClinicalTrials.gov NCT01003288 ↗
Enrolled (actual)
255
Serious AEs
0.0%
Results posted
Aug 2016
Primary outcomePrimary: Number of Participants With Local and Systemic Adverse Events — 207 participants
Summary
Haukeland University Hospital has approximately 8000 employees many of whom will be in the front line to receive the pandemic A/H1N1 vaccine. We propose to conduct a safety and immunogenicity study in these subjects
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Local and Systemic Adverse Events |
207 | — |
| SECONDARY Number of Participants With Immunogenicity as Determined Using Haemagglutination Inhibition Assay |
251 | — |
Eligibility Criteria
Inclusion Criteria
Signed informed consent Subjects able to understand and comply with the study protocol and complete the Adverse Event Form Subjects able to attend the scheduled visits for the kinetic study
Exclusion Criteria
- Persons with a history of anaphylaxis or serious reactions to any vaccine
- Person with known hypersensitivity to any of the vaccine components
- Persons who have had a temperature >38oC during the previous 72 hours
- Persons who have had an acute respiratory infection during the last 7 days
- Suspected non-compliance
Data sourced from ClinicalTrials.gov (NCT01003288). 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.