Observational Study to Assess Safety of H1N1 Pandemic Influenza Vaccine

Ology Bioservices

Status: Completed

Conditions: Pandemic Influenza; Influenza

Treatments: Biological: H1N1 Pandemic Influenza Vaccine (whole virion, Vero Cell-derived, inactivated)

Study type: Observational

Funder types: Industry

Identifiers

NCT00950456

820901

Details and patient eligibility

About

The purpose of this observational study, which will be initiated as soon as the licensed H1N1 Pandemic Influenza Vaccine is used in a mass vaccination campaign, is to estimate the incidence of any medically-attended adverse events in all vaccinated subjects.

Enrollment: 3,216 patients

Sex: All

Ages: 2+ months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Male and female subjects, per indication on license or per official vaccine recommendations, will be eligible for participation in this study if:

• They will be administered CELVAPAN (= Baxter´s H1N1 pandemic influenza vaccine)
• They are 2 months of age or older at the time of first vaccine administration
• Their medical history is available
• The investigator believes they will comply with the foreseen vaccination schedule and will reliably observe signs or symptoms of adverse events during the observational period
• They and/or their parent(s)/legal guardian(s) provide written informed consent, and assent where appropriate, prior to study entry according to national law

Exclusion criteria

Male and female subjects will be excluded from participation in this study if:

• They have already been administered another H1N1 pandemic vaccine
• They have any contraindication to vaccination (as per the Summary of Product Characteristics and/or relevant national immunization guidelines)

Trial design

3,216 participants in 1 patient group

H1N1 Pandemic Influenza Vaccine

Description:

Subjects will be enrolled and vaccinated according to national policy and standard practice.

Treatment:

Biological: H1N1 Pandemic Influenza Vaccine (whole virion, Vero Cell-derived, inactivated)