Observational Study to Assess Safety of H1N1 Pandemic Influenza Vaccine

A Prospective Non-Interventional Observational Study to Assess the Safety of Two Vaccinations of a Vero Cell-Derived, Whole Virus H1N1 Pandemic Influenza Vaccine in Subjects Exposed to the Vaccine Through Policies by Governments or Health Authorities

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00950456

Enrollment

3216

Registered

2009-07-31

Start date

2009-11-30

Completion date

2011-02-28

Last updated

2015-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza, Pandemic Influenza

Brief summary

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.

Interventions

BIOLOGICALH1N1 Pandemic Influenza Vaccine (whole virion, Vero Cell-derived, inactivated)

It is anticipated that subjects will receive two intramuscular injections approximately 3 weeks apart. The vaccine will be provided in two doses, one for adults, the other for children.

Study design

Observational model

ECOLOGIC_OR_COMMUNITY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

2 Months to No maximum

Healthy volunteers

Yes

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)

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026