Observational Study to Assess Safety of H1N1 Pandemic Influenza Vaccine

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections Pandemic Influenza RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

2 month and older

Sex eligibility

All sexes

Study type

Observational

Primary location

General Practice, Bludenz, Austria

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

H1N1 pandemic influenza vaccine (whole virion, Vero Cell-derived, inactivated)

Biological

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.

Other names: CELVAPAN

Sponsors and collaborators

Lead sponsor

Alachua Government Services, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2011
First posted: Jul 31, 2009
Registry last updated: Oct 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed