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OpenTrials
Completed

NCT Number: NCT01040741

Observational Safety Study of Adjuvanted Swine Origin A (H1N1) Pandemic Subunit Egg Derived Vaccine

This is an observational safety study of a prophylactic use of Flu Egg Derived Adjuvanted Swine Origin A(H1N1) Vaccine in subjects 6 months of age and older. Subjects may receive either 1 or 2 doses: children and elderly will receive 2 doses and adults will receive either 1 or 2 doses.

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Key information

Conditions

Pandemic Influenza A (H1N1) A New Flu Virus of Swine Origin

Age range

6 month and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Garrahan, Combate de Los Pozos 1881, Buenos Aires F.D., Argentina

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Subject's age in accordance with the approved product label of the country where the study is conducted
  • Subjects will be vaccinated with Focetria®, independently of this study.
  • Subjects or parent/guardian willing to provide informed consent prior to vaccination administration and complete all of the study, including follow-up contact

Exclusion criteria

  • Received any prior H1N1 vaccination

Treatment and study plan

Non-intervention observational study

Other

Non-intervention observational study

Primary outcomes

  1. To quantify the safety of Flu Egg Derived Adjuvanted Swine Origin A(H1N1) Pandemic Subunit Vaccine in actively monitored subjects; To characterize the incidence of AEs in specific age groups following an active surveillance of vaccinated subjects.

    Time frame: 6 Months

Secondary outcomes

  1. To assess the occurrence of laboratory confirmed H1N1sw and influenza-like illness following vaccination with Flu Egg Derived Adjuvanted Swine Origin A(H1N1) Pandemic Subunit Vaccine.

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Novartis Vaccines

Industry

Registry information

Official study title

A Prospective Observational Study of Safety and Occurrence of Influenza-like Illness Following Administration of Adjuvanted Swine Origin A(H1N1) Pandemic Subunit Vaccine Focetria

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Dec 30, 2009
Registry last updated
Oct 5, 2011

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.

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