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NCT Number: NCT01218685

Evaluation of Pandemic Influenza A (H1N1) Vaccine in Chronic and or Immunocompromised Patients, Elderly and Pregnants

The objective of this study is to describe the safety and immunogenicity of a non-adjuvanted vaccine against pandemic influenza A (H1N1)in patients with chronic and or immunocompromised disease, elderly and pregnants. The primary immunological endpoint is to analyze the proportion of subjects with antibody titers of 1:40 or more on hemagglutination-inhibition assay 21 days after 1 dose of the vaccine. Volunteers will be monitored for safety during 21 days after vaccination. Volunteers will be recruited based on inclusion and exclusion criteria. Vaccine composition is: 15 micrograms of split inactivated virus (A/California/7/2009 (H1N1) (NYMC X179A). The hypothesis of the study is that the vaccine is safe and immunogenic in the volunteers recruited.

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Key information

Conditions

Immunocompromised Patients Immunogenicity of Pandemic Influenza A (H1N1)Vaccine Safety of Pandemic Influenza A (H1N1)Vaccine

Age range

6 month–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Avenida Vital Brasil 1500

São Paulo, 05503-900, Brazil

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Volunteers able to understand and agree to participate in the study.

Exclusion criteria

  • Have egg allergy
  • Have past history of allergy to seasonal influenza vaccine
  • Have received another inactivated vaccine within the prior 2 weeks or live vaccine in the past four weeks to his/her participation in the study
  • Acute infectious disease during seven days prior vaccination
  • Confirmed prior infection by pandemic influenza A (H1N1)
  • Have participated in another clinical trial in the last 6 months
  • Any other condition identified by the principal investigators which is considered not safe for enrollment of the volunteer.

Treatment and study plan

Split inactivated A/California/7/2009 (H1N1) (NYMC X-179A) VIRUS

Biological

1 full dose of 15 micrograms, IM, for volunteers 9 years of age or older; children 6 months to 2 years of age, half of the dose,IM, with 21 days interval; children 3 years old up to 8 years old, 1 full dose, IM, twice, with 21 days interval.

Primary outcomes

  1. Antibody titers of 1:40 or more for influenza A pandemic (H1N1)

    Time frame: 21 days after vaccination

    the proportion of subjects with antibody titers of 1:40 or more on hemagglutination-inhibition assay

Secondary outcomes

  1. Safety of the vaccine

    Time frame: 21 days after vaccination

    Evaluation of local and systemic adverse effects through the study period including 30 minutes after vaccination

Sponsors and collaborators

Lead sponsor

Butantan Institute

Other Gov

Collaborators

  • Centro de Referencia e Treinamento em DST/AIDS
  • Insituto Adolfo Lutz
  • University of Sao Paulo

Registry information

Official study title

Evaluation Aof Safety and Immunogenicity of Non-adjuvanted Pandemic Influenza A (H1N1) Vaccine in Chronic and or Immunocompromised Patients, Elderly and Pregnants, Produced by Butantan Institute

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
Oct 11, 2010
Registry last updated
Feb 6, 2013

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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