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

NCT01218685 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1152

Last updated 2013-02-06

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

BIOLOGICAL

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

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.

Sponsors & Collaborators

  • University of Sao Paulo

    collaborator OTHER

  • Insituto Adolfo Lutz

    collaborator UNKNOWN

  • Centro de Referencia e Treinamento em DST/AIDS

    collaborator UNKNOWN

  • Butantan Institute

    lead OTHER_GOV

Principal Investigators

  • Alexander Roberto Precioso, MD, PhD · Butantan Foundation

Eligibility

Min Age
6 Months
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2010-09-30
Completion
2011-04-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01218685 on ClinicalTrials.gov