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

This study has been completed.
Sponsor:
Collaborators:
University of Sao Paulo
Insituto Adolfo Lutz
Centro de Referencia e Treinamento em DST/AIDS
Information provided by (Responsible Party):
Butantan Institute
ClinicalTrials.gov Identifier:
NCT01218685
First received: October 8, 2010
Last updated: February 5, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Immunocompromised Patients
Safety of Pandemic Influenza A (H1N1)Vaccine
Immunogenicity of Pandemic Influenza A (H1N1)Vaccine
Biological: Split inactivated A/California/7/2009 (H1N1) (NYMC X-179A) VIRUS

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official 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

Resource links provided by NLM:


Further study details as provided by Butantan Institute:

Primary Outcome Measures:
  • Antibody titers of 1:40 or more for influenza A pandemic (H1N1) [ Time Frame: 21 days after vaccination ] [ Designated as safety issue: No ]
    the proportion of subjects with antibody titers of 1:40 or more on hemagglutination-inhibition assay


Secondary Outcome Measures:
  • Safety of the vaccine [ Time Frame: 21 days after vaccination ] [ Designated as safety issue: Yes ]
    Evaluation of local and systemic adverse effects through the study period including 30 minutes after vaccination


Enrollment: 1152
Study Start Date: April 2010
Study Completion Date: April 2011
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Health adults 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.
Health children 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.
Pregnants 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.
Elderly over 65 years old 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.
HIV patients 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.
Kidney transplant 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.
Oncologic patients 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.
Rheumatologic adult patients 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.
Rheumatologic children patients 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.

  Eligibility

Ages Eligible for Study:   6 Months to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Volunteers with chronic and or immunocompromised disease, elderly and pregnant in follow - up at the institutions participants in the study will be recruited.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01218685

Locations
Brazil
Avenida Vital Brasil 1500
Sao Paulo, Brazil, 05503-900
Sponsors and Collaborators
Butantan Institute
University of Sao Paulo
Insituto Adolfo Lutz
Centro de Referencia e Treinamento em DST/AIDS
Investigators
Study Chair: Alexander Roberto Precioso, MD, PhD Butantan Foundation
  More Information

No publications provided by Butantan Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Butantan Institute
ClinicalTrials.gov Identifier: NCT01218685     History of Changes
Other Study ID Numbers: BUTVAC-Influenza A (H1N1) 2.0
Study First Received: October 8, 2010
Last Updated: February 5, 2013
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Butantan Institute:
Immunocompromised patients
Safety of pandemic influenza A (H1N1)vaccine
Immunogenicity of pandemic influenza A (H1N1)vaccine

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 21, 2014