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

Immunocompromised Patients Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01218685
• Other study ID #: BUTVAC-Influenza A (H1N1) 2.0
• Status: Completed
• Phase: N/A
• First received: October 8, 2010
• Last updated: February 5, 2013
• Start date: April 2010
• Est. completion date: April 2011

Study information

• Verified date: February 2013
• Source: Butantan Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1152
• Est. completion date: April 2011
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 90 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Brazil	Avenida Vital Brasil 1500	Sao Paulo

Sponsors (4)

Lead Sponsor	Collaborator
Butantan Institute	Centro de Referencia e Treinamento em DST/AIDS, Insituto Adolfo Lutz, University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antibody titers of 1:40 or more for influenza A pandemic (H1N1)	the proportion of subjects with antibody titers of 1:40 or more on hemagglutination-inhibition assay	21 days after vaccination	No
Secondary	Safety of the vaccine	Evaluation of local and systemic adverse effects through the study period including 30 minutes after vaccination	21 days after vaccination	Yes