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

Butantan Institute

Status: Completed

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

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

Study type: Observational

Funder types: Other

Identifiers

NCT01218685

BUTVAC-Influenza A (H1N1) 2.0

Details and patient eligibility

About

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.

Enrollment: 1,152 patients

Sex: All

Ages: 6 months to 90 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

1,152 participants in 9 patient groups

Health adults

Treatment:

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

Health children

Treatment:

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

Pregnants

Treatment:

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

Elderly over 65 years old

Treatment:

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

HIV patients

Treatment:

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

Kidney transplant

Treatment:

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

Oncologic patients

Treatment:

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

Rheumatologic adult patients

Treatment:

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

Rheumatologic children patients

Treatment:

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