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

Butantan Institute1,152 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,152

Conditions

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

Interventions

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

Sex: ALLMin age: 6 MonthsMax age: 90 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: 21 days after vaccination

Secondary Outcomes

Safety of the vaccine

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