NCT01218685

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,152 (actual)
• Sponsor: Butantan Institute · Other Government
• Sex: All
• Age: 6 Months – 90 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2010-04-01
• Primary completion: 2010-09-01
• Completion: 2011-04-01
• First posted: 2010-10-11
• Last updated: 2013-02-06

Locations

1 site across 1 country: Brazil