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

Completed

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

• Registration Number: NCT01218685
• Lead Sponsor: Butantan Institute

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Primary Completion: 2010-09
• Study First Submitted: 2010-10-08
• Study First Submitted QC: 2010-10-08
• Study First Posted: 2010-10-11
• Study Completion: 2011-04
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-05
• Last Update Posted: 2013-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1152

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Elderly over 65 years old	Split inactivated A/California/7/2009 (H1N1) (NYMC X-179A) VIRUS	-
HIV patients	Split inactivated A/California/7/2009 (H1N1) (NYMC X-179A) VIRUS	-
Health children	Split inactivated A/California/7/2009 (H1N1) (NYMC X-179A) VIRUS	-
Kidney transplant	Split inactivated A/California/7/2009 (H1N1) (NYMC X-179A) VIRUS	-
Health adults	Split inactivated A/California/7/2009 (H1N1) (NYMC X-179A) VIRUS	-
Pregnants	Split inactivated A/California/7/2009 (H1N1) (NYMC X-179A) VIRUS	-
Oncologic patients	Split inactivated A/California/7/2009 (H1N1) (NYMC X-179A) VIRUS	-
Rheumatologic children patients	Split inactivated A/California/7/2009 (H1N1) (NYMC X-179A) VIRUS	-
Rheumatologic adult patients	Split inactivated A/California/7/2009 (H1N1) (NYMC X-179A) VIRUS	-

Primary Outcome Measures

Name	Time	Method
Antibody titers of 1:40 or more for influenza A pandemic (H1N1)	21 days after vaccination	the proportion of subjects with antibody titers of 1:40 or more on hemagglutination-inhibition assay

Secondary Outcome Measures

Name	Time	Method
Safety of the vaccine	21 days after vaccination	Evaluation of local and systemic adverse effects through the study period including 30 minutes after vaccination

Trial Locations

Locations (1)

Avenida Vital Brasil 1500; 🇧🇷 Sao Paulo, Brazil