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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01218685

Enrollment

1152

Registered

2010-10-11

Start date

2010-04-30

Completion date

2011-04-30

Last updated

2013-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Immunocompromised patients, Safety of pandemic influenza A (H1N1)vaccine, Immunogenicity of pandemic influenza A (H1N1)vaccine

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.

Interventions

BIOLOGICALSplit 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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

6 Months to 90 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 27, 2026