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

CompletedOBSERVATIONAL
Enrollment

1,152

Participants

Timeline

Start Date

April 30, 2010

Primary Completion Date

September 30, 2010

Study Completion Date

April 30, 2011

Conditions
Immunocompromised PatientsSafety of Pandemic Influenza A (H1N1)VaccineImmunogenicity of Pandemic Influenza A (H1N1)Vaccine
Interventions
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.

Trial Locations (1)

05503-900

Avenida Vital Brasil 1500, São Paulo

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

University of Sao Paulo

OTHER

collaborator

Insituto Adolfo Lutz

UNKNOWN

collaborator

Centro de Referencia e Treinamento em DST/AIDS

UNKNOWN

lead

Butantan Institute

OTHER_GOV