NCT01111968 - Evaluation of Pandemic Influenza A (H1N1)Candidate Vaccines | Biotech Hunter

Enrollment

266

Participants

Timeline

Start Date

January 31, 2010

Primary Completion Date

December 31, 2010

Study Completion Date

March 31, 2011

Conditions

Influenza

Interventions

BIOLOGICAL

pandemic vaccine 1

7,5µg of A/H1N1 with MPLA adjuvant - IB, suspension (5µg) + Al(OH)3

BIOLOGICAL

pandemic vaccine 2

3,75µg of A/H1N1 with MPLA adjuvant - IB, suspension (5µg) + Al(OH)3

BIOLOGICAL

pandemic vaccine 5

7,5µg of A/H1N1 with MPLA adjuvant - IB, emultion (5µg) + Al(OH)3 + Squalene 2% emulsion

BIOLOGICAL

pandemic vaccine 6

3,75µg of A/H1N1 with MPLA adjuvant - IB, emultion (5µg) + Al(OH)3 + Squalene 2% emultion

BIOLOGICAL

pandemic vaccine 9

7,5 µg of A/H1N1 with Al(OH)3 + Squalene 2% emultion

BIOLOGICAL

pandemic vaccine 10

3,75 µg of A/H1N1 with Al(OH)3 + Squalene 2% emultion

BIOLOGICAL

pandmeic vaccine 11

7,5µg of A/H1N1 with Al(OH)3

BIOLOGICAL

pandmeic vaccine 12

3,75µg of A/H1N1 with Al(OH)3

BIOLOGICAL

pandmic vaccine 13

15µg of A/H1N1 with no adjuvant

BIOLOGICAL

placebo group 14

All elements of the vaccine but antigen and adjuvant

Trial Locations (2)

Centro de Pesquisa Clinica do Instituto da Criança do hospital das Clinicas da Faculdade de Medicina da USP, São Paulo

Centro de Pesquisa Clínica do Hospital Universitário da USP, São Paulo