Evaluation of Pandemic Influenza A (H1N1)Candidate Vaccines

Summary

This is a prospective phase I study to evaluate the safety, tolerability and immunogenicity of nine adjuvanted candidate vaccines against pandemic influenza A (H1N1) virus.

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

Sponsors & Collaborators

• Hospital Universitario da USP

  collaborator UNKNOWN

• University of Sao Paulo

  collaborator OTHER

• Butantan Institute

  lead OTHER_GOV

Principal Investigators

• Lucia MA Campos, MD. PhD · Children´s Institute - School of Medicine of University of Sao Paulo

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2010-01-31

Primary Completion

2010-12-31

Completion

2011-03-31

Countries

• Brazil

Study Locations