NCT01111968

Evaluation of Pandemic Influenza A (H1N1)Candidate Vaccines

Evaluation of Safety, Tolerability and Immunogenicity of Adjuvanted Candidate Vaccines Against Pandemic Influenza A (H1N1)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 266 (actual)
• Sponsor: Butantan Institute · Other Government
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

The candidate vaccines are produced by Butantan institute - Sao Paulo, Brazil

Conditions

• Influenza

Interventions

Type	Name	Description
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

Timeline

• Start date: 2010-01-01
• Primary completion: 2010-12-01
• Completion: 2011-03-01
• First posted: 2010-04-28
• Last updated: 2013-02-06

Locations

2 sites across 1 country: Brazil