Trial | NCT01111968  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    inactivated influenza vaccine ...

  • Study Participants

    266
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.
The candidate vaccines are produced by Butantan institute - Sao Paulo, Brazil
Study Started
Jan 31
2010
Primary Completion
Dec 31
2010
Study Completion
Mar 31
2011
Last Update
Feb 06
2013
Estimate

Biological pandemic vaccine 1

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

  • Other names: vaccine group C

Biological pandemic vaccine 2

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

  • Other names: vaccine group I

Biological pandemic vaccine 5

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

  • Other names: vaccine group N

Biological pandemic vaccine 6

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

  • Other names: vaccine group A

Biological pandemic vaccine 9

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

  • Other names: vaccine group F

Biological pandemic vaccine 10

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

  • Other names: vaccine group L

Biological pandmeic vaccine 11

7,5µg of A/H1N1 with Al(OH)3

  • Other names: vaccine group E

Biological pandmeic vaccine 12

3,75µg of A/H1N1 with Al(OH)3

  • Other names: vaccine group K

Biological pandmic vaccine 13

15µg of A/H1N1 with no adjuvant

  • Other names: vaccine group H

Biological placebo group 14

All elements of the vaccine but antigen and adjuvant

  • Other names: vaccine group B

pandemic vaccine 1 Experimental

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

pandemic vaccine 2 Experimental

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

pandemic vaccine 5 Experimental

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

pandemic vaccine 6 Experimental

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

pandemic vaccine 9 Experimental

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

pandemic vaccine 10 Experimental

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

pandemic vaccine 11 Experimental

7,5µg of A/H1N1 with Al(OH)3

pandemic vaccine 12 Experimental

3,75µg of A/H1N1 with Al(OH)3

pandemic vaccine 13 Experimental

15µg of A/H1N1 with no adjuvant

placebo group 14 Placebo Comparator

placebo

Criteria 

Inclusion Criteria:

Health adults of both genders
Age ≥ 18 ≤ 50 years
Able to understand every required study procedure
Female volunteers should agree to take an acceptable contraceptive method Menopause is characterized by absence of menstrual flux for two consective years
Normal values for pre-stablished laboratory assays
Accpetance to participate and sign the consent form

Exclusion Criteria:

Any chronic condition
Be on immunossupressive or stimulant therapy
Have egg alergy
Have past history of alergy to sazonal influenza vaccine
Have received another inactivated vaccine within the prior 2 weeks or a live vaccine in the past four weeks to his/her participation in the study
Acute infectious disease during seven days prior vaccination
Female on breasthfeeding
Confirmed prior infection by pandemic influenza A
Participation in another clinical trial in the last 6 months
Any other condition identified by the principal investigator which is considered not safe for enrollment of the volunteer
No Results Posted