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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01111968

Enrollment

266

Registered

2010-04-28

Start date

2010-01-31

Completion date

2011-03-31

Last updated

2013-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza

Keywords

vaccine, pandemic influenza A, adjuvant, safety

Brief 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

Interventions

BIOLOGICALpandemic vaccine 1

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

BIOLOGICALpandemic vaccine 2

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

BIOLOGICALpandemic vaccine 5

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

BIOLOGICALpandemic vaccine 6

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

BIOLOGICALpandemic vaccine 9

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

BIOLOGICALpandemic vaccine 10

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

BIOLOGICALpandmeic vaccine 11

7,5µg of A/H1N1 with Al(OH)3

BIOLOGICALpandmeic vaccine 12

3,75µg of A/H1N1 with Al(OH)3

BIOLOGICALpandmic vaccine 13

15µg of A/H1N1 with no adjuvant

BIOLOGICALplacebo group 14

All elements of the vaccine but antigen and adjuvant

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
the proportion of subjects with antibody titers of 1:40 or more on hemagglutination-inhibition assay	21 days after each vaccination	Volunteers will receive two doses of vaccine,21 days apart.

Secondary

Measure	Time frame	Description
Safety and tolerability	30 minutes and 72 hours after vaccination	Evaluation of local and systemic adverse effects throught the study period

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026