Study to Evaluate Safety, Tolerability and Immunogenicity of a Bedside Mixing Combination of Two Adjuvanted Influenza Vaccines

A Phase I, Observer-Blind, Randomized, Single-Center Study to Evaluate Safety, Tolerability and Immunogenicity of a Bedside Mixing Combination of Two Adjuvanted Influenza Vaccines in Healthy Adults Aged 18 to 39 Years.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00735020

Enrollment

Registered

2008-08-14

Start date

2008-06-30

Completion date

2008-08-31

Last updated

2014-01-24

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

Conditions

Influenza

Keywords

influenza, vaccine, adjuvants, flu

Brief summary

This trial is designed to evaluate safety, tolerability and immunogenicity of a bedside mixing formulation of adjuvanted influenza vaccines.

Interventions

BIOLOGICALAdjuvanted Influenza Vaccine

1 dose of Adjuvanted Influenza Vaccine

BIOLOGICALInfluenza Vaccine

1 dose of Influenza Vaccine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 39 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy 18 to 39 year old males and females who are in good health and have provided informed consent prior to enrollment

Exclusion criteria

* serious medical conditions * allergies to vaccine components, including but not limited to egg/chicken products * reduced immune function * recent use of immunosuppressive therapy * recent use of influenza vaccine

Design outcomes

Primary

Measure	Time frame
Safety as measured through local and systemic reactions and efficacy (immunogenicity) as measured by antibody titers.	36 Days

Secondary

Measure	Time frame
To evaluate immunogenicity of a single IM injection of adjuvanted Influenza vaccine	36 Days

Countries

Switzerland

Outcome results

None listed

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