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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2008-08-31

Brief Summary

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

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Detailed Description

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Conditions

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Influenza

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Group Type EXPERIMENTAL

Adjuvanted Influenza Vaccine

Intervention Type BIOLOGICAL

1 dose of Adjuvanted Influenza Vaccine

2

Group Type ACTIVE_COMPARATOR

Influenza Vaccine

Intervention Type BIOLOGICAL

1 dose of Influenza Vaccine

Interventions

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Adjuvanted Influenza Vaccine

1 dose of Adjuvanted Influenza Vaccine

Intervention Type BIOLOGICAL

Influenza Vaccine

1 dose of Influenza Vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Vaccines

Role: STUDY_CHAIR

Novartis Vaccines

Locations

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I.P.A.S.

Ligornetto, , Switzerland

Site Status

Countries

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Switzerland

References

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Della Cioppa G, Vesikari T, Sokal E, Lindert K, Nicolay U. Trivalent and quadrivalent MF59((R))-adjuvanted influenza vaccine in young children: a dose- and schedule-finding study. Vaccine. 2011 Nov 3;29(47):8696-704. doi: 10.1016/j.vaccine.2011.08.111. Epub 2011 Sep 9.

Reference Type RESULT

PMID: 21906647 (View on PubMed)

Other Identifiers

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V104P1

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

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Detailed Description

Conditions

Study Design

Study Groups

1

Adjuvanted Influenza Vaccine

2

Influenza Vaccine

Interventions

Adjuvanted Influenza Vaccine

Influenza Vaccine

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Novartis Vaccines

Responsible Party

Principal Investigators

Novartis Vaccines

Locations

I.P.A.S.

Countries

References

Della Cioppa G, Vesikari T, Sokal E, Lindert K, Nicolay U. Trivalent and quadrivalent MF59((R))-adjuvanted influenza vaccine in young children: a dose- and schedule-finding study. Vaccine. 2011 Nov 3;29(47):8696-704. doi: 10.1016/j.vaccine.2011.08.111. Epub 2011 Sep 9.

Other Identifiers

V104P1

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