Safety and Immunogenicity of a Commerci… | Clinical Trial

Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dipartimento di Medicina e Scienze dell'Invecchiamento, Chieti, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

65 years of age or older

Exclusion criteria

any serious disease such as cancer, autoimmune disease, advanced arteriosclerotic disease or insulin-dependent diabetes mellitus, chronic obstructive pulmonary disease (COPD) that requires oxygen therapy, acute or progressive hepatic disease, acute or progressive renal disease, congestive heart failure and bleeding diathesis or conditions associated with prolonged bleeding time
hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or kanamycin or any other component of the vaccine
history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine
known or suspected (or high risk of developing) impairment/alteration of immune function
any acute disease or infections requiring systemic antibiotic or antiviral therapy within the past 7 days
fever within the past 3 days

Treatment and study plan

Surface Antigen, Inactivated, Adjuvanted Influenza Vaccine, Formulation 2007-2008

Biological

A single 0.5mL dose of Novartis adjuvanted subunit influenza vaccine, Fluad contained 45μg of viral hemagglutinin, composed of 15μg of the three influenza antigens:

A(H1N1) strain: IVR-145 (Solomon Island/3/2006 - like strain)
A(H3N2) strain: NYMC X-161B (A/Wisconsin/67/2005-like strain)
B strain: (B/Malaysia/2506/2004-like strain) in accordance with the recommendations of the World Health Organization, the EU and the national Regulatory Agencies for the 2007/2008 season.

The vaccine is a milky liquid, and was packaged in ready to use, single dose syringes.

A single dose of FLUAD vaccine was administered intramuscularly, preferably in the deltoid muscle of the non dominant arm.

Primary outcomes

Antibody response to each influenza vaccine antigen as measured by Single Radial Hemolysis in elderly subjects (≥65y) in compliance with the requirements of the current EU recommendations for a new formulation of a licensed flu vaccine (CPMP/BWP/214/96)

Time frame: 21 days post-vaccination
The measures of immunogenicity for each antigen are:
- the geometric mean area (GMA) on Day 0 and Day 21
- the Day 21/Day 0 geometric mean area ratio (GMR)
- the percentage of subjects achieving seroconversion1 or significant increase in antibody titer2
- the percentage of subjects achieving an SRH area ≥ 25 mm2 on Day 0 and Day 21
- Seroconversion is defined as negative prevaccination serum/postvaccination serum area ≥ 25 mm2.
- Significant increase in antibody titer is defined as at least a 50% increase in area.

Secondary outcomes

To evaluate the safety of the administration of a single intramuscular (IM) injection of FLUAD® vaccine (formulation 2007/2008) in elderly subjects (≥ 65 years).

Time frame: 3 days, respectively 21 days post-vaccination

Number and percentage of subjects with at least one local reaction between Day 0 and Day 3 after vaccine injection.

Number and percentage of subjects with at least one systemic reaction between Day 0 and Day 3 after vaccine injection.

Number and percentage of subjects with at least one adverse event between Day 0 and the study termination visit (Day 21, window: 20-24).

Sponsors and collaborators

Lead sponsor

Novartis Vaccines

Industry

Registry information

Official study title

A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of a Surface Antigen, Inactivated, Adjuvanted Influenza Vaccine, Formulation 2007-2008, When Administered to Elderly Subjects

Important dates

Study start: 2007
Primary completion: 2007
Study completion: 2007
First posted: Aug 29, 2007
Registry last updated: Jan 25, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed