Safety, Tolerability, and Immunogenicity of Different Combinations of Trivalent Influenza Vaccine Varying Influenza Antigen Dose, Adjuvant Dose, and Route of Administration in Healthy Elderly Individuals Ages 65 Years and Older - Full Text View

Sponsors and Collaborators:	Novartis Novartis Vaccines
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00848848

Purpose

The study will evaluate the safety, tolerability and immunogenicity of different doses and types of Influenza Vaccine in healthy elderly subjects.

Condition	Intervention	Phase
Influenza	Biological: Trivalent Influenza Vaccine Biological: Trivalent Influenza Vaccine + high A Biological: Trivalent Influenza Vaccine + ¼ dose adjuvant Biological: Trivalent Influenza Vaccine + high A + ¼ dose adjuvant Biological: Trivalent Influenza Vaccine + ½ dose adjuvant Biological: Trivalent Influenza Vaccine + high A + ½ dose adjuvant Biological: Trivalent Influenza Vaccine + adjuvant Biological: Trivalent Influenza Vaccine + high A + adjuvant Biological: Trivalent Influenza Vaccine intradermal dose Biological: Trivalent Influenza Vaccine + high A intradermal dose	Phase I

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Subject), Dose Comparison, Factorial Assignment, Safety/Efficacy Study
Official Title:	A Phase Ib, Multi-Center, Randomized, Observer-Blind, Proof of Concept, Dose- and Formulation-Ranging Study to Evaluate Safety, Tolerability, and Immunogenicity of One Dose of Trivalent Inactivated Influenza Vaccine in Different Presentations (Intramuscular and Intradermal Delivery), Dosages (Regular or Higher A/H3N2 Content) and Doses of Adjuvant Administered to Healthy Elderly Aged ≥ 65 Years

Resource links provided by NLM:

MedlinePlus related topics: Flu

Drug Information available for: Fluvirin Influenza Vaccines

Further study details as provided by Novartis:

Primary Outcome Measures:

Assessment of all adverse events from time of vaccination through study end will be collected to for safety assessment. [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Strain-specific influenza antibody titers will be used to assess Immunogenicity [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	700
Study Start Date:	October 2008
Estimated Study Completion Date:	February 2009
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Biological: Trivalent Influenza Vaccine 1 dose of Trivalent Influenza Vaccine
2: Active Comparator	Biological: Trivalent Influenza Vaccine + high A 1 dose of Trivalent Influenza Vaccine with high A content
3: Active Comparator	Biological: Trivalent Influenza Vaccine + ¼ dose adjuvant 1 dose of Trivalent Influenza Vaccine plus ¼ dose adjuvant
4: Active Comparator	Biological: Trivalent Influenza Vaccine + high A + ¼ dose adjuvant 1 dose of Trivalent Influenza Vaccine with high A plus ¼ dose adjuvant
5: Active Comparator	Biological: Trivalent Influenza Vaccine + ½ dose adjuvant 1 dose of Trivalent Influenza Vaccine plus ½ dose adjuvant
6: Active Comparator	Biological: Trivalent Influenza Vaccine + high A + ½ dose adjuvant 1 dose of Trivalent Influenza Vaccine with high A plus ½ dose adjuvant
7: Active Comparator	Biological: Trivalent Influenza Vaccine + adjuvant 1 dose of Trivalent Influenza Vaccine plus adjuvant
8: Active Comparator	Biological: Trivalent Influenza Vaccine + high A + adjuvant 1 dose of Trivalent Influenza Vaccine with high A plus adjuvant
9: Active Comparator	Biological: Trivalent Influenza Vaccine intradermal dose 1 dose of Trivalent Influenza Vaccine intradermal dose
10: Active Comparator	Biological: Trivalent Influenza Vaccine + high A intradermal dose 1 intradermal dose of Trivalent Influenza Vaccine + high A

Eligibility

Criteria

Inclusion Criteria:

Subjects 65 years or older generally in good health as determined by medical history, physical assessment and clinical judgment of the investigator.

Exclusion Criteria:

Subjects who have received influenza vaccine within the past 6 month and who have received adjuvanted vaccine in the past two years.
Subjects with hypersensitivity to vaccine components. Subjects who are on or were recently on immunosuppressive therapy.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00848848

Contacts

Contact: Novartis Drug Information Services

+1 800 244 7668

Locations

Belgium
Center for Vaccinology	Recruiting
Ghent, Belgium, 9000
Principal Investigator: Novartis Vaccines

Sponsors and Collaborators

Novartis

Novartis Vaccines

Investigators

Study Chair:

Novartis Vaccines

More Information

No publications provided

Responsible Party:	Novartis Vaccines ( Novartis )
Study ID Numbers:	V104P3, 2008-002625-36
Study First Received:	February 19, 2009
Last Updated:	June 29, 2009
ClinicalTrials.gov Identifier:	NCT00848848 History of Changes
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products; Germany: Paul-Ehrlich-Institut; Poland: CEBK

Keywords provided by Novartis:

Influenza
Flu
Vaccine
Intradermal
Adjuvant

Study placed in the following topic categories:

Virus Diseases
Immunologic Factors
Respiratory Tract Diseases
Respiratory Tract Infections

Adjuvants, Immunologic
Influenza, Human
Healthy
Orthomyxoviridae Infections

Additional relevant MeSH terms:

Virus Diseases
RNA Virus Infections
Immunologic Factors
Respiratory Tract Diseases
Respiratory Tract Infections

Physiological Effects of Drugs
Adjuvants, Immunologic
Influenza, Human
Orthomyxoviridae Infections
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 30, 2009