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

This study has been completed.
Sponsor:
Collaborator:
Novartis Vaccines
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00848848
First received: February 19, 2009
Last updated: December 7, 2011
Last verified: December 2011
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
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:


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 ]

Enrollment: 450
Study Start Date: October 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Biological: Trivalent Influenza Vaccine
1 dose of Trivalent Influenza Vaccine
Active Comparator: 2 Biological: Trivalent Influenza Vaccine + high A
1 dose of Trivalent Influenza Vaccine with high A content
Active Comparator: 3 Biological: Trivalent Influenza Vaccine + ¼ dose adjuvant
1 dose of Trivalent Influenza Vaccine plus ¼ dose adjuvant
Active Comparator: 4 Biological: Trivalent Influenza Vaccine + high A + ¼ dose adjuvant
1 dose of Trivalent Influenza Vaccine with high A plus ¼ dose adjuvant
Active Comparator: 5 Biological: Trivalent Influenza Vaccine + ½ dose adjuvant
1 dose of Trivalent Influenza Vaccine plus ½ dose adjuvant
Active Comparator: 6 Biological: Trivalent Influenza Vaccine + high A + ½ dose adjuvant
1 dose of Trivalent Influenza Vaccine with high A plus ½ dose adjuvant
Active Comparator: 7 Biological: Trivalent Influenza Vaccine + adjuvant
1 dose of Trivalent Influenza Vaccine plus adjuvant
Active Comparator: 8 Biological: Trivalent Influenza Vaccine + high A + adjuvant
1 dose of Trivalent Influenza Vaccine with high A plus adjuvant
Active Comparator: 9 Biological: Trivalent Influenza Vaccine intradermal dose
1 dose of Trivalent Influenza Vaccine intradermal dose
Active Comparator: 10 Biological: Trivalent Influenza Vaccine + high A intradermal dose
1 intradermal dose of Trivalent Influenza Vaccine + high A

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Belgium
Center For Vaccinology
Ghent, Belgium, 9000
Sponsors and Collaborators
Novartis
Novartis Vaccines
Investigators
Study Chair: Novartis Vaccines Novartis Vaccines
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00848848     History of Changes
Other Study ID Numbers: V104P3, 2008-002625-36
Study First Received: February 19, 2009
Last Updated: December 7, 2011
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

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 30, 2014