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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:
ClinicalTrials.gov Identifier:
NCT00848848
First Posted: February 20, 2009
Last Update Posted: May 9, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Novartis Vaccines
Information provided by (Responsible Party):
Seqirus
  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
Intervention Model: Factorial Assignment
Masking: Single (Participant)
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 Seqirus:

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 ]

Secondary Outcome Measures:
  • Strain-specific influenza antibody titers will be used to assess Immunogenicity [ Time Frame: 21 days ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00848848


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Seqirus
ClinicalTrials.gov Identifier: NCT00848848     History of Changes
Other Study ID Numbers: V104P3
2008-002625-36
First Submitted: February 19, 2009
First Posted: February 20, 2009
Last Update Posted: May 9, 2016
Last Verified: May 2016

Keywords provided by Seqirus:
Influenza
Flu
Vaccine
Intradermal
Adjuvant

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs