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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

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ClinicalTrials.gov Identifier: NCT00848848
Recruitment Status : Completed
First Posted : February 20, 2009
Last Update Posted : May 9, 2016
Sponsor:
Collaborator:
Novartis Vaccines
Information provided by (Responsible Party):
Seqirus

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

Condition or disease Intervention/treatment 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  (Clinical Trial)
Actual Enrollment : 450 participants
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
Study Start Date : October 2008
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 :
  1. Strain-specific influenza antibody titers will be used to assess Immunogenicity [ Time Frame: 21 days ]


Information from the National Library of Medicine

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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.

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

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 Posted: February 20, 2009    Key Record Dates
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