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:
Novartis
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
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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:
MedlinePlus related topics:
Flu
Drug Information available for:
Influenza Vaccines
U.S. FDA Resources
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 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 Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013