Trials / Completed
CompletedNCT00848848
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
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 450 (actual)
- Sponsor
- Seqirus · Industry
- Sex
- All
- Age
- 65 Years
- Healthy volunteers
- Accepted
Summary
The study will evaluate the safety, tolerability and immunogenicity of different doses and types of Influenza Vaccine in healthy elderly subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Trivalent Influenza Vaccine | 1 dose of Trivalent Influenza Vaccine |
| BIOLOGICAL | Trivalent Influenza Vaccine + high A | 1 dose of Trivalent Influenza Vaccine with high A content |
| BIOLOGICAL | Trivalent Influenza Vaccine + ¼ dose adjuvant | 1 dose of Trivalent Influenza Vaccine plus ¼ dose adjuvant |
| BIOLOGICAL | Trivalent Influenza Vaccine + high A + ¼ dose adjuvant | 1 dose of Trivalent Influenza Vaccine with high A plus ¼ dose adjuvant |
| BIOLOGICAL | Trivalent Influenza Vaccine + ½ dose adjuvant | 1 dose of Trivalent Influenza Vaccine plus ½ dose adjuvant |
| BIOLOGICAL | Trivalent Influenza Vaccine + high A + ½ dose adjuvant | 1 dose of Trivalent Influenza Vaccine with high A plus ½ dose adjuvant |
| BIOLOGICAL | Trivalent Influenza Vaccine + adjuvant | 1 dose of Trivalent Influenza Vaccine plus adjuvant |
| BIOLOGICAL | Trivalent Influenza Vaccine + high A + adjuvant | 1 dose of Trivalent Influenza Vaccine with high A plus adjuvant |
| BIOLOGICAL | Trivalent Influenza Vaccine intradermal dose | 1 dose of Trivalent Influenza Vaccine intradermal dose |
| BIOLOGICAL | Trivalent Influenza Vaccine + high A intradermal dose | 1 intradermal dose of Trivalent Influenza Vaccine + high A |
Timeline
- Start date
- 2008-10-01
- Primary completion
- 2009-04-01
- Completion
- 2009-04-01
- First posted
- 2009-02-20
- Last updated
- 2016-05-09
Locations
1 site across 1 country: Belgium
Source: ClinicalTrials.gov record NCT00848848. Inclusion in this directory is not an endorsement.