Trial abstract · §2
TA1-VACCINE-ELDERLY — design and population
Design, allocation, arms and the population enrolled.
§2Design and population
§2.1Design and allocation
- Design class
- Randomised, double-blind, placebo-controlled, parallel-group
- Masking
- Double-blind (participant, investigator and sponsor)
- Arms
- 4
- Allocation
- Randomised across dose arms and a common comparator
- Endpoint adjudication
- Not applicable to the primary endpoint of this design
- Data monitoring
- As specified in the protocol
§2.2Arms
Table 2. Randomised arms. Illustrative: arm-level allocations are reconstructed by the Institute from the design class and the randomised total where the published report does not state them.
| Arm | Allocated | Share | Description |
|---|---|---|---|
| Thymosin alpha-1, dose level 1 | — | — | Randomised dose arm |
| Thymosin alpha-1, dose level 2 | — | — | Randomised dose arm |
| Thymosin alpha-1, dose level 3 | — | — | Randomised dose arm |
| Placebo | — | — | Matched placebo |
| The randomised total is not recorded by the Institute and arm-level figures are therefore not presented. | |||
§2.3Population
Indication. Immune modulation and adjunctive immunotherapy
Pharmacological modification of innate or adaptive immune function, assessed by cell counts, functional assays and clinical infection or oncological endpoints.
Geographic footprint. Norway · Finland.
§2.4Eligibility as the Institute reads it
- Included. Pharmacological modification of innate or adaptive immune function, assessed by cell counts, functional assays and clinical infection or oncological endpoints.
- Excluded. Participants for whom the intervention is contraindicated, including known hypersensitivity. Exclusion criteria narrow the population to which the estimate applies and are the principal source of indirectness where a trial estimate is applied to ordinary practice.
Compound Evidence Institute · CEI-TR-0122/2 · https://compoundevidence.com/trials/ta1-vaccine-elderly/design/ · retrieved 30 July 2026