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Adjuvanted and un-adjuvanted influenza vaccines · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Adjuvanted and un-adjuvanted influenza vaccines | BIOLOGICAL | 16 different formulations of trivalent influenza vaccine and 1 marketed influenza vaccine comparator. |
Inclusion Criteria: * Children of 6 month to \<36 month of age in good health as determined by medical history, physical assessment and clinical judgement of the investigator. Exclusion Criteria: * History of serious disease. History of serious reaction following administration of vaccine or hype...
Adjuvanted and un-adjuvanted influenza vaccines are used for influenza, a viral infection of the respiratory tract. They are being studied in healthy children aged 6 to less than 36 months to assess different combinations of adjuvanted and non-adjuvanted formulations for immune response and safety.
Adjuvanted and un-adjuvanted influenza vaccines are being developed by Novartis AG, a global healthcare company. Novartis is listed on the New York Stock Exchange under the ticker symbol NVS.
Adjuvanted and un-adjuvanted influenza vaccines are in Phase 1 clinical development. The single completed trial was a Phase 1 study, indicating the vaccines are still in early-stage clinical testing and are investigational, not yet approved for use.
Adjuvanted and un-adjuvanted influenza vaccines have one completed clinical trial, NCT00848887. This Phase 1 study, titled 'A Dose Ranging Study Comparing Different Combinations of Adjuvanted and Non-adjuvanted Influenza Vaccines in Healthy Children 6 to <36 Months of Age,' enrolled 410 participants in Belgium.
Adjuvanted and un-adjuvanted influenza vaccines are not FDA approved. They are investigational products in Phase 1 clinical development. The completed trial was a dose-ranging study in healthy children, and the vaccines have not yet progressed to later-stage trials or regulatory approval.