Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Novartis Investigational H5N1 vaccine · 1 trial · 1 indication
Seroconversion is defined as hemagglutination inhibition (HI) ≥1:40 for subjects who were seronegative at baseline \[day 1 HI titer \<1:10\] or a minimum 4-fold increase in HI titer for subjects who were seropositive at baseline \[day 1 HI titer ≥1:10\])
In pooled age groups 18 years of age and older subjects who are healthy or with underlying medical condition who have received aTIV or aH5N1 vaccine.
| Arm | Type | Description |
|---|---|---|
| Arm 1: aH5N1 adult | EXPERIMENTAL | aH5N1 healthy and non-healthy adults |
| Arm 2: aH5N1 elderly | EXPERIMENTAL | aH5N1 healthy and non-healthy elderly |
| Arm 3: aTIV adult | ACTIVE_COMPARATOR | aTIV healthy and non-healthy adults |
| Arm 4: aTIV elderly | ACTIVE_COMPARATOR | aTIV healthy and non-healthy elderly |
| Name | Type | Description |
|---|---|---|
| Novartis Investigational H5N1 vaccine | BIOLOGICAL | 2 doses of 0.5 ml, 3 weeks apart |
| Novartis Seasonal Influenza Vaccine | BIOLOGICAL | 2 doses of 0.5 ml, 3 weeks apart |
Inclusion Criteria: * \- Male and female individuals 18 years of age and older at the time of enrollment who are mentally competent, willing and able to understand the nature and risks of the proposed study, and able to sign the consent form prior to study entry; * Individuals who are able to compl...
The Novartis Investigational H5N1 vaccine is used for influenza in humans, specifically targeting the H5N1 strain. It is being developed as a preventative vaccine against this type of avian influenza virus.
The Novartis Investigational H5N1 vaccine is developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS.
The Novartis Investigational H5N1 vaccine is in Phase 3 clinical development. It is an investigational product and has not yet been approved by regulatory authorities.
The Novartis Investigational H5N1 vaccine has one completed Phase 3 clinical trial, identified as NCT02091908. This trial evaluated the safety and immunogenicity of two doses of the vaccine in adult and elderly subjects with and without underlying medical conditions.
The Novartis Investigational H5N1 vaccine is a monoclonal antibody designed to target the H5N1 influenza virus. It works by binding to the virus to help the immune system recognize and neutralize it, potentially providing protection against infection.
The Novartis Investigational H5N1 vaccine is a specific vaccine candidate developed by Novartis. It is distinct from other H5N1 vaccines produced by different manufacturers, and its formulation and clinical development are unique to Novartis.