Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PIKA COVID-19 vaccine · 1 trial · 1 indication
Geometric mean titer (GMT) of neutralizing antibody against Omicron virus on D14 after the booster dose
Incidence of first occurrence of Rt-PCR positive symptomatic illness after D14 of booster dose
Incidence of AE, MAAE, SAE, SUSAR and AESI after booster dose
| Arm | Type | Description |
|---|---|---|
| PIKA COVID-19 vaccine | EXPERIMENTAL | One dose of the experimental vaccine should be administered on Study Day 0 in the deltoid muscle. |
| Inactivated Covid-19 vaccine | ACTIVE_COMPARATOR | One dose of the control vaccine should be administered on Study Day 0 in the deltoid muscle. |
| Name | Type | Description |
|---|---|---|
| PIKA COVID-19 vaccine | BIOLOGICAL | SARS-CoV-2 spike subunit protein (Also called "Recombinant SARS-CoV-2 S-trimer protein"), PIKA adjuvant. |
| Inactivated Covid-19 vaccine | BIOLOGICAL | Inactivated SARS-CoV-2 virus |
Inclusion Criteria: Subject who met all of the following criteria may be enrolled. 1. Age more than or equal 18 years on Screening. 2. Judged by the investigator to be healthy based on medical history, physical examination and vital signs performed at screening. 3. Able to provide informed consent...
PIKA COVID-19 Vaccine, Arm A is an investigational vaccine being studied for use against COVID-19, including as a booster dose. It is developed by LakeShore Biopharma Co., Ltd (ticker: LSB) and is currently in clinical development, with trials completed for both primary vaccination and booster indications.
PIKA COVID-19 Vaccine, Arm A is developed by LakeShore Biopharma Co., Ltd, a company listed on the stock exchange under the ticker LSB. The vaccine is being studied for the prevention of COVID-19 and as a booster dose against the disease.
PIKA COVID-19 Vaccine, Arm A is in Phase 1 clinical development. It is an investigational vaccine, not yet approved by regulatory authorities, and has completed early-stage trials to evaluate its safety, tolerability, and immunogenicity in healthy individuals.
PIKA COVID-19 Vaccine, Arm A has been studied in two completed trials. NCT05305300 was a Phase 1 study in healthy individuals in the United Arab Emirates, and NCT05463419 was a Phase II/III study of the vaccine as a booster dose, conducted in the Philippines and the United Arab Emirates.
PIKA COVID-19 Vaccine, Arm A is associated with the PIKA Recombinant SARS-CoV-2 Vaccine, which was evaluated in a Phase II/III booster dose trial. The vaccine is being developed by LakeShore Biopharma Co., Ltd and is intended for use against COVID-19.