Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05463419 | A Phase II/III Study of PIKA Recombinant SARS-CoV-2 Vaccine as a Booster Dose. | PHASE2 | COMPLETED | 5,860 | — | — | Oct 3, 2022 | Apr 11, 2024 | Jul 23, 2024 | 6 | Philippines, United Arab Emirates |
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...