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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05519839 | A Study to Evaluate the Safety and Immunogenicity of COVID-19 and Influenza Combination Vaccine | PHASE2 | COMPLETED | 1,579 | — | — | Dec 30, 2022 | Dec 24, 2023 | Jul 16, 2024 | 35 | Australia, New Zealand |
Numbers of participants with solicited local and systemic AEs over the 7 days post-vaccination.
Proportions of participants reporting all AEs, solicited and unsolicited, over 21 days post-vaccination.
Proportions of participants with MAAEs, AESIs (including PIMMCs and myocarditis and/or pericarditis), SAEs, will be collected for 6 months (approximately 182 days) post-vaccination
| Arm | Type | Description |
|---|---|---|
| Group A (Part 1) | EXPERIMENTAL | CIC Vaccine Formulation1. 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70 |
| Group B (Part 1) | EXPERIMENTAL | CIC Vaccine Formulation 2. 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70 |
| Group C (Part 1) | EXPERIMENTAL | CIC Vaccine Formulation 3. 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70 |
| Group D (Part 1) | EXPERIMENTAL | CIC Vaccine Formulation 3. 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70 |
| Group E (Part 1) | EXPERIMENTAL | CIC Vaccine Formulation 1. 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70 |
| Group F (Part 1) | EXPERIMENTAL | CIC Vaccine Formulation 2. 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70 |
| Group G (Part 1) | EXPERIMENTAL | CIC Vaccine Formulation 3. 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70 |
| Group H (Part 1) | EXPERIMENTAL | CIC Vaccine Formulation 4. 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70 |
| Group I (Part 1) | EXPERIMENTAL | CIC Vaccine Formulation 5. 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70 |
| Group J (Part 1) | EXPERIMENTAL | CIC Vaccine Formulation 6. 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70 |
| Group K (Part 1) | EXPERIMENTAL | CIC Vaccine Formulation 7. 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70 |
| Group L (Part 1) | EXPERIMENTAL | qNIV Vaccine Formulation 1. 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70 |
| Group M (Part 1) | EXPERIMENTAL | qNIV Vaccine Formulation 2. 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70 |
| Group N (Part 1) | EXPERIMENTAL | qNIV Vaccine Formulation 3 . 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70 |
| Group O (Part 1) | EXPERIMENTAL | SARS-CoV-2 rS Vaccine Formulation 1. 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70 |
| Group P (Part 1) | EXPERIMENTAL | SARS-CoV-2 rS Vaccine Formulation 2. 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70 |
| Group Q (Part 1) | EXPERIMENTAL | SARS-CoV-2 rS Vaccine Formulation 3. 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70 |
| Group R (Part 1) | EXPERIMENTAL | SARS-CoV-2 rS Vaccine Formulation 4. 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70 |
| Group S (Part 1) | EXPERIMENTAL | Influenza Vaccine Formulation 1. 1 intramuscular (IM) doses of vaccine, on Day 0. |
| Group T (Part 2) | EXPERIMENTAL | CIC Vaccine Formulation 8. 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70 (if applicable). |
| Group U (Part 2) | EXPERIMENTAL | CIC Vaccine Formulation 9. 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70 (if applicable). |
| Group S (Part 1)-Placebo | PLACEBO_COMPARATOR | 1 intramuscular (IM) doses of placebo, on Day 70. |
| Name | Type | Description |
|---|---|---|
| qNIV Vaccine with Matrix-M Adjuvant | DRUG | Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV vaccine given on Day 0 and Day 70 . |
| Influenza Vaccine | DRUG | Intramuscular (deltoid) injections of Comparator influenza vaccine given on Day 0 and Day 70 (if applicable). |
| CIC Vaccine with Matrix-M Adjuvant | DRUG | Intramuscular (deltoid) injections of co-formulated mix of various doses and formulations of CIC Vaccine given on Day 0 and Day 70 |
| Placebo Comparator | OTHER | Intramuscular (deltoid) injection of placebo given on Day 70. |
| SARS-CoV-2 rS Vaccine with Matrix-M Adjuvant | DRUG | Intramuscular (deltoid) injections of in-clinic mix of various doses of SARS-CoV-2 rS vaccine given on Day 0 and Day 70 . |
Inclusion Criteria: To be included in this study, each individual must satisfy all the following criteria: 1. Medically stable adult male or females ≥ 50 to ≤ 80 years of age at screening. 2. Participants may have 1 or more chronic medical diagnoses, but should be clinically stable as assessed by:...