Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
qNIV Vaccine with Matrix-M Adjuvant · 1 trial · 2 indications
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:...
Top 9 of 11 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Pfizer Inc. | PFE | 7 | PHASE3 | ibuzatrelvir, Nirmatrelvir/ ritonavir, BNT162b2/RIV |
| Merck & Co., Inc. | MRK | 2 | PHASE3 | Molnupiravir |
| Invivyd, Inc. | IVVD | 2 | PHASE3 | VYD2311 |
| Vanda Pharmaceuticals Inc. | VNDA | 1 | PHASE3 | Tradipitant |
| Moderna, Inc. | MRNA | 2 | PHASE2 | mRNA-1283, mRNA-1273 |
| ImmunityBio Inc | IBRX | 2 | PHASE2 | Nogapendekin alfa inbakicept |
| Traws Pharma, Inc. | TRAW | 1 | PHASE2 | Ratutrelvir |
| GeoVax Labs, Inc. | GOVX | 1 | PHASE2 | GEO-CM04S1 |
| Gilead Sciences, Inc. | GILD | 1 | PHASE2 | Remdesivir |
qNIV Vaccine with Matrix-M Adjuvant is an investigational combination vaccine developed by Novavax, Inc. for COVID-19 and influenza. It combines a quadrivalent influenza vaccine component with a COVID-19 vaccine component and the Matrix-M adjuvant. It is administered to healthy adult volunteers and is being studied for its ability to generate immune responses against both viruses.
qNIV Vaccine with Matrix-M Adjuvant is being developed for the prevention of COVID-19 and influenza. It is intended to protect against both respiratory viruses in a single combination vaccine. The vaccine is investigational and has not been approved for use.
qNIV Vaccine with Matrix-M Adjuvant is developed by Novavax, Inc., which trades on the Nasdaq under the ticker symbol NVAX. Novavax is a biotechnology company focused on vaccines for infectious diseases.
qNIV Vaccine with Matrix-M Adjuvant is in Phase 2 clinical development. It is an investigational vaccine and has not been approved by the FDA or any regulatory authority. The Phase 2 trial has been completed.
qNIV Vaccine with Matrix-M Adjuvant has been studied in one completed Phase 2 clinical trial, NCT05519839. This trial evaluated the safety and immunogenicity of a COVID-19 and influenza combination vaccine in 1,579 healthy volunteers aged 50 years and older in Australia and New Zealand. It was randomized, double-blind, and placebo-controlled.