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cTIV
cTIV is a recombinant tetravalent influenza vaccine designed to provide broader and more durable immune protection against multiple influenza virus strains.
cTIV is a recombinant tetravalent influenza vaccine designed to provide broader and more durable immune protection against multiple influenza virus strains. Used for Seasonal influenza prevention in adults.
At a glance
| Generic name | cTIV |
|---|---|
| Sponsor | Novavax |
| Drug class | Recombinant influenza vaccine |
| Target | Influenza hemagglutinin (HA) antigens |
| Modality | Biologic |
| Therapeutic area | Immunology / Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
cTIV uses recombinant DNA technology to produce influenza hemagglutinin antigens from four influenza virus strains (two A subtypes and two B lineages). This approach aims to improve upon traditional egg-based or cell-based flu vaccines by enabling faster manufacturing, potentially higher antigen yields, and more consistent immunogenicity across diverse populations.
Approved indications
- Seasonal influenza prevention in adults
Common side effects
- Injection site pain or erythema
- Myalgia
- Headache
- Fatigue
Key clinical trials
- Safety and Immunogenicity of 3 Lots of Cell-derived Subunit Influenza Vaccine as Compared to 1 Lot to Egg-derived Subunit Influenza Vaccine in Healthy Adults (>=18 to <=60) (PHASE3)
- Comparison of Safety, Tolerability and Immunogenicity of Influenza Vaccines in Adults and Elderly (PHASE3)
- Flucelvax Pregnancy Registry
- Study of the Safety and Immunogenicity of an Influenza Vaccine Administered to Healthy Adults (PHASE2)
- Second Extension Study to Evaluate Safety and Tolerability of Influenza Vaccines in Adults and Elderly, and to Evaluate Immunogenicity and Concomitant Vaccination With Pneumococcal Vaccine in a Subgroup (PHASE3)
- Safety of a Influenza Vaccine Produced Either in Mammalian Cell Culture or in Embryonated Hen Eggs in Adults and Elderly With and Without Underlying Medical Conditions, and Immunogenicity in a Subset of Subjects With Underlying Medical Conditions (PHASE4)
- Safety and Immunogenicity of a Cell Culture-derived Influenza Vaccine in Healthy Adults and Elderly (PHASE3)
- Pediatric Safety and Immunogenicity Study of Cell-Culture Derived and Egg-based Subunit Influenza Vaccines in Healthy Children and Adolescents (PHASE2, PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |