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Pandemic influenza A/H1N1 vaccine
This vaccine stimulates the immune system to produce antibodies and cellular immunity against pandemic influenza A/H1N1 virus.
This vaccine stimulates the immune system to produce antibodies and cellular immunity against pandemic influenza A/H1N1 virus. Used for Prevention of pandemic influenza A/H1N1 infection.
At a glance
| Generic name | Pandemic influenza A/H1N1 vaccine |
|---|---|
| Sponsor | Sinovac Biotech Co., Ltd |
| Drug class | inactivated influenza vaccine |
| Modality | Biologic |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
Mechanism of action
The vaccine contains inactivated influenza A/H1N1 virus particles that trigger both humoral (antibody) and cell-mediated immune responses. Upon vaccination, the immune system recognizes viral antigens and generates protective antibodies (primarily IgG) and T-cell responses that provide immunity against infection with the H1N1 strain. This prevents or reduces severity of infection if the vaccinated individual is subsequently exposed to the virus.
Approved indications
- Prevention of pandemic influenza A/H1N1 infection
Common side effects
- Injection site pain, redness, or swelling
- Fever
- Myalgia
- Fatigue
- Headache
Key clinical trials
- Safety and Efficacy of an Inactivated and Non Adjuvanted Vaccine Against Influenza A in Renal Transplant Recipients (PHASE2)
- "COhort Study on A/H1N1 FLU During PREGnancy"
- Cohort Study Evaluating the Clinical Effectiveness, Safety and Immunogenicity to the Pandemic Influenza Vaccination (PHASE4)
- Study of Immune Responses After Vaccination Against Seasonal Influenza Virus and Against Influenza H1N1-v Pandemic Virus in a Medical Staff. (PHASE4)
- Immunologic Response After Pandemic Influenza A (H1N1) Vaccine in Onco- Hematologic Patients
- Safety and Efficacy of H1N1 Vaccines in Children Aged 6 Months to Less Than 10 Years of Age (PHASE3)
- Immunogenicity, Safety and Tolerability of Two Doses of Adjuvanted and Non-adjuvanted Swine Origin A/H1N1 Monovalent Influenza Vaccine in Healthy Subjects 18 or More Years of Age (PHASE3)
- Studies of Pandemic Influenza (H1N1) 2009 Vaccine in Bergen (NA)
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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Pandemic influenza A/H1N1 vaccine CI brief — competitive landscape report
- Pandemic influenza A/H1N1 vaccine updates RSS · CI watch RSS
- Sinovac Biotech Co., Ltd portfolio CI