Immunogenicity

Results: 349



#Item
271Health / Influenza vaccine / Influenza / FluMist / Fluzone / MedImmune / Flu season / Immunogenicity / H5N1 clinical trials / Vaccines / Medicine / Vaccination

TITLE PAGE AND GENERAL INFORMATION sBLA Number: [removed]Related IND Numbers: --(b)(4)--Reviewer Name, Division, and Mail Code: Clinical Reviewer: Melisse Baylor, MD. CBER/OVRR/DVRPA/DVRPA, HFM-475 Supervisory Review

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Source URL: www.fda.gov

Language: English
272Biology / Chickenpox / Herpesviruses / Viral diseases / Varicella vaccine / Immunogenicity / Varicella zoster virus / Vaccination / H5N1 clinical trials / Medicine / Vaccines / Health

Varicella Virus Vaccine Live, Varivax

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Source URL: www.fda.gov

Language: English
273Health / Vaccines / Immunology / Microbiology / Vaccine / Virology / Immunization / Immunogenicity / DNA vaccination / Vaccination / Medicine / Biology

Guidance for Industry: Considerations for Developmental Toxicity Studies for Preventive and Therapeutic Vaccines for Infectious Disease Indications

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Source URL: www.fda.gov

Language: English
274Medicine / Meningococcal disease / Meningococcal vaccine / Neisseria / MeNZB / Conjugate vaccine / NmVac4-A/C/Y/W-135 / Immunogenicity / Vaccination / Bacteria / Vaccines / Microbiology

Approaches to Licensure of Meningococcal Vaccines for Prevention of Serogroup B Invasive Meningococcal Disease Briefing Document for the Vaccines and Related Biologic Products Advisory Committee Meeting, April 7, 2011 I

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Source URL: www.fda.gov

Language: English
275Vaccines / Immunology / Anthrax / Microbiology / Biological warfare / Vaccination / Immune system / Bioterrorism / Immunogenicity / Biology / Medicine / Health

Pathway to Licensure for Protective Antigen-based Anthrax Vaccines using the Animal Rule

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Source URL: www.fda.gov

Language: English
276Biology / Hepatitis / Viral structural proteins / Hepatitis B vaccine / Vaccination / HBsAg / Hepatitis B / Immunogenicity / Twinrix / Medicine / Vaccines / Health

Vaccines and Related Biological Products Advisory Committee Meeting

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Source URL: www.fda.gov

Language: English
277Pharmacology / Meningococcal vaccine / Meningococcal disease / NmVac4-A/C/Y/W-135 / Neisseria / Conjugate vaccine / Immunogenicity / Pneumococcal conjugate vaccine / Meningitis / Vaccines / Medicine / Health

Menactra - Meningococcal Polysaccharide (Serogroups A, C, Y and W-135) Diphtheria Toxoid Conjugate Vaccine

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Language: English
278AstraZeneca / Health / Influenza vaccines / Orthomyxoviridae / Flu pandemic / FluMist / MedImmune / Influenza / Immunogenicity / Vaccination / Vaccines / Medicine

According to the CBER Manual of Standard Operating Procedures and Policies, Regulatory - License Applications, SOPP 8404: Refu

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279Vaccines / Meningococcal vaccine / Neisseria / Immunology / Meningococcal disease / Immunogenicity / Bacteria / Microbiology / Proteobacteria

Summary Basis for Regulatory Action Date: April 1, 2011 From: Cara R. Fiore, Ph D, Chair of the Review Committee BLA/ STN#: [removed]Applicant Name: Novartis Vaccines and Diagnostics Date of Submission: March 4, 2010

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280Pharmacology / Pneumococcal conjugate vaccine / Meningococcal vaccine / Immunogenicity / Meningococcal disease / Vaccination schedule / Vaccination / DPT vaccine / NmVac4-A/C/Y/W-135 / Vaccines / Medicine / Health

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Center for Biologics Evaluation and Research Office of Biostatistics and Epidemiology Division of Biostatistics

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Source URL: www.fda.gov

Language: English
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