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Immunogenicity
Results: 349

#	Item
281	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 18, 2010 Add to Reading List Source URL: www.fda.gov Language: English Medicine Meningococcal vaccine Meningococcal disease Neisseria Conjugate vaccine Immunogenicity NmVac4-A/C/Y/W-135 Vaccines Bacteria Microbiology
282	Clinical Review: Hepatitis A Vaccine, Purified, Inactivated VAQTA Add to Reading List Source URL: www.fda.gov Language: English Pharmacology Twinrix Hepatitis A vaccine Immunogenicity Pneumococcal conjugate vaccine DPT vaccine Vaccination H5N1 clinical trials Hepacivac Vaccines Medicine Health
283	APPENDIX 1: Secondary objectives in study HAV-048 and respective results which did not provide support for approval of supplement are included in Appendix 1 Add to Reading List Source URL: www.fda.gov Language: English Biology Cervarix Human papillomavirus Median lethal dose Immunogenicity HPV vaccine H5N1 clinical trials Papillomavirus Vaccines Medicine
284	DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service Food and Drug Administration Center for Biologics Evaluation and Research Add to Reading List Source URL: www.fda.gov Language: English Health Hepatitis B vaccine Pneumococcal conjugate vaccine DPT vaccine Immunogenicity FluMist Varicella vaccine Pertussis Influenza vaccine Vaccines Vaccination Medicine
285	Havrix, Hepatitis A Vaccine, Inactivated Add to Reading List Source URL: www.fda.gov Language: English Biology Hepatitis A vaccine Hepatitis A Immunogenicity Influenza Clinical trial Twinrix H5N1 clinical trials Medicine Vaccines Health
286	Guidance for Industry Immunogenicity Assessment for Therapeutic Protein Products DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding this draft documen Add to Reading List Source URL: www.fda.gov Language: English Anatomy Immune system Vaccination Immunogenicity Glycoproteins Vaccine PEGylation Antigen Cancer vaccine Immunology Biology Medicine
287	FDA Workshop: Anthrax Vaccines: Bridging Correlates Of Protection In Animals To Immunogenicity In Humans Add to Reading List Source URL: www.fda.gov Language: English Anthrax Biological warfare Vaccines Food and Drug Administration Bioethics Center for Biologics Evaluation and Research Biodefense Court reporter Biology Health Medicine
288	September 17, [removed]Vol[removed]No. RR-13 Recommendations and Reports Add to Reading List Source URL: www.cdc.gov Language: English - Date: 2001-08-06 09:57:03 Biology Hib vaccine Vaccination schedule DPT vaccine Haemophilus influenzae Pertussis Vaccination Conjugate vaccine Immunogenicity Vaccines Medicine Health
289	Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein) Clinical Review Add to Reading List Source URL: www.fda.gov Language: English Pharmacology Pneumococcal polysaccharide vaccine Health Immunogenicity Wyeth Vaccination schedule Pneumococcal vaccine Vaccines Medicine Pneumococcal conjugate vaccine
290	Clinical Reviewer: Doran L. Fink, M.D., Ph.D. STN: [removed]Application Type STN CBER Received Date Add to Reading List Source URL: www.fda.gov Language: English Biology Immunogenicity Influenza vaccine Japanese encephalitis Pneumococcal conjugate vaccine Fluzone Vaccines Medicine Health

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