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Pharmacology / 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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Company

Novartis Vaccines and Diagnostics Inc. / Novartis Vaccines & Diagnostics Inc / Randomized Routine Vaccines USA / /

Country

Colombia / United States / Saudi Arabia / Canada / Argentina / /

Event

FDA Phase / /

IndustryTerm

prevention of invasive disease / study protocol / protein carrier / /

MedicalCondition

meningitides / Hepatitis A / invasive meningococcal disease / HBV / invasive disease / revised pertussis / meningococcal disease / polio non-inferiority margin / Neisseria meningitides / /

MedicalTreatment

Active immunization / vaccinations / vaccination / /

Organization

Related Biological Products Advisory Committee / Research office of Biostatistics / Biostatistics and Epidemiology Division / Food and Drug Administration Center for Biologics Evaluation / FDA / DEPARTMENT OF HEALTH AND HUMAN SERVICES / Vaccines and Related Biological Products Advisory Committee / /

Person

Barbara Krasnicka / Multicenter Argetyna / Cara Fiore / Tammy Massie / A. D. Horne / /

Position

Team Leader / Manager ChronFile/HFM-210 Meghan Ferris / Chair / BLA Committee / Major / General / Regulatory Project Manager / /

Product

Hyun Won US2 Portable Audio Device / LA6 / Colombia vaccine / MenACWY® / MENVEO® (MenACWY) / MENVEO / MenACWY / V59P21 / HFM-210 / V59P5 / V59P14 / MENVEO® / /

RadioStation

Am 6 / /

Region

Latin America / /

Technology

study protocol / CRM / antibodies / V59P14 protocol / Clinical Study Protocol / /

SocialTag