Implementing Vaccine and Treatment Evaluation Unit (VTEU) Clinical Site: COVPN 3004 Boost

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Principal Investigator: Karen L. Kotloff
Organization: UNIVERSITY OF MARYLAND BALTIMORE
Fiscal Year: 2022
Award: $1,382,804
Funding agency: National Institute of Allergy and Infectious Diseases

Novavax CoVPN 3004 Adult and Pediatric Booster Administration
Project Summary/Abstract:
Novavax Adult and Pediatric booster
To date, 485 adult and 29 pediatric participants have received the initial series of vaccinations, had associated
follow-up visits, and participated in a blinded cross-over. We estimate 380 adult and 29 pediatric participants
will be invited to receive booster dose of vaccine and participate in associated follow-up visits. Blood and other
protocol-required specimens collected at theses visits will be processed, stored, and shipped per protocol.
Data will be entered, and data queries will be resolved in a timely manner.
Surveillance for illness visits will continue and with the advent of new variants, it is expected illness visits will
increase following major holidays with a gradual reduction to follow.

Terms: <0-11 years old><18 year old><18 years of age><2019-nCoV vaccine><2019-nCoV variant><2019-nCoV variant forms><2019-nCoV variant strains><21+ years old><Active Follow-up><Adolescent><Adolescent Youth><Adult><Adult Human><Blinded><Blood><Blood Reticuloendothelial System><CDC><COVID-19><COVID-19 Prevention Network><COVID-19 positive><COVID-19 positivity><COVID-19 vaccine><COVID-19 variant><COVID-19 variant forms><COVID-19 variant strains><COVID19><COVID19 positive><COVID19 positivity><COVID19 vaccine><CV-19><CV19><Centers for Disease Control><Centers for Disease Control and Prevention><Centers for Disease Control and Prevention (U.S.)><Child><Child Youth><Childhood><Children (0-21)><Classification><CoVPN><Data><Dose><Evaluation><Genes><Holidays><Incidence><Messenger RNA><Participant><Process><Protocol><Protocols documentation><Public Health><Refrigeration><Research Specimen><SARS-CoV-2 positive><SARS-CoV-2 positivity><SARS-CoV-2 vaccine><SARS-CoV-2 variant><SARS-CoV-2 variant forms><SARS-CoV-2 variant strains><SARS-CoV2 vaccine><SARS-coronavirus-2 vaccine><Safety><Series><Severe Acute Respiratory Syndrome CoV 2 vaccine><Severe acute respiratory syndrome coronavirus 2 positive><Severe acute respiratory syndrome coronavirus 2 positivity><Severe acute respiratory syndrome coronavirus 2 vaccine><Ships><Specimen><Systematics><Time><United States Centers for Disease Control><United States Centers for Disease Control and Prevention><Vaccination><Vaccines><Variant><Variation><Visit><active followup><adulthood><age 18 years><base><booster dose><booster shot><booster vaccine><clinical research site><clinical site><corona virus disease 2019><corona virus disease 2019 vaccine><coronavirus disease 2019><coronavirus disease 2019 positive><coronavirus disease 2019 positivity><coronavirus disease 2019 prevention network><coronavirus disease 2019 vaccine><coronavirus disease 2019 variant><coronavirus disease 2019 variant forms><coronavirus disease 2019 variant strains><coronavirus disease-19><coronavirus disease-19 vaccine><coronavirus infectious disease-19><eighteen year old><eighteen years of age><evaluate vaccines><fight against><follow up><follow-up><followed up><followup><interest><juvenile><juvenile human><life-threatening COVID><life-threatening COVID-19><life-threatening SARS-CoV-2><life-threatening coronavirus disease><life-threatening coronavirus disease 2019><life-threatening severe acute respiratory syndrome coronavirus 2><mRNA><pediatric><serious COVID><serious COVID-19><serious SARS-CoV-2><serious coronavirus disease><serious coronavirus disease 2019><serious severe acute respiratory syndrome coronavirus 2><severe COVID><severe COVID-19><severe COVID19><severe SARS-CoV-2><severe acute respiratory syndrome coronavirus 2 variant><severe acute respiratory syndrome coronavirus 2 variant forms><severe acute respiratory syndrome coronavirus 2 variant strains><severe coronavirus disease><severe coronavirus disease 19><severe coronavirus disease 2019><severe severe acute respiratory syndrome coronavirus 2><symptomatic COVID-19><symptomatic COVID19><symptomatic coronavirus disease 2019><vaccine against 2019-nCov><vaccine against SARS-CoV-2><vaccine against SARS-CoV2><vaccine against SARS-coronavirus-2><vaccine against Severe Acute Respiratory Syndrome CoV 2><vaccine against Severe acute respiratory syndrome coronavirus 2><vaccine evaluation><vaccine for novel coronavirus><vaccine platform><vaccine screening><vaccine testing><variants of concern><youngster>