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Influenza clinical trials

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NCT ID: NCT01946425 Completed - Influenza Clinical Trials

Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Quadrivalent Influenza Virus Vaccine

Start date: September 2013
Phase: Phase 4
Study type: Interventional

The aim of this study is to evaluate the safety and immunogenicity of Fluzone® Quadrivalent vaccine in participants aged 6 months to < 9 years at enrollment, divided into 2 age strata (6 months to < 36 months and 3 years to < 9 years) Primary Objective: - To describe the safety of the 2013-2014 formulation of Fluzone Quadrivalent vaccine, administered in a 1- or 2-dose schedule, in accordance with Advisory Committee on Immunization Practices (ACIP) recommendations, in children 6 months to < 9 years of age. Observational Objectives: - To describe the immunogenicity of the 2013-2014 formulation of Fluzone Quadrivalent vaccine, administered in a 1- or 2-dose schedule in accordance with ACIP recommendations, in children 6 months to < 9 years of age. - To submit sera from subjects to the Center for Biologics Evaluation and Research (CBER) for further analysis by the World Health Organization (WHO), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA) to support formulation recommendations for subsequent influenza vaccines.

NCT ID: NCT01945424 Completed - Pregnancy Clinical Trials

Sanofi Pasteur Quadrivalent Influenza Vaccine (QIV) Pregnancy Registry

Start date: August 16, 2013
Phase:
Study type: Observational [Patient Registry]

The Sanofi Pasteur Quadrivalent Influenza Vaccine (QIV) Pregnancy Registry will be a prospectively recruited pregnancy surveillance program designed to collect and analyze information on vaccine exposures, pregnancy outcomes, and fetal and offspring outcomes.

NCT ID: NCT01942265 Completed - Influenza Clinical Trials

H7N9 Mix and Match With AS03 and MF59 in Healthy Adults

Start date: September 2013
Phase: Phase 2
Study type: Interventional

This Phase II randomized, double-blinded, controlled study in up to 1000 males and non-pregnant females, 19 to 64 years old, inclusive, who are in good health and meet all eligibility criteria is designed to provide data on an A/H7N9 vaccine made with HA antigen derived from the influenza A/Shanghai/2/2013 virus.

NCT ID: NCT01938742 Completed - Influenza Clinical Trials

H7N9 Mix and Match With MF59 in Healthy Adults

Start date: September 2013
Phase: Phase 2
Study type: Interventional

This is a Phase II randomized, double-blinded, controlled study in up to 700 males and non-pregnant females, 19 to 64 years old, inclusive, designed to assess the safety, reactogenicity, and immunogenicity of a monovalent influenza A/H7N9 virus vaccine administered at different dosages (3.75, 7.5, or 15 mcg of HA/0.5 mL dose) given with and without MF59 adjuvant and without adjuvant (15 mcg of HA/0.5 mL dose and 45 mcg of HA/0.75 mL dose). Subjects will receive two doses via intramuscular injection, approximately 21 days apart. Safety, reactogenicity, and immunogenicity data will be collected at standard time points with safety follow-up to continue through one year post dose 2. The duration of the study for each subject will be approximately 13 months.

NCT ID: NCT01938352 Completed - Influenza Clinical Trials

Evaluation of the Protective Efficacy and Safety of CR8020 in an Influenza Challenge

Start date: October 2, 2013
Phase: Phase 2
Study type: Interventional

After prophylactic vaccination with CR8020, a monoclonal antibody, subjects will be challenged with the H3N2 virus. The protective efficacy, safety, tolerability, pharmacokinetics, and potential immunogenicity will be assessed.

NCT ID: NCT01938170 Active, not recruiting - Influenza Clinical Trials

Home Administration of FluMist by Parents/Caregivers

Start date: September 2014
Phase: N/A
Study type: Interventional

This study will examine the feasibility of having parents and caregivers administer FluMist live intranasal vaccine to their children at home outside the traditional medical environment and without the involvement of medical personnel. The study will recruit patients and families that are already eligible to receive the FluMist vaccine. After consent is obtained and vaccine is given to the family, they will go home to administer vaccine to other members within 24 hours. Telephone follow up within 48 hours will confirm that vaccine was given successfully and within 9-12 days to assess patient preferences for giving vaccine at home and if there were any adverse events.

NCT ID: NCT01934127 Completed - Influenza Clinical Trials

Immunogenicity and Safety Study of Different Formulations of GlaxoSmithKline (GSK) Biologicals H7N1 Influenza Vaccine Administered to Adults 21 to 64 Years of Age

Start date: August 26, 2013
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety and immunogenicity of different formulations of GSK Biologicals H7N1 influenza vaccine in subjects 21 to 64 years of age. The study will evaluate safety related events and antibody immune responses to different formulations of study vaccine and placebo.

NCT ID: NCT01933048 Completed - Influenza Clinical Trials

Self-Administered Nasal Influenza Feasibility Study

SNIF
Start date: September 2012
Phase: Phase 4
Study type: Interventional

The purpose of this prospective, open-label clinical trial is to evaluate the immunogenicity of self-administered (SA) live, attenuated influenza vaccine (LAIV) in comparison with healthcare worker administered (HCWA) LAIV and to evaluate the feasibility of group self-administration of LAIV.

NCT ID: NCT01916759 Completed - HIV Clinical Trials

Differences in Response to the Flu Vaccine Among Adults With HIV and Without HIV in Uganda

Start date: June 2013
Phase: N/A
Study type: Interventional

To use a systems biological approach to study the molecular signatures of innate and adaptive responses to vaccination in a HIV infected versus uninfected adult population in Kampala, Uganda.

NCT ID: NCT01911754 Completed - Influenza Clinical Trials

Japanese Pediatric H5N1 Vaccine Study

Start date: August 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to obtain immunogenicity and safety data of an H5N1 pandemic influenza vaccine in a Japanese pediatric population aged 6 months to 17 years