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Influenza clinical trials

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NCT ID: NCT00921947 Completed - Influenza Clinical Trials

Comparative Safety and Immunogenicity of 1.0 µg Intramuscular (i.m.) and 2.0 µg Subcutaneous (s.c.) Dosing With VAX102 (M2e-flagellin) Universal Influenza Vaccine in Healthy Adults

Start date: June 2009
Phase: Phase 1/Phase 2
Study type: Interventional

1. To assess the safety, reactogenicity, tolerability, and adverse events (AEs) of the VAX102 vaccine in a two dose regimen (Day 0 and Day 28) at the 1.0 µg dose level delivered i.m., or the 2.0 µg dose level delivered s.c. in a healthy adult population. 2. To assess the immunogenicity (anti-M2e serum antibody concentration) of the VAX102 vaccine in a two dose regimen (Day 0 and Day 28) at the 1.0 µg dose level delivered i.m., or the 2.0 µg dose level delivered s.c. as measured by an enzyme-linked immunosorbent assay (ELISA) in a healthy adult population.

NCT ID: NCT00921726 Completed - Influenza Clinical Trials

Pharmacokinetic Study of Oseltamivir and Intravenous Zanamivir in Healthy Adults

Start date: July 2009
Phase: Phase 1
Study type: Interventional

Due in part to widespread availability of oseltamivir and clinical experience using oseltamivir to treat H5N1 influenza virus infections, many strains of influenza have become resistant to it. Other reliable methods of treating H5N1 must be identified in case of a pandemic. One such option is intravenous zanamivir used in combination with oseltamivir. The primary purpose of this study is to evaluate the interaction between oral oseltamivir and intravenous zanamivir administered as either a continuous or intermittent infusion in healthy adults.

NCT ID: NCT00921206 Completed - Influenza Clinical Trials

Study to Investigate the Immune Response to Two Doses of VAX102 Healthy Adults

Start date: June 2009
Phase: Phase 1
Study type: Interventional

The objective is to assess the humoral and cellular immune response of the VAX102 vaccine delivered IM and SC in a prime-boost regimen at dose levels 1 µg or 2 µg in healthy adults against the influenza A virus M2e antigen after each vaccination.

NCT ID: NCT00920374 Completed - Influenza Clinical Trials

A Study for Evaluation of Immunogenicity and Reactogenicity of FluarixTM / Influsplit SSW® 2009/2010 in Adults

Start date: June 16, 2009
Phase: Phase 3
Study type: Interventional

This study is designed to test the immunogenicity and reactogenicity of the FluarixTM/Influsplit SSW® influenza vaccine containing the influenza strains recommended for the 2009-2010 season.

NCT ID: NCT00915187 Completed - Influenza Clinical Trials

Safety and Immunogenicity Study of Intramuscular CCS/C-adjuvanted Influenza Vaccine in Elderly

Start date: October 2009
Phase: Phase 2
Study type: Interventional

To examine the safety and immunogenicity of two formulation of liposomal adjuvant / delivery system (VaxiSomeTM=CCS-Cholesterol [CCS/C]), combined with commercial influenza vaccine in an elderly healthy population when given once intramuscularly (IM).

NCT ID: NCT00912496 Completed - Influenza Clinical Trials

Booster Trial to 07-0019 With A/Anhui/05 With and Without MF59

Start date: June 2010
Phase: Phase 1
Study type: Interventional

This research will study safety and the body's immune (defense system) responses, including anti-H5 flu antibodies (the body's protective proteins found in the blood), to an inactivated influenza "H5" bird flu, virus vaccine. Participants will be assigned by chance to receive the vaccine injections with and without an adjuvant, (substance that can improve vaccine effectiveness so less vaccine may be used) MF59, or placebo (inactive substance). Five different vaccine dose strengths will be evaluated. About 735 healthy participants, ages 18-49 will be asked to take part in this study. Study procedures include physical exam, blood sampling, and use of a memory aid. Volunteers will participate for up to 13 months.

NCT ID: NCT00905125 Completed - Influenza Clinical Trials

Influenza Vaccine in Pregnant Women

Start date: June 2009
Phase: Phase 2
Study type: Interventional

In pregnant women, flu may cause complications like pneumonia (infection of the lungs) or hospitalization. In the United States (US) it is recommend that all women get flu vaccine if they are going to be pregnant or deliver during the flu season but only a few studies have measured a pregnant woman's immune response (the body's defense against the flu) after getting the flu vaccine. About 200, 18-39 year old, inclusive, pregnant women in their second or third trimester (from 14 weeks of gestation to term, inclusive) will be enrolled in this US based study. Participation will be about 8 months in duration. Women will be randomized (assigned by chance) to receive either Fluzone® or Fluarix®. Blood collection will occur on Day 0 and 28 days post vaccination.

NCT ID: NCT00900991 Completed - Influenza Clinical Trials

Safety and Immunogenicity of a Split-Virion Pandemic Influenza A (H5N1) Vaccine in Children

Start date: n/a
Phase: Phase 2
Study type: Interventional

A single center, stratified, randomized and double-blind phase II clinical trial was conducted in children to evaluate the safety and immunogenicity of an split-virion pandemic influenza A vaccine (H5N1).

NCT ID: NCT00900588 Completed - Influenza Clinical Trials

Safety and Immunogenicity of a Split-Virion Pandemic Influenza A (H5N1) Vaccine in Adolescents

Start date: n/a
Phase: Phase 2
Study type: Interventional

A single center, stratified, randomized and double-blind phase II clinical trial was conducted in adolescents to evaluate the safety and immunogenicity of a split-virion pandemic influenza A vaccine (H5N1).

NCT ID: NCT00895544 Completed - Influenza Clinical Trials

Immunogenicity and Safety Study of a Single Prime-Boost Vaccination Schedule With a H5N1 Influenza Vaccine in Adults

Start date: May 2009
Phase: Phase 1/Phase 2
Study type: Interventional

The main objective of the study is to assess the immune response to a non-adjuvanted H5N1 influenza vaccine in an adult population when administered according to a single prime-boost schedule.