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Influenza, Human clinical trials

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NCT ID: NCT00996307 Completed - Influenza Clinical Trials

Pivotal, Multicenter, Observer-Blind, Randomized Study of Influenza A (H1N1)2009 Monovalent Subunit Vaccine With and Without Adjuvant in Children Ages 6 to <36 Months

Start date: October 2009
Phase: Phase 2/Phase 3
Study type: Interventional

This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 2009 (swine flu) vaccine in healthy young children

NCT ID: NCT00996138 Completed - Influenza Clinical Trials

Single-blind, Dose-ranging Study of Novel Swine Influenza Virus Vaccine in Japanese Adult Subjects

Start date: September 2009
Phase: Phase 2/Phase 3
Study type: Interventional

This study is to identify the preferred vaccine dosage (of antigen and adjuvant) and schedule (one or two administrations) of the cell-derived H1N1sw monovalent vaccine in healthy adults based on EMEA/CHMP criteria, and safety & tolerability.

NCT ID: NCT00995982 Completed - Influenza, Human Clinical Trials

VRC 309: A Multi-Center, Open-Label, Randomized Phase I Study of an Investigational Influenza DNA Vaccine Followed by 2009/2010 Seasonal Influenza Trivalent Inactivated Vaccine (TIV) Compared to Two Injections of TIV in Adults 45-70 Years

Start date: October 8, 2009
Phase: Phase 1
Study type: Interventional

Background: - Vaccines are substances used to try to create resistance or immunity to a disease and to prevent an infection. Investigators are looking into improved ways to give and test the results of different kinds of vaccines. - Researchers are interested in comparing the results of an experimental DNA vaccine for the prevention of seasonal influenza against a standard FDA-approved vaccine for the prevention of seasonal influenza. The experimental DNA vaccine is not yet approved by the FDA for preventing the flu. Objectives: - To test the safety and immune response of an experimental DNA vaccine for seasonal influenza, compared to the standard vaccine for seasonal influenza. Eligibility: - Healthy individuals between ages 45 and 70 who have not yet received the seasonal influenza vaccine. Design: - Participants will have six planned clinic visits (Weeks 0, 1, 3, 4, 6, and 27) and two telephone follow-up contacts (within 2 days after each injection) during this study. - Participants will be divided into two groups: one group will receive two standard (TIV) flu vaccine injections given using a needle and syringe, while the other will receive the DNA flu vaccine using a needleless injection system followed by the TIV vaccine. - The vaccine injections for both groups will be given approximately 3 weeks apart, - Clinic staff will observe participants for at least 30 minutes after each vaccination. One to two days after each injection, participants must telephone the clinic staff, and for 7 days after the vaccination participants will keep a diary card to report on possible side effects. - During study visits, blood samples will be collected for research purposes to test for responses to vaccine.

NCT ID: NCT00993668 Completed - Clinical trials for Rheumatoid Arthritis

Assessing the Use of Certolizumab Pegol in Adult Subjects With Rheumatoid Arthritis on the Antibody Response When Receiving Influenza Virus and Pneumococcal Vaccines

Start date: September 2009
Phase: Phase 4
Study type: Interventional

The purpose of this trial is to assess the affect of Certolizumab Pegol (CZP) treatment on antibody response to T cell-independent and T cell-dependent immunizations using pneumococcal and influenza vaccines, respectively.

NCT ID: NCT00993083 Completed - Influenza Clinical Trials

A Study to Assess the Safety and Efficacy of a New Influenza Candidate Vaccine MVA-NP+M1 In Healthy Adults

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

This is a Phase IIa open label, non placebo controlled, non-randomised controlled challenge study. The primary objective of this study is to assess the safety of a new influenza vaccine, MVA-NP+M1, when administered as a single dose to healthy volunteers. Initially two volunteers will be vaccinated and challenged with Influenza, followed by vaccination of a further 12 volunteers and an Influenza challenge of those 12 along with 12 non-vaccinated controls.

NCT ID: NCT00992836 Completed - HIV Infections Clinical Trials

Safety of and Immune Response to an H1N1 Influenza Virus Vaccine in HIV Infected Children and Youth

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

Children and people infected with HIV are particularly susceptible to influenza infections. This study testED the safety and effectiveness of a vaccine for the new H1N1 influenza virus in children and youth infected with HIV.

NCT ID: NCT00992784 Completed - Influenza Clinical Trials

Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline Biologicals' Influenza Vaccine in Elderly People

Start date: October 15, 2009
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate the safety of GSK Biologicals' influenza vaccine. Elderly subjects were randomized in the primary study (NCT00760617) and will now receive the same vaccine for the third time. For this study the masking is "observer-blind" for elderly subjects and "open" for young adult subjects.

NCT ID: NCT00992719 Completed - Influenza Clinical Trials

Novartis H1N1 Vaccine in Pregnant Women

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

The purpose of this study is to evaluate the safety of a 2009 H1N1 influenza vaccine in pregnant women and to determine how their body reacts to different strengths of the vaccine. Two strengths of the H1N1 influenza vaccine will be tested. Since it is not known if the response to the vaccine in pregnant women is the same or different than in non-pregnant women, the study also includes a group of women who are not pregnant for comparison. Participants include 200 pregnant women and 100 non-pregnant women ages 18-39. Study procedures include physical exams, several blood samples and maintaining a memory aid to document daily temperature and side effects for 8 days following vaccination. Participants will be involved in study related procedures for about 6 months.

NCT ID: NCT00992511 Completed - Influenza Clinical Trials

Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza (H1N1 Influenza Virus) Vaccine in Adults, Using Two Different Manufacturing Processes

Start date: October 14, 2009
Phase: Phase 3
Study type: Interventional

The objective of this study is to evaluate the immunogenicity and safety of one or two doses of GSK Biologicals' investigational influenza vaccine GSK2340272A, manufactured using two different processes, in adults aged 18 to 60 years.

NCT ID: NCT00992433 Completed - Influenza Clinical Trials

H1N1 Vaccine at Two Dose Levels in HIV Positive Adults

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

The purpose of this study is to see how the body reacts to different strengths of the H1N1 flu shot in persons infected with human immunodeficiency virus (HIV). This study will also compare how the CD4 count (cells that help fight disease) affects the body's response to the H1N1 flu shot. In this study, 2 strengths of the H1N1 flu shot will be given twice, about 3 weeks apart. The results of this study will help researchers find out if the different strengths of the H1N1 flu shot make the body produce H1N1 antibodies that are better at fighting H1N1 flu. About 240 HIV positive subjects, ages 18-64 years, will be asked to take part in this study. Study procedures include: blood sampling, physical exams, and use of memory aids to record temperature, medications and symptoms. The length of patient participation is about 7 months.