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Influenza, Human clinical trials

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NCT ID: NCT00970307 Completed - Hepatitis B Clinical Trials

Immunogenicity and Safety Study of GSK Biologicals' GSK2202083A Vaccine in Healthy Infants at 2, 3 and 4 Months of Age

Start date: August 13, 2009
Phase: Phase 2
Study type: Interventional

This study will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083A vaccine co-administered with GSK Biologicals' 10-valent pneumococcal conjugate (GSK1024850A) vaccine given as a three-dose primary vaccination course at 2, 3 and 4 months of age.

NCT ID: NCT00970177 Completed - Pandemic Influenza Clinical Trials

Immunogenicity, Safety and Tolerability of Two Doses of Adjuvanted and Non-adjuvanted Swine Origin A/H1N1 Monovalent Influenza Vaccine in Healthy Subjects 18 or More Years of Age

Start date: August 2009
Phase: Phase 3
Study type: Interventional

This present study, randomized, single-blind, dose-ranging, multicenter study, will evaluate immunogenicity, safety and tolerability of two doses of an adjuvanted and not-adjuvanted new swine-origin influenza A/H1N1 virus monovalent subunit vaccine in healthy adult and elderly subjects. A booster dose will be administered 12 months after the first vaccination.

NCT ID: NCT00968890 Completed - Influenza Clinical Trials

Immunogenicity and Safety of Vaccine GSK2340272A (H1N1) and GSK Biologicals Fluarix™ Vaccine When Co-administered in Elderly

Start date: September 12, 2009
Phase: Phase 2
Study type: Interventional

The purpose of the present study is to assess the immunogenicity, safety and reactogenicity of a two-dose schedule with vaccine GSK2340272A when co-administered with GSK Biologicals' Fluarix™ vaccine either at the time of first or second vaccination in elderly subjects aged 61 years and older.

NCT ID: NCT00968539 Completed - Influenza Clinical Trials

Study to Evaluate the Immunogenicity & Safety of an Investigational Influenza Vaccine (H1N1) in Adults

Start date: September 8, 2009
Phase: Phase 3
Study type: Interventional

The objective of the study is to evaluate the immunogenicity and safety of GSK Biologicals' investigational vaccine GSK2340272A.

NCT ID: NCT00968526 Completed - Influenza Clinical Trials

Study to Evaluate Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Adults

Start date: September 8, 2009
Phase: Phase 3
Study type: Interventional

The objective of the study is to evaluate the immunogenicity and safety of GSK Biologicals' investigational vaccine GSK2340272A.

NCT ID: NCT00966238 Completed - Influenza Clinical Trials

Safety and Immunogenicity of VAX125 Influenza Vaccine in Community-living Adults >= 65 Years of Age

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

A multi-center, open-label, escalating dose-ranging study to assess the safety, reactogenicity, and immunogenicity of four different VAX125 vaccine doses; 0.5 µg, 1.0 µg, 2.0 µg, or 3.0 µg, delivered i.m. as a single dose vaccination on Day 0. Hypothesis: VAX125 is safe and immunogenic at one or more of the doses tested.

NCT ID: NCT00965354 Completed - Influenza Clinical Trials

Mechanisms of Severe Acute Influenza Consortium (MOSAIC)

MOSAIC
Start date: December 2009
Phase:
Study type: Observational

The ultimate goal of this collaborative, intensive study is to discover new and effective treatments and to develop better vaccines that can be used in future outbreaks of Influenza A. By integrating the information that we will gather, we will create a unique overview of how influenza causes illness and what might be done to improve patient management.

NCT ID: NCT00964158 Completed - Influenza Clinical Trials

Safety and Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (H1N1) (GSK2340272A)

Start date: September 10, 2009
Phase: Phase 3
Study type: Interventional

This trial is designed to assess the safety and immunogenicity of a prime-boost schedule of GSK Biologicals' investigational vaccine GSK2340272A in children aged between 3 and 17 years.

NCT ID: NCT00963430 Completed - Influenza Clinical Trials

H1N1 Vaccine in Pregnant Women

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

The purpose of this study is to evaluate an investigational 2009 H1N1 influenza vaccine to determine vaccine safety in pregnant women and the body's immune response (body's defense against disease) to different strengths of the H1N1 influenza vaccine. In this study, 2 strengths of the H1N1 influenza vaccine will be tested (given 3 weeks apart). Participants will include approximately 120 healthy pregnant women, ages 18-39 years, in their second or third trimester of pregnancy (14-34 weeks gestation). Study procedures will include 2 doses of vaccine, blood samples, cord blood samples at delivery, and recording temperature and vaccine side effects in a memory aid for 8 days following each vaccination. Participants will be involved in study related procedures for about 7 months.

NCT ID: NCT00963157 Completed - Influenza Clinical Trials

Sanofi H1N1 Influenza Vaccine Administered at Different Dose Levels With and Without AS03 Adjuvant in Healthy Adult and Elderly Populations

Start date: September 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 when it is given with or without an "adjuvant." An adjuvant is a substance that may cause the body to produce more antibodies when it is given with a vaccine. This study will also compare how age affects the body's response to the H1N1 flu shot. In this study, 3 strengths of the H1N1 flu shot will be tested combined with an adjuvant. In addition, 2 strengths of the H1N1 flu shot will be tested without adjuvant. Two H1N1 flu shots of the same strength, with or without adjuvant, will be given about 3 weeks apart. Participants will include up to 800 healthy adults, approximately 500 individuals ages 18-64 and 250 individuals greater than or equal to age 65. Study procedures include: physical exam, blood samples, completing a memory aid to record vaccine side effects, medications and daily oral temperature. Participants will be involved in study related procedures for up to 13 months.