
A Study of Inactivated Swine-Origin A/H1N1 Influenza Vaccines in Healthy European Subjects Aged...
InfluenzaSwine-origin A/H1N1 InfluenzaThe purpose of this study is to generate data on immunogenicity and safety of the monovalent H1N1 vaccine in support of the development and registration. Primary objectives: To describe the immune response to vaccines 21 days after each vaccination in all participants. To describe the antibody persistence eight months after the first vaccine administration using HAI method, in a subset of participants who received two injections. To describe the immune response against the A/H1N1 strain using HAI method 21 days after a vaccination with the 2010-2011 NH seasonal TIV administered approximately 13 months after the first vaccination in the subset of participants who received two injections. To describe the safety profile of each vaccine in all participants.

H1N1 Vaccine in Pregnant Women
InfluenzaThe 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.

Immunogenicity, Safety and Tolerability of Two Doses of Adjuvanted and Non-adjuvanted Swine Origin...
Pandemic InfluenzaThis 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.

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

Dose Sparing Intradermal S-OIV H1N1 Influenza Vaccination Device
Influenza InfectionPrimary objective: To evaluate the safety and immunogenicity of low-dose ID S-OIV H1N1 vaccines delivered via a novel microneedle device (MicronJet600) and compare this to the full-dose standard IM injection. Hypothesis: Low dose (20%) intradermal (ID) S-OIV H1N1 vaccine delivered via a novel microneedle device (MicronJet600) is equally effective as full-dose standard intramuscular (IM) vaccine.

H1N1v Vaccination of Pregnant Women: A Longitudinal Cohort Study Characterizing Influenza A H1N1v...
H1N1v InfluenzaPregnant women are at particular risk during the imminent H1N1v influenza pandemic. The new H1N1v virus requires urgent political and medical decisions on vaccination strategies in order to minimize severe disease and death from this pandemic. However, there is a lack of evidence to build such decisions upon. A vaccine will be provided in the fourth quarter of 2009, but there is little knowledge on the immunogenicity. Particularly its clinical effectiveness and duration of immunity in pregnant women and their newborn infants is unknown. Therefore, it will be important to study the optimal vaccination regimens with respect to dosing and use of adjuvant to decide future health policies on vaccination of pregnant women. We have a unique possibility to study these aspects of H1N1v infection in pregnant women in our ongoing unselected, prospective, birth-cohort study recruiting 800 pregnant mothers between Q1- 2009 and Q4-2010. Pregnant women from East-Denmark are being enrolled during the 2nd trimester and their infant will undergo a close clinical follow-up. The H1N1v pandemic is expected to reach Denmark Q4-2009. The timing of this enrollment and the imminent pandemic allows for an "experiment of nature" whereby the first half of the mothers completes pregnancy before the H1N1v pandemic. The other half of this cohort will be pregnant while H1N1v is prevalent in the community and will require H1N1v vaccination. The aim of this randomized, controlled, trial is to compare and evaluate the dose-related immune protection conferred by vaccine and adjuvant (Novartis vaccine Focetria) in pregnant women and non-pregnant women. In addition the protocol will assess the passive immunity conferred to the newborn from these vaccine regimes. The study will provide evidence-based guidance for health policies on vaccination for the population of pregnant women during future H1N1v pandemics.

Comparison of Different Methods for Reducing Pain From Influenza Vaccine Injections
PainAnxietyThe purpose of this study is to compare four different analgesic strategies in adults undergoing routine influenza immunization

Effects of Tea Catechin Consumption on the Prophylaxis of Influenza Infection
Influenza InfectionThe Purpose of this study is to evaluate the effects of 5 months catechin consumption on the prevention of influenza infection.

A Pilot Study to Evaluate the Safety and Immunogenicity of Low Dose Flu Vaccines
InfluenzaHumanThe purpose of this study is to determine whether low dose flu vaccines delivered with microneedles into the skin (intradermally) are effective.

Phase IV Clinical Trial of an Influenza Split Vaccine Anflu
InfluenzaTo evaluate the safety and immunogenicity of the three consecutive lots of an seasonal split influenza vaccine Anflu in adults, a randomized, double-blind and controlled clinical trial was conducted in 560 subjects in Tianjin City of China.