SEA034 Site Initiation Training Launched in Vietnam

The MSD® POC Influenza Test is a new device designed to diagnose different strains of influenza with improved precision and more quickly compared to the standard diagnostic tools such as PCR and RT-PCR. 

The SEA034 study—Clinical Validation of the Point-Of-Care (POC) MSD® Influenza Test in Asia conducted in Network sites in Vietnam will verify the accuracy and usefulness of the POC Test especially in the context of the current influenza pandemic. 

Four Network partner sites in Vietnam: National Hospital of Tropical Diseases (Hanoi); Hospital of Tropical Diseases;Children’s Hospital No 1 and Children’s Hospital No 2, all three in Ho Chi Minh City,  participated in a Site Initiation Training for the SEA034 Study on January 25, 2010 in HCMC.

The training facilitators, Julie Welch (NIH), Dennis Mertz (MSD), Nguyen Thi Hanh (PPD) and FHI Vietnam Team provided the participants with a protocol overview, study background, purpose, timelines and recruitment goals.  Included in the training topics were study procedures, CRF completion and coordination of laboratory procedures. The participants also learned about regulatory and GCP Obligations and the POC device itself. 

The majority of participants have been involved in other studies with the Network.

Following the training, the NIH and MSD representatives visited all four sites to observe study preparation and to install the MSD® POC devices for the study.

The SEA034 study will evaluate the performance of the MSD® POC Influenza Test  in detecting and differentiating influenza strains, including influenza A subtypes H1 (A/H1), H3 (A/H3) and H5 (A/H5). The test will also detect influenza B in subjects with influenza-like illness (ILI) in POC settings in Asia using nasal and throat swabs.

The study is targeted to enroll 30 A/H1-positive (seasonal) patients, 30 A/H3-positive patients and 30 B-positive patients through screening a total of approximately 1500 patients.