Pneumonia | Flu Vaccine Against Childhood Pneumonia, Bangladesh
Pneumonia research study
What is the primary objective of this study?
Pneumonia is the leading cause of child death worldwide. Data from Bangladesh indicates that influenza has a substantial association with pneumonia among children less than two years old. This study will use commercially available trivalent inactivated vaccine (killed vaccine) to see if it can prevent early childhood pneumonia among children less than two years old. The study will vaccinate children across three seasons (3 years), and look at the effect on the attack rate of pneumonia, as well as its effects on laboratory-confirmed influenza. It will also look at the effect on laboratory-confirmed influenza illness among the non-vaccinated household contacts of all ages of these children.
Who is eligible to participate?
Inclusion Criteria: - Children will be included if they are de jure residents 6 months to 23 months old at the time of first dose vaccination residing in households under surveillance. Exclusion Criteria: - Children will be excluded if they have known chronic respiratory, cardiac, or neurological (including seizure disorders) illnesses, are severely malnourished or require hospitalisation for any other reason, are suspected of having tuberculosis (WHO guidelines) , are known to have egg allergy, or parents withhold consent.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Laboratory Confirmed Influenza
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Biological:Trivalent inactivated influenza vaccineTwo doses of 0.25 ml vaccine delivered IM at least 4 weeks apart.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Influenza vaccine (trivalent inactivated vaccine)
Inactivated polio vaccine
Start Date: August 2010
Completed Date: April 2017
Phase: Phase 3
Primary Outcome: Clinical pneumonia
Secondary Outcome: Indirect effects
Study sponsors, principal investigator, and references
Principal Investigator: W. Abdullah Brooks, MD, MPH
Lead Sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh
Collaborator: Johns Hopkins University
Brooks WA, Goswami D, Rahman M, Nahar K, Fry AM, Balish A, Iftekharuddin N, Azim T, Xu X, Klimov A, Bresee J, Bridges C, Luby S. Influenza is a major contributor to childhood pneumonia in a tropical developing country. Pediatr Infect Dis J. 2010 Mar;29(3):216-21. doi: 10.1097/INF.0b013e3181bc23fd.