Influenza Vaccine Efficacy against Childhood Pneumonia in Urban Tropical Setting

Dates

Start Date: 07/01/2009
End Date: 06/30/2012

Pneumonia is the primary cause of child mortality worldwide. Data from Bangladesh indicate that influenza has a high incidence of over 10% per year among children < 5 years, and that among children who get influenza infection, 28% develop pneumonia, including severe pneumonia. Influenza-infected children who develop pneumonia are significantly younger (< 2y) than those who do not. Due to the high influenza incidence, and the high proportion of influenza-infected children who develop pneumonia, influenza is a major contributor to childhood pneumonia, not only in Bangladesh, but likely throughout the pneumonia endemic tropical and sub-tropical belt. Although trials have been conducted to examine influenza vaccine impact on influenza, none have been conducted specifically to determine the effect on childhood pneumonia, particularly among those < 2 years who are at highest pneumonia risk. We propose to conduct such a trial. The project goal is to determine whether influenza vaccine (trivalent inactivated vaccine or TIV) can reduce childhood pneumonia burden including: influenza-associated, other aetiology-mediated, and overall pneumonia incidence. The specific objectives are to determine influenza vaccine efficacy on 1) early childhood pneumonia (children < 2 years), 2) laboratory-confirmed influenza and 3) the rates of influenza-specific complications including severe disease, hospitalisation, and otitis media. Secondary objectives include determining the effect of influenza vaccine on household transmission and associated complications among all age groups, the effect on proven non-influenza viral and bacterial invasive diseases, the occurrence of adverse events associated with the vaccine, and to measure immune responsiveness to influenza vaccine in these young children. Critical milestones include comparison between vaccinated and vaccine-controlled children of 1) pneumonia incidence (vaccine efficacy against pneumonia), 2) influenza incidence (vaccine efficacy against influenza) 3) rates of other clinical syndromes (vaccine efficacy against other childhood morbidity). Milestones related to secondary objectives include comparison between vaccinated and vaccine-controlled children of 1) rates of laboratory-confirmed infection and clinical illness among household contacts and 2) rates of other invasive bacterial and viral diseases, and 3) rates of adverse events. We will also measure childhood immune responsiveness to influenza vaccine and relate that to observed rates of infection and clinical illness.

Dhaka, Bulgaria

People

Yukari C. Manabe, MD

Associate Director of Global Health Research and Innovation

Robert Bollinger Jr., MD MPH

Director, Johns Hopkins Center for Clinical Global Health Education (CCGHE); Associate Director, Johns Hopkins Center for Global...

Joanne Katz, ScD MS,BSc

Associate Chair, Director of Academic Programs

Caitlin Kennedy, PhD MPH,BA

Co-Director, MPH concentration in Social and Behavioral Sciences in Public Health; Associate Director, Center for Qualitative...

Stefan Baral, MD MPH,MBA,MSc

Director, Key Populations Program

Noreen Hynes, MD MPH

Director, Geographic Medicine Center of the Division of Infectious Diseases
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December 2019

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