NCT01319955|CompletedPhase 3DMC
Flu Vaccine Against Childhood Pneumonia, Bangladesh
Influenza Vaccine Efficacy Against Childhood Pneumonia in an Urban Tropical Setting
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Sponsor study identifier
Secondary identifiers
OTHER · Johns Hopkins University
interventional
3,508
1 country
1
Study Start
August 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2017
Actual (reported)Study Completion
April 2017
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2010
Date type not reportedThis date has not been verified as actual or estimated.
March 9, 2011
Actual (reported)March 22, 2011
Actual (reported)April 2017
Actual (reported)April 2017
Actual (reported)Clinical pneumonia
Children who present with age-specific tachypnoea, cough with crepitations on auscultation will be determined to have clinical pneumonia. If this occurs ≥14 days post two doses of influenza vaccine, they will be considered fully vaccinated. Comparisons will be made between groups on the number of such episodes.
Up to 12 months post-vaccination
Laboratory confirmed influenza infection
Influenza infection will be determined by RT-PCR among children with signs and symptoms of febrile and/or respiratory symptoms, including pneumonia.
Up to 12 months post-vaccination
Indirect effects
Up to 12 months post-vaccination
Epidemiological and clinical characteristics of influenza infection
Up to 12 months post vaccination
Effect on non-influenza viral and bacterial invasive disease
Up to 12 months post vaccination
Immunogenicity
Within 4 months of vaccine administration
Adverse events associated with the vaccine
Beginning Day 0 (day of vaccination) and for the next 7 days
Two doses of 0.25 ml vaccine delivered IM at least 4 weeks apart.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
ICDDR,B
Dhaka, 1000, Bangladesh
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.
Rolfes MA, Goswami D, Sharmeen AT, Yeasmin S, Parvin N, Nahar K, Rahman M, Barends M, Ahmed D, Rahman MZ, Bresee J, Luby S, Moulton LH, Santosham M, Fry AM, Brooks WA. Efficacy of trivalent influenza vaccine against laboratory-confirmed influenza among young children in a randomized trial in Bangladesh. Vaccine. 2017 Dec 15;35(50):6967-6976. doi: 10.1016/j.vaccine.2017.10.074. Epub 2017 Oct 31.
W. Abdullah Brooks, MD, MPH
International Centre for Diarrhoeal Disease Research, Bangladesh
3,508 participants (actual enrollment reported by the registry).
First Submitted
March 9, 2011
First Posted
March 22, 2011
Study Start
August 2010
Date type not reportedThis date has not been verified as actual or estimated.
The Efficacy of Zinc as Adjunct Therapy in the Treatment of Severe Pneumonia in Children
Contact the study team to confirm eligibility.
Primary Completion
April 2017
Actual (reported)Study Completion
April 2017
Actual (reported)Last Updated
September 25, 2017
Record last verified: 2016-08
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Source: ClinicalTrials.gov.
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