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Flu Vaccine Against Childhood Pneumonia, Bangladesh

NCT01319955 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3508

Last updated 2017-09-25

No results posted yet for this study

Summary

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.

Conditions

Interventions

BIOLOGICAL

Trivalent inactivated influenza vaccine

Two doses of 0.25 ml vaccine delivered IM at least 4 weeks apart.

Sponsors & Collaborators

Principal Investigators

  • W. Abdullah Brooks, MD, MPH · International Centre for Diarrhoeal Disease Research, Bangladesh

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
23 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2017-04-30
Completion
2017-04-30

Countries

  • Bangladesh

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01319955 on ClinicalTrials.gov