Flu Vaccine Against Childhood Pneumonia, Bangladesh

NCT01319955 | Completed Phase 3 DMC

• 2 other identifiers: PR-0905400002579
• Study Type: interventional
• Target: 3,508
• Locations: 1 country
• Sites: 1

Brief 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

Pneumonia; Laboratory Confirmed Influenza

Keywords

Pneumonia; Influenza; Child; Respiratory; Pathogen

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (5)

• 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

Study Arms (2)

Influenza vaccine (trivalent inactivated vaccine)

EXPERIMENTAL

Biological: Trivalent inactivated influenza vaccine

Inactivated polio vaccine

ACTIVE COMPARATOR

Biological: Trivalent inactivated influenza vaccine

Interventions

Trivalent inactivated influenza vaccine BIOLOGICAL

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

Also known as: Vaxigrip Junior

Inactivated polio vaccine; Influenza vaccine (trivalent inactivated vaccine)

Eligibility Criteria

• Age: 6 Months - 23 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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) \[83\], are known to have egg allergy, or parents withhold consent.

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead
• Johns Hopkins University: collaborator
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

ICDDR,B

Dhaka, 1000, Bangladesh

Location

Related Publications (2)

• 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.

  PMID: 20190613 BACKGROUND

• 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.

  PMID: 29100706 DERIVED

MeSH Terms

Conditions

Pneumonia; Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases

Study Officials

• W. Abdullah Brooks, MD, MPH

  International Centre for Diarrhoeal Disease Research, Bangladesh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2011
• First Posted: March 22, 2011
• Study Start: August 1, 2010
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: September 25, 2017

Record last verified: 2016-08

Locations

BA (1)