A Randomized, Controlled Trial on the Efficacy and Safety of Live-Attenuated Influenza Vaccine (LAIV) Among Children in Bangladesh

NCT01797029 | Completed Phase 3 Results DMC

• 1 other identifier: LAIV-CE-01
• Study Type: interventional
• Target: 1,761
• Locations: 1 country
• Sites: 2

Brief Summary

This is a single center, multi-site, double-blind, parallel group, placebo-controlled trial of the clinical efficacy of trivalent Serum Institute of India, Ltd. (SIIL)live-attenuated influenza vaccine (LAIV) vaccine among children aged 24 through 59 months in Bangladesh. Background:

1. 1.Burden: Within Bangladesh, community- based influenza surveillance identified 84.5 cases/1000 children-years among children \<5 years, while 10% of clinical pneumonia cases were influenza positive in this age group.
2. 2.Knowledge gap: There has never been a randomized clinical efficacy trial of the SIIL LAIV vaccine conducted among children in a low-income country.
3. 3.Relevance: Another LAIV vaccine (made by MedImmune) has been shown to have high efficacy against laboratory-confirmed influenza among children. The SIIL LAIV has the potential to be an inexpensive intervention to prevent pediatric influenza disease.

Conditions

Influenza

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Symptomatic, Laboratory-confirmed Influenza Virus Infection (Vaccine-matched Strains).

  Through 7 to 9 months post-vaccination

Secondary Outcomes (11)

• Safety Profile of LAIV: Solicited and Unsolicited Local and Systemic Reactions

  Through one week post-vaccination

• Safety Profile of LAIV: Immediate Reactions

  30 minutes post-vaccination

• Safety Profile of LAIV: Serious Adverse Events

  Through 7 to 9 months post-vaccination

• Safety Profile of LAIV: Protocol Defined Wheezing Illness

  Through 7 to 9 months post-vaccination

• Percentage of Participants With Symptomatic, Laboratory-confirmed, Influenza Virus Infection (All Strains)

  Through 7 to 9 months post-vaccination

Other Outcomes (4)

• Percentage of Participants With Moderate to Severe, Laboratory-confirmed Influenza Virus Infection Among Children

  Through 7 to 9 months post-vaccination

• Percentage of Participants With Moderate to Severe, Laboratory-confirmed Influenza Virus Infection Among Children

  Through 16 to 19 months post-vaccination

• Percentage of Participants With Symptomatic, Laboratory-confirmed Influenza Virus Infection (Vaccine-matched Strains) Among Children

  From approx. 6 months to approximately 19 months post-vaccination

Study Arms (2)

Vaccine

EXPERIMENTAL

Biological: SIIL Live Attenuated Influenza Vaccine

Placebo

PLACEBO COMPARATOR

Biological: Placebo

Interventions

SIIL Live Attenuated Influenza Vaccine BIOLOGICAL

A single dose of SIIL Trivalent LAIV--2012/2013 Northern Hemisphere vaccine containing A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010

Vaccine

Placebo BIOLOGICAL

A single dose of inactive placebo will be identical to reconstituted SIIL LAIV in ingredients and concentrations except A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010 will be replaced with egg allantoic fluid.

Placebo

Eligibility Criteria

• Age: 24 Months - 59 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy male or female child at least 24 months of age and no older than 59 months of age at the time of study vaccination.
• A child whose parent or guardian's primary residence, at the time of study vaccinations, is within the Kamalapur surveillance site catchment area or Matlab service area and who intends to be present in the area for the duration of the trial.
• A child whose parent or legal guardian is willing to provide written informed consent prior to the participant's study vaccination.

You may not qualify if:

• Has any serious, active, medical conditions, including: a chronic disease of any body system, chronic infections such as tuberculosis, genetic disorders, such as Down's syndrome or other cytogenetic disorder, known or suspected disease of the immune system.
• Is receiving immunosuppressive agents, including systemic corticosteroids, during the month prior to study vaccination.
• Has a history of documented hypersensitivity to eggs or other components of the vaccine (including gelatin, sorbitol, lactalbumin and chicken protein), or with life-threatening reactions to previous influenza vaccinations.
• Has ever received influenza vaccine (LAIV or inactivated).
• History of Guillain-Barre syndrome
• Is receiving aspirin therapy or aspirin-containing therapy currently or two weeks before.
• Lives in household with somebody currently participating in a respiratory vaccination or antiviral study.
• Has current or past participation (within 2 months of trial enrollment visit) in any clinical trial involving a drug or biologic with activity against respiratory disease.
• History of a previous severe allergic reaction with generalized urticarial, angioedema, or anaphylaxis.
• Has any condition determined by investigator as likely to interfere with evaluation of the vaccine or be a significant potential health risk to the child or make it unlikely that the child would complete the study
• Concurrent febrile illness (measured temperature 38 degrees C axillary).
• Active wheezing illness

Sponsors & Collaborators

• PATH: lead
• Johns Hopkins University: collaborator
• International Centre for Diarrhoeal Disease Research, Bangladesh: collaborator
• Centers for Disease Control and Prevention: collaborator
• Bill and Melinda Gates Foundation: collaborator

Study Sites (2)

icddr, b Kamalapur

Dhaka, Bangladesh

Location

icddr,b Matlab

Matlab, Bangladesh

Location

Related Publications (2)

• Rotrosen E, Zaman K, Feser J, Ortiz JR, Goswami D, Sharmeen AT, Rahman M, Lewis KDC, Rahman MZ, Barin B, Brooks WA, Neuzil KM. Influenza Among Young Children in Bangladesh: Clinical Characteristics and Outcomes From a Randomized Clinical Trial. Clin Infect Dis. 2017 Nov 13;65(11):1914-1920. doi: 10.1093/cid/cix674.

  PMID: 29028980 DERIVED

• Brooks WA, Zaman K, Lewis KD, Ortiz JR, Goswami D, Feser J, Sharmeen AT, Nahar K, Rahman M, Rahman MZ, Barin B, Yunus M, Fry AM, Bresee J, Azim T, Neuzil KM. Efficacy of a Russian-backbone live attenuated influenza vaccine among young children in Bangladesh: a randomised, double-blind, placebo-controlled trial. Lancet Glob Health. 2016 Dec;4(12):e946-e954. doi: 10.1016/S2214-109X(16)30200-5. Epub 2016 Oct 13.

  PMID: 27746226 DERIVED

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Senior Clinical Research Scientist
• Organization: PATH

klewis@path.org

206-285-3500

Study Officials

• Abdullah Brooks, MD, MPH

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

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: February 20, 2013
• First Posted: February 22, 2013
• Study Start: February 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: June 11, 2015
• Results First Posted: May 15, 2015

Record last verified: 2014-07

Locations

BA (2)