Clinical Efficacy of Trivalent Live-Attenuated Influenza Vaccine (LAIV) Among Children in Senegal

NCT01854632 | Completed Phase 3 Results

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

Brief Summary

This study will provide the Senegal Ministry of Health with data on the clinical efficacy of the Live-Attenuated Influenza Vaccine (LAIV). This data will inform future policy considerations for influenza vaccine.

Conditions

Influenza

Keywords

influenza vaccine; trivalent live-attenuated influenza vaccine; efficacy; Africa; Senegal

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Symptomatic, Laboratory-confirmed Influenza Virus Infection (Regardless of Vaccine Match)

  Through 7 to 8 months post vaccination

Secondary Outcomes (10)

• Safety Profile of LAIV: Immediate Reactions Occurring Within 30 Minutes of Administration of Study Vaccine.

  Through 30 minutes post vaccination

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

  Through 7 days post vaccination

• Safety Profile of LAIV: Serious Adverse Events

  Through 1 month post vaccination

• Safety Profile of LAIV: Other Non-serious Adverse Events

  Through 1 month post vaccination

• Safety Profile of LAIV: Protocol Defined Wheezing Illness

  Through 7 to 8 months post vaccination

Study Arms (2)

SIIL Live Attenuated Influenza Vaccine

EXPERIMENTAL

Single 0.5 mL dose of trivalent live-attenuated influenza vaccine 2012/2013 Northern Hemisphere vaccine containing A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010

Biological: SIIL Live Attenuated Influenza Vaccine

Matched placebo

PLACEBO COMPARATOR

Single 0.5mL 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.

Biological: Matched placebo

Interventions

SIIL Live Attenuated Influenza Vaccine BIOLOGICAL

Trivalent live-attenuated influenza vaccine 2012/2013 Northern Hemisphere vaccine containing A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010

SIIL Live Attenuated Influenza Vaccine

Matched placebo BIOLOGICAL

Matched 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.

Matched placebo

Eligibility Criteria

• Age: 24 Months - 71 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 71 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 Niakhar DSS 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:

• Serious, active, medical condition, including: 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 of any kind.
• 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.
• History of Guillain-Barré syndrome.
• Receipt of immunosuppressive agents, including systemic corticosteroids, during the month before planned study vaccination.
• Receipt of aspirin therapy or aspirin-containing therapy within the two weeks before planned study vaccination.
• History of any severe allergic reaction with generalized urticarial, angioedema, or anaphylaxis.
• Receipt of an influenza vaccine within the past 12 months.
• 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.
• Temporary Contraindications:
• Acute illness accompanied by a body temperature of 37.5°C or above (axillary measurement) within 14 days of enrollment visit.
• Any acute respiratory infection within 14 days of enrollment visit.
• Any illness accompanied by active wheezing within 14 days of enrollment visit.

Sponsors & Collaborators

• PATH: lead
• Institut de Recherche pour le Developpement: collaborator
• Institut Pasteur de Dakar: collaborator
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

Institut de Recherche pour le Développement (IRD), Niakhar station

Niakhar, Senegal

Location

Related Publications (1)

• Victor JC, Lewis KD, Diallo A, Niang MN, Diarra B, Dia N, Ortiz JR, Widdowson MA, Feser J, Hoagland R, Emery SL, Lafond KE, Neuzil KM. Efficacy of a Russian-backbone live attenuated influenza vaccine among children in Senegal: a randomised, double-blind, placebo-controlled trial. Lancet Glob Health. 2016 Dec;4(12):e955-e965. doi: 10.1016/S2214-109X(16)30201-7. Epub 2016 Oct 13.

  PMID: 27746224 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

• Aldiouma Diallo, MD

  Institut de Recherche pour le Développement (IRD)

  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: May 13, 2013
• First Posted: May 15, 2013
• Study Start: May 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: June 3, 2015
• Results First Posted: June 3, 2015

Record last verified: 2014-02

Locations

SE (1)