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

Primary Purpose

Influenza

Status

Completed

Phase

Phase 3

Locations

Senegal

Study Type

Interventional

Intervention

SIIL Live Attenuated Influenza Vaccine

Matched placebo

About this trial

This is an interventional prevention trial for Influenza focused on measuring influenza vaccine, trivalent live-attenuated influenza vaccine, efficacy, Africa, Senegal

Eligibility Criteria

24 Months - 71 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

SIIL Live Attenuated Influenza Vaccine

Matched placebo

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

Safety Profile of LAIV: Serious Adverse Events

Safety Profile of LAIV: Other Non-serious Adverse Events

Safety Profile of LAIV: Protocol Defined Wheezing Illness

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

Percentage of Participants With Symptomatic, Laboratory-confirmed Influenza Virus Infection by Influenza Type/Subtype (Influenza A/H1N1, Influenza A/H3N2, and Influenza B)

Clinical Characteristics of Influenza in the Study Population

Etiologies of Influenza-like Illness in the Study Population

Bacterial and viral etiologies of acute respiratory and febrile illness will be parameterized as the percentage of those with each particular laboratory-confirmed infection categorized by vaccine allocation.

Evaluation of Vaccine-take as Shedding of Vaccine Virus Post-vaccination, Including Viral Load and Duration of Virus Detection

Vaccine take will be parameterized as the percentage of participants with detectable vaccine-virus in nasal or throat swab on each day pre- (day 0) and post vaccination (i.e., 2 and 4 days post vaccination), and the quantity of detected virus.

Full Information

NCT ID

NCT01854632

First Posted

May 13, 2013

Last Updated

June 1, 2015

Sponsor

PATH

Collaborators

Institut de Recherche pour le Developpement, Institut Pasteur de Dakar, Centers for Disease Control and Prevention

1. Study Identification

Unique Protocol Identification Number

NCT01854632

Brief Title

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

Official Title

A Randomized, Double-Blind, Placebo-Controlled Trial of the Clinical Efficacy of Trivalent Live-Attenuated Influenza Vaccine (LAIV) Among Children in Senegal

Study Type

Interventional

2. Study Status

Record Verification Date

February 2014

Overall Recruitment Status

Completed

Study Start Date

May 2013 (undefined)

Primary Completion Date

December 2013 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

PATH

Collaborators

Institut de Recherche pour le Developpement, Institut Pasteur de Dakar, Centers for Disease Control and Prevention

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

This study is a double-blind, individual-randomized, placebo-controlled, clinical efficacy trial among healthy children aged 24 through 71 months in the Niakhar area of Senegal. A total of 1,761 healthy children will be randomized in a 2:1 ratio of LAIV to placebo. For evaluation of efficacy, passive and active surveillance will be conducted weekly throughout the study to identify outcomes among vaccinated subjects. Children meeting the protocol-defined clinical case definition will have a nasal swab and throat swab specimen collected for testing by rRT-PCR for evidence of influenza virus infection. 100 of the 1,761 participants were also included in a substudy designed to evaluate virologic evidence of LAIV replication. As such, nasal and throat swab specimens were collected on day 0 (prior to vaccination), as well as on post-vaccination days 2, and 4 from all subjects included in the substudy. These specimens will be tested for presence of wild-type and vaccine virus. Additionally, a more detailed assessment of vaccine reactogenicity will be made among these children by actively collecting solicited and unsolicited reactions at each study visit for the week post vaccination (days 2 and 4).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

1761 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SIIL Live Attenuated Influenza Vaccine

Arm Type

Experimental

Arm Description

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

Arm Title

Matched placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Biological

Intervention Name(s)

SIIL Live Attenuated Influenza Vaccine

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

Matched placebo

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Time Frame

Through 7 to 8 months post vaccination

Secondary Outcome Measure Information:

Title

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

Time Frame

Through 30 minutes post vaccination

Title

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

Time Frame

Through 7 days post vaccination

Title

Safety Profile of LAIV: Serious Adverse Events

Time Frame

Through 1 month post vaccination

Title

Safety Profile of LAIV: Other Non-serious Adverse Events

Time Frame

Through 1 month post vaccination

Title

Safety Profile of LAIV: Protocol Defined Wheezing Illness

Time Frame

Through 7 to 8 months post vaccination

Title

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

Time Frame

Through 7 to 8 months post vaccination

Title

Percentage of Participants With Symptomatic, Laboratory-confirmed Influenza Virus Infection by Influenza Type/Subtype (Influenza A/H1N1, Influenza A/H3N2, and Influenza B)

Time Frame

Through 7 to 8 months post vaccination

Title

Clinical Characteristics of Influenza in the Study Population

Time Frame

Through 7 to 8 months post vaccination

Title

Etiologies of Influenza-like Illness in the Study Population

Description

Time Frame

Through 7 to 8 months post vaccination

Title

Evaluation of Vaccine-take as Shedding of Vaccine Virus Post-vaccination, Including Viral Load and Duration of Virus Detection

Description

Time Frame

Through 4 days post vaccination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

24 Months

Maximum Age & Unit of Time

71 Months

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Aldiouma Diallo, MD

Organizational Affiliation

Institut de Recherche pour le Développement (IRD)

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Niakhar

Country

Senegal

12. IPD Sharing Statement

Citations:

PubMed Identifier

27746224

Citation

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.

Results Reference

derived

Learn more about this trial

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

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