- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01854632
Clinical Efficacy of Trivalent Live-Attenuated Influenza Vaccine (LAIV) Among Children in Senegal
A Randomized, Double-Blind, Placebo-Controlled Trial of the Clinical Efficacy of Trivalent Live-Attenuated Influenza Vaccine (LAIV) Among Children in Senegal
Study Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Niakhar, Senegal
- Institut de Recherche pour le Développement (IRD), Niakhar station
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: SIIL Live Attenuated Influenza Vaccine
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
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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
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PLACEBO_COMPARATOR: Matched placebo
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of Participants With Symptomatic, Laboratory-confirmed Influenza Virus Infection (Regardless of Vaccine Match)
Time Frame: Through 7 to 8 months post vaccination
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Through 7 to 8 months post vaccination
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety Profile of LAIV: Immediate Reactions Occurring Within 30 Minutes of Administration of Study Vaccine.
Time Frame: Through 30 minutes post vaccination
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Through 30 minutes post vaccination
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Safety Profile of LAIV: Solicited and Unsolicited Local and Systemic Reactions
Time Frame: Through 7 days post vaccination
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Through 7 days post vaccination
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Safety Profile of LAIV: Serious Adverse Events
Time Frame: Through 1 month post vaccination
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Through 1 month post vaccination
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Safety Profile of LAIV: Other Non-serious Adverse Events
Time Frame: Through 1 month post vaccination
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Through 1 month post vaccination
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Safety Profile of LAIV: Protocol Defined Wheezing Illness
Time Frame: Through 7 to 8 months post vaccination
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Through 7 to 8 months post vaccination
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Percentage of Participants With Symptomatic, Laboratory-confirmed Influenza Virus Infection (Vaccine-matched Strains)
Time Frame: Through 7 to 8 months post vaccination
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Through 7 to 8 months post vaccination
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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
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Through 7 to 8 months post vaccination
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Clinical Characteristics of Influenza in the Study Population
Time Frame: Through 7 to 8 months post vaccination
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Through 7 to 8 months post vaccination
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Etiologies of Influenza-like Illness in the Study Population
Time Frame: Through 7 to 8 months post vaccination
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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.
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Through 7 to 8 months post vaccination
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Evaluation of Vaccine-take as Shedding of Vaccine Virus Post-vaccination, Including Viral Load and Duration of Virus Detection
Time Frame: Through 4 days post vaccination
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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.
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Through 4 days post vaccination
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Aldiouma Diallo, MD, Institut de Recherche pour le Développement (IRD)
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LAIV-SEN-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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