Back to resultsSafety and Immunogenicity of a Single Dose of Intranasal Seasonal Trivalent Live-Attenuated Influenza Vaccine
Primary Purpose
Influenza
Status
Completed
Phase
Phase 2
Locations
Bangladesh
Study Type
Interventional
Intervention
SIIL LAIV (live, trivalent seasonal influenza vaccine)
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring Influenza vaccines, Influenza, Human, Live Attenuated Influenza Vaccine
Eligibility Criteria
Inclusion Criteria:
- 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 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:
- Has any serious chronic disease including progressive neurologic disease, tuberculosis, Down's syndrome or other cytogenetic disorder, or known or suspected disease of the immune system
- Is receiving immunosuppressive agents including systemic corticosteroids during the two weeks 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
- 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
- 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
Sites / Locations
- ICDDR,B Kamalapur
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
SIIL LAIV
Placebo
Arm Description
SII LAIV is a live, trivalent seasonal influenza vaccine. The viral strains in seasonal trivalent influenza vaccine (human, live attenuated) are antigenically similar to A/California/7/2009 (H1N1), A/Perth/16/2009 (H3N2) and B/Brisbane/60/2008 Type B, as per the WHO recommended strains for the Northern hemisphere 2011-12 influenza season
Placebo identical in appearance to experimental vaccine.
Outcomes
Primary Outcome Measures
Number of Participants With Serious Adverse Events (SAEs), All-cause Hospitalizations, and Protocol-defined Wheezing Illness (PDWI) Episodes
PDWI: Participants meeting illness criteria, seeking care in health facility, and with wheeze identified by a study physician
Illness criteria: The presence of one Category A (Fever (>=38°C), tachypnea, danger signs (chest-indrawing, lethargy, cyanosis, inability to drink, convulsions), difficult breathing, noisy breathing, ear pain or discharge) or two Category B findings (Cough, rhinorrhea, sore throat, myalgia/arthralgia, chills, headache, irritability/decreased activity, vomiting)
Wheeze: Long high-pitched whistling or musical sound on expiration heard by auscultation
Number of Participants With Serious Adverse Events (SAEs), All-cause Hospitalizations, and Protocol-defined Wheezing Illness (PDWI) Episodes
PDWI: Participants meeting illness criteria, seeking care in health facility, and with wheeze identified by a study physician
Illness criteria: The presence of one Category A (Fever (>=38°C), tachypnea, danger signs (chest-indrawing, lethargy, cyanosis, inability to drink, convulsions), difficult breathing, noisy breathing, ear pain or discharge) or two Category B findings (Cough, rhinorrhea, sore throat, myalgia/arthralgia, chills, headache, irritability/decreased activity, vomiting)
Wheeze: Long high-pitched whistling or musical sound on expiration heard by auscultation
Percentage of Participants With Unsolicited Adverse Events (AEs)
Percentage of Participants With Solicited Local and Systemic Reactions
Local reactions: Nasal discomfort, Runny nose, Stuffy nose, Sneezing, Ear pain
Systemic Reactions: Cough, Headache, Loss of Appetite, Fever, Irritability, Nausea, Sore throat, Lethargy
Secondary Outcome Measures
The Post-vaccination Anti-influenza Immunologic Response Will be Measured Based on the Type of Immunologic Assay and Categorized by Vaccine Virus Strain, Participant Baseline Serostatus, and Vaccine Allocation
Post Vaccination SIIL LAIV Virus Shedding/Vaccine-take Will be Parameterized by the Percentage of Participants With Detectable Virus by Post Vaccination Day.
Clinical Characteristics of Influenza, Including Influenza Coinfections With Other Bacterial and Viral Respiratory Pathogens, Will be Parameterized as the Percentage of Participants Categorized by Vaccine Allocation
Viral Etiologies of Acute Respiratory and Febrile Illness Will be Parameterized as the Percentage of Those With Each Particular Laboratory-confirmed Respiratory Virus Infection Categorized by Vaccine Allocation
Full Information
NCT ID
NCT01625689
First Posted
June 14, 2012
Last Updated
May 15, 2015
Sponsor
PATH Vaccine Solutions
Collaborators
Johns Hopkins Bloomberg School of Public Health, International Centre for Diarrhoeal Disease Research, Bangladesh
1. Study Identification
Unique Protocol Identification Number
NCT01625689
Brief Title
Safety and Immunogenicity of a Single Dose of Intranasal Seasonal Trivalent Live-Attenuated Influenza Vaccine
Official Title
Assessment of the Safety and Immunogenicity of a Single Dose of Intranasal Seasonal Trivalent Live-Attenuated Influenza Vaccine Among Children Aged 24 Through 59 Months in Bangladesh
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PATH Vaccine Solutions
Collaborators
Johns Hopkins Bloomberg School of Public Health, International Centre for Diarrhoeal Disease Research, Bangladesh
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
In this Phase II randomized controlled clinical trial, generally healthy male and female children from 24 through 59 months of age will be enrolled in Kamalapur (Dhaka), Bangladesh. The study is expected to continue for at least 6 months following vaccination. The experimental intervention is Serum Institute of India Ltd's Trivalent, Seasonal Live Attenuated Influenza Vaccine (SIIL LAIV). The study vaccine has been formulated according to WHO recommendations for the 2011-2012 Northern Hemisphere influenza season. The SIIL LAIV is administered in a 0.5 ml intranasal dose (one spray of 0.25 ml per nostril) via a reusable sprayer device and a single-use nozzle that produces a fine mist that is primarily deposited in the nose and nasopharynx. The comparator vaccine will be an inactive placebo identical in appearance to the active vaccine.
The primary study hypothesis is that LAIV is safe and well tolerated by children aged 24 through 59 months in Bangladesh. A secondary hypothesis is that LAIV is immunogenic among children receiving study vaccine as compared to children receiving placebo.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Influenza vaccines, Influenza, Human, Live Attenuated Influenza Vaccine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
309 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SIIL LAIV
Arm Type
Experimental
Arm Description
SII LAIV is a live, trivalent seasonal influenza vaccine. The viral strains in seasonal trivalent influenza vaccine (human, live attenuated) are antigenically similar to A/California/7/2009 (H1N1), A/Perth/16/2009 (H3N2) and B/Brisbane/60/2008 Type B, as per the WHO recommended strains for the Northern hemisphere 2011-12 influenza season
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo identical in appearance to experimental vaccine.
Intervention Type
Biological
Intervention Name(s)
SIIL LAIV (live, trivalent seasonal influenza vaccine)
Intervention Description
Dose: 0.5 mL, The viral strains in seasonal trivalent influenza vaccine (human, live attenuated) are antigenically similar to A/California/7/2009 (H1N1), A/Perth/16/2009 (H3N2) and B/Brisbane/60/2008 Type B, as per the WHO recommended strains for the Northern hemisphere 2011-12 influenza season
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Inactive placebo will be identical to SII LAIV in appearance, ingredients, and concentrations, except it will be missing attenuated influenza virus.
Primary Outcome Measure Information:
Title
Number of Participants With Serious Adverse Events (SAEs), All-cause Hospitalizations, and Protocol-defined Wheezing Illness (PDWI) Episodes
Description
PDWI: Participants meeting illness criteria, seeking care in health facility, and with wheeze identified by a study physician
Illness criteria: The presence of one Category A (Fever (>=38°C), tachypnea, danger signs (chest-indrawing, lethargy, cyanosis, inability to drink, convulsions), difficult breathing, noisy breathing, ear pain or discharge) or two Category B findings (Cough, rhinorrhea, sore throat, myalgia/arthralgia, chills, headache, irritability/decreased activity, vomiting)
Wheeze: Long high-pitched whistling or musical sound on expiration heard by auscultation
Time Frame
6 months following vaccination
Title
Number of Participants With Serious Adverse Events (SAEs), All-cause Hospitalizations, and Protocol-defined Wheezing Illness (PDWI) Episodes
Description
PDWI: Participants meeting illness criteria, seeking care in health facility, and with wheeze identified by a study physician
Illness criteria: The presence of one Category A (Fever (>=38°C), tachypnea, danger signs (chest-indrawing, lethargy, cyanosis, inability to drink, convulsions), difficult breathing, noisy breathing, ear pain or discharge) or two Category B findings (Cough, rhinorrhea, sore throat, myalgia/arthralgia, chills, headache, irritability/decreased activity, vomiting)
Wheeze: Long high-pitched whistling or musical sound on expiration heard by auscultation
Time Frame
42 days following vaccination
Title
Percentage of Participants With Unsolicited Adverse Events (AEs)
Time Frame
Throughout study period, through at least 6 months following vaccination
Title
Percentage of Participants With Solicited Local and Systemic Reactions
Description
Local reactions: Nasal discomfort, Runny nose, Stuffy nose, Sneezing, Ear pain
Systemic Reactions: Cough, Headache, Loss of Appetite, Fever, Irritability, Nausea, Sore throat, Lethargy
Time Frame
Through 7 days following vaccination
Secondary Outcome Measure Information:
Title
The Post-vaccination Anti-influenza Immunologic Response Will be Measured Based on the Type of Immunologic Assay and Categorized by Vaccine Virus Strain, Participant Baseline Serostatus, and Vaccine Allocation
Time Frame
Approximately 21 days post-vaccination
Title
Post Vaccination SIIL LAIV Virus Shedding/Vaccine-take Will be Parameterized by the Percentage of Participants With Detectable Virus by Post Vaccination Day.
Time Frame
2, 4, and 7 days post-vaccination
Title
Clinical Characteristics of Influenza, Including Influenza Coinfections With Other Bacterial and Viral Respiratory Pathogens, Will be Parameterized as the Percentage of Participants Categorized by Vaccine Allocation
Time Frame
6 months post-vaccination
Title
Viral Etiologies of Acute Respiratory and Febrile Illness Will be Parameterized as the Percentage of Those With Each Particular Laboratory-confirmed Respiratory Virus Infection Categorized by Vaccine Allocation
Time Frame
6 months post-vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
24 Months
Maximum Age & Unit of Time
59 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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 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:
Has any serious chronic disease including progressive neurologic disease, tuberculosis, Down's syndrome or other cytogenetic disorder, or known or suspected disease of the immune system
Is receiving immunosuppressive agents including systemic corticosteroids during the two weeks 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
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
W. Abdullah Brooks, MD, MPH
Organizational Affiliation
JHSPH, ICDDR,B
Official's Role
Principal Investigator
Facility Information:
Facility Name
ICDDR,B Kamalapur
City
Dhaka
Country
Bangladesh
12. IPD Sharing Statement
Citations:
PubMed Identifier
30481272
Citation
Lewis KDC, Ortiz JR, Rahman MZ, Levine MZ, Rudenko L, Wright PF, Katz JM, Dally L, Rahman M, Isakova-Sivak I, Ilyushina NA, Matyushenko V, Fry AM, Lindstrom SE, Bresee JS, Brooks WA, Neuzil KM. Immunogenicity and Viral Shedding of Russian-Backbone, Seasonal, Trivalent, Live, Attenuated Influenza Vaccine in a Phase II, Randomized, Placebo-Controlled Trial Among Preschool-Aged Children in Urban Bangladesh. Clin Infect Dis. 2019 Aug 16;69(5):777-785. doi: 10.1093/cid/ciy1003.
Results Reference
derived
PubMed Identifier
30481269
Citation
Brickley EB, Wright PF, Khalenkov A, Neuzil KM, Ortiz JR, Rudenko L, Levine MZ, Katz JM, Brooks WA. The Effect of Preexisting Immunity on Virus Detection and Immune Responses in a Phase II, Randomized Trial of a Russian-Backbone, Live, Attenuated Influenza Vaccine in Bangladeshi Children. Clin Infect Dis. 2019 Aug 16;69(5):786-794. doi: 10.1093/cid/ciy1004.
Results Reference
derived
Learn more about this trial
Safety and Immunogenicity of a Single Dose of Intranasal Seasonal Trivalent Live-Attenuated Influenza Vaccine
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