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| Name | Class |
|---|---|
| Johns Hopkins Bloomberg School of Public Health | OTHER |
| International Centre for Diarrhoeal Disease Research, Bangladesh | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SIIL LAIV | Experimental | 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 | Placebo Comparator | Placebo identical in appearance to experimental vaccine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SIIL LAIV (live, trivalent seasonal influenza vaccine) | Biological | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 months following vaccination |
| 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 | 42 days following vaccination |
| Percentage of Participants With Unsolicited Adverse Events (AEs) | Throughout study period, through at least 6 months following vaccination | |
| 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 | Through 7 days following vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Approximately 21 days post-vaccination | |
| Post Vaccination SIIL LAIV Virus Shedding/Vaccine-take Will be Parameterized by the Percentage of Participants With Detectable Virus by Post Vaccination Day. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| W. Abdullah Brooks, MD, MPH | JHSPH, ICDDR,B | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICDDR,B Kamalapur | Dhaka | Bangladesh |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30481272 | Derived | 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. | |
| 30481269 |
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309 participants were consented and enrolled in the study. 9 participants were ineligible to receive study vaccination. 300 total participants were vaccinated and followed through the study period.
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| ID | Title | Description |
|---|---|---|
| FG000 | Serum Institute of India, Ltd. (SIIL) LAIV | The Serum Institute of India, Ltd. (SIIL) live attenuated influenza vaccine (LAIV) (human, live attenuated, trivalent seasonal influenza vaccine): The viral strains in 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 |
| FG001 | Placebo | Inactive placebo was identical to SIIL LAIV in appearance, ingredients, and concentrations, except it was missing attenuated influenza virus. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All participants enrolled who received a single dose of LAIV or placebo.
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| ID | Title | Description |
|---|---|---|
| BG000 | SIIL LAIV | The SIIL LAIV (human, live attenuated, trivalent seasonal influenza vaccine): The viral strains in 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Safety analysis population | Posted | Number | participants | 6 months following vaccination |
|
Throughout study period, through at least 6 months post-vaccination.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SIIL LAIV | The SIIL LAIV (human, live attenuated, trivalent seasonal influenza vaccine): The viral strains in 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Traumatic Injury/fracture/overdose | Injury, poisoning and procedural complications | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| diarrheal illness | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Clinical Research Scientist | PATH | 206-285-3500 | klewis@path.org |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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|
| Placebo | Biological | Inactive placebo will be identical to SII LAIV in appearance, ingredients, and concentrations, except it will be missing attenuated influenza virus. |
|
| 2, 4, and 7 days post-vaccination |
| 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 | 6 months post-vaccination |
| 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 | 6 months post-vaccination |
| Derived |
| 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. |
| Placebo |
Inactive placebo was identical to the SIIL LAIV in appearance, ingredients, and concentrations, except it was missing attenuated influenza virus. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Placebo | Inactive placebo was identical to SII LAIV in appearance, ingredients, and concentrations, except it was missing attenuated influenza virus. |
|
|
| Primary | 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 | Not Posted | 42 days following vaccination |
| Primary | Percentage of Participants With Unsolicited Adverse Events (AEs) | Posted | Number | percentage of participants | Throughout study period, through at least 6 months following vaccination |
|
|
|
| Primary | 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 | Safety analysis population | Posted | Number | percentage of participants | Through 7 days following vaccination |
|
|
|
|
| Secondary | 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 | Not Posted | Approximately 21 days post-vaccination |
| Secondary | Post Vaccination SIIL LAIV Virus Shedding/Vaccine-take Will be Parameterized by the Percentage of Participants With Detectable Virus by Post Vaccination Day. | Not Posted | 2, 4, and 7 days post-vaccination |
| Secondary | 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 | Not Posted | 6 months post-vaccination |
| Secondary | 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 | Not Posted | 6 months post-vaccination |
| 6 |
| 150 |
| 96 |
| 150 |
| EG001 | Placebo | Inactive placebo was identical to SII LAIV in appearance, ingredients, and concentrations, except it was missing attenuated influenza virus. | 0 | 150 | 94 | 150 |
| abdominal pain/gastroenteritis | Gastrointestinal disorders | Systematic Assessment |
|
| Oral thrush | Infections and infestations | Systematic Assessment |
|
| Boil/Abscess/skin infection/ulcer/cyst | Infections and infestations | Systematic Assessment |
|
| Helminthiasis | Infections and infestations | Systematic Assessment |
|
| Scabies | Infections and infestations | Systematic Assessment |
|
| Abdominal pain/distension | Gastrointestinal disorders | Systematic Assessment |
|
| Allergy | General disorders | Systematic Assessment |
|
| Fungal Infection | Infections and infestations | Systematic Assessment |
|
| Other | Infections and infestations | Systematic Assessment |
|
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| Boil/abscess/skin infection/ulcer/cyst |
|
| Helminthiasis |
|
| Scabies |
|
| Abdominal pain/distension |
|
| Allergy |
|
| Fungal Infection |
|
| Other |
|
| Cough |
|
| Runny nose/nasal congestion |
|
| Sore throat |
|
| Headache |
|
| Irritability/decreased activitity |
|
| Vomiting |
|
| Lethargy |
|