InfluenzaPhase 2NCT01625689

Safety and Immunogenicity of a Single Dose of Intranasal Seasonal Trivalent Live-Attenuated Influenza Vaccine

A Phase 2 study testing SIIL LAIV (live, trivalent seasonal influenza vaccine) in people with Influenza, run by PATH Vaccine Solutions at 1 site in Bangladesh.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 24 to 59 monthsHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: SIIL LAIV (live, trivalent seasonal influenza vaccine)
Type of treatment: Vaccines
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 309 participants
Where: 1 siteBangladesh
Study dates: Jun 2012to Feb 2013
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 24 to 59 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Bangladesh1 site

ICDDR,B Kamalapur
Dhaka

Other trials in Bangladesh

About this study

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

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.

Conditions: Influenza
Being tested: SIIL LAIV (live, trivalent seasonal influenza vaccine), Placebo
Keywords: Influenza vaccines, Influenza, Human, Live Attenuated Influenza Vaccine
Medical subject headings: Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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
PlaceboBiological
Inactive placebo will be identical to SII LAIV in appearance, ingredients, and concentrations, except it will be missing attenuated influenza virus.

Study groups in NCT01625689
Study group	Role	What they receive
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 Receives: Biological: SIIL LAIV (live, trivalent seasonal influenza vaccine)
Placebo	Placebo comparator	Placebo identical in appearance to experimental vaccine. Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 42 days following vaccination
Percentage of Participants With Unsolicited Adverse Events (AEs)
Measured: 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
Measured: Through 7 days following vaccination

Secondary outcomes (4)

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
Measured: 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.
Measured: 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
Measured: 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
Measured: 6 months post-vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2012Feb 2013

First posted21 Jun 2012 (estimated)
Study startJun 2012
Primary completionFeb 2013
Study completionFeb 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for InfluenzaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 309 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01625689
Sponsor's protocol ID: LAIV-BD-01
Status last verified: Jun 2012
First submitted: 14 Jun 2012
Last updated: 1 Jun 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 30481272
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.
PubMed 30481269

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Influenza trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01625689
Acronym / sponsor ID: LAIV-BD-01
Conditions: Influenza
Keywords: Influenza vaccines, Influenza, Human, Live Attenuated Influenza Vaccine
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 309 participants (actual)
Lead sponsor: PATH Vaccine SolutionsUniversity, hospital or other
Collaborators: Johns Hopkins Bloomberg School of Public Health, International Centre for Diarrhoeal Disease Research, Bangladesh
Study start: Jun 2012
Primary completion: Feb 2013 (actual)
Study completion: Feb 2013 (actual)
First posted: 21 Jun 2012 (estimated)
Results: Posted 1 Jun 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
SIIL LAIV	Experimental	Biological: SIIL LAIV (live, trivalent seasonal influenza vaccine)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	Biological: PlaceboPlacebo identical in appearance to experimental vaccine.

Who may qualify

Ages: 24 to 59 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (3 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SIIL LAIV (live, trivalent seasonal influenza vaccine)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	Biological	SIIL LAIV
PlaceboInactive placebo will be identical to SII LAIV in appearance, ingredients, and concentrations, except it will be missing attenuated influenza virus.	Biological	Placebo

Primary outcome

Number of Participants With Serious Adverse Events (SAEs), All-cause Hospitalizations, and Protocol-defined Wheezing Illness (PDWI) Episodes
Time frame: 6 months following vaccination
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
Time frame: 42 days following vaccination
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)
Time frame: Throughout study period, through at least 6 months following vaccination
Percentage of Participants With Solicited Local and Systemic Reactions
Time frame: Through 7 days following vaccination
Local reactions: Nasal discomfort, Runny nose, Stuffy nose, Sneezing, Ear pain Systemic Reactions: Cough, Headache, Loss of Appetite, Fever, Irritability, Nausea, Sore throat, Lethargy

4 secondary outcomes

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
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
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
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

Results and safety

Results posted to the registry on 1 Jun 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Serum Institute of India, Ltd. (SIIL) LAIV	150	148
Placebo	150	149

Primary outcome: Number of Participants With Serious Adverse Events (SAEs), All-cause Hospitalizations, and Protocol-defined Wheezing Illness (PDWI) Episodes

Time frame: 6 months following vaccination. Number. Unit: participants

Measure	SIIL LAIV n = 150	Placebo n = 150
Serious Adverse Events	6	0
Protocol Defined Wheezing Illness (PDWI)	13	16
Hospitalizations	3	0

Population analysed: Safety analysis population

Primary outcome: Number of Participants With Serious Adverse Events (SAEs), All-cause Hospitalizations, and Protocol-defined Wheezing Illness (PDWI) Episodes

Time frame: 42 days following vaccination

The sponsor has not posted figures for this outcome.

Primary outcome: Percentage of Participants With Unsolicited Adverse Events (AEs)

Time frame: Throughout study period, through at least 6 months following vaccination. Number. Unit: percentage of participants

Measure	SIIL LAIV n = 150	Placebo n = 150
Diarrheal Illness	25.3	21.3
Oral thrush	17.3	12.0
Boil/abscess/skin infection/ulcer/cyst	7.3	12.0
Helminthiasis	6.0	7.3
Scabies	5.3	4.0
Abdominal pain/distension	3.3	4.0
Allergy	4.0	4.0
Fungal Infection	4.0	3.3

Primary outcome: Percentage of Participants With Solicited Local and Systemic Reactions

Time frame: Through 7 days following vaccination. Number. Unit: percentage of participants

Measure	SIIL LAIV n = 150	Placebo n = 150
Measured fever (>=38.0)	3.3	3.3
Ear pain	1.3	1.3
Cough	6.7	5.3
Runny nose/nasal congestion	20.7	22.7
Sore throat	1.3	0.0
Headache	0.7	0.0
Irritability/decreased activitity	0.0	0.0
Vomiting	1.3	2.0

SIIL LAIV vs Placebo: p >=0.498, Fisher Exact

Population analysed: Safety analysis population

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Throughout study period, through at least 6 months post-vaccination.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SIIL LAIV	6 of 150 (4%)	96 of 150 (64%)	Not reported
Placebo	0 of 150 (0%)	94 of 150 (62.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30481272Lewis 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.
Derived from this study: PubMed 30481269Brickley 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

W. Abdullah Brooks, MD, MPH principal investigator

JHSPH, ICDDR,B

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SIIL LAIV (live, trivalent seasonal influenza vaccine) in people with Influenza, run by PATH Vaccine Solutions at 1 site in Bangladesh.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Serious Adverse Events (SAEs), All-cause Hospitalizations, and Protocol-defined Wheezing Illness (PDWI) Episodes (time frame: 6 months following vaccination). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01625689, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2015.