InfluenzaPhase 3NCT01797029
A Randomized, Controlled Trial on the Efficacy and Safety of Live-Attenuated Influenza Vaccine (LAIV) Among Children in Bangladesh
A Phase 3 study testing SIIL Live Attenuated Influenza Vaccine in people with Influenza, run by PATH at 2 sites in Bangladesh.
Trial summary
This is a single center, multi-site, double-blind, parallel group, placebo-controlled trial of the clinical efficacy of trivalent Serum Institute of India, Ltd. (SIIL)live-attenuated influenza vaccine (LAIV) vaccine among children aged 24 through 59 months in Bangladesh. Background: 1. Read more about this study
- Who is it for?
- Ages 24 to 59 monthsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- SIIL Live Attenuated Influenza Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,761 participants
- Where
- 2 sitesBangladesh
- Study dates
- Feb 2013to Sep 2014
- Phase
- Phase 3
- 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 or Matlab service 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, active, medical conditions, including: a 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.
- Is receiving immunosuppressive agents, including systemic corticosteroids, during the month 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.
- Has ever received influenza vaccine (LAIV or inactivated).
- History of Guillain-Barre syndrome
- Is receiving aspirin therapy or aspirin-containing therapy currently or two weeks before.
Show all 13Show fewer
- 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.
- History of a previous severe allergic reaction with generalized urticarial, angioedema, or anaphylaxis.
- 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 Inclusion Contraindications:
- Concurrent febrile illness (measured temperature 38 degrees C axillary).
- Active wheezing illness
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Trial on the Clinical Efficacy and Safety of a Single Dose of Trivalent Seasonal Live-Attenuated Influenza Vaccine(LAIV) Among Children Aged 24 Through 59 Months in Bangladesh
This is a single center, multi-site, double-blind, parallel group, placebo-controlled trial of the clinical efficacy of trivalent Serum Institute of India, Ltd. (SIIL)live-attenuated influenza vaccine (LAIV) vaccine among children aged 24 through 59 months in Bangladesh.
Background:
Read more
- Burden: Within Bangladesh, community- based influenza surveillance identified 84.5 cases/1000 children-years among children <5 years, while 10% of clinical pneumonia cases were influenza positive in this age group.
- Knowledge gap: There has never been a randomized clinical efficacy trial of the SIIL LAIV vaccine conducted among children in a low-income country.
- Relevance: Another LAIV vaccine (made by MedImmune) has been shown to have high efficacy against laboratory-confirmed influenza among children. The SIIL LAIV has the potential to be an inexpensive intervention to prevent pediatric influenza disease.
Primary Hypothesis: In children aged 24 through 59 months in Bangladesh, LAIV is efficacious in reducing rates of symptomatic, laboratory-confirmed influenza (vaccine-matched strains) among children vaccinated with LAIV as compared to children vaccinated with a placebo through the first influenza season following vaccination.
Primary Objective: To determine the efficacy of LAIV in reducing rates of symptomatic, laboratory-confirmed influenza virus infection (vaccine-matched strains) among children receiving LAIV as compared to children receiving a placebo through the first influenza season following vaccination (through December 2013).
Methods: A total of 1761 children will be enrolled and randomized in a 2:1 ratio of LAIV to placebo beginning in March 2013. After vaccination, all children will be evaluated for reactions with one home visit four days post vaccination. Subsequently, all children will be monitored weekly for safety outcomes and illness signs at weekly field worker home visits through December 2013. An extended surveillance period was added to this study and, for participants consenting to additional follow-up, surveillance will extend through a second season (through September 2014). Participants with illness signs will be referred to the study clinic for evaluation using standardized diagnostic criteria and treatment by a study physician. Children meeting protocol-defined clinical Specimen Collection Criteria will have a nasopharyngeal wash specimen collected. Clinical specimens will be tested by Real time polymerase chain reaction (rRT-PCR) for evidence of influenza virus infection.
Primary Outcome measures/variables: Vaccine efficacy will be assessed against symptomatic, laboratory-confirmed influenza for all circulating virus strains.
- Conditions
- Influenza
- Being tested
- SIIL Live Attenuated Influenza Vaccine, Placebo
- 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 Live Attenuated Influenza VaccineBiological
A single dose of SIIL Trivalent LAIV--2012/2013 Northern Hemisphere vaccine containing A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010
PlaceboBiological
A single dose of 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.
| Study group | Role | What they receive |
|---|---|---|
| Vaccine | Experimental | Not described Receives: Biological: SIIL Live Attenuated Influenza Vaccine |
| Placebo | Placebo comparator | Not described Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Symptomatic, Laboratory-confirmed Influenza Virus Infection (Vaccine-matched Strains).
Measured: Through 7 to 9 months post-vaccination
Secondary outcomes (11)
Safety Profile of LAIV: Solicited and Unsolicited Local and Systemic Reactions
Measured: Through one week post-vaccination
Safety Profile of LAIV: Immediate Reactions
Measured: 30 minutes post-vaccination
Safety Profile of LAIV: Serious Adverse Events
Measured: Through 7 to 9 months post-vaccination
Safety Profile of LAIV: Protocol Defined Wheezing Illness
Measured: Through 7 to 9 months post-vaccination
Percentage of Participants With Symptomatic, Laboratory-confirmed, Influenza Virus Infection (All Strains)
Measured: Through 7 to 9 months post-vaccination
The Clinical Characteristics of Influenza, Including Influenza Co-infections With Other Bacterial and Viral Respiratory Pathogens
Measured: Through 16 to 19 months post-vaccination
The Viral Etiologies of Acute Respiratory and Febrile Illness
Measured: Through 16 to 19 months post-vaccination
Safety Profile of LAIV: Serious Adverse Events
Measured: Through 16 to 19 months post-vaccination
Safety Profile of LAIV: Protocol Defined Wheezing Illness
Measured: Through 16 to 19 months post-vaccination
Percentage of Participants With Symptomatic, Laboratory-confirmed, Influenza Virus Infection (All Strains)
Measured: Through 16 to 19 months post-vaccination
Percentage of Participants With Symptomatic, Laboratory-confirmed Influenza Virus Infection (Vaccine-matched Strains).
Measured: Through 16 to 19 months post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionSep 2014
- Study completionSep 2014
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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,761 participants (actual)
Sponsor and investigators
- Lead sponsor
- PATH
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University, International Centre for Diarrhoeal Disease Research, Bangladesh, Centers for Disease Control and Prevention, Bill and Melinda Gates Foundation
- Responsible party
- Sponsor
- Investigators
- Abdullah Brooks, MD, MPH, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01797029
- Sponsor's protocol ID
- LAIV-CE-01
- Status last verified
- Jul 2014
- First submitted
- 20 Feb 2013
- Last updated
- 11 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Rotrosen E, Zaman K, Feser J, Ortiz JR, Goswami D, Sharmeen AT, Rahman M, Lewis KDC, Rahman MZ, Barin B, Brooks WA, Neuzil KM. Influenza Among Young Children in Bangladesh: Clinical Characteristics and Outcomes From a Randomized Clinical Trial. Clin Infect Dis. 2017 Nov 13;65(11):1914-1920. doi: 10.1093/cid/cix674.
PubMed 29028980Brooks WA, Zaman K, Lewis KD, Ortiz JR, Goswami D, Feser J, Sharmeen AT, Nahar K, Rahman M, Rahman MZ, Barin B, Yunus M, Fry AM, Bresee J, Azim T, Neuzil KM. Efficacy of a Russian-backbone live attenuated influenza vaccine among young children in Bangladesh: a randomised, double-blind, placebo-controlled trial. Lancet Glob Health. 2016 Dec;4(12):e946-e954. doi: 10.1016/S2214-109X(16)30200-5. Epub 2016 Oct 13.
PubMed 27746226
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Trial on the Clinical Efficacy and Safety of a Single Dose of Trivalent Seasonal Live-Attenuated Influenza Vaccine(LAIV) Among Children Aged 24 Through 59 Months in Bangladesh
- ClinicalTrials.gov ID
- NCT01797029
- Acronym / sponsor ID
- LAIV-CE-01
- Conditions
- Influenza
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,761 participants (actual)
- Lead sponsor
- PATHUniversity, hospital or other
- Collaborators
- Johns Hopkins University, International Centre for Diarrhoeal Disease Research, Bangladesh, Centers for Disease Control and Prevention, Bill and Melinda Gates Foundation
- Study start
- Feb 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 22 Feb 2013 (estimated)
- Results
- Posted 15 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single center, multi-site, double-blind, parallel group, placebo-controlled trial of the clinical efficacy of trivalent Serum Institute of India, Ltd. (SIIL)live-attenuated influenza vaccine (LAIV) vaccine among children aged 24 through 59 months in Bangladesh.
Background:
- Burden: Within Bangladesh, community- based influenza surveillance identified 84.5 cases/1000 children-years among children <5 years, while 10% of clinical pneumonia cases were influenza positive in this age group.
- Knowledge gap: There has never been a randomized clinical efficacy trial of the SIIL LAIV vaccine conducted among children in a low-income country.
- Relevance: Another LAIV vaccine (made by MedImmune) has been shown to have high efficacy against laboratory-confirmed influenza among children. The SIIL LAIV has the potential to be an inexpensive intervention to prevent pediatric influenza disease.
Primary Hypothesis: In children aged 24 through 59 months in Bangladesh, LAIV is efficacious in reducing rates of symptomatic, laboratory-confirmed influenza (vaccine-matched strains) among children vaccinated with LAIV as compared to children vaccinated with a placebo through the first influenza season following vaccination.
Primary Objective: To determine the efficacy of LAIV in reducing rates of symptomatic, laboratory-confirmed influenza virus infection (vaccine-matched strains) among children receiving LAIV as compared to children receiving a placebo through the first influenza season following vaccination (through December 2013).
Methods: A total of 1761 children will be enrolled and randomized in a 2:1 ratio of LAIV to placebo beginning in March 2013. After vaccination, all children will be evaluated for reactions with one home visit four days post vaccination. Subsequently, all children will be monitored weekly for safety outcomes and illness signs at weekly field worker home visits through December 2013. An extended surveillance period was added to this study and, for participants consenting to additional follow-up, surveillance will extend through a second season (through September 2014). Participants with illness signs will be referred to the study clinic for evaluation using standardized diagnostic criteria and treatment by a study physician. Children meeting protocol-defined clinical Specimen Collection Criteria will have a nasopharyngeal wash specimen collected. Clinical specimens will be tested by Real time polymerase chain reaction (rRT-PCR) for evidence of influenza virus infection.
Primary Outcome measures/variables: Vaccine efficacy will be assessed against symptomatic, laboratory-confirmed influenza for all circulating virus strains.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaccine | Experimental | Biological: SIIL Live Attenuated Influenza Vaccine |
| Placebo | Placebo comparator | Biological: Placebo |
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 or Matlab service 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 (13 listed)
- Has any serious, active, medical conditions, including: a 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.
- Is receiving immunosuppressive agents, including systemic corticosteroids, during the month 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.
- Has ever received influenza vaccine (LAIV or inactivated).
- History of Guillain-Barre syndrome
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 Live Attenuated Influenza VaccineA single dose of SIIL Trivalent LAIV--2012/2013 Northern Hemisphere vaccine containing A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010 | Biological | Vaccine |
| PlaceboA single dose of 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. | Biological | Placebo |
Primary outcome
Percentage of Participants With Symptomatic, Laboratory-confirmed Influenza Virus Infection (Vaccine-matched Strains).
Time frame: Through 7 to 9 months post-vaccination
11 secondary outcomes
Safety Profile of LAIV: Solicited and Unsolicited Local and Systemic Reactions
Time frame: Through one week post-vaccination
Safety Profile of LAIV: Immediate Reactions
Time frame: 30 minutes post-vaccination
Safety Profile of LAIV: Serious Adverse Events
Time frame: Through 7 to 9 months post-vaccination
Safety Profile of LAIV: Protocol Defined Wheezing Illness
Time frame: Through 7 to 9 months post-vaccination
Percentage of Participants With Symptomatic, Laboratory-confirmed, Influenza Virus Infection (All Strains)
Time frame: Through 7 to 9 months post-vaccination
The Clinical Characteristics of Influenza, Including Influenza Co-infections With Other Bacterial and Viral Respiratory Pathogens
Time frame: Through 16 to 19 months post-vaccination
The Viral Etiologies of Acute Respiratory and Febrile Illness
Time frame: Through 16 to 19 months post-vaccination
Safety Profile of LAIV: Serious Adverse Events
Time frame: Through 16 to 19 months post-vaccination
Safety Profile of LAIV: Protocol Defined Wheezing Illness
Time frame: Through 16 to 19 months post-vaccination
Percentage of Participants With Symptomatic, Laboratory-confirmed, Influenza Virus Infection (All Strains)
Time frame: Through 16 to 19 months post-vaccination
Percentage of Participants With Symptomatic, Laboratory-confirmed Influenza Virus Infection (Vaccine-matched Strains).
Time frame: Through 16 to 19 months post-vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29028980Rotrosen E, Zaman K, Feser J, Ortiz JR, Goswami D, Sharmeen AT, Rahman M, Lewis KDC, Rahman MZ, Barin B, Brooks WA, Neuzil KM. Influenza Among Young Children in Bangladesh: Clinical Characteristics and Outcomes From a Randomized Clinical Trial. Clin Infect Dis. 2017 Nov 13;65(11):1914-1920. doi: 10.1093/cid/cix674.
- Derived from this study: PubMed 27746226Brooks WA, Zaman K, Lewis KD, Ortiz JR, Goswami D, Feser J, Sharmeen AT, Nahar K, Rahman M, Rahman MZ, Barin B, Yunus M, Fry AM, Bresee J, Azim T, Neuzil KM. Efficacy of a Russian-backbone live attenuated influenza vaccine among young children in Bangladesh: a randomised, double-blind, placebo-controlled trial. Lancet Glob Health. 2016 Dec;4(12):e946-e954. doi: 10.1016/S2214-109X(16)30200-5. Epub 2016 Oct 13.
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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.
Abdullah Brooks, MD, MPH principal investigator
Johns Hopkins University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SIIL Live Attenuated Influenza Vaccine in people with Influenza, run by PATH at 2 sites 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 13 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 11 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 2 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 15 May 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?
Percentage of Participants With Symptomatic, Laboratory-confirmed Influenza Virus Infection (Vaccine-matched Strains). (time frame: Through 7 to 9 months post-vaccination). 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 NCT01797029, 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 11 Jun 2015.