InfluenzaPhase 4NCT00893906
Inactivated Influenza Vaccine Effectiveness in Tropical Africa
A Phase 4 study testing seasonal trivalent inactivated influenza vaccine and inactivated polio vaccine in people with Influenza, run by PATH at 1 site in Senegal.
Trial summary
Influenza, a highly communicable acute respiratory disease, is one of the major infectious disease threats to the human population. In Africa, information on the occurrence of influenza and its disease burden is seriously lacking. Read more about this study
- Who is it for?
- Ages 6 months to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- seasonal trivalent inactivated influenza vaccine and inactivated polio vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,000 participants
- Where
- 1 siteSenegal
- Study dates
- May 2009to Apr 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 6 months to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- A male or female child at least 6 months of age and no older than 10 years of age (has not yet reached 11 years of age) at the enrollment visit.
- A child whose parent or guardian's primary residence, at the time of study vaccinations, is a village compound selected to receive TIV or IPV.
- Subject's parent or legal guardian is willing to provide written informed consent prior to the subject's first study vaccination.
Who cannot join
- Hypersensitivity to the active substance or any component in either TIV (which includes egg protein) or IPV. (Please see information on composition of vaccines.)
- Hypersensitivity after previous administration of any influenza or polio vaccine.
- Acute severe febrile illness. (Administration of TIV or IPV should be postponed until after recovery. Minor illnesses, such as mild upper respiratory infection, with or without low grade fever, are not reason for postponing vaccination. Acute severe febrile illness is only a temporary exclusion.)
- Any condition that, in the opinion of the investigator, would pose a health risk to the participant or interfere with the evaluation of the study objectives.
Trial locations and contacts
1 site in 1 country.
Senegal1 site
Niakhar Demographic Surveillance System
Niakhar, Fatick District
About this study
Official title: Assessment of the Effectiveness of Seasonal Trivalent Influenza Vaccine Among Children in Senegal
Influenza, a highly communicable acute respiratory disease, is one of the major infectious disease threats to the human population. In Africa, information on the occurrence of influenza and its disease burden is seriously lacking. Such data would be important in determining the contribution of influenza to the more than two million annual pneumonia deaths among children globally, mostly in the developing world, and the potential number of deaths that could be prevented by influenza vaccination.
A single dose of trivalent inactivated influenza vaccine (TIV) is 70 to 90 percent effective in preventing influenza in healthy older children and young and middle-aged adults, but is less efficacious in young children and the elderly. Young children who suffer substantial influenza morbidity and are unlikely to have pre-existing immunity should receive two doses of TIV to provide adequate immunity. Because family studies of influenza transmission conducted during the 1970's found children to be the main introducers of influenza into households, vaccination of children may decrease the chances of spreading influenza to contacts. Mass vaccination of schoolchildren has been correlated with reduced respiratory illness in unvaccinated persons suggesting that immunization of children on a larger scale can affect community epidemics.
Read more
In temperate industrialized countries with seasonal disease, influenza vaccine is given annually, prior to the influenza season, and generally targeted to individuals with the highest risk of severe disease. Influenza prevention strategies may need to differ in tropical developing countries due to a variety of reasons. Given the varying influenza circulation patterns, it is unknown which hemisphere vaccine formulation will provide year-round protection against the diverse strains that may exist in tropical countries. Persons residing in developing countries also may have nutritional deficiencies or underlying diseases and infections that affect vaccine immunogenicity. Consideration must be given to programmatic issues as well. Adolescent and adult preventive health services are poorly developed in many countries, and thus a strategy that targets children may be the most feasible option. In addition, vaccinating children may be the most cost-effective option, as it has the potential to provide direct benefit to those vaccinated, as well as indirect benefits to unvaccinated members of the population. Thus, an influenza vaccine effectiveness study in a tropical developing country population will help to elucidate burden of seasonal influenza and may inform optimal use of vaccine for either seasonal and pandemic situations.
Thus, this study in Senegal will to evaluate the direct effects of TIV in reducing the occurrence of laboratory-confirmed influenza among children who receive it as well as the potential indirect effects experienced by the population as a result of reducing transmission among children.
Read the detailed description
The trial will take place in the study area of the Niakhar demographic surveillance system in Senegal, a population representative of rural impoverished Africa. Villages will be randomized to TIV or a beneficial control vaccine-inactivated polio vaccine-and children 6 months to 10 years of age will be targeted for vaccination. Four hundred children will be further enrolled into an immunogenicity and safety substudy which will measure their immune response to vaccination and assess in detail reactions and adverse events to the vaccines in these populations. For evaluation of effectiveness, passive and active surveillance will be conducted to identify laboratory-confirmed influenza among enrolled children and in the population in which they live. Such surveillance will also allow a determination of the rates of influenza and a description of the clinical characteristics of the disease in an African population. With such epidemiologic data, national and global public health officials will have better data for developing future influenza control strategies for either seasonal or pandemic influenza.
- Conditions
- Influenza
- Being tested
- seasonal trivalent inactivated influenza vaccine, inactivated polio vaccine
- Keywords
- influenza, influenza vaccine, vaccine effectiveness, cluster randomized, Africa
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
seasonal trivalent inactivated influenza vaccineBiological
Also called Vaxigrip
vaccine to be used according to marketed dosage and frequency
inactivated polio vaccineBiological
Also called Imovax Polio
vaccine to be used according to marketed dosage and frequency
| Study group | Role | What they receive |
|---|---|---|
| TIV | Experimental | Children living in villages randomized to influenza vaccine Receives: Biological: seasonal trivalent inactivated influenza vaccine |
| IPV | Experimental | Children living in villages randomized to polio vaccine Receives: Biological: inactivated polio vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total effectiveness of vaccine against laboratory-confirmed symptomatic influenza.
Measured: Two weeks post-vaccination through February 28 the following calendar year
Secondary outcomes (3)
Indirect effectiveness against laboratory-confirmed symptomatic influenza
Measured: Two weeks post-vaccination through February 28 the following calendar year
Overall effectiveness of vaccine against laboratory-confirmed symptomatic influenza
Measured: Two weeks post-vaccination through February 28 the following calendar year
Direct effectiveness of vaccine against laboratory-confirmed symptomatic influenza
Measured: Two weeks post-vaccination through February 28 the following calendar year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2009 (estimated)
- Study startMay 2009
- Primary completionDec 2012
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PATH
- Sponsor type
- University, hospital or other
- Collaborators
- Institut de Recherche pour le Developpement, Institut Pasteur, Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- John C Victor, PhD, MPH, Study director, PATHAldiouma Diallo, MD, Principal investigator, IRD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00893906
- Sponsor's protocol ID
- TIV-SEN-01
- Status last verified
- Sep 2013
- First submitted
- 4 May 2009
- Last updated
- 23 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Niang MN, Sugimoto JD, Diallo A, Diarra B, Ortiz JR, Lewis KDC, Lafond KE, Halloran ME, Widdowson MA, Neuzil KM, Victor JC. Estimates of Inactivated Influenza Vaccine Effectiveness Among Children in Senegal: Results From 2 Consecutive Cluster-Randomized Controlled Trials in 2010 and 2011. Clin Infect Dis. 2021 Jun 15;72(12):e959-e969. doi: 10.1093/cid/ciaa1689.
PubMed 33165566Diallo A, Diop OM, Diop D, Niang MN, Sugimoto JD, Ortiz JR, Faye EHA, Diarra B, Goudiaby D, Lewis KDC, Emery SL, Zangeneh SZ, Lafond KE, Sokhna C, Halloran ME, Widdowson MA, Neuzil KM, Victor JC. Effectiveness of Seasonal Influenza Vaccination in Children in Senegal During a Year of Vaccine Mismatch: A Cluster-randomized Trial. Clin Infect Dis. 2019 Oct 30;69(10):1780-1788. doi: 10.1093/cid/ciz066.
PubMed 30689757
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effectiveness of Seasonal Trivalent Influenza Vaccine Among Children in Senegal
- ClinicalTrials.gov ID
- NCT00893906
- Acronym / sponsor ID
- TIV-SEN-01
- Conditions
- Influenza
- Keywords
- influenza, influenza vaccine, vaccine effectiveness, cluster randomized, Africa
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- PATHUniversity, hospital or other
- Collaborators
- Institut de Recherche pour le Developpement, Institut Pasteur, Centers for Disease Control and Prevention
- Study start
- May 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 6 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Influenza, a highly communicable acute respiratory disease, is one of the major infectious disease threats to the human population. In Africa, information on the occurrence of influenza and its disease burden is seriously lacking. Such data would be important in determining the contribution of influenza to the more than two million annual pneumonia deaths among children globally, mostly in the developing world, and the potential number of deaths that could be prevented by influenza vaccination.
A single dose of trivalent inactivated influenza vaccine (TIV) is 70 to 90 percent effective in preventing influenza in healthy older children and young and middle-aged adults, but is less efficacious in young children and the elderly. Young children who suffer substantial influenza morbidity and are unlikely to have pre-existing immunity should receive two doses of TIV to provide adequate immunity. Because family studies of influenza transmission conducted during the 1970's found children to be the main introducers of influenza into households, vaccination of children may decrease the chances of spreading influenza to contacts. Mass vaccination of schoolchildren has been correlated with reduced respiratory illness in unvaccinated persons suggesting that immunization of children on a larger scale can affect community epidemics.
In temperate industrialized countries with seasonal disease, influenza vaccine is given annually, prior to the influenza season, and generally targeted to individuals with the highest risk of severe disease. Influenza prevention strategies may need to differ in tropical developing countries due to a variety of reasons. Given the varying influenza circulation patterns, it is unknown which hemisphere vaccine formulation will provide year-round protection against the diverse strains that may exist in tropical countries. Persons residing in developing countries also may have nutritional deficiencies or underlying diseases and infections that affect vaccine immunogenicity. Consideration must be given to programmatic issues as well. Adolescent and adult preventive health services are poorly developed in many countries, and thus a strategy that targets children may be the most feasible option. In addition, vaccinating children may be the most cost-effective option, as it has the potential to provide direct benefit to those vaccinated, as well as indirect benefits to unvaccinated members of the population. Thus, an influenza vaccine effectiveness study in a tropical developing country population will help to elucidate burden of seasonal influenza and may inform optimal use of vaccine for either seasonal and pandemic situations.
Thus, this study in Senegal will to evaluate the direct effects of TIV in reducing the occurrence of laboratory-confirmed influenza among children who receive it as well as the potential indirect effects experienced by the population as a result of reducing transmission among children.
Detailed description
The trial will take place in the study area of the Niakhar demographic surveillance system in Senegal, a population representative of rural impoverished Africa. Villages will be randomized to TIV or a beneficial control vaccine-inactivated polio vaccine-and children 6 months to 10 years of age will be targeted for vaccination. Four hundred children will be further enrolled into an immunogenicity and safety substudy which will measure their immune response to vaccination and assess in detail reactions and adverse events to the vaccines in these populations. For evaluation of effectiveness, passive and active surveillance will be conducted to identify laboratory-confirmed influenza among enrolled children and in the population in which they live. Such surveillance will also allow a determination of the rates of influenza and a description of the clinical characteristics of the disease in an African population. With such epidemiologic data, national and global public health officials will have better data for developing future influenza control strategies for either seasonal or pandemic influenza.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TIV | Experimental | Biological: seasonal trivalent inactivated influenza vaccineChildren living in villages randomized to influenza vaccine |
| IPV | Experimental | Biological: inactivated polio vaccineChildren living in villages randomized to polio vaccine |
Who may qualify
- Ages
- 6 months to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- A male or female child at least 6 months of age and no older than 10 years of age (has not yet reached 11 years of age) at the enrollment visit.
- A child whose parent or guardian's primary residence, at the time of study vaccinations, is a village compound selected to receive TIV or IPV.
- Subject's parent or legal guardian is willing to provide written informed consent prior to the subject's first study vaccination.
Key exclusion criteria (4 listed)
- Hypersensitivity to the active substance or any component in either TIV (which includes egg protein) or IPV. (Please see information on composition of vaccines.)
- Hypersensitivity after previous administration of any influenza or polio vaccine.
- Acute severe febrile illness. (Administration of TIV or IPV should be postponed until after recovery. Minor illnesses, such as mild upper respiratory infection, with or without low grade fever, are not reason for postponing vaccination. Acute severe febrile illness is only a temporary exclusion.)
- Any condition that, in the opinion of the investigator, would pose a health risk to the participant or interfere with the evaluation of the study objectives.
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 |
|---|---|---|
| seasonal trivalent inactivated influenza vaccineAlso: Vaxigripvaccine to be used according to marketed dosage and frequency | Biological | TIV |
| inactivated polio vaccineAlso: Imovax Poliovaccine to be used according to marketed dosage and frequency | Biological | IPV |
Primary outcome
Total effectiveness of vaccine against laboratory-confirmed symptomatic influenza.
Time frame: Two weeks post-vaccination through February 28 the following calendar year
3 secondary outcomes
Indirect effectiveness against laboratory-confirmed symptomatic influenza
Time frame: Two weeks post-vaccination through February 28 the following calendar year
Overall effectiveness of vaccine against laboratory-confirmed symptomatic influenza
Time frame: Two weeks post-vaccination through February 28 the following calendar year
Direct effectiveness of vaccine against laboratory-confirmed symptomatic influenza
Time frame: Two weeks post-vaccination through February 28 the following calendar year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2013.
- Derived from this study: PubMed 33165566Niang MN, Sugimoto JD, Diallo A, Diarra B, Ortiz JR, Lewis KDC, Lafond KE, Halloran ME, Widdowson MA, Neuzil KM, Victor JC. Estimates of Inactivated Influenza Vaccine Effectiveness Among Children in Senegal: Results From 2 Consecutive Cluster-Randomized Controlled Trials in 2010 and 2011. Clin Infect Dis. 2021 Jun 15;72(12):e959-e969. doi: 10.1093/cid/ciaa1689.
- Derived from this study: PubMed 30689757Diallo A, Diop OM, Diop D, Niang MN, Sugimoto JD, Ortiz JR, Faye EHA, Diarra B, Goudiaby D, Lewis KDC, Emery SL, Zangeneh SZ, Lafond KE, Sokhna C, Halloran ME, Widdowson MA, Neuzil KM, Victor JC. Effectiveness of Seasonal Influenza Vaccination in Children in Senegal During a Year of Vaccine Mismatch: A Cluster-randomized Trial. Clin Infect Dis. 2019 Oct 30;69(10):1780-1788. doi: 10.1093/cid/ciz066.
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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.
John C Victor, PhD, MPH study director
PATH
Aldiouma Diallo, MD principal investigator
IRD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing seasonal trivalent inactivated influenza vaccine and inactivated polio vaccine in people with Influenza, run by PATH at 1 site in Senegal.
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 4 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 23 Sep 2013. 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 Senegal. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Total effectiveness of vaccine against laboratory-confirmed symptomatic influenza. (time frame: Two weeks post-vaccination through February 28 the following calendar year). 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 NCT00893906, 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 23 Sep 2013.