InfluenzaPhase 2NCT01819155
Immunogenicity and Safety Trial of Adjuvanted and Non-adjuvanted Trivalent Influenza Vaccine in Tropical Africa
A Phase 2 study testing Adjuvanted seasonal trivalent inactivated influenza vaccine, Seasonal trivalent inactivated influenza vaccine and Saline (bacteriostatic 0.9% sodium chloride for injection) in people with Influenza, run by PATH at 1 site in Senegal.
Trial summary
This study will provide the Senegal Ministry of Health with data on the safety and immunogenicity of adjuvanted trivalent inactivated influenza vaccine (adjTIV) and full-dose seasonal non-adjuvanted trivalent inactivated influenza vaccine (TIV) in children. Read more about this study
- Who is it for?
- Ages 6 to 71 monthsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Adjuvanted seasonal trivalent inactivated influenza vaccine, Seasonal trivalent inactivated influenza vaccine and Saline (bacteriostatic 0.9% sodium chloride for injection)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 296 participants
- Where
- 1 siteSenegal
- Study dates
- Apr 2013to Sep 2013
- Phase
- Phase 2
- 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 to 71 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- A male or female child at least 6 months of age and under 6 years of age (has not yet reached 72 months of age) at the enrollment visit.
- Free of obvious health problems, as established by the medical history and screening evaluations, including physical examination.
- Subject's parent or legal guardian is willing to provide written informed consent prior to the subject's first study vaccination.
Who cannot join
- Known hypersensitivity to any component in adjTIV or TIV (which include egg protein) or placebo.
- Receipt of any non-study vaccine within two weeks prior to enrollment or refusal to postpone receipt of such vaccines until after the Day 56 visit.
- Previous receipt of any influenza vaccine.
- Hypersensitivity after previous administration of any vaccine.
- Acute illness accompanied by a body temperature of 37.5°C or greater (axillary measurement) within 14 days of enrollment visit. (Enrollment and administration of adjTIV, TIV, or placebo should be postponed until at least 14 days after recovery. Minor illnesses, such as mild upper respiratory infection, with an axillary temperature of <37.5°C, are not reason for exclusion or postponing study vaccination.)
- Any condition that, in the opinion of the investigator, would pose a health risk to the participant if he/she participates in the study or would interfere with the evaluation of the study objectives.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Immunogenicity and Safety of an MF59™- Adjuvanted Trivalent Influenza Vaccine and a Non-adjuvanted Trivalent Influenza Vaccine Among Children in Senegal
This study will provide the Senegal Ministry of Health with data on the safety and immunogenicity of adjuvanted trivalent inactivated influenza vaccine (adjTIV) and full-dose seasonal non-adjuvanted trivalent inactivated influenza vaccine (TIV) in children. This data will inform future policy considerations for influenza vaccine. The study is not powered to detect significant differences between vaccines or groups, and no hypotheses are to be tested; therefore, immunogenicity and safety objectives are to be analyzed descriptively.
Read the detailed description
The is a phase 2b, single-center, randomized, observer-blind, parallel group, placebo-controlled trial of the immunogenicity and safety of adjTIV and seasonal TIV among healthy children aged 6 months through 71 months in the town of Niakhar, Senegal. A total of 300 healthy children will be randomized in a 2:2:1 ratio of adjTIV to TIV to placebo. Each child will receive two doses of one of the three study vaccines, with each dose given 28 days apart. Each child will be followed closely for safety after each dose for the period from one month post-dose two to 3 months post-dose two. For determination of immune response to vaccination or background influenza infection, 3 mL of blood will be obtained at three time points: pre-vaccination, 28 days post-dose one (prior to receipt of dose two), and at 28 days post-dose two. Serum anti-influenza antibodies produced against virus strains contained in the vaccine will be detected using hemagglutination inhibition assay.
- Conditions
- Influenza
- Being tested
- Adjuvanted seasonal trivalent inactivated influenza vaccine, Seasonal trivalent inactivated influenza vaccine, Saline (bacteriostatic 0.9% sodium chloride for injection)
- Keywords
- influenza, influenza vaccine, immunogenicity, Africa, Senegal
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjuvanted seasonal trivalent inactivated influenza vaccineBiological
Also called Fluad
Seasonal trivalent inactivated influenza vaccineBiological
Also called VaxiGrip
Saline (bacteriostatic 0.9% sodium chloride for injection)Biological
| Study group | Role | What they receive |
|---|---|---|
| adjTIV | Experimental | Children randomized to receive adjTIV Receives: Biological: Adjuvanted seasonal trivalent inactivated influenza vaccine |
| TIV | Experimental | Children randomized to receive TIV Receives: Biological: Seasonal trivalent inactivated influenza vaccine |
| Placebo | Placebo comparator | Children randomized to receive Placebo Receives: Biological: Saline (bacteriostatic 0.9% sodium chloride for injection) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity of adjTIV
serum hemagglutination-inhibition antibodies
Measured: 28 days post-dose 2
Immunogenicity of TIV
serum hemagglutination-inhibition antibodies
Measured: 28 days post-dose 2
Secondary outcomes (1)
Adverse events
Measured: through three months post-dose 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2013 (estimated)
- Study startApr 2013
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 296 participants (actual)
Sponsor and investigators
- Lead sponsor
- PATH
- Sponsor type
- University, hospital or other
- Collaborators
- Institut de Recherche pour le Developpement, Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Aldiouma Diallo, MD, Principal investigator, Institut de Recherche pour le DeveloppementJohn C Victor, PhD, MPH, Study director, PATH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01819155
- Sponsor's protocol ID
- MF59-TIV-SEN-01
- Status last verified
- Jun 2013
- First submitted
- 22 Mar 2013
- Last updated
- 22 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Diallo A, Victor JC, Feser J, Ortiz JR, Kanesa-Thasan N, Ndiaye M, Diarra B, Cheikh S, Diene D, Ndiaye T, Ndiaye A, Lafond KE, Widdowson MA, Neuzil KM. Immunogenicity and safety of MF59-adjuvanted and full-dose unadjuvanted trivalent inactivated influenza vaccines among vaccine-naive children in a randomized clinical trial in rural Senegal. Vaccine. 2018 Oct 15;36(43):6424-6432. doi: 10.1016/j.vaccine.2018.08.032. Epub 2018 Sep 14.
PubMed 30224199
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Immunogenicity and Safety of an MF59™- Adjuvanted Trivalent Influenza Vaccine and a Non-adjuvanted Trivalent Influenza Vaccine Among Children in Senegal
- ClinicalTrials.gov ID
- NCT01819155
- Acronym / sponsor ID
- MF59-TIV-SEN-01
- Conditions
- Influenza
- Keywords
- influenza, influenza vaccine, immunogenicity, Africa, Senegal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 296 participants (actual)
- Lead sponsor
- PATHUniversity, hospital or other
- Collaborators
- Institut de Recherche pour le Developpement, Centers for Disease Control and Prevention
- Study start
- Apr 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 27 Mar 2013 (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.
This study will provide the Senegal Ministry of Health with data on the safety and immunogenicity of adjuvanted trivalent inactivated influenza vaccine (adjTIV) and full-dose seasonal non-adjuvanted trivalent inactivated influenza vaccine (TIV) in children. This data will inform future policy considerations for influenza vaccine. The study is not powered to detect significant differences between vaccines or groups, and no hypotheses are to be tested; therefore, immunogenicity and safety objectives are to be analyzed descriptively.
Detailed description
The is a phase 2b, single-center, randomized, observer-blind, parallel group, placebo-controlled trial of the immunogenicity and safety of adjTIV and seasonal TIV among healthy children aged 6 months through 71 months in the town of Niakhar, Senegal. A total of 300 healthy children will be randomized in a 2:2:1 ratio of adjTIV to TIV to placebo. Each child will receive two doses of one of the three study vaccines, with each dose given 28 days apart. Each child will be followed closely for safety after each dose for the period from one month post-dose two to 3 months post-dose two. For determination of immune response to vaccination or background influenza infection, 3 mL of blood will be obtained at three time points: pre-vaccination, 28 days post-dose one (prior to receipt of dose two), and at 28 days post-dose two. Serum anti-influenza antibodies produced against virus strains contained in the vaccine will be detected using hemagglutination inhibition assay.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| adjTIV | Experimental | Biological: Adjuvanted seasonal trivalent inactivated influenza vaccineChildren randomized to receive adjTIV |
| TIV | Experimental | Biological: Seasonal trivalent inactivated influenza vaccineChildren randomized to receive TIV |
| Placebo | Placebo comparator | Biological: Saline (bacteriostatic 0.9% sodium chloride for injection)Children randomized to receive Placebo |
Who may qualify
- Ages
- 6 to 71 months
- 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 under 6 years of age (has not yet reached 72 months of age) at the enrollment visit.
- Free of obvious health problems, as established by the medical history and screening evaluations, including physical examination.
- Subject's parent or legal guardian is willing to provide written informed consent prior to the subject's first study vaccination.
Key exclusion criteria (6 listed)
- Known hypersensitivity to any component in adjTIV or TIV (which include egg protein) or placebo.
- Receipt of any non-study vaccine within two weeks prior to enrollment or refusal to postpone receipt of such vaccines until after the Day 56 visit.
- Previous receipt of any influenza vaccine.
- Hypersensitivity after previous administration of any vaccine.
- Acute illness accompanied by a body temperature of 37.5°C or greater (axillary measurement) within 14 days of enrollment visit. (Enrollment and administration of adjTIV, TIV, or placebo should be postponed until at least 14 days after recovery. Minor illnesses, such as mild upper respiratory infection, with an axillary temperature of <37.5°C, are not reason for exclusion or postponing study vaccination.)
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 |
|---|---|---|
| Adjuvanted seasonal trivalent inactivated influenza vaccineAlso: Fluad | Biological | adjTIV |
| Seasonal trivalent inactivated influenza vaccineAlso: VaxiGrip | Biological | TIV |
| Saline (bacteriostatic 0.9% sodium chloride for injection) | Biological | Placebo |
Primary outcome
Immunogenicity of adjTIV
Time frame: 28 days post-dose 2
serum hemagglutination-inhibition antibodies
Immunogenicity of TIV
Time frame: 28 days post-dose 2
serum hemagglutination-inhibition antibodies
1 secondary outcome
Adverse events
Time frame: through three months post-dose 2
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 22 Oct 2013.
- Derived from this study: PubMed 30224199Diallo A, Victor JC, Feser J, Ortiz JR, Kanesa-Thasan N, Ndiaye M, Diarra B, Cheikh S, Diene D, Ndiaye T, Ndiaye A, Lafond KE, Widdowson MA, Neuzil KM. Immunogenicity and safety of MF59-adjuvanted and full-dose unadjuvanted trivalent inactivated influenza vaccines among vaccine-naive children in a randomized clinical trial in rural Senegal. Vaccine. 2018 Oct 15;36(43):6424-6432. doi: 10.1016/j.vaccine.2018.08.032. Epub 2018 Sep 14.
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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.
Aldiouma Diallo, MD principal investigator
Institut de Recherche pour le Developpement
John C Victor, PhD, MPH study director
PATH
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 Adjuvanted seasonal trivalent inactivated influenza vaccine, Seasonal trivalent inactivated influenza vaccine and Saline (bacteriostatic 0.9% sodium chloride for injection) 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 6 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 22 Oct 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. 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?
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?
Immunogenicity of adjTIV (time frame: 28 days post-dose 2). The study lists 2 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 NCT01819155, which also lists 1 linked publication.
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 22 Oct 2013.