Influenza, HumanPhase 3NCT05779020
Immunogenicity and Safety of Butantan Quadrivalent Influenza Vaccine (Split Virion, Inactivated) in Infants and Children .
A Phase 3 study testing Quadrivalent Influenza Vaccine (split virion, inactivated), Trivalent Influenza Vaccine (split virion, inactivated) containing Influenza B virus - Victoria lineage and Trivalent Influenza Vaccine (split virion, inactivated) containing Influenza B virus - Yamagata lineage in people with Influenza, Human, run by Butantan Institute at 10 sites in Brazil.
Trial summary
This is a Phase III Randomized Clinical Trial, blind, multicenter, with active controls, to evaluate the immunogenicity and safety of the Quadrivalent Influenza Vaccine (split virion, inactivated) from Instituto Butantan, in two dose scheme (0.25ml and 0.50ml), in infants and children under 3 years of age. Read more about this study
- Who is it for?
- Ages 6 to 35 monthsHealthy volunteers can take part
- Conditions the study is for
- Influenza, Human
- What is being tested?
- Quadrivalent Influenza Vaccine (split virion, inactivated), Trivalent Influenza Vaccine (split virion, inactivated) containing Influenza B virus - Victoria lineage and Trivalent Influenza Vaccine (split virion, inactivated) containing Influenza B virus - Yamagata lineage
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,373 participants
- Where
- 10 sitesBrazil
- Study dates
- 25 Apr 2023to 2 Aug 2025
- Phase
- Phase 3
- 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 35 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy infant and child of either sex aged between 6 and 35 months on the day of the first study vaccination.
- Born at term (≥ 37 weeks of gestational age) and birth weight ≥ 2.5 kg.
- Parents/legal guardians of the infant or child able and willing to attend all scheduled visits and comply with all study procedures, including blood draws.
- Parents/legal guardians of the infant or child have provided informed consent.
Who cannot join
- Having received any influenza vaccine from the current season and/or 6 months before the first study vaccination.
- History of allergy to egg, chicken proteins, or other components of the influenza vaccine.
- History of serious adverse reaction to any influenza vaccine.
- Have any clinically significant condition or situation that, in the Investigator's opinion, would interfere with study evaluations or participation.
- History of Guillain-Barré or other demyelinating diseases.
- History of neurological disease and/or clinically significant developmental delay (at the discretion of the Investigator), or seizure (except for an isolated febrile seizure episode).
Show all 23Show fewer
- Having received immune globulin, blood, or any blood product 3 months before the planned date of the first study vaccination or planned administration during the study period.
- Any confirmed or suspected immunosuppressive condition, congenital or acquired immunodeficiency (including human immunodeficiency virus - HIV) based on medical history and physical examination.
- Immediate personal or family history of congenital immunodeficiency.
- Having received or are using radiation therapy, chemotherapy, immunosuppressive drugs, or other immunomodulatory drugs within three months before the planned date of the first study vaccination or planned use during the study.
- Be a solid organ or bone marrow/stem cell transplant recipient.
- Thrombocytopenia, bleeding disorder, use of anticoagulants, or any condition that contraindicates intramuscular injection.
- Significant chronic disease (cancer, autoimmune disease, diabetes mellitus, acute or progressive liver disease, acute or progressive kidney disease, severe heart or lung disease) or which in the Investigator's opinion poses a risk to the health of the infant or child participating in the study or which may interfere with the conduct or conclusion of the study.
- History of seropositivity for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
- Major surgery or surgery using general anesthesia planned to occur during the period between the first vaccination and 28 days after full vaccination in the study.
- Any condition that, in the opinion of the Investigator, may interfere with the conduct or completion of the study (such as travelling or planned moving of residence, among others).
- Participation in another clinical trial involving another experimental or unregistered product 1 year before the planned date of the study's first vaccination, or plans to entering a clinical trial during the study.
- Infant and institutionalized child.
- Be related to the Investigator, research site staff member, or employee directly involved in the study.
- Postponement Criteria:
- Have received any vaccine (including routine childhood vaccines) within 28 days of the first study vaccination (delay until the 28-day deadline from the date of the last vaccination).
- Moderate or severe (as judged by the Investigator) acute illness/infection or febrile illness (temperature ≥ 37.8°C) 48 hours before the planned date of the first study vaccination.
- Acute respiratory illness within 14 days preceding the planned date of the first study vaccination.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Brazil10 sites
Centro Oncológico de Roraima - CECOR (Site BVB-01)
Boa Vista, Roraima, 69304-015
Centro de Pesquisas Clínicas da Universidade Federal de Sergipe (Site AJU01)
Laranjeiras, Sergipe, 49170-000
Instituto Auto Imune de Pesquisa e Educação Continuada - Real Hospital Português de Beneficência em Pernambuco (Site REC01)
Recife, Pernambuco
Hospital das Clínicas da Faculdade de Medicina Ribeirão Preto - USP (Site RAO 04)
Ribeirão Preto, São Paulo, 14051-140
CPQuali Pesquisa Clínica Ltda (Site 002)
São Paulo, 01228-000
Instituto de Pesquisa PENSI (Site SAO09)
São Paulo, 01228-200
Centro de Pesquisa Clínica do Instituto da Criança - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (Site SAO08)
São Paulo, 05403-000
Centro de Pesquisa Clínica S (Site RAO03)
Serrana, São Paulo
CPMC Pesquisa Clínica - Clinica De Alergia Martti Antila Sorocaba
Sorocaba, São Paulo, 18040-425
A2Z Clinical Centro Avançado de Pesquisa Clínica Ltda.(Site 001)
Valinhos, São Paulo, 13271-130
About this study
Official title: A Blind Randomized Clinical Trial, With Active Controls, to Evaluate the Immunogenicity and Safety of the Quadrivalent Influenza Vaccine (Split Virion, Inactivated) From Instituto Butantan, in Infants and Children Aged 6 to 35 Months.
This is a Phase III Randomized Clinical Trial, blind, multicenter, with active controls, to evaluate the immunogenicity and safety of the Quadrivalent Influenza Vaccine (split virion, inactivated) from Instituto Butantan, in two dose scheme (0.25ml and 0.50ml), in infants and children under 3 years of age.
Read the detailed description
The study will be carried out in multiple sites in Brazil, using a community-based recruitment strategy.
The study interventions are the Butantan Quadrivalent Influenza Vaccine (split virion, inactivated) in two dose scheme (QIV-IB/0.25ml and QIV-IB/0.50ml) and the active controls Butantan Trivalent Influenza Vaccine (split virion, inactivated) containing Influenza B virus - Victoria or Yamagata lineage (TIVV-IB and TIVY-IB), in a ratio 1:1:1:1.
The study population is healthy infants and children aged 6 to 35 months and all participants will be followed up 6 months after the last vaccination.
- Conditions
- Influenza, Human
- Being tested
- Quadrivalent Influenza Vaccine (split virion, inactivated), Trivalent Influenza Vaccine (split virion, inactivated) containing Influenza B virus - Victoria lineage, Trivalent Influenza Vaccine (split virion, inactivated) containing Influenza B virus - Yamagata lineage
- Keywords
- Influenza Vaccines
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadrivalent Influenza Vaccine (split virion, inactivated)Biological
Quadrivalent Influenza Vaccine (split virion, inactivated) from Instituto Butantan (dose 0.25ml and 0.50ml)
Trivalent Influenza Vaccine (split virion, inactivated) containing Influenza B virus - Victoria lineageBiological
Trivalent Influenza Vaccine (split virion, inactivated) containing Influenza B virus - Victoria lineage/dose 0.50ml
Trivalent Influenza Vaccine (split virion, inactivated) containing Influenza B virus - Yamagata lineageBiological
Trivalent Influenza Vaccine (split virion, inactivated) containing Influenza B virus - Yamagata lineage/dose 0.25ml
| Study group | Role | What they receive |
|---|---|---|
| QIV-IB/dose 0.25ml | Experimental | Butantan Quadrivalent Influenza Vaccine (split virion, inactivated)/dose 0.25ml Receives: Biological: Quadrivalent Influenza Vaccine (split virion, inactivated) |
| QIV-IB/dose 0.50ml | Experimental | Butantan Quadrivalent Influenza Vaccine (split virion, inactivated)/dose 0.50ml Receives: Biological: Quadrivalent Influenza Vaccine (split virion, inactivated) |
| TIVV-IB | Active comparator | Butantan Trivalent Influenza Vaccine (split virion, inactivated)/dose 0.25ml containing Influenza B virus - Victoria lineage Receives: Biological: Trivalent Influenza Vaccine (split virion, inactivated) containing Influenza B virus - Victoria lineage |
| TIVY-IB | Active comparator | Butantan Trivalent Influenza Vaccine (split virion, inactivated)/dose 0.25ml containing Influenza B virus - Yamagata lineage Receives: Biological: Trivalent Influenza Vaccine (split virion, inactivated) containing Influenza B virus - Yamagata lineage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of Geometric Mean Titers (rGMT) of antibodies induced by QIV-IB/0.25ml compared to those induced by TIVV-IB and TIVY-IB, for each strain, in infants and children from 6 to 35 months of age.
Immunogenicity outcomes assessed in serum samples by hemagglutination inhibition (HAI) assay.
Measured: 28 days after last vaccination
Ratio of Geometric Mean Titers (rGMT) of antibodies induced by QIV-IB/0.50ml compared to those induced by TIVV-IB and TIVY-IB, for each strain, in infants and children from 6 to 35 months of age.
Immunogenicity outcomes assessed in serum samples by hemagglutination inhibition (HAI) assay.
Measured: 28 days after last vaccination
Ratio of Geometric Mean Titers (rGMT) of antibodies induced by QIV-IB/0.25ml compared to those induced by TIV that does not contain the B strain, for B lineage Victoria and Yamagata, in infants and children aged 6 to 35 months age.
Immunogenicity outcomes assessed in serum samples by hemagglutination inhibition (HAI) assay.
Measured: 28 days after last vaccination
Ratio of Geometric Mean Titers (rGMT) of antibodies induced by QIV-IB/0.50ml compared to those induced by TIV that does not contain the B strain, for B lineage Victoria and Yamagata, in infants and children aged 6 to 35 months age.
Immunogenicity outcomes assessed in serum samples by hemagglutination inhibition (HAI) assay.
Measured: 28 days after last vaccination
Secondary outcomes (8)
Ratio of Geometric Mean Titers (rGMT) of antibodies induced by QIV-IB/0.50ml compared to those induced by QIV-IB/0.25ml, for each strain, in infants and children from 6 to 35 months of age.
Immunogenicity outcomes assessed in serum samples by hemagglutination inhibition (HAI) assay.
Measured: 28 days after last vaccination
Percentage of Participants With Seroconversion (Seroconversion Rate - SCR) to Influenza Vaccine Antigens.
SCR is defined as the percentage of subjects with either a prevaccination HAI titer < 1:10 and a postvaccination HI titer ≥ 1:40, or a prevaccination HI titer ≥ 1:10 and a ≥ 4-fold increase in postvaccination HI titer.
Measured: At Days 0 and 28/56
Percentage of Participants achieving seroprotection (Seroprotection Rate - SPR) to Influenza Vaccine Antigens.
Seroprotection Rate is defined as the percentage of subjects with HAI titer ≥1:40
Measured: At Days 0 and 28/56
Pre- and post-vaccination Geometric Mean Titers (GMT) induced by QIV-IB/0.25ml, QIV-IB/0.50ml, TIVV-IB e TIVY-IB, for each strain, in infants and children from 6 to 35 months of age.
Immunogenicity outcomes assessed in serum samples by hemagglutination inhibition (HAI) assay.
Measured: At Days 0 and 28/56
Ratio of Pre- and post-vaccination Geometric Mean Titers (rGMT) induced by QIV-IB/0.25ml, QIV-IB/0.50ml, TIVV-IB e TIVY-IB, for each strain, in infants and children from 6 to 35 months of age.
Immunogenicity outcomes assessed in serum samples by hemagglutination inhibition (HAI) assay.
Measured: At Days 0 and 28/56
Solicited local Site or Systemic Reactions After each Injection
Percentage of subjects with Solicited local Site or Systemic Reactions After each Injection
Measured: Day 0 up to Day 7 post-injection
Related Unsolicited Adverse Events
Percentage of subjects with Related Unsolicited Adverse Events
Measured: 28 days after last vaccination
Serious Adverse Events (SAE) and adverse events of special interest (AESI)
Percentage of subjects with Serious Adverse Events (SAE) and adverse events of special interest (AESI)
Measured: Entire study participant's follow-up period (6 months after the last vaccination)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start25 Apr 2023
- Primary completion12 Sep 2024
- Study completion2 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza, HumanStudies 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
- 1,373 participants (actual)
Sponsor and investigators
- Lead sponsor
- Butantan Institute
- Sponsor type
- Other government
- Collaborators
- Butantan Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05779020
- Sponsor's protocol ID
- FLQ-02-IB
- Status last verified
- Sep 2025
- First submitted
- 9 Mar 2023
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Blind Randomized Clinical Trial, With Active Controls, to Evaluate the Immunogenicity and Safety of the Quadrivalent Influenza Vaccine (Split Virion, Inactivated) From Instituto Butantan, in Infants and Children Aged 6 to 35 Months.
- ClinicalTrials.gov ID
- NCT05779020
- Acronym / sponsor ID
- FLQ-02-IB
- Conditions
- Influenza, Human
- Keywords
- Influenza Vaccines
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,373 participants (actual)
- Lead sponsor
- Butantan InstituteOther government
- Collaborators
- Butantan Foundation
- Study start
- 25 Apr 2023 (actual)
- Primary completion
- 12 Sep 2024 (actual)
- Study completion
- 2 Aug 2025 (actual)
- First posted
- 22 Mar 2023 (actual)
- 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 is a Phase III Randomized Clinical Trial, blind, multicenter, with active controls, to evaluate the immunogenicity and safety of the Quadrivalent Influenza Vaccine (split virion, inactivated) from Instituto Butantan, in two dose scheme (0.25ml and 0.50ml), in infants and children under 3 years of age.
Detailed description
The study will be carried out in multiple sites in Brazil, using a community-based recruitment strategy.
The study interventions are the Butantan Quadrivalent Influenza Vaccine (split virion, inactivated) in two dose scheme (QIV-IB/0.25ml and QIV-IB/0.50ml) and the active controls Butantan Trivalent Influenza Vaccine (split virion, inactivated) containing Influenza B virus - Victoria or Yamagata lineage (TIVV-IB and TIVY-IB), in a ratio 1:1:1:1.
The study population is healthy infants and children aged 6 to 35 months and all participants will be followed up 6 months after the last vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| QIV-IB/dose 0.25ml | Experimental | Biological: Quadrivalent Influenza Vaccine (split virion, inactivated)Butantan Quadrivalent Influenza Vaccine (split virion, inactivated)/dose 0.25ml |
| QIV-IB/dose 0.50ml | Experimental | Biological: Quadrivalent Influenza Vaccine (split virion, inactivated)Butantan Quadrivalent Influenza Vaccine (split virion, inactivated)/dose 0.50ml |
| TIVV-IB | Active comparator | Biological: Trivalent Influenza Vaccine (split virion, inactivated) containing Influenza B virus - Victoria lineageButantan Trivalent Influenza Vaccine (split virion, inactivated)/dose 0.25ml containing Influenza B virus - Victoria lineage |
| TIVY-IB | Active comparator | Biological: Trivalent Influenza Vaccine (split virion, inactivated) containing Influenza B virus - Yamagata lineageButantan Trivalent Influenza Vaccine (split virion, inactivated)/dose 0.25ml containing Influenza B virus - Yamagata lineage |
Who may qualify
- Ages
- 6 to 35 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Healthy infant and child of either sex aged between 6 and 35 months on the day of the first study vaccination.
- Born at term (≥ 37 weeks of gestational age) and birth weight ≥ 2.5 kg.
- Parents/legal guardians of the infant or child able and willing to attend all scheduled visits and comply with all study procedures, including blood draws.
- Parents/legal guardians of the infant or child have provided informed consent.
Key exclusion criteria (23 listed)
- Having received any influenza vaccine from the current season and/or 6 months before the first study vaccination.
- History of allergy to egg, chicken proteins, or other components of the influenza vaccine.
- History of serious adverse reaction to any influenza vaccine.
- Have any clinically significant condition or situation that, in the Investigator's opinion, would interfere with study evaluations or participation.
- History of Guillain-Barré or other demyelinating diseases.
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 |
|---|---|---|
| Quadrivalent Influenza Vaccine (split virion, inactivated)Quadrivalent Influenza Vaccine (split virion, inactivated) from Instituto Butantan (dose 0.25ml and 0.50ml) | Biological | QIV-IB/dose 0.25ml, QIV-IB/dose 0.50ml |
| Trivalent Influenza Vaccine (split virion, inactivated) containing Influenza B virus - Victoria lineageTrivalent Influenza Vaccine (split virion, inactivated) containing Influenza B virus - Victoria lineage/dose 0.50ml | Biological | TIVV-IB |
| Trivalent Influenza Vaccine (split virion, inactivated) containing Influenza B virus - Yamagata lineageTrivalent Influenza Vaccine (split virion, inactivated) containing Influenza B virus - Yamagata lineage/dose 0.25ml | Biological | TIVY-IB |
Primary outcome
Ratio of Geometric Mean Titers (rGMT) of antibodies induced by QIV-IB/0.25ml compared to those induced by TIVV-IB and TIVY-IB, for each strain, in infants and children from 6 to 35 months of age.
Time frame: 28 days after last vaccination
Immunogenicity outcomes assessed in serum samples by hemagglutination inhibition (HAI) assay.
Ratio of Geometric Mean Titers (rGMT) of antibodies induced by QIV-IB/0.50ml compared to those induced by TIVV-IB and TIVY-IB, for each strain, in infants and children from 6 to 35 months of age.
Time frame: 28 days after last vaccination
Immunogenicity outcomes assessed in serum samples by hemagglutination inhibition (HAI) assay.
Ratio of Geometric Mean Titers (rGMT) of antibodies induced by QIV-IB/0.25ml compared to those induced by TIV that does not contain the B strain, for B lineage Victoria and Yamagata, in infants and children aged 6 to 35 months age.
Time frame: 28 days after last vaccination
Immunogenicity outcomes assessed in serum samples by hemagglutination inhibition (HAI) assay.
Ratio of Geometric Mean Titers (rGMT) of antibodies induced by QIV-IB/0.50ml compared to those induced by TIV that does not contain the B strain, for B lineage Victoria and Yamagata, in infants and children aged 6 to 35 months age.
Time frame: 28 days after last vaccination
Immunogenicity outcomes assessed in serum samples by hemagglutination inhibition (HAI) assay.
8 secondary outcomes
Ratio of Geometric Mean Titers (rGMT) of antibodies induced by QIV-IB/0.50ml compared to those induced by QIV-IB/0.25ml, for each strain, in infants and children from 6 to 35 months of age.
Time frame: 28 days after last vaccination
Percentage of Participants With Seroconversion (Seroconversion Rate - SCR) to Influenza Vaccine Antigens.
Time frame: At Days 0 and 28/56
Percentage of Participants achieving seroprotection (Seroprotection Rate - SPR) to Influenza Vaccine Antigens.
Time frame: At Days 0 and 28/56
Pre- and post-vaccination Geometric Mean Titers (GMT) induced by QIV-IB/0.25ml, QIV-IB/0.50ml, TIVV-IB e TIVY-IB, for each strain, in infants and children from 6 to 35 months of age.
Time frame: At Days 0 and 28/56
Ratio of Pre- and post-vaccination Geometric Mean Titers (rGMT) induced by QIV-IB/0.25ml, QIV-IB/0.50ml, TIVV-IB e TIVY-IB, for each strain, in infants and children from 6 to 35 months of age.
Time frame: At Days 0 and 28/56
Solicited local Site or Systemic Reactions After each Injection
Time frame: Day 0 up to Day 7 post-injection
Related Unsolicited Adverse Events
Time frame: 28 days after last vaccination
Serious Adverse Events (SAE) and adverse events of special interest (AESI)
Time frame: Entire study participant's follow-up period (6 months after the last vaccination)
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 19 Sep 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
10 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 Quadrivalent Influenza Vaccine (split virion, inactivated), Trivalent Influenza Vaccine (split virion, inactivated) containing Influenza B virus - Victoria lineage and Trivalent Influenza Vaccine (split virion, inactivated) containing Influenza B virus - Yamagata lineage in people with Influenza, Human, run by Butantan Institute at 10 sites in Brazil.
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 4 inclusion and 23 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 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Brazil. 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 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?
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?
Ratio of Geometric Mean Titers (rGMT) of antibodies induced by QIV-IB/0.25ml compared to those induced by TIVV-IB and TIVY-IB, for each strain, in infants and children from 6 to 35 months of age. (time frame: 28 days after last 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?
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 19 Sep 2025.