InfluenzaPhase 2NCT01195779
Trial to Evaluate Safety and Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2584786A in Healthy Children
A Phase 2 study testing GSK Bio's influenza vaccine GSK2584786A, different formulations, GSK Bio's influenza vaccine GSK2321138A and Fluarix™ in people with Influenza and Influenza Vaccines, run by GlaxoSmithKline at 1 site in Spain.
Trial summary
The purpose of this observer-blind study is to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals' influenza vaccine GSK2584786A in healthy children 6 to 35 months 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, Influenza Vaccines
- What is being tested?
- GSK Bio's influenza vaccine GSK2584786A, different formulations, GSK Bio's influenza vaccine GSK2321138A and Fluarix™
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteSpain
- Study dates
- 30 Sep 2010to 22 Mar 2011
- 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 6 to 35 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All subjects must satisfy ALL the following criteria at study entry:
- Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol
- Children, male or female between, and including, 6 and 35 months of age at the time of the first vaccination.
- Written informed consent obtained from the parent(s)/LAR(s) of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Age appropriate scheduled childhood vaccinations completed to the best of parent(s)/LAR(s) knowledge.
- Born after gestation period of 36 to 42 weeks inclusive
Who cannot join
- The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study:
- Child in "care"
- Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Prior receipt of any influenza vaccination or planned administration during the study period.
- Planned administration of any vaccine 30 days prior and 30 days after any study vaccine administration.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
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- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- A family history of congenital or hereditary immunodeficiency.
- A family history of febrile seizures or/and epilepsy
- Any known or suspected allergy to any constituent of influenza or routine paediatric vaccines, a history of severe adverse reaction to any previous vaccination; or a history of anaphylactic-type reaction to any constituent of influenza vaccine.
- History of any progressive neurological disorders or seizures.
- Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history or physical examination.
- Acute disease and/or fever at the time of enrolment:
- - Fever is defined as temperature ≥ 37.5°C on oral, axillary or tympanic setting, or ≥38.0°C on rectal setting.
- Subjects with a minor illness without fever might be enrolled at the discretion of the investigator.
- Administration of immunoglobulins and/or any blood products within the 3 month preceding the first dose of study vaccine or planned administration during the study period.
- Any condition which, in the opinion of the investigator, render the subject unfit for participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observer-blind Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Adjuvanted Quadrivalent Influenza Candidate Vaccines (GSK2584786A) in Children Aged 6 to 35 Months
The purpose of this observer-blind study is to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals' influenza vaccine GSK2584786A in healthy children 6 to 35 months of age.
- Conditions
- Influenza, Influenza Vaccines
- Being tested
- GSK Bio's influenza vaccine GSK2584786A, different formulations, GSK Bio's influenza vaccine GSK2321138A, Fluarix™
- Keywords
- immunogenicity, safety, Influenza, children, 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.
GSK Bio's influenza vaccine GSK2584786A, different formulationsBiological
Intramuscular injections
GSK Bio's influenza vaccine GSK2321138ABiological
Intramuscular injections
Fluarix™Biological
Intramuscular injections
| Study group | Role | What they receive |
|---|---|---|
| GSK2584786A vaccine 1 dose of Formulation A1 Group | Experimental | Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1. Receives: Biological: GSK Bio's influenza vaccine GSK2584786A, different formulations |
| GSK2584786A vaccine 2 doses of Formulation A1 Group | Experimental | Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1. Receives: Biological: GSK Bio's influenza vaccine GSK2584786A, different formulations |
| GSK2584786A vaccine 1 dose of Formulation A2 Group | Experimental | Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2. Receives: Biological: GSK Bio's influenza vaccine GSK2584786A, different formulations |
| GSK2584786A vaccine 2 doses of Formulation A2 Group | Experimental | Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2. Receives: Biological: GSK Bio's influenza vaccine GSK2584786A, different formulations |
| GSK2584786A vaccine 1 dose of Formulation A3 Group | Experimental | Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3. Receives: Biological: GSK Bio's influenza vaccine GSK2584786A, different formulations |
| GSK2584786A vaccine 2 doses of Formulation A3 Group | Experimental | Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3. Receives: Biological: GSK Bio's influenza vaccine GSK2584786A, different formulations |
| GSK2584786A vaccine 1 dose of Formulation B1 Group | Experimental | Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1. Receives: Biological: GSK Bio's influenza vaccine GSK2584786A, different formulations |
| GSK2584786A vaccine 2 doses of Formulation B1 Group | Experimental | Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1. Receives: Biological: GSK Bio's influenza vaccine GSK2584786A, different formulations |
| GSK2584786A vaccine 1 dose of Formulation B2 Group | Experimental | Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2. Receives: Biological: GSK Bio's influenza vaccine GSK2584786A, different formulations |
| GSK2584786A vaccine 2 doses of Formulation B2 Group | Experimental | Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2. Receives: Biological: GSK Bio's influenza vaccine GSK2584786A, different formulations |
| GSK2584786A vaccine 1 dose of Formulation B3 Group | Experimental | Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3. Receives: Biological: GSK Bio's influenza vaccine GSK2584786A, different formulations |
| GSK2584786A vaccine 2 doses of Formulation B3 Group | Experimental | Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3. Receives: Biological: GSK Bio's influenza vaccine GSK2584786A, different formulations |
| GSK2321138A vaccine Group | Experimental | Subjects received 2 doses of GSK Biologicals' non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A). Receives: Biological: GSK Bio's influenza vaccine GSK2321138A |
| Fluarix Group | Active comparator | Subjects received 2 doses of Fluarix Vaccine. Receives: Biological: Fluarix™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Haemagglutination-inhibition (HI) Antibody Titers
Titers were planned to be expressed as Geometric Mean Titers (GMTs). Analysis was planned to be done for antibodies against all 4 vaccine strains.
Measured: at Day 28/ Day 56
Serum Neutralizing Antibody Titers
Measured: at Day 28/ Day 56
Geometric Mean Number of All-CD4 Cytokine Positive Cells
Geometric mean of the number of CD4 cytokine positive T cells per million T cells.
Measured: at Day 28/ Day 56
Number of Subjects Reporting Fever of at Least Grade 2 or Higher
Grade 2 fever was defined as axillary temperature above 38 degrees Celcius.
Measured: Within 7 days (Day 0 to 6) follow-up period after any dose of study vaccine
Secondary outcomes (7)
Serum HI Antibody Titers
Titers were planned to be expressed as Geometric Mean Titers (GMTs). Analysis was planned to be done for antibodies against all 4 vaccine strains.
Measured: on Days 0, 28/56 and 180
Serum Neutralising Antibody Titers
Titers were planned to be expressed as Geometric Mean Titers (GMTs). Analysis was planned to be done for antibodies against all 4 vaccine strains.
Measured: on Days 0, 28/56 and 180
Number of Subjects Reporting Solicited Local and General Symptoms
Solicited local symptoms included pain, redness and swelling at the injection site. Solicited general symptoms included drowsiness, fever, irritability and loss of appetite.
Measured: during a 7 day follow-up period (Day 0 to 6) after any vaccination
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Measured: within 28 days (Day 0 to Day 27) after any vaccination
Number of Subjects Reporting Adverse Events With Medically Attended Visits
A mediaclly attended visit is defined as hospitalisation, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason.
Measured: From Day 0 to 179
Number of Subjects Reporting Potential Immune-mediated Diseases
Potential Immune-Mediated Diseases (pIMDs) are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.
Measured: From Day 0 to 179
Number of Subjects Reporting Serious Adverse Events
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Measured: From Day 0 to 179
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2010 (estimated)
- Study start30 Sep 2010
- Primary completion22 Mar 2011
- Study completion22 Mar 2011
Why it stopped: The study was terminated for logistic reasons not related to safety or efficacy of the vaccine.
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.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- 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
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01195779
- Sponsor's protocol ID
- 114294
- Other IDs
- 2010-020312-12
- Status last verified
- Oct 2020
- First submitted
- 3 Sep 2010
- Last updated
- 30 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observer-blind Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Adjuvanted Quadrivalent Influenza Candidate Vaccines (GSK2584786A) in Children Aged 6 to 35 Months
- ClinicalTrials.gov ID
- NCT01195779
- Acronym / sponsor ID
- 114294
- Conditions
- Influenza, Influenza Vaccines
- Keywords
- immunogenicity, safety, Influenza, children, vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated for logistic reasons not related to safety or efficacy of the vaccine.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2010 (actual)
- Primary completion
- 22 Mar 2011 (actual)
- Study completion
- 22 Mar 2011 (actual)
- First posted
- 6 Sep 2010 (estimated)
- Results
- Posted 24 Apr 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this observer-blind study is to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals' influenza vaccine GSK2584786A in healthy children 6 to 35 months of age.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 14
| Arm | Type | Receives |
|---|---|---|
| GSK2584786A vaccine 1 dose of Formulation A1 Group | Experimental | Biological: GSK Bio's influenza vaccine GSK2584786A, different formulationsSubjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1. |
| GSK2584786A vaccine 2 doses of Formulation A1 Group | Experimental | Biological: GSK Bio's influenza vaccine GSK2584786A, different formulationsSubjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1. |
| GSK2584786A vaccine 1 dose of Formulation A2 Group | Experimental | Biological: GSK Bio's influenza vaccine GSK2584786A, different formulationsSubjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2. |
| GSK2584786A vaccine 2 doses of Formulation A2 Group | Experimental | Biological: GSK Bio's influenza vaccine GSK2584786A, different formulationsSubjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2. |
| GSK2584786A vaccine 1 dose of Formulation A3 Group | Experimental | Biological: GSK Bio's influenza vaccine GSK2584786A, different formulationsSubjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3. |
| GSK2584786A vaccine 2 doses of Formulation A3 Group | Experimental | Biological: GSK Bio's influenza vaccine GSK2584786A, different formulationsSubjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3. |
| GSK2584786A vaccine 1 dose of Formulation B1 Group | Experimental | Biological: GSK Bio's influenza vaccine GSK2584786A, different formulationsSubjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1. |
| GSK2584786A vaccine 2 doses of Formulation B1 Group | Experimental | Biological: GSK Bio's influenza vaccine GSK2584786A, different formulationsSubjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1. |
| GSK2584786A vaccine 1 dose of Formulation B2 Group | Experimental | Biological: GSK Bio's influenza vaccine GSK2584786A, different formulationsSubjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2. |
| GSK2584786A vaccine 2 doses of Formulation B2 Group | Experimental | Biological: GSK Bio's influenza vaccine GSK2584786A, different formulationsSubjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2. |
| GSK2584786A vaccine 1 dose of Formulation B3 Group | Experimental | Biological: GSK Bio's influenza vaccine GSK2584786A, different formulationsSubjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3. |
| GSK2584786A vaccine 2 doses of Formulation B3 Group | Experimental | Biological: GSK Bio's influenza vaccine GSK2584786A, different formulationsSubjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3. |
| GSK2321138A vaccine Group | Experimental | Biological: GSK Bio's influenza vaccine GSK2321138ASubjects received 2 doses of GSK Biologicals' non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A). |
| Fluarix Group | Active comparator | Biological: Fluarix™Subjects received 2 doses of Fluarix Vaccine. |
Who may qualify
- Ages
- 6 to 35 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol
- Children, male or female between, and including, 6 and 35 months of age at the time of the first vaccination.
- Written informed consent obtained from the parent(s)/LAR(s) of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Age appropriate scheduled childhood vaccinations completed to the best of parent(s)/LAR(s) knowledge.
Key exclusion criteria (17 listed)
- The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study:
- Child in "care"
- Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Prior receipt of any influenza vaccination or planned administration during the study period.
- Planned administration of any vaccine 30 days prior and 30 days after any study vaccine administration.
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 |
|---|---|---|
| GSK Bio's influenza vaccine GSK2584786A, different formulationsIntramuscular injections | Biological | GSK2584786A vaccine 1 dose of Formulation A1 Group, GSK2584786A vaccine 1 dose of Formulation A2 Group, GSK2584786A vaccine 1 dose of Formulation A3 Group, GSK2584786A vaccine 1 dose of Formulation B1 Group, GSK2584786A vaccine 1 dose of Formulation B2 Group, GSK2584786A vaccine 1 dose of Formulation B3 Group, GSK2584786A vaccine 2 doses of Formulation A1 Group, GSK2584786A vaccine 2 doses of Formulation A2 Group, GSK2584786A vaccine 2 doses of Formulation A3 Group, GSK2584786A vaccine 2 doses of Formulation B1 Group, GSK2584786A vaccine 2 doses of Formulation B2 Group, GSK2584786A vaccine 2 doses of Formulation B3 Group |
| GSK Bio's influenza vaccine GSK2321138AIntramuscular injections | Biological | GSK2321138A vaccine Group |
| Fluarix™Intramuscular injections | Biological | Fluarix Group |
Primary outcome
Serum Haemagglutination-inhibition (HI) Antibody Titers
Time frame: at Day 28/ Day 56
Titers were planned to be expressed as Geometric Mean Titers (GMTs). Analysis was planned to be done for antibodies against all 4 vaccine strains.
Serum Neutralizing Antibody Titers
Time frame: at Day 28/ Day 56
Geometric Mean Number of All-CD4 Cytokine Positive Cells
Time frame: at Day 28/ Day 56
Geometric mean of the number of CD4 cytokine positive T cells per million T cells.
Number of Subjects Reporting Fever of at Least Grade 2 or Higher
Time frame: Within 7 days (Day 0 to 6) follow-up period after any dose of study vaccine
Grade 2 fever was defined as axillary temperature above 38 degrees Celcius.
7 secondary outcomes
Serum HI Antibody Titers
Time frame: on Days 0, 28/56 and 180
Serum Neutralising Antibody Titers
Time frame: on Days 0, 28/56 and 180
Number of Subjects Reporting Solicited Local and General Symptoms
Time frame: during a 7 day follow-up period (Day 0 to 6) after any vaccination
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
Time frame: within 28 days (Day 0 to Day 27) after any vaccination
Number of Subjects Reporting Adverse Events With Medically Attended Visits
Time frame: From Day 0 to 179
Number of Subjects Reporting Potential Immune-mediated Diseases
Time frame: From Day 0 to 179
Number of Subjects Reporting Serious Adverse Events
Time frame: From Day 0 to 179
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
GSK Clinical Trials study director
GlaxoSmithKline
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 GSK Bio's influenza vaccine GSK2584786A, different formulations, GSK Bio's influenza vaccine GSK2321138A and Fluarix™ in people with Influenza and Influenza Vaccines, run by GlaxoSmithKline at 1 site in Spain.
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 7 inclusion and 17 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: stopped early, as of the sponsor's last update on 30 Oct 2020. 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 Spain. 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 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 24 Apr 2012). 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?
Serum Haemagglutination-inhibition (HI) Antibody Titers (time frame: at Day 28/ Day 56). 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 30 Oct 2020.