Influenza, HumanPhase 3NCT03460743
Evaluation of a Recombinant Quadrivalent Influenza Vaccine Versus a Marketed Quadrivalent Inactivated Influenza Vaccine in Children 3 to 17.
A Phase 3 study testing Study group - quadrivalent recombinant hemagglutinin influenza vaccine in people with Influenza, Human, run by Laboratorios Liomont at 11 sites in Mexico.
Trial summary
Multicentric study, Phase III; this study is a randomized, participant- and observer-blind, parallel group evaluation to evaluate the immunogenicity, relative efficacy, safety and reactogenicity of a recombinant quadrivalent hemagglutinin influenza vaccine versus an inactivated quadrivalent influenza vaccine in… Read more about this study
- Who is it for?
- Ages 3 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza, Human
- What is being tested?
- Study group - quadrivalent recombinant hemagglutinin influenza vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,556 participants
- Where
- 11 sitesMexico
- Study dates
- 22 Mar 2018to 22 Oct 2019
- 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 3 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Male or female age 3 to 17 years.
- History of two previous influenza immunizations at any time, or influenza infection during the previous year.
- Female subjects of child-bearing potential (as defined by the onset of menses) must agree to prevent pregnancy and usage of an effective contraception, or having practiced sexual abstinence for at least 28 day prior to the first study vaccine administration. Female subjects of child-bearing potential must be tested for pregnancy within 24 hours prior to vaccine administration.
- In good general health, healthy or medically stable, as determined by the medical history, physical examination and the Investigator's judgment.
- Parent(s) or legal representative of each potential subject must comprehend the study requirements, sign the informed consent before any procedure, and agree to comply with planned study procedures and visits. Provide written consent prior to enrollment and initiation of any study procedure.
- Pediatric consent will be attained as per the Research Ethics Committee's determination when subject is aged 8 or older.
Who cannot join
- Known allergy to eggs (anaphylaxis, angioedema, respiratory distress), severe allergy (e.g. anaphylaxis) to other components of the vaccine or contraindications to receive the comparator IIV4.
- Use of systemic steroids at doses of 2mg/kg/day for more than 10 days of prednisone or its equivalent.
- (The use of nasal or topical steroids will be allowed).
- Active neoplastic disease or a history of any malignancy.
- History of receiving the influenza vaccine within the previous 6 months.
- Plan to receive another influenza vaccine, during the study term.
Show all 14Show fewer
- History of receiving immunoglobulin or another blood product within the 3 months prior to enrollment in this study.
- Acute or chronic medical condition that, in the opinion of the Investigator, would render immunization unsafe or would interfere with the evaluation of efficacy or the immune response to the vaccine.
- An acute illness, including a body temperature greater than 37.7°C, within 3 days prior to immunization.
- Receive an experimental vaccine or medication within 1 month prior to enrollment in this study, or the expectation to receive an experimental vaccine, medication, or blood product during the study period.
- Developmental delay, neurologic disorder, or seizure disorder requiring ongoing medical assistance (note: history of febrile seizure is not considered an exclusion criterion).
- History of Guillain-Barré syndrome within 6 weeks after the application a previous influenza vaccine.
- Concurrent participation in another clinical trial (active or follow-up phase).
- Any other condition or situation that would, in the opinion of the investigator, place them at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Mexico11 sites
Centro de Investigacion Clinica del Pacifico
Acapulco de Juárez, Guerrero, 39670
JM Research
Cuernavaca, Morelos, 62290
Instituto Jalisciencie de Metabolismo
Guadalajara, Jalisco, 44670
Instituto Nacional de Pediatria
Mexico City, 04530
CEMDEC
Mexico City, 06100
Clinical Research Institute Darwin
Mexico City, 11590
AINPAD Morelia
Morelia, Michoacán, 58070
AMIC Pachuca
Pachuca, Hidalgo, 42070
UDEP Puebla
Puebla City, 72160
Clinical Research Institute Saltillo
Saltillo, Coahuila, 25020
Centro Especializado en Investigación Clínica CEIC
Veracruz, 94290
About this study
Official title: Evaluation of the Immunogenicity, Relative Efficacy, Safety and Reactogenicity of Flublok Quadrivalent® (Quadrivalent Recombinant Influenza Vaccine, Seasonal Formulation) Compared With a Marketed Quadrivalent Vaccine in Healthy Children and Adolescents Aged 3 to 17 Years-old.
Multicentric study, Phase III; this study is a randomized, participant- and observer-blind, parallel group evaluation to evaluate the immunogenicity, relative efficacy, safety and reactogenicity of a recombinant quadrivalent hemagglutinin influenza vaccine versus an inactivated quadrivalent influenza vaccine in pediatric subjects and adolescents of 3-17 years of age. Investigational vaccine is indicated for active immunization against influenza A and B for strains contained in the vaccine marketed in the United States for persons 18 years of age or older.
Read the detailed description
Abbreviated title Evaluation of immunogenicity, relative efficacy, safety and reactogenicity of Flublok Quadrivalent® in healthy children and adolescents aged 3 to17 years.
Sponsor Product Identifiers Flublok® Quadrivalent of Laboratories Liomont, S.A. de C.V.
Flublok Quadrivalent consists of 180 μg total recombinant hemagglutinins Study Phase Phase 3 Study National multicentric Participating sites: Mexico: At least 10 research sites distributed in different states.
Clinical indication Vaccine indicated for active immunization against influenza A and B for strains contained in the vaccine; authorized in the United States for persons 18 years of age or older.
It will be evaluated in a population aged 3 to 17 years. Treatment Groups Flublok® Quadrivalent (research product) Fluzone® Quadrivalent (active comparator) Number of participants in the study 1,556 Estimated study duration: 25 months Duration of participation 6 months Randomization ratio 1:1 Study visits Visit 1: It corresponds to the screening visit, baseline blood sampling and administration of the study vaccine that can be performed on Day 0.
Visit 1A and 2: Remote contacts on day 2 and 7 post-vaccination. Visit 3: i. Follow up and blood sampling (for the 1-dose group); ii. Visit 3A, follow-up and application of the second dose of the vaccine (for the corresponding group); iii. Visit 3B, follow-up and blood sampling for the 2-dose group. The visits occur on Day 28.
Months 3, 4, 5: Remote Contacts for safety tracking Visit 4: Remote contact for study closure and safety tracking at Month 6. Statistical analysis plan • Primary efficacy analysis: Proportion of subjects in each age category and vaccine group who seroconvert, with seroconversion being defined as (a) a >4-fold rise in HAI antibody titer in those subjects seropositive (titer >10) at baseline or (b) achievement of an HAI titer of >40 in those seronegative at baseline. Seroconversion will be evaluated against each of the 4 vaccine antigens, on Study Day 28 (or Day 56 for 2-dose subjects), by category A and B separated
- Geometric Mean Titer (GMT) of HAI antibody against each vaccine antigen in each age category and vaccine group 28 days after immunization (Day 56 for 2-dose subjects) by category A and B separated Secondary efficacy analysis. Efficacy analysis and analysis of safety results associated to reactogenicity and other adverse events.
Final contribution of the study results The direct benefit for subjects, individually, is expected to be seasonal influenza protection with the expected degree of protection, specially among recipients of the IIV4 control vaccine, which is also approved for use in the age groups of the study population, evaluating in detail the comparative response of the research product.
The results of the study are intended to evaluate the immunogenicity, efficacy and safety of Flublok Quadrivalent in this population age and in this way, support the use of Flublok Quadrivalent for children and adolescents 3-17 years of age.
If the results are favorable and if the hypothesis is fulfilled, the extension of the indication to the evaluated age segment may result in greater protection of the child population so as, not to be unprotected by the limited resources in health, the shortage of vaccines in certain regions, and to improve the supply and accessibility of the population in general for influenza prevention.
The hypothesis underlying the study design and sample size estimated for the trial population from 3 to 17 years of age is based on the immunogenicity of Flublok Tetravalent, considering that the haemagglutination inhibition (HAI) seroconversion titers and the geometric mean of post-vaccination titers for the four hemagglutinin antigens in the vaccines after completion of vaccination with Flublok Quadrivalent are not inferior to those titers observed in those vaccinated with IIV4.
Statistical considerations. sample size is 330 subjects in each age cohort for each treatment group, reaching a power of 80% to detect a marginal difference of non-inferiority for the seroconversion rate between the groups of -0.1000. The seroconversion rate of the control group is 0.7000. The Flublok Quadrivalent seroconversion rate is assumed to be 0.6000 under the null hypothesis of inferiority. The power was estimated for the case that the relative seroconversion rate of Flublok Quadrivalent is 0.7000. The statistical test use is a one tailed Z test (unpooled). The significance level for the test was established in 0.0250.
A total of 1,556 subjects (330 complete cases per treatment group in subjects from 3 to 17 years of age) will be enrolled, considering possible losses up to a maximum of 15%.
- Conditions
- Influenza, Human
- Being tested
- Study group - quadrivalent recombinant hemagglutinin influenza vaccine, Control group - quadrivalent inactivated influenza vaccine
- Keywords
- hemagglutinin influenza vaccine, recombinant influenza 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.
Study group - quadrivalent recombinant hemagglutinin influenza vaccineBiological
Eligible subjects will be randomized, 1:1, to receive one or two doses of same vaccine. Subjects will be categorized in two age groups: subjects 9 to 17 years will be allocated in Group A and will receive one dose; Subjects 3 to 8 will be allocated to group B and the ACIP/CDC algorithm will be applied to determine should one or two doses will be applied 28 days apart. Vaccinator will be non blind and will not participate in the clinical evaluation.
Control group - quadrivalent inactivated influenza vaccineBiological
Eligible subjects will be randomized, 1:1, to receive one or two doses of same vaccine. Subjects will be categorized in two age groups: subjects 9 to 17 years will be allocated in Group A and will receive one dose; Subjects 3 to 8 will be allocated to group B and the ACIP/CDC algorithm will be applied to determine should one or two doses will be applied 28 days apart. Vaccinator will be non blind and will not participate in the clinical evaluation.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | single or two doses of quadrivalent recombinant 180 ugm hemagglutinin influenza vaccine Receives: Biological: Study group - quadrivalent recombinant hemagglutinin influenza vaccine |
| Control group | Active comparator | single or two doses of quadrivalent inactivated influenza vaccine. Receives: Biological: Control group - quadrivalent inactivated influenza vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroconversion
Proportion of subjects with seroconversion defined as (a) a >4-fold rise in HAI antibody titer in subjects seropositive (titer >10) at baseline or (b) an HAI titer of >40 in those seronegative at baseline.
Measured: To be evaluated against each of the 4 vaccine antigens, on Day 28 (or Day 56 for 2-dose subjects), by category aged
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2018
- Study start22 Mar 2018
- Primary completion22 Oct 2019
- Study completion22 Oct 2019
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 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Visit 1: screening visit, baseline blood sampling and administration of the study vaccine that can be performed on Day 0. Visit 1A and 2: Remote follow up contacts on day 2 and 7 post-vaccination. Visit 3: i. Follow up and blood sampling (for the 1-dose group); ii. Visit 3A, follow-up and application of the second dose of the vaccine (for the corresponding group); iii. Visit 3B, follow-up and blood sampling for the 2-dose group. The visits occur on Day 28. Months 3, 4, 5: Remote Contacts for safety tracking Visit 4: Remote contact for study closure and safety tracking at Month 6
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,556 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorios Liomont
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- EPIC Research CRO, ILS Clinical Research, Q Square Solutions
- Responsible party
- Sponsor
- Investigators
- Mercedes Macias, MD, Study chair, National Institute of Pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03460743
- Sponsor's protocol ID
- LIO-04-16
- Status last verified
- Nov 2019
- First submitted
- 4 Mar 2018
- Last updated
- 13 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
King JC Jr, Cox MM, Reisinger K, Hedrick J, Graham I, Patriarca P. Evaluation of the safety, reactogenicity and immunogenicity of FluBlok trivalent recombinant baculovirus-expressed hemagglutinin influenza vaccine administered intramuscularly to healthy children aged 6-59 months. Vaccine. 2009 Nov 5;27(47):6589-94. doi: 10.1016/j.vaccine.2009.08.032. Epub 2009 Aug 27.
PubMed 19716456Baxter R, Patriarca PA, Ensor K, Izikson R, Goldenthal KL, Cox MM. Evaluation of the safety, reactogenicity and immunogenicity of FluBlok(R) trivalent recombinant baculovirus-expressed hemagglutinin influenza vaccine administered intramuscularly to healthy adults 50-64 years of age. Vaccine. 2011 Mar 9;29(12):2272-8. doi: 10.1016/j.vaccine.2011.01.039. Epub 2011 Jan 28.
PubMed 21277410
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Immunogenicity, Relative Efficacy, Safety and Reactogenicity of Flublok Quadrivalent® (Quadrivalent Recombinant Influenza Vaccine, Seasonal Formulation) Compared With a Marketed Quadrivalent Vaccine in Healthy Children and Adolescents Aged 3 to 17 Years-old.
- ClinicalTrials.gov ID
- NCT03460743
- Acronym / sponsor ID
- LIO-04-16
- Conditions
- Influenza, Human
- Keywords
- hemagglutinin influenza vaccine, recombinant influenza vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,556 participants (actual)
- Lead sponsor
- Laboratorios LiomontIndustry (pharma, biotech, devices)
- Collaborators
- EPIC Research CRO, ILS Clinical Research, Q Square Solutions
- Study start
- 22 Mar 2018 (actual)
- Primary completion
- 22 Oct 2019 (actual)
- Study completion
- 22 Oct 2019 (actual)
- First posted
- 9 Mar 2018 (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.
Multicentric study, Phase III; this study is a randomized, participant- and observer-blind, parallel group evaluation to evaluate the immunogenicity, relative efficacy, safety and reactogenicity of a recombinant quadrivalent hemagglutinin influenza vaccine versus an inactivated quadrivalent influenza vaccine in pediatric subjects and adolescents of 3-17 years of age. Investigational vaccine is indicated for active immunization against influenza A and B for strains contained in the vaccine marketed in the United States for persons 18 years of age or older.
Detailed description
Abbreviated title Evaluation of immunogenicity, relative efficacy, safety and reactogenicity of Flublok Quadrivalent® in healthy children and adolescents aged 3 to17 years.
Sponsor Product Identifiers Flublok® Quadrivalent of Laboratories Liomont, S.A. de C.V.
Flublok Quadrivalent consists of 180 μg total recombinant hemagglutinins Study Phase Phase 3 Study National multicentric Participating sites: Mexico: At least 10 research sites distributed in different states.
Clinical indication Vaccine indicated for active immunization against influenza A and B for strains contained in the vaccine; authorized in the United States for persons 18 years of age or older.
It will be evaluated in a population aged 3 to 17 years. Treatment Groups Flublok® Quadrivalent (research product) Fluzone® Quadrivalent (active comparator) Number of participants in the study 1,556 Estimated study duration: 25 months Duration of participation 6 months Randomization ratio 1:1 Study visits Visit 1: It corresponds to the screening visit, baseline blood sampling and administration of the study vaccine that can be performed on Day 0.
Visit 1A and 2: Remote contacts on day 2 and 7 post-vaccination. Visit 3: i. Follow up and blood sampling (for the 1-dose group); ii. Visit 3A, follow-up and application of the second dose of the vaccine (for the corresponding group); iii. Visit 3B, follow-up and blood sampling for the 2-dose group. The visits occur on Day 28.
Months 3, 4, 5: Remote Contacts for safety tracking Visit 4: Remote contact for study closure and safety tracking at Month 6. Statistical analysis plan • Primary efficacy analysis: Proportion of subjects in each age category and vaccine group who seroconvert, with seroconversion being defined as (a) a >4-fold rise in HAI antibody titer in those subjects seropositive (titer >10) at baseline or (b) achievement of an HAI titer of >40 in those seronegative at baseline. Seroconversion will be evaluated against each of the 4 vaccine antigens, on Study Day 28 (or Day 56 for 2-dose subjects), by category A and B separated
- Geometric Mean Titer (GMT) of HAI antibody against each vaccine antigen in each age category and vaccine group 28 days after immunization (Day 56 for 2-dose subjects) by category A and B separated Secondary efficacy analysis. Efficacy analysis and analysis of safety results associated to reactogenicity and other adverse events.
Final contribution of the study results The direct benefit for subjects, individually, is expected to be seasonal influenza protection with the expected degree of protection, specially among recipients of the IIV4 control vaccine, which is also approved for use in the age groups of the study population, evaluating in detail the comparative response of the research product.
The results of the study are intended to evaluate the immunogenicity, efficacy and safety of Flublok Quadrivalent in this population age and in this way, support the use of Flublok Quadrivalent for children and adolescents 3-17 years of age.
If the results are favorable and if the hypothesis is fulfilled, the extension of the indication to the evaluated age segment may result in greater protection of the child population so as, not to be unprotected by the limited resources in health, the shortage of vaccines in certain regions, and to improve the supply and accessibility of the population in general for influenza prevention.
The hypothesis underlying the study design and sample size estimated for the trial population from 3 to 17 years of age is based on the immunogenicity of Flublok Tetravalent, considering that the haemagglutination inhibition (HAI) seroconversion titers and the geometric mean of post-vaccination titers for the four hemagglutinin antigens in the vaccines after completion of vaccination with Flublok Quadrivalent are not inferior to those titers observed in those vaccinated with IIV4.
Statistical considerations. sample size is 330 subjects in each age cohort for each treatment group, reaching a power of 80% to detect a marginal difference of non-inferiority for the seroconversion rate between the groups of -0.1000. The seroconversion rate of the control group is 0.7000. The Flublok Quadrivalent seroconversion rate is assumed to be 0.6000 under the null hypothesis of inferiority. The power was estimated for the case that the relative seroconversion rate of Flublok Quadrivalent is 0.7000. The statistical test use is a one tailed Z test (unpooled). The significance level for the test was established in 0.0250.
A total of 1,556 subjects (330 complete cases per treatment group in subjects from 3 to 17 years of age) will be enrolled, considering possible losses up to a maximum of 15%.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Visit 1: screening visit, baseline blood sampling and administration of the study vaccine that can be performed on Day 0. Visit 1A and 2: Remote follow up contacts on day 2 and 7 post-vaccination. Visit 3: i. Follow up and blood sampling (for the 1-dose group); ii. Visit 3A, follow-up and application of the second dose of the vaccine (for the corresponding group); iii. Visit 3B, follow-up and blood sampling for the 2-dose group. The visits occur on Day 28. Months 3, 4, 5: Remote Contacts for safety tracking Visit 4: Remote contact for study closure and safety tracking at Month 6
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Biological: Study group - quadrivalent recombinant hemagglutinin influenza vaccinesingle or two doses of quadrivalent recombinant 180 ugm hemagglutinin influenza vaccine |
| Control group | Active comparator | Biological: Control group - quadrivalent inactivated influenza vaccinesingle or two doses of quadrivalent inactivated influenza vaccine. |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Male or female age 3 to 17 years.
- History of two previous influenza immunizations at any time, or influenza infection during the previous year.
- Female subjects of child-bearing potential (as defined by the onset of menses) must agree to prevent pregnancy and usage of an effective contraception, or having practiced sexual abstinence for at least 28 day prior to the first study vaccine administration. Female subjects of child-bearing potential must be tested for pregnancy within 24 hours prior to vaccine administration.
- In good general health, healthy or medically stable, as determined by the medical history, physical examination and the Investigator's judgment.
- Parent(s) or legal representative of each potential subject must comprehend the study requirements, sign the informed consent before any procedure, and agree to comply with planned study procedures and visits. Provide written consent prior to enrollment and initiation of any study procedure.
Key exclusion criteria (14 listed)
- Known allergy to eggs (anaphylaxis, angioedema, respiratory distress), severe allergy (e.g. anaphylaxis) to other components of the vaccine or contraindications to receive the comparator IIV4.
- Use of systemic steroids at doses of 2mg/kg/day for more than 10 days of prednisone or its equivalent.
- (The use of nasal or topical steroids will be allowed).
- Active neoplastic disease or a history of any malignancy.
- History of receiving the influenza vaccine within the previous 6 months.
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 |
|---|---|---|
| Study group - quadrivalent recombinant hemagglutinin influenza vaccineEligible subjects will be randomized, 1:1, to receive one or two doses of same vaccine. Subjects will be categorized in two age groups: subjects 9 to 17 years will be allocated in Group A and will receive one dose; Subjects 3 to 8 will be allocated to group B and the ACIP/CDC algorithm will be applied to determine should one or two doses will be applied 28 days apart. Vaccinator will be non blind and will not participate in the clinical evaluation. | Biological | Study group |
| Control group - quadrivalent inactivated influenza vaccineEligible subjects will be randomized, 1:1, to receive one or two doses of same vaccine. Subjects will be categorized in two age groups: subjects 9 to 17 years will be allocated in Group A and will receive one dose; Subjects 3 to 8 will be allocated to group B and the ACIP/CDC algorithm will be applied to determine should one or two doses will be applied 28 days apart. Vaccinator will be non blind and will not participate in the clinical evaluation. | Biological | Control group |
Primary outcome
Seroconversion
Time frame: To be evaluated against each of the 4 vaccine antigens, on Day 28 (or Day 56 for 2-dose subjects), by category aged
Proportion of subjects with seroconversion defined as (a) a >4-fold rise in HAI antibody titer in subjects seropositive (titer >10) at baseline or (b) an HAI titer of >40 in those seronegative at baseline.
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 13 Nov 2019.
- Background: PubMed 19716456King JC Jr, Cox MM, Reisinger K, Hedrick J, Graham I, Patriarca P. Evaluation of the safety, reactogenicity and immunogenicity of FluBlok trivalent recombinant baculovirus-expressed hemagglutinin influenza vaccine administered intramuscularly to healthy children aged 6-59 months. Vaccine. 2009 Nov 5;27(47):6589-94. doi: 10.1016/j.vaccine.2009.08.032. Epub 2009 Aug 27.
- Background: PubMed 21277410Baxter R, Patriarca PA, Ensor K, Izikson R, Goldenthal KL, Cox MM. Evaluation of the safety, reactogenicity and immunogenicity of FluBlok(R) trivalent recombinant baculovirus-expressed hemagglutinin influenza vaccine administered intramuscularly to healthy adults 50-64 years of age. Vaccine. 2011 Mar 9;29(12):2272-8. doi: 10.1016/j.vaccine.2011.01.039. Epub 2011 Jan 28.
- 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.
Mercedes Macias, MD study chair
National Institute of Pediatrics
11 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 Study group - quadrivalent recombinant hemagglutinin influenza vaccine in people with Influenza, Human, run by Laboratorios Liomont at 11 sites in Mexico.
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 6 inclusion and 14 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 13 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Mexico. 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?
Seroconversion (time frame: To be evaluated against each of the 4 vaccine antigens, on Day 28 (or Day 56 for 2-dose subjects), by category aged). 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 NCT03460743, 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 13 Nov 2019.