TransplantationCOVAGREFNCT03180359
Vaccines Immunogenicity in Renal, Hepatic, Cardiac or Pulmonary Transplanted Children
A study testing Recommended vaccine scheme according to French Vaccine Schedule 2015 in people with Transplantation, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Thanks to improved surgical techniques, postoperative management and immunosuppressive therapies, an increasing number of children benefit from renal, hepatic, cardiac and pulmonary transplantation. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Transplantation
- What is being tested?
- Recommended vaccine scheme according to French Vaccine Schedule 2015
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2016to 13 Oct 2019
- Phase
- Interventional
- 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 Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children and adolescent between 0 and 17 years old
- registered in the database of the Agency of Biomedicine
- transplanted or waiting for a renal, hepatic, cardiac or pulmonary transplantation
- followed up in the Rhône-Alpes region between January 1st , 2015 and December 31th, 2016
- patients requiring vaccination in standard care
Who cannot join
- adults
- children or adolescent not able not comply with protocol
- children, adolescent or patient parents or legal guardian not opposed to study participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vaccines Immunogenicity in Children Transplanted or Candidate for a Renal, Hepatic, Cardiac or Pulmonary Transplantation, Followed in the Rhône-Alpes Region. A Descriptive and Prospective Monocentric Cohort Study
Thanks to improved surgical techniques, postoperative management and immunosuppressive therapies, an increasing number of children benefit from renal, hepatic, cardiac and pulmonary transplantation. Infection is a significant cause of mortality and morbidity in these patients, particularly due to vaccine-preventable diseases. Vaccination is one of the effective means of reducing infection-related mortality in these particularly vulnerable children. It is mostly well-tolerated, but all the more effective as it is performed early before transplantation, at best during a dedicated consultation, according to a vaccine scheme adapted to the immunocompromised child. In the almost constant absence of clinical efficacy data in populations of immunocompromised individuals, vaccine efficacy is most often indirectly estimated by immunogenicity, using protective correlates obtained by extrapolation in immunocompetent individuals.
Primary objective: To estimate the immunogenicity of vaccines recommended in children transplanted or candidate for renal, hepatic, cardiac and pulmonary transplantation, using serological titers measurements before and after a vaccine injection for: influenza, pneumococcus, chicken pox, measles, tetanus, hepatitis A and hepatitis B.
Read more
These serological titers will be compared to correlates of protection existing for each valency.
The evolution of serological titers will be described during the first year. The vaccination will be carried out within the routine care, according to the recommendations.
Secondary objectives:
- describe and quantify the vaccination status of patients
- describe the vaccination coverage of their entourage
- evaluate the tolerance and efficacy of vaccines
- Conditions
- Transplantation
- Being tested
- Recommended vaccine scheme according to French Vaccine Schedule 2015
- Keywords
- solid transplant, grafted children, vaccine recommendation, immunization efficacy, solid grafted children, solid transplant candidate children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recommended vaccine scheme according to French Vaccine Schedule 2015Biological
- BCG
- Measles mumps rubella (MMR)
- Varicella (chicken pox)
- Rotavirus
- Seasonal flu (live vaccine delivered nasally and inactivated vaccine injectable)
- Yellow Fever
- Diphteria tetanus poliomyelitis whopping cough (DTwP)
- Haemophilus influenzae type b
- Hepatitis B
- Meningococcus conjugate
- Pneumococcus
- Human papillomavirus
- Hepatitis A
Vaccine administration would be done according to French Vaccine Schedule 2015 for mainstream population and for grafted children or transplant candidate children
| Study group | Role | What they receive |
|---|---|---|
| Patient already transplanted or waiting for a transplantation | Experimental | Not described Receives: Biological: Recommended vaccine scheme according to French Vaccine Schedule 2015 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity of vaccines recommended in children transplanted or candidate for renal, hepatic, cardiac and pulmonary transplantation
The immunogenicity is appraised from serological titer before and after vaccine injection. These serological titers will be compared to existing reference protection correlates for each valency, and defined as protective or non-protective: Tetanus (>0,1 UI/ml), hepatitis B (>10 mUI/ml), hepatitis A (> 20 mUI/ml), measles (0,18 in EIA index), chicken pox (> 5 gp Elisa UI/ml or > 50 UI/l with an highly sensitive test), influenza (Hemagglutination Inhibition Assay > 1/40), pneumococcus (0,35 µg/ml, > 0,4 mg/l for each specific serotype, if > 2/3 or 4/6, protecting serotype)
Measured: at Month 0
Immunogenicity of vaccines recommended in children transplanted or candidate for renal, hepatic, cardiac and pulmonary transplantation
The immunogenicity is appraised from serological titer before and after vaccine injection. These serological titers will be compared to existing reference protection correlates for each valency, and defined as protective or non-protective: Tetanus (>0,1 UI/ml), hepatitis B (>10 mUI/ml), hepatitis A (> 20 mUI/ml), measles (0,18 in EIA index), chicken pox (> 5 gp Elisa UI/ml or > 50 UI/l with an highly sensitive test), influenza (Hemagglutination Inhibition Assay > 1/40), pneumococcus (0,35 µg/ml, > 0,4 mg/l for each specific serotype, if > 2/3 or 4/6, protecting serotype)
Measured: between Month 1 and Month 3
Immunogenicity of vaccines recommended in children transplanted or candidate for renal, hepatic, cardiac and pulmonary transplantation
The immunogenicity is appraised from serological titer before and after vaccine injection. These serological titers will be compared to existing reference protection correlates for each valency, and defined as protective or non-protective: Tetanus (>0,1 UI/ml), hepatitis B (>10 mUI/ml), hepatitis A (> 20 mUI/ml), measles (0,18 in EIA index), chicken pox (> 5 gp Elisa UI/ml or > 50 UI/l with an highly sensitive test), influenza (Hemagglutination Inhibition Assay > 1/40), pneumococcus (0,35 µg/ml, > 0,4 mg/l for each specific serotype, if > 2/3 or 4/6, protecting serotype)
Measured: Month 12
Immunogenicity of vaccines recommended in children transplanted or candidate for renal, hepatic, cardiac and pulmonary transplantation
The immunogenicity is appraised from serological titer before and after vaccine injection. These serological titers will be compared to existing reference protection correlates for each valency, and defined as protective or non-protective: Tetanus (>0,1 UI/ml), hepatitis B (>10 mUI/ml), hepatitis A (> 20 mUI/ml), measles (0,18 in EIA index), chicken pox (> 5 gp Elisa UI/ml or > 50 UI/l with an highly sensitive test), influenza (Hemagglutination Inhibition Assay > 1/40), pneumococcus (0,35 µg/ml, > 0,4 mg/l for each specific serotype, if > 2/3 or 4/6, protecting serotype)
Measured: 3-month post-transplantation (if transplantation occurs during the study)
Secondary outcomes (16)
Levels of blood antibodies corresponding to the following vaccine valencies: influenza, pneumococcus, chicken pox (varicella), measles, tetanus, hepatitis A and hepatitis B.
Measured: at Month 0
Levels of blood antibodies corresponding to the following vaccine valencies: influenza, pneumococcus, chicken pox (varicella), measles, tetanus, hepatitis A and hepatitis B.
Measured: between Month 1 and Month 3
Levels of blood antibodies corresponding to the following vaccine valencies: influenza, pneumococcus, chicken pox (varicella), measles, tetanus, hepatitis A and hepatitis B.
Measured: at Month 12
Levels of blood antibodies corresponding to the following vaccine valencies: influenza, pneumococcus, chicken pox (varicella), measles, tetanus, hepatitis A and hepatitis B.
Measured: 3-month post-transplantation (if transplantation occurs during the study)
the number of early or late injections
Vaccine status compliance with vaccine recommendation, from literature data and from the opinion of the Vaccine Technical Committee President.
Compliance will be appraised by considering for each valence:
- the number of early or late injections
- the number of missing injections and supplementary injections
- the number of days in advance or delayed from recommended injections (per injection and cumulative) 2 age groups will be differentiate : <2 years (primary vaccination) and >2 years For each age group, early or late injections are defined by considering literature data and the opinion of the Vaccine Technical Committee President.
Measured: at Month 0,
the number of missing injections and supplementary injections
Vaccine status compliance with vaccine recommendation, from literature data and from the opinion of the Vaccine Technical Committee President.
Compliance will be appraised by considering for each valence:
- the number of early or late injections
- the number of missing injections and supplementary injections
- the number of days in advance or delayed from recommended injections (per injection and cumulative) 2 age groups will be differentiate : <2 years (primary vaccination) and >2 years For each age group, early or late injections are defined by considering literature data and the opinion of the Vaccine Technical Committee President.
Measured: at Month 0,
the number of days in advance or delayed from recommended injections (per injection and cumulative)
Vaccine status compliance with vaccine recommendation, from literature data and from the opinion of the Vaccine Technical Committee President.
Compliance will be appraised by considering for each valence:
- the number of early or late injections
- the number of missing injections and supplementary injections
- the number of days in advance or delayed from recommended injections (per injection and cumulative) 2 age groups will be differentiate : <2 years (primary vaccination) and >2 years For each age group, early or late injections are defined by considering literature data and the opinion of the Vaccine Technical Committee President.
Measured: at Month 0,
the number of early or late injections
Vaccine status compliance with vaccine recommendation, from literature data and from the opinion of the Vaccine Technical Committee President.
Compliance will be appraised by considering for each valence:
- the number of early or late injections
- the number of missing injections and supplementary injections
- the number of days in advance or delayed from recommended injections (per injection and cumulative) 2 age groups will be differentiate : <2 years (primary vaccination) and >2 years For each age group, early or late injections are defined by considering literature data and the opinion of the Vaccine Technical Committee President.
Measured: between Month 1 and Month 3
the number of missing injections and supplementary injections
Vaccine status compliance with vaccine recommendation, from literature data and from the opinion of the Vaccine Technical Committee President.
Compliance will be appraised by considering for each valence:
- the number of early or late injections
- the number of missing injections and supplementary injections
- the number of days in advance or delayed from recommended injections (per injection and cumulative) 2 age groups will be differentiate : <2 years (primary vaccination) and >2 years For each age group, early or late injections are defined by considering literature data and the opinion of the Vaccine Technical Committee President.
Measured: between Month 1 and Month 3
the number of days in advance or delayed from recommended injections (per injection and cumulative)
Vaccine status compliance with vaccine recommendation, from literature data and from the opinion of the Vaccine Technical Committee President.
Compliance will be appraised by considering for each valence:
- the number of early or late injections
- the number of missing injections and supplementary injections
- the number of days in advance or delayed from recommended injections (per injection and cumulative) 2 age groups will be differentiate : <2 years (primary vaccination) and >2 years For each age group, early or late injections are defined by considering literature data and the opinion of the Vaccine Technical Committee President.
Measured: between Month 1 and Month 3
the number of early or late injections
Vaccine status compliance with vaccine recommendation, from literature data and from the opinion of the Vaccine Technical Committee President.
Compliance will be appraised by considering for each valence:
- the number of early or late injections
- the number of missing injections and supplementary injections
- the number of days in advance or delayed from recommended injections (per injection and cumulative) 2 age groups will be differentiate : <2 years (primary vaccination) and >2 years For each age group, early or late injections are defined by considering literature data and the opinion of the Vaccine Technical Committee President.
Measured: at Month 12
the number of missing injections and supplementary injections
Vaccine status compliance with vaccine recommendation, from literature data and from the opinion of the Vaccine Technical Committee President.
Compliance will be appraised by considering for each valence:
- the number of early or late injections
- the number of missing injections and supplementary injections
- the number of days in advance or delayed from recommended injections (per injection and cumulative) 2 age groups will be differentiate : <2 years (primary vaccination) and >2 years For each age group, early or late injections are defined by considering literature data and the opinion of the Vaccine Technical Committee President.
Measured: at Month 12
the number of days in advance or delayed from recommended injections (per injection and cumulative)
Vaccine status compliance with vaccine recommendation, from literature data and from the opinion of the Vaccine Technical Committee President.
Compliance will be appraised by considering for each valence:
- the number of early or late injections
- the number of missing injections and supplementary injections
- the number of days in advance or delayed from recommended injections (per injection and cumulative) 2 age groups will be differentiate : <2 years (primary vaccination) and >2 years For each age group, early or late injections are defined by considering literature data and the opinion of the Vaccine Technical Committee President.
Measured: at Month 12
Vaccination coverage of patients' entourage
Number of missing, additional, early or late injections, compared to vaccine recommendations.
Measured: at month 0
Patients' vaccine tolerance
Local reactions, fever, clinical or biological signs of rejection
Measured: at Week 1
Patients' vaccine tolerance
Local reactions, fever, clinical or biological signs of rejection
Measured: at Month 1 after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2017
- Study start1 Jan 2016
- Primary completion13 Oct 2019
- Study completion13 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TransplantationStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laure HEES, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03180359
- Sponsor's protocol ID
- 69HCL17_0354
- Other IDs
- 2015-A00854-45
- Acronym
- COVAGREF
- Status last verified
- Mar 2023
- First submitted
- 31 May 2017
- Last updated
- 8 Mar 2023
- 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 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaccines Immunogenicity in Children Transplanted or Candidate for a Renal, Hepatic, Cardiac or Pulmonary Transplantation, Followed in the Rhône-Alpes Region. A Descriptive and Prospective Monocentric Cohort Study
- ClinicalTrials.gov ID
- NCT03180359
- Acronym / sponsor ID
- COVAGREF / 69HCL17_0354
- Conditions
- Transplantation
- Keywords
- solid transplant, grafted children, vaccine recommendation, immunization efficacy, solid grafted children, solid transplant candidate children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 13 Oct 2019 (actual)
- Study completion
- 13 Oct 2019 (actual)
- First posted
- 8 Jun 2017 (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.
Thanks to improved surgical techniques, postoperative management and immunosuppressive therapies, an increasing number of children benefit from renal, hepatic, cardiac and pulmonary transplantation. Infection is a significant cause of mortality and morbidity in these patients, particularly due to vaccine-preventable diseases. Vaccination is one of the effective means of reducing infection-related mortality in these particularly vulnerable children. It is mostly well-tolerated, but all the more effective as it is performed early before transplantation, at best during a dedicated consultation, according to a vaccine scheme adapted to the immunocompromised child. In the almost constant absence of clinical efficacy data in populations of immunocompromised individuals, vaccine efficacy is most often indirectly estimated by immunogenicity, using protective correlates obtained by extrapolation in immunocompetent individuals.
Primary objective: To estimate the immunogenicity of vaccines recommended in children transplanted or candidate for renal, hepatic, cardiac and pulmonary transplantation, using serological titers measurements before and after a vaccine injection for: influenza, pneumococcus, chicken pox, measles, tetanus, hepatitis A and hepatitis B.
These serological titers will be compared to correlates of protection existing for each valency.
The evolution of serological titers will be described during the first year. The vaccination will be carried out within the routine care, according to the recommendations.
Secondary objectives:
- describe and quantify the vaccination status of patients
- describe the vaccination coverage of their entourage
- evaluate the tolerance and efficacy of vaccines
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient already transplanted or waiting for a transplantation | Experimental | Biological: Recommended vaccine scheme according to French Vaccine Schedule 2015 |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- children and adolescent between 0 and 17 years old
- registered in the database of the Agency of Biomedicine
- transplanted or waiting for a renal, hepatic, cardiac or pulmonary transplantation
- followed up in the Rhône-Alpes region between January 1st , 2015 and December 31th, 2016
- patients requiring vaccination in standard care
Key exclusion criteria (3 listed)
- adults
- children or adolescent not able not comply with protocol
- children, adolescent or patient parents or legal guardian not opposed to study participation
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 |
|---|---|---|
| Recommended vaccine scheme according to French Vaccine Schedule 2015* BCG * Measles mumps rubella (MMR) * Varicella (chicken pox) * Rotavirus * Seasonal flu (live vaccine delivered nasally and inactivated vaccine injectable) * Yellow Fever * Diphteria tetanus poliomyelitis whopping cough (DTwP) * Haemophilus influenzae type b * Hepatitis B * Meningococcus conjugate * Pneumococcus * Human papillomavirus * Hepatitis A Vaccine administration would be done according to French Vaccine Schedule 2015 for mainstream population and for grafted children or transplant candidate children | Biological | Patient already transplanted or waiting for a transplantation |
Primary outcome
Immunogenicity of vaccines recommended in children transplanted or candidate for renal, hepatic, cardiac and pulmonary transplantation
Time frame: at Month 0
The immunogenicity is appraised from serological titer before and after vaccine injection. These serological titers will be compared to existing reference protection correlates for each valency, and defined as protective or non-protective: Tetanus (>0,1 UI/ml), hepatitis B (>10 mUI/ml), hepatitis A (> 20 mUI/ml), measles (0,18 in EIA index), chicken pox (> 5 gp Elisa UI/ml or > 50 UI/l with an highly sensitive test), influenza (Hemagglutination Inhibition Assay > 1/40), pneumococcus (0,35 µg/ml, > 0,4 mg/l for each specific serotype, if > 2/3 or 4/6, protecting serotype)
Immunogenicity of vaccines recommended in children transplanted or candidate for renal, hepatic, cardiac and pulmonary transplantation
Time frame: between Month 1 and Month 3
The immunogenicity is appraised from serological titer before and after vaccine injection. These serological titers will be compared to existing reference protection correlates for each valency, and defined as protective or non-protective: Tetanus (>0,1 UI/ml), hepatitis B (>10 mUI/ml), hepatitis A (> 20 mUI/ml), measles (0,18 in EIA index), chicken pox (> 5 gp Elisa UI/ml or > 50 UI/l with an highly sensitive test), influenza (Hemagglutination Inhibition Assay > 1/40), pneumococcus (0,35 µg/ml, > 0,4 mg/l for each specific serotype, if > 2/3 or 4/6, protecting serotype)
Immunogenicity of vaccines recommended in children transplanted or candidate for renal, hepatic, cardiac and pulmonary transplantation
Time frame: Month 12
The immunogenicity is appraised from serological titer before and after vaccine injection. These serological titers will be compared to existing reference protection correlates for each valency, and defined as protective or non-protective: Tetanus (>0,1 UI/ml), hepatitis B (>10 mUI/ml), hepatitis A (> 20 mUI/ml), measles (0,18 in EIA index), chicken pox (> 5 gp Elisa UI/ml or > 50 UI/l with an highly sensitive test), influenza (Hemagglutination Inhibition Assay > 1/40), pneumococcus (0,35 µg/ml, > 0,4 mg/l for each specific serotype, if > 2/3 or 4/6, protecting serotype)
Immunogenicity of vaccines recommended in children transplanted or candidate for renal, hepatic, cardiac and pulmonary transplantation
Time frame: 3-month post-transplantation (if transplantation occurs during the study)
The immunogenicity is appraised from serological titer before and after vaccine injection. These serological titers will be compared to existing reference protection correlates for each valency, and defined as protective or non-protective: Tetanus (>0,1 UI/ml), hepatitis B (>10 mUI/ml), hepatitis A (> 20 mUI/ml), measles (0,18 in EIA index), chicken pox (> 5 gp Elisa UI/ml or > 50 UI/l with an highly sensitive test), influenza (Hemagglutination Inhibition Assay > 1/40), pneumococcus (0,35 µg/ml, > 0,4 mg/l for each specific serotype, if > 2/3 or 4/6, protecting serotype)
16 secondary outcomes
Levels of blood antibodies corresponding to the following vaccine valencies: influenza, pneumococcus, chicken pox (varicella), measles, tetanus, hepatitis A and hepatitis B.
Time frame: at Month 0
Levels of blood antibodies corresponding to the following vaccine valencies: influenza, pneumococcus, chicken pox (varicella), measles, tetanus, hepatitis A and hepatitis B.
Time frame: between Month 1 and Month 3
Levels of blood antibodies corresponding to the following vaccine valencies: influenza, pneumococcus, chicken pox (varicella), measles, tetanus, hepatitis A and hepatitis B.
Time frame: at Month 12
Levels of blood antibodies corresponding to the following vaccine valencies: influenza, pneumococcus, chicken pox (varicella), measles, tetanus, hepatitis A and hepatitis B.
Time frame: 3-month post-transplantation (if transplantation occurs during the study)
the number of early or late injections
Time frame: at Month 0,
the number of missing injections and supplementary injections
Time frame: at Month 0,
the number of days in advance or delayed from recommended injections (per injection and cumulative)
Time frame: at Month 0,
the number of early or late injections
Time frame: between Month 1 and Month 3
the number of missing injections and supplementary injections
Time frame: between Month 1 and Month 3
the number of days in advance or delayed from recommended injections (per injection and cumulative)
Time frame: between Month 1 and Month 3
the number of early or late injections
Time frame: at Month 12
the number of missing injections and supplementary injections
Time frame: at Month 12
the number of days in advance or delayed from recommended injections (per injection and cumulative)
Time frame: at Month 12
Vaccination coverage of patients' entourage
Time frame: at month 0
Patients' vaccine tolerance
Time frame: at Week 1
Patients' vaccine tolerance
Time frame: at Month 1 after injection
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 8 Mar 2023.
- 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.
Laure HEES, MD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recommended vaccine scheme according to French Vaccine Schedule 2015 in people with Transplantation, run by Hospices Civils de Lyon at 1 site in France.
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 5 inclusion and 3 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 8 Mar 2023. 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 France. 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.
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 vaccines recommended in children transplanted or candidate for renal, hepatic, cardiac and pulmonary transplantation (time frame: at Month 0). 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 8 Mar 2023.