Splenectomised PatientsPhase 2SPLENEVAC-2NCT03873727
Revaccination With PPS23 Boosted or Not by PCV13 in Splenectomised Patients.
A Phase 2 study testing Prevenar13 (PCV13) and Pneumovax (PPS23) and Blood sample in people with Splenectomised Patients, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
This research is a multi-center French randomized and double blind phase IIb clinical trial evaluating 2 revaccination strategies against pneumococcal infections among splenectomised patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Splenectomised Patients
- What is being tested?
- Prevenar13 (PCV13) and Pneumovax (PPS23) and Blood sample
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteFrance
- Study dates
- 27 Aug 2019to 16 May 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Splenectomised patients.
- For patients not enrolled in SPLENEVAC clinical trial: presence of Jolly Body at blood smear and spelenectomy confirmation by abdominal ultrasound.
- Vaccinated according to the schedule of SPLENEVAC clinical trial (PCV13 / PPS23 two months later (until +4 months)), enrolled or not from this study. Vaccination of PPS23 must have been administered 5 years - 6 months/+ 1 year before inclusion.
- Patients will be followed during the 24 months from the inclusion visit.
- Patients must give written informed consent prior to any trial procedure.
- Women of childbearing age must have an effective contraception during the first 13 months of the study.
- Patients must be covered by social security regimen or equivalent.
Who cannot join
- History of pneumococcal revaccination in the last five years.
- Having received any another vaccines within 4 weeks prior to enrolment or who is planning to receive any vaccine (for example: ZOSTAVAX®) within the first 13 months of the study (excepted seasonal influenza vaccine which is permitted 4 weeks before and after each vaccination visit of the study and then allowed at any time during the study follow up. Furthermore, the vaccination against Sars-CoV-2 is allowed during the study with a minimum interval of 14 days between pneumococcal vaccine and Sars-Cov-2 vaccine injection)
- History of known allergies to any component of both study vaccines (active substances, excipients or diphtheria toxoid).
- History of anaphylactic reaction following vaccination.
- Infusion of immunoglobulins within the three months preceding the inclusion.
- Any pathology or condition that may impair the immune response, apart from splenectomy: immunosuppressive therapy in progress or in the 6 months prior to inclusion, hematopoietic stem cells allo / autograft, primary immunodeficiency, nephrotic syndrome, progressive neoplasia, evolutive cancer, cirrhosis, known infection to HIV and / or hepatitis B virus (HBV) (HBs Ag +) and / or hepatitis C virus (HCV), taking corticosteroids > 10mg for more than 14 days within the month preceding the inclusion , inhaled corticosteroid and cutaneous topical being allowed.
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- Coagulation disorder contra-indicating intramuscularly injections.
- Acute respiratory tract infection or severe acute febrile illness or systemic reaction which could represent a significant risk in case of vaccination within the month before inclusion.
- Pregnancy, breastfeeding or positive pregnancy test up to 13 months after inclusion.
- History of suspected or documented invasive pneumococcal infection within the year before inclusion.
- Immunosuppressive factors associated.
- Enrolment in any other clinical trial during the whole trial period except observational study.
- Adults under protection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Immunological Response Following a Revaccination With PPS23 Boosted or Not by PCV13 in Splenectomised Patients
This research is a multi-center French randomized and double blind phase IIb clinical trial evaluating 2 revaccination strategies against pneumococcal infections among splenectomised patients. The main objective is to evaluate at M13 the immunological response of 2 pneumococcal revaccination strategies (combined revaccination by a boost dose of PCV13 following 12 months later by PPS23, versus PPS23 alone) in splenectomised adults.
Read the detailed description
For the prevention of invasive pneumococcal diseases, two polysaccharide vaccines are currently available: a non-conjugate vaccine, Pneumovax® (PPS23), and a conjugate vaccine, Prevenar13® (PCV13), inducing protection against 23 and 13 pneumococcal serotypes, respectively. The PPS23 is considered weakly immunogenic, especially in infants, elderly and immunocompromised patients, while PCV13 is now available for adults. In France, in April 2017, the new recommendations for at risk patients including asplenic patients are to revaccinate by PPS23 at least five years after the previous PPS23. However a phenomenon of vaccine hyporesponsiveness and a risk of immune tolerance to pneumococcus after repeated administrations of PPS23 are described. Large doses of polysaccharide antigens recruit memory and naive B cells, resulting in the production of low and high avidity antibodies, while low doses only stimulate memory B cells, inducing high affinity antibodies. Because of that, Swiss current recommendations are to revaccinate with PCV13 at 5 years the splenectomised patients. The recommendations of revaccination by PPS23 for USA or PCV13 for Switzerland have never been evaluated in clinical trial. Moreover, using combined PCV13/PPS23 could increase serotype coverage. Studying the immune response following combined revaccination by a boost dose of PCV13 following by PPS23 versus PPS23 alone will help to document and improve the vaccine recommendations.
The main objective is to evaluate at M13 the immunological response of 2 pneumococcal revaccination strategies (combined revaccination by a boost dose of PCV13 following 12 months later by PPS23, versus PPS23 alone), in splenectomised adults.
The primary endpoint is the proportion of patients responding to a minimum of 5 of the 9 serotypes analysed (9 serotypes among the 12 common serotypes to both PPS23 and PCV13: 1, 3, 6B, 7F, 9V, 14, 19A, 19F, and 23F) at M13 in each arm. A responder to a serotype is defined as a four-fold increase of the rate of OPA (OpsonoPhagocytic Assay) compared to baseline and titer ≥ LLOQ (Lower Limit of Quantification).
- Conditions
- Splenectomised Patients
- Being tested
- Prevenar13 (PCV13) and Pneumovax (PPS23), Placebo / Pneumovax (PPS23), Blood sample
- Keywords
- Vaccination / Re-vaccination, Asplenic patient, Splenectomy, Pneumococcal infections, immunological response, Pneumovax, Prevenar13
- Medical subject headings
- Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prevenar13 (PCV13) and Pneumovax (PPS23)Biological
One dose of PCV13 at Month 0 and one dose of PPS23 at Month 12
Placebo / Pneumovax (PPS23)Biological
One dose of Placebo at Month 0 and one dose of PPS23 at Month 12
Blood sampleBiological
an additional 5 mL sample of blood at one of the visits, preferably at the first visit, concerning patients included in Parisian centers who did not participate in SPLENEVAC 1 study.
| Study group | Role | What they receive |
|---|---|---|
| Prevenar13/ Pneumovax | Experimental | Prime-boost strategy combining a single dose of 13-valent pneumococcal conjugate vaccine (Prevenar 13, PCV13) at month 0 (M0) followed by a single dose of 23-valent unconjugated vaccine (Pneumovax, PPS23) at month 12 (M12). Receives: Biological: Prevenar13 (PCV13) and Pneumovax (PPS23); Biological: Blood sample |
| Placebo / Pneumovax | Placebo comparator | Standard strategy combining a single dose of placebo vaccine (Prevenar 13 placebo) at month 0 (M0) followed by a single dose of 23-valent unconjugated vaccine (Pneumovax, PPS23) at month 12 (M12) Receives: Biological: Placebo / Pneumovax (PPS23); Biological: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity
Immune response at M13 against minimum of 5 of the 9 serotypes analysed (9 serotypes among the 12 common serotypes to both PPS23 and PCV13: 1, 3, 6B, 7F, 9V, 14, 19A, 19F, and 23F) in each arm.
A responder to a serotype is defined as a four-fold increase of the rate of OpsonoPhagocytic Assay (OPA) compared to baseline (M0) and titer ≥ Lower Limit of Quantification (LLOQ).
Measured: at Month 13
Secondary outcomes (12)
Enzyme-linked immunosorbent assay (ELISA) antibody dosages
ELISA antibody concentration against 9 common serotypes (1, 3, 6B, 7F, 9V, 14, 19A, 19F and 23F), and, the proportion of positive serotypes: serotype is considered positive if the immunoglobulin G (IgG) antibody concentration in ELISA shows a two-fold increase from baseline (M0) in each arm from baseline.
Measured: Month 0 to Month 24
Enzyme-linked immunosorbent assay (ELISA) antibody dosages
ELISA antibody concentration against 9 common serotypes (1, 3, 6B, 7F, 9V, 14, 19A, 19F and 23F), and, the proportion of positive serotypes: serotype is considered positive if the IgG antibody concentration is ≥ 1μg/ml in each arm from baseline.
Measured: Month 0 to Month 24
Enzyme-linked immunosorbent assay (ELISA) antibody dosages
ELISA antibody concentration against 9 common serotypes (1, 3, 6B, 7F, 9V, 14, 19A, 19F and 23F), and, the proportion of positive serotypes: serotype is considered positive if the IgG antibody concentration shows a two-fold increase from baseline (M0) in each arm and IgG ≥ 1μg/ml from baseline.
Measured: Month 0 to Month 24
Titration of OPA -
OPA titers against 9 common serotypes (1, 3, 6B, 7F, 9V, 14, 19A, 19F and 23F) and the proportion of positive serotype: serotype is considered positive if the antibody titer shows a four-fold increase from baseline (M0).
Measured: at Month 0, Month 13 and Month 24
Titration of OPA -
OPA titers against 9 common serotypes (1, 3, 6B, 7F, 9V, 14, 19A, 19F and 23F) and the proportion of positive serotype: serotype is considered positive if the antibody titer ≥ LLOQ.
Measured: at Month 0, Month 13 and Month 24
Titration of OPA -
OPA titers against 9 common serotypes (1, 3, 6B, 7F, 9V, 14, 19A, 19F and 23F) and the proportion of positive serotype: serotype is considered positive if the antibody titer shows a four-fold increase from baseline (M0) and titer ≥ LLOQ.
Measured: at Month 0, Month 13 and Month 24
ELISA antibody dosages
ELISA antibody concentration against 3 uncommon specific serotypes of PPS23 (12F, 10A and15B) and the proportion of positive serotypes: serotype is considered positive if the IgG antibody concentration shows a two-fold increase from baseline (M12) in each arm and IgG ≥ 1 μg/ml
Measured: at Month 12, Month 13 and Month 24
ELISA antibody dosages
ELISA antibody concentration against 3 uncommon specific serotypes of PPS23 (12F, 10A and 15B) and the proportion of positive serotypes: serotype is considered positive if the IgG antibody concentration shows a two-fold increase from baseline (M12) in each arm.
Measured: at Month 12, Month 13 and Month 24
ELISA antibody dosages
ELISA antibody concentration against 3 uncommon specific serotypes of PPS23 (12F, 10A and 15B) and the proportion of positive serotypes: serotype is considered positive if the IgG antibody concentration in ELISA is ≥ 1μg/ml in each arm.
Measured: at Month 12, Month 13 and Month 24
Sustainability and evolution of the immune response
Measure of ELISA concentration and OPA titers for the 9 PCV13 serotypes in each arm.
Measured: at Month 0 and Month 24
ELISA antibody dosages
ELISA antibody concentration against 9 common specific serotypes (1, 3, 6B, 7F, 9V, 14, 19A, 19F and 23F) and the proportion of positive serotype: serotype is considered positive if the IgG antibody concentration in ELISA and shows a two-fold increase from baseline (M0) in each arm in SPLENEVAC 1
Measured: at Month 3
Percentage of patients presenting local or systemic reactions post-immunization
Number of subjects with local and systemic reactions following vaccinations (tolerability) in each arm.
Measured: Month0 to Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2019
- Study start27 Aug 2019
- Primary completion24 May 2022
- Study completion16 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Splenectomised PatientsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- EUCLID Clinical Trial Platform, CIC 1417 Cochin-Pasteur, I-REIVAC Innovative Clinical Research Network In Vaccinology, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Odile Launay, MD,PhD, Principal investigator, CIC 1417 Clinical Center Investigation - Cochin Hospital, AP-HPOlivier Lortholary, Md,PhD, Principal investigator, Service des Maladies Infectieuses et Tropicales, Necker-Enfants malades Hospital, AP-HPHélène Coignard-Biehler, MD,PhD, Principal investigator, COREB - Hospices Civils de LyonMarc Michel, MD,PhD, Principal investigator, Service de médecine interne, Henri Mondor Hospital, APHPBenjamin Rossi, MD, Principal investigator, Service de Médecine interne et de Maladies infectieuses, Robert Ballanger Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03873727
- Sponsor's protocol ID
- P170934J
- Other IDs
- 2018-003068-29, 2018
- Acronym
- SPLENEVAC-2
- Status last verified
- Jun 2026
- First submitted
- 12 Feb 2019
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Immunological Response Following a Revaccination With PPS23 Boosted or Not by PCV13 in Splenectomised Patients
- ClinicalTrials.gov ID
- NCT03873727
- Acronym / sponsor ID
- SPLENEVAC-2 / P170934J
- Conditions
- Splenectomised Patients
- Keywords
- Vaccination / Re-vaccination, Asplenic patient, Splenectomy, Pneumococcal infections, immunological response, Pneumovax, Prevenar13
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- EUCLID Clinical Trial Platform, CIC 1417 Cochin-Pasteur, I-REIVAC Innovative Clinical Research Network In Vaccinology, URC-CIC Paris Descartes Necker Cochin
- Study start
- 27 Aug 2019 (actual)
- Primary completion
- 24 May 2022 (actual)
- Study completion
- 16 May 2024 (actual)
- First posted
- 13 Mar 2019 (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 research is a multi-center French randomized and double blind phase IIb clinical trial evaluating 2 revaccination strategies against pneumococcal infections among splenectomised patients. The main objective is to evaluate at M13 the immunological response of 2 pneumococcal revaccination strategies (combined revaccination by a boost dose of PCV13 following 12 months later by PPS23, versus PPS23 alone) in splenectomised adults.
Detailed description
For the prevention of invasive pneumococcal diseases, two polysaccharide vaccines are currently available: a non-conjugate vaccine, Pneumovax® (PPS23), and a conjugate vaccine, Prevenar13® (PCV13), inducing protection against 23 and 13 pneumococcal serotypes, respectively. The PPS23 is considered weakly immunogenic, especially in infants, elderly and immunocompromised patients, while PCV13 is now available for adults. In France, in April 2017, the new recommendations for at risk patients including asplenic patients are to revaccinate by PPS23 at least five years after the previous PPS23. However a phenomenon of vaccine hyporesponsiveness and a risk of immune tolerance to pneumococcus after repeated administrations of PPS23 are described. Large doses of polysaccharide antigens recruit memory and naive B cells, resulting in the production of low and high avidity antibodies, while low doses only stimulate memory B cells, inducing high affinity antibodies. Because of that, Swiss current recommendations are to revaccinate with PCV13 at 5 years the splenectomised patients. The recommendations of revaccination by PPS23 for USA or PCV13 for Switzerland have never been evaluated in clinical trial. Moreover, using combined PCV13/PPS23 could increase serotype coverage. Studying the immune response following combined revaccination by a boost dose of PCV13 following by PPS23 versus PPS23 alone will help to document and improve the vaccine recommendations.
The main objective is to evaluate at M13 the immunological response of 2 pneumococcal revaccination strategies (combined revaccination by a boost dose of PCV13 following 12 months later by PPS23, versus PPS23 alone), in splenectomised adults.
The primary endpoint is the proportion of patients responding to a minimum of 5 of the 9 serotypes analysed (9 serotypes among the 12 common serotypes to both PPS23 and PCV13: 1, 3, 6B, 7F, 9V, 14, 19A, 19F, and 23F) at M13 in each arm. A responder to a serotype is defined as a four-fold increase of the rate of OPA (OpsonoPhagocytic Assay) compared to baseline and titer ≥ LLOQ (Lower Limit of Quantification).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prevenar13/ Pneumovax | Experimental | Biological: Prevenar13 (PCV13) and Pneumovax (PPS23), Biological: Blood samplePrime-boost strategy combining a single dose of 13-valent pneumococcal conjugate vaccine (Prevenar 13, PCV13) at month 0 (M0) followed by a single dose of 23-valent unconjugated vaccine (Pneumovax, PPS23) at month 12 (M12). |
| Placebo / Pneumovax | Placebo comparator | Biological: Placebo / Pneumovax (PPS23), Biological: Blood sampleStandard strategy combining a single dose of placebo vaccine (Prevenar 13 placebo) at month 0 (M0) followed by a single dose of 23-valent unconjugated vaccine (Pneumovax, PPS23) at month 12 (M12) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years
- Splenectomised patients.
- For patients not enrolled in SPLENEVAC clinical trial: presence of Jolly Body at blood smear and spelenectomy confirmation by abdominal ultrasound.
- Vaccinated according to the schedule of SPLENEVAC clinical trial (PCV13 / PPS23 two months later (until +4 months)), enrolled or not from this study. Vaccination of PPS23 must have been administered 5 years - 6 months/+ 1 year before inclusion.
- Patients will be followed during the 24 months from the inclusion visit.
Key exclusion criteria (13 listed)
- History of pneumococcal revaccination in the last five years.
- Having received any another vaccines within 4 weeks prior to enrolment or who is planning to receive any vaccine (for example: ZOSTAVAX®) within the first 13 months of the study (excepted seasonal influenza vaccine which is permitted 4 weeks before and after each vaccination visit of the study and then allowed at any time during the study follow up. Furthermore, the vaccination against Sars-CoV-2 is allowed during the study with a minimum interval of 14 days between pneumococcal vaccine and Sars-Cov-2 vaccine injection)
- History of known allergies to any component of both study vaccines (active substances, excipients or diphtheria toxoid).
- History of anaphylactic reaction following vaccination.
- Infusion of immunoglobulins within the three months preceding the inclusion.
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 |
|---|---|---|
| Prevenar13 (PCV13) and Pneumovax (PPS23)One dose of PCV13 at Month 0 and one dose of PPS23 at Month 12 | Biological | Prevenar13/ Pneumovax |
| Placebo / Pneumovax (PPS23)One dose of Placebo at Month 0 and one dose of PPS23 at Month 12 | Biological | Placebo / Pneumovax |
| Blood samplean additional 5 mL sample of blood at one of the visits, preferably at the first visit, concerning patients included in Parisian centers who did not participate in SPLENEVAC 1 study. | Biological | Placebo / Pneumovax, Prevenar13/ Pneumovax |
Primary outcome
Immunogenicity
Time frame: at Month 13
Immune response at M13 against minimum of 5 of the 9 serotypes analysed (9 serotypes among the 12 common serotypes to both PPS23 and PCV13: 1, 3, 6B, 7F, 9V, 14, 19A, 19F, and 23F) in each arm. A responder to a serotype is defined as a four-fold increase of the rate of OpsonoPhagocytic Assay (OPA) compared to baseline (M0) and titer ≥ Lower Limit of Quantification (LLOQ).
12 secondary outcomes
Enzyme-linked immunosorbent assay (ELISA) antibody dosages
Time frame: Month 0 to Month 24
Enzyme-linked immunosorbent assay (ELISA) antibody dosages
Time frame: Month 0 to Month 24
Enzyme-linked immunosorbent assay (ELISA) antibody dosages
Time frame: Month 0 to Month 24
Titration of OPA -
Time frame: at Month 0, Month 13 and Month 24
Titration of OPA -
Time frame: at Month 0, Month 13 and Month 24
Titration of OPA -
Time frame: at Month 0, Month 13 and Month 24
ELISA antibody dosages
Time frame: at Month 12, Month 13 and Month 24
ELISA antibody dosages
Time frame: at Month 12, Month 13 and Month 24
ELISA antibody dosages
Time frame: at Month 12, Month 13 and Month 24
Sustainability and evolution of the immune response
Time frame: at Month 0 and Month 24
ELISA antibody dosages
Time frame: at Month 3
Percentage of patients presenting local or systemic reactions post-immunization
Time frame: Month0 to Month 24
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 1 Jul 2026.
- Individual participant dataSharing planned: No
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.
Odile Launay, MD,PhD principal investigator
CIC 1417 Clinical Center Investigation - Cochin Hospital, AP-HP
Olivier Lortholary, Md,PhD principal investigator
Service des Maladies Infectieuses et Tropicales, Necker-Enfants malades Hospital, AP-HP
Hélène Coignard-Biehler, MD,PhD principal investigator
COREB - 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 Phase 2 study testing Prevenar13 (PCV13) and Pneumovax (PPS23) and Blood sample in people with Splenectomised Patients, run by Assistance Publique - Hôpitaux de Paris 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 8 inclusion and 13 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 1 Jul 2026. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunogenicity (time frame: at Month 13). 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 1 Jul 2026.