Vaccination; InfectionPhase 4MADI-02NCT05856396
Maternal Determinants of Infant Immunity to Pertussis
A Phase 4 study testing Triaxis® (Pertussis-containing vaccine) and Vaxelis® (Pertussis-containing vaccine) in people with Vaccination; Infection and Maternal-Fetal Relations, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.
Trial summary
The overall objective of the project is to identify the determinants of antibody-mediated immunity in infants born to mothers immunized during pregnancy. Using maternal pertussis immunization as a model, the project will identify key predictors and potential determinants of vaccine responses in pregnant women, of the… Read more about this study
- Who is it for?
- Ages 2 months to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Vaccination; Infection, Maternal-Fetal Relations, Pertussis
- What is being tested?
- Triaxis® (Pertussis-containing vaccine) and Vaxelis® (Pertussis-containing vaccine)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteBelgium
- Study dates
- 12 Sep 2023to 23 Dec 2025
- Phase
- Phase 4
- 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 2 months to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- For non-pregnant \& pregnant women Age between 18 and 45 years Eligible for Tdap vaccination
- For infants Born to mothers vaccinated or not with Tdap Vaccinated with hexavalent vaccine Age between 2 and 3 months
Who cannot join
- For pregnant and non-pregnant women
- Inability to understand the nature and extent of the study and the procedures required
- Grade III/IV anemia,
- Acute infection at the time of immunization
- Chronic infections such as Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV) infection, acute toxoplasmosis
- Current or recent use of immunosuppressive drugs
Show all 17Show fewer
- Active neoplasia
- Other vaccine(s) administered at the same time as Tdap vaccination (wash out of 4 weeks after others vaccinations and 28 days after Tdap vaccination )
- For pregnant women
- Risk of premature delivery or intrauterine growth retardation
- Twin or triplet pregnancies
- For non-pregnant women Last Tdap vaccination < 12 months before
- For infants:
- Infants born before 35 weeks of gestation
- Birthweight below 2.5 kg,
- Severe neonatal distress
- Serious congenital abnormalities or congenital infection.
Trial locations and contacts
1 site in 1 country.
About this study
The overall objective of the project is to identify the determinants of antibody-mediated immunity in infants born to mothers immunized during pregnancy. Using maternal pertussis immunization as a model, the project will identify key predictors and potential determinants of vaccine responses in pregnant women, of the transfer of maternal antibodies to the newborn and of vaccine responses in infants. A systems biology approach will be used to delineate pre-vaccination and post-vaccination cellular and molecular correlates of the immune response to pertussis immunization in peripheral blood and in breastmilk.
Read the detailed description
The overall objective of the project is to identify the determinants of antibody-mediated immunity to pertussis in infants born to mothers immunized during pregnancy. Three specific objectives will be targeted:
- Determine the impact of pregnancy on the quality of antibody response to pertussis immunization and identify immune predictors of vaccine responses in pregnant and non-pregnant women.
- Identify immune predictors of the transfer of maternal antibodies to the newborn and the presence of antibody in breastmilk following pertussis immunization during pregnancy.
- Determine the impact of maternal antibodies on the quality of antibody response to pertussis immunization in infants born to mothers immunized or not immunized during pregnancy and identify immune predictors of vaccine responses in the first months of life.
To reach these objectives, 40 non-pregnant and 80 pregnant women will be recruited into the study and vaccinated with a single dose of a pertussis containing vaccine (Triaxis). Blood samples will be collected from:
- non-pregnant women: before vaccination, and day 1/7/28 and month 5 post-vaccination.
- pregnant women: before vaccination, day 1/7/28 post-vaccination, at delivery, and week 6/12 post-delivery. At week 6/12 post-delivery, breast milk samples will be collected as well.
At delivery, a placenta fragment will be collected.
In addition, infants 2-3 months old born either from mothers who were not vaccinated against pertussis during pregnancy (n=40) or born from mothers who were vaccinated against pertussis during pregnancy (n=80) will be recruited in the study. Infants will be vaccinated with three doses of a pertussis containing vaccine (Vaxelis), each one month apart starting from 2-3 months of age. Blood samples will be collected from:
- infants from vaccinated mothers: cord blood, before 1st vaccine dose, day 1 post 1st vaccine dose, before 3rd vaccine dose, and day 28 post 3rd vaccine dose.
- infants from unvaccinated mothers: before 1st vaccine dose, day 1 post 1st vaccine dose, before 3rd vaccine dose, and day 28 post 3rd vaccine dose.
- Being tested
- Triaxis® (Pertussis-containing vaccine), Vaxelis® (Pertussis-containing vaccine)
- Medical subject headings
- Infections, Whooping Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triaxis® (Pertussis-containing vaccine)Biological
Triaxis® (Pertussis-containing vaccine) will be administered:
- in non-pregnant women presenting to the Travel and Vaccine clinic for pertussis immunization only or hospital member staff requiring Tetanus Toxoid (TT)-booster immunisation
- in Pregnant women between 16 and 29 weeks of gestation.
Vaxelis® (Pertussis-containing vaccine)Biological
Vaxelis® (Hexavalent vaccine) will be proposed in infants at 8, 12 and 16 weeks of life.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women | Active comparator | Pregnant women will receive one dose of Pertussis-containing vaccine during pregnancy. Receives: Biological: Triaxis® (Pertussis-containing vaccine) |
| Non pregnant women | Active comparator | Non-Pregnant women will receive one dose of Pertussis-containing vaccine. Receives: Biological: Triaxis® (Pertussis-containing vaccine) |
| Infants born to Tdap-vaccinated mothers | Active comparator | Infants whose mothers have been immunized during pregnancy with Tdap vaccine. Infants will receive three doses of Pertussis-containing vaccine (with 28 days interval starting at two months of age). Receives: Biological: Vaxelis® (Pertussis-containing vaccine) |
| Infants born to non Tdap-vaccinated mothers | Active comparator | Infants whose mothers have not been immunized during pregnancy with Tdap vaccine.
Infants will receive three doses of Pertussis-containing vaccine (with 28 days interval starting at two months of age). Receives: Biological: Vaxelis® (Pertussis-containing vaccine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
IgG titers specific to Bordetella Pertussis Antigens by Enzyme-linked immunosorbent assay (ELISA)
IgG titers specific to Bordetella Pertussis Antigens will be assessed by ELISA:
- in women (pregnant and non-pregnant) at 28 days post vaccination
- in infants (from unvaccinated mothers and mothers vaccinated during pregnancy) at 28 days post third vaccine dose
Measured: Day 28 post-vaccination
IgG titers specific to Bordetella Pertussis Antigens by Enzyme-linked immunosorbent assay (ELISA)
IgG titers specific to Bordetella Pertussis Antigens will be assessed by ELISA:
- in women vaccinated during pregnancy, at delivery
- in umbilical cord blood of infants born to mothers vaccinated during pregnancy
Measured: At delivery
Secondary outcomes (2)
IgG titers specific to Bordetella Pertussis Antigens by Enzyme-linked immunosorbent assay (ELISA)
IgG titers specific to Bordetella Pertussis Antigens will be assessed by ELISA:
- in pregnant women (PW): at day of vaccination , day 7 post-vaccination, week 6 and 12 post-delivery
- in non-pregnant women (non PW): at day of vaccination, day 7 and Month 5 post-vaccination
- in infants (from unvaccinated mothers and mothers vaccinated during pregnancy) at day of first and third vaccine dose
Measured: up to 9 month after vaccination
CD4+ T cell frequencies specific to Bordetella Pertussis Antigens by flow cytometry
The percentage of CD4+ T cells expressing any of the following biomarkers (CD154, Interferon gamma, IL-2) in response to in vitro stimulation with Bordetella Pertussis Antigens will be measured by flow cytometry:
- in pregnant and non-pregnant women: at day of vaccination, and day 28 post vaccination ii. in infants (from unvaccinated mothers and mothers vaccinated during pregnancy) at day of first vaccine dose and 28 days after third vaccine dose
Measured: up to 9 month after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study start12 Sep 2023
- Primary completion23 Dec 2025
- Study completion23 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Vaccination; InfectionStudies 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 4
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- * Non pregnant and pregnant women will be recruited in parallel * Infants born to Tdap vaccinated-mothers (enrolled or not in the study) or not vaccinated mothers will be recruited
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Saint Pierre
- Sponsor type
- University, hospital or other
- Collaborators
- Université Libre de Bruxelles
- Responsible party
- Principal investigator, Tessa Goetghebuer, Centre Hospitalier Universitaire Saint Pierre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05856396
- Sponsor's protocol ID
- B0762022220909
- Acronym
- MADI-02
- Status last verified
- Jan 2026
- First submitted
- 5 Oct 2022
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Marchant A, Sadarangani M, Garand M, Dauby N, Verhasselt V, Pereira L, Bjornson G, Jones CE, Halperin SA, Edwards KM, Heath P, Openshaw PJ, Scheifele DW, Kollmann TR. Maternal immunisation: collaborating with mother nature. Lancet Infect Dis. 2017 Jul;17(7):e197-e208. doi: 10.1016/S1473-3099(17)30229-3. Epub 2017 Apr 19.
PubMed 28433705Gunn BM, Alter G. Modulating Antibody Functionality in Infectious Disease and Vaccination. Trends Mol Med. 2016 Nov;22(11):969-982. doi: 10.1016/j.molmed.2016.09.002. Epub 2016 Oct 15.
PubMed 27756530Jennewein MF, Alter G. The Immunoregulatory Roles of Antibody Glycosylation. Trends Immunol. 2017 May;38(5):358-372. doi: 10.1016/j.it.2017.02.004. Epub 2017 Apr 3.
PubMed 28385520Jennewein MF, Abu-Raya B, Jiang Y, Alter G, Marchant A. Transfer of maternal immunity and programming of the newborn immune system. Semin Immunopathol. 2017 Nov;39(6):605-613. doi: 10.1007/s00281-017-0653-x. Epub 2017 Oct 2.
PubMed 28971246Jennewein MF, Goldfarb I, Dolatshahi S, Cosgrove C, Noelette FJ, Krykbaeva M, Das J, Sarkar A, Gorman MJ, Fischinger S, Boudreau CM, Brown J, Cooperrider JH, Aneja J, Suscovich TJ, Graham BS, Lauer GM, Goetghebuer T, Marchant A, Lauffenburger D, Kim AY, Riley LE, Alter G. Fc Glycan-Mediated Regulation of Placental Antibody Transfer. Cell. 2019 Jun 27;178(1):202-215.e14. doi: 10.1016/j.cell.2019.05.044. Epub 2019 Jun 13.
PubMed 31204102Jennewein MF, Kosikova M, Noelette FJ, Radvak P, Boudreau CM, Campbell JD, Chen WH, Xie H, Alter G, Pasetti MF. Functional and structural modifications of influenza antibodies during pregnancy. iScience. 2022 Mar 16;25(4):104088. doi: 10.1016/j.isci.2022.104088. eCollection 2022 Apr 15.
PubMed 35402869Tsang JS. Utilizing population variation, vaccination, and systems biology to study human immunology. Trends Immunol. 2015 Aug;36(8):479-93. doi: 10.1016/j.it.2015.06.005. Epub 2015 Jul 14.
PubMed 26187853
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Determinants of Infant Immunity to Pertussis
- ClinicalTrials.gov ID
- NCT05856396
- Acronym / sponsor ID
- MADI-02 / B0762022220909
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire Saint PierreUniversity, hospital or other
- Collaborators
- Université Libre de Bruxelles
- Study start
- 12 Sep 2023 (actual)
- Primary completion
- 23 Dec 2025 (actual)
- Study completion
- 23 Dec 2025 (actual)
- First posted
- 12 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall objective of the project is to identify the determinants of antibody-mediated immunity in infants born to mothers immunized during pregnancy. Using maternal pertussis immunization as a model, the project will identify key predictors and potential determinants of vaccine responses in pregnant women, of the transfer of maternal antibodies to the newborn and of vaccine responses in infants. A systems biology approach will be used to delineate pre-vaccination and post-vaccination cellular and molecular correlates of the immune response to pertussis immunization in peripheral blood and in breastmilk.
Detailed description
The overall objective of the project is to identify the determinants of antibody-mediated immunity to pertussis in infants born to mothers immunized during pregnancy. Three specific objectives will be targeted:
- Determine the impact of pregnancy on the quality of antibody response to pertussis immunization and identify immune predictors of vaccine responses in pregnant and non-pregnant women.
- Identify immune predictors of the transfer of maternal antibodies to the newborn and the presence of antibody in breastmilk following pertussis immunization during pregnancy.
- Determine the impact of maternal antibodies on the quality of antibody response to pertussis immunization in infants born to mothers immunized or not immunized during pregnancy and identify immune predictors of vaccine responses in the first months of life.
To reach these objectives, 40 non-pregnant and 80 pregnant women will be recruited into the study and vaccinated with a single dose of a pertussis containing vaccine (Triaxis). Blood samples will be collected from:
- non-pregnant women: before vaccination, and day 1/7/28 and month 5 post-vaccination.
- pregnant women: before vaccination, day 1/7/28 post-vaccination, at delivery, and week 6/12 post-delivery. At week 6/12 post-delivery, breast milk samples will be collected as well.
At delivery, a placenta fragment will be collected.
In addition, infants 2-3 months old born either from mothers who were not vaccinated against pertussis during pregnancy (n=40) or born from mothers who were vaccinated against pertussis during pregnancy (n=80) will be recruited in the study. Infants will be vaccinated with three doses of a pertussis containing vaccine (Vaxelis), each one month apart starting from 2-3 months of age. Blood samples will be collected from:
- infants from vaccinated mothers: cord blood, before 1st vaccine dose, day 1 post 1st vaccine dose, before 3rd vaccine dose, and day 28 post 3rd vaccine dose.
- infants from unvaccinated mothers: before 1st vaccine dose, day 1 post 1st vaccine dose, before 3rd vaccine dose, and day 28 post 3rd vaccine dose.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- * Non pregnant and pregnant women will be recruited in parallel * Infants born to Tdap vaccinated-mothers (enrolled or not in the study) or not vaccinated mothers will be recruited
| Arm | Type | Receives |
|---|---|---|
| Pregnant women | Active comparator | Biological: Triaxis® (Pertussis-containing vaccine)Pregnant women will receive one dose of Pertussis-containing vaccine during pregnancy. |
| Non pregnant women | Active comparator | Biological: Triaxis® (Pertussis-containing vaccine)Non-Pregnant women will receive one dose of Pertussis-containing vaccine. |
| Infants born to Tdap-vaccinated mothers | Active comparator | Biological: Vaxelis® (Pertussis-containing vaccine)Infants whose mothers have been immunized during pregnancy with Tdap vaccine. Infants will receive three doses of Pertussis-containing vaccine (with 28 days interval starting at two months of age). |
| Infants born to non Tdap-vaccinated mothers | Active comparator | Biological: Vaxelis® (Pertussis-containing vaccine)Infants whose mothers have not been immunized during pregnancy with Tdap vaccine. Infants will receive three doses of Pertussis-containing vaccine (with 28 days interval starting at two months of age). |
Who may qualify
- Ages
- 2 months to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- For non-pregnant \& pregnant women Age between 18 and 45 years Eligible for Tdap vaccination
- For infants Born to mothers vaccinated or not with Tdap Vaccinated with hexavalent vaccine Age between 2 and 3 months
Key exclusion criteria (17 listed)
- For pregnant and non-pregnant women
- For pregnant women
- For non-pregnant women Last Tdap vaccination < 12 months before
- Infants born before 35 weeks of gestation
- Birthweight below 2.5 kg,
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 |
|---|---|---|
| Triaxis® (Pertussis-containing vaccine)Triaxis® (Pertussis-containing vaccine) will be administered: * in non-pregnant women presenting to the Travel and Vaccine clinic for pertussis immunization only or hospital member staff requiring Tetanus Toxoid (TT)-booster immunisation * in Pregnant women between 16 and 29 weeks of gestation. | Biological | Non pregnant women, Pregnant women |
| Vaxelis® (Pertussis-containing vaccine)Vaxelis® (Hexavalent vaccine) will be proposed in infants at 8, 12 and 16 weeks of life. | Biological | Infants born to Tdap-vaccinated mothers, Infants born to non Tdap-vaccinated mothers |
Primary outcome
IgG titers specific to Bordetella Pertussis Antigens by Enzyme-linked immunosorbent assay (ELISA)
Time frame: Day 28 post-vaccination
IgG titers specific to Bordetella Pertussis Antigens will be assessed by ELISA: * in women (pregnant and non-pregnant) at 28 days post vaccination * in infants (from unvaccinated mothers and mothers vaccinated during pregnancy) at 28 days post third vaccine dose
IgG titers specific to Bordetella Pertussis Antigens by Enzyme-linked immunosorbent assay (ELISA)
Time frame: At delivery
IgG titers specific to Bordetella Pertussis Antigens will be assessed by ELISA: * in women vaccinated during pregnancy, at delivery * in umbilical cord blood of infants born to mothers vaccinated during pregnancy
2 secondary outcomes
IgG titers specific to Bordetella Pertussis Antigens by Enzyme-linked immunosorbent assay (ELISA)
Time frame: up to 9 month after vaccination
CD4+ T cell frequencies specific to Bordetella Pertussis Antigens by flow cytometry
Time frame: up to 9 month after vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Background: PubMed 28433705Marchant A, Sadarangani M, Garand M, Dauby N, Verhasselt V, Pereira L, Bjornson G, Jones CE, Halperin SA, Edwards KM, Heath P, Openshaw PJ, Scheifele DW, Kollmann TR. Maternal immunisation: collaborating with mother nature. Lancet Infect Dis. 2017 Jul;17(7):e197-e208. doi: 10.1016/S1473-3099(17)30229-3. Epub 2017 Apr 19.
- Background: PubMed 27756530Gunn BM, Alter G. Modulating Antibody Functionality in Infectious Disease and Vaccination. Trends Mol Med. 2016 Nov;22(11):969-982. doi: 10.1016/j.molmed.2016.09.002. Epub 2016 Oct 15.
- Background: PubMed 28385520Jennewein MF, Alter G. The Immunoregulatory Roles of Antibody Glycosylation. Trends Immunol. 2017 May;38(5):358-372. doi: 10.1016/j.it.2017.02.004. Epub 2017 Apr 3.
- Background: PubMed 28971246Jennewein MF, Abu-Raya B, Jiang Y, Alter G, Marchant A. Transfer of maternal immunity and programming of the newborn immune system. Semin Immunopathol. 2017 Nov;39(6):605-613. doi: 10.1007/s00281-017-0653-x. Epub 2017 Oct 2.
- Background: PubMed 31204102Jennewein MF, Goldfarb I, Dolatshahi S, Cosgrove C, Noelette FJ, Krykbaeva M, Das J, Sarkar A, Gorman MJ, Fischinger S, Boudreau CM, Brown J, Cooperrider JH, Aneja J, Suscovich TJ, Graham BS, Lauer GM, Goetghebuer T, Marchant A, Lauffenburger D, Kim AY, Riley LE, Alter G. Fc Glycan-Mediated Regulation of Placental Antibody Transfer. Cell. 2019 Jun 27;178(1):202-215.e14. doi: 10.1016/j.cell.2019.05.044. Epub 2019 Jun 13.
- Background: PubMed 35402869Jennewein MF, Kosikova M, Noelette FJ, Radvak P, Boudreau CM, Campbell JD, Chen WH, Xie H, Alter G, Pasetti MF. Functional and structural modifications of influenza antibodies during pregnancy. iScience. 2022 Mar 16;25(4):104088. doi: 10.1016/j.isci.2022.104088. eCollection 2022 Apr 15.
- Background: PubMed 26187853Tsang JS. Utilizing population variation, vaccination, and systems biology to study human immunology. Trends Immunol. 2015 Aug;36(8):479-93. doi: 10.1016/j.it.2015.06.005. Epub 2015 Jul 14.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Triaxis® (Pertussis-containing vaccine) and Vaxelis® (Pertussis-containing vaccine) in people with Vaccination; Infection and Maternal-Fetal Relations, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.
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 2 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: finished, as of the sponsor's last update on 13 Jan 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 Belgium. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
IgG titers specific to Bordetella Pertussis Antigens by Enzyme-linked immunosorbent assay (ELISA) (time frame: Day 28 post-vaccination). The study lists 2 primary outcomes in all. 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 NCT05856396, which also lists 7 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 Jan 2026.