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Trial · NCT05252845

Safety and Immunogenicity of the Malaria Vaccine, R21/MatrixM, in Healthy Thai Adults

NCT05252845, Phase 2, Completed, University of Oxford; results first posted 2025-07-03

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Safety and Immunogenicity of the Malaria Vaccine, R21/MatrixM, in Healthy Thai Adults. Trials, record NCT05252845. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05252845

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Safety and Immunogenicity of the Malaria Vaccine, R21/MatrixM, in Healthy Thai Adults
NCT number
NCT05252845
Status
Completed
Phases
Phase 2
Enrollment
127 participants, actual
Lead sponsor
University of Oxford
Conditions
Malaria,Falciparum
Interventions
R21/Matrix-M vaccination, DHA-PIP, PQ
First posted
2022-02-23
Last updated
2025-07-03
Results first posted
2025-07-03

Source ClinicalTrials.gov

Registered outcomes25

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryOccurrence of Unsolicited Adverse Events (AEs), According to the Medical Dictionary for Regulatory Activities (MedRA) Classification.From the date of the first vaccination to 28 days after the last vaccination (up to approximately 1 month)
PrimaryOccurrence of Serious Adverse Events (SAEs), According to the MedRA Classification.During the whole study period, i.e. during a 6-month follow-up period from the receipt of first vaccination
PrimaryOccurrence of Solicited Adverse Event Within 7 Days of Each VaccinationWithin 7 days of each vaccination.
SecondaryNumber of Participants With Seroconversions in C-Termat study Month 1Number of Participants with Seroconversions in C-Term
SecondaryNumber of Participants With Seroconversions in C-Termat study Month 2Number of Participants with Seroconversions in C-Term
SecondaryNumber of Participants With Seroconversions in C-Termat study Month 3Number of Participants with Seroconversions in C-Term
SecondaryNumber of Participants With Seroconversions in C-Termat study Month 6Number of Participants with Seroconversions in C-Term
SecondaryNumber of Participants With Seroconversions in NANPat study Month 1Number of Participants with Seroconversions in NANP
SecondaryNumber of Participants With Seroconversions in NANPat study Month2Number of Participants with Seroconversions in NANP
SecondaryNumber of Participants With Seroconversions in NANPat study Month 3Number of Participants with Seroconversions in NANP

Outcomes25

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYOccurrence of Unsolicited Adverse Events (AEs), According to the Medical Dictionary for Regulatory Activities (MedRA) Classification.From the date of the first vaccination to 28 days after the last vaccination (up to approximately 1 month)ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYOccurrence of Serious Adverse Events (SAEs), According to the MedRA Classification.During the whole study period, i.e. during a 6-month follow-up period from the receipt of first vaccinationParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYOccurrence of Solicited Adverse Event Within 7 Days of Each VaccinationWithin 7 days of each vaccination.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants With Seroconversions in C-Termat study Month 1ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants With Seroconversions in C-Termat study Month 2ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants With Seroconversions in C-Termat study Month 3ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants With Seroconversions in C-Termat study Month 6ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants With Seroconversions in NANPat study Month 1ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants With Seroconversions in NANPat study Month2ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants With Seroconversions in NANPat study Month 3ParticipantsCOUNT_OF_PARTICIPANTS

Results by group69

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Occurrence of Unsolicited Adverse Events (AEs), According to the Medical Dictionary for Regulatory Activities (MedRA) Classification.R21/Matrix-M + DHA-PIP+PQ17Participants
Occurrence of Unsolicited Adverse Events (AEs), According to the Medical Dictionary for Regulatory Activities (MedRA) Classification.R21/Matrix-M Only6Participants
Occurrence of Unsolicited Adverse Events (AEs), According to the Medical Dictionary for Regulatory Activities (MedRA) Classification.DHA-PIP+PQ Only4Participants
Occurrence of Serious Adverse Events (SAEs), According to the MedRA Classification.R21/Matrix-M + DHA-PIP+PQ1Participants
Occurrence of Serious Adverse Events (SAEs), According to the MedRA Classification.R21/Matrix-M Only0Participants
Occurrence of Serious Adverse Events (SAEs), According to the MedRA Classification.DHA-PIP+PQ Only1Participants
Occurrence of Solicited Adverse Event Within 7 Days of Each VaccinationR21/Matrix-M + DHA-PIP+PQ37Participants
Occurrence of Solicited Adverse Event Within 7 Days of Each VaccinationR21/Matrix-M Only36Participants
Occurrence of Solicited Adverse Event Within 7 Days of Each VaccinationDHA-PIP+PQ Only0Participants
Number of Participants With Seroconversions in C-TermR21/Matrix-M + DHA-PIP+PQ41Participants

Participant flow9

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDR21/Matrix-M + DHA-PIP+PQ52
Overall StudySTARTEDR21/Matrix-M Only53
Overall StudySTARTEDDHA-PIP+PQ Only22
Overall StudyCOMPLETEDR21/Matrix-M + DHA-PIP+PQ48
Overall StudyCOMPLETEDR21/Matrix-M Only48
Overall StudyCOMPLETEDDHA-PIP+PQ Only20
Overall StudyNOT COMPLETEDR21/Matrix-M + DHA-PIP+PQ4
Overall StudyNOT COMPLETEDR21/Matrix-M Only5
Overall StudyNOT COMPLETEDDHA-PIP+PQ Only2

Adverse events162

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherMalaiseGeneral disordersR21/Matrix-M + DHA-PIP+PQ4524
otherMalaiseGeneral disordersR21/Matrix-M Only3533
otherMalaiseGeneral disordersDHA-PIP+PQ Only0220
otherFeverInfections and infestationsR21/Matrix-M + DHA-PIP+PQ145216
otherFeverInfections and infestationsR21/Matrix-M Only9539
otherFeverInfections and infestationsDHA-PIP+PQ Only1221
otherALT increasedHepatobiliary disordersR21/Matrix-M + DHA-PIP+PQ4524
otherALT increasedHepatobiliary disordersR21/Matrix-M Only0530
otherALT increasedHepatobiliary disordersDHA-PIP+PQ Only0220
otherDiarrheaGastrointestinal disordersR21/Matrix-M + DHA-PIP+PQ145218

Adverse event totals9

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityR21/Matrix-M + DHA-PIP+PQ052
Total, all-cause mortalityR21/Matrix-M Only053
Total, all-cause mortalityDHA-PIP+PQ Only022
Total, other adverse eventsR21/Matrix-M + DHA-PIP+PQ3852
Total, other adverse eventsR21/Matrix-M Only3953
Total, other adverse eventsDHA-PIP+PQ Only522
Total, serious adverse eventsR21/Matrix-M + DHA-PIP+PQ152
Total, serious adverse eventsR21/Matrix-M Only053
Total, serious adverse eventsDHA-PIP+PQ Only122

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT05252845

GET https://conductscience.org/api/trials/v1/NCT05252845/registered?page=2