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
Cite this record
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
On this page
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.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Occurrence 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) | |
| Primary | Occurrence 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 | |
| Primary | Occurrence of Solicited Adverse Event Within 7 Days of Each Vaccination | Within 7 days of each vaccination. | |
| Secondary | Number of Participants With Seroconversions in C-Term | at study Month 1 | Number of Participants with Seroconversions in C-Term |
| Secondary | Number of Participants With Seroconversions in C-Term | at study Month 2 | Number of Participants with Seroconversions in C-Term |
| Secondary | Number of Participants With Seroconversions in C-Term | at study Month 3 | Number of Participants with Seroconversions in C-Term |
| Secondary | Number of Participants With Seroconversions in C-Term | at study Month 6 | Number of Participants with Seroconversions in C-Term |
| Secondary | Number of Participants With Seroconversions in NANP | at study Month 1 | Number of Participants with Seroconversions in NANP |
| Secondary | Number of Participants With Seroconversions in NANP | at study Month2 | Number of Participants with Seroconversions in NANP |
| Secondary | Number of Participants With Seroconversions in NANP | at study Month 3 | Number of Participants with Seroconversions in NANP |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 registered outcomesOutcomes25
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Occurrence 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) | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Occurrence 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 | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Occurrence of Solicited Adverse Event Within 7 Days of Each Vaccination | Within 7 days of each vaccination. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Seroconversions in C-Term | at study Month 1 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Seroconversions in C-Term | at study Month 2 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Seroconversions in C-Term | at study Month 3 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Seroconversions in C-Term | at study Month 6 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Seroconversions in NANP | at study Month 1 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Seroconversions in NANP | at study Month2 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Seroconversions in NANP | at study Month 3 | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 outcomesResults by group69
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Occurrence of Unsolicited Adverse Events (AEs), According to the Medical Dictionary for Regulatory Activities (MedRA) Classification. | R21/Matrix-M + DHA-PIP+PQ | 17 | Participants | ||
| Occurrence of Unsolicited Adverse Events (AEs), According to the Medical Dictionary for Regulatory Activities (MedRA) Classification. | R21/Matrix-M Only | 6 | Participants | ||
| Occurrence of Unsolicited Adverse Events (AEs), According to the Medical Dictionary for Regulatory Activities (MedRA) Classification. | DHA-PIP+PQ Only | 4 | Participants | ||
| Occurrence of Serious Adverse Events (SAEs), According to the MedRA Classification. | R21/Matrix-M + DHA-PIP+PQ | 1 | Participants | ||
| Occurrence of Serious Adverse Events (SAEs), According to the MedRA Classification. | R21/Matrix-M Only | 0 | Participants | ||
| Occurrence of Serious Adverse Events (SAEs), According to the MedRA Classification. | DHA-PIP+PQ Only | 1 | Participants | ||
| Occurrence of Solicited Adverse Event Within 7 Days of Each Vaccination | R21/Matrix-M + DHA-PIP+PQ | 37 | Participants | ||
| Occurrence of Solicited Adverse Event Within 7 Days of Each Vaccination | R21/Matrix-M Only | 36 | Participants | ||
| Occurrence of Solicited Adverse Event Within 7 Days of Each Vaccination | DHA-PIP+PQ Only | 0 | Participants | ||
| Number of Participants With Seroconversions in C-Term | R21/Matrix-M + DHA-PIP+PQ | 41 | Participants |
1 to 10 of 69Source ClinicalTrials.gov
See all 69 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | R21/Matrix-M + DHA-PIP+PQ | 52 | |
| Overall Study | STARTED | R21/Matrix-M Only | 53 | |
| Overall Study | STARTED | DHA-PIP+PQ Only | 22 | |
| Overall Study | COMPLETED | R21/Matrix-M + DHA-PIP+PQ | 48 | |
| Overall Study | COMPLETED | R21/Matrix-M Only | 48 | |
| Overall Study | COMPLETED | DHA-PIP+PQ Only | 20 | |
| Overall Study | NOT COMPLETED | R21/Matrix-M + DHA-PIP+PQ | 4 | |
| Overall Study | NOT COMPLETED | R21/Matrix-M Only | 5 | |
| Overall Study | NOT COMPLETED | DHA-PIP+PQ Only | 2 |
Source ClinicalTrials.gov
Adverse events162
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Malaise | General disorders | R21/Matrix-M + DHA-PIP+PQ | 4 | 52 | 4 |
| other | Malaise | General disorders | R21/Matrix-M Only | 3 | 53 | 3 |
| other | Malaise | General disorders | DHA-PIP+PQ Only | 0 | 22 | 0 |
| other | Fever | Infections and infestations | R21/Matrix-M + DHA-PIP+PQ | 14 | 52 | 16 |
| other | Fever | Infections and infestations | R21/Matrix-M Only | 9 | 53 | 9 |
| other | Fever | Infections and infestations | DHA-PIP+PQ Only | 1 | 22 | 1 |
| other | ALT increased | Hepatobiliary disorders | R21/Matrix-M + DHA-PIP+PQ | 4 | 52 | 4 |
| other | ALT increased | Hepatobiliary disorders | R21/Matrix-M Only | 0 | 53 | 0 |
| other | ALT increased | Hepatobiliary disorders | DHA-PIP+PQ Only | 0 | 22 | 0 |
| other | Diarrhea | Gastrointestinal disorders | R21/Matrix-M + DHA-PIP+PQ | 14 | 52 | 18 |
1 to 10 of 162Source ClinicalTrials.gov
See all 162 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | R21/Matrix-M + DHA-PIP+PQ | 0 | 52 |
| Total, all-cause mortality | R21/Matrix-M Only | 0 | 53 |
| Total, all-cause mortality | DHA-PIP+PQ Only | 0 | 22 |
| Total, other adverse events | R21/Matrix-M + DHA-PIP+PQ | 38 | 52 |
| Total, other adverse events | R21/Matrix-M Only | 39 | 53 |
| Total, other adverse events | DHA-PIP+PQ Only | 5 | 22 |
| Total, serious adverse events | R21/Matrix-M + DHA-PIP+PQ | 1 | 52 |
| Total, serious adverse events | R21/Matrix-M Only | 0 | 53 |
| Total, serious adverse events | DHA-PIP+PQ Only | 1 | 22 |
Source ClinicalTrials.gov
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.
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