Trial · NCT02992119
Malaria Vaccine Safety and Immunogenicity Study in Healthy Adults
NCT02992119, Phase 2, Completed, University of Oxford; results first posted 2019-07-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Malaria Vaccine Safety and Immunogenicity Study in Healthy Adults. Trials, record NCT02992119. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02992119
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Malaria Vaccine Safety and Immunogenicity Study in Healthy Adults
- NCT number
- NCT02992119
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 193 participants, actual
- Lead sponsor
- University of Oxford
- Conditions
- Malaria Vaccine
- Interventions
RTS,S/AS01B Fractional dose, Double RTS,S/AS01E Fractional dose, RTS,S/AS01E Standard dose, RTS,S/AS01E + DHA-PIP+PQ Standard dose, RTS,S/AS01E Fractional dose, RTS,S/AS01E + DHA-PIP+PQ Fractional dose, RTS,S/AS01E + DHA-PIP+PQ Fractional two-dose
- First posted
- 2016-12-14
- Last updated
- 2022-03-31
- Results first posted
- 2019-07-29
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Experience a Serious Adverse Events (SAEs) 29 Days After the Last Vaccination | 29 days after last vaccination | Occurrence of serious adverse events (SAEs) from the date of the first vaccination to 29 days after the last vaccination, according to the MedRA classification. |
| Primary | Number of Participants Who Experience a Serious Adverse Events (SAEs) During a 6 Month Follow up Period From the Receipt of First Vaccination | 6 months | Occurrence of SAEs during the whole study period, i.e. during a 6 month follow up period from the receipt of first vaccination, according to the MedRA classification. |
| Primary | Number of Participants Who Seroconverted One Month After First Dose. | 1 months | The percentage of subjects seroconverting after each immunization based on a value greater than the mean titer at baseline (before immunization # 1) plus 2 standard deviations for all subjects included in the analysis (ITT). |
| Primary | Number of Participants Who Seroconverted One Month After the Second Dose. | 2 months | The percentage of subjects seroconverting after each immunization based on a value greater than the mean titer at baseline (before immunization # 1) plus 2 standard deviations for all subjects included in the analysis (ITT). |
| Primary | Number of Participants Who Seroconverted One Month After the Third Dose. | 3 months | The percentage of subjects seroconverting after each immunization based on a value greater than the mean titer at baseline (before immunization # 1) plus 2 standard deviations for all subjects included in the analysis (ITT). |
| Primary | Number of Participants Who Seroconverted at Month Six After First Dose. | 6 months | The percentage of subjects seroconverting after each immunization based on a value greater than the mean titer at baseline (before immunization # 1) plus 2 standard deviations for all subjects included in the analysis (ITT). |
| Primary | Number of Participants Who Received RTS,S/AS01E + DHA-PIP+PQ Fractional Two-dose (Group 7) That Seroconverted at Month Two After First Dose. | 2 months | The percentage of subjects seroconverting after each immunization based on a value greater than the mean titer at baseline (before immunization # 1) plus 2 standard deviations for all subjects included in the analysis (ITT).(For group 7) |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Who Experience a Serious Adverse Events (SAEs) 29 Days After the Last Vaccination | 29 days after last vaccination | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number of Participants Who Experience a Serious Adverse Events (SAEs) During a 6 Month Follow up Period From the Receipt of First Vaccination | 6 months | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number of Participants Who Seroconverted One Month After First Dose. | 1 months | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number of Participants Who Seroconverted One Month After the Second Dose. | 2 months | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number of Participants Who Seroconverted One Month After the Third Dose. | 3 months | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number of Participants Who Seroconverted at Month Six After First Dose. | 6 months | Analysed subjects who returned for the month 6 follow-up.~There are 4 subjects lost follow-up as follows:~1 subject from group 1~1. subject from group 3~2. subjects from group 7 | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Who Received RTS,S/AS01E + DHA-PIP+PQ Fractional Two-dose (Group 7) That Seroconverted at Month Two After First Dose. | 2 months | There were 30 subjects at group 7 received 1st vaccination and came back for follow-up at month 2 visit | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group42
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Who Experience a Serious Adverse Events (SAEs) 29 Days After the Last Vaccination | Group 1 | 1 | Participants | ||
| Number of Participants Who Experience a Serious Adverse Events (SAEs) 29 Days After the Last Vaccination | Group 2 | 0 | Participants | ||
| Number of Participants Who Experience a Serious Adverse Events (SAEs) 29 Days After the Last Vaccination | Group 3 | 0 | Participants | ||
| Number of Participants Who Experience a Serious Adverse Events (SAEs) 29 Days After the Last Vaccination | Group 4 | 1 | Participants | ||
| Number of Participants Who Experience a Serious Adverse Events (SAEs) 29 Days After the Last Vaccination | Group 5 | 1 | Participants | ||
| Number of Participants Who Experience a Serious Adverse Events (SAEs) 29 Days After the Last Vaccination | Group 6 | 0 | Participants | ||
| Number of Participants Who Experience a Serious Adverse Events (SAEs) 29 Days After the Last Vaccination | Group 7 | 0 | Participants | ||
| Number of Participants Who Experience a Serious Adverse Events (SAEs) During a 6 Month Follow up Period From the Receipt of First Vaccination | Group 1 | 1 | Participants | ||
| Number of Participants Who Experience a Serious Adverse Events (SAEs) During a 6 Month Follow up Period From the Receipt of First Vaccination | Group 2 | 0 | Participants | ||
| Number of Participants Who Experience a Serious Adverse Events (SAEs) During a 6 Month Follow up Period From the Receipt of First Vaccination | Group 3 | 0 | Participants |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group 1 RTS,S/AS01B Fractional Dose | 21 | |
| Overall Study | STARTED | Group 2 Double RTS,S/AS01E Fractional Dose | 21 | |
| Overall Study | STARTED | Group 3 RTS,S/AS01E Standard Dose | 30 | |
| Overall Study | STARTED | Group 4 RTS,S/AS01E + DHA-PIP+PQ Standard Dose | 30 | |
| Overall Study | STARTED | Group 5 RTS,S/AS01E Fractional Dose | 30 | |
| Overall Study | STARTED | Group 6 RTS,S/AS01E + DHA-PIP+PQ Fractional Dose | 30 | |
| Overall Study | STARTED | Group 7 RTS,S/AS01E + DHA-PIP+PQ Fractional Two-dose | 31 | |
| Overall Study | COMPLETED | Group 1 RTS,S/AS01B Fractional Dose | 19 | |
| Overall Study | COMPLETED | Group 2 Double RTS,S/AS01E Fractional Dose | 20 | |
| Overall Study | COMPLETED | Group 3 RTS,S/AS01E Standard Dose | 29 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events126
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 | Injection site pain | Injury, poisoning and procedural complications | Group 1 | 20 | 21 | 46 |
| other | Injection site pain | Injury, poisoning and procedural complications | Group 2 | 20 | 21 | 42 |
| other | Injection site pain | Injury, poisoning and procedural complications | Group 3 | 30 | 30 | 79 |
| other | Injection site pain | Injury, poisoning and procedural complications | Group 4 | 25 | 30 | 60 |
| other | Injection site pain | Injury, poisoning and procedural complications | Group 5 | 29 | 30 | 65 |
| other | Injection site pain | Injury, poisoning and procedural complications | Group 6 | 27 | 30 | 57 |
| other | Injection site pain | Injury, poisoning and procedural complications | Group 7 | 28 | 31 | 48 |
| other | Fatigue | General disorders | Group 1 | 18 | 21 | 41 |
| other | Fatigue | General disorders | Group 2 | 16 | 21 | 23 |
| other | Fatigue | General disorders | Group 3 | 24 | 30 | 53 |
1 to 10 of 126Source ClinicalTrials.gov
See all 126 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group 1 | 0 | 21 |
| Total, all-cause mortality | Group 2 | 0 | 21 |
| Total, all-cause mortality | Group 3 | 0 | 30 |
| Total, all-cause mortality | Group 4 | 0 | 30 |
| Total, all-cause mortality | Group 5 | 0 | 30 |
| Total, all-cause mortality | Group 6 | 0 | 30 |
| Total, all-cause mortality | Group 7 | 0 | 31 |
| Total, other adverse events | Group 1 | 21 | 21 |
| Total, other adverse events | Group 2 | 21 | 21 |
| Total, other adverse events | Group 3 | 30 | 30 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers0
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/NCT02992119
GET https://conductscience.org/api/trials/v1/NCT02992119/results?page=2