Trial Outcomes & Findings for Malaria Vaccine Safety and Immunogenicity Study in Healthy Adults (NCT NCT02992119)
NCT ID: NCT02992119
Last Updated: 2022-03-31
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
193 participants
Primary outcome timeframe
29 days after last vaccination
Results posted on
2022-03-31
Participant Flow
Participant milestones
| Measure |
Group 1 RTS,S/AS01B Fractional Dose
RTS,S/AS01B Fractional dose
RTS,S/AS01B Fractional dose: RTS,S/AS01B standard dose at Month 0 and Month 1 + RTS,S/AS01B fractional dose (1/5th dose) at Month 2.
|
Group 2 Double RTS,S/AS01E Fractional Dose
Double RTS,S/AS01E Fractional dose
Double RTS,S/AS01E Fractional dose: A double dose of RTS,S/AS01E standard dose at Month 0 and Month 1 + a double dose of RTS,S/AS01E fractional dose (1/5th dose) at Month 2.
|
Group 3 RTS,S/AS01E Standard Dose
RTS,S/AS01E Standard dose
RTS,S/AS01E Standard dose: RTS,S/AS01E standard dose at Month 0, Month 1 and Month 2.
|
Group 4 RTS,S/AS01E + DHA-PIP+PQ Standard Dose
RTS,S/AS01E + DHA-PIP+PQ Standard dose
RTS,S/AS01E + DHA-PIP+PQ Standard dose: RTS,S/AS01E standard dose + DHA-PIP+PQ at Month 0, Month 1 and Month 2
|
Group 5 RTS,S/AS01E Fractional Dose
RTS,S/AS01E Fractional dose
RTS,S/AS01E Fractional dose: RTS,S/AS01E standard dose at Month 0 and Month 1 + RTS,S/AS01E fractional dose (1/5th dose) at Month 2.
|
Group 6 RTS,S/AS01E + DHA-PIP+PQ Fractional Dose
RTS,S/AS01E + DHA-PIP+PQ Fractional dose
RTS,S/AS01E + DHA-PIP+PQ Fractional dose: RTS,S/AS01E standard dose + DHA-PIP+PQ at Month 0 and Month 1 + RTS,S/AS01E fractional dose (1/5th dose) + DHA-PIP+PQ at Month 2.
|
Group 7 RTS,S/AS01E + DHA-PIP+PQ Fractional Two-dose
RTS,S/AS01E + DHA-PIP+PQ Fractional two-dose
RTS,S/AS01E + DHA-PIP+PQ Fractional two-dose: RTS,S/AS01E standard dose + DHA-PIP+PQ at Month 0 + RTS,S/AS01E fractional dose (1/5th dose) + DHA-PIP+PQ at Month 2
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
21
|
21
|
30
|
30
|
30
|
30
|
31
|
|
Overall Study
COMPLETED
|
19
|
20
|
29
|
30
|
30
|
30
|
28
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
1
|
0
|
0
|
0
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Group 1
n=21 Participants
RTS,S/AS01B Fractional dose
RTS,S/AS01B Fractional dose: RTS,S/AS01B standard dose at Month 0 and Month 1 + RTS,S/AS01B fractional dose (1/5th dose) at Month 2.
|
Group 2
n=21 Participants
Double RTS,S/AS01E Fractional dose
Double RTS,S/AS01E Fractional dose: A double dose of RTS,S/AS01E standard dose at Month 0 and Month 1 + a double dose of RTS,S/AS01E fractional dose (1/5th dose) at Month 2.
|
Group 3
n=30 Participants
RTS,S/AS01E Standard dose
RTS,S/AS01E Standard dose: RTS,S/AS01E standard dose at Month 0, Month 1 and Month 2.
|
Group 4
n=30 Participants
RTS,S/AS01E + DHA-PIP+PQ Standard dose
RTS,S/AS01E + DHA-PIP+PQ Standard dose: RTS,S/AS01E standard dose + DHA-PIP+PQ at Month 0, Month 1 and Month 2
|
Group 5
n=30 Participants
RTS,S/AS01E Fractional dose
RTS,S/AS01E Fractional dose: RTS,S/AS01E standard dose at Month 0 and Month 1 + RTS,S/AS01E fractional dose (1/5th dose) at Month 2.
|
Group 6
n=30 Participants
RTS,S/AS01E + DHA-PIP+PQ Fractional dose
RTS,S/AS01E + DHA-PIP+PQ Fractional dose: RTS,S/AS01E standard dose + DHA-PIP+PQ at Month 0 and Month 1 + RTS,S/AS01E fractional dose (1/5th dose) + DHA-PIP+PQ at Month 2.
|
Group 7
n=31 Participants
RTS,S/AS01E + DHA-PIP+PQ Fractional two-dose
RTS,S/AS01E + DHA-PIP+PQ Fractional two-dose: RTS,S/AS01E standard dose + DHA-PIP+PQ at Month 0 + RTS,S/AS01E fractional dose (1/5th dose) + DHA-PIP+PQ at Month 2
|
Total
n=193 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=21 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=193 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=21 Participants
|
21 Participants
n=21 Participants
|
30 Participants
n=30 Participants
|
30 Participants
n=30 Participants
|
30 Participants
n=30 Participants
|
30 Participants
n=30 Participants
|
31 Participants
n=31 Participants
|
193 Participants
n=193 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=21 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=193 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=21 Participants
|
11 Participants
n=21 Participants
|
16 Participants
n=30 Participants
|
17 Participants
n=30 Participants
|
17 Participants
n=30 Participants
|
16 Participants
n=30 Participants
|
17 Participants
n=31 Participants
|
106 Participants
n=193 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=21 Participants
|
10 Participants
n=21 Participants
|
14 Participants
n=30 Participants
|
13 Participants
n=30 Participants
|
13 Participants
n=30 Participants
|
14 Participants
n=30 Participants
|
14 Participants
n=31 Participants
|
87 Participants
n=193 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
fever
|
0 Participants
n=21 Participants • Analysed all participants at the baseline visit
|
0 Participants
n=21 Participants • Analysed all participants at the baseline visit
|
0 Participants
n=30 Participants • Analysed all participants at the baseline visit
|
0 Participants
n=30 Participants • Analysed all participants at the baseline visit
|
0 Participants
n=30 Participants • Analysed all participants at the baseline visit
|
0 Participants
n=30 Participants • Analysed all participants at the baseline visit
|
0 Participants
n=31 Participants • Analysed all participants at the baseline visit
|
0 Participants
n=193 Participants • Analysed all participants at the baseline visit
|
PRIMARY outcome
Timeframe: 29 days after last vaccinationOccurrence of serious adverse events (SAEs) from the date of the first vaccination to 29 days after the last vaccination, according to the MedRA classification.
Outcome measures
| Measure |
Group 1
n=19 Participants
RTS,S/AS01B Fractional dose
RTS,S/AS01B Fractional dose: RTS,S/AS01B standard dose at Month 0 and Month 1 + RTS,S/AS01B fractional dose (1/5th dose) at Month 2.
|
Group 2
n=20 Participants
Double RTS,S/AS01E Fractional dose
Double RTS,S/AS01E Fractional dose: A double dose of RTS,S/AS01E standard dose at Month 0 and Month 1 + a double dose of RTS,S/AS01E fractional dose (1/5th dose) at Month 2.
|
Group 3
n=29 Participants
RTS,S/AS01E Standard dose
RTS,S/AS01E Standard dose: RTS,S/AS01E standard dose at Month 0, Month 1 and Month 2.
|
Group 4
n=30 Participants
RTS,S/AS01E + DHA-PIP+PQ Standard dose
RTS,S/AS01E + DHA-PIP+PQ Standard dose: RTS,S/AS01E standard dose + DHA-PIP+PQ at Month 0, Month 1 and Month 2
|
Group 5
n=30 Participants
RTS,S/AS01E Fractional dose
RTS,S/AS01E Fractional dose: RTS,S/AS01E standard dose at Month 0 and Month 1 + RTS,S/AS01E fractional dose (1/5th dose) at Month 2.
|
Group 6
n=30 Participants
RTS,S/AS01E + DHA-PIP+PQ Fractional dose
RTS,S/AS01E + DHA-PIP+PQ Fractional dose: RTS,S/AS01E standard dose + DHA-PIP+PQ at Month 0 and Month 1 + RTS,S/AS01E fractional dose (1/5th dose) + DHA-PIP+PQ at Month 2.
|
Group 7
n=28 Participants
RTS,S/AS01E + DHA-PIP+PQ Fractional two-dose
RTS,S/AS01E + DHA-PIP+PQ Fractional two-dose: RTS,S/AS01E standard dose + DHA-PIP+PQ at Month 0 + RTS,S/AS01E fractional dose (1/5th dose) + DHA-PIP+PQ at Month 2
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Who Experience a Serious Adverse Events (SAEs) 29 Days After the Last Vaccination
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 6 monthsOccurrence 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.
Outcome measures
| Measure |
Group 1
n=21 Participants
RTS,S/AS01B Fractional dose
RTS,S/AS01B Fractional dose: RTS,S/AS01B standard dose at Month 0 and Month 1 + RTS,S/AS01B fractional dose (1/5th dose) at Month 2.
|
Group 2
n=21 Participants
Double RTS,S/AS01E Fractional dose
Double RTS,S/AS01E Fractional dose: A double dose of RTS,S/AS01E standard dose at Month 0 and Month 1 + a double dose of RTS,S/AS01E fractional dose (1/5th dose) at Month 2.
|
Group 3
n=30 Participants
RTS,S/AS01E Standard dose
RTS,S/AS01E Standard dose: RTS,S/AS01E standard dose at Month 0, Month 1 and Month 2.
|
Group 4
n=30 Participants
RTS,S/AS01E + DHA-PIP+PQ Standard dose
RTS,S/AS01E + DHA-PIP+PQ Standard dose: RTS,S/AS01E standard dose + DHA-PIP+PQ at Month 0, Month 1 and Month 2
|
Group 5
n=30 Participants
RTS,S/AS01E Fractional dose
RTS,S/AS01E Fractional dose: RTS,S/AS01E standard dose at Month 0 and Month 1 + RTS,S/AS01E fractional dose (1/5th dose) at Month 2.
|
Group 6
n=30 Participants
RTS,S/AS01E + DHA-PIP+PQ Fractional dose
RTS,S/AS01E + DHA-PIP+PQ Fractional dose: RTS,S/AS01E standard dose + DHA-PIP+PQ at Month 0 and Month 1 + RTS,S/AS01E fractional dose (1/5th dose) + DHA-PIP+PQ at Month 2.
|
Group 7
n=31 Participants
RTS,S/AS01E + DHA-PIP+PQ Fractional two-dose
RTS,S/AS01E + DHA-PIP+PQ Fractional two-dose: RTS,S/AS01E standard dose + DHA-PIP+PQ at Month 0 + RTS,S/AS01E fractional dose (1/5th dose) + DHA-PIP+PQ at Month 2
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Who Experience a Serious Adverse Events (SAEs) During a 6 Month Follow up Period From the Receipt of First Vaccination
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 1 monthsThe 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).
Outcome measures
| Measure |
Group 1
n=20 Participants
RTS,S/AS01B Fractional dose
RTS,S/AS01B Fractional dose: RTS,S/AS01B standard dose at Month 0 and Month 1 + RTS,S/AS01B fractional dose (1/5th dose) at Month 2.
|
Group 2
n=20 Participants
Double RTS,S/AS01E Fractional dose
Double RTS,S/AS01E Fractional dose: A double dose of RTS,S/AS01E standard dose at Month 0 and Month 1 + a double dose of RTS,S/AS01E fractional dose (1/5th dose) at Month 2.
|
Group 3
n=30 Participants
RTS,S/AS01E Standard dose
RTS,S/AS01E Standard dose: RTS,S/AS01E standard dose at Month 0, Month 1 and Month 2.
|
Group 4
n=30 Participants
RTS,S/AS01E + DHA-PIP+PQ Standard dose
RTS,S/AS01E + DHA-PIP+PQ Standard dose: RTS,S/AS01E standard dose + DHA-PIP+PQ at Month 0, Month 1 and Month 2
|
Group 5
n=30 Participants
RTS,S/AS01E Fractional dose
RTS,S/AS01E Fractional dose: RTS,S/AS01E standard dose at Month 0 and Month 1 + RTS,S/AS01E fractional dose (1/5th dose) at Month 2.
|
Group 6
n=30 Participants
RTS,S/AS01E + DHA-PIP+PQ Fractional dose
RTS,S/AS01E + DHA-PIP+PQ Fractional dose: RTS,S/AS01E standard dose + DHA-PIP+PQ at Month 0 and Month 1 + RTS,S/AS01E fractional dose (1/5th dose) + DHA-PIP+PQ at Month 2.
|
Group 7
n=30 Participants
RTS,S/AS01E + DHA-PIP+PQ Fractional two-dose
RTS,S/AS01E + DHA-PIP+PQ Fractional two-dose: RTS,S/AS01E standard dose + DHA-PIP+PQ at Month 0 + RTS,S/AS01E fractional dose (1/5th dose) + DHA-PIP+PQ at Month 2
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Who Seroconverted One Month After First Dose.
|
20 Participants
|
20 Participants
|
29 Participants
|
30 Participants
|
28 Participants
|
29 Participants
|
30 Participants
|
PRIMARY outcome
Timeframe: 2 monthsThe 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).
Outcome measures
| Measure |
Group 1
n=20 Participants
RTS,S/AS01B Fractional dose
RTS,S/AS01B Fractional dose: RTS,S/AS01B standard dose at Month 0 and Month 1 + RTS,S/AS01B fractional dose (1/5th dose) at Month 2.
|
Group 2
n=20 Participants
Double RTS,S/AS01E Fractional dose
Double RTS,S/AS01E Fractional dose: A double dose of RTS,S/AS01E standard dose at Month 0 and Month 1 + a double dose of RTS,S/AS01E fractional dose (1/5th dose) at Month 2.
|
Group 3
n=30 Participants
RTS,S/AS01E Standard dose
RTS,S/AS01E Standard dose: RTS,S/AS01E standard dose at Month 0, Month 1 and Month 2.
|
Group 4
n=30 Participants
RTS,S/AS01E + DHA-PIP+PQ Standard dose
RTS,S/AS01E + DHA-PIP+PQ Standard dose: RTS,S/AS01E standard dose + DHA-PIP+PQ at Month 0, Month 1 and Month 2
|
Group 5
n=30 Participants
RTS,S/AS01E Fractional dose
RTS,S/AS01E Fractional dose: RTS,S/AS01E standard dose at Month 0 and Month 1 + RTS,S/AS01E fractional dose (1/5th dose) at Month 2.
|
Group 6
n=30 Participants
RTS,S/AS01E + DHA-PIP+PQ Fractional dose
RTS,S/AS01E + DHA-PIP+PQ Fractional dose: RTS,S/AS01E standard dose + DHA-PIP+PQ at Month 0 and Month 1 + RTS,S/AS01E fractional dose (1/5th dose) + DHA-PIP+PQ at Month 2.
|
Group 7
RTS,S/AS01E + DHA-PIP+PQ Fractional two-dose
RTS,S/AS01E + DHA-PIP+PQ Fractional two-dose: RTS,S/AS01E standard dose + DHA-PIP+PQ at Month 0 + RTS,S/AS01E fractional dose (1/5th dose) + DHA-PIP+PQ at Month 2
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Who Seroconverted One Month After the Second Dose.
|
19 Participants
|
20 Participants
|
30 Participants
|
30 Participants
|
30 Participants
|
30 Participants
|
—
|
PRIMARY outcome
Timeframe: 3 monthsThe 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).
Outcome measures
| Measure |
Group 1
n=20 Participants
RTS,S/AS01B Fractional dose
RTS,S/AS01B Fractional dose: RTS,S/AS01B standard dose at Month 0 and Month 1 + RTS,S/AS01B fractional dose (1/5th dose) at Month 2.
|
Group 2
n=20 Participants
Double RTS,S/AS01E Fractional dose
Double RTS,S/AS01E Fractional dose: A double dose of RTS,S/AS01E standard dose at Month 0 and Month 1 + a double dose of RTS,S/AS01E fractional dose (1/5th dose) at Month 2.
|
Group 3
n=30 Participants
RTS,S/AS01E Standard dose
RTS,S/AS01E Standard dose: RTS,S/AS01E standard dose at Month 0, Month 1 and Month 2.
|
Group 4
n=30 Participants
RTS,S/AS01E + DHA-PIP+PQ Standard dose
RTS,S/AS01E + DHA-PIP+PQ Standard dose: RTS,S/AS01E standard dose + DHA-PIP+PQ at Month 0, Month 1 and Month 2
|
Group 5
n=30 Participants
RTS,S/AS01E Fractional dose
RTS,S/AS01E Fractional dose: RTS,S/AS01E standard dose at Month 0 and Month 1 + RTS,S/AS01E fractional dose (1/5th dose) at Month 2.
|
Group 6
n=30 Participants
RTS,S/AS01E + DHA-PIP+PQ Fractional dose
RTS,S/AS01E + DHA-PIP+PQ Fractional dose: RTS,S/AS01E standard dose + DHA-PIP+PQ at Month 0 and Month 1 + RTS,S/AS01E fractional dose (1/5th dose) + DHA-PIP+PQ at Month 2.
|
Group 7
n=30 Participants
RTS,S/AS01E + DHA-PIP+PQ Fractional two-dose
RTS,S/AS01E + DHA-PIP+PQ Fractional two-dose: RTS,S/AS01E standard dose + DHA-PIP+PQ at Month 0 + RTS,S/AS01E fractional dose (1/5th dose) + DHA-PIP+PQ at Month 2
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Who Seroconverted One Month After the Third Dose.
|
20 Participants
|
20 Participants
|
30 Participants
|
30 Participants
|
30 Participants
|
30 Participants
|
30 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: 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
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).
Outcome measures
| Measure |
Group 1
n=19 Participants
RTS,S/AS01B Fractional dose
RTS,S/AS01B Fractional dose: RTS,S/AS01B standard dose at Month 0 and Month 1 + RTS,S/AS01B fractional dose (1/5th dose) at Month 2.
|
Group 2
n=20 Participants
Double RTS,S/AS01E Fractional dose
Double RTS,S/AS01E Fractional dose: A double dose of RTS,S/AS01E standard dose at Month 0 and Month 1 + a double dose of RTS,S/AS01E fractional dose (1/5th dose) at Month 2.
|
Group 3
n=29 Participants
RTS,S/AS01E Standard dose
RTS,S/AS01E Standard dose: RTS,S/AS01E standard dose at Month 0, Month 1 and Month 2.
|
Group 4
n=30 Participants
RTS,S/AS01E + DHA-PIP+PQ Standard dose
RTS,S/AS01E + DHA-PIP+PQ Standard dose: RTS,S/AS01E standard dose + DHA-PIP+PQ at Month 0, Month 1 and Month 2
|
Group 5
n=30 Participants
RTS,S/AS01E Fractional dose
RTS,S/AS01E Fractional dose: RTS,S/AS01E standard dose at Month 0 and Month 1 + RTS,S/AS01E fractional dose (1/5th dose) at Month 2.
|
Group 6
n=30 Participants
RTS,S/AS01E + DHA-PIP+PQ Fractional dose
RTS,S/AS01E + DHA-PIP+PQ Fractional dose: RTS,S/AS01E standard dose + DHA-PIP+PQ at Month 0 and Month 1 + RTS,S/AS01E fractional dose (1/5th dose) + DHA-PIP+PQ at Month 2.
|
Group 7
n=28 Participants
RTS,S/AS01E + DHA-PIP+PQ Fractional two-dose
RTS,S/AS01E + DHA-PIP+PQ Fractional two-dose: RTS,S/AS01E standard dose + DHA-PIP+PQ at Month 0 + RTS,S/AS01E fractional dose (1/5th dose) + DHA-PIP+PQ at Month 2
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Who Seroconverted at Month Six After First Dose.
|
19 Participants
|
20 Participants
|
29 Participants
|
30 Participants
|
30 Participants
|
30 Participants
|
27 Participants
|
PRIMARY outcome
Timeframe: 2 monthsPopulation: There were 30 subjects at group 7 received 1st vaccination and came back for follow-up at month 2 visit
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)
Outcome measures
| Measure |
Group 1
n=30 Participants
RTS,S/AS01B Fractional dose
RTS,S/AS01B Fractional dose: RTS,S/AS01B standard dose at Month 0 and Month 1 + RTS,S/AS01B fractional dose (1/5th dose) at Month 2.
|
Group 2
Double RTS,S/AS01E Fractional dose
Double RTS,S/AS01E Fractional dose: A double dose of RTS,S/AS01E standard dose at Month 0 and Month 1 + a double dose of RTS,S/AS01E fractional dose (1/5th dose) at Month 2.
|
Group 3
RTS,S/AS01E Standard dose
RTS,S/AS01E Standard dose: RTS,S/AS01E standard dose at Month 0, Month 1 and Month 2.
|
Group 4
RTS,S/AS01E + DHA-PIP+PQ Standard dose
RTS,S/AS01E + DHA-PIP+PQ Standard dose: RTS,S/AS01E standard dose + DHA-PIP+PQ at Month 0, Month 1 and Month 2
|
Group 5
RTS,S/AS01E Fractional dose
RTS,S/AS01E Fractional dose: RTS,S/AS01E standard dose at Month 0 and Month 1 + RTS,S/AS01E fractional dose (1/5th dose) at Month 2.
|
Group 6
RTS,S/AS01E + DHA-PIP+PQ Fractional dose
RTS,S/AS01E + DHA-PIP+PQ Fractional dose: RTS,S/AS01E standard dose + DHA-PIP+PQ at Month 0 and Month 1 + RTS,S/AS01E fractional dose (1/5th dose) + DHA-PIP+PQ at Month 2.
|
Group 7
RTS,S/AS01E + DHA-PIP+PQ Fractional two-dose
RTS,S/AS01E + DHA-PIP+PQ Fractional two-dose: RTS,S/AS01E standard dose + DHA-PIP+PQ at Month 0 + RTS,S/AS01E fractional dose (1/5th dose) + DHA-PIP+PQ at Month 2
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Who Received RTS,S/AS01E + DHA-PIP+PQ Fractional Two-dose (Group 7) That Seroconverted at Month Two After First Dose.
|
30 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Group 1
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
Group 2
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Group 3
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Group 4
Serious events: 1 serious events
Other events: 29 other events
Deaths: 0 deaths
Group 5
Serious events: 1 serious events
Other events: 30 other events
Deaths: 0 deaths
Group 6
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Group 7
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1
n=21 participants at risk
RTS,S/AS01B Fractional dose
RTS,S/AS01B Fractional dose: RTS,S/AS01B standard dose at Month 0 and Month 1 + RTS,S/AS01B fractional dose (1/5th dose) at Month 2.
|
Group 2
n=21 participants at risk
Double RTS,S/AS01E Fractional dose
Double RTS,S/AS01E Fractional dose: A double dose of RTS,S/AS01E standard dose at Month 0 and Month 1 + a double dose of RTS,S/AS01E fractional dose (1/5th dose) at Month 2.
|
Group 3
n=30 participants at risk
RTS,S/AS01E Standard dose
RTS,S/AS01E Standard dose: RTS,S/AS01E standard dose at Month 0, Month 1 and Month 2.
|
Group 4
n=30 participants at risk
RTS,S/AS01E + DHA-PIP+PQ Standard dose
RTS,S/AS01E + DHA-PIP+PQ Standard dose: RTS,S/AS01E standard dose + DHA-PIP+PQ at Month 0, Month 1 and Month 2
|
Group 5
n=30 participants at risk
RTS,S/AS01E Fractional dose
RTS,S/AS01E Fractional dose: RTS,S/AS01E standard dose at Month 0 and Month 1 + RTS,S/AS01E fractional dose (1/5th dose) at Month 2.
|
Group 6
n=30 participants at risk
RTS,S/AS01E + DHA-PIP+PQ Fractional dose
RTS,S/AS01E + DHA-PIP+PQ Fractional dose: RTS,S/AS01E standard dose + DHA-PIP+PQ at Month 0 and Month 1 + RTS,S/AS01E fractional dose (1/5th dose) + DHA-PIP+PQ at Month 2.
|
Group 7
n=31 participants at risk
RTS,S/AS01E + DHA-PIP+PQ Fractional two-dose
RTS,S/AS01E + DHA-PIP+PQ Fractional two-dose: RTS,S/AS01E standard dose + DHA-PIP+PQ at Month 0 + RTS,S/AS01E fractional dose (1/5th dose) + DHA-PIP+PQ at Month 2
|
|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
acute pharyngitis
|
0.00%
0/21 • 6 months
clinicaltrials.gov definitions
|
0.00%
0/21 • 6 months
clinicaltrials.gov definitions
|
0.00%
0/30 • 6 months
clinicaltrials.gov definitions
|
3.3%
1/30 • Number of events 1 • 6 months
clinicaltrials.gov definitions
|
0.00%
0/30 • 6 months
clinicaltrials.gov definitions
|
0.00%
0/30 • 6 months
clinicaltrials.gov definitions
|
0.00%
0/31 • 6 months
clinicaltrials.gov definitions
|
|
Psychiatric disorders
Depression
|
4.8%
1/21 • Number of events 1 • 6 months
clinicaltrials.gov definitions
|
0.00%
0/21 • 6 months
clinicaltrials.gov definitions
|
0.00%
0/30 • 6 months
clinicaltrials.gov definitions
|
0.00%
0/30 • 6 months
clinicaltrials.gov definitions
|
0.00%
0/30 • 6 months
clinicaltrials.gov definitions
|
0.00%
0/30 • 6 months
clinicaltrials.gov definitions
|
0.00%
0/31 • 6 months
clinicaltrials.gov definitions
|
|
Respiratory, thoracic and mediastinal disorders
Acute sinusitis
|
0.00%
0/21 • 6 months
clinicaltrials.gov definitions
|
0.00%
0/21 • 6 months
clinicaltrials.gov definitions
|
0.00%
0/30 • 6 months
clinicaltrials.gov definitions
|
0.00%
0/30 • 6 months
clinicaltrials.gov definitions
|
3.3%
1/30 • Number of events 1 • 6 months
clinicaltrials.gov definitions
|
0.00%
0/30 • 6 months
clinicaltrials.gov definitions
|
0.00%
0/31 • 6 months
clinicaltrials.gov definitions
|
Other adverse events
| Measure |
Group 1
n=21 participants at risk
RTS,S/AS01B Fractional dose
RTS,S/AS01B Fractional dose: RTS,S/AS01B standard dose at Month 0 and Month 1 + RTS,S/AS01B fractional dose (1/5th dose) at Month 2.
|
Group 2
n=21 participants at risk
Double RTS,S/AS01E Fractional dose
Double RTS,S/AS01E Fractional dose: A double dose of RTS,S/AS01E standard dose at Month 0 and Month 1 + a double dose of RTS,S/AS01E fractional dose (1/5th dose) at Month 2.
|
Group 3
n=30 participants at risk
RTS,S/AS01E Standard dose
RTS,S/AS01E Standard dose: RTS,S/AS01E standard dose at Month 0, Month 1 and Month 2.
|
Group 4
n=30 participants at risk
RTS,S/AS01E + DHA-PIP+PQ Standard dose
RTS,S/AS01E + DHA-PIP+PQ Standard dose: RTS,S/AS01E standard dose + DHA-PIP+PQ at Month 0, Month 1 and Month 2
|
Group 5
n=30 participants at risk
RTS,S/AS01E Fractional dose
RTS,S/AS01E Fractional dose: RTS,S/AS01E standard dose at Month 0 and Month 1 + RTS,S/AS01E fractional dose (1/5th dose) at Month 2.
|
Group 6
n=30 participants at risk
RTS,S/AS01E + DHA-PIP+PQ Fractional dose
RTS,S/AS01E + DHA-PIP+PQ Fractional dose: RTS,S/AS01E standard dose + DHA-PIP+PQ at Month 0 and Month 1 + RTS,S/AS01E fractional dose (1/5th dose) + DHA-PIP+PQ at Month 2.
|
Group 7
n=31 participants at risk
RTS,S/AS01E + DHA-PIP+PQ Fractional two-dose
RTS,S/AS01E + DHA-PIP+PQ Fractional two-dose: RTS,S/AS01E standard dose + DHA-PIP+PQ at Month 0 + RTS,S/AS01E fractional dose (1/5th dose) + DHA-PIP+PQ at Month 2
|
|---|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Injection site pain
|
95.2%
20/21 • Number of events 46 • 6 months
clinicaltrials.gov definitions
|
95.2%
20/21 • Number of events 42 • 6 months
clinicaltrials.gov definitions
|
100.0%
30/30 • Number of events 79 • 6 months
clinicaltrials.gov definitions
|
83.3%
25/30 • Number of events 60 • 6 months
clinicaltrials.gov definitions
|
96.7%
29/30 • Number of events 65 • 6 months
clinicaltrials.gov definitions
|
90.0%
27/30 • Number of events 57 • 6 months
clinicaltrials.gov definitions
|
90.3%
28/31 • Number of events 48 • 6 months
clinicaltrials.gov definitions
|
|
General disorders
Fatigue
|
85.7%
18/21 • Number of events 41 • 6 months
clinicaltrials.gov definitions
|
76.2%
16/21 • Number of events 23 • 6 months
clinicaltrials.gov definitions
|
80.0%
24/30 • Number of events 53 • 6 months
clinicaltrials.gov definitions
|
70.0%
21/30 • Number of events 44 • 6 months
clinicaltrials.gov definitions
|
63.3%
19/30 • Number of events 34 • 6 months
clinicaltrials.gov definitions
|
83.3%
25/30 • Number of events 56 • 6 months
clinicaltrials.gov definitions
|
61.3%
19/31 • Number of events 31 • 6 months
clinicaltrials.gov definitions
|
|
Nervous system disorders
Headache
|
66.7%
14/21 • Number of events 27 • 6 months
clinicaltrials.gov definitions
|
61.9%
13/21 • Number of events 17 • 6 months
clinicaltrials.gov definitions
|
63.3%
19/30 • Number of events 42 • 6 months
clinicaltrials.gov definitions
|
46.7%
14/30 • Number of events 23 • 6 months
clinicaltrials.gov definitions
|
46.7%
14/30 • Number of events 20 • 6 months
clinicaltrials.gov definitions
|
56.7%
17/30 • Number of events 29 • 6 months
clinicaltrials.gov definitions
|
35.5%
11/31 • Number of events 17 • 6 months
clinicaltrials.gov definitions
|
|
General disorders
Pyrexia
|
61.9%
13/21 • Number of events 18 • 6 months
clinicaltrials.gov definitions
|
61.9%
13/21 • Number of events 19 • 6 months
clinicaltrials.gov definitions
|
53.3%
16/30 • Number of events 22 • 6 months
clinicaltrials.gov definitions
|
46.7%
14/30 • Number of events 21 • 6 months
clinicaltrials.gov definitions
|
40.0%
12/30 • Number of events 18 • 6 months
clinicaltrials.gov definitions
|
53.3%
16/30 • Number of events 22 • 6 months
clinicaltrials.gov definitions
|
25.8%
8/31 • Number of events 9 • 6 months
clinicaltrials.gov definitions
|
|
General disorders
Malaise
|
42.9%
9/21 • Number of events 15 • 6 months
clinicaltrials.gov definitions
|
23.8%
5/21 • Number of events 7 • 6 months
clinicaltrials.gov definitions
|
26.7%
8/30 • Number of events 12 • 6 months
clinicaltrials.gov definitions
|
36.7%
11/30 • Number of events 15 • 6 months
clinicaltrials.gov definitions
|
16.7%
5/30 • Number of events 5 • 6 months
clinicaltrials.gov definitions
|
46.7%
14/30 • Number of events 15 • 6 months
clinicaltrials.gov definitions
|
25.8%
8/31 • Number of events 9 • 6 months
clinicaltrials.gov definitions
|
|
Injury, poisoning and procedural complications
Injection site reaction (pain)
|
38.1%
8/21 • Number of events 14 • 6 months
clinicaltrials.gov definitions
|
28.6%
6/21 • Number of events 10 • 6 months
clinicaltrials.gov definitions
|
30.0%
9/30 • Number of events 18 • 6 months
clinicaltrials.gov definitions
|
20.0%
6/30 • Number of events 10 • 6 months
clinicaltrials.gov definitions
|
26.7%
8/30 • Number of events 16 • 6 months
clinicaltrials.gov definitions
|
10.0%
3/30 • Number of events 3 • 6 months
clinicaltrials.gov definitions
|
9.7%
3/31 • Number of events 3 • 6 months
clinicaltrials.gov definitions
|
|
Gastrointestinal disorders
Nausea
|
19.0%
4/21 • Number of events 5 • 6 months
clinicaltrials.gov definitions
|
9.5%
2/21 • Number of events 4 • 6 months
clinicaltrials.gov definitions
|
10.0%
3/30 • Number of events 6 • 6 months
clinicaltrials.gov definitions
|
40.0%
12/30 • Number of events 22 • 6 months
clinicaltrials.gov definitions
|
10.0%
3/30 • Number of events 5 • 6 months
clinicaltrials.gov definitions
|
20.0%
6/30 • Number of events 8 • 6 months
clinicaltrials.gov definitions
|
12.9%
4/31 • Number of events 7 • 6 months
clinicaltrials.gov definitions
|
|
Injury, poisoning and procedural complications
Injection site reaction (redness)
|
9.5%
2/21 • Number of events 3 • 6 months
clinicaltrials.gov definitions
|
47.6%
10/21 • Number of events 14 • 6 months
clinicaltrials.gov definitions
|
23.3%
7/30 • Number of events 14 • 6 months
clinicaltrials.gov definitions
|
10.0%
3/30 • Number of events 7 • 6 months
clinicaltrials.gov definitions
|
20.0%
6/30 • Number of events 10 • 6 months
clinicaltrials.gov definitions
|
16.7%
5/30 • Number of events 5 • 6 months
clinicaltrials.gov definitions
|
3.2%
1/31 • Number of events 1 • 6 months
clinicaltrials.gov definitions
|
|
Nervous system disorders
Dizziness
|
4.8%
1/21 • Number of events 1 • 6 months
clinicaltrials.gov definitions
|
9.5%
2/21 • Number of events 3 • 6 months
clinicaltrials.gov definitions
|
6.7%
2/30 • Number of events 4 • 6 months
clinicaltrials.gov definitions
|
13.3%
4/30 • Number of events 6 • 6 months
clinicaltrials.gov definitions
|
13.3%
4/30 • Number of events 5 • 6 months
clinicaltrials.gov definitions
|
26.7%
8/30 • Number of events 15 • 6 months
clinicaltrials.gov definitions
|
9.7%
3/31 • Number of events 4 • 6 months
clinicaltrials.gov definitions
|
|
General disorders
Haemoglobin low
|
9.5%
2/21 • Number of events 2 • 6 months
clinicaltrials.gov definitions
|
4.8%
1/21 • Number of events 1 • 6 months
clinicaltrials.gov definitions
|
23.3%
7/30 • Number of events 7 • 6 months
clinicaltrials.gov definitions
|
20.0%
6/30 • Number of events 6 • 6 months
clinicaltrials.gov definitions
|
10.0%
3/30 • Number of events 3 • 6 months
clinicaltrials.gov definitions
|
13.3%
4/30 • Number of events 4 • 6 months
clinicaltrials.gov definitions
|
19.4%
6/31 • Number of events 6 • 6 months
clinicaltrials.gov definitions
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
23.8%
5/21 • Number of events 9 • 6 months
clinicaltrials.gov definitions
|
9.5%
2/21 • Number of events 3 • 6 months
clinicaltrials.gov definitions
|
10.0%
3/30 • Number of events 3 • 6 months
clinicaltrials.gov definitions
|
10.0%
3/30 • Number of events 3 • 6 months
clinicaltrials.gov definitions
|
6.7%
2/30 • Number of events 2 • 6 months
clinicaltrials.gov definitions
|
10.0%
3/30 • Number of events 3 • 6 months
clinicaltrials.gov definitions
|
3.2%
1/31 • Number of events 1 • 6 months
clinicaltrials.gov definitions
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/21 • 6 months
clinicaltrials.gov definitions
|
4.8%
1/21 • Number of events 1 • 6 months
clinicaltrials.gov definitions
|
6.7%
2/30 • Number of events 2 • 6 months
clinicaltrials.gov definitions
|
26.7%
8/30 • Number of events 8 • 6 months
clinicaltrials.gov definitions
|
6.7%
2/30 • Number of events 2 • 6 months
clinicaltrials.gov definitions
|
16.7%
5/30 • Number of events 5 • 6 months
clinicaltrials.gov definitions
|
9.7%
3/31 • Number of events 4 • 6 months
clinicaltrials.gov definitions
|
|
Investigations
Loose stools
|
0.00%
0/21 • 6 months
clinicaltrials.gov definitions
|
0.00%
0/21 • 6 months
clinicaltrials.gov definitions
|
13.3%
4/30 • Number of events 4 • 6 months
clinicaltrials.gov definitions
|
20.0%
6/30 • Number of events 6 • 6 months
clinicaltrials.gov definitions
|
0.00%
0/30 • 6 months
clinicaltrials.gov definitions
|
3.3%
1/30 • Number of events 1 • 6 months
clinicaltrials.gov definitions
|
22.6%
7/31 • Number of events 7 • 6 months
clinicaltrials.gov definitions
|
|
Musculoskeletal and connective tissue disorders
chills
|
14.3%
3/21 • Number of events 4 • 6 months
clinicaltrials.gov definitions
|
9.5%
2/21 • Number of events 2 • 6 months
clinicaltrials.gov definitions
|
13.3%
4/30 • Number of events 4 • 6 months
clinicaltrials.gov definitions
|
16.7%
5/30 • Number of events 5 • 6 months
clinicaltrials.gov definitions
|
3.3%
1/30 • Number of events 1 • 6 months
clinicaltrials.gov definitions
|
3.3%
1/30 • Number of events 2 • 6 months
clinicaltrials.gov definitions
|
0.00%
0/31 • 6 months
clinicaltrials.gov definitions
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place