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Efficacy, Immunogenicity and Safety Study of GSK Biologicals' Candidate Malaria Vaccine Evaluating Different Dose Schedules in a Sporozoite Challenge Model in Healthy Malaria-naïve Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03162614
Recruitment Status : Completed
First Posted : May 22, 2017
Results First Posted : July 24, 2019
Last Update Posted : November 14, 2019
Sponsor:
Collaborator:
The PATH Malaria Vaccine Initiative (MVI)
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Malaria
Interventions Biological: RTS,S/AS01E
Biological: RTS,S/AS01B
Procedure: Sporozoite-infected mosquitoes challenge.
Enrollment 154
Recruitment Details  
Pre-assignment Details  
Arm/Group Title AduFx Group 2PedFx Group PedFx Group Adu2Fx Group Adu1Fx Group Control Group
Hide Arm/Group Description Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and Month 1 and 1/5th of RTS,S/AS01B full dose at Month 7, and underwent sporozoite challenge. Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E double dose at Month 0 and Month 1, and 1/5th of double dose RTS,S/AS01E at Month 7, and underwent sporozoite challenge. Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E full dose at Month 0 and Month 1, and 1/5th of RTS,S/AS01E full dose at Month 7, and underwent sporozoite challenge. Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose at Month 1 and Month 7, and underwent sporozoite challenge. Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose administered at Month 7, and underwent sporozoite challenge. Healthy subjects, between, and including, 18 and 55 years of age, who did not receive any immunization but underwent sporozoite challenge
Period Title: Overall Study
Started 26 26 26 26 26 24
Completed 20 21 22 19 21 24
Not Completed 6 5 4 7 5 0
Reason Not Completed
Lost to Follow-up             2             1             1             1             2             0
Protocol Violation             0             1             0             1             0             0
Withdrawal by Subject             2             1             1             1             0             0
Missed vaccination, exclusion criteria             2             2             2             4             3             0
Arm/Group Title AduFx Group 2PedFx Group PedFx Group Adu2Fx Group Adu1Fx Group Control Group Total
Hide Arm/Group Description Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and Month 1 and 1/5th of RTS,S/AS01B full dose at Month 7, and underwent sporozoite challenge. Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E double dose at Month 0 and Month 1, and 1/5th of double dose RTS,S/AS01E at Month 7, and underwent sporozoite challenge. Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E full dose at Month 0 and Month 1, and 1/5th of RTS,S/AS01E full dose at Month 7, and underwent sporozoite challenge. Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose at Month 1 and Month 7, and underwent sporozoite challenge. Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose administered at Month 7, and underwent sporozoite challenge. Healthy subjects, between, and including, 18 and 55 years of age, who did not receive any immunization but underwent sporozoite challenge Total of all reporting groups
Overall Number of Baseline Participants 26 26 26 26 26 24 154
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants 26 participants 26 participants 26 participants 26 participants 24 participants 154 participants
31.7  (8.4) 30.8  (9.6) 32.0  (10.4) 32.4  (10.9) 32.2  (10.3) 34.6  (11.9) 32.3  (10.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 26 participants 26 participants 26 participants 26 participants 24 participants 154 participants
Female
11
  42.3%
10
  38.5%
12
  46.2%
4
  15.4%
10
  38.5%
10
  41.7%
57
  37.0%
Male
15
  57.7%
16
  61.5%
14
  53.8%
22
  84.6%
16
  61.5%
14
  58.3%
97
  63.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 26 participants 26 participants 26 participants 26 participants 24 participants 154 participants
Asian
1
   3.8%
3
  11.5%
2
   7.7%
2
   7.7%
1
   3.8%
0
   0.0%
9
   5.8%
Black Or African American
8
  30.8%
6
  23.1%
10
  38.5%
9
  34.6%
7
  26.9%
8
  33.3%
48
  31.2%
Native Hawaiian Or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   4.2%
1
   0.6%
Other, Not Specified
0
   0.0%
1
   3.8%
2
   7.7%
2
   7.7%
4
  15.4%
1
   4.2%
10
   6.5%
White
17
  65.4%
16
  61.5%
12
  46.2%
13
  50.0%
14
  53.8%
14
  58.3%
86
  55.8%
1.Primary Outcome
Title Number of Subjects With at Least One Occurrence of Plasmodium Falciparum (P. Falciparum) Parasitemia for Each Vaccination Schedule Versus Infectivity Controls
Hide Description Occurrence of P. falciparum parasitemia (defined by a positive blood slide) following sporozoite challenge. Post-challenge, parasitemia was determined by microscopy of Giemsa-stained thick blood films (smear). Microscopy was performed on thick smears using a validated standard operation procedure. For the analysis of proportion affected (relative risk), all subjects included in the analysis were considered at risk of infection and no censoring or elimination was applied for subjects not completing the entire protocol defined post challenge follow-up (Day 315 - 28 days post challenge).
Time Frame Following sporozoite challenge starting 3 months after the last vaccine dose (Day 287) for up to 28 days post-challenge (Day 315).
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Per-Protocol Set, which included all subjects fulfilling eligibility criteria who received vaccinations according to protocol procedures, did not report any underlying medical condition influencing the efficacy response, had available data concerning immunogenicity outcome measures, and underwent P. falciparum challenge.
Arm/Group Title AduFx Group 2PedFx Group PedFx Group Adu2Fx Group Adu1Fx Group Control Group
Hide Arm/Group Description:
Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and Month 1 and 1/5th of RTS,S/AS01B full dose at Month 7, and underwent sporozoite challenge.
Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E double dose at Month 0 and Month 1, and 1/5th of double dose RTS,S/AS01E at Month 7, and underwent sporozoite challenge.
Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E full dose at Month 0 and Month 1, and 1/5th of RTS,S/AS01E full dose at Month 7, and underwent sporozoite challenge.
Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose at Month 1 and Month 7, and underwent sporozoite challenge.
Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose administered at Month 7, and underwent sporozoite challenge.
Healthy subjects, between, and including, 18 and 55 years of age, who did not receive any immunization but underwent sporozoite challenge
Overall Number of Participants Analyzed 20 21 22 20 21 22
Measure Type: Count of Participants
Unit of Measure: Participants
9
  45.0%
5
  23.8%
8
  36.4%
9
  45.0%
15
  71.4%
22
 100.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AduFx Group, Control Group
Comments Efficacy analysis aimed at comparing RTS,S/AS01B administered as full doses at Month 0 and Month 1 and 1/5th dose at Month 7 (AduFx Group versus Control Group).
Type of Statistical Test Other
Comments Vaccine efficacy rate was calculated as 100*(1-RR) with RR=relative risk of developing the disease for vaccinated people compared to unvaccinated people.
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine efficacy rate
Estimated Value 55
Confidence Interval (2-Sided) 95%
27 to 72
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 2PedFx Group, Control Group
Comments Efficacy analysis aimed at comparing RTS,S/AS01E administered as double full doses at Month 0 and Month 1 and 1/5th double dose at Month 7 (2Ped Fx Group versus Control Group).
Type of Statistical Test Other
Comments Vaccine efficacy rate was calculated as 100*(1-RR) with RR=relative risk of developing the disease for vaccinated people compared to unvaccinated people.
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine efficacy rate
Estimated Value 76
Confidence Interval (2-Sided) 95%
49 to 89
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PedFx Group, Control Group
Comments Efficacy analysis aimed at comparing RTS,S/AS01E administered as full doses at Month 0 and Month 1 and 1/5th dose at Month 7 (PedFx Group versus Control Group).
Type of Statistical Test Other
Comments Vaccine efficacy rate was calculated as 100*(1-RR) with RR=relative risk of developing the disease for vaccinated people compared to unvaccinated people.
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine efficacy rate
Estimated Value 64
Confidence Interval (2-Sided) 95%
37 to 79
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Adu2Fx Group, Control Group
Comments Efficacy analysis aimed at comparing RTS,S/AS01B administered as full dose at Month 0 and 1/5th dose at Month 1 and Month 7 (Adu2Fx Group versus Control Group).
Type of Statistical Test Other
Comments Vaccine efficacy rate was calculated as 100*(1-RR) with RR=relative risk of developing the disease for vaccinated people compared to unvaccinated people.
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine efficacy rate
Estimated Value 55
Confidence Interval (2-Sided) 95%
27 to 72
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Adu1Fx Group, Control Group
Comments Efficacy analysis aimed at comparing RTS,S/AS01B administered as full dose at Month 0 and 1/5th dose at Month 7 (Adu1Fx Group versus Control Group).
Type of Statistical Test Other
Comments Vaccine efficacy rate was calculated as 100*(1-RR) with RR=relative risk of developing the disease for vaccinated people compared to unvaccinated people.
Statistical Test of Hypothesis P-Value 0.009
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine efficacy rate
Estimated Value 29
Confidence Interval (2-Sided) 95%
6 to 46
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Time to Onset of P. Falciparum Parasitemia After Sporozoite Challenge for Each Vaccination Schedule
Hide Description For the analyses of time to onset of parasitemia, time at risk started on first day of challenge. Time at risk was censored on Day 315 (28 days post challenge), drop-out date, start date of antimalarial treatment or date meeting an endpoint, whichever occurs first.
Time Frame Following sporozoite challenge starting 3 months after the last vaccine dose (at Day 287) for up to 28 days post-challenge (at Day 315).
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Per-Protocol Set, which included all subjects fulfilling eligibility criteria who received vaccinations according to protocol procedures, did not report any underlying medical condition influencing the efficacy response, had available data concerning immunogenicity outcome measures, and underwent P. falciparum challenge.
Arm/Group Title AduFx Group 2PedFx Group PedFx Group Adu2Fx Group Adu1Fx Group Control Group
Hide Arm/Group Description:
Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and Month 1 and 1/5th of RTS,S/AS01B full dose at Month 7, and underwent sporozoite challenge.
Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E double dose at Month 0 and Month 1, and 1/5th of double dose RTS,S/AS01E at Month 7, and underwent sporozoite challenge.
Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E full dose at Month 0 and Month 1, and 1/5th of RTS,S/AS01E full dose at Month 7, and underwent sporozoite challenge.
Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose at Month 1 and Month 7, and underwent sporozoite challenge.
Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose administered at Month 7, and underwent sporozoite challenge.
Healthy subjects, between, and including, 18 and 55 years of age, who did not receive any immunization but underwent sporozoite challenge
Overall Number of Participants Analyzed 9 5 8 9 15 22
Mean (Standard Deviation)
Unit of Measure: Days
14.8  (1.2) 14.6  (1.1) 14.3  (2.0) 14.9  (2.1) 14.2  (2.4) 12.7  (1.9)
3.Secondary Outcome
Title Anti-Circumsporozoite (Anti-CS) Repeat Region Antibody Concentrations
Hide Description Anti-CS antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in Enzyme-linked immunosorbent assay Unit per milliliter (EU/mL). The cut-off for the assay was 1.9 EU/mL. The GMC calculations were performed by taking the anti-log of the mean of the log transformations (base 10). Antibody concentrations below the cut-off of the assay were given an arbitrary value of half the cut-off (=1.0) for the purpose of GMC calculation.
Time Frame At Day 1, Day 59, Day 197, Day 227, Day 287, Day 315, and Day 377 for subjects from AduFx, 2PedFx, PedFx, and Adu2Fx Groups. At Day 1, Day 197, Day 227, Day 287, Day 315, and Day 377 for subjects from Adu1Fx Group
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on subjects fulfilling eligibility criteria, who received study vaccination according to protocol procedures (therefore, not on subjects from the Control Group), did not report any medical condition influencing the efficacy response, had data concerning immunogenicity outcome measures, and underwent P. falciparum challenge.
Arm/Group Title AduFx Group 2PedFx Group PedFx Group Adu2Fx Group Adu1Fx Group
Hide Arm/Group Description:
Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and Month 1 and 1/5th of RTS,S/AS01B full dose at Month 7, and underwent sporozoite challenge.
Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E double dose at Month 0 and Month 1, and 1/5th of double dose RTS,S/AS01E at Month 7, and underwent sporozoite challenge.
Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E full dose at Month 0 and Month 1, and 1/5th of RTS,S/AS01E full dose at Month 7, and underwent sporozoite challenge.
Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose at Month 1 and Month 7, and underwent sporozoite challenge.
Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose administered at Month 7, and underwent sporozoite challenge.
Overall Number of Participants Analyzed 20 21 22 20 21
Geometric Mean (95% Confidence Interval)
Unit of Measure: EU/mL
At Day 1 Number Analyzed 20 participants 21 participants 22 participants 20 participants 21 participants
1
(1.0 to 1.0)
1
(1.0 to 1.0)
1
(1.0 to 1.0)
1
(1.0 to 1.0)
1
(1.0 to 1.0)
At Day 59 Number Analyzed 20 participants 21 participants 22 participants 20 participants 0 participants
108.2
(70.1 to 167.0)
107.8
(73.0 to 159.1)
53.8
(39.0 to 74.1)
61.7
(47.6 to 79.9)
At Day 197 Number Analyzed 20 participants 21 participants 22 participants 20 participants 21 participants
30
(17.9 to 50.5)
39.3
(23.8 to 64.8)
15.1
(9.3 to 24.5)
19.4
(13.2 to 28.5)
3.8
(2.0 to 7.2)
At Day 227 Number Analyzed 20 participants 21 participants 22 participants 20 participants 21 participants
85.9
(50.8 to 145.5)
79.8
(54.7 to 116.6)
50.2
(35.5 to 70.9)
64
(42.8 to 95.8)
22.1
(12.0 to 40.8)
At Day 287 Number Analyzed 20 participants 21 participants 22 participants 20 participants 21 participants
61.4
(34.7 to 108.8)
57.6
(38.2 to 87.1)
34.4
(23.1 to 51.1)
38.1
(20.8 to 69.9)
12.3
(6.2 to 24.4)
At Day 315 Number Analyzed 20 participants 21 participants 22 participants 20 participants 21 participants
56.6
(32.5 to 98.4)
51
(33.3 to 78.0)
31.3
(21.2 to 46.3)
44.1
(27.8 to 70.1)
10.6
(5.2 to 21.5)
At Day 377 Number Analyzed 20 participants 20 participants 22 participants 19 participants 20 participants
43.7
(24.9 to 76.8)
38.1
(24.3 to 59.8)
25
(16.5 to 37.9)
31.7
(19.6 to 51.3)
9.5
(4.8 to 19.0)
4.Secondary Outcome
Title Anti-Hepatitis B (Anti-HBs) Immunoglobulin G (IgG) Antibody Concentrations
Hide Description Anti-HBs IgG antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in milli-International Unit per milliliter (mIU/ml). The cut-off for the assay was 6.2 mIU/mL.
Time Frame At Day 1, Day 59, Day 197, Day 227, Day 287, Day 315, and Day 377 for subjects from AduFx, 2PedFx, PedFx, and Adu2Fx Groups. At Day 1, Day 197, Day 227, Day 287, Day 315, and Day 377 for subjects from Adu1Fx Group
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on subjects fulfilling eligibility criteria, who received study vaccination according to protocol procedures (therefore, not on subjects from the Control Group), did not report any medical condition influencing the efficacy response, had data concerning immunogenicity outcome measures, and underwent P. falciparum challenge.
Arm/Group Title AduFx Group 2PedFx Group PedFx Group Adu2Fx Group Adu1Fx Group
Hide Arm/Group Description:
Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and Month 1 and 1/5th of RTS,S/AS01B full dose at Month 7, and underwent sporozoite challenge.
Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E double dose at Month 0 and Month 1, and 1/5th of double dose RTS,S/AS01E at Month 7, and underwent sporozoite challenge.
Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E full dose at Month 0 and Month 1, and 1/5th of RTS,S/AS01E full dose at Month 7, and underwent sporozoite challenge.
Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose at Month 1 and Month 7, and underwent sporozoite challenge.
Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose administered at Month 7, and underwent sporozoite challenge.
Overall Number of Participants Analyzed 20 21 22 20 21
Geometric Mean (95% Confidence Interval)
Unit of Measure: mIU/mL
At Day 1 Number Analyzed 20 participants 21 participants 21 participants 20 participants 21 participants
44.1
(15.6 to 124.3)
68.8
(20.4 to 231.7)
45.7
(15.2 to 137.5)
21.8
(9.0 to 52.6)
16
(6.5 to 39.6)
At Day 59 Number Analyzed 20 participants 21 participants 20 participants 20 participants 0 participants
42616.7
(12325.1 to 147356.7)
28894.8
(8705.8 to 95903.3)
26149.3
(8588.7 to 79615.2)
14710.6
(3837.0 to 56398.8)
At Day 197 Number Analyzed 20 participants 21 participants 21 participants 20 participants 21 participants
19369.3
(8325.5 to 45062.6)
15358.8
(5971.2 to 39505.1)
11269.1
(4892.1 to 25958.8)
6846.7
(2273.5 to 20618.8)
2031.7
(715.9 to 5766.4)
At Day 227 Number Analyzed 20 participants 21 participants 22 participants 20 participants 21 participants
45959.9
(27093.8 to 77962.8)
30994.5
(15352.8 to 62572.4)
28560.6
(15532.4 to 52516.4)
26717
(12916.3 to 55263.3)
35620.9
(22337.4 to 56803.7)
At Day 287 Number Analyzed 20 participants 21 participants 22 participants 19 participants 21 participants
36266.3
(21828.7 to 60252.9)
20712.2
(10050.4 to 42684.5)
19126.1
(9889.0 to 36991.5)
13911.3
(4939.4 to 39179.9)
16376.8
(9798.1 to 27372.8)
At Day 315 Number Analyzed 20 participants 21 participants 22 participants 19 participants 21 participants
33027.7
(19159.7 to 56933.4)
18527.8
(8862.8 to 38732.5)
17465.5
(8798.2 to 34671.2)
16685
(8192.0 to 33982.9)
12609.9
(7499.3 to 21203.5)
At Day 377 Number Analyzed 20 participants 20 participants 21 participants 19 participants 20 participants
27823
(15910.1 to 48655.8)
15083.7
(6953.8 to 32718.4)
13716
(6456.7 to 29136.9)
11257.6
(5164.7 to 24538.5)
10975.2
(5889.9 to 20451.3)
5.Secondary Outcome
Title Number of Subjects With Any Solicited Local Symptoms
Hide Description Solicited local symptoms assessed are pain, redness and swelling. Any occurrence of symptom regardless of intensity grade. Any Redness or any Swelling symptom = any symptom greater than (>) 0 millimeter (mm).
Time Frame Within the 7-day period (Days 1-7) after dose 1, dose 2 (except for Adu1Fx Group) and dose 3.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on Intent-To-Treat Set, which included all subjects who received at least one dose of study vaccine
Arm/Group Title AduFx Group 2PedFx Group PedFx Group Adu2Fx Group Adu1Fx Group
Hide Arm/Group Description:
Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and Month 1 and 1/5th of RTS,S/AS01B full dose at Month 7, and underwent sporozoite challenge.
Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E double dose at Month 0 and Month 1, and 1/5th of double dose RTS,S/AS01E at Month 7, and underwent sporozoite challenge.
Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E full dose at Month 0 and Month 1, and 1/5th of RTS,S/AS01E full dose at Month 7, and underwent sporozoite challenge.
Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose at Month 1 and Month 7, and underwent sporozoite challenge.
Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose administered at Month 7, and underwent sporozoite challenge.
Overall Number of Participants Analyzed 26 26 26 26 25
Measure Type: Count of Participants
Unit of Measure: Participants
Pain, dose 1 Number Analyzed 26 participants 26 participants 26 participants 26 participants 25 participants
23
  88.5%
21
  80.8%
22
  84.6%
22
  84.6%
19
  76.0%
Redness, dose 1 Number Analyzed 26 participants 26 participants 26 participants 26 participants 25 participants
8
  30.8%
11
  42.3%
4
  15.4%
8
  30.8%
9
  36.0%
Swelling, dose 1 Number Analyzed 26 participants 26 participants 26 participants 26 participants 25 participants
5
  19.2%
12
  46.2%
3
  11.5%
4
  15.4%
5
  20.0%
Pain, dose 2 Number Analyzed 26 participants 25 participants 26 participants 26 participants 0 participants
20
  76.9%
16
  64.0%
20
  76.9%
12
  46.2%
Redness, dose 2 Number Analyzed 26 participants 25 participants 26 participants 26 participants 0 participants
8
  30.8%
10
  40.0%
5
  19.2%
4
  15.4%
Swelling, dose 2 Number Analyzed 26 participants 25 participants 26 participants 26 participants 0 participants
5
  19.2%
8
  32.0%
6
  23.1%
3
  11.5%
Pain, dose 3 Number Analyzed 23 participants 24 participants 24 participants 25 participants 23 participants
11
  47.8%
12
  50.0%
13
  54.2%
16
  64.0%
15
  65.2%
Redness, dose 3 Number Analyzed 23 participants 24 participants 24 participants 25 participants 23 participants
7
  30.4%
10
  41.7%
10
  41.7%
11
  44.0%
6
  26.1%
Swelling, dose 3 Number Analyzed 23 participants 24 participants 24 participants 25 participants 23 participants
3
  13.0%
6
  25.0%
5
  20.8%
3
  12.0%
3
  13.0%
6.Secondary Outcome
Title Number of Subjects With Any Solicited General Symptoms
Hide Description Solicited general symptoms assessed are fatigue, gastrointestinal symptoms, headache and fever. Any occurrence of symptom regardless of intensity grade. Fever was defined as temperature equal or greater than (≥) 37.5 degrees Celsius (°C) for oral route, axillary or tympanic route or 38.0°C for rectal route.
Time Frame Within the 7-day period (Days 1-7) after dose 1, dose 2 (except for Adu1Fx Group) and dose 3.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on Intent-To-Treat Set, which included all subjects who received at least one dose of study vaccine
Arm/Group Title AduFx Group 2PedFx Group PedFx Group Adu2Fx Group Adu1Fx Group
Hide Arm/Group Description:
Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and Month 1 and 1/5th of RTS,S/AS01B full dose at Month 7, and underwent sporozoite challenge.
Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E double dose at Month 0 and Month 1, and 1/5th of double dose RTS,S/AS01E at Month 7, and underwent sporozoite challenge.
Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E full dose at Month 0 and Month 1, and 1/5th of RTS,S/AS01E full dose at Month 7, and underwent sporozoite challenge.
Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose at Month 1 and Month 7, and underwent sporozoite challenge.
Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose administered at Month 7, and underwent sporozoite challenge.
Overall Number of Participants Analyzed 26 26 26 26 25
Measure Type: Count of Participants
Unit of Measure: Participants
Fatigue, dose 1 Number Analyzed 26 participants 26 participants 26 participants 26 participants 25 participants
13
  50.0%
14
  53.8%
13
  50.0%
10
  38.5%
11
  44.0%
Gastrointestinal symptoms, dose 1 Number Analyzed 26 participants 26 participants 26 participants 26 participants 25 participants
5
  19.2%
8
  30.8%
5
  19.2%
4
  15.4%
6
  24.0%
Headache, dose 1 Number Analyzed 26 participants 26 participants 26 participants 26 participants 25 participants
15
  57.7%
14
  53.8%
10
  38.5%
12
  46.2%
9
  36.0%
Fever, dose 1 Number Analyzed 26 participants 26 participants 26 participants 26 participants 25 participants
3
  11.5%
6
  23.1%
2
   7.7%
3
  11.5%
3
  12.0%
Fatigue, dose 2 Number Analyzed 26 participants 25 participants 26 participants 26 participants 0 participants
11
  42.3%
12
  48.0%
10
  38.5%
6
  23.1%
Gastrointestinal symptoms, dose 2 Number Analyzed 26 participants 25 participants 26 participants 26 participants 0 participants
3
  11.5%
6
  24.0%
7
  26.9%
3
  11.5%
Headache, dose 2 Number Analyzed 26 participants 25 participants 26 participants 26 participants 0 participants
13
  50.0%
14
  56.0%
11
  42.3%
6
  23.1%
Fever, dose 2 Number Analyzed 26 participants 25 participants 26 participants 26 participants 0 participants
6
  23.1%
6
  24.0%
3
  11.5%
1
   3.8%
Fatigue, dose 3 Number Analyzed 23 participants 24 participants 24 participants 25 participants 23 participants
4
  17.4%
6
  25.0%
8
  33.3%
11
  44.0%
8
  34.8%
Gastrointestinal symptoms, dose 3 Number Analyzed 23 participants 24 participants 24 participants 25 participants 23 participants
4
  17.4%
2
   8.3%
6
  25.0%
0
   0.0%
5
  21.7%
Headache, dose 3 Number Analyzed 23 participants 24 participants 24 participants 25 participants 23 participants
6
  26.1%
7
  29.2%
6
  25.0%
9
  36.0%
9
  39.1%
Fever, dose 3 Number Analyzed 23 participants 24 participants 24 participants 25 participants 23 participants
0
   0.0%
2
   8.3%
0
   0.0%
2
   8.0%
0
   0.0%
7.Secondary Outcome
Title Number of Subjects With Any Unsolicited Adverse Events (AEs) After Any Vaccination
Hide Description An unsolicited adverse event is any untoward medical occurrence in a clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. An unsolicited adverse event is any event reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Time Frame Within the 30-day period (Days 1-30), after any vaccination (across doses)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on Intent-To-Treat Set, which included all subjects who received at least one dose of study vaccine
Arm/Group Title AduFx Group 2PedFx Group PedFx Group Adu2Fx Group Adu1Fx Group
Hide Arm/Group Description:
Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and Month 1 and 1/5th of RTS,S/AS01B full dose at Month 7, and underwent sporozoite challenge.
Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E double dose at Month 0 and Month 1, and 1/5th of double dose RTS,S/AS01E at Month 7, and underwent sporozoite challenge.
Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E full dose at Month 0 and Month 1, and 1/5th of RTS,S/AS01E full dose at Month 7, and underwent sporozoite challenge.
Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose at Month 1 and Month 7, and underwent sporozoite challenge.
Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose administered at Month 7, and underwent sporozoite challenge.
Overall Number of Participants Analyzed 26 26 26 26 26
Measure Type: Count of Participants
Unit of Measure: Participants
18
  69.2%
18
  69.2%
15
  57.7%
17
  65.4%
10
  38.5%
8.Secondary Outcome
Title Number of Subjects With Any Unsolicited AEs After Challenge
Hide Description An adverse event is any untoward medical occurrence in a clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product.
Time Frame Within the 30-day (Days 1-30) period post-challenge
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on Intent-To-Treat Set, which included all subjects who received at least one dose of study vaccine
Arm/Group Title AduFx Group 2PedFx Group PedFx Group Adu2Fx Group Adu1Fx Group Control Group
Hide Arm/Group Description:
Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and Month 1 and 1/5th of RTS,S/AS01B full dose at Month 7, and underwent sporozoite challenge.
Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E double dose at Month 0 and Month 1, and 1/5th of double dose RTS,S/AS01E at Month 7, and underwent sporozoite challenge.
Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E full dose at Month 0 and Month 1, and 1/5th of RTS,S/AS01E full dose at Month 7, and underwent sporozoite challenge.
Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose at Month 1 and Month 7, and underwent sporozoite challenge.
Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose administered at Month 7, and underwent sporozoite challenge.
Healthy subjects, between, and including, 18 and 55 years of age, who did not receive any immunization but underwent sporozoite challenge
Overall Number of Participants Analyzed 26 26 26 26 26 24
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
9.Secondary Outcome
Title Number of Subjects With Any, Fatal or Related Serious Adverse Events (SAEs) After Each Vaccination
Hide Description SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time Frame Within the 30-day period (Days 1-30) after any vaccination (across doses)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on Intent-To-Treat Set, which included all subjects who received at least one dose of study vaccine
Arm/Group Title AduFx Group 2PedFx Group PedFx Group Adu2Fx Group Adu1Fx Group
Hide Arm/Group Description:
Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and Month 1 and 1/5th of RTS,S/AS01B full dose at Month 7, and underwent sporozoite challenge.
Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E double dose at Month 0 and Month 1, and 1/5th of double dose RTS,S/AS01E at Month 7, and underwent sporozoite challenge.
Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E full dose at Month 0 and Month 1, and 1/5th of RTS,S/AS01E full dose at Month 7, and underwent sporozoite challenge.
Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose at Month 1 and Month 7, and underwent sporozoite challenge.
Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose administered at Month 7, and underwent sporozoite challenge.
Overall Number of Participants Analyzed 26 26 26 26 26
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
10.Secondary Outcome
Title Number of Subjects With Any, Fatal or Related SAEs During the Whole Study Period
Hide Description SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time Frame From Day 1 up to study conclusion (Day 377)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on Intent-To-Treat Set, which included all subjects who received at least one dose of study vaccine
Arm/Group Title AduFx Group 2PedFx Group PedFx Group Adu2Fx Group Adu1Fx Group Control Group
Hide Arm/Group Description:
Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and Month 1 and 1/5th of RTS,S/AS01B full dose at Month 7, and underwent sporozoite challenge.
Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E double dose at Month 0 and Month 1, and 1/5th of double dose RTS,S/AS01E at Month 7, and underwent sporozoite challenge.
Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E full dose at Month 0 and Month 1, and 1/5th of RTS,S/AS01E full dose at Month 7, and underwent sporozoite challenge.
Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose at Month 1 and Month 7, and underwent sporozoite challenge.
Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose administered at Month 7, and underwent sporozoite challenge.
Healthy subjects, between, and including, 18 and 55 years of age, who did not receive any immunization but underwent sporozoite challenge
Overall Number of Participants Analyzed 26 26 26 26 26 24
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
11.Secondary Outcome
Title Number of Subjects With Any AE and SAE Leading to Withdrawal From Further Vaccination
Hide Description An adverse event is any untoward medical occurrence in a clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. SAEs include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time Frame From Day 1 up to study conclusion (Day 377)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on Intent-To-Treat Set, which included all subjects who received at least one dose of study vaccine
Arm/Group Title AduFx Group 2PedFx Group PedFx Group Adu2Fx Group Adu1Fx Group Control Group
Hide Arm/Group Description:
Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and Month 1 and 1/5th of RTS,S/AS01B full dose at Month 7, and underwent sporozoite challenge.
Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E double dose at Month 0 and Month 1, and 1/5th of double dose RTS,S/AS01E at Month 7, and underwent sporozoite challenge.
Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E full dose at Month 0 and Month 1, and 1/5th of RTS,S/AS01E full dose at Month 7, and underwent sporozoite challenge.
Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose at Month 1 and Month 7, and underwent sporozoite challenge.
Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose administered at Month 7, and underwent sporozoite challenge.
Healthy subjects, between, and including, 18 and 55 years of age, who did not receive any immunization but underwent sporozoite challenge
Overall Number of Participants Analyzed 26 26 26 26 26 24
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
12.Secondary Outcome
Title Number of Subjects With Potential Immune Mediated Diseases (pIMDs)
Hide Description Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.
Time Frame From Day 1 up to study conclusion (Day 377)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on Intent-To-Treat Set, which included all subjects who received at least one dose of study vaccine
Arm/Group Title AduFx Group 2PedFx Group PedFx Group Adu2Fx Group Adu1Fx Group Control Group
Hide Arm/Group Description:
Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and Month 1 and 1/5th of RTS,S/AS01B full dose at Month 7, and underwent sporozoite challenge.
Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E double dose at Month 0 and Month 1, and 1/5th of double dose RTS,S/AS01E at Month 7, and underwent sporozoite challenge.
Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E full dose at Month 0 and Month 1, and 1/5th of RTS,S/AS01E full dose at Month 7, and underwent sporozoite challenge.
Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose at Month 1 and Month 7, and underwent sporozoite challenge.
Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose administered at Month 7, and underwent sporozoite challenge.
Healthy subjects, between, and including, 18 and 55 years of age, who did not receive any immunization but underwent sporozoite challenge
Overall Number of Participants Analyzed 26 26 26 26 26 24
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
13.Secondary Outcome
Title Number of Subjects With Meningitis
Hide Description Meningitis is to be reported as an adverse event of specific interest and tabulated per study group.
Time Frame From Day 1 up to study conclusion (Day 377)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on Intent-To-Treat Set, which included all subjects who received at least one dose of study vaccine
Arm/Group Title AduFx Group 2PedFx Group PedFx Group Adu2Fx Group Adu1Fx Group Control Group
Hide Arm/Group Description:
Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and Month 1 and 1/5th of RTS,S/AS01B full dose at Month 7, and underwent sporozoite challenge.
Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E double dose at Month 0 and Month 1, and 1/5th of double dose RTS,S/AS01E at Month 7, and underwent sporozoite challenge.
Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E full dose at Month 0 and Month 1, and 1/5th of RTS,S/AS01E full dose at Month 7, and underwent sporozoite challenge.
Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose at Month 1 and Month 7, and underwent sporozoite challenge.
Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose administered at Month 7, and underwent sporozoite challenge.
Healthy subjects, between, and including, 18 and 55 years of age, who did not receive any immunization but underwent sporozoite challenge
Overall Number of Participants Analyzed 26 26 26 26 26 24
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
14.Secondary Outcome
Title Number of Subjects With Abnormal Laboratory Values Gradings
Hide Description Biochemistry (Alanine Aminotransferase [ALT], Aspartate Aminotransferase [AST] and creatinine) and hematological (hemoglobin, platelets, White Blood Cells [WBC] decrease and WBC increase) laboratory values were presented according to toxicity grading scales (Grade 0 [GR0], Grade 1 [GR1], Grade 2 [GR2] Grade 3 [GR3]) and tabulated by group. Grading scale is taken from the [FDA guidance for industry: toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials (September 2007)].
Time Frame At Visit 1 Screening (Day -89 to Day 1), Day 36, Day 59, Day 204, Day 227, between Day 292 & Day 313, and Day 315 for each vaccinated subject.For Infectivity Control subjects at Visit 1b Screening (Day 231 to Day 287),between Day 292 & Day 313,and Day 315
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on Intent-To-Treat Set, which included all subjects who received at least one dose of study vaccine
Arm/Group Title AduFx Group 2PedFx Group PedFx Group Adu2Fx Group Adu1Fx Group Control Group
Hide Arm/Group Description:
Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and Month 1 and 1/5th of RTS,S/AS01B full dose at Month 7, and underwent sporozoite challenge.
Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E double dose at Month 0 and Month 1, and 1/5th of double dose RTS,S/AS01E at Month 7, and underwent sporozoite challenge.
Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E full dose at Month 0 and Month 1, and 1/5th of RTS,S/AS01E full dose at Month 7, and underwent sporozoite challenge.
Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose at Month 1 and Month 7, and underwent sporozoite challenge.
Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose administered at Month 7, and underwent sporozoite challenge.
Healthy subjects, between, and including, 18 and 55 years of age, who did not receive any immunization but underwent sporozoite challenge
Overall Number of Participants Analyzed 26 26 26 26 26 24
Measure Type: Count of Participants
Unit of Measure: Participants
Alanine Aminotransferase, SCR, Gr0 Number Analyzed 26 participants 26 participants 26 participants 26 participants 26 participants 24 participants
25
  96.2%
24
  92.3%
25
  96.2%
25
  96.2%
26
 100.0%
24
 100.0%
Alanine Aminotransferase, SCR, Gr1 Number Analyzed 26 participants 26 participants 26 participants 26 participants 26 participants 24 participants
1
   3.8%
2
   7.7%
1
   3.8%
0
   0.0%
0
   0.0%
0
   0.0%
Alanine Aminotransferase, SCR, Gr2 Number Analyzed 26 participants 26 participants 26 participants 26 participants 26 participants 24 participants
0
   0.0%
0
   0.0%
0
   0.0%
1
   3.8%
0
   0.0%
0
   0.0%
Alanine Aminotransferase, D36, Gr0 Number Analyzed 26 participants 25 participants 25 participants 26 participants 0 participants 0 participants
26
 100.0%
24
  96.0%
25
 100.0%
25
  96.2%
Alanine Aminotransferase, D36, Gr1 Number Analyzed 26 participants 25 participants 25 participants 26 participants 0 participants 0 participants
0
   0.0%
1
   4.0%
0
   0.0%
1
   3.8%
Alanine Aminotransferase, D59, Gr0 Number Analyzed 26 participants 25 participants 25 participants 26 participants 0 participants 0 participants
26
 100.0%
24
  96.0%
24
  96.0%
24
  92.3%
Alanine Aminotransferase, D59, Gr1 Number Analyzed 26 participants 25 participants 25 participants 26 participants 0 participants 0 participants
0
   0.0%
1
   4.0%
1
   4.0%
2
   7.7%
Alanine Aminotransferase, D204, Gr0 Number Analyzed 23 participants 24 participants 24 participants 25 participants 23 participants 0 participants
21
  91.3%
22
  91.7%
24
 100.0%
24
  96.0%
20
  87.0%
Alanine Aminotransferase, D204, Gr1 Number Analyzed 23 participants 24 participants 24 participants 25 participants 23 participants 0 participants
2
   8.7%
2
   8.3%
0
   0.0%
1
   4.0%
3
  13.0%
Alanine Aminotransferase, D227, Gr0 Number Analyzed 23 participants 23 participants 24 participants 24 participants 23 participants 0 participants
22
  95.7%
20
  87.0%
23
  95.8%
23
  95.8%
22
  95.7%
Alanine Aminotransferase, D227, Gr1 Number Analyzed 23 participants 23 participants 24 participants 24 participants 23 participants 0 participants
1
   4.3%
2
   8.7%
1
   4.2%
1
   4.2%
1
   4.3%
Alanine Aminotransferase, D227, Gr2 Number Analyzed 23 participants 23 participants 24 participants 24 participants 23 participants 0 participants
0
   0.0%
1
   4.3%
0
   0.0%
0
   0.0%
0
   0.0%
Alanine Aminotransferase, D292, Gr0 Number Analyzed 9 participants 5 participants 8 participants 9 participants 15 participants 23 participants
9
 100.0%
4
  80.0%
7
  87.5%
8
  88.9%
10
  66.7%
22
  95.7%
Alanine Aminotransferase, D292, Gr1 Number Analyzed 9 participants 5 participants 8 participants 9 participants 15 participants 23 participants
0
   0.0%
0
   0.0%
1
  12.5%
1
  11.1%
5
  33.3%
0
   0.0%
Alanine Aminotransferase, D292, Gr2 Number Analyzed 9 participants 5 participants 8 participants 9 participants 15 participants 23 participants
0
   0.0%
1
  20.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   4.3%
Alanine Aminotransferase, D315, Gr0 Number Analyzed 20 participants 21 participants 22 participants 20 participants 21 participants 24 participants
16
  80.0%
20
  95.2%
18
  81.8%
18
  90.0%
18
  85.7%
21
  87.5%
Alanine Aminotransferase, D315, Gr1 Number Analyzed 20 participants 21 participants 22 participants 20 participants 21 participants 24 participants
3
  15.0%
1
   4.8%
4
  18.2%
2
  10.0%
2
   9.5%
3
  12.5%
Alanine Aminotransferase, D315, Gr2 Number Analyzed 20 participants 21 participants 22 participants 20 participants 21 participants 24 participants
1
   5.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   4.8%
0
   0.0%
Aspartate Aminotransferase, SCR, Gr0 Number Analyzed 26 participants 26 participants 26 participants 26 participants 26 participants 24 participants
26
 100.0%
25
  96.2%
25
  96.2%
25
  96.2%
26
 100.0%
23
  95.8%
Aspartate Aminotransferase, SCR, Gr1 Number Analyzed 26 participants 26 participants 26 participants 26 participants 26 participants 24 participants
0
   0.0%
1
   3.8%
1
   3.8%
1
   3.8%
0
   0.0%
1
   4.2%
Aspartate Aminotransferase, D36, Gr0 Number Analyzed 26 participants 25 participants 25 participants 26 participants 0 participants 0 participants
26
 100.0%
25
 100.0%
24
  96.0%
26
 100.0%
Aspartate Aminotransferase, D36, Gr1 Number Analyzed 26 participants 25 participants 25 participants 26 participants 0 participants 0 participants
0
   0.0%
0
   0.0%
1
   4.0%
0
   0.0%
Aspartate Aminotransferase, D59, Gr0 Number Analyzed 26 participants 25 participants 25 participants 26 participants 0 participants 0 participants
26
 100.0%
24
  96.0%
24
  96.0%
25
  96.2%
Aspartate Aminotransferase, D59, Gr1 Number Analyzed 26 participants 25 participants 25 participants 26 participants 0 participants 0 participants
0
   0.0%
1
   4.0%
1
   4.0%
1
   3.8%
Aspartate Aminotransferase, D204, Gr0 Number Analyzed 23 participants 24 participants 24 participants 25 participants 23 participants 0 participants
22
  95.7%
23
  95.8%
24
 100.0%
25
 100.0%
22
  95.7%
Aspartate Aminotransferase, D204, Gr1 Number Analyzed 23 participants 24 participants 24 participants 25 participants 23 participants 0 participants
1
   4.3%
1
   4.2%
0
   0.0%
0
   0.0%
1
   4.3%
Aspartate Aminotransferase, D227, Gr0 Number Analyzed 23 participants 23 participants 24 participants 24 participants 23 participants 0 participants
23
 100.0%
22
  95.7%
23
  95.8%
23
  95.8%
22
  95.7%
Aspartate Aminotransferase, D227, Gr1 Number Analyzed 23 participants 23 participants 24 participants 24 participants 23 participants 0 participants
0
   0.0%
0
   0.0%
1
   4.2%
0
   0.0%
1
   4.3%
Aspartate Aminotransferase, D227, Gr2 Number Analyzed 23 participants 23 participants 24 participants 24 participants 23 participants 0 participants
0
   0.0%
1
   4.3%
0
   0.0%
1
   4.2%
0
   0.0%
Aspartate Aminotransferase, D292, Gr0 Number Analyzed 9 participants 5 participants 8 participants 9 participants 15 participants 23 participants
9
 100.0%
4
  80.0%
7
  87.5%
9
 100.0%
13
  86.7%
22
  95.7%
Aspartate Aminotransferase, D292, Gr1 Number Analyzed 9 participants 5 participants 8 participants 9 participants 15 participants 23 participants
0
   0.0%
0
   0.0%
1
  12.5%
0
   0.0%
2
  13.3%
0
   0.0%
Aspartate Aminotransferase, D292, Gr2 Number Analyzed 9 participants 5 participants 8 participants 9 participants 15 participants 23 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   4.3%
Aspartate Aminotransferase, D292, Gr3 Number Analyzed 9 participants 5 participants 8 participants 9 participants 15 participants 23 participants
0
   0.0%
1
  20.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Aspartate Aminotransferase, D315, Gr0 Number Analyzed 20 participants 21 participants 22 participants 20 participants 21 participants 24 participants
20
 100.0%
21
 100.0%
21
  95.5%
18
  90.0%
20
  95.2%
24
 100.0%
Aspartate Aminotransferase, D315, Gr1 Number Analyzed 20 participants 21 participants 22 participants 20 participants 21 participants 24 participants
0
   0.0%
0
   0.0%
1
   4.5%
2
  10.0%
1
   4.8%
0
   0.0%
Creatinine, SCR, Gr0 Number Analyzed 26 participants 26 participants 26 participants 26 participants 26 participants 24 participants
26
 100.0%
26
 100.0%
26
 100.0%
25
  96.2%
26
 100.0%
24
 100.0%
Creatinine, SCR, Gr1 Number Analyzed 26 participants 26 participants 26 participants 26 participants 26 participants 24 participants
0
   0.0%
0
   0.0%
0
   0.0%
1
   3.8%
0
   0.0%
0
   0.0%
Creatinine, D36, Gr0 Number Analyzed 26 participants 25 participants 25 participants 26 participants 0 participants 0 participants
25
  96.2%
25
 100.0%
25
 100.0%
26
 100.0%
Creatinine, D36, Gr1 Number Analyzed 26 participants 25 participants 25 participants 26 participants 0 participants 0 participants
1
   3.8%
0
   0.0%
0
   0.0%
0
   0.0%
Creatinine, D59, Gr0 Number Analyzed 26 participants 25 participants 25 participants 26 participants 0 participants 0 participants
26
 100.0%
25
 100.0%
25
 100.0%
26
 100.0%
Creatinine, D204, Gr0 Number Analyzed 23 participants 24 participants 24 participants 25 participants 23 participants 0 participants
23
 100.0%
24
 100.0%
24
 100.0%
25
 100.0%
22
  95.7%
Creatinine, D204, Gr1 Number Analyzed 23 participants 24 participants 24 participants 25 participants 23 participants 0 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   4.3%
Creatinine, D227, Gr0 Number Analyzed 23 participants 23 participants 24 participants 24 participants 23 participants 0 participants
23
 100.0%
23
 100.0%
24
 100.0%
24
 100.0%
22
  95.7%
Creatinine, D227, Gr1 Number Analyzed 23 participants 23 participants 24 participants 24 participants 23 participants 0 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   4.3%
Creatinine, D292, Gr0 Number Analyzed 9 participants 5 participants 8 participants 9 participants 15 participants 23 participants
9
 100.0%
5
 100.0%
8
 100.0%
8
  88.9%
15
 100.0%
22
  95.7%
Creatinine, D292, Gr1 Number Analyzed 9 participants 5 participants 8 participants 9 participants 15 participants 23 participants
0
   0.0%
0
   0.0%
0
   0.0%
1
  11.1%
0
   0.0%
0
   0.0%
Creatinine, D292, UNK Number Analyzed 9 participants 5 participants 8 participants 9 participants 15 participants 23 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   4.3%
Creatinine, D315, Gr0 Number Analyzed 20 participants 21 participants 22 participants 20 participants 21 participants 24 participants
20
 100.0%
21
 100.0%
21
  95.5%
20
 100.0%
20
  95.2%
24
 100.0%
Creatinine, D315, Gr1 Number Analyzed 20 participants 21 participants 22 participants 20 participants 21 participants 24 participants
0
   0.0%
0
   0.0%
1
   4.5%
0
   0.0%
1
   4.8%
0
   0.0%
Hemoglobin, SCR, Gr0 Number Analyzed 26 participants 26 participants 26 participants 26 participants 26 participants 24 participants
26
 100.0%
26
 100.0%
26
 100.0%
26
 100.0%
26
 100.0%
23
  95.8%
Hemoglobin, SCR, Gr1 Number Analyzed 26 participants 26 participants 26 participants 26 participants 26 participants 24 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   4.2%
Hemoglobin, D36, Gr0 Number Analyzed 26 participants 25 participants 25 participants 26 participants 0 participants 0 participants
23
  88.5%
24
  96.0%
22
  88.0%
25
  96.2%
Hemoglobin, D36, Gr1 Number Analyzed 26 participants 25 participants 25 participants 26 participants 0 participants 0 participants
3
  11.5%
1
   4.0%
3
  12.0%
1
   3.8%
Hemoglobin, D59, Gr0 Number Analyzed 26 participants 25 participants 25 participants 26 participants 0 participants 0 participants
25
  96.2%
25
 100.0%
24
  96.0%
25
  96.2%
Hemoglobin, D59, Gr1 Number Analyzed 26 participants 25 participants 25 participants 26 participants 0 participants 0 participants
1
   3.8%
0
   0.0%
1
   4.0%
1
   3.8%
Hemoglobin, D204, Gr0 Number Analyzed 23 participants 24 participants 24 participants 25 participants 23 participants 0 participants
20
  87.0%
24
 100.0%
21
  87.5%
25
 100.0%
23
 100.0%
Hemoglobin, D204, Gr1 Number Analyzed 23 participants 24 participants 24 participants 25 participants 23 participants 0 participants
3
  13.0%
0
   0.0%
3
  12.5%
0
   0.0%
0
   0.0%
Hemoglobin, D227, Gr0 Number Analyzed 23 participants 23 participants 24 participants 24 participants 23 participants 0 participants
19
  82.6%
23
 100.0%
23
  95.8%
23
  95.8%
23
 100.0%
Hemoglobin, D227, Gr1 Number Analyzed 23 participants 23 participants 24 participants 24 participants 23 participants 0 participants
4
  17.4%
0
   0.0%
1
   4.2%
1
   4.2%
0
   0.0%
Hemoglobin, D292, Gr0 Number Analyzed 9 participants 5 participants 8 participants 9 participants 15 participants 23 participants
9
 100.0%
5
 100.0%
8
 100.0%
8
  88.9%
15
 100.0%
23
 100.0%
Hemoglobin, D292, Gr1 Number Analyzed 9 participants 5 participants 8 participants 9 participants 15 participants 23 participants
0
   0.0%
0
   0.0%
0
   0.0%
1
  11.1%
0
   0.0%
0
   0.0%
Hemoglobin, D315, Gr0 Number Analyzed 20 participants 21 participants 22 participants 20 participants 21 participants 24 participants
16
  80.0%
21
 100.0%
19
  86.4%
18
  90.0%
21
 100.0%
24
 100.0%
Hemoglobin, D315, Gr1 Number Analyzed 20 participants 21 participants 22 participants 20 participants 21 participants 24 participants
4
  20.0%
0
   0.0%
3
  13.6%
1
   5.0%
0
   0.0%
0
   0.0%
Hemoglobin, D315, Gr2 Number Analyzed 20 participants 21 participants 22 participants 20 participants 21 participants 24 participants
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.0%
0
   0.0%
0
   0.0%
Platelets, SCR, Gr0 Number Analyzed 26 participants 26 participants 26 participants 26 participants 26 participants 24 participants
26
 100.0%
26
 100.0%
26
 100.0%
26
 100.0%
26
 100.0%
24
 100.0%
Platelets, D36, Gr0 Number Analyzed 26 participants 25 participants 25 participants 26 participants 0 participants 0 participants
26
 100.0%
25
 100.0%
25
 100.0%
26
 100.0%
Platelets, D59, Gr0 Number Analyzed 26 participants 25 participants 25 participants 26 participants 0 participants 0 participants
26
 100.0%
25
 100.0%
25
 100.0%
26
 100.0%
Platelets, D204, Gr0 Number Analyzed 23 participants 24 participants 24 participants 25 participants 23 participants 0 participants
23
 100.0%
24
 100.0%
24
 100.0%
25
 100.0%
23
 100.0%
Platelets, D227, Gr0 Number Analyzed 23 participants 23 participants 24 participants 24 participants 23 participants 0 participants
23
 100.0%
23
 100.0%
24
 100.0%
24
 100.0%
23
 100.0%
Platelets, D292, Gr0 Number Analyzed 9 participants 5 participants 8 participants 9 participants 15 participants 22 participants
9
 100.0%
5
 100.0%
8
 100.0%
8
  88.9%
15
 100.0%
19
  86.4%
Platelets, D292, Gr1 Number Analyzed 9 participants 5 participants 8 participants 9 participants 15 participants 22 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   9.1%
Platelets, D292, Gr2 Number Analyzed 9 participants 5 participants 8 participants 9 participants 15 participants 22 participants
0
   0.0%
0
   0.0%
0
   0.0%
1
  11.1%
0
   0.0%
0
   0.0%
Platelets, D292, Gr3 Number Analyzed 9 participants 5 participants 8 participants 9 participants 15 participants 22 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   4.5%
Platelets, D315, Gr0 Number Analyzed 20 participants 21 participants 22 participants 20 participants 21 participants 23 participants
20
 100.0%
21
 100.0%
22
 100.0%
19
  95.0%
21
 100.0%
22
  95.7%
Platelets, D315, Gr1 Number Analyzed 20 participants 21 participants 22 participants 20 participants 21 participants 23 participants
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.0%
0
   0.0%
1
   4.3%
WBC Decrease, SCR, Gr0 Number Analyzed 26 participants 26 participants 26 participants 26 participants 26 participants 24 participants
25
  96.2%
25
  96.2%
26
 100.0%
26
 100.0%
26
 100.0%
24
 100.0%
WBC Decrease, SCR, Gr1 Number Analyzed 26 participants 26 participants 26 participants 26 participants 26 participants 24 participants
1
   3.8%
1
   3.8%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
WBC Decrease, D36, Gr0 Number Analyzed 26 participants 25 participants 25 participants 26 participants 0 participants 0 participants
26
 100.0%
24
  96.0%
25
 100.0%
26
 100.0%
WBC Decrease, D36, Gr1 Number Analyzed 26 participants 25 participants 25 participants 26 participants 0 participants 0 participants
0
   0.0%
1
   4.0%
0
   0.0%
0
   0.0%
WBC Decrease, D59, Gr0 Number Analyzed 26 participants 25 participants 25 participants 26 participants 0 participants 0 participants
26
 100.0%
25
 100.0%
24
  96.0%
26
 100.0%
WBC Decrease, D59, Gr1 Number Analyzed 26 participants 25 participants 25 participants 26 participants 0 participants 0 participants
0
   0.0%
0
   0.0%
1
   4.0%
0
   0.0%
WBC Decrease, D204, Gr0 Number Analyzed 23 participants 24 participants 24 participants 25 participants 23 participants 0 participants
23
 100.0%
24
 100.0%
24
 100.0%
25
 100.0%
23
 100.0%
WBC Decrease, D227, Gr0 Number Analyzed 23 participants 23 participants 24 participants 24 participants 23 participants 0 participants
23
 100.0%
23
 100.0%
22
  91.7%
24
 100.0%
23
 100.0%
WBC Decrease, D227, Gr1 Number Analyzed 23 participants 23 participants 24 participants 24 participants 23 participants 0 participants
0
   0.0%
0
   0.0%
2
   8.3%
0
   0.0%
0
   0.0%
WBC Decrease, D292, Gr0 Number Analyzed 9 participants 5 participants 8 participants 9 participants 15 participants 23 participants
8
  88.9%
4
  80.0%
6
  75.0%
8
  88.9%
15
 100.0%
20
  87.0%
WBC Decrease, D292, Gr1 Number Analyzed 9 participants 5 participants 8 participants 9 participants 15 participants 23 participants
1
  11.1%
1
  20.0%
2
  25.0%
1
  11.1%
0
   0.0%
3
  13.0%
WBC Decrease, D315, Gr0 Number Analyzed 20 participants 21 participants 22 participants 20 participants 21 participants 24 participants
20
 100.0%
21
 100.0%
21
  95.5%
20
 100.0%
20
  95.2%
24
 100.0%
WBC Decrease, D315, Gr1 Number Analyzed 20 participants 21 participants 22 participants 20 participants 21 participants 24 participants
0
   0.0%
0
   0.0%
1
   4.5%
0
   0.0%
1
   4.8%
0
   0.0%
WBC Increase, SCR, Gr0 Number Analyzed 26 participants 26 participants 26 participants 26 participants 26 participants 24 participants
25
  96.2%
26
 100.0%
26
 100.0%
25
  96.2%
25
  96.2%
22
  91.7%
WBC Increase, SCR, Gr1 Number Analyzed 26 participants 26 participants 26 participants 26 participants 26 participants 24 participants
1
   3.8%
0
   0.0%
0
   0.0%
1
   3.8%
1
   3.8%
2
   8.3%
WBC Increase, D36, Gr0 Number Analyzed 26 participants 25 participants 25 participants 26 participants 0 participants 0 participants
25
  96.2%
25
 100.0%
25
 100.0%
23
  88.5%
WBC Increase, D36, Gr1 Number Analyzed 26 participants 25 participants 25 participants 26 participants 0 participants 0 participants
1
   3.8%
0
   0.0%
0
   0.0%
3
  11.5%
WBC Increase, D59, Gr0 Number Analyzed 26 participants 25 participants 25 participants 26 participants 0 participants 0 participants
26
 100.0%
25
 100.0%
25
 100.0%
26
 100.0%
WBC Increase, D204, Gr0 Number Analyzed 23 participants 24 participants 24 participants 25 participants 23 participants 0 participants
23
 100.0%
24
 100.0%
24
 100.0%
23
  92.0%
21
  91.3%
WBC Increase, D204, Gr1 Number Analyzed 23 participants 24 participants 24 participants 25 participants 23 participants 0 participants
0
   0.0%
0
   0.0%
0
   0.0%
2
   8.0%
2
   8.7%
WBC Increase, D227, Gr0 Number Analyzed 23 participants 23 participants 24 participants 24 participants 23 participants 0 participants
22
  95.7%
23
 100.0%
23
  95.8%
24
 100.0%
23
 100.0%
WBC Increase, D227, Gr1 Number Analyzed 23 participants 23 participants 24 participants 24 participants 23 participants 0 participants
1
   4.3%
0
   0.0%
1
   4.2%
0
   0.0%
0
   0.0%
WBC Increase, D292, Gr0 Number Analyzed 9 participants 5 participants 8 participants 9 participants 15 participants 23 participants
9
 100.0%
5
 100.0%
8
 100.0%
9
 100.0%
15
 100.0%
23
 100.0%
WBC Increase, D315, Gr0 Number Analyzed 20 participants 21 participants 22 participants 20 participants 21 participants 24 participants
19
  95.0%
20
  95.2%
22
 100.0%
20
 100.0%
19
  90.5%
24
 100.0%
WBC Increase, D315, Gr1 Number Analyzed 20 participants 21 participants 22 participants 20 participants 21 participants 24 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   9.5%
0
   0.0%
WBC Increase, D315, Gr2 Number Analyzed 20 participants 21 participants 22 participants 20 participants 21 participants 24 participants
0
   0.0%
1
   4.8%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
WBC Increase, D315, Gr3 Number Analyzed 20 participants 21 participants 22 participants 20 participants 21 participants 24 participants
1
   5.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
15.Secondary Outcome
Title Number of Subjects With Any, Fatal or Related SAE, After Challenge
Hide Description SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time Frame From day of challenge (Day 287) to the end of the challenge phase (Day 315)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on Intent-To-Treat Set, which included all subjects who received at least one dose of study vaccine
Arm/Group Title AduFx Group 2PedFx Group PedFx Group Adu2Fx Group Adu1Fx Group Control Group
Hide Arm/Group Description:
Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and Month 1 and 1/5th of RTS,S/AS01B full dose at Month 7, and underwent sporozoite challenge.
Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E double dose at Month 0 and Month 1, and 1/5th of double dose RTS,S/AS01E at Month 7, and underwent sporozoite challenge.
Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E full dose at Month 0 and Month 1, and 1/5th of RTS,S/AS01E full dose at Month 7, and underwent sporozoite challenge.
Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose at Month 1 and Month 7, and underwent sporozoite challenge.
Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose administered at Month 7, and underwent sporozoite challenge.
Healthy subjects, between, and including, 18 and 55 years of age, who did not receive any immunization but underwent sporozoite challenge
Overall Number of Participants Analyzed 26 26 26 26 26 24
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Time Frame Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title AduFx Group 2PedFx Group PedFx Group Adu2Fx Group Adu1Fx Group Control Group
Hide Arm/Group Description Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and Month 1 and 1/5th of RTS,S/AS01B full dose at Month 7, and underwent sporozoite challenge. Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E double dose at Month 0 and Month 1, and 1/5th of double dose RTS,S/AS01E at Month 7, and underwent sporozoite challenge. Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E full dose at Month 0 and Month 1, and 1/5th of RTS,S/AS01E full dose at Month 7, and underwent sporozoite challenge. Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose at Month 1 and Month 7, and underwent sporozoite challenge. Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose administered at Month 7, and underwent sporozoite challenge. Healthy subjects, between, and including, 18 and 55 years of age, who did not receive any immunization but underwent sporozoite challenge
All-Cause Mortality
AduFx Group 2PedFx Group PedFx Group Adu2Fx Group Adu1Fx Group Control Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/26 (0.00%)      0/26 (0.00%)      0/26 (0.00%)      0/26 (0.00%)      0/26 (0.00%)      0/24 (0.00%)    
Hide Serious Adverse Events
AduFx Group 2PedFx Group PedFx Group Adu2Fx Group Adu1Fx Group Control Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/26 (0.00%)      0/26 (0.00%)      0/26 (0.00%)      0/26 (0.00%)      0/26 (0.00%)      0/24 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
AduFx Group 2PedFx Group PedFx Group Adu2Fx Group Adu1Fx Group Control Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   26/26 (100.00%)      25/26 (96.15%)      23/26 (88.46%)      25/26 (96.15%)      24/26 (92.31%)      0/24 (0.00%)    
Blood and lymphatic system disorders             
Lymphadenopathy  1  1/26 (3.85%)  2 0/26 (0.00%)  0 0/26 (0.00%)  0 0/26 (0.00%)  0 2/26 (7.69%)  2 0/24 (0.00%)  0
Eye disorders             
Eye irritation  1  0/26 (0.00%)  0 1/26 (3.85%)  1 0/26 (0.00%)  0 0/26 (0.00%)  0 0/26 (0.00%)  0 0/24 (0.00%)  0
Eye pain  1  0/26 (0.00%)  0 0/26 (0.00%)  0 0/26 (0.00%)  0 1/26 (3.85%)  1 0/26 (0.00%)  0 0/24 (0.00%)  0
Gastrointestinal disorders             
Abdominal pain  1  0/26 (0.00%)  0 0/26 (0.00%)  0 0/26 (0.00%)  0 1/26 (3.85%)  1 0/26 (0.00%)  0 0/24 (0.00%)  0
Dental caries  1  0/26 (0.00%)  0 0/26 (0.00%)  0 1/26 (3.85%)  1 0/26 (0.00%)  0 0/26 (0.00%)  0 0/24 (0.00%)  0
Dry mouth  1  0/26 (0.00%)  0 1/26 (3.85%)  1 0/26 (0.00%)  0 0/26 (0.00%)  0 0/26 (0.00%)  0 0/24 (0.00%)  0
Gastrointestinal disorder  1  9/26 (34.62%)  12 11/26 (42.31%)  16 9/26 (34.62%)  18 6/26 (23.08%)  7 8/26 (30.77%)  11 0/24 (0.00%)  0
Gingival pain  1  0/26 (0.00%)  0 0/26 (0.00%)  0 1/26 (3.85%)  1 0/26 (0.00%)  0 0/26 (0.00%)  0 0/24 (0.00%)  0
Haematochezia  1  0/26 (0.00%)  0 0/26 (0.00%)  0 1/26 (3.85%)  1 0/26 (0.00%)  0 0/26 (0.00%)  0 0/24 (0.00%)  0
Sensitivity of teeth  1  0/26 (0.00%)  0 0/26 (0.00%)  0 1/26 (3.85%)  2 0/26 (0.00%)  0 0/26 (0.00%)  0 0/24 (0.00%)  0
Toothache  1  0/26 (0.00%)  0 0/26 (0.00%)  0 2/26 (7.69%)  3 0/26 (0.00%)  0 0/26 (0.00%)  0 0/24 (0.00%)  0
General disorders             
Asthenia  1  1/26 (3.85%)  1 0/26 (0.00%)  0 0/26 (0.00%)  0 0/26 (0.00%)  0 0/26 (0.00%)  0 0/24 (0.00%)  0
Chest pain  1  1/26 (3.85%)  1 0/26 (0.00%)  0 0/26 (0.00%)  0 0/26 (0.00%)  0 0/26 (0.00%)  0 0/24 (0.00%)  0
Chills  1  4/26 (15.38%)  7 3/26 (11.54%)  4 5/26 (19.23%)  6 5/26 (19.23%)  7 0/26 (0.00%)  0 0/24 (0.00%)  0
Fatigue  1  16/26 (61.54%)  28 20/26 (76.92%)  33 15/26 (57.69%)  31 13/26 (50.00%)  29 14/26 (53.85%)  20 0/24 (0.00%)  0
Feeling hot  1  0/26 (0.00%)  0 0/26 (0.00%)  0 1/26 (3.85%)  1 0/26 (0.00%)  0 0/26 (0.00%)  0 0/24 (0.00%)  0
Injection site erythema  1  14/26 (53.85%)  23 18/26 (69.23%)  31 12/26 (46.15%)  19 15/26 (57.69%)  23 12/26 (46.15%)  15 0/24 (0.00%)  0
Injection site pain  1  23/26 (88.46%)  54 23/26 (88.46%)  49 23/26 (88.46%)  55 22/26 (84.62%)  50 20/26 (76.92%)  34 0/24 (0.00%)  0
Injection site swelling  1  9/26 (34.62%)  13 15/26 (57.69%)  26 9/26 (34.62%)  14 9/26 (34.62%)  10 8/26 (30.77%)  8 0/24 (0.00%)  0
Injection site warmth  1  0/26 (0.00%)  0 1/26 (3.85%)  1 0/26 (0.00%)  0 0/26 (0.00%)  0 1/26 (3.85%)  1 0/24 (0.00%)  0
Malaise  1  1/26 (3.85%)  1 2/26 (7.69%)  2 1/26 (3.85%)  1 1/26 (3.85%)  1 0/26 (0.00%)  0 0/24 (0.00%)  0
Pain  1  2/26 (7.69%)  2 2/26 (7.69%)  2 1/26 (3.85%)  1 2/26 (7.69%)  2 0/26 (0.00%)  0 0/24 (0.00%)  0
Pyrexia  1  8/26 (30.77%)  10 12/26 (46.15%)  15 4/26 (15.38%)  5 5/26 (19.23%)  6 3/26 (11.54%)  3 0/24 (0.00%)  0
Infections and infestations             
Bronchitis  1  0/26 (0.00%)  0 0/26 (0.00%)  0 1/26 (3.85%)  1 0/26 (0.00%)  0 0/26 (0.00%)  0 0/24 (0.00%)  0
Eye infection  1  0/26 (0.00%)  0 1/26 (3.85%)  1 0/26 (0.00%)  0 0/26 (0.00%)  0 0/26 (0.00%)  0 0/24 (0.00%)  0
Eyelid infection  1  0/26 (0.00%)  0 0/26 (0.00%)  0 0/26 (0.00%)  0 1/26 (3.85%)  1 0/26 (0.00%)  0 0/24 (0.00%)  0
Oral herpes  1  0/26 (0.00%)  0 0/26 (0.00%)  0 1/26 (3.85%)  1 0/26 (0.00%)  0 0/26 (0.00%)  0 0/24 (0.00%)  0
Pharyngitis streptococcal  1  1/26 (3.85%)  1 0/26 (0.00%)  0 0/26 (0.00%)  0 0/26 (0.00%)  0 0/26 (0.00%)  0 0/24 (0.00%)  0
Pyelonephritis  1  0/26 (0.00%)  0 0/26 (0.00%)  0 0/26 (0.00%)  0 1/26 (3.85%)  1 0/26 (0.00%)  0 0/24 (0.00%)  0
Upper respiratory tract infection  1  1/26 (3.85%)  1 3/26 (11.54%)  3 3/26 (11.54%)  3 7/26 (26.92%)  8 2/26 (7.69%)  2 0/24 (0.00%)  0
Viral upper respiratory tract infection  1  2/26 (7.69%)  2 0/26 (0.00%)  0 0/26 (0.00%)  0 0/26 (0.00%)  0 0/26 (0.00%)  0 0/24 (0.00%)  0
Injury, poisoning and procedural complications             
Hypobarism  1  0/26 (0.00%)  0 1/26 (3.85%)  1 0/26 (0.00%)  0 0/26 (0.00%)  0 0/26 (0.00%)  0 0/24 (0.00%)  0
Muscle strain  1  0/26 (0.00%)  0 1/26 (3.85%)  1 0/26 (0.00%)  0 0/26 (0.00%)  0 0/26 (0.00%)  0 0/24 (0.00%)  0
Procedural pain  1  1/26 (3.85%)  1 1/26 (3.85%)  1 0/26 (0.00%)  0 1/26 (3.85%)  1 0/26 (0.00%)  0 0/24 (0.00%)  0
Skin laceration  1  0/26 (0.00%)  0 0/26 (0.00%)  0 1/26 (3.85%)  1 0/26 (0.00%)  0 0/26 (0.00%)  0 0/24 (0.00%)  0
Investigations             
White blood cell count increased  1  0/26 (0.00%)  0 0/26 (0.00%)  0 0/26 (0.00%)  0 1/26 (3.85%)  1 0/26 (0.00%)  0 0/24 (0.00%)  0
Metabolism and nutrition disorders             
Decreased appetite  1  1/26 (3.85%)  2 2/26 (7.69%)  2 0/26 (0.00%)  0 0/26 (0.00%)  0 0/26 (0.00%)  0 0/24 (0.00%)  0
Musculoskeletal and connective tissue disorders             
Arthralgia  1  0/26 (0.00%)  0 2/26 (7.69%)  2 0/26 (0.00%)  0 0/26 (0.00%)  0 2/26 (7.69%)  2 0/24 (0.00%)  0
Back pain  1  0/26 (0.00%)  0 0/26 (0.00%)  0 2/26 (7.69%)  2 1/26 (3.85%)  1 1/26 (3.85%)  1 0/24 (0.00%)  0
Costochondritis  1  1/26 (3.85%)  1 0/26 (0.00%)  0 0/26 (0.00%)  0 0/26 (0.00%)  0 0/26 (0.00%)  0 0/24 (0.00%)  0
Joint stiffness  1  0/26 (0.00%)  0 1/26 (3.85%)  1 0/26 (0.00%)  0 0/26 (0.00%)  0 0/26 (0.00%)  0 0/24 (0.00%)  0
Muscle spasms  1  0/26 (0.00%)  0 0/26 (0.00%)  0 0/26 (0.00%)  0 1/26 (3.85%)  1 0/26 (0.00%)  0 0/24 (0.00%)  0
Musculoskeletal chest pain  1  1/26 (3.85%)  1 0/26 (0.00%)  0 0/26 (0.00%)  0 0/26 (0.00%)  0 0/26 (0.00%)  0 0/24 (0.00%)  0
Musculoskeletal pain  1  1/26 (3.85%)  1 1/26 (3.85%)  1 1/26 (3.85%)  1 0/26 (0.00%)  0 0/26 (0.00%)  0 0/24 (0.00%)  0
Myalgia  1  2/26 (7.69%)  3 1/26 (3.85%)  2 2/26 (7.69%)  4 2/26 (7.69%)  3 1/26 (3.85%)  1 0/24 (0.00%)  0
Neck pain  1  1/26 (3.85%)  1 0/26 (0.00%)  0 2/26 (7.69%)  2 1/26 (3.85%)  1 0/26 (0.00%)  0 0/24 (0.00%)  0
Nervous system disorders             
Dizziness  1  1/26 (3.85%)  1 1/26 (3.85%)  1 1/26 (3.85%)  1 1/26 (3.85%)  1 1/26 (3.85%)  1 0/24 (0.00%)  0
Headache  1  20/26 (76.92%)  35 20/26 (76.92%)  35 18/26 (69.23%)  28 16/26 (61.54%)  28 12/26 (46.15%)  19 0/24 (0.00%)  0
Hypoaesthesia  1  0/26 (0.00%)  0 1/26 (3.85%)  1 0/26 (0.00%)  0 0/26 (0.00%)  0 0/26 (0.00%)  0 0/24 (0.00%)  0
Loss of consciousness  1  0/26 (0.00%)  0 0/26 (0.00%)  0 1/26 (3.85%)  1 0/26 (0.00%)  0 0/26 (0.00%)  0 0/24 (0.00%)  0
Paraesthesia  1  0/26 (0.00%)  0 1/26 (3.85%)  1 0/26 (0.00%)  0 0/26 (0.00%)  0 0/26 (0.00%)  0 0/24 (0.00%)  0
Presyncope  1  0/26 (0.00%)  0 0/26 (0.00%)  0 0/26 (0.00%)  0 0/26 (0.00%)  0 1/26 (3.85%)  1 0/24 (0.00%)  0
Psychiatric disorders             
Abnormal dreams  1  0/26 (0.00%)  0 0/26 (0.00%)  0 0/26 (0.00%)  0 1/26 (3.85%)  1 0/26 (0.00%)  0 0/24 (0.00%)  0
Depression  1  0/26 (0.00%)  0 0/26 (0.00%)  0 0/26 (0.00%)  0 0/26 (0.00%)  0 1/26 (3.85%)  1 0/24 (0.00%)  0
Insomnia  1  0/26 (0.00%)  0 1/26 (3.85%)  1 0/26 (0.00%)  0 0/26 (0.00%)  0 0/26 (0.00%)  0 0/24 (0.00%)  0
Sleep disorder  1  0/26 (0.00%)  0 0/26 (0.00%)  0 1/26 (3.85%)  1 0/26 (0.00%)  0 0/26 (0.00%)  0 0/24 (0.00%)  0
Respiratory, thoracic and mediastinal disorders             
Cough  1  1/26 (3.85%)  1 2/26 (7.69%)  2 0/26 (0.00%)  0 0/26 (0.00%)  0 0/26 (0.00%)  0 0/24 (0.00%)  0
Respiratory tract congestion  1  0/26 (0.00%)  0 1/26 (3.85%)  1 0/26 (0.00%)  0 0/26 (0.00%)  0 0/26 (0.00%)  0 0/24 (0.00%)  0
Rhinorrhoea  1  0/26 (0.00%)  0 0/26 (0.00%)  0 1/26 (3.85%)  1 1/26 (3.85%)  1 0/26 (0.00%)  0 0/24 (0.00%)  0
Sinus congestion  1  0/26 (0.00%)  0 0/26 (0.00%)  0 1/26 (3.85%)  1 0/26 (0.00%)  0 0/26 (0.00%)  0 0/24 (0.00%)  0
Skin and subcutaneous tissue disorders             
Acne  1  0/26 (0.00%)  0 0/26 (0.00%)  0 0/26 (0.00%)  0 1/26 (3.85%)  1 0/26 (0.00%)  0 0/24 (0.00%)  0
Dermatitis contact  1  0/26 (0.00%)  0 1/26 (3.85%)  1 0/26 (0.00%)  0 0/26 (0.00%)  0 0/26 (0.00%)  0 0/24 (0.00%)  0
Erythema  1  2/26 (7.69%)  2 0/26 (0.00%)  0 0/26 (0.00%)  0 0/26 (0.00%)  0 0/26 (0.00%)  0 0/24 (0.00%)  0
Hyperhidrosis  1  0/26 (0.00%)  0 0/26 (0.00%)  0 2/26 (7.69%)  2 1/26 (3.85%)  1 0/26 (0.00%)  0 0/24 (0.00%)  0
Night sweats  1  1/26 (3.85%)  1 2/26 (7.69%)  2 0/26 (0.00%)  0 0/26 (0.00%)  0 0/26 (0.00%)  0 0/24 (0.00%)  0
Photosensitivity reaction  1  0/26 (0.00%)  0 1/26 (3.85%)  1 0/26 (0.00%)  0 0/26 (0.00%)  0 0/26 (0.00%)  0 0/24 (0.00%)  0
Rash  1  1/26 (3.85%)  1 2/26 (7.69%)  2 1/26 (3.85%)  1 0/26 (0.00%)  0 0/26 (0.00%)  0 0/24 (0.00%)  0
Sensitive skin  1  1/26 (3.85%)  1 2/26 (7.69%)  3 1/26 (3.85%)  1 1/26 (3.85%)  2 0/26 (0.00%)  0 0/24 (0.00%)  0
1
Term from vocabulary, MedDRA 21.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Efficacy, immunogenicity and safety study of GSK Biologicals’ candidate malaria vaccine (SB257049)
Organization: GlaxoSmithKline
Phone: 877-379-3718
EMail: GSKClinicalSupportHD@gsk.com
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03162614    
Other Study ID Numbers: 205081
First Submitted: May 15, 2017
First Posted: May 22, 2017
Results First Submitted: July 1, 2019
Results First Posted: July 24, 2019
Last Update Posted: November 14, 2019