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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

Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT03162614
Collaborator
The PATH Malaria Vaccine Initiative (MVI) (Other)
154
Enrollment
1
Location
6
Arms
16
Actual Duration (Months)
9.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is designed to evaluate efficacy, immunogenicity and safety of various dose schedules of GSK Biologicals' candidate malaria vaccines RTS,S/AS01B (adult formulation) and RTS,S/AS01E (pediatric formulation) in healthy malaria-naïve subjects aged 18-55 years. The purpose of this study is to investigate whether changes in dosing schedule are associated with increased or equivalent protection, and to evaluate the immune mechanisms associated with vaccine efficacy under varying dosing schedules.

Condition or Disease Intervention/Treatment Phase
  • Biological: RTS,S/AS01E
  • Biological: RTS,S/AS01B
  • Procedure: Sporozoite-infected mosquitoes challenge.
 Phase 2

Detailed Description

Protocol Amendment 1 incorporated: additional blood sampling for assessment of parasitemia (polymerase chain reaction [PCR] testing); clarification that blood samples for both peripheral blood mononuclear cells (PBMC) and plasma will be collected for repository storage; revision of volume of whole blood samples to be taken for parasitemia assessment; clarification that urine pregnancy tests will be conducted for all females and not just those of childbearing potential; deletion of visit at Day 1 post day of challenge; clarification that RNA sequencing and not deep sequencing will be performed in this study.

Note that as a result of internal change in data standards terminology, the study data collected was converted to cDISC and the statistical analysis plan was amended accordingly. "Day 0" in the study design was replaced by "Day 1"; consequently, "Day n" was replaced by "Day n+1". Thus, the timeframes (Day 0, Day n) of Outcome Measures described in this study record are different to that denoted in the full protocol document posted.

Study Design

Study Type:
Interventional
Actual Enrollment :
154 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Efficacy, Immunogenicity and Safety Study of GSK Biologicals' Candidate Malaria Vaccine (SB257049) Evaluating Various Dose Schedules in a Sporozoite Challenge Model in Healthy Malaria-naïve Adults
Actual Study Start Date :
May 24, 2017
Actual Primary Completion Date :
Jul 9, 2018
Actual Study Completion Date :
Sep 24, 2018

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: AduFx Group

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.

Biological: RTS,S/AS01B
Subjects will receive intramuscular injection of RTS,S/AS01B.

Procedure: Sporozoite-infected mosquitoes challenge.
Mosquitoes infected approximately 2-3 weeks earlier that are likely to contain sporozoites in their salivary glands will be allowed to feed on the subjects. For each subject, five mosquitoes will be allowed to feed over five minutes, after which they will be dissected to confirm how many were infected, and the salivary glands scored. If required additional mosquitoes will be allowed to feed until a total of five infected mosquitoes with a minimum of 2+ salivary gland scores have fed. The challenge occurs approximately 90 days (three months) after the last vaccination. Subjects will be monitored during 28 days after having bitten by mosquitoes and when parasites are found in their blood, they will be treated with appropriate anti-malarial drugs.
Experimental: 2PedFx Group

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.

Biological: RTS,S/AS01E
Subjects will receive intramuscular injection of RTS,S/AS01E.

Procedure: Sporozoite-infected mosquitoes challenge.
Mosquitoes infected approximately 2-3 weeks earlier that are likely to contain sporozoites in their salivary glands will be allowed to feed on the subjects. For each subject, five mosquitoes will be allowed to feed over five minutes, after which they will be dissected to confirm how many were infected, and the salivary glands scored. If required additional mosquitoes will be allowed to feed until a total of five infected mosquitoes with a minimum of 2+ salivary gland scores have fed. The challenge occurs approximately 90 days (three months) after the last vaccination. Subjects will be monitored during 28 days after having bitten by mosquitoes and when parasites are found in their blood, they will be treated with appropriate anti-malarial drugs.
Experimental: PedFx Group

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.

Biological: RTS,S/AS01E
Subjects will receive intramuscular injection of RTS,S/AS01E.

Procedure: Sporozoite-infected mosquitoes challenge.
Mosquitoes infected approximately 2-3 weeks earlier that are likely to contain sporozoites in their salivary glands will be allowed to feed on the subjects. For each subject, five mosquitoes will be allowed to feed over five minutes, after which they will be dissected to confirm how many were infected, and the salivary glands scored. If required additional mosquitoes will be allowed to feed until a total of five infected mosquitoes with a minimum of 2+ salivary gland scores have fed. The challenge occurs approximately 90 days (three months) after the last vaccination. Subjects will be monitored during 28 days after having bitten by mosquitoes and when parasites are found in their blood, they will be treated with appropriate anti-malarial drugs.
Experimental: Adu2Fx Group

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.

Biological: RTS,S/AS01B
Subjects will receive intramuscular injection of RTS,S/AS01B.

Procedure: Sporozoite-infected mosquitoes challenge.
Mosquitoes infected approximately 2-3 weeks earlier that are likely to contain sporozoites in their salivary glands will be allowed to feed on the subjects. For each subject, five mosquitoes will be allowed to feed over five minutes, after which they will be dissected to confirm how many were infected, and the salivary glands scored. If required additional mosquitoes will be allowed to feed until a total of five infected mosquitoes with a minimum of 2+ salivary gland scores have fed. The challenge occurs approximately 90 days (three months) after the last vaccination. Subjects will be monitored during 28 days after having bitten by mosquitoes and when parasites are found in their blood, they will be treated with appropriate anti-malarial drugs.
Active Comparator: Adu1Fx Group

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.

Biological: RTS,S/AS01B
Subjects will receive intramuscular injection of RTS,S/AS01B.

Procedure: Sporozoite-infected mosquitoes challenge.
Mosquitoes infected approximately 2-3 weeks earlier that are likely to contain sporozoites in their salivary glands will be allowed to feed on the subjects. For each subject, five mosquitoes will be allowed to feed over five minutes, after which they will be dissected to confirm how many were infected, and the salivary glands scored. If required additional mosquitoes will be allowed to feed until a total of five infected mosquitoes with a minimum of 2+ salivary gland scores have fed. The challenge occurs approximately 90 days (three months) after the last vaccination. Subjects will be monitored during 28 days after having bitten by mosquitoes and when parasites are found in their blood, they will be treated with appropriate anti-malarial drugs.
Other: Control Group

Healthy subjects, between, and including, 18 and 55 years of age, who did not receive any immunization but underwent sporozoite challenge.

Procedure: Sporozoite-infected mosquitoes challenge.
Mosquitoes infected approximately 2-3 weeks earlier that are likely to contain sporozoites in their salivary glands will be allowed to feed on the subjects. For each subject, five mosquitoes will be allowed to feed over five minutes, after which they will be dissected to confirm how many were infected, and the salivary glands scored. If required additional mosquitoes will be allowed to feed until a total of five infected mosquitoes with a minimum of 2+ salivary gland scores have fed. The challenge occurs approximately 90 days (three months) after the last vaccination. Subjects will be monitored during 28 days after having bitten by mosquitoes and when parasites are found in their blood, they will be treated with appropriate anti-malarial drugs.

Outcome Measures

Primary Outcome Measures

  1. Number of Subjects With at Least One Occurrence of Plasmodium Falciparum (P. Falciparum) Parasitemia for Each Vaccination Schedule Versus Infectivity Controls [Following sporozoite challenge starting 3 months after the last vaccine dose (Day 287) for up to 28 days post-challenge (Day 315).]

    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).

Secondary Outcome Measures

  1. Time to Onset of P. Falciparum Parasitemia After Sporozoite Challenge for Each Vaccination Schedule [Following sporozoite challenge starting 3 months after the last vaccine dose (at Day 287) for up to 28 days post-challenge (at Day 315).]

    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.

  2. Anti-Circumsporozoite (Anti-CS) Repeat Region Antibody Concentrations [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]

    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.

  3. Anti-Hepatitis B (Anti-HBs) Immunoglobulin G (IgG) Antibody Concentrations [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]

    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.

  4. Number of Subjects With Any Solicited Local Symptoms [Within the 7-day period (Days 1-7) after dose 1, dose 2 (except for Adu1Fx Group) and dose 3.]

    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).

  5. Number of Subjects With Any Solicited General Symptoms [Within the 7-day period (Days 1-7) after dose 1, dose 2 (except for Adu1Fx Group) and dose 3.]

    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.

  6. Number of Subjects With Any Unsolicited Adverse Events (AEs) After Any Vaccination [Within the 30-day period (Days 1-30), after any vaccination (across doses)]

    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.

  7. Number of Subjects With Any Unsolicited AEs After Challenge [Within the 30-day (Days 1-30) period post-challenge]

    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.

  8. Number of Subjects With Any, Fatal or Related Serious Adverse Events (SAEs) After Each Vaccination [Within the 30-day period (Days 1-30) after any vaccination (across doses)]

    SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

  9. Number of Subjects With Any, Fatal or Related SAEs During the Whole Study Period [From Day 1 up to study conclusion (Day 377)]

    SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

  10. Number of Subjects With Any AE and SAE Leading to Withdrawal From Further Vaccination [From Day 1 up to study conclusion (Day 377)]

    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.

  11. Number of Subjects With Potential Immune Mediated Diseases (pIMDs) [From Day 1 up to study conclusion (Day 377)]

    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.

  12. Number of Subjects With Meningitis [From Day 1 up to study conclusion (Day 377)]

    Meningitis is to be reported as an adverse event of specific interest and tabulated per study group.

  13. Number of Subjects With Abnormal Laboratory Values Gradings [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]

    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)].

  14. Number of Subjects With Any, Fatal or Related SAE, After Challenge [From day of challenge (Day 287) to the end of the challenge phase (Day 315)]

    SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.

  • Written informed consent obtained from the subject prior to performing of any study specific procedure.

  • A male or female between, and including, 18 and 55 years of age at the time of enrolment.

  • Healthy subjects as established by medical history and clinical examination before entering into the study.

  • Available to participate for the duration of the study.

  • Female subjects of non-childbearing potential may be enrolled in the study.

  • Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.

  • Female subjects of childbearing potential may be enrolled in the study, if the subject:

  • has practiced adequate contraception for 30 days prior to vaccination, and

  • has a negative pregnancy test at enrolment, and

  • has agreed to continue adequate contraception during the entire treatment period and for two months after completion of the vaccination series and/or malaria challenge.

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines during the period starting 30 days before the first dose of study vaccines (Day -29 to Day 0), or planned use during the study period.

  • Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.

  • Chronic administration of immunosuppressants or other immune-modifying drugs during the period starting six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone ≥ 20 mg/day, or equivalent. Inhaled and topical steroids are allowed.

  • Administration of long-acting immune-modifying drugs at any time during the study period.

  • Chronic use of antibiotics with antimalarial effects.

  • Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting seven days before the first dose.

  • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product.

  • Seropositive for hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).

  • Documented HIV-positive subject.

  • Previous vaccination against malaria.

  • History of malaria chemoprophylaxis within 60 days prior to vaccination.

  • Any history of malaria (for the vaccine groups).

  • Planned travel to malaria endemic areas during the study period.

  • History of splenectomy.

  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.

  • Family history of congenital or hereditary immunodeficiency.

  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.

  • History of anaphylaxis post-vaccination.

  • Hypersensitivity to latex.

  • History of any reaction or hypersensitivity likely to be exacerbated by chloroquine.

  • History of psoriasis and porphyria, which may be exacerbated after chloroquine treatment.

  • Current use of medications known to cause drug reactions to chloroquine.

  • History of severe reactions to mosquito bites.

  • Major congenital defects.

  • Serious chronic illness.

  • History of any neurological disorders or seizures.

  • Acute disease and/or fever at the time of enrolment. Fever is defined as temperature ≥ 37.5°C/99.5°F for oral, axillary or tympanic route, or ≥ 38.0°C/100.4°F for rectal route.

  • Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.

  • Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.

  • Any abnormal baseline laboratory screening tests: alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine, hemoglobin, platelet count, total white blood cells (WBC), out of normal range as defined in the protocol.

  • Evidence of increased cardiovascular disease risk, "moderate" or "high", according to the National health and nutrition examination survey I criteria.

  • Hepatomegaly, right upper quadrant abdominal pain or tenderness.

  • Personal history of autoimmune disease.

  • Administration of immunoglobulins and/or any blood products during the period starting three months before the first dose of study vaccine or planned administration during the study period.

  • Pregnant or lactating female.

  • History of chronic alcohol consumption and/or drug abuse.

  • Female planning to become pregnant or planning to discontinue contraceptive precautions.

  • History of blood donation within 56 days preceding enrolment.

  • Any other significant finding that in the opinion of the investigator would increase the risk of having an adverse outcome from participating in this study.

Contacts and Locations

Locations

Site City State Country Postal Code
1 GSK Investigational Site Silver Spring Maryland United States 20910

Sponsors and Collaborators

  • GlaxoSmithKline
  • The PATH Malaria Vaccine Initiative (MVI)

Investigators

  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT03162614
Other Study ID Numbers:
  • 205081
First Posted:
May 22, 2017
Last Update Posted:
Oct 27, 2020
Last Verified:
Oct 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by GlaxoSmithKline
healthy volunteers
Malaria
malaria vaccine
controlled human challenge
RTS,S/AS01
Additional relevant MeSH terms:
Malaria

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title AduFx Group 2PedFx Group PedFx Group Adu2Fx Group Adu1Fx Group Control Group
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

Baseline Characteristics

Arm/Group Title AduFx Group 2PedFx Group PedFx Group Adu2Fx Group Adu1Fx Group Control Group Total
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 Participants 26 26 26 26 26 24 154
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]
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 (Count of Participants)
Female
11
42.3%
10
38.5%
12
46.2%
4
15.4%
10
38.5%
10
41.7%
57
37%
Male
15
57.7%
16
61.5%
14
53.8%
22
84.6%
16
61.5%
14
58.3%
97
63%
Race/Ethnicity, Customized (Count of Participants)
Asian
1
3.8%
3
11.5%
2
7.7%
2
7.7%
1
3.8%
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%
1
4.2%
1
0.6%
Other, Not Specified
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%
14
53.8%
14
58.3%
86
55.8%

Outcome Measures

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
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).

Outcome Measure Data

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
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
Measure Participants 20 21 22 20 21 22
Count of Participants [Participants]
9
34.6%
5
19.2%
8
30.8%
9
34.6%
15
57.7%
22
91.7%
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
Method Fisher Exact
Comments
Method of Estimation Estimation Parameter Vaccine efficacy rate
Estimated Value 55
Confidence Interval (2-Sided) 95%
27 to 72
Parameter Dispersion Type:
Value:
Estimation Comments
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
Method Fisher Exact
Comments
Method of Estimation Estimation Parameter Vaccine efficacy rate
Estimated Value 76
Confidence Interval (2-Sided) 95%
49 to 89
Parameter Dispersion Type:
Value:
Estimation Comments
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
Method Fisher Exact
Comments
Method of Estimation Estimation Parameter Vaccine efficacy rate
Estimated Value 64
Confidence Interval (2-Sided) 95%
37 to 79
Parameter Dispersion Type:
Value:
Estimation Comments
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
Method Fisher Exact
Comments
Method of Estimation Estimation Parameter Vaccine efficacy rate
Estimated Value 55
Confidence Interval (2-Sided) 95%
27 to 72
Parameter Dispersion Type:
Value:
Estimation Comments
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
Method Fisher Exact
Comments
Method of Estimation Estimation Parameter Vaccine efficacy rate
Estimated Value 29
Confidence Interval (2-Sided) 95%
6 to 46
Parameter Dispersion Type:
Value:
Estimation Comments
2. Secondary Outcome
Title Time to Onset of P. Falciparum Parasitemia After Sporozoite Challenge for Each Vaccination Schedule
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).

Outcome Measure Data

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
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
Measure Participants 9 5 8 9 15 22
Mean (Standard Deviation) [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
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

Outcome Measure Data

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
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.
Measure Participants 20 21 22 20 21
At Day 1
1
1
1
1
1
At Day 59
108.2
107.8
53.8
61.7
At Day 197
30
39.3
15.1
19.4
3.8
At Day 227
85.9
79.8
50.2
64
22.1
At Day 287
61.4
57.6
34.4
38.1
12.3
At Day 315
56.6
51
31.3
44.1
10.6
At Day 377
43.7
38.1
25
31.7
9.5
4. Secondary Outcome
Title Anti-Hepatitis B (Anti-HBs) Immunoglobulin G (IgG) Antibody Concentrations
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

Outcome Measure Data

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
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.
Measure Participants 20 21 22 20 21
At Day 1
44.1
68.8
45.7
21.8
16
At Day 59
42616.7
28894.8
26149.3
14710.6
At Day 197
19369.3
15358.8
11269.1
6846.7
2031.7
At Day 227
45959.9
30994.5
28560.6
26717
35620.9
At Day 287
36266.3
20712.2
19126.1
13911.3
16376.8
At Day 315
33027.7
18527.8
17465.5
16685
12609.9
At Day 377
27823
15083.7
13716
11257.6
10975.2
5. Secondary Outcome
Title Number of Subjects With Any Solicited Local Symptoms
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.

Outcome Measure Data

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
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.
Measure Participants 26 26 26 26 25
Pain, dose 1
23
88.5%
21
80.8%
22
84.6%
22
84.6%
19
73.1%
Redness, dose 1
8
30.8%
11
42.3%
4
15.4%
8
30.8%
9
34.6%
Swelling, dose 1
5
19.2%
12
46.2%
3
11.5%
4
15.4%
5
19.2%
Pain, dose 2
20
76.9%
16
61.5%
20
76.9%
12
46.2%
Redness, dose 2
8
30.8%
10
38.5%
5
19.2%
4
15.4%
Swelling, dose 2
5
19.2%
8
30.8%
6
23.1%
3
11.5%
Pain, dose 3
11
42.3%
12
46.2%
13
50%
16
61.5%
15
57.7%
Redness, dose 3
7
26.9%
10
38.5%
10
38.5%
11
42.3%
6
23.1%
Swelling, dose 3
3
11.5%
6
23.1%
5
19.2%
3
11.5%
3
11.5%
6. Secondary Outcome
Title Number of Subjects With Any Solicited General Symptoms
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.

Outcome Measure Data

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
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.
Measure Participants 26 26 26 26 25
Fatigue, dose 1
13
50%
14
53.8%
13
50%
10
38.5%
11
42.3%
Gastrointestinal symptoms, dose 1
5
19.2%
8
30.8%
5
19.2%
4
15.4%
6
23.1%
Headache, dose 1
15
57.7%
14
53.8%
10
38.5%
12
46.2%
9
34.6%
Fever, dose 1
3
11.5%
6
23.1%
2
7.7%
3
11.5%
3
11.5%
Fatigue, dose 2
11
42.3%
12
46.2%
10
38.5%
6
23.1%
Gastrointestinal symptoms, dose 2
3
11.5%
6
23.1%
7
26.9%
3
11.5%
Headache, dose 2
13
50%
14
53.8%
11
42.3%
6
23.1%
Fever, dose 2
6
23.1%
6
23.1%
3
11.5%
1
3.8%
Fatigue, dose 3
4
15.4%
6
23.1%
8
30.8%
11
42.3%
8
30.8%
Gastrointestinal symptoms, dose 3
4
15.4%
2
7.7%
6
23.1%
0
0%
5
19.2%
Headache, dose 3
6
23.1%
7
26.9%
6
23.1%
9
34.6%
9
34.6%
Fever, dose 3
0
0%
2
7.7%
0
0%
2
7.7%
0
0%
7. Secondary Outcome
Title Number of Subjects With Any Unsolicited Adverse Events (AEs) After Any Vaccination
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)

Outcome Measure Data

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
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.
Measure Participants 26 26 26 26 26
Count of Participants [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
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

Outcome Measure Data

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
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
Measure Participants 26 26 26 26 26 24
Count of Participants [Participants]
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
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)

Outcome Measure Data

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
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.
Measure Participants 26 26 26 26 26
Count of Participants [Participants]
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
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)

Outcome Measure Data

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
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
Measure Participants 26 26 26 26 26 24
Count of Participants [Participants]
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
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)

Outcome Measure Data

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
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
Measure Participants 26 26 26 26 26 24
Count of Participants [Participants]
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)
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)

Outcome Measure Data

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
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
Measure Participants 26 26 26 26 26 24
Count of Participants [Participants]
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
13. Secondary Outcome
Title Number of Subjects With Meningitis
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)

Outcome Measure Data

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
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
Measure Participants 26 26 26 26 26 24
Count of Participants [Participants]
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
14. Secondary Outcome
Title Number of Subjects With Abnormal Laboratory Values Gradings
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

Outcome Measure Data

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
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
Measure Participants 26 26 26 26 26 24
Alanine Aminotransferase, SCR, Gr0
25
96.2%
24
92.3%
25
96.2%
25
96.2%
26
100%
24
100%
Alanine Aminotransferase, SCR, Gr1
1
3.8%
2
7.7%
1
3.8%
0
0%
0
0%
0
0%
Alanine Aminotransferase, SCR, Gr2
0
0%
0
0%
0
0%
1
3.8%
0
0%
0
0%
Alanine Aminotransferase, D36, Gr0
26
100%
24
92.3%
25
96.2%
25
96.2%
Alanine Aminotransferase, D36, Gr1
0
0%
1
3.8%
0
0%
1
3.8%
Alanine Aminotransferase, D59, Gr0
26
100%
24
92.3%
24
92.3%
24
92.3%
Alanine Aminotransferase, D59, Gr1
0
0%
1
3.8%
1
3.8%
2
7.7%
Alanine Aminotransferase, D204, Gr0
21
80.8%
22
84.6%
24
92.3%
24
92.3%
20
76.9%
Alanine Aminotransferase, D204, Gr1
2
7.7%
2
7.7%
0
0%
1
3.8%
3
11.5%
Alanine Aminotransferase, D227, Gr0
22
84.6%
20
76.9%
23
88.5%
23
88.5%
22
84.6%
Alanine Aminotransferase, D227, Gr1
1
3.8%
2
7.7%
1
3.8%
1
3.8%
1
3.8%
Alanine Aminotransferase, D227, Gr2
0
0%
1
3.8%
0
0%
0
0%
0
0%
Alanine Aminotransferase, D292, Gr0
9
34.6%
4
15.4%
7
26.9%
8
30.8%
10
38.5%
22
91.7%
Alanine Aminotransferase, D292, Gr1
0
0%
0
0%
1
3.8%
1
3.8%
5
19.2%
0
0%
Alanine Aminotransferase, D292, Gr2
0
0%
1
3.8%
0
0%
0
0%
0
0%
1
4.2%
Alanine Aminotransferase, D315, Gr0
16
61.5%
20
76.9%
18
69.2%
18
69.2%
18
69.2%
21
87.5%
Alanine Aminotransferase, D315, Gr1
3
11.5%
1
3.8%
4
15.4%
2
7.7%
2
7.7%
3
12.5%
Alanine Aminotransferase, D315, Gr2
1
3.8%
0
0%
0
0%
0
0%
1
3.8%
0
0%
Aspartate Aminotransferase, SCR, Gr0
26
100%
25
96.2%
25
96.2%
25
96.2%
26
100%
23
95.8%
Aspartate Aminotransferase, SCR, Gr1
0
0%
1
3.8%
1
3.8%
1
3.8%
0
0%
1
4.2%
Aspartate Aminotransferase, D36, Gr0
26
100%
25
96.2%
24
92.3%
26
100%
Aspartate Aminotransferase, D36, Gr1
0
0%
0
0%
1
3.8%
0
0%
Aspartate Aminotransferase, D59, Gr0
26
100%
24
92.3%
24
92.3%
25
96.2%
Aspartate Aminotransferase, D59, Gr1
0
0%
1
3.8%
1
3.8%
1
3.8%
Aspartate Aminotransferase, D204, Gr0
22
84.6%
23
88.5%
24
92.3%
25
96.2%
22
84.6%
Aspartate Aminotransferase, D204, Gr1
1
3.8%
1
3.8%
0
0%
0
0%
1
3.8%
Aspartate Aminotransferase, D227, Gr0
23
88.5%
22
84.6%
23
88.5%
23
88.5%
22
84.6%
Aspartate Aminotransferase, D227, Gr1
0
0%
0
0%
1
3.8%
0
0%
1
3.8%
Aspartate Aminotransferase, D227, Gr2
0
0%
1
3.8%
0
0%
1
3.8%
0
0%
Aspartate Aminotransferase, D292, Gr0
9
34.6%
4
15.4%
7
26.9%
9
34.6%
13
50%
22
91.7%
Aspartate Aminotransferase, D292, Gr1
0
0%
0
0%
1
3.8%
0
0%
2
7.7%
0
0%
Aspartate Aminotransferase, D292, Gr2
0
0%
0
0%
0
0%
0
0%
0
0%
1
4.2%
Aspartate Aminotransferase, D292, Gr3
0
0%
1
3.8%
0
0%
0
0%
0
0%
0
0%
Aspartate Aminotransferase, D315, Gr0
20
76.9%
21
80.8%
21
80.8%
18
69.2%
20
76.9%
24
100%
Aspartate Aminotransferase, D315, Gr1
0
0%
0
0%
1
3.8%
2
7.7%
1
3.8%
0
0%
Creatinine, SCR, Gr0
26
100%
26
100%
26
100%
25
96.2%
26
100%
24
100%
Creatinine, SCR, Gr1
0
0%
0
0%
0
0%
1
3.8%
0
0%
0
0%
Creatinine, D36, Gr0
25
96.2%
25
96.2%
25
96.2%
26
100%
Creatinine, D36, Gr1
1
3.8%
0
0%
0
0%
0
0%
Creatinine, D59, Gr0
26
100%
25
96.2%
25
96.2%
26
100%
Creatinine, D204, Gr0
23
88.5%
24
92.3%
24
92.3%
25
96.2%
22
84.6%
Creatinine, D204, Gr1
0
0%
0
0%
0
0%
0
0%
1
3.8%
Creatinine, D227, Gr0
23
88.5%
23
88.5%
24
92.3%
24
92.3%
22
84.6%
Creatinine, D227, Gr1
0
0%
0
0%
0
0%
0
0%
1
3.8%
Creatinine, D292, Gr0
9
34.6%
5
19.2%
8
30.8%
8
30.8%
15
57.7%
22
91.7%
Creatinine, D292, Gr1
0
0%
0
0%
0
0%
1
3.8%
0
0%
0
0%
Creatinine, D292, UNK
0
0%
0
0%
0
0%
0
0%
0
0%
1
4.2%
Creatinine, D315, Gr0
20
76.9%
21
80.8%
21
80.8%
20
76.9%
20
76.9%
24
100%
Creatinine, D315, Gr1
0
0%
0
0%
1
3.8%
0
0%
1
3.8%
0
0%
Hemoglobin, SCR, Gr0
26
100%
26
100%
26
100%
26
100%
26
100%
23
95.8%
Hemoglobin, SCR, Gr1
0
0%
0
0%
0
0%
0
0%
0
0%
1
4.2%
Hemoglobin, D36, Gr0
23
88.5%
24
92.3%
22
84.6%
25
96.2%
Hemoglobin, D36, Gr1
3
11.5%
1
3.8%
3
11.5%
1
3.8%
Hemoglobin, D59, Gr0
25
96.2%
25
96.2%
24
92.3%
25
96.2%
Hemoglobin, D59, Gr1
1
3.8%
0
0%
1
3.8%
1
3.8%
Hemoglobin, D204, Gr0
20
76.9%
24
92.3%
21
80.8%
25
96.2%
23
88.5%
Hemoglobin, D204, Gr1
3
11.5%
0
0%
3
11.5%
0
0%
0
0%
Hemoglobin, D227, Gr0
19
73.1%
23
88.5%
23
88.5%
23
88.5%
23
88.5%
Hemoglobin, D227, Gr1
4
15.4%
0
0%
1
3.8%
1
3.8%
0
0%
Hemoglobin, D292, Gr0
9
34.6%
5
19.2%
8
30.8%
8
30.8%
15
57.7%
23
95.8%
Hemoglobin, D292, Gr1
0
0%
0
0%
0
0%
1
3.8%
0
0%
0
0%
Hemoglobin, D315, Gr0
16
61.5%
21
80.8%
19
73.1%
18
69.2%
21
80.8%
24
100%
Hemoglobin, D315, Gr1
4
15.4%
0
0%
3
11.5%
1
3.8%
0
0%
0
0%
Hemoglobin, D315, Gr2
0
0%
0
0%
0
0%
1
3.8%
0
0%
0
0%
Platelets, SCR, Gr0
26
100%
26
100%
26
100%
26
100%
26
100%
24
100%
Platelets, D36, Gr0
26
100%
25
96.2%
25
96.2%
26
100%
Platelets, D59, Gr0
26
100%
25
96.2%
25
96.2%
26
100%
Platelets, D204, Gr0
23
88.5%
24
92.3%
24
92.3%
25
96.2%
23
88.5%
Platelets, D227, Gr0
23
88.5%
23
88.5%
24
92.3%
24
92.3%
23
88.5%
Platelets, D292, Gr0
9
34.6%
5
19.2%
8
30.8%
8
30.8%
15
57.7%
19
79.2%
Platelets, D292, Gr1
0
0%
0
0%
0
0%
0
0%
0
0%
2
8.3%
Platelets, D292, Gr2
0
0%
0
0%
0
0%
1
3.8%
0
0%
0
0%
Platelets, D292, Gr3
0
0%
0
0%
0
0%
0
0%
0
0%
1
4.2%
Platelets, D315, Gr0
20
76.9%
21
80.8%
22
84.6%
19
73.1%
21
80.8%
22
91.7%
Platelets, D315, Gr1
0
0%
0
0%
0
0%
1
3.8%
0
0%
1
4.2%
WBC Decrease, SCR, Gr0
25
96.2%
25
96.2%
26
100%
26
100%
26
100%
24
100%
WBC Decrease, SCR, Gr1
1
3.8%
1
3.8%
0
0%
0
0%
0
0%
0
0%
WBC Decrease, D36, Gr0
26
100%
24
92.3%
25
96.2%
26
100%
WBC Decrease, D36, Gr1
0
0%
1
3.8%
0
0%
0
0%
WBC Decrease, D59, Gr0
26
100%
25
96.2%
24
92.3%
26
100%
WBC Decrease, D59, Gr1
0
0%
0
0%
1
3.8%
0
0%
WBC Decrease, D204, Gr0
23
88.5%
24
92.3%
24
92.3%
25
96.2%
23
88.5%
WBC Decrease, D227, Gr0
23
88.5%
23
88.5%
22
84.6%
24
92.3%
23
88.5%
WBC Decrease, D227, Gr1
0
0%
0
0%
2
7.7%
0
0%
0
0%
WBC Decrease, D292, Gr0
8
30.8%
4
15.4%
6
23.1%
8
30.8%
15
57.7%
20
83.3%
WBC Decrease, D292, Gr1
1
3.8%
1
3.8%
2
7.7%
1
3.8%
0
0%
3
12.5%
WBC Decrease, D315, Gr0
20
76.9%
21
80.8%
21
80.8%
20
76.9%
20
76.9%
24
100%
WBC Decrease, D315, Gr1
0
0%
0
0%
1
3.8%
0
0%
1
3.8%
0
0%
WBC Increase, SCR, Gr0
25
96.2%
26
100%
26
100%
25
96.2%
25
96.2%
22
91.7%
WBC Increase, SCR, Gr1
1
3.8%
0
0%
0
0%
1
3.8%
1
3.8%
2
8.3%
WBC Increase, D36, Gr0
25
96.2%
25
96.2%
25
96.2%
23
88.5%
WBC Increase, D36, Gr1
1
3.8%
0
0%
0
0%
3
11.5%
WBC Increase, D59, Gr0
26
100%
25
96.2%
25
96.2%
26
100%
WBC Increase, D204, Gr0
23
88.5%
24
92.3%
24
92.3%
23
88.5%
21
80.8%
WBC Increase, D204, Gr1
0
0%
0
0%
0
0%
2
7.7%
2
7.7%
WBC Increase, D227, Gr0
22
84.6%
23
88.5%
23
88.5%
24
92.3%
23
88.5%
WBC Increase, D227, Gr1
1
3.8%
0
0%
1
3.8%
0
0%
0
0%
WBC Increase, D292, Gr0
9
34.6%
5
19.2%
8
30.8%
9
34.6%
15
57.7%
23
95.8%
WBC Increase, D315, Gr0
19
73.1%
20
76.9%
22
84.6%
20
76.9%
19
73.1%
24
100%
WBC Increase, D315, Gr1
0
0%
0
0%
0
0%
0
0%
2
7.7%
0
0%
WBC Increase, D315, Gr2
0
0%
1
3.8%
0
0%
0
0%
0
0%
0
0%
WBC Increase, D315, Gr3
1
3.8%
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
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)

Outcome Measure Data

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
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
Measure Participants 26 26 26 26 26 24
Count of Participants [Participants]
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%

Adverse Events

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
Arm/Group Title AduFx Group 2PedFx Group PedFx Group Adu2Fx Group Adu1Fx Group Control Group
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 (%) # 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%) 0/26 (0%) 0/26 (0%) 0/26 (0%) 0/26 (0%) 0/24 (0%)
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%) 0/26 (0%) 0/26 (0%) 0/26 (0%) 0/26 (0%) 0/24 (0%)
Other (Not Including 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 26/26 (100%) 25/26 (96.2%) 23/26 (88.5%) 25/26 (96.2%) 24/26 (92.3%) 0/24 (0%)
Blood and lymphatic system disorders
Lymphadenopathy 1/26 (3.8%) 2 0/26 (0%) 0 0/26 (0%) 0 0/26 (0%) 0 2/26 (7.7%) 2 0/24 (0%) 0
Eye disorders
Eye irritation 0/26 (0%) 0 1/26 (3.8%) 1 0/26 (0%) 0 0/26 (0%) 0 0/26 (0%) 0 0/24 (0%) 0
Eye pain 0/26 (0%) 0 0/26 (0%) 0 0/26 (0%) 0 1/26 (3.8%) 1 0/26 (0%) 0 0/24 (0%) 0
Gastrointestinal disorders
Abdominal pain 0/26 (0%) 0 0/26 (0%) 0 0/26 (0%) 0 1/26 (3.8%) 1 0/26 (0%) 0 0/24 (0%) 0
Dental caries 0/26 (0%) 0 0/26 (0%) 0 1/26 (3.8%) 1 0/26 (0%) 0 0/26 (0%) 0 0/24 (0%) 0
Dry mouth 0/26 (0%) 0 1/26 (3.8%) 1 0/26 (0%) 0 0/26 (0%) 0 0/26 (0%) 0 0/24 (0%) 0
Gastrointestinal disorder 9/26 (34.6%) 12 11/26 (42.3%) 16 9/26 (34.6%) 18 6/26 (23.1%) 7 8/26 (30.8%) 11 0/24 (0%) 0
Gingival pain 0/26 (0%) 0 0/26 (0%) 0 1/26 (3.8%) 1 0/26 (0%) 0 0/26 (0%) 0 0/24 (0%) 0
Haematochezia 0/26 (0%) 0 0/26 (0%) 0 1/26 (3.8%) 1 0/26 (0%) 0 0/26 (0%) 0 0/24 (0%) 0
Sensitivity of teeth 0/26 (0%) 0 0/26 (0%) 0 1/26 (3.8%) 2 0/26 (0%) 0 0/26 (0%) 0 0/24 (0%) 0
Toothache 0/26 (0%) 0 0/26 (0%) 0 2/26 (7.7%) 3 0/26 (0%) 0 0/26 (0%) 0 0/24 (0%) 0
General disorders
Asthenia 1/26 (3.8%) 1 0/26 (0%) 0 0/26 (0%) 0 0/26 (0%) 0 0/26 (0%) 0 0/24 (0%) 0
Chest pain 1/26 (3.8%) 1 0/26 (0%) 0 0/26 (0%) 0 0/26 (0%) 0 0/26 (0%) 0 0/24 (0%) 0
Chills 4/26 (15.4%) 7 3/26 (11.5%) 4 5/26 (19.2%) 6 5/26 (19.2%) 7 0/26 (0%) 0 0/24 (0%) 0
Fatigue 16/26 (61.5%) 28 20/26 (76.9%) 33 15/26 (57.7%) 31 13/26 (50%) 29 14/26 (53.8%) 20 0/24 (0%) 0
Feeling hot 0/26 (0%) 0 0/26 (0%) 0 1/26 (3.8%) 1 0/26 (0%) 0 0/26 (0%) 0 0/24 (0%) 0
Injection site erythema 14/26 (53.8%) 23 18/26 (69.2%) 31 12/26 (46.2%) 19 15/26 (57.7%) 23 12/26 (46.2%) 15 0/24 (0%) 0
Injection site pain 23/26 (88.5%) 54 23/26 (88.5%) 49 23/26 (88.5%) 55 22/26 (84.6%) 50 20/26 (76.9%) 34 0/24 (0%) 0
Injection site swelling 9/26 (34.6%) 13 15/26 (57.7%) 26 9/26 (34.6%) 14 9/26 (34.6%) 10 8/26 (30.8%) 8 0/24 (0%) 0
Injection site warmth 0/26 (0%) 0 1/26 (3.8%) 1 0/26 (0%) 0 0/26 (0%) 0 1/26 (3.8%) 1 0/24 (0%) 0
Malaise 1/26 (3.8%) 1 2/26 (7.7%) 2 1/26 (3.8%) 1 1/26 (3.8%) 1 0/26 (0%) 0 0/24 (0%) 0
Pain 2/26 (7.7%) 2 2/26 (7.7%) 2 1/26 (3.8%) 1 2/26 (7.7%) 2 0/26 (0%) 0 0/24 (0%) 0
Pyrexia 8/26 (30.8%) 10 12/26 (46.2%) 15 4/26 (15.4%) 5 5/26 (19.2%) 6 3/26 (11.5%) 3 0/24 (0%) 0
Infections and infestations
Bronchitis 0/26 (0%) 0 0/26 (0%) 0 1/26 (3.8%) 1 0/26 (0%) 0 0/26 (0%) 0 0/24 (0%) 0
Eye infection 0/26 (0%) 0 1/26 (3.8%) 1 0/26 (0%) 0 0/26 (0%) 0 0/26 (0%) 0 0/24 (0%) 0
Eyelid infection 0/26 (0%) 0 0/26 (0%) 0 0/26 (0%) 0 1/26 (3.8%) 1 0/26 (0%) 0 0/24 (0%) 0
Oral herpes 0/26 (0%) 0 0/26 (0%) 0 1/26 (3.8%) 1 0/26 (0%) 0 0/26 (0%) 0 0/24 (0%) 0
Pharyngitis streptococcal 1/26 (3.8%) 1 0/26 (0%) 0 0/26 (0%) 0 0/26 (0%) 0 0/26 (0%) 0 0/24 (0%) 0
Pyelonephritis 0/26 (0%) 0 0/26 (0%) 0 0/26 (0%) 0 1/26 (3.8%) 1 0/26 (0%) 0 0/24 (0%) 0
Upper respiratory tract infection 1/26 (3.8%) 1 3/26 (11.5%) 3 3/26 (11.5%) 3 7/26 (26.9%) 8 2/26 (7.7%) 2 0/24 (0%) 0
Viral upper respiratory tract infection 2/26 (7.7%) 2 0/26 (0%) 0 0/26 (0%) 0 0/26 (0%) 0 0/26 (0%) 0 0/24 (0%) 0
Injury, poisoning and procedural complications
Hypobarism 0/26 (0%) 0 1/26 (3.8%) 1 0/26 (0%) 0 0/26 (0%) 0 0/26 (0%) 0 0/24 (0%) 0
Muscle strain 0/26 (0%) 0 1/26 (3.8%) 1 0/26 (0%) 0 0/26 (0%) 0 0/26 (0%) 0 0/24 (0%) 0
Procedural pain 1/26 (3.8%) 1 1/26 (3.8%) 1 0/26 (0%) 0 1/26 (3.8%) 1 0/26 (0%) 0 0/24 (0%) 0
Skin laceration 0/26 (0%) 0 0/26 (0%) 0 1/26 (3.8%) 1 0/26 (0%) 0 0/26 (0%) 0 0/24 (0%) 0
Investigations
White blood cell count increased 0/26 (0%) 0 0/26 (0%) 0 0/26 (0%) 0 1/26 (3.8%) 1 0/26 (0%) 0 0/24 (0%) 0
Metabolism and nutrition disorders
Decreased appetite 1/26 (3.8%) 2 2/26 (7.7%) 2 0/26 (0%) 0 0/26 (0%) 0 0/26 (0%) 0 0/24 (0%) 0
Musculoskeletal and connective tissue disorders
Arthralgia 0/26 (0%) 0 2/26 (7.7%) 2 0/26 (0%) 0 0/26 (0%) 0 2/26 (7.7%) 2 0/24 (0%) 0
Back pain 0/26 (0%) 0 0/26 (0%) 0 2/26 (7.7%) 2 1/26 (3.8%) 1 1/26 (3.8%) 1 0/24 (0%) 0
Costochondritis 1/26 (3.8%) 1 0/26 (0%) 0 0/26 (0%) 0 0/26 (0%) 0 0/26 (0%) 0 0/24 (0%) 0
Joint stiffness 0/26 (0%) 0 1/26 (3.8%) 1 0/26 (0%) 0 0/26 (0%) 0 0/26 (0%) 0 0/24 (0%) 0
Muscle spasms 0/26 (0%) 0 0/26 (0%) 0 0/26 (0%) 0 1/26 (3.8%) 1 0/26 (0%) 0 0/24 (0%) 0
Musculoskeletal chest pain 1/26 (3.8%) 1 0/26 (0%) 0 0/26 (0%) 0 0/26 (0%) 0 0/26 (0%) 0 0/24 (0%) 0
Musculoskeletal pain 1/26 (3.8%) 1 1/26 (3.8%) 1 1/26 (3.8%) 1 0/26 (0%) 0 0/26 (0%) 0 0/24 (0%) 0
Myalgia 2/26 (7.7%) 3 1/26 (3.8%) 2 2/26 (7.7%) 4 2/26 (7.7%) 3 1/26 (3.8%) 1 0/24 (0%) 0
Neck pain 1/26 (3.8%) 1 0/26 (0%) 0 2/26 (7.7%) 2 1/26 (3.8%) 1 0/26 (0%) 0 0/24 (0%) 0
Nervous system disorders
Dizziness 1/26 (3.8%) 1 1/26 (3.8%) 1 1/26 (3.8%) 1 1/26 (3.8%) 1 1/26 (3.8%) 1 0/24 (0%) 0
Headache 20/26 (76.9%) 35 20/26 (76.9%) 35 18/26 (69.2%) 28 16/26 (61.5%) 28 12/26 (46.2%) 19 0/24 (0%) 0
Hypoaesthesia 0/26 (0%) 0 1/26 (3.8%) 1 0/26 (0%) 0 0/26 (0%) 0 0/26 (0%) 0 0/24 (0%) 0
Loss of consciousness 0/26 (0%) 0 0/26 (0%) 0 1/26 (3.8%) 1 0/26 (0%) 0 0/26 (0%) 0 0/24 (0%) 0
Paraesthesia 0/26 (0%) 0 1/26 (3.8%) 1 0/26 (0%) 0 0/26 (0%) 0 0/26 (0%) 0 0/24 (0%) 0
Presyncope 0/26 (0%) 0 0/26 (0%) 0 0/26 (0%) 0 0/26 (0%) 0 1/26 (3.8%) 1 0/24 (0%) 0
Psychiatric disorders
Abnormal dreams 0/26 (0%) 0 0/26 (0%) 0 0/26 (0%) 0 1/26 (3.8%) 1 0/26 (0%) 0 0/24 (0%) 0
Depression 0/26 (0%) 0 0/26 (0%) 0 0/26 (0%) 0 0/26 (0%) 0 1/26 (3.8%) 1 0/24 (0%) 0
Insomnia 0/26 (0%) 0 1/26 (3.8%) 1 0/26 (0%) 0 0/26 (0%) 0 0/26 (0%) 0 0/24 (0%) 0
Sleep disorder 0/26 (0%) 0 0/26 (0%) 0 1/26 (3.8%) 1 0/26 (0%) 0 0/26 (0%) 0 0/24 (0%) 0
Respiratory, thoracic and mediastinal disorders
Cough 1/26 (3.8%) 1 2/26 (7.7%) 2 0/26 (0%) 0 0/26 (0%) 0 0/26 (0%) 0 0/24 (0%) 0
Respiratory tract congestion 0/26 (0%) 0 1/26 (3.8%) 1 0/26 (0%) 0 0/26 (0%) 0 0/26 (0%) 0 0/24 (0%) 0
Rhinorrhoea 0/26 (0%) 0 0/26 (0%) 0 1/26 (3.8%) 1 1/26 (3.8%) 1 0/26 (0%) 0 0/24 (0%) 0
Sinus congestion 0/26 (0%) 0 0/26 (0%) 0 1/26 (3.8%) 1 0/26 (0%) 0 0/26 (0%) 0 0/24 (0%) 0
Skin and subcutaneous tissue disorders
Acne 0/26 (0%) 0 0/26 (0%) 0 0/26 (0%) 0 1/26 (3.8%) 1 0/26 (0%) 0 0/24 (0%) 0
Dermatitis contact 0/26 (0%) 0 1/26 (3.8%) 1 0/26 (0%) 0 0/26 (0%) 0 0/26 (0%) 0 0/24 (0%) 0
Erythema 2/26 (7.7%) 2 0/26 (0%) 0 0/26 (0%) 0 0/26 (0%) 0 0/26 (0%) 0 0/24 (0%) 0
Hyperhidrosis 0/26 (0%) 0 0/26 (0%) 0 2/26 (7.7%) 2 1/26 (3.8%) 1 0/26 (0%) 0 0/24 (0%) 0
Night sweats 1/26 (3.8%) 1 2/26 (7.7%) 2 0/26 (0%) 0 0/26 (0%) 0 0/26 (0%) 0 0/24 (0%) 0
Photosensitivity reaction 0/26 (0%) 0 1/26 (3.8%) 1 0/26 (0%) 0 0/26 (0%) 0 0/26 (0%) 0 0/24 (0%) 0
Rash 1/26 (3.8%) 1 2/26 (7.7%) 2 1/26 (3.8%) 1 0/26 (0%) 0 0/26 (0%) 0 0/24 (0%) 0
Sensitive skin 1/26 (3.8%) 1 2/26 (7.7%) 3 1/26 (3.8%) 1 1/26 (3.8%) 2 0/26 (0%) 0 0/24 (0%) 0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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

Name/Title GSK Response Center
Organization GlaxoSmithKline
Phone 877-379-3718
Email GSKClinicalSupportHD@gsk.com
Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT03162614
Other Study ID Numbers:
  • 205081
First Posted:
May 22, 2017
Last Update Posted:
Oct 27, 2020
Last Verified:
Oct 1, 2020