Safety, Immunogenicity of RTS,S/AS02A, and RTS,S/AS01B Malaria Vaccines in Malaria-experienced Adults.

• Sponsor: U.S. Army Medical Research and Development Command (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT00197054
• Collaborator: GlaxoSmithKline (Industry), Walter Reed Army Institute of Research (WRAIR) (U.S. Fed)
• Enrollment: 255
• Location: 1
• Arms: 3
• Actual Duration (Months): 14
• Patients Per Site Per Month: 18.2

Study Details

Study Description

Brief Summary

The candidate malaria vaccine RTS,S/AS02A developed by GSK Biologicals demonstrated 30% efficacy against clinical episodes of malaria and approximately 58% efficacy against severe malaria disease. As a potential improvement to RTS,S/AS02A, another candidate vaccine RTS,S/AS01B is being developed in parallel in collaboration with the Walter Reed Army Institute of Research (WRAIR). This study will be the first administration of the RTS,S/AS01B vaccine to the African adults to establish safety and immunogenicity in this population. Preliminary indication of vaccine efficacy with this adjuvant will be established by monitoring the time to the first infection with Plasmodium falciparum.

Condition or Disease	Intervention/Treatment	Phase
Plasmodium Falciparum	Biological: RTS, S/AS01B; Biological: RTS, S/AS02A; Biological: Rabipur (Rabies) Vaccine	Phase 2

Detailed Description

The study comprises of 3 groups and the participating subjects will be randomly allocated to one of the three groups. The first group will receive RTS,S/AS01B, the second group will receive RTS,S/AS02A and the third group will receive rabies vaccine. Immunization will be given by IM injection on 0, 1, 2 month schedule. Infants will be followed up daily for 7 days for solicited symptoms and 30 days for unsolicited symptoms after each vaccine dose. Serious adverse events will be recorded throughout the study period. A week prior to Dose 3, subjects will be treated with a licenced anti-malarial drug. Starting from two weeks after Dose 3, the subjects will be monitored for a 14-week duration for detection of malaria infection.

Study Design

• Study Type: Interventional
• Actual Enrollment: 255 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: A Phase IIb Randomized, Double-blind, Controlled Study of the Safety, Immunogenicity and Proof-of-concept of RTS,S/AS02A, and RTS,S/AS01B, Two Candidate Malaria Vaccines in Malaria-experienced Adults Living in Western Kenya.
• Actual Study Start Date: Jul 1, 2005
• Actual Primary Completion Date: Sep 1, 2006
• Actual Study Completion Date: Sep 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: VACC 1 (RTS, S/AS01B) RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Biological: RTS, S/AS01B; 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.
Experimental: VACC 2 (RTS, S/AS02A) RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Biological: RTS, S/AS02A; 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.
Active Comparator: Rabipur (Rabies) Vaccine Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Biological: Rabipur (Rabies) Vaccine; 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months

Outcome Measures

Primary Outcome Measures

1. Safety: Proportion of Subjects With Grade 3 Solicited and Unsolicited General Reactions After Vaccination of RTS, S/AS02A and RTS, S/AS01B [7 day follow-up (day of vaccination + 6 days)]

   Proportion of subjects with grade 3 solicited and unsolicited general reactions after vaccination of RTS, S/AS02A and RTS, S/AS01B during a 7 day follow-up period (day of vaccination + 6 days).

2. Safety: Number of Administered Doses Eliciting Grade 3 Unsolicited Symptoms [6.5 months]

   Grade 3 unsolicited symptoms reported following any number of administered doses

3. Safety: Number of Doses Eliciting Solicited Local Symptoms Reported Over 7 Day Follow-up Period [7 day follow-up period (day of vaccination + 6 days)]

   Incidence overall solicited general and local reactions over 7 day follow-up period after dose 1, 2 and 3 (Total Cohort)

Secondary Outcome Measures

1. Safety: Occurrence of SAEs [months 6.5 thru 12]

   Percentage of subjects experiencing SAEs classified by MedRA System Organ Class and Preferred Term (Month 6.5-12)

2. Safety: Occurrence of SAEs [months 0 thru 12]

   Percentage of subjects reporting SAEs classified by MedDRA System Organ Class and Preferred Term (Month 0-12)

3. Occurrence of Hematology Parameters Below Normal Range [Days 0, 6, 66, and 90; Months 6 and 12]

   Occurrence of hematology parameters below normal range (Total Cohort)

4. Occurrence of Biochemistry Parameters Above Normal Ranges [Days 0, 6, and 90]

   Occurrence of parameters of biochemical monitoring above normal ranges (Total Cohort)

Other Outcome Measures

1. Seropositivity Rates for Anti-HBs Antibodies by Infection Status PRE [Prevaccination]

   Seropositivity rates and GMTs for Anti-HBs antibodies by infection status (Total Cohort) Seropositive >3.3 mlU/mL; Seroprotected >10 mIU/mL Infection defined as P. falciparum asexual parasitemia >0 PRE= Prevaccination

2. Seropositivity Rates for Anti-HBs Antibodies by Infection Status PIII(D90) [Day 90]

   Seropositivity rates and GMTs for Anti-HBs antibodies by infection status (Total Cohort) Seropositive >3.3 mlU/mL; Seroprotected: >10 mlU/mL Infection defined as P. falciparum asexual parasitemia >0 PIII(D90)= post dose 3 (day 90)

3. Seropositivity Rates for Anti-HBs Antibodies by Infection Status PIII(M12) [Month 12]

   Seropositivity rates and GMTs for Anti-HBs antibodies by infection status (Total Cohort) Seropositive >3.3 mlU/mL; Seroprotected: >10 mlU/mL Infection defined as P. falciparum asexual parasitemia >0 PIII(M12)= post dose 3 (month 12)

4. Seropositivity Rates for Anti-HBs Antibodies by Vaccine Group PRE [Prevaccination]

   Seropositivity rates for Anti-HBs antibodies by vaccine group (ATP Cohort for Immunogenicity). Seropositive >3.3 mlU/ML PRE=Prevaccination

5. Seropositivity Rates for Anti-HBs Antibodies by Vaccine Group PIII(D90) [Day 90]

   Seropositivity rates for Anti-HBs antibodies by vaccine group (ATP Cohort for Immunogenicity). Seropositive >3.3 mlU/ML PIII(D90)= post dose 3 (Day 90)

6. Seropositivity Rates for Anti-HBs Antibodies by Vaccine Group PIII(M12) [Month 12]

   Seropositivity rates for Anti-HBs antibodies by vaccine group (ATP Cohort for Immunogenicity). Seropositive >3.3 mlU/ML PIII(M12)= post dose 3 (Month 12)

7. Seroprotection Rates for Anti-HBs Antibodies by Vaccine Group PRE [Prevaccination]

   Seroprotection rates for Anti-HBs antibodies by vaccine group (ATP Cohort for Immunogenicity). Seroprotected >10 mlU/mL PRE=Prevaccination

8. Seroprotection Rates for Anti-HBs Antibodies by Vaccine Group PIII (D90) [Day 90]

   Seroprotection rates for Anti-HBs antibodies by vaccine group (ATP Cohort for Immunogenicity). Seroprotected >10 mlU/mL PIII(D90)= post dose 3 (Day 90)

9. Seroprotection Rates for Anti-HBs Antibodies by Vaccine Group PIII (M12) [Month 12]

   Seroprotection rates for Anti-HBs antibodies by vaccine group (ATP Cohort for Immunogenicity). Seroprotected >10 mlU/mL PIII(M12)= post dose 3 (Month 12)

10. Geometric Mean Antibody Titers (GMTs) for Anti-HBs Antibodies by Vaccine Group PRE [Prevaccination]

    Geometric mean antibody titers (GMTs) for Anti-HBs antibodies by vaccine group (According to protocol (ATP) Cohort for Immunogenicity) PRE=Prevaccination

11. Geometric Mean Titers (GMTs) for Anti-HBs Antibodies by Vaccine Group PIII (D90) [Day 90]

    Geometric mean titers (GMTs) for Anti-HBs antibodies by vaccine group (According to protocol (ATP) Cohort for Immunogenicity) PIII(D90)= post dose 3 (Day 90)

12. Geometric Mean Titers (GMTs) for Anti-HBs Antibodies by Vaccine Group PIII (M12) [Month 12]

    Geometric mean titers (GMTs) for Anti-HBs antibodies by vaccine group (According to protocol (ATP) Cohort for Immunogenicity) PIII(M12)= post dose 3 (Month 12)

13. Geometric Mean Titers (GMTs) for Anti-HBs Antibodies by Infection Status PRE [Prevaccination]

    Geometric mean titers (GMTs) for Anti-HBs antibodies by infection status (Total Cohort) Infection defined as P. falciparum asexual parasitemia >0 PRE= Prevaccination

14. Geometric Mean Titers (GMTs) for Anti-HBs Antibodies by Infection Status PIII (D90) [Day 90]

    Geometric mean titers (GMTs) for Anti-HBs antibodies by infection status (Total Cohort) Infection defined as P. falciparum asexual parasitemia >0 PIII(D90)= post dose 3 (day 90)

15. Geometric Mean Titers (GMTs) for Anti-HBs Antibodies by Infection Status PIII (M12) [Month 12]

    Geometric mean titers (GMTs) for Anti-HBs antibodies by infection status (Total Cohort) Infection defined as P. falciparum asexual parasitemia >0 PIII(M12)= post dose 3 (month 12)

16. Geometric Mean Titers (GMTs) for Anti-CS Antibodies up to Month 12 by Vaccine Group PRE [Prevaccination]

    Geometric mean titers (GMTs) for Anti-CS antibodies accessed prevaccination, 1 month post dose 2, 1 month post dose 3, 4 months post dose 3 and 10 months post dose 3 PRE= prevaccination

17. Geometric Mean Titers (GMTs) for Anti-CS Antibodies up to Month 12 by Vaccine Group PII (D60) [1 month post dose 2]

    Geometric mean titers (GMTs) for Anti-CS antibodies accessed prevaccination, 1 month post dose 2, 1 month post dose 3, 4 months post dose 3 and 10 months post dose 3 PII(D60)= post dose 2 (day 60)

18. Geometric Mean Titers (GMTs) for Anti-CS Antibodies up to Month 12 by Vaccine Group PIII (D90) [1 month post dose 3]

    Geometric mean titers (GMTs) for Anti-CS antibodies accessed prevaccination, 1 month post dose 2, 1 month post dose 3, 4 months post dose 3 and 10 months post dose 3 PIII(D90)= post dose 3 (day 90)

19. Geometric Mean Titers (GMTs) for Anti-CS Antibodies up to Month 12 by Vaccine Group PIII (M6.5) [4 months post dose 3]

    Geometric mean titers (GMTs) for Anti-CS antibodies accessed prevaccination, 1 month post dose 2, 1 month post dose 3, 4 months post dose 3 and 10 months post dose 3 PIII(M6.5)= post dose 3 (month 6.5)

20. Geometric Mean Titers (GMTs) for Anti-CS Antibodies up to Month 12 by Vaccine Group PIII (M12) [10 months post dose 3]

    Geometric mean titers (GMTs) for Anti-CS antibodies accessed prevaccination, 1 month post dose 2, 1 month post dose 3, 4 months post dose 3 and 10 months post dose 3 PIII(M12)= post dose 3 (month 12)

21. Geometric Mean Antibody Titers (GMTs) for Anti-CS Antibodies by Infection Status PRE [PRE]

    Geometric mean antibody titers (GMTs) for Anti-CS antibodies by infection status on RTS,S/AS01B and RTS,S/AS02A recipients only Infection defined as P. falciparum asexual parasitemia >0 PRE= Pre-vaccination

22. Geometric Mean Antibody Titers (GMTs) for Anti-CS Antibodies by Infection Status PII (D60) [post dose 2 (day 60)]

    Geometric mean antibody titers (GMTs) for Anti-CS antibodies by infection status on RTS,S/AS01B and RTS,S/AS02A recipients only Infection defined as P. falciparum asexual parasitemia >0 PII(D60)= post dose 2 (day 60)

23. Geometric Mean Antibody Titers (GMTs) for Anti-CS Antibodies by Infection Status PIII (D90) [post dose 3 (day 90)]

    Geometric mean antibody titers (GMTs) for Anti-CS antibodies by infection status on RTS,S/AS01B and RTS,S/AS02A recipients only Infection defined as P. falciparum asexual parasitemia >0 PIII(D90)= post dose 3 (day 90)

24. Geometric Mean Antibody Titers (GMTs) for Anti-CS Antibodies by Infection Status PIII (M6.5) [post dose 3 (month 6.5)]

    Geometric mean antibody titers (GMTs) for Anti-CS antibodies by infection status on RTS,S/AS01B and RTS,S/AS02A recipients only Infection defined as P. falciparum asexual parasitemia >0 PIII(M6.5)= post dose 3 (month 6.5)

25. Seropositivity Rates for Anti-CS Antibodies by Vaccine Group PRE [Prevaccination]

    Seropositivity rates for Anti-CS antibodies accessed prevaccination, 1 month post dose 2, 1 month post dose 3, 4 months post dose 3 and 10 months post dose 3 PRE= prevaccination

26. Seropositivity Rates for Anti-CS Antibodies by Vaccine Group PII (D60) [1 month post dose 2]

    Seropositivity rates for Anti-CS antibodies accessed prevaccination, 1 month post dose 2, 1 month post dose 3, 4 months post dose 3 and 10 months post dose 3. PII(D60)= post dose 2 (day 60)

27. Seropositivity Rates for Anti-CS Antibodies by Vaccine Group PIII (D90) [1 month post dose 3]

    Seropositivity rates for Anti-CS antibodies accessed prevaccination, 1 month post dose 2, 1 month post dose 3, 4 months post dose 3 and 10 months post dose 3 PIII(D90)= post dose 3 (day 90)

28. Seropositivity Rates for Anti-CS Antibodies by Vaccine Group PIII (M6.5) [4 months post dose 3]

    Seropositivity rates for Anti-CS antibodies accessed prevaccination, 1 month post dose 2, 1 month post dose 3, 4 months post dose 3 and 10 months post dose 3 PIII(M6.5)= post dose 3 (month 6.5)

29. Seropositivity Rates for Anti-CS Antibodies by Vaccine Group PIII (M12) [10 months post dose 3]

    Seropositivity rates for Anti-CS antibodies accessed prevaccination, 1 month post dose 2, 1 month post dose 3, 4 months post dose 3 and 10 months post dose 3 PIII(M12)= post dose 3 (month 12)

30. Seropositivity Rates for Anti-CS Antibodies by Infection Status PRE [Prevaccination]

    Seropositivity rates for Anti-CS antibodies by infection status on RTS,S/AS01B and RTS,S/AS02A recipients only Seropositive: >0.5EU/mL Infection defined as P. falciparum asexual parasitemia >0 PRE= Pre-vaccination

31. Seropositivity Rates for Anti-CS Antibodies by Infection Status PII (D60) [post dose 2 (day 60)]

    Seropositivity rates for Anti-CS antibodies by infection status on RTS,S/AS01B and RTS,S/AS02A recipients only Seropositive: >0.5EU/mL Infection defined as P. falciparum asexual parasitemia >0 PII(D60)= post dose 2 (day 60)

32. Seropositivity Rates for Anti-CS Antibodies by Infection Status PIII (D90) [post dose 3 (day 90)]

    Seropositivity rates for Anti-CS antibodies by infection status on RTS,S/AS01B and RTS,S/AS02A recipients only Seropositive: >0.5EU/mL Infection defined as P. falciparum asexual parasitemia >0 PIII(D90)= post dose 3 (day 90)

33. Seropositivity Rates for Anti-CS Antibodies by Infection Status PIII (M6.5) [post dose 3 (month 6.5)]

    Seropositivity rates for Anti-CS antibodies by infection status on RTS,S/AS01B and RTS,S/AS02A recipients only Seropositive: >0.5EU/mL Infection defined as P. falciparum asexual parasitemia >0 PIII(M6.5)= post dose 3 (month 6.5)

34. Efficacy: Vaccine Efficacy Against P. Falciparum Infection [14 days after dose 3 and extending for 14 weeks]

    Number of subjects with an episode of parasitemia (first recording of infection of asexual stage falciparum parasites >0 detected by active detection of infection (ADI) or passive case detection)

35. Percentage of Participants With Positive and Negative Parasite Density [at month 6.5]

    Percentage of participants with positive and negative parasite density at month 6.5

36. Geometric Mean Antibody Titers (GMTs) of Asexual P. Falciparum Parasitemia [Month 6.5]

    Geometric Mean Antibody Titers (GMTs) of Asexual P. falciparum parasitemia at Month 6.5

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion criteria:

• Healthy male or female volunteers aged between 18 and 35 years at the time of first vaccination who have given written consent for their participation in the study were included

• If the volunteer is female, she must be of non-childbearing potential, i.e. either surgically sterilized or one year post-menopausal; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series

Exclusion criteria:

• If a subject plans to take vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine(s) with the exception of tetanus toxoid will be excluded

• Volunteers with any confirmed or suspected immunosuppressive or immunodeficient conditions

• Family history of congenital or hereditary immunodeficiency

• History of allergic reactions to previous immunizations

• HBsAg positive subjects

• History of splenectomy

• Pregnant or lactating females will be excluded from the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	U.S. Army Research Unit-Kenya	Kisumu		Kenya

Sponsors and Collaborators

• U.S. Army Medical Research and Development Command
• GlaxoSmithKline
• Walter Reed Army Institute of Research (WRAIR)

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: U.S. Army Medical Research and Development Command
• ClinicalTrials.gov Identifier: NCT00197054
• Other Study ID Numbers: A-12227; IND 11220
• First Posted: Sep 20, 2005
• Last Update Posted: Feb 12, 2021
• Last Verified: Feb 1, 2021

• 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
• Additional relevant MeSH terms: Malaria

Study Results

Participant Flow

Recruitment Details	255 subjects were enrolled and randomized 1:1:1 into each arm at Kombewa Clinic, US Army Medical Research Unit, Kisumu Kenya.

Arm/Group Title	RTS, S/AS02A	RTS, S/AS01B	Rabipur (Rabies) Vaccine
Arm/Group Description	RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
Period Title: Overall Study
STARTED	85	85	85
COMPLETED	68	64	73
NOT COMPLETED	17	21	12

Baseline Characteristics

Arm/Group Title	RTS, S/AS02A	RTS, S/AS01B	Rabipur (Rabies) Vaccine	Total
Arm/Group Description	RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months	Total of all reporting groups
Overall Participants	85	85	85	255
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	25.2 (5.16)	24.9 (5.50)	26.1 (5.10)	25.4 (5.26)
Sex: Female, Male (Count of Participants)
Female	19 22.4%	21 24.7%	12 14.1%	52 20.4%
Male	66 77.6%	64 75.3%	73 85.9%	203 79.6%
Region of Enrollment (participants) [Number]
Kenya	85 100%	85 100%	85 100%	255 100%

Outcome Measures

1. Primary Outcome

Title	Safety: Proportion of Subjects With Grade 3 Solicited and Unsolicited General Reactions After Vaccination of RTS, S/AS02A and RTS, S/AS01B
Description	Proportion of subjects with grade 3 solicited and unsolicited general reactions after vaccination of RTS, S/AS02A and RTS, S/AS01B during a 7 day follow-up period (day of vaccination + 6 days).
Time Frame	7 day follow-up (day of vaccination + 6 days)

Outcome Measure Data

Analysis Population Description

Rabipur was a comparator vaccine and not relevant to results of this primary outcome. Results for Rabipur were not presented in data table.

Arm/Group Title	RTS, S/AS02A	RTS, S/AS01B
Arm/Group Description	RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.
Measure Participants	85	85
Number (95% Confidence Interval) [participants]	0 0%	1 1.2%

2. Primary Outcome

Title	Safety: Number of Administered Doses Eliciting Grade 3 Unsolicited Symptoms
Description	Grade 3 unsolicited symptoms reported following any number of administered doses
Time Frame	6.5 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	RTS, S/AS01B	RTS, S/AS02A	Rabipur (Rabies) Vaccine
Arm/Group Description	RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
Measure Participants	85	85	85
Measure Doses	242	247	247
At least one symptom	3	0	1
Sinusitis	1	0	0
Headache	1	0	1
Cough	1	0	0

3. Primary Outcome

Title	Safety: Number of Doses Eliciting Solicited Local Symptoms Reported Over 7 Day Follow-up Period
Description	Incidence overall solicited general and local reactions over 7 day follow-up period after dose 1, 2 and 3 (Total Cohort)
Time Frame	7 day follow-up period (day of vaccination + 6 days)

Outcome Measure Data

Analysis Population Description

number of administered doses

Arm/Group Title	RTS, S/AS01B	RTS, S/AS02A	Rabipur (Rabies) Vaccine
Arm/Group Description	RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
Measure Participants	85	85	85
Measure Doses	242	247	247
Pain	132	166	68
Swelling	12	22	2
Fatigue	43	33	35
Fever (Axillary)	21	14	12
Gastrointestinal	48	42	44
Headache	84	95	67
Joint pain at other location	27	22	22
Muscle aches	27	23	29

4. Secondary Outcome

Title	Safety: Occurrence of SAEs
Description	Percentage of subjects experiencing SAEs classified by MedRA System Organ Class and Preferred Term (Month 6.5-12)
Time Frame	months 6.5 thru 12

Outcome Measure Data

Analysis Population Description

Number of subjects with at least one administered dose

Arm/Group Title	RTS, S/AS01B	RTS, S/AS02A	Rabipur (Rabies) Vaccine
Arm/Group Description	RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
Measure Participants	74	76	76
Anaemia	1.4	0.0	0.0
Cardiac Failure	0.0	0.0	1.3
Pericardial Effusion	0.0	0.0	1.3
Cataract	0.0	0.0	1.3
Wound Necrosis	1.4	0.0	0.0
Abscess Limb	0.0	0.0	1.3
HIV Infection	1.4	0.0	1.3
Lobar Pneumonia	1.4	0.0	0.0
Malaria	0.0	1.3	0.0
Meningitis	1.4	0.0	1.3
Pneumonia	1.4	0.0	0.0
Pulmonary Tuberculosis	0.0	0.0	1.3
Trichomoniasis	1.4	0.0	0.0
Abortion	1.4	0.0	0.0
Haemoptysis	2.4	0.0	0.0
Pleural Effusion	0.0	0.0	1.3

5. Secondary Outcome

Title	Safety: Occurrence of SAEs
Description	Percentage of subjects reporting SAEs classified by MedDRA System Organ Class and Preferred Term (Month 0-12)
Time Frame	months 0 thru 12

Outcome Measure Data

Analysis Population Description

Number of subjects with at least one administered dose

Arm/Group Title	RTS, S/AS01B	RTS, S/AS02A	Rabipur (Rabies) Vaccine
Arm/Group Description	RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
Measure Participants	85	85	85
Anaemia	1.2	0.0	0.0
Cardiac Failure	0.0	0.0	1.2
Pericardial Effusion	0.0	0.0	1.2
Cataract	0.0	0.0	1.2
Peptic Ulcer Haemorrhage	1.2	0.0	0.0
Wound Necrosis	1.2	0.0	0.0
Abscess Limb	0.0	0.0	1.2
Disseminated Tuberculosis	1.2	0.0	0.0
HIV Infection	2.4	0.0	3.5
Lobar Pneumonia	1.2	0.0	0.0
Malaria	0.0	1.2	0.0
Meningitis	1.2	0.0	1.2
Meningitis Cryptococcal	0.0	0.0	1.2
Pneumocystis Jiroveci Pheumonia	1.2	0.0	0.0
Pneumonia	1.2	0.0	0.0
Pulmonary Tuberculosis	0.0	0.0	1.2
Trichomoniasis	1.2	0.0	0.0
Osteoarthritis	1.2	0.0	0.0
Encephalitis	1.2	0.0	0.0
Abortion	1.2	0.0	0.0
Haemoptysis	1.2	0.0	0.0
Pleural Effusion	0.0	0.0	1.2

6. Secondary Outcome

Title	Occurrence of Hematology Parameters Below Normal Range
Description	Occurrence of hematology parameters below normal range (Total Cohort)
Time Frame	Days 0, 6, 66, and 90; Months 6 and 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	RTS, S/AS01B	RTS, S/AS02A	Rabipur (Rabies) Vaccine
Arm/Group Description	RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
Measure Participants	85	85	85
Hemoglobin: Day 0	0 0%	0 0%	0 0%
Hemoglobin: Day 6	4 4.7%	1 1.2%	1 1.2%
Hemoglobin: Day 66	2 2.4%	1 1.2%	2 2.4%
Hemoglobin: Day 90	2 2.4%	0 0%	2 2.4%
hemoglobin: Month 6	2 2.4%	1 1.2%	1 1.2%
Hemoglobin: Month 12	4 4.7%	2 2.4%	0 0%
WBC: Day 0	0 0%	0 0%	0 0%
WBC: Day 6	0 0%	0 0%	1 1.2%
WBC: Day 66	0 0%	0 0%	1 1.2%
WBC: Day 90	3 3.5%	0 0%	0 0%
WBC: Month 6	2 2.4%	0 0%	1 1.2%
WBC: Month 12	2 2.4%	0 0%	0 0%
Lymphocytes: Day 0	0 0%	0 0%	0 0%
Lymphocytes: Day 6	0 0%	0 0%	1 1.2%
Lymphocytes: Day 66	0 0%	0 0%	0 0%
Lymphocytes: Day 90	1 1.2%	0 0%	0 0%
Lymphocytes: Month 6	1 1.2%	0 0%	0 0%
Lymphocytes: Month 12	1 1.2%	0 0%	0 0%

7. Secondary Outcome

Title	Occurrence of Biochemistry Parameters Above Normal Ranges
Description	Occurrence of parameters of biochemical monitoring above normal ranges (Total Cohort)
Time Frame	Days 0, 6, and 90

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	RTS, S/AS01B	RTS, S/AS02A	Rabipur (Rabies) Vaccine
Arm/Group Description	RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.
Measure Participants	85	85	85
Bilirubin: Day 0	10 11.8%	9 10.6%	11 12.9%
Bilirubin: Day 6	6 7.1%	4 4.7%	7 8.2%
Bilirubin: Day 90	3 3.5%	3 3.5%	6 7.1%
ALT: Day 0	0 0%	0 0%	0 0%
ALT: Day 6	1 1.2%	6 7.1%	0 0%
ALT: Day 90	0 0%	1 1.2%	3 3.5%

8. Other Pre-specified Outcome

Title	Seropositivity Rates for Anti-HBs Antibodies by Infection Status PRE
Description	Seropositivity rates and GMTs for Anti-HBs antibodies by infection status (Total Cohort) Seropositive >3.3 mlU/mL; Seroprotected >10 mIU/mL Infection defined as P. falciparum asexual parasitemia >0 PRE= Prevaccination
Time Frame	Prevaccination

Outcome Measure Data

Analysis Population Description

The Total Vaccinated Cohort includes all vaccinated subjects for whom data were available. For seropositivity rates by infection status arms have been combined.

Arm/Group Title	>=3.3 MIU/ML	>=10 MIU/ML
Arm/Group Description	Seropositive: >3.3 mlU/mL	Seroprotected: >10 mlU/mL
Measure Participants	163	163
% of Non-infected	38.8 45.6%	37.3 43.9%
% of Infected	50.0 58.8%	44.8 52.7%

9. Other Pre-specified Outcome

Title	Seropositivity Rates for Anti-HBs Antibodies by Infection Status PIII(D90)
Description	Seropositivity rates and GMTs for Anti-HBs antibodies by infection status (Total Cohort) Seropositive >3.3 mlU/mL; Seroprotected: >10 mlU/mL Infection defined as P. falciparum asexual parasitemia >0 PIII(D90)= post dose 3 (day 90)
Time Frame	Day 90

Outcome Measure Data

Analysis Population Description

The Total Vaccinated Cohort includes all vaccinated subjects for whom data were available. For seropositivity rates by infection status arms have been combined.

Arm/Group Title	>=3.3 MIU/ML	>=10 MIU/ML
Arm/Group Description	Seropositive: >3.3 mlU/mL	Seroprotected: >10 mlU/mL
Measure Participants	152	152
% of Non-infected: PIII(D90)	96.5 113.5%	93.0 109.4%
% of Infected: PIII(D90)	93.7 110.2%	91.6 107.8%

10. Other Pre-specified Outcome

Title	Seropositivity Rates for Anti-HBs Antibodies by Infection Status PIII(M12)
Description	Seropositivity rates and GMTs for Anti-HBs antibodies by infection status (Total Cohort) Seropositive >3.3 mlU/mL; Seroprotected: >10 mlU/mL Infection defined as P. falciparum asexual parasitemia >0 PIII(M12)= post dose 3 (month 12)
Time Frame	Month 12

Outcome Measure Data

Analysis Population Description

The Total Vaccinated Cohort includes all vaccinated subjects for whom data were available. For seropositivity rates by infection status arms have been combined.

Arm/Group Title	>=3.3 MIU/ML	>=10 MIU/ML
Arm/Group Description	Seropositive: >3.3 mlU/mL	Seroprotected: >10 mlU/mL
Measure Participants	132	132
% of Non-infected: PIII(M12)	97.9 115.2%	91.5 107.6%
% of Infected: PIII(M12)	92.9 109.3%	90.6 106.6%

11. Other Pre-specified Outcome

Title	Seropositivity Rates for Anti-HBs Antibodies by Vaccine Group PRE
Description	Seropositivity rates for Anti-HBs antibodies by vaccine group (ATP Cohort for Immunogenicity). Seropositive >3.3 mlU/ML PRE=Prevaccination
Time Frame	Prevaccination

Outcome Measure Data

Analysis Population Description

Subject with available results

Arm/Group Title	RTS, S/AS01B	RTS, S/AS02A	Rabipur (Rabies) Vaccine
Arm/Group Description	RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.
Measure Participants	73	70	68
Count of Participants [Participants]	31 36.5%	38 44.7%	35 41.2%

12. Other Pre-specified Outcome

Title	Seropositivity Rates for Anti-HBs Antibodies by Vaccine Group PIII(D90)
Description	Seropositivity rates for Anti-HBs antibodies by vaccine group (ATP Cohort for Immunogenicity). Seropositive >3.3 mlU/ML PIII(D90)= post dose 3 (Day 90)
Time Frame	Day 90

Outcome Measure Data

Analysis Population Description

Subjects with available results

Arm/Group Title	RTS, S/AS01B	RTS, S/AS02A	Rabipur (Rabies) Vaccine
Arm/Group Description	RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.
Measure Participants	72	72	65
Count of Participants [Participants]	68 80%	68 80%	37 43.5%

13. Other Pre-specified Outcome

Title	Seropositivity Rates for Anti-HBs Antibodies by Vaccine Group PIII(M12)
Description	Seropositivity rates for Anti-HBs antibodies by vaccine group (ATP Cohort for Immunogenicity). Seropositive >3.3 mlU/ML PIII(M12)= post dose 3 (Month 12)
Time Frame	Month 12

Outcome Measure Data

Analysis Population Description

Subjects with available results

Arm/Group Title	RTS, S/AS01B	RTS, S/AS02A	Rabipur (Rabies) Vaccine
Arm/Group Description	RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.
Measure Participants	61	62	66
Count of Participants [Participants]	57 67.1%	59 69.4%	40 47.1%

14. Other Pre-specified Outcome

Title	Seroprotection Rates for Anti-HBs Antibodies by Vaccine Group PRE
Description	Seroprotection rates for Anti-HBs antibodies by vaccine group (ATP Cohort for Immunogenicity). Seroprotected >10 mlU/mL PRE=Prevaccination
Time Frame	Prevaccination

Outcome Measure Data

Analysis Population Description

Subjects with available results

Arm/Group Title	RTS, S/AS01B	RTS, S/AS02A	Rabipur (Rabies) Vaccine
Arm/Group Description	RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.
Measure Participants	73	70	68
Count of Participants [Participants]	29 34.1%	34 40%	33 38.8%

15. Other Pre-specified Outcome

Title	Seroprotection Rates for Anti-HBs Antibodies by Vaccine Group PIII (D90)
Description	Seroprotection rates for Anti-HBs antibodies by vaccine group (ATP Cohort for Immunogenicity). Seroprotected >10 mlU/mL PIII(D90)= post dose 3 (Day 90)
Time Frame	Day 90

Outcome Measure Data

Analysis Population Description

Subject with available results

Arm/Group Title	RTS, S/AS01B	RTS, S/AS02A	Rabipur (Rabies) Vaccine
Arm/Group Description	RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.
Measure Participants	72	72	65
Count of Participants [Participants]	65 76.5%	67 78.8%	33 38.8%

16. Other Pre-specified Outcome

Title	Seroprotection Rates for Anti-HBs Antibodies by Vaccine Group PIII (M12)
Description	Seroprotection rates for Anti-HBs antibodies by vaccine group (ATP Cohort for Immunogenicity). Seroprotected >10 mlU/mL PIII(M12)= post dose 3 (Month 12)
Time Frame	Month 12

Outcome Measure Data

Analysis Population Description

Subjects with available results

Arm/Group Title	RTS, S/AS01B	RTS, S/AS02A	Rabipur (Rabies) Vaccine
Arm/Group Description	RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.
Measure Participants	61	62	66
Count of Participants [Participants]	55 64.7%	57 67.1%	33 38.8%

17. Other Pre-specified Outcome

Title	Geometric Mean Antibody Titers (GMTs) for Anti-HBs Antibodies by Vaccine Group PRE
Description	Geometric mean antibody titers (GMTs) for Anti-HBs antibodies by vaccine group (According to protocol (ATP) Cohort for Immunogenicity) PRE=Prevaccination
Time Frame	Prevaccination

Outcome Measure Data

Analysis Population Description

Subjects with available results

Arm/Group Title	RTS, S/AS01B	RTS, S/AS02A	Rabipur (Rabies) Vaccine
Arm/Group Description	RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
Measure Participants	73	70	68
Geometric Mean (95% Confidence Interval) [titers]	11.1	18.3	23.6

18. Other Pre-specified Outcome

Title	Geometric Mean Titers (GMTs) for Anti-HBs Antibodies by Vaccine Group PIII (D90)
Description	Geometric mean titers (GMTs) for Anti-HBs antibodies by vaccine group (According to protocol (ATP) Cohort for Immunogenicity) PIII(D90)= post dose 3 (Day 90)
Time Frame	Day 90

Outcome Measure Data

Analysis Population Description

Subjects with available results

Arm/Group Title	RTS, S/AS01B	RTS, S/AS02A	Rabipur (Rabies) Vaccine
Arm/Group Description	RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
Measure Participants	72	72	65
Geometric Mean (95% Confidence Interval) [titers]	1434.9	1714.3	31.7

19. Other Pre-specified Outcome

Title	Geometric Mean Titers (GMTs) for Anti-HBs Antibodies by Vaccine Group PIII (M12)
Description	Geometric mean titers (GMTs) for Anti-HBs antibodies by vaccine group (According to protocol (ATP) Cohort for Immunogenicity) PIII(M12)= post dose 3 (Month 12)
Time Frame	Month 12

Outcome Measure Data

Analysis Population Description

Subjects with available results

Arm/Group Title	RTS, S/AS01B	RTS, S/AS02A	Rabipur (Rabies) Vaccine
Arm/Group Description	RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
Measure Participants	61	62	66
Geometric Mean (95% Confidence Interval) [titers]	593.7	635.8	28.6

20. Other Pre-specified Outcome

Title	Geometric Mean Titers (GMTs) for Anti-HBs Antibodies by Infection Status PRE
Description	Geometric mean titers (GMTs) for Anti-HBs antibodies by infection status (Total Cohort) Infection defined as P. falciparum asexual parasitemia >0 PRE= Prevaccination
Time Frame	Prevaccination

Outcome Measure Data

Analysis Population Description

The Total Vaccinated Cohort includes all vaccinated subjects for whom data were available. For GMTs by infection status arms have been combined.

Arm/Group Title	Geometric Mean Antibody
Arm/Group Description	Geometric Mean Antibody titer calculated on all subjects
Measure Participants	163
Non-infected: PRE	11.1
Infected: PRE	13.5

21. Other Pre-specified Outcome

Title	Geometric Mean Titers (GMTs) for Anti-HBs Antibodies by Infection Status PIII (D90)
Description	Geometric mean titers (GMTs) for Anti-HBs antibodies by infection status (Total Cohort) Infection defined as P. falciparum asexual parasitemia >0 PIII(D90)= post dose 3 (day 90)
Time Frame	Day 90

Outcome Measure Data

Analysis Population Description

The Total Vaccinated Cohort includes all vaccinated subjects for whom data were available. For GMTs by infection status arms have been combined.

Arm/Group Title	Geometric Mean Antibody
Arm/Group Description	Geometric Mean Antibody titer calculated on all subjects
Measure Participants	152
Non-infected: PIII(D90)	1558.3
Infected: PIII(D90)	1532.6

22. Other Pre-specified Outcome

Title	Geometric Mean Titers (GMTs) for Anti-HBs Antibodies by Infection Status PIII (M12)
Description	Geometric mean titers (GMTs) for Anti-HBs antibodies by infection status (Total Cohort) Infection defined as P. falciparum asexual parasitemia >0 PIII(M12)= post dose 3 (month 12)
Time Frame	Month 12

Outcome Measure Data

Analysis Population Description

The Total Vaccinated Cohort includes all vaccinated subjects for whom data were available. For GMTs by infection status arms have been combined.

Arm/Group Title	Geometric Mean Antibody
Arm/Group Description	Geometric Mean Antibody titer calculated on all subjects
Measure Participants	132
Non-infected: PIII(M12)	765.8
Infected: PIII(M12)	499.0

23. Other Pre-specified Outcome

Title	Geometric Mean Titers (GMTs) for Anti-CS Antibodies up to Month 12 by Vaccine Group PRE
Description	Geometric mean titers (GMTs) for Anti-CS antibodies accessed prevaccination, 1 month post dose 2, 1 month post dose 3, 4 months post dose 3 and 10 months post dose 3 PRE= prevaccination
Time Frame	Prevaccination

Outcome Measure Data

Analysis Population Description

Immunogenicity (According to protocol (ATP) Cohort): 222 subjects (75 RTS,S/AS01B, 74 RTS,S/AS02A, 73 rabies vaccine)

Arm/Group Title	RTS, S/AS01B	RTS, S/AS02A	Rabipur (Rabies) Vaccine
Arm/Group Description	RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
Measure Participants	75	74	73
Geometric Mean (95% Confidence Interval) [titers]	2.2	1.2	1.9

24. Other Pre-specified Outcome

Title	Geometric Mean Titers (GMTs) for Anti-CS Antibodies up to Month 12 by Vaccine Group PII (D60)
Description	Geometric mean titers (GMTs) for Anti-CS antibodies accessed prevaccination, 1 month post dose 2, 1 month post dose 3, 4 months post dose 3 and 10 months post dose 3 PII(D60)= post dose 2 (day 60)
Time Frame	1 month post dose 2

Outcome Measure Data

Analysis Population Description

Immunogenicity (According to protocol (ATP) Cohort): 222 subjects (75 RTS,S/AS01B, 74 RTS,S/AS02A, 73 rabies vaccine)

Arm/Group Title	RTS, S/AS01B	RTS, S/AS02A	Rabipur (Rabies) Vaccine
Arm/Group Description	RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
Measure Participants	75	74	73
Geometric Mean (95% Confidence Interval) [titers]	31.6	16.7	1.8

25. Other Pre-specified Outcome

Title	Geometric Mean Titers (GMTs) for Anti-CS Antibodies up to Month 12 by Vaccine Group PIII (D90)
Description	Geometric mean titers (GMTs) for Anti-CS antibodies accessed prevaccination, 1 month post dose 2, 1 month post dose 3, 4 months post dose 3 and 10 months post dose 3 PIII(D90)= post dose 3 (day 90)
Time Frame	1 month post dose 3

Outcome Measure Data

Analysis Population Description

Immunogenicity (According to protocol (ATP) Cohort): 213 subjects (72 RTS,S/AS01B, 72 RTS,S/AS02A, 69 rabies vaccine)

Arm/Group Title	RTS, S/AS01B	RTS, S/AS02A	Rabipur (Rabies) Vaccine
Arm/Group Description	RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
Measure Participants	72	72	69
Geometric Mean (95% Confidence Interval) [titers]	41.4	21.4	1.1

26. Other Pre-specified Outcome

Title	Geometric Mean Titers (GMTs) for Anti-CS Antibodies up to Month 12 by Vaccine Group PIII (M6.5)
Description	Geometric mean titers (GMTs) for Anti-CS antibodies accessed prevaccination, 1 month post dose 2, 1 month post dose 3, 4 months post dose 3 and 10 months post dose 3 PIII(M6.5)= post dose 3 (month 6.5)
Time Frame	4 months post dose 3

Outcome Measure Data

Analysis Population Description

Immunogenicity (According to protocol (ATP) Cohort): 207 subjects (69 RTS,S/AS01B, 69 RTS,S/AS02A, 69 rabies vaccine)

Arm/Group Title	RTS, S/AS01B	RTS, S/AS02A	Rabipur (Rabies) Vaccine
Arm/Group Description	RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
Measure Participants	69	69	69
Geometric Mean (95% Confidence Interval) [titers]	23.1	13.1	1.5

27. Other Pre-specified Outcome

Title	Geometric Mean Titers (GMTs) for Anti-CS Antibodies up to Month 12 by Vaccine Group PIII (M12)
Description	Geometric mean titers (GMTs) for Anti-CS antibodies accessed prevaccination, 1 month post dose 2, 1 month post dose 3, 4 months post dose 3 and 10 months post dose 3 PIII(M12)= post dose 3 (month 12)
Time Frame	10 months post dose 3

Outcome Measure Data

Analysis Population Description

Immunogenicity (According to protocol (ATP) Cohort): 189 subjects (61 RTS,S/AS01B, 62 RTS,S/AS02A, 66 rabies vaccine)

Arm/Group Title	RTS, S/AS01B	RTS, S/AS02A	Rabipur (Rabies) Vaccine
Arm/Group Description	RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
Measure Participants	61	62	66
Geometric Mean (95% Confidence Interval) [titers]	14.2	7.3	1.7

28. Other Pre-specified Outcome

Title	Geometric Mean Antibody Titers (GMTs) for Anti-CS Antibodies by Infection Status PRE
Description	Geometric mean antibody titers (GMTs) for Anti-CS antibodies by infection status on RTS,S/AS01B and RTS,S/AS02A recipients only Infection defined as P. falciparum asexual parasitemia >0 PRE= Pre-vaccination
Time Frame	PRE

Outcome Measure Data

Analysis Population Description

The ATP Cohort includes all evaluable subjects for whom data were available. For GMTs by infection status arms have been combined.

Arm/Group Title	Geometric Mean Antibody Titer
Arm/Group Description	GMTs calculated on all subjects
Measure Participants	153
Infected: PRE	1.2
Non-infected: PRE	2.0

29. Other Pre-specified Outcome

Title	Geometric Mean Antibody Titers (GMTs) for Anti-CS Antibodies by Infection Status PII (D60)
Description	Geometric mean antibody titers (GMTs) for Anti-CS antibodies by infection status on RTS,S/AS01B and RTS,S/AS02A recipients only Infection defined as P. falciparum asexual parasitemia >0 PII(D60)= post dose 2 (day 60)
Time Frame	post dose 2 (day 60)

Outcome Measure Data

Analysis Population Description

The ATP Cohort includes all evaluable subjects for whom data were available. For GMTs by infection status arms have been combined.

Arm/Group Title	Geometric Mean Antibody Titer
Arm/Group Description	GMTs calculated on all subjects
Measure Participants	153
Infected: PII(D60)	11.9
Non-infected: PII(D60)	33.9

30. Other Pre-specified Outcome

Title	Geometric Mean Antibody Titers (GMTs) for Anti-CS Antibodies by Infection Status PIII (D90)
Description	Geometric mean antibody titers (GMTs) for Anti-CS antibodies by infection status on RTS,S/AS01B and RTS,S/AS02A recipients only Infection defined as P. falciparum asexual parasitemia >0 PIII(D90)= post dose 3 (day 90)
Time Frame	post dose 3 (day 90)

Outcome Measure Data

Analysis Population Description

The ATP Cohort includes all evaluable subjects for whom data were available. For GMTs by infection status arms have been combined.

Arm/Group Title	Geometric Mean Antibody Titer
Arm/Group Description	GMTs calculated on all subjects
Measure Participants	151
Infected: PIII(D90)	18.3
Non-infected: PIII(D90)	40.1

31. Other Pre-specified Outcome

Title	Geometric Mean Antibody Titers (GMTs) for Anti-CS Antibodies by Infection Status PIII (M6.5)
Description	Geometric mean antibody titers (GMTs) for Anti-CS antibodies by infection status on RTS,S/AS01B and RTS,S/AS02A recipients only Infection defined as P. falciparum asexual parasitemia >0 PIII(M6.5)= post dose 3 (month 6.5)
Time Frame	post dose 3 (month 6.5)

Outcome Measure Data

Analysis Population Description

The ATP Cohort includes all evaluable subjects for whom data were available. For GMTs by infection status arms have been combined.

Arm/Group Title	Geometric Mean Antibody Titer
Arm/Group Description	GMTs calculated on all subjects
Measure Participants	143
Infected: PIII(M6.5)	9.9
Non-infected: PIII(M6.5)	25.1

32. Other Pre-specified Outcome

Title	Seropositivity Rates for Anti-CS Antibodies by Vaccine Group PRE
Description	Seropositivity rates for Anti-CS antibodies accessed prevaccination, 1 month post dose 2, 1 month post dose 3, 4 months post dose 3 and 10 months post dose 3 PRE= prevaccination
Time Frame	Prevaccination

Outcome Measure Data

Analysis Population Description

Immunogenicity (ATP Cohort): 222 subjects (75 RTS,S/AS01B, 74 RTS,S/AS02A, 73 rabies vaccine)

Arm/Group Title	RTS, S/AS01B	RTS, S/AS02A	Rabipur (Rabies) Vaccine
Arm/Group Description	RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
Measure Participants	75	74	73
Number (95% Confidence Interval) [percentage of participants]	86.7 102%	75.7 89.1%	84.9 99.9%

33. Other Pre-specified Outcome

Title	Seropositivity Rates for Anti-CS Antibodies by Vaccine Group PII (D60)
Description	Seropositivity rates for Anti-CS antibodies accessed prevaccination, 1 month post dose 2, 1 month post dose 3, 4 months post dose 3 and 10 months post dose 3. PII(D60)= post dose 2 (day 60)
Time Frame	1 month post dose 2

Outcome Measure Data

Analysis Population Description

Immunogenicity (According to protocol (ATP) Cohort): 222 subjects (75 RTS,S/AS01B, 74 RTS,S/AS02A, 73 rabies vaccine)

Arm/Group Title	RTS, S/AS01B	RTS, S/AS02A	Rabipur (Rabies) Vaccine
Arm/Group Description	RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
Measure Participants	75	74	73
Number (95% Confidence Interval) [percentage of participants]	98.7 116.1%	100 117.6%	84.9 99.9%

34. Other Pre-specified Outcome

Title	Seropositivity Rates for Anti-CS Antibodies by Vaccine Group PIII (D90)
Description	Seropositivity rates for Anti-CS antibodies accessed prevaccination, 1 month post dose 2, 1 month post dose 3, 4 months post dose 3 and 10 months post dose 3 PIII(D90)= post dose 3 (day 90)
Time Frame	1 month post dose 3

Outcome Measure Data

Analysis Population Description

Immunogenicity (According to protocol (ATP) Cohort): 213 subjects (72 RTS,S/AS01B, 72 RTS,S/AS02A, 69 rabies vaccine)

Arm/Group Title	RTS, S/AS01B	RTS, S/AS02A	Rabipur (Rabies) Vaccine
Arm/Group Description	RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
Measure Participants	72	72	69
Number (95% Confidence Interval) [percentage of participants]	98.6 116%	100 117.6%	82.6 97.2%

35. Other Pre-specified Outcome

Title	Seropositivity Rates for Anti-CS Antibodies by Vaccine Group PIII (M6.5)
Description	Seropositivity rates for Anti-CS antibodies accessed prevaccination, 1 month post dose 2, 1 month post dose 3, 4 months post dose 3 and 10 months post dose 3 PIII(M6.5)= post dose 3 (month 6.5)
Time Frame	4 months post dose 3

Outcome Measure Data

Analysis Population Description

Immunogenicity (According to protocol (ATP) Cohort): 207 subjects (69 RTS,S/AS01B, 69 RTS,S/AS02A, 69 rabies vaccine)

Arm/Group Title	RTS, S/AS01B	RTS, S/AS02A	Rabipur (Rabies) Vaccine
Arm/Group Description	RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
Measure Participants	69	69	69
Number (95% Confidence Interval) [percentage of participants]	98.6 116%	98.6 116%	79.7 93.8%

36. Other Pre-specified Outcome

Title	Seropositivity Rates for Anti-CS Antibodies by Vaccine Group PIII (M12)
Description	Seropositivity rates for Anti-CS antibodies accessed prevaccination, 1 month post dose 2, 1 month post dose 3, 4 months post dose 3 and 10 months post dose 3 PIII(M12)= post dose 3 (month 12)
Time Frame	10 months post dose 3

Outcome Measure Data

Analysis Population Description

Immunogenicity (According to protocol (ATP) Cohort): 189 subjects (61 RTS,S/AS01B, 62 RTS,S/AS02A, 66 rabies vaccine)

Arm/Group Title	RTS, S/AS01B	RTS, S/AS02A	Rabipur (Rabies) Vaccine
Arm/Group Description	RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
Measure Participants	61	62	66
Number (95% Confidence Interval) [percentage of participants]	100 117.6%	95.2 112%	80.3 94.5%

37. Other Pre-specified Outcome

Title	Seropositivity Rates for Anti-CS Antibodies by Infection Status PRE
Description	Seropositivity rates for Anti-CS antibodies by infection status on RTS,S/AS01B and RTS,S/AS02A recipients only Seropositive: >0.5EU/mL Infection defined as P. falciparum asexual parasitemia >0 PRE= Pre-vaccination
Time Frame	Prevaccination

Outcome Measure Data

Analysis Population Description

The ATP Cohort includes all evaluable subjects for whom data were available. For seropositivity rates by infection status arms have been combined.

Arm/Group Title	Seropositive
Arm/Group Description	Seropositive: >0.5 EU/mL
Measure Participants	153
% of Infected: PRE	76.8 90.4%
% of Non-infected: PRE	83.5 98.2%

38. Other Pre-specified Outcome

Title	Seropositivity Rates for Anti-CS Antibodies by Infection Status PII (D60)
Description	Seropositivity rates for Anti-CS antibodies by infection status on RTS,S/AS01B and RTS,S/AS02A recipients only Seropositive: >0.5EU/mL Infection defined as P. falciparum asexual parasitemia >0 PII(D60)= post dose 2 (day 60)
Time Frame	post dose 2 (day 60)

Outcome Measure Data

Analysis Population Description

The ATP Cohort includes all evaluable subjects for whom data were available. For seropositivity rates by infection status arms have been combined.

Arm/Group Title	Seropositive
Arm/Group Description	Seropositive: >0.5 EU/mL
Measure Participants	153
% of Infected: PII(D60)	98.2 115.5%
% of Non-infected: PII(D60)	100 117.6%

39. Other Pre-specified Outcome

Title	Seropositivity Rates for Anti-CS Antibodies by Infection Status PIII (D90)
Description	Seropositivity rates for Anti-CS antibodies by infection status on RTS,S/AS01B and RTS,S/AS02A recipients only Seropositive: >0.5EU/mL Infection defined as P. falciparum asexual parasitemia >0 PIII(D90)= post dose 3 (day 90)
Time Frame	post dose 3 (day 90)

Outcome Measure Data

Analysis Population Description

The ATP Cohort includes all evaluable subjects for whom data were available. For seropositivity rates by infection status arms have been combined.

Arm/Group Title	Seropositive
Arm/Group Description	Seropositive: >0.5 EU/mL
Measure Participants	151
% of Infected: PIII(D90)	98.2 115.5%
% of Non-infected: PIII(D90)	100 117.6%

40. Other Pre-specified Outcome

Title	Seropositivity Rates for Anti-CS Antibodies by Infection Status PIII (M6.5)
Description	Seropositivity rates for Anti-CS antibodies by infection status on RTS,S/AS01B and RTS,S/AS02A recipients only Seropositive: >0.5EU/mL Infection defined as P. falciparum asexual parasitemia >0 PIII(M6.5)= post dose 3 (month 6.5)
Time Frame	post dose 3 (month 6.5)

Outcome Measure Data

Analysis Population Description

The ATP Cohort includes all evaluable subjects for whom data were available. For seropositivity rates by infection status arms have been combined.

Arm/Group Title	Seropositive
Arm/Group Description	Seropositive: >0.5 EU/mL
Measure Participants	143
% of Infected: PIII(M6.5)	98.1 115.4%
% of Non-infected: PIII(M6.5)	98.9 116.4%

41. Other Pre-specified Outcome

Title	Efficacy: Vaccine Efficacy Against P. Falciparum Infection
Description	Number of subjects with an episode of parasitemia (first recording of infection of asexual stage falciparum parasites >0 detected by active detection of infection (ADI) or passive case detection)
Time Frame	14 days after dose 3 and extending for 14 weeks

Outcome Measure Data

Analysis Population Description

Efficacy (According to protocol (ATP) Cohort): 228 subjects (74 RTS,S/AS01B, 79 RTS,S/AS02A, 75 rabies vaccine).

Arm/Group Title	RTS, S/AS01B	RTS, S/AS02A	Rabipur (Rabies) Vaccine
Arm/Group Description	RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
Measure Participants	74	79	75
Number [participants]	28 32.9%	28 32.9%	37 43.5%

42. Other Pre-specified Outcome

Title	Percentage of Participants With Positive and Negative Parasite Density
Description	Percentage of participants with positive and negative parasite density at month 6.5
Time Frame	at month 6.5

Outcome Measure Data

Analysis Population Description

Efficacy (According to protocol (ATP) Cohort): 228 subjects (74 RTS,S/AS01B, 79 RTS,S/AS02A, 75 rabies vaccine). Missing subject data: S/AS01B = 4, S/AS02A = 6, Rabipur = 4

Arm/Group Title	RTS, S/AS01B	RTS, S/AS02A	Rabipur (Rabies) Vaccine
Arm/Group Description	RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months	RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months	Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
Measure Participants	74	79	75
Parasite Density: % of Negative Subjects	91.4	93.2	95.8
Parasite Density: % of Positive Subjects	8.6	6.8	4.2

43. Other Pre-specified Outcome

Title	Geometric Mean Antibody Titers (GMTs) of Asexual P. Falciparum Parasitemia
Description	Geometric Mean Antibody Titers (GMTs) of Asexual P. falciparum parasitemia at Month 6.5
Time Frame	Month 6.5

Outcome Measure Data

Analysis Population Description

Efficacy (According to protocol (ATP) Cohort): 228 subjects (74 RTS,S/AS01B, 79 RTS,S/AS02A, 75 rabies vaccine).

Arm/Group Title	RTS, S/AS01B	RTS, S/AS02A	Rabipur (Rabies) Vaccine
Arm/Group Description	RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months	RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months	Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
Measure Participants	74	79	75
Geometric Mean (95% Confidence Interval) [titers]	1122	342	711

Adverse Events

Time Frame	12 months
Arm/Group Title	(RTS, S/AS01B)		(RTS, S/AS02A)		Rabipur (Rabies) Vaccine
Arm/Group Description	RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months. RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.		RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months. RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.		Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months Rabipur (Rabies) Vaccine: .0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
All Cause Mortality
	(RTS, S/AS01B)		(RTS, S/AS02A)		Rabipur (Rabies) Vaccine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/85 (0%)		0/85 (0%)		0/85 (0%)
Serious Adverse Events
	(RTS, S/AS01B)		(RTS, S/AS02A)		Rabipur (Rabies) Vaccine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/85 (5.9%)		1/85 (1.2%)		5/85 (5.9%)
Blood and lymphatic system disorders
Anaemia	1/85 (1.2%)	1	0/85 (0%)	0	0/85 (0%)	0
Cardiac disorders
Cardiac failure	0/85 (0%)	0	0/85 (0%)	0	1/85 (1.2%)	1
Pericardial effusion	0/85 (0%)	0	0/85 (0%)	0	1/85 (1.2%)	1
Eye disorders
Cataract	0/85 (0%)	0	0/85 (0%)	0	1/85 (1.2%)	1
Gastrointestinal disorders
Peptic Ulcer	1/85 (1.2%)	1	0/85 (0%)	0	0/85 (0%)	0
General disorders
Wound necrosis	1/85 (1.2%)	1	0/85 (0%)	0	0/85 (0%)	0
Infections and infestations
Abscess limb	0/85 (0%)	0	0/85 (0%)	0	1/85 (1.2%)	1
HIV infection	2/85 (2.4%)	2	0/85 (0%)	0	3/85 (3.5%)	3
Lobar pneumonia	1/85 (1.2%)	1	0/85 (0%)	0	0/85 (0%)	0
Malaria	0/85 (0%)	0	1/85 (1.2%)	1	0/85 (0%)	0
Meningitis	1/85 (1.2%)	1	0/85 (0%)	0	1/85 (1.2%)	1
Pneumonia	1/85 (1.2%)	1	0/85 (0%)	0	0/85 (0%)	0
Pulmonary tuberculosis	0/85 (0%)	0	0/85 (0%)	0	1/85 (1.2%)	1
Trichomoniasis	1/85 (1.2%)	1	0/85 (0%)	0	0/85 (0%)	0
Disseminated tuberculosis	1/85 (1.2%)	1	0/85 (0%)	0	0/85 (0%)	0
Meningitis cryptococcal	0/85 (0%)	0	0/85 (0%)	0	1/85 (1.2%)	1
Pneumocystis jiroveci pneumonia	1/85 (1.2%)	1	0/85 (0%)	0	0/85 (0%)	0
Metabolism and nutrition disorders
Osteoarthritis	1/85 (1.2%)	1	0/85 (0%)	0	0/85 (0%)	0
Nervous system disorders
Encephalitis	1/85 (1.2%)	1	0/85 (0%)	0	0/85 (0%)	0
Pregnancy, puerperium and perinatal conditions
Abortion	1/85 (1.2%)	1	0/85 (0%)	0	0/85 (0%)	0
Respiratory, thoracic and mediastinal disorders
Haemoptysis	1/85 (1.2%)	1	0/85 (0%)	0	0/85 (0%)	0
Pleural effusion	0/85 (0%)	0	0/85 (0%)	0	1/85 (1.2%)	1
Other (Not Including Serious) Adverse Events
	(RTS, S/AS01B)		(RTS, S/AS02A)		Rabipur (Rabies) Vaccine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	81/85 (95.3%)		82/85 (96.5%)		82/85 (96.5%)
Blood and lymphatic system disorders
Anaemia	0/85 (0%)	0	2/85 (2.4%)	2	1/85 (1.2%)	1
Eosinophilia	0/85 (0%)	0	1/85 (1.2%)	1	0/85 (0%)	0
Iron deficiency anaemia	0/85 (0%)	0	1/85 (1.2%)	1	0/85 (0%)	0
Lymphadenitis	0/85 (0%)	0	0/85 (0%)	0	1/85 (1.2%)	1
Lymphadenopathy	0/85 (0%)	0	1/85 (1.2%)	1	0/85 (0%)	0
Cardiac disorders
Palpitations	1/85 (1.2%)	1	0/85 (0%)	0	0/85 (0%)	0
Ear and labyrinth disorders
Cerumen impaction	2/85 (2.4%)	2	3/85 (3.5%)	3	6/85 (7.1%)	6
Ear pain	6/85 (7.1%)	6	3/85 (3.5%)	3	2/85 (2.4%)	2
Eye disorders
Conjunctivitis	10/85 (11.8%)	10	9/85 (10.6%)	9	8/85 (9.4%)	8
Conjunctivitis allergic	6/85 (7.1%)	6	9/85 (10.6%)	9	4/85 (4.7%)	4
Eye pain	0/85 (0%)	0	3/85 (3.5%)	3	3/85 (3.5%)	3
Gastrointestinal disorders
Gastrointestinal	37/85 (43.5%)	37	33/85 (38.8%)	33	33/85 (38.8%)	33
Abdominal discomfort	2/85 (2.4%)	2	7/85 (8.2%)	7	3/85 (3.5%)	3
Abdominal distension	1/85 (1.2%)	1	2/85 (2.4%)	2	3/85 (3.5%)	3
Abdominal pain	17/85 (20%)	17	17/85 (20%)	17	14/85 (16.5%)	14
Abdominal pain	5/85 (5.9%)	5	4/85 (4.7%)	4	3/85 (3.5%)	3
Anal skin tags	0/85 (0%)	0	1/85 (1.2%)	1	1/85 (1.2%)	1
Anal ulcer	0/85 (0%)	0	0/85 (0%)	0	1/85 (1.2%)	1
Aphthous stomatitis	1/85 (1.2%)	1	1/85 (1.2%)	1	0/85 (0%)	0
Bowel sounds	3/85 (3.5%)	3	1/85 (1.2%)	1	0/85 (0%)	0
Constipation	2/85 (2.4%)	2	1/85 (1.2%)	1	1/85 (1.2%)	1
Diarrhea	3/85 (3.5%)	3	3/85 (3.5%)	3	6/85 (7.1%)	6
Diarrhea haemorrhagic	1/85 (1.2%)	1	1/85 (1.2%)	1	0/85 (0%)	0
Dyspepsia	5/85 (5.9%)	5	3/85 (3.5%)	3	1/85 (1.2%)	1
Enteritis	1/85 (1.2%)	1	0/85 (0%)	0	0/85 (0%)	0
Flatulence	1/85 (1.2%)	1	0/85 (0%)	0	0/85 (0%)	0
Gastritis	2/85 (2.4%)	2	1/85 (1.2%)	1	0/85 (0%)	0
Gastrooesophageal reflux disease	0/85 (0%)	0	1/85 (1.2%)	1	0/85 (0%)	0
Gingival pain	0/85 (0%)	0	1/85 (1.2%)	1	1/85 (1.2%)	1
Gingivitis	4/85 (4.7%)	4	0/85 (0%)	0	2/85 (2.4%)	2
Glossitis	0/85 (0%)	0	1/85 (1.2%)	1	0/85 (0%)	0
Glossodynia	1/85 (1.2%)	1	0/85 (0%)	0	1/85 (1.2%)	1
Hyperchlorhydria	4/85 (4.7%)	4	2/85 (2.4%)	2	2/85 (2.4%)	2
Lip exfoliation	0/85 (0%)	0	1/85 (1.2%)	1	0/85 (0%)	0
Mouth ulceration	1/85 (1.2%)	1	1/85 (1.2%)	1	0/85 (0%)	0
Nausea	1/85 (1.2%)	1	3/85 (3.5%)	3	4/85 (4.7%)	4
Oesophagitis	0/85 (0%)	0	1/85 (1.2%)	1	1/85 (1.2%)	1
Peptic ulcer	3/85 (3.5%)	3	7/85 (8.2%)	7	3/85 (3.5%)	3
Peptic ulcer haemorrhage	1/85 (1.2%)	1	0/85 (0%)	0	0/85 (0%)	0
Proctalgia	0/85 (0%)	0	1/85 (1.2%)	1	0/85 (0%)	0
Stomatitis	1/85 (1.2%)	1	0/85 (0%)	0	0/85 (0%)	0
Toothache	14/85 (16.5%)	14	9/85 (10.6%)	9	2/85 (2.4%)	2
Vomiting	1/85 (1.2%)	1	2/85 (2.4%)	2	2/85 (2.4%)	2
General disorders
Fatigue	35/85 (41.2%)	35	28/85 (32.9%)	28	26/85 (30.6%)	26
Fever	17/85 (20%)	17	11/85 (12.9%)	11	10/85 (11.8%)	10
Asthenia	3/85 (3.5%)	3	0/85 (0%)	0	2/85 (2.4%)	2
Chest pain	9/85 (10.6%)	9	7/85 (8.2%)	7	12/85 (14.1%)	12
Chills	6/85 (7.1%)	6	4/85 (4.7%)	4	3/85 (3.5%)	3
Fatigue	2/85 (2.4%)	2	2/85 (2.4%)	2	4/85 (4.7%)	4
Feeling hot	1/85 (1.2%)	1	0/85 (0%)	0	1/85 (1.2%)	1
Hangover	0/85 (0%)	0	0/85 (0%)	0	1/85 (1.2%)	1
Hunger	0/85 (0%)	0	0/85 (0%)	0	1/85 (1.2%)	1
Inflammation	0/85 (0%)	0	0/85 (0%)	0	1/85 (1.2%)	1
Malaise	7/85 (8.2%)	7	3/85 (3.5%)	3	4/85 (4.7%)	4
Nodule	1/85 (1.2%)	1	0/85 (0%)	0	2/85 (2.4%)	2
Pain	8/85 (9.4%)	8	4/85 (4.7%)	4	3/85 (3.5%)	3
Pitting oedema	1/85 (1.2%)	1	0/85 (0%)	0	0/85 (0%)	0
Pyrexia	15/85 (17.6%)	15	12/85 (14.1%)	12	11/85 (12.9%)	11
Swelling	0/85 (0%)	0	1/85 (1.2%)	1	0/85 (0%)	0
Thirst	0/85 (0%)	0	0/85 (0%)	0	1/85 (1.2%)	1
Immune system disorders
Hypersensitivity	1/85 (1.2%)	1	1/85 (1.2%)	1	0/85 (0%)	0
Multiple allergies	0/85 (0%)	0	1/85 (1.2%)	1	0/85 (0%)	0
Infections and infestations
Abscess	1/85 (1.2%)	1	0/85 (0%)	0	0/85 (0%)	0
Abscess limb	0/85 (0%)	0	1/85 (1.2%)	1	0/85 (0%)	0
Acarodermatitis	0/85 (0%)	0	1/85 (1.2%)	1	1/85 (1.2%)	1
Amoebiasis	2/85 (2.4%)	2	0/85 (0%)	0	1/85 (1.2%)	1
Ascariasis	1/85 (1.2%)	1	3/85 (3.5%)	3	1/85 (1.2%)	1
Body tinea	6/85 (7.1%)	6	6/85 (7.1%)	6	5/85 (5.9%)	5
Bronchitis	1/85 (1.2%)	1	0/85 (0%)	0	0/85 (0%)	0
Candidiasis	1/85 (1.2%)	1	1/85 (1.2%)	1	1/85 (1.2%)	1
Cellulitis	3/85 (3.5%)	3	4/85 (4.7%)	4	4/85 (4.7%)	4
Conjunctivitis infective	2/85 (2.4%)	2	1/85 (1.2%)	1	1/85 (1.2%)	1
Dental caries	7/85 (8.2%)	7	5/85 (5.9%)	5	4/85 (4.7%)	4
Dysentery	0/85 (0%)	0	2/85 (2.4%)	2	2/85 (2.4%)	2
Folliculitis	0/85 (0%)	0	0/85 (0%)	0	1/85 (1.2%)	1
Fungal infection	1/85 (1.2%)	1	0/85 (0%)	0	0/85 (0%)	0
Furuncle	1/85 (1.2%)	1	0/85 (0%)	0	2/85 (2.4%)	2
Gastroenteritis	1/85 (1.2%)	1	2/85 (2.4%)	2	6/85 (7.1%)	6
Gastroenteritis bacterial	0/85 (0%)	0	0/85 (0%)	0	1/85 (1.2%)	1
Genitourinary tract infection	1/85 (1.2%)	1	0/85 (0%)	0	1/85 (1.2%)	1
Giardiasis	7/85 (8.2%)	7	11/85 (12.9%)	11	9/85 (10.6%)	9
Gonorrhea	2/85 (2.4%)	2	0/85 (0%)	0	0/85 (0%)	0
Helminthic infection	8/85 (9.4%)	8	7/85 (8.2%)	7	3/85 (3.5%)	3
Herpes simplex	2/85 (2.4%)	2	1/85 (1.2%)	1	0/85 (0%)	0
Hookworm infection	1/85 (1.2%)	1	1/85 (1.2%)	1	1/85 (1.2%)	1
Hordeolum	0/85 (0%)	0	3/85 (3.5%)	3	1/85 (1.2%)	1
Impetigo	6/85 (7.1%)	6	7/85 (8.2%)	7	8/85 (9.4%)	8
Laryngitis	3/85 (3.5%)	3	1/85 (1.2%)	1	0/85 (0%)	0
Malaria	19/85 (22.4%)	19	14/85 (16.5%)	14	21/85 (24.7%)	21
Otitis externa	0/85 (0%)	0	1/85 (1.2%)	1	0/85 (0%)	0
Otitis media	1/85 (1.2%)	1	2/85 (2.4%)	2	0/85 (0%)	0
Otitis media acute	0/85 (0%)	0	2/85 (2.4%)	2	0/85 (0%)	0
Pelvic inflammatory disease	2/85 (2.4%)	2	3/85 (3.5%)	3	1/85 (1.2%)	1
Pharyngitis	7/85 (8.2%)	7	5/85 (5.9%)	5	9/85 (10.6%)	9
Pneumonia	5/85 (5.9%)	5	3/85 (3.5%)	3	1/85 (1.2%)	1
Pulpitis dental	0/85 (0%)	0	1/85 (1.2%)	1	0/85 (0%)	0
Respiratory tract infection	0/85 (0%)	0	1/85 (1.2%)	1	2/85 (2.4%)	2
Rhinitis	12/85 (14.1%)	12	8/85 (9.4%)	8	9/85 (10.6%)	9
Schistosomiasis	1/85 (1.2%)	1	1/85 (1.2%)	1	1/85 (1.2%)	1
Septic rash	0/85 (0%)	0	1/85 (1.2%)	1	0/85 (0%)	0
Sexually transmitted disease	0/85 (0%)	0	1/85 (1.2%)	1	0/85 (0%)	0
Sinusitis	2/85 (2.4%)	2	2/85 (2.4%)	2	0/85 (0%)	0
Strongyloidiasis	0/85 (0%)	0	2/85 (2.4%)	2	0/85 (0%)	0
Subcutaneous abscess	0/85 (0%)	0	2/85 (2.4%)	2	0/85 (0%)	0
Tinea capitis	1/85 (1.2%)	1	1/85 (1.2%)	1	1/85 (1.2%)	1
Tinea cruris	0/85 (0%)	0	0/85 (0%)	0	1/85 (1.2%)	1
Tinea infection	1/85 (1.2%)	1	0/85 (0%)	0	0/85 (0%)	0
Tinea pedis	0/85 (0%)	0	0/85 (0%)	0	1/85 (1.2%)	1
Tinea versicolour	3/85 (3.5%)	3	1/85 (1.2%)	1	4/85 (4.7%)	4
Tonsillitis	4/85 (4.7%)	4	4/85 (4.7%)	4	1/85 (1.2%)	1
Tooth abscess	1/85 (1.2%)	1	0/85 (0%)	0	0/85 (0%)	0
Trichomoniasis	1/85 (1.2%)	1	0/85 (0%)	0	0/85 (0%)	0
Typhoid fever	1/85 (1.2%)	1	1/85 (1.2%)	1	1/85 (1.2%)	1
Upper respiratory tract infection	50/85 (58.8%)	50	54/85 (63.5%)	54	48/85 (56.5%)	48
Urethritis	3/85 (3.5%)	3	0/85 (0%)	0	3/85 (3.5%)	3
Urinary tract infection	2/85 (2.4%)	2	2/85 (2.4%)	2	3/85 (3.5%)	3
Vaginal candidiasis	0/85 (0%)	0	2/85 (2.4%)	2	0/85 (0%)	0
Vulvovaginitis	1/85 (1.2%)	1	1/85 (1.2%)	1	0/85 (0%)	0
Wound infection	1/85 (1.2%)	1	1/85 (1.2%)	1	0/85 (0%)	0
Wound sepsis	2/85 (2.4%)	2	1/85 (1.2%)	1	1/85 (1.2%)	1
Injury, poisoning and procedural complications
Animal bite	0/85 (0%)	0	1/85 (1.2%)	1	1/85 (1.2%)	1
Arthropod bite	0/85 (0%)	0	0/85 (0%)	0	1/85 (1.2%)	1
Arthropod sting	0/85 (0%)	0	0/85 (0%)	0	1/85 (1.2%)	1
Contusion	2/85 (2.4%)	2	0/85 (0%)	0	0/85 (0%)	0
Excoriation	0/85 (0%)	0	0/85 (0%)	0	1/85 (1.2%)	1
Eye injury	1/85 (1.2%)	1	0/85 (0%)	0	0/85 (0%)	0
Face injury	0/85 (0%)	0	1/85 (1.2%)	1	0/85 (0%)	0
Joint sprain	2/85 (2.4%)	2	2/85 (2.4%)	2	1/85 (1.2%)	1
Laceration	3/85 (3.5%)	3	0/85 (0%)	0	6/85 (7.1%)	6
Neck injury	0/85 (0%)	0	1/85 (1.2%)	1	0/85 (0%)	0
Procedural pain	1/85 (1.2%)	1	0/85 (0%)	0	0/85 (0%)	0
Skin laceration	0/85 (0%)	0	1/85 (1.2%)	1	1/85 (1.2%)	1
Soft tissue injury	14/85 (16.5%)	14	18/85 (21.2%)	18	20/85 (23.5%)	20
Wound	5/85 (5.9%)	5	3/85 (3.5%)	3	5/85 (5.9%)	5
Investigations
Mean cell volume decreased	0/85 (0%)	0	1/85 (1.2%)	1	0/85 (0%)	0
Metabolism and nutrition disorders
Anorexia	1/85 (1.2%)	1	0/85 (0%)	0	2/85 (2.4%)	2
Decreased appetite	25/85 (29.4%)	25	15/85 (17.6%)	15	19/85 (22.4%)	19
Hypoglycaemia	0/85 (0%)	0	0/85 (0%)	0	1/85 (1.2%)	1
Musculoskeletal and connective tissue disorders
Joint pain at other location	23/85 (27.1%)	23	19/85 (22.4%)	19	17/85 (20%)	17
Muscle aches	21/85 (24.7%)	21	21/85 (24.7%)	21	24/85 (28.2%)	24
Arthralgia	11/85 (12.9%)	11	5/85 (5.9%)	5	10/85 (11.8%)	10
Arthropathy	0/85 (0%)	0	1/85 (1.2%)	1	1/85 (1.2%)	1
Back pain	16/85 (18.8%)	16	13/85 (15.3%)	13	20/85 (23.5%)	20
Chest wall pain	0/85 (0%)	0	1/85 (1.2%)	1	0/85 (0%)	0
Flank pain	0/85 (0%)	0	1/85 (1.2%)	1	0/85 (0%)	0
Muscle spasms	1/85 (1.2%)	1	0/85 (0%)	0	0/85 (0%)	0
Myalgia	11/85 (12.9%)	11	9/85 (10.6%)	9	13/85 (15.3%)	13
Neck pain	7/85 (8.2%)	7	4/85 (4.7%)	4	0/85 (0%)	0
Pain in extremity	3/85 (3.5%)	3	3/85 (3.5%)	3	3/85 (3.5%)	3
Pain in jaw	0/85 (0%)	0	0/85 (0%)	0	1/85 (1.2%)	1
Sensation of heaviness	2/85 (2.4%)	2	0/85 (0%)	0	0/85 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma	1/85 (1.2%)	1	0/85 (0%)	0	0/85 (0%)	0
Nervous system disorders
Headache	54/85 (63.5%)	54	57/85 (67.1%)	57	45/85 (52.9%)	45
Dizziness	9/85 (10.6%)	9	3/85 (3.5%)	3	5/85 (5.9%)	5
Headache	24/85 (28.2%)	24	32/85 (37.6%)	32	37/85 (43.5%)	37
Sinus headache	0/85 (0%)	0	1/85 (1.2%)	1	0/85 (0%)	0
Tension headache	1/85 (1.2%)	1	1/85 (1.2%)	1	1/85 (1.2%)	1
Psychiatric disorders
Alcoholism	1/85 (1.2%)	1	0/85 (0%)	0	1/85 (1.2%)	1
Insomnia	0/85 (0%)	0	0/85 (0%)	0	1/85 (1.2%)	1
Renal and urinary disorders
Dysuria	0/85 (0%)	0	0/85 (0%)	0	1/85 (1.2%)	1
Reproductive system and breast disorders
Balanitis	0/85 (0%)	0	0/85 (0%)	0	1/85 (1.2%)	1
Dysmenorrhoea	0/85 (0%)	0	2/85 (2.4%)	2	2/85 (2.4%)	2
Genital ulceration	1/85 (1.2%)	1	1/85 (1.2%)	1	0/85 (0%)	0
Mammory duct ectasia	0/85 (0%)	0	0/85 (0%)	0	1/85 (1.2%)	1
Respiratory, thoracic and mediastinal disorders
Cough epistaxis	15/85 (17.6%)	15	11/85 (12.9%)	11	10/85 (11.8%)	10
Epixtaxis	0/85 (0%)	0	0/85 (0%)	0	3/85 (3.5%)	3
Nasal congestion	0/85 (0%)	0	0/85 (0%)	0	1/85 (1.2%)	1
Pharyngolaryngeal pain	6/85 (7.1%)	6	7/85 (8.2%)	7	10/85 (11.8%)	10
Pleurisy	0/85 (0%)	0	0/85 (0%)	0	1/85 (1.2%)	1
Pleuritic pain	1/85 (1.2%)	1	0/85 (0%)	0	0/85 (0%)	0
Respiratory tract congestion	0/85 (0%)	0	1/85 (1.2%)	1	0/85 (0%)	0
Rhinitis allergic	0/85 (0%)	0	1/85 (1.2%)	1	0/85 (0%)	0
Rhinorrhoea	3/85 (3.5%)	3	1/85 (1.2%)	1	0/85 (0%)	0
Rhonchi	0/85 (0%)	0	1/85 (1.2%)	1	0/85 (0%)	0
Skin and subcutaneous tissue disorders
Acne	0/85 (0%)	0	0/85 (0%)	0	2/85 (2.4%)	2
Dermatitis allergic	0/85 (0%)	0	0/85 (0%)	0	1/85 (1.2%)	1
Dermatitis allergic	1/85 (1.2%)	1	0/85 (0%)	0	0/85 (0%)	0
Eczema	3/85 (3.5%)	3	5/85 (5.9%)	5	1/85 (1.2%)	1
Hyperhidrosis	0/85 (0%)	0	0/85 (0%)	0	1/85 (1.2%)	1
Night sweats	1/85 (1.2%)	1	0/85 (0%)	0	0/85 (0%)	0
Pruritus	4/85 (4.7%)	4	10/85 (11.8%)	10	4/85 (4.7%)	4
Pruritus generalised	1/85 (1.2%)	1	1/85 (1.2%)	1	2/85 (2.4%)	2
Rash pruritis	1/85 (1.2%)	1	0/85 (0%)	0	0/85 (0%)	0
Swelling face	1/85 (1.2%)	1	0/85 (0%)	0	0/85 (0%)	0
Urticaria	1/85 (1.2%)	1	2/85 (2.4%)	2	3/85 (3.5%)	3

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There is NOT 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.