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CompletedNCT00197054Updated Feb 12, 2021Results posted

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

A Phase 2 interventional study of RTS, S/AS01B and RTS, S/AS02A in Plasmodium Falciparum, sponsored by U.S. Army Medical Research and Development Command. Completed at 1 site in Kenya. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-12.

Sponsored by U.S. Army Medical Research and Development Command · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
255
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Plasmodium Falciparum

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03

In context

Malaria

1,299 studies on the registry are indexed under Malaria; 86 are open to participants now.

This study's enrollment of 255 is above the median of 220 across 1,027 interventional studies indexed under Malaria.

Browse Malaria studies →

Lead sponsor

U.S. Army Medical Research and Development Command is the lead sponsor of 151 studies on the registry; 8 are open to participants now.

Of its 23 completed or terminated interventional studies of FDA-regulated products, 16 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
255 participants (actual)

Study arms

  • 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

  • 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

  • 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

Interventions

  • BiologicalRTS, 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.

  • BiologicalRTS, 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.

  • BiologicalRabipur (Rabies) Vaccine

    1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months

06

What researchers measure

Primary outcomes

  1. Safety: Proportion of Subjects With Grade 3 Solicited and Unsolicited General Reactions After Vaccination of RTS, S/AS02A and RTS, S/AS01B

    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)

  2. Safety: Number of Administered Doses Eliciting Grade 3 Unsolicited Symptoms

    Grade 3 unsolicited symptoms reported following any number of administered doses

    Time frame: 6.5 months

  3. Safety: Number of Doses Eliciting Solicited Local Symptoms Reported Over 7 Day Follow-up Period

    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)

Secondary outcomes

  1. Safety: Occurrence of SAEs

    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

  2. Safety: Occurrence of SAEs

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

    Time frame: months 0 thru 12

  3. Occurrence of Hematology Parameters Below Normal Range

    Occurrence of hematology parameters below normal range (Total Cohort)

    Time frame: Days 0, 6, 66, and 90; Months 6 and 12

  4. Occurrence of Biochemistry Parameters Above Normal Ranges

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

    Time frame: Days 0, 6, and 90

Other outcomes

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

    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

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

    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

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

    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

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

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

    Time frame: Prevaccination

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

    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

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

    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

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

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

    Time frame: Prevaccination

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

    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

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

    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

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

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

    Time frame: Prevaccination

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

    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

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

    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

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

    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

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

    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

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

    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

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

    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

  17. Geometric Mean Titers (GMTs) for Anti-CS Antibodies up to Month 12 by Vaccine Group PII (D60)

    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

  18. Geometric Mean Titers (GMTs) for Anti-CS Antibodies up to Month 12 by Vaccine Group PIII (D90)

    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

  19. Geometric Mean Titers (GMTs) for Anti-CS Antibodies up to Month 12 by Vaccine Group PIII (M6.5)

    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

  20. Geometric Mean Titers (GMTs) for Anti-CS Antibodies up to Month 12 by Vaccine Group PIII (M12)

    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

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

    Time frame: PRE

  22. Geometric Mean Antibody Titers (GMTs) for Anti-CS Antibodies by Infection Status PII (D60)

    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)

  23. Geometric Mean Antibody Titers (GMTs) for Anti-CS Antibodies by Infection Status PIII (D90)

    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)

  24. Geometric Mean Antibody Titers (GMTs) for Anti-CS Antibodies by Infection Status PIII (M6.5)

    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)

    Time frame: post dose 3 (month 6.5)

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

    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

  26. Seropositivity Rates for Anti-CS Antibodies by Vaccine Group PII (D60)

    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

  27. Seropositivity Rates for Anti-CS Antibodies by Vaccine Group PIII (D90)

    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

  28. Seropositivity Rates for Anti-CS Antibodies by Vaccine Group PIII (M6.5)

    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

  29. Seropositivity Rates for Anti-CS Antibodies by Vaccine Group PIII (M12)

    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

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

    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

  31. Seropositivity Rates for Anti-CS Antibodies by Infection Status PII (D60)

    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)

  32. Seropositivity Rates for Anti-CS Antibodies by Infection Status PIII (D90)

    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)

  33. Seropositivity Rates for Anti-CS Antibodies by Infection Status PIII (M6.5)

    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)

    Time frame: post dose 3 (month 6.5)

  34. Efficacy: Vaccine Efficacy Against P. Falciparum Infection

    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

  35. Percentage of Participants With Positive and Negative Parasite Density

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

    Time frame: at month 6.5

  36. Geometric Mean Antibody Titers (GMTs) of Asexual P. Falciparum Parasitemia

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

    Time frame: Month 6.5

07

Results

Posted Dec 11, 2020

Participant flow

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

Participant flow — Overall Study
MilestoneRTS, S/AS02ARTS, S/AS01BRabipur (Rabies) Vaccine
Started858585
Completed686473
Not completed172112
Withdrew: Withdrawal by subject933
Withdrew: Moved from area7149
Withdrew: Lost to follow-up140

Outcome measures

PrimarySafety: Proportion of Subjects With Grade 3 Solicited and Unsolicited General Reactions After Vaccination of RTS, S/AS02A and RTS, S/AS01B

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)
Reported as:
Number · participants
Safety: Proportion of Subjects With Grade 3 Solicited and Unsolicited General Reactions After Vaccination of RTS, S/AS02A and RTS, S/AS01B
participantsRTS, S/AS02ARTS, S/AS01B
Safety: Proportion of Subjects With Grade 3 Solicited and Unsolicited General Reactions After Vaccination of RTS, S/AS02A and RTS, S/AS01B0 (0.0 to 4.2)1 (0.0 to 6.4)
PrimarySafety: Number of Administered Doses Eliciting Grade 3 Unsolicited Symptoms

Grade 3 unsolicited symptoms reported following any number of administered doses

Time frame:
6.5 months
Reported as:
Number · administered doses
Safety: Number of Administered Doses Eliciting Grade 3 Unsolicited Symptoms
administered dosesRTS, S/AS01BRTS, S/AS02ARabipur (Rabies) Vaccine
At least one symptom3 (0.3 to 3.6)0 (0.0 to 1.5)1 (0.0 to 2.2)
Sinusitis1 (0.0 to 2.3)0 (0.0 to 1.5)0 (0.0 to 1.5)
Headache1 (0.0 to 2.3)0 (0.0 to 1.5)1 (0.0 to 2.2)
Cough1 (0.0 to 2.3)0 (0.0 to 1.5)0 (0.0 to 1.5)
PrimarySafety: Number of Doses Eliciting Solicited Local Symptoms Reported Over 7 Day Follow-up Period

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)
Reported as:
Number · Doses
Safety: Number of Doses Eliciting Solicited Local Symptoms Reported Over 7 Day Follow-up Period
DosesRTS, S/AS01BRTS, S/AS02ARabipur (Rabies) Vaccine
Pain13216668
Swelling12222
Fatigue433335
Fever (Axillary)211412
Gastrointestinal484244
Headache849567
Joint pain at other location272222
Muscle aches272329
SecondarySafety: Occurrence of SAEs

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
Reported as:
Number · % of subjects
Safety: Occurrence of SAEs
% of subjectsRTS, S/AS01BRTS, S/AS02ARabipur (Rabies) Vaccine
Anaemia1.4 (0.0 to 7.3)0.0 (0.0 to 4.7)0.0 (0.0 to 4.7)
Cardiac Failure0.0 (0.0 to 4.9)0.0 (0.0 to 4.7)1.3 (0.0 to 7.1)
Pericardial Effusion0.0 (0.0 to 4.9)0.0 (0.0 to 4.7)1.3 (0.0 to 7.1)
Cataract0.0 (0.0 to 4.9)0.0 (0.0 to 4.7)1.3 (0.0 to 7.1)
Wound Necrosis1.4 (0.0 to 7.3)0.0 (0.0 to 4.7)0.0 (0.0 to 4.7)
Abscess Limb0.0 (0.0 to 4.9)0.0 (0.0 to 4.7)1.3 (0.0 to 7.1)
HIV Infection1.4 (0.0 to 7.3)0.0 (0.0 to 4.7)1.3 (0.0 to 7.1)
Lobar Pneumonia1.4 (0.0 to 7.3)0.0 (0.0 to 4.7)0.0 (0.0 to 4.7)
Malaria0.0 (0.0 to 4.9)1.3 (0.0 to 7.1)0.0 (0.0 to 4.7)
Meningitis1.4 (0.0 to 7.3)0.0 (0.0 to 4.7)1.3 (0.0 to 7.1)
Pneumonia1.4 (0.0 to 7.3)0.0 (0.0 to 4.7)0.0 (0.0 to 4.7)
Pulmonary Tuberculosis0.0 (0.0 to 4.9)0.0 (0.0 to 4.7)1.3 (0.0 to 7.1)
Trichomoniasis1.4 (0.0 to 7.3)0.0 (0.0 to 4.7)0.0 (0.0 to 4.7)
Abortion1.4 (0.0 to 7.3)0.0 (0.0 to 4.7)0.0 (0.0 to 4.7)
Haemoptysis2.4 (0.0 to 7.3)0.0 (0.0 to 4.7)0.0 (0.0 to 4.7)
Pleural Effusion0.0 (0.0 to 4.9)0.0 (0.0 to 4.7)1.3 (0.0 to 7.1)
SecondarySafety: Occurrence of SAEs

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

Time frame:
months 0 thru 12
Reported as:
Number · % of subjects reporting symptom
Safety: Occurrence of SAEs
% of subjects reporting symptomRTS, S/AS01BRTS, S/AS02ARabipur (Rabies) Vaccine
Anaemia1.2 (0.0 to 6.4)0.0 (0.0 to 4.2)0.0 (0.0 to 4.2)
Cardiac Failure0.0 (0.0 to 4.2)0.0 (0.0 to 4.2)1.2 (0.0 to 6.4)
Pericardial Effusion0.0 (0.0 to 4.2)0.0 (0.0 to 4.2)1.2 (0.0 to 6.4)
Cataract0.0 (0.0 to 4.2)0.0 (0.0 to 4.2)1.2 (0.0 to 6.4)
Peptic Ulcer Haemorrhage1.2 (0.0 to 6.4)0.0 (0.0 to 4.2)0.0 (0.0 to 4.2)
Wound Necrosis1.2 (0.0 to 6.4)0.0 (0.0 to 4.2)0.0 (0.0 to 4.2)
Abscess Limb0.0 (0.0 to 4.2)0.0 (0.0 to 4.2)1.2 (0.0 to 6.4)
Disseminated Tuberculosis1.2 (0.0 to 6.4)0.0 (0.0 to 4.2)0.0 (0.0 to 4.2)
HIV Infection2.4 (0.3 to 8.2)0.0 (0.0 to 4.2)3.5 (0.7 to 10.0)
Lobar Pneumonia1.2 (0.0 to 6.4)0.0 (0.0 to 4.2)0.0 (0.0 to 4.2)
Malaria0.0 (0.0 to 4.2)1.2 (0.0 to 6.4)0.0 (0.0 to 4.2)
Meningitis1.2 (0.0 to 6.4)0.0 (0.0 to 4.2)1.2 (0.0 to 6.4)
Meningitis Cryptococcal0.0 (0.0 to 4.2)0.0 (0.0 to 4.2)1.2 (0.0 to 6.4)
Pneumocystis Jiroveci Pheumonia1.2 (0.0 to 6.4)0.0 (0.0 to 4.2)0.0 (0.0 to 4.2)
Pneumonia1.2 (0.0 to 6.4)0.0 (0.0 to 4.2)0.0 (0.0 to 4.2)
Pulmonary Tuberculosis0.0 (0.0 to 4.2)0.0 (0.0 to 4.2)1.2 (0.0 to 6.4)
Trichomoniasis1.2 (0.0 to 6.4)0.0 (0.0 to 4.2)0.0 (0.0 to 4.2)
Osteoarthritis1.2 (0.0 to 6.4)0.0 (0.0 to 4.2)0.0 (0.0 to 4.2)
Encephalitis1.2 (0.0 to 6.4)0.0 (0.0 to 4.2)0.0 (0.0 to 4.2)
Abortion1.2 (0.0 to 6.4)0.0 (0.0 to 4.2)0.0 (0.0 to 4.2)
Haemoptysis1.2 (0.0 to 6.4)0.0 (0.0 to 4.2)0.0 (0.0 to 4.2)
Pleural Effusion0.0 (0.0 to 4.2)0.0 (0.0 to 4.2)1.2 (0.0 to 6.4)
SecondaryOccurrence of Hematology Parameters Below Normal Range

Occurrence of hematology parameters below normal range (Total Cohort)

Time frame:
Days 0, 6, 66, and 90; Months 6 and 12
Reported as:
Count of participants · Participants
Occurrence of Hematology Parameters Below Normal Range
ParticipantsRTS, S/AS01BRTS, S/AS02ARabipur (Rabies) Vaccine
Hemoglobin: Day 0000
Hemoglobin: Day 6411
Hemoglobin: Day 66212
Hemoglobin: Day 90202
hemoglobin: Month 6211
Hemoglobin: Month 12420
WBC: Day 0000
WBC: Day 6001
WBC: Day 66001
WBC: Day 90300
WBC: Month 6201
WBC: Month 12200
Lymphocytes: Day 0000
Lymphocytes: Day 6001
Lymphocytes: Day 66000
Lymphocytes: Day 90100
Lymphocytes: Month 6100
Lymphocytes: Month 12100
SecondaryOccurrence of Biochemistry Parameters Above Normal Ranges

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

Time frame:
Days 0, 6, and 90
Reported as:
Count of participants · Participants
Occurrence of Biochemistry Parameters Above Normal Ranges
ParticipantsRTS, S/AS01BRTS, S/AS02ARabipur (Rabies) Vaccine
Bilirubin: Day 010911
Bilirubin: Day 6647
Bilirubin: Day 90336
ALT: Day 0000
ALT: Day 6160
ALT: Day 90013
Other pre-specifiedSeropositivity Rates for Anti-HBs Antibodies by Infection Status PRE

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
Reported as:
Number · percentage of participants
Seropositivity Rates for Anti-HBs Antibodies by Infection Status PRE
percentage of participants>=3.3 MIU/ML>=10 MIU/ML
% of Non-infected38.8 (27.1 to 51.5)37.3 (25.8 to 50.0)
% of Infected50.0 (39.6 to 60.4)44.8 (34.6 to 55.3)
Other pre-specifiedSeropositivity Rates for Anti-HBs Antibodies by Infection Status PIII(D90)

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
Reported as:
Number · percentage of participants
Seropositivity Rates for Anti-HBs Antibodies by Infection Status PIII(D90)
percentage of participants>=3.3 MIU/ML>=10 MIU/ML
% of Non-infected: PIII(D90)96.5 (87.9 to 99.6)93.0 (83.0 to 98.1)
% of Infected: PIII(D90)93.7 (86.8 to 97.6)91.6 (84.1 to 96.3)
Other pre-specifiedSeropositivity Rates for Anti-HBs Antibodies by Infection Status PIII(M12)

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
Reported as:
Number · percentage of participants
Seropositivity Rates for Anti-HBs Antibodies by Infection Status PIII(M12)
percentage of participants>=3.3 MIU/ML>=10 MIU/ML
% of Non-infected: PIII(M12)97.9 (88.7 to 99.9)91.5 (79.6 to 97.6)
% of Infected: PIII(M12)92.9 (85.3 to 97.4)90.6 (82.3 to 95.8)
Other pre-specifiedSeropositivity Rates for Anti-HBs Antibodies by Vaccine Group PRE

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

Time frame:
Prevaccination
Reported as:
Count of participants · Participants
Seropositivity Rates for Anti-HBs Antibodies by Vaccine Group PRE
ParticipantsRTS, S/AS01BRTS, S/AS02ARabipur (Rabies) Vaccine
Seropositivity Rates for Anti-HBs Antibodies by Vaccine Group PRE313835
Other pre-specifiedSeropositivity Rates for Anti-HBs Antibodies by Vaccine Group PIII(D90)

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
Reported as:
Count of participants · Participants
Seropositivity Rates for Anti-HBs Antibodies by Vaccine Group PIII(D90)
ParticipantsRTS, S/AS01BRTS, S/AS02ARabipur (Rabies) Vaccine
Seropositivity Rates for Anti-HBs Antibodies by Vaccine Group PIII(D90)686837
Other pre-specifiedSeropositivity Rates for Anti-HBs Antibodies by Vaccine Group PIII(M12)

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
Reported as:
Count of participants · Participants
Seropositivity Rates for Anti-HBs Antibodies by Vaccine Group PIII(M12)
ParticipantsRTS, S/AS01BRTS, S/AS02ARabipur (Rabies) Vaccine
Seropositivity Rates for Anti-HBs Antibodies by Vaccine Group PIII(M12)575940
Other pre-specifiedSeroprotection Rates for Anti-HBs Antibodies by Vaccine Group PRE

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

Time frame:
Prevaccination
Reported as:
Count of participants · Participants
Seroprotection Rates for Anti-HBs Antibodies by Vaccine Group PRE
ParticipantsRTS, S/AS01BRTS, S/AS02ARabipur (Rabies) Vaccine
Seroprotection Rates for Anti-HBs Antibodies by Vaccine Group PRE293433
Other pre-specifiedSeroprotection Rates for Anti-HBs Antibodies by Vaccine Group PIII (D90)

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
Reported as:
Count of participants · Participants
Seroprotection Rates for Anti-HBs Antibodies by Vaccine Group PIII (D90)
ParticipantsRTS, S/AS01BRTS, S/AS02ARabipur (Rabies) Vaccine
Seroprotection Rates for Anti-HBs Antibodies by Vaccine Group PIII (D90)656733
Other pre-specifiedSeroprotection Rates for Anti-HBs Antibodies by Vaccine Group PIII (M12)

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
Reported as:
Count of participants · Participants
Seroprotection Rates for Anti-HBs Antibodies by Vaccine Group PIII (M12)
ParticipantsRTS, S/AS01BRTS, S/AS02ARabipur (Rabies) Vaccine
Seroprotection Rates for Anti-HBs Antibodies by Vaccine Group PIII (M12)555733
Other pre-specifiedGeometric Mean Antibody Titers (GMTs) for Anti-HBs Antibodies by Vaccine Group PRE

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

Time frame:
Prevaccination
Reported as:
Geometric mean · titers
Geometric Mean Antibody Titers (GMTs) for Anti-HBs Antibodies by Vaccine Group PRE
titersRTS, S/AS01BRTS, S/AS02ARabipur (Rabies) Vaccine
Geometric Mean Antibody Titers (GMTs) for Anti-HBs Antibodies by Vaccine Group PRE11.1 (6.0 to 20.4)18.3 (9.4 to 35.3)23.6 (11.3 to 49.0)
Other pre-specifiedGeometric Mean Titers (GMTs) for Anti-HBs Antibodies by Vaccine Group PIII (D90)

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
Reported as:
Geometric mean · titers
Geometric Mean Titers (GMTs) for Anti-HBs Antibodies by Vaccine Group PIII (D90)
titersRTS, S/AS01BRTS, S/AS02ARabipur (Rabies) Vaccine
Geometric Mean Titers (GMTs) for Anti-HBs Antibodies by Vaccine Group PIII (D90)1434.9 (743.0 to 2770.9)1714.3 (836.1 to 3515.0)31.7 (14.6 to 68.9)
Other pre-specifiedGeometric Mean Titers (GMTs) for Anti-HBs Antibodies by Vaccine Group PIII (M12)

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
Reported as:
Geometric mean · titers
Geometric Mean Titers (GMTs) for Anti-HBs Antibodies by Vaccine Group PIII (M12)
titersRTS, S/AS01BRTS, S/AS02ARabipur (Rabies) Vaccine
Geometric Mean Titers (GMTs) for Anti-HBs Antibodies by Vaccine Group PIII (M12)593.7 (317.0 to 1111.9)635.8 (341.9 to 1182.5)28.6 (13.8 to 59.1)
Other pre-specifiedGeometric Mean Titers (GMTs) for Anti-HBs Antibodies by Infection Status PRE

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
Reported as:
Geometric mean · titer
Geometric Mean Titers (GMTs) for Anti-HBs Antibodies by Infection Status PRE
titerGeometric Mean Antibody
Non-infected: PRE11.1 (5.7 to 21.6)
Infected: PRE13.5 (7.9 to 22.9)
Other pre-specifiedGeometric Mean Titers (GMTs) for Anti-HBs Antibodies by Infection Status PIII (D90)

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
Reported as:
Geometric mean · titer
Geometric Mean Titers (GMTs) for Anti-HBs Antibodies by Infection Status PIII (D90)
titerGeometric Mean Antibody
Non-infected: PIII(D90)1558.3 (744.7 to 3260.7)
Infected: PIII(D90)1532.6 (844.2 to 2782.4)
Other pre-specifiedGeometric Mean Titers (GMTs) for Anti-HBs Antibodies by Infection Status PIII (M12)

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
Reported as:
Geometric mean · titer
Geometric Mean Titers (GMTs) for Anti-HBs Antibodies by Infection Status PIII (M12)
titerGeometric Mean Antibody
Non-infected: PIII(M12)765.8 (384.8 to 1524.3)
Infected: PIII(M12)499.0 (293.1 to 849.5)
Other pre-specifiedGeometric Mean Titers (GMTs) for Anti-CS Antibodies up to Month 12 by Vaccine Group PRE

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
Reported as:
Geometric mean · titers
Geometric Mean Titers (GMTs) for Anti-CS Antibodies up to Month 12 by Vaccine Group PRE
titersRTS, S/AS01BRTS, S/AS02ARabipur (Rabies) Vaccine
Geometric Mean Titers (GMTs) for Anti-CS Antibodies up to Month 12 by Vaccine Group PRE2.2 (1.6 to 2.9)1.2 (0.9 to 1.6)1.9 (1.4 to 2.5)
Other pre-specifiedGeometric Mean Titers (GMTs) for Anti-CS Antibodies up to Month 12 by Vaccine Group PII (D60)

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
Reported as:
Geometric mean · titers
Geometric Mean Titers (GMTs) for Anti-CS Antibodies up to Month 12 by Vaccine Group PII (D60)
titersRTS, S/AS01BRTS, S/AS02ARabipur (Rabies) Vaccine
Geometric Mean Titers (GMTs) for Anti-CS Antibodies up to Month 12 by Vaccine Group PII (D60)31.6 (23.9 to 41.6)16.7 (12.9 to 21.7)1.8 (1.4 to 2.3)
Other pre-specifiedGeometric Mean Titers (GMTs) for Anti-CS Antibodies up to Month 12 by Vaccine Group PIII (D90)

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
Reported as:
Geometric mean · titers
Geometric Mean Titers (GMTs) for Anti-CS Antibodies up to Month 12 by Vaccine Group PIII (D90)
titersRTS, S/AS01BRTS, S/AS02ARabipur (Rabies) Vaccine
Geometric Mean Titers (GMTs) for Anti-CS Antibodies up to Month 12 by Vaccine Group PIII (D90)41.4 (31.7 to 54.2)21.4 (16.0 to 28.7)1.1 (1.1 to 2.0)
Other pre-specifiedGeometric Mean Titers (GMTs) for Anti-CS Antibodies up to Month 12 by Vaccine Group PIII (M6.5)

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
Reported as:
Geometric mean · titers
Geometric Mean Titers (GMTs) for Anti-CS Antibodies up to Month 12 by Vaccine Group PIII (M6.5)
titersRTS, S/AS01BRTS, S/AS02ARabipur (Rabies) Vaccine
Geometric Mean Titers (GMTs) for Anti-CS Antibodies up to Month 12 by Vaccine Group PIII (M6.5)23.1 (17.1 to 31.1)13.1 (9.7 to 17.7)1.5 (1.1 to 2.0)
Other pre-specifiedGeometric Mean Titers (GMTs) for Anti-CS Antibodies up to Month 12 by Vaccine Group PIII (M12)

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
Reported as:
Geometric mean · titers
Geometric Mean Titers (GMTs) for Anti-CS Antibodies up to Month 12 by Vaccine Group PIII (M12)
titersRTS, S/AS01BRTS, S/AS02ARabipur (Rabies) Vaccine
Geometric Mean Titers (GMTs) for Anti-CS Antibodies up to Month 12 by Vaccine Group PIII (M12)14.2 (10.7 to 18.9)7.3 (5.2 to 10.2)1.7 (1.3 to 2.3)
Other pre-specifiedGeometric Mean Antibody Titers (GMTs) for Anti-CS Antibodies by Infection Status 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

Time frame:
PRE
Reported as:
Geometric mean · titers
Geometric Mean Antibody Titers (GMTs) for Anti-CS Antibodies by Infection Status PRE
titersGeometric Mean Antibody Titer
Infected: PRE1.2 (0.9 to 1.7)
Non-infected: PRE2.0 (1.6 to 2.6)
Other pre-specifiedGeometric Mean Antibody Titers (GMTs) for Anti-CS Antibodies by Infection Status PII (D60)

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)
Reported as:
Geometric mean · titers
Geometric Mean Antibody Titers (GMTs) for Anti-CS Antibodies by Infection Status PII (D60)
titersGeometric Mean Antibody Titer
Infected: PII(D60)11.9 (8.4 to 17.0)
Non-infected: PII(D60)33.9 (28.1 to 40.9)
Other pre-specifiedGeometric Mean Antibody Titers (GMTs) for Anti-CS Antibodies by Infection Status PIII (D90)

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)
Reported as:
Geometric mean · titers
Geometric Mean Antibody Titers (GMTs) for Anti-CS Antibodies by Infection Status PIII (D90)
titersGeometric Mean Antibody Titer
Infected: PIII(D90)18.3 (12.7 to 26.5)
Non-infected: PIII(D90)40.1 (32.6 to 49.2)
Other pre-specifiedGeometric Mean Antibody Titers (GMTs) for Anti-CS Antibodies by Infection Status PIII (M6.5)

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)

Time frame:
post dose 3 (month 6.5)
Reported as:
Geometric mean · titers
Geometric Mean Antibody Titers (GMTs) for Anti-CS Antibodies by Infection Status PIII (M6.5)
titersGeometric Mean Antibody Titer
Infected: PIII(M6.5)9.9 (6.7 to 14.6)
Non-infected: PIII(M6.5)25.1 (20.3 to 31.0)
Other pre-specifiedSeropositivity Rates for Anti-CS Antibodies by Vaccine Group PRE

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
Reported as:
Number · percentage of participants
Seropositivity Rates for Anti-CS Antibodies by Vaccine Group PRE
percentage of participantsRTS, S/AS01BRTS, S/AS02ARabipur (Rabies) Vaccine
Seropositivity Rates for Anti-CS Antibodies by Vaccine Group PRE86.7 (76.8 to 93.4)75.7 (64.3 to 84.9)84.9 (74.6 to 92.2)
Other pre-specifiedSeropositivity Rates for Anti-CS Antibodies by Vaccine Group PII (D60)

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
Reported as:
Number · percentage of participants
Seropositivity Rates for Anti-CS Antibodies by Vaccine Group PII (D60)
percentage of participantsRTS, S/AS01BRTS, S/AS02ARabipur (Rabies) Vaccine
Seropositivity Rates for Anti-CS Antibodies by Vaccine Group PII (D60)98.7 (92.8 to 100)100 (95.1 to 100)84.9 (74.6 to 92.2)
Other pre-specifiedSeropositivity Rates for Anti-CS Antibodies by Vaccine Group PIII (D90)

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
Reported as:
Number · percentage of participants
Seropositivity Rates for Anti-CS Antibodies by Vaccine Group PIII (D90)
percentage of participantsRTS, S/AS01BRTS, S/AS02ARabipur (Rabies) Vaccine
Seropositivity Rates for Anti-CS Antibodies by Vaccine Group PIII (D90)98.6 (92.5 to 100)100 (95.0 to 100)82.6 (71.6 to 90.7)
Other pre-specifiedSeropositivity Rates for Anti-CS Antibodies by Vaccine Group PIII (M6.5)

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
Reported as:
Number · percentage of participants
Seropositivity Rates for Anti-CS Antibodies by Vaccine Group PIII (M6.5)
percentage of participantsRTS, S/AS01BRTS, S/AS02ARabipur (Rabies) Vaccine
Seropositivity Rates for Anti-CS Antibodies by Vaccine Group PIII (M6.5)98.6 (92.2 to 100)98.6 (92.2 to 100)79.7 (68.3 to 88.4)
Other pre-specifiedSeropositivity Rates for Anti-CS Antibodies by Vaccine Group PIII (M12)

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
Reported as:
Number · percentage of participants
Seropositivity Rates for Anti-CS Antibodies by Vaccine Group PIII (M12)
percentage of participantsRTS, S/AS01BRTS, S/AS02ARabipur (Rabies) Vaccine
Seropositivity Rates for Anti-CS Antibodies by Vaccine Group PIII (M12)100 (94.1 to 100)95.2 (86.5 to 99.0)80.3 (68.7 to 89.1)
Other pre-specifiedSeropositivity Rates for Anti-CS Antibodies by Infection Status PRE

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
Reported as:
Number · percentage of participants
Seropositivity Rates for Anti-CS Antibodies by Infection Status PRE
percentage of participantsSeropositive
% of Infected: PRE76.8 (63.6 to 87.0)
% of Non-infected: PRE83.5 (74.6 to 90.3)
Other pre-specifiedSeropositivity Rates for Anti-CS Antibodies by Infection Status PII (D60)

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)
Reported as:
Number · percentage of participants
Seropositivity Rates for Anti-CS Antibodies by Infection Status PII (D60)
percentage of participantsSeropositive
% of Infected: PII(D60)98.2 (90.4 to 100)
% of Non-infected: PII(D60)100 (96.3 to 100)
Other pre-specifiedSeropositivity Rates for Anti-CS Antibodies by Infection Status PIII (D90)

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)
Reported as:
Number · percentage of participants
Seropositivity Rates for Anti-CS Antibodies by Infection Status PIII (D90)
percentage of participantsSeropositive
% of Infected: PIII(D90)98.2 (90.4 to 100)
% of Non-infected: PIII(D90)100 (96.2 to 100)
Other pre-specifiedSeropositivity Rates for Anti-CS Antibodies by Infection Status PIII (M6.5)

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)

Time frame:
post dose 3 (month 6.5)
Reported as:
Number · percentage of participants
Seropositivity Rates for Anti-CS Antibodies by Infection Status PIII (M6.5)
percentage of participantsSeropositive
% of Infected: PIII(M6.5)98.1 (90.1 to 100)
% of Non-infected: PIII(M6.5)98.9 (93.9 to 100)
Other pre-specifiedEfficacy: Vaccine Efficacy Against P. Falciparum Infection

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
Reported as:
Number · participants
Efficacy: Vaccine Efficacy Against P. Falciparum Infection
participantsRTS, S/AS01BRTS, S/AS02ARabipur (Rabies) Vaccine
Efficacy: Vaccine Efficacy Against P. Falciparum Infection282837
Other pre-specifiedPercentage of Participants With Positive and Negative Parasite Density

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

Time frame:
at month 6.5
Reported as:
Number · % of subjects
Percentage of Participants With Positive and Negative Parasite Density
% of subjectsRTS, S/AS01BRTS, S/AS02ARabipur (Rabies) Vaccine
Parasite Density: % of Negative Subjects91.493.295.8
Parasite Density: % of Positive Subjects8.66.84.2
Other pre-specifiedGeometric Mean Antibody Titers (GMTs) of Asexual P. Falciparum Parasitemia

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

Time frame:
Month 6.5
Reported as:
Geometric mean · titers
Geometric Mean Antibody Titers (GMTs) of Asexual P. Falciparum Parasitemia
titersRTS, S/AS01BRTS, S/AS02ARabipur (Rabies) Vaccine
Geometric Mean Antibody Titers (GMTs) of Asexual P. Falciparum Parasitemia1122 (-525.0 to 2769.0)342 (-115.4 to 799.8)711 (-846.8 to 2268.8)

Adverse events

Collected over 12 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
(RTS, S/AS01B)0/85 (0%)5/85 (5.9%)81/85 (95.3%)
(RTS, S/AS02A)0/85 (0%)1/85 (1.2%)82/85 (96.5%)
Rabipur (Rabies) Vaccine0/85 (0%)5/85 (5.9%)82/85 (96.5%)
Most frequent serious events
Showing 10 of 22
Most frequent serious events
Event(RTS, S/AS01B)(RTS, S/AS02A)Rabipur (Rabies) Vaccine
HIV infectionInfections and infestations2/850/853/85
AnaemiaBlood and lymphatic system disorders1/850/850/85
Cardiac failureCardiac disorders0/850/851/85
Pericardial effusionCardiac disorders0/850/851/85
CataractEye disorders0/850/851/85
Wound necrosisGeneral disorders1/850/850/85
Abscess limbInfections and infestations0/850/851/85
Lobar pneumoniaInfections and infestations1/850/850/85
MalariaInfections and infestations0/851/850/85
MeningitisInfections and infestations1/850/851/85
Most frequent other events
Showing 10 of 185
Most frequent other events
Event(RTS, S/AS01B)(RTS, S/AS02A)Rabipur (Rabies) Vaccine
HeadacheNervous system disorders54/8557/8545/85
Upper respiratory tract infectionInfections and infestations50/8554/8548/85
GastrointestinalGastrointestinal disorders37/8533/8533/85
HeadacheNervous system disorders24/8532/8537/85
FatigueGeneral disorders35/8528/8526/85
Decreased appetiteMetabolism and nutrition disorders25/8515/8519/85
Muscle achesMusculoskeletal and connective tissue disorders21/8521/8524/85
Joint pain at other locationMusculoskeletal and connective tissue disorders23/8519/8517/85
MalariaInfections and infestations19/8514/8521/85
Soft tissue injuryInjury, poisoning and procedural complications14/8518/8520/85

Baseline characteristics

Age, Continuous
Age, Continuous(years)RTS, S/AS02ARTS, S/AS01BRabipur (Rabies) VaccineTotal
Mean25.2 ± 5.1624.9 ± 5.5026.1 ± 5.1025.4 ± 5.26
Sex: Female, Male
Sex: Female, Male(Participants)RTS, S/AS02ARTS, S/AS01BRabipur (Rabies) VaccineTotal
Female19211252
Male666473203
Region of Enrollment
Region of Enrollment(participants)RTS, S/AS02ARTS, S/AS01BRabipur (Rabies) VaccineTotal
Kenya858585255
08

Study locations

1 site
  • U.S. Army Research Unit-Kenya
    Kisumu, Kenya
09

References and documents

Publications

  • Polhemus ME, Remich SA, Ogutu BR, Waitumbi JN, Otieno L, Apollo S, Cummings JF, Kester KE, Ockenhouse CF, Stewart A, Ofori-Anyinam O, Ramboer I, Cahill CP, Lievens M, Dubois MC, Demoitie MA, Leach A, Cohen J, Ballou WR, Heppner DG Jr. Evaluation of RTS,S/AS02A and RTS,S/AS01B in adults in a high malaria transmission area. PLoS One. 2009 Jul 31;4(7):e6465. doi: 10.1371/journal.pone.0006465. PubMed 19649245 ↗

Individual participant data

Plan to share: Yes — GSK and WRAIR

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 12, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00197054
Lead sponsor
U.S. Army Medical Research and Development Command
Collaborators
GlaxoSmithKline, Walter Reed Army Institute of Research (WRAIR)
Responsible party
Sponsor
First posted
Sep 20, 2005
Start date
Jul 2005
Primary completion
Sep 2006
Completion
Sep 2006
Results posted
Dec 11, 2020
Last update
Feb 12, 2021

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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