Plasmodium Falciparum
Conditions
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.
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.
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
Sponsors
GlaxoSmithKline
Walter Reed Army Institute of Research (WRAIR)
U.S. Army Medical Research and Development Command
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| Safety: Number of Administered Doses Eliciting Grade 3 Unsolicited Symptoms | 6.5 months | Grade 3 unsolicited symptoms reported following any number of administered doses |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
| Occurrence of Biochemistry Parameters Above Normal Ranges | Days 0, 6, and 90 | Occurrence of parameters of biochemical monitoring above normal ranges (Total Cohort) |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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) |
| 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) |
| 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 |
| 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) |
| 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) |
| 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 |
| 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) |
| 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) |
| 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 |
| 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) |
| 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) |
| 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) |
| 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) |
| 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 |
| 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) |
| 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) |
| 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) |
| 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 |
| 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) |
| 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 |
| 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) |
| 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) |
| 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 |
| 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) |
| 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) |
| 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) |
| 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) |
| 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 |
| 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 |
| 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) |
| 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) |
| 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) |
| 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 |
| 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) |
| 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) |
Countries
Kenya
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 85 |
| 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. | 85 |
| Rabipur (Rabies) Vaccine Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months | 85 |
| Total | 255 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 4 | 0 |
| Overall Study | Moved from area | 7 | 14 | 9 |
| Overall Study | Withdrawal by Subject | 9 | 3 | 3 |
Baseline characteristics
| Characteristic | RTS, S/AS02A | RTS, S/AS01B | Rabipur (Rabies) Vaccine | Total |
|---|---|---|---|---|
| Age, Continuous | 25.2 years STANDARD_DEVIATION 5.16 | 24.9 years STANDARD_DEVIATION 5.5 | 26.1 years STANDARD_DEVIATION 5.1 | 25.4 years STANDARD_DEVIATION 5.26 |
| Region of Enrollment Kenya | 85 participants | 85 participants | 85 participants | 255 participants |
| Sex: Female, Male Female | 19 Participants | 21 Participants | 12 Participants | 52 Participants |
| Sex: Female, Male Male | 66 Participants | 64 Participants | 73 Participants | 203 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 85 | 0 / 85 | 0 / 85 |
| other Total, other adverse events | 81 / 85 | 82 / 85 | 82 / 85 |
| serious Total, serious adverse events | 5 / 85 | 1 / 85 | 5 / 85 |
Outcome results
Primary
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RTS, S/AS02A | Safety: Number of Administered Doses Eliciting Grade 3 Unsolicited Symptoms | At least one symptom | 3 administered doses |
| RTS, S/AS02A | Safety: Number of Administered Doses Eliciting Grade 3 Unsolicited Symptoms | Sinusitis | 1 administered doses |
| RTS, S/AS02A | Safety: Number of Administered Doses Eliciting Grade 3 Unsolicited Symptoms | Headache | 1 administered doses |
| RTS, S/AS02A | Safety: Number of Administered Doses Eliciting Grade 3 Unsolicited Symptoms | Cough | 1 administered doses |
| RTS, S/AS01B | Safety: Number of Administered Doses Eliciting Grade 3 Unsolicited Symptoms | Cough | 0 administered doses |
| RTS, S/AS01B | Safety: Number of Administered Doses Eliciting Grade 3 Unsolicited Symptoms | At least one symptom | 0 administered doses |
| RTS, S/AS01B | Safety: Number of Administered Doses Eliciting Grade 3 Unsolicited Symptoms | Headache | 0 administered doses |
| RTS, S/AS01B | Safety: Number of Administered Doses Eliciting Grade 3 Unsolicited Symptoms | Sinusitis | 0 administered doses |
| Rabipur (Rabies) Vaccine | Safety: Number of Administered Doses Eliciting Grade 3 Unsolicited Symptoms | Cough | 0 administered doses |
| Rabipur (Rabies) Vaccine | Safety: Number of Administered Doses Eliciting Grade 3 Unsolicited Symptoms | Sinusitis | 0 administered doses |
| Rabipur (Rabies) Vaccine | Safety: Number of Administered Doses Eliciting Grade 3 Unsolicited Symptoms | Headache | 1 administered doses |
| Rabipur (Rabies) Vaccine | Safety: Number of Administered Doses Eliciting Grade 3 Unsolicited Symptoms | At least one symptom | 1 administered doses |
Primary
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)
Population: number of administered doses
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RTS, S/AS02A | Safety: Number of Doses Eliciting Solicited Local Symptoms Reported Over 7 Day Follow-up Period | Pain | 132 Doses |
| RTS, S/AS02A | Safety: Number of Doses Eliciting Solicited Local Symptoms Reported Over 7 Day Follow-up Period | Swelling | 12 Doses |
| RTS, S/AS02A | Safety: Number of Doses Eliciting Solicited Local Symptoms Reported Over 7 Day Follow-up Period | Fatigue | 43 Doses |
| RTS, S/AS02A | Safety: Number of Doses Eliciting Solicited Local Symptoms Reported Over 7 Day Follow-up Period | Fever (Axillary) | 21 Doses |
| RTS, S/AS02A | Safety: Number of Doses Eliciting Solicited Local Symptoms Reported Over 7 Day Follow-up Period | Gastrointestinal | 48 Doses |
| RTS, S/AS02A | Safety: Number of Doses Eliciting Solicited Local Symptoms Reported Over 7 Day Follow-up Period | Headache | 84 Doses |
| RTS, S/AS02A | Safety: Number of Doses Eliciting Solicited Local Symptoms Reported Over 7 Day Follow-up Period | Joint pain at other location | 27 Doses |
| RTS, S/AS02A | Safety: Number of Doses Eliciting Solicited Local Symptoms Reported Over 7 Day Follow-up Period | Muscle aches | 27 Doses |
| RTS, S/AS01B | Safety: Number of Doses Eliciting Solicited Local Symptoms Reported Over 7 Day Follow-up Period | Fatigue | 33 Doses |
| RTS, S/AS01B | Safety: Number of Doses Eliciting Solicited Local Symptoms Reported Over 7 Day Follow-up Period | Joint pain at other location | 22 Doses |
| RTS, S/AS01B | Safety: Number of Doses Eliciting Solicited Local Symptoms Reported Over 7 Day Follow-up Period | Fever (Axillary) | 14 Doses |
| RTS, S/AS01B | Safety: Number of Doses Eliciting Solicited Local Symptoms Reported Over 7 Day Follow-up Period | Gastrointestinal | 42 Doses |
| RTS, S/AS01B | Safety: Number of Doses Eliciting Solicited Local Symptoms Reported Over 7 Day Follow-up Period | Headache | 95 Doses |
| RTS, S/AS01B | Safety: Number of Doses Eliciting Solicited Local Symptoms Reported Over 7 Day Follow-up Period | Pain | 166 Doses |
| RTS, S/AS01B | Safety: Number of Doses Eliciting Solicited Local Symptoms Reported Over 7 Day Follow-up Period | Swelling | 22 Doses |
| RTS, S/AS01B | Safety: Number of Doses Eliciting Solicited Local Symptoms Reported Over 7 Day Follow-up Period | Muscle aches | 23 Doses |
| Rabipur (Rabies) Vaccine | Safety: Number of Doses Eliciting Solicited Local Symptoms Reported Over 7 Day Follow-up Period | Fatigue | 35 Doses |
| Rabipur (Rabies) Vaccine | Safety: Number of Doses Eliciting Solicited Local Symptoms Reported Over 7 Day Follow-up Period | Swelling | 2 Doses |
| Rabipur (Rabies) Vaccine | Safety: Number of Doses Eliciting Solicited Local Symptoms Reported Over 7 Day Follow-up Period | Pain | 68 Doses |
| Rabipur (Rabies) Vaccine | Safety: Number of Doses Eliciting Solicited Local Symptoms Reported Over 7 Day Follow-up Period | Fever (Axillary) | 12 Doses |
| Rabipur (Rabies) Vaccine | Safety: Number of Doses Eliciting Solicited Local Symptoms Reported Over 7 Day Follow-up Period | Joint pain at other location | 22 Doses |
| Rabipur (Rabies) Vaccine | Safety: Number of Doses Eliciting Solicited Local Symptoms Reported Over 7 Day Follow-up Period | Headache | 67 Doses |
| Rabipur (Rabies) Vaccine | Safety: Number of Doses Eliciting Solicited Local Symptoms Reported Over 7 Day Follow-up Period | Gastrointestinal | 44 Doses |
| Rabipur (Rabies) Vaccine | Safety: Number of Doses Eliciting Solicited Local Symptoms Reported Over 7 Day Follow-up Period | Muscle aches | 29 Doses |
Primary
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)
Population: Rabipur was a comparator vaccine and not relevant to results of this primary outcome. Results for Rabipur were not presented in data table.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RTS, S/AS02A | Safety: Proportion of Subjects With Grade 3 Solicited and Unsolicited General Reactions After Vaccination of RTS, S/AS02A and RTS, S/AS01B | 0 participants |
| RTS, S/AS01B | Safety: Proportion of Subjects With Grade 3 Solicited and Unsolicited General Reactions After Vaccination of RTS, S/AS02A and RTS, S/AS01B | 1 participants |
Secondary
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RTS, S/AS02A | Occurrence of Biochemistry Parameters Above Normal Ranges | ALT: Day 6 | 1 Participants |
| RTS, S/AS02A | Occurrence of Biochemistry Parameters Above Normal Ranges | Bilirubin: Day 90 | 3 Participants |
| RTS, S/AS02A | Occurrence of Biochemistry Parameters Above Normal Ranges | ALT: Day 0 | 0 Participants |
| RTS, S/AS02A | Occurrence of Biochemistry Parameters Above Normal Ranges | ALT: Day 90 | 0 Participants |
| RTS, S/AS02A | Occurrence of Biochemistry Parameters Above Normal Ranges | Bilirubin: Day 6 | 6 Participants |
| RTS, S/AS02A | Occurrence of Biochemistry Parameters Above Normal Ranges | Bilirubin: Day 0 | 10 Participants |
| RTS, S/AS01B | Occurrence of Biochemistry Parameters Above Normal Ranges | Bilirubin: Day 90 | 3 Participants |
| RTS, S/AS01B | Occurrence of Biochemistry Parameters Above Normal Ranges | Bilirubin: Day 0 | 9 Participants |
| RTS, S/AS01B | Occurrence of Biochemistry Parameters Above Normal Ranges | Bilirubin: Day 6 | 4 Participants |
| RTS, S/AS01B | Occurrence of Biochemistry Parameters Above Normal Ranges | ALT: Day 0 | 0 Participants |
| RTS, S/AS01B | Occurrence of Biochemistry Parameters Above Normal Ranges | ALT: Day 6 | 6 Participants |
| RTS, S/AS01B | Occurrence of Biochemistry Parameters Above Normal Ranges | ALT: Day 90 | 1 Participants |
| Rabipur (Rabies) Vaccine | Occurrence of Biochemistry Parameters Above Normal Ranges | Bilirubin: Day 6 | 7 Participants |
| Rabipur (Rabies) Vaccine | Occurrence of Biochemistry Parameters Above Normal Ranges | ALT: Day 90 | 3 Participants |
| Rabipur (Rabies) Vaccine | Occurrence of Biochemistry Parameters Above Normal Ranges | ALT: Day 6 | 0 Participants |
| Rabipur (Rabies) Vaccine | Occurrence of Biochemistry Parameters Above Normal Ranges | Bilirubin: Day 90 | 6 Participants |
| Rabipur (Rabies) Vaccine | Occurrence of Biochemistry Parameters Above Normal Ranges | Bilirubin: Day 0 | 11 Participants |
| Rabipur (Rabies) Vaccine | Occurrence of Biochemistry Parameters Above Normal Ranges | ALT: Day 0 | 0 Participants |
Secondary
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RTS, S/AS02A | Occurrence of Hematology Parameters Below Normal Range | hemoglobin: Month 6 | 2 Participants |
| RTS, S/AS02A | Occurrence of Hematology Parameters Below Normal Range | Hemoglobin: Day 6 | 4 Participants |
| RTS, S/AS02A | Occurrence of Hematology Parameters Below Normal Range | Hemoglobin: Day 66 | 2 Participants |
| RTS, S/AS02A | Occurrence of Hematology Parameters Below Normal Range | Hemoglobin: Day 90 | 2 Participants |
| RTS, S/AS02A | Occurrence of Hematology Parameters Below Normal Range | Hemoglobin: Day 0 | 0 Participants |
| RTS, S/AS02A | Occurrence of Hematology Parameters Below Normal Range | Hemoglobin: Month 12 | 4 Participants |
| RTS, S/AS02A | Occurrence of Hematology Parameters Below Normal Range | WBC: Day 0 | 0 Participants |
| RTS, S/AS02A | Occurrence of Hematology Parameters Below Normal Range | WBC: Day 6 | 0 Participants |
| RTS, S/AS02A | Occurrence of Hematology Parameters Below Normal Range | WBC: Day 66 | 0 Participants |
| RTS, S/AS02A | Occurrence of Hematology Parameters Below Normal Range | WBC: Day 90 | 3 Participants |
| RTS, S/AS02A | Occurrence of Hematology Parameters Below Normal Range | WBC: Month 6 | 2 Participants |
| RTS, S/AS02A | Occurrence of Hematology Parameters Below Normal Range | WBC: Month 12 | 2 Participants |
| RTS, S/AS02A | Occurrence of Hematology Parameters Below Normal Range | Lymphocytes: Day 0 | 0 Participants |
| RTS, S/AS02A | Occurrence of Hematology Parameters Below Normal Range | Lymphocytes: Day 6 | 0 Participants |
| RTS, S/AS02A | Occurrence of Hematology Parameters Below Normal Range | Lymphocytes: Day 66 | 0 Participants |
| RTS, S/AS02A | Occurrence of Hematology Parameters Below Normal Range | Lymphocytes: Day 90 | 1 Participants |
| RTS, S/AS02A | Occurrence of Hematology Parameters Below Normal Range | Lymphocytes: Month 6 | 1 Participants |
| RTS, S/AS02A | Occurrence of Hematology Parameters Below Normal Range | Lymphocytes: Month 12 | 1 Participants |
| RTS, S/AS01B | Occurrence of Hematology Parameters Below Normal Range | Lymphocytes: Month 12 | 0 Participants |
| RTS, S/AS01B | Occurrence of Hematology Parameters Below Normal Range | Hemoglobin: Day 0 | 0 Participants |
| RTS, S/AS01B | Occurrence of Hematology Parameters Below Normal Range | WBC: Day 90 | 0 Participants |
| RTS, S/AS01B | Occurrence of Hematology Parameters Below Normal Range | Lymphocytes: Day 0 | 0 Participants |
| RTS, S/AS01B | Occurrence of Hematology Parameters Below Normal Range | Hemoglobin: Day 6 | 1 Participants |
| RTS, S/AS01B | Occurrence of Hematology Parameters Below Normal Range | Lymphocytes: Day 66 | 0 Participants |
| RTS, S/AS01B | Occurrence of Hematology Parameters Below Normal Range | Lymphocytes: Day 90 | 0 Participants |
| RTS, S/AS01B | Occurrence of Hematology Parameters Below Normal Range | Hemoglobin: Day 66 | 1 Participants |
| RTS, S/AS01B | Occurrence of Hematology Parameters Below Normal Range | WBC: Month 6 | 0 Participants |
| RTS, S/AS01B | Occurrence of Hematology Parameters Below Normal Range | Lymphocytes: Month 6 | 0 Participants |
| RTS, S/AS01B | Occurrence of Hematology Parameters Below Normal Range | Hemoglobin: Day 90 | 0 Participants |
| RTS, S/AS01B | Occurrence of Hematology Parameters Below Normal Range | WBC: Day 66 | 0 Participants |
| RTS, S/AS01B | Occurrence of Hematology Parameters Below Normal Range | Lymphocytes: Day 6 | 0 Participants |
| RTS, S/AS01B | Occurrence of Hematology Parameters Below Normal Range | hemoglobin: Month 6 | 1 Participants |
| RTS, S/AS01B | Occurrence of Hematology Parameters Below Normal Range | WBC: Day 6 | 0 Participants |
| RTS, S/AS01B | Occurrence of Hematology Parameters Below Normal Range | WBC: Month 12 | 0 Participants |
| RTS, S/AS01B | Occurrence of Hematology Parameters Below Normal Range | Hemoglobin: Month 12 | 2 Participants |
| RTS, S/AS01B | Occurrence of Hematology Parameters Below Normal Range | WBC: Day 0 | 0 Participants |
| Rabipur (Rabies) Vaccine | Occurrence of Hematology Parameters Below Normal Range | Hemoglobin: Month 12 | 0 Participants |
| Rabipur (Rabies) Vaccine | Occurrence of Hematology Parameters Below Normal Range | WBC: Day 0 | 0 Participants |
| Rabipur (Rabies) Vaccine | Occurrence of Hematology Parameters Below Normal Range | WBC: Day 6 | 1 Participants |
| Rabipur (Rabies) Vaccine | Occurrence of Hematology Parameters Below Normal Range | Lymphocytes: Day 66 | 0 Participants |
| Rabipur (Rabies) Vaccine | Occurrence of Hematology Parameters Below Normal Range | WBC: Day 66 | 1 Participants |
| Rabipur (Rabies) Vaccine | Occurrence of Hematology Parameters Below Normal Range | Lymphocytes: Month 12 | 0 Participants |
| Rabipur (Rabies) Vaccine | Occurrence of Hematology Parameters Below Normal Range | WBC: Day 90 | 0 Participants |
| Rabipur (Rabies) Vaccine | Occurrence of Hematology Parameters Below Normal Range | WBC: Month 6 | 1 Participants |
| Rabipur (Rabies) Vaccine | Occurrence of Hematology Parameters Below Normal Range | Lymphocytes: Day 90 | 0 Participants |
| Rabipur (Rabies) Vaccine | Occurrence of Hematology Parameters Below Normal Range | WBC: Month 12 | 0 Participants |
| Rabipur (Rabies) Vaccine | Occurrence of Hematology Parameters Below Normal Range | Hemoglobin: Day 0 | 0 Participants |
| Rabipur (Rabies) Vaccine | Occurrence of Hematology Parameters Below Normal Range | Hemoglobin: Day 6 | 1 Participants |
| Rabipur (Rabies) Vaccine | Occurrence of Hematology Parameters Below Normal Range | Lymphocytes: Day 0 | 0 Participants |
| Rabipur (Rabies) Vaccine | Occurrence of Hematology Parameters Below Normal Range | Hemoglobin: Day 66 | 2 Participants |
| Rabipur (Rabies) Vaccine | Occurrence of Hematology Parameters Below Normal Range | Hemoglobin: Day 90 | 2 Participants |
| Rabipur (Rabies) Vaccine | Occurrence of Hematology Parameters Below Normal Range | hemoglobin: Month 6 | 1 Participants |
| Rabipur (Rabies) Vaccine | Occurrence of Hematology Parameters Below Normal Range | Lymphocytes: Day 6 | 1 Participants |
| Rabipur (Rabies) Vaccine | Occurrence of Hematology Parameters Below Normal Range | Lymphocytes: Month 6 | 0 Participants |
Secondary
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
Population: Number of subjects with at least one administered dose
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RTS, S/AS02A | Safety: Occurrence of SAEs | Cataract | 0.0 % of subjects reporting symptom |
| RTS, S/AS02A | Safety: Occurrence of SAEs | Pneumonia | 1.2 % of subjects reporting symptom |
| RTS, S/AS02A | Safety: Occurrence of SAEs | HIV Infection | 2.4 % of subjects reporting symptom |
| RTS, S/AS02A | Safety: Occurrence of SAEs | Abortion | 1.2 % of subjects reporting symptom |
| RTS, S/AS02A | Safety: Occurrence of SAEs | Pneumocystis Jiroveci Pheumonia | 1.2 % of subjects reporting symptom |
| RTS, S/AS02A | Safety: Occurrence of SAEs | Lobar Pneumonia | 1.2 % of subjects reporting symptom |
| RTS, S/AS02A | Safety: Occurrence of SAEs | Pericardial Effusion | 0.0 % of subjects reporting symptom |
| RTS, S/AS02A | Safety: Occurrence of SAEs | Meningitis Cryptococcal | 0.0 % of subjects reporting symptom |
| RTS, S/AS02A | Safety: Occurrence of SAEs | Malaria | 0.0 % of subjects reporting symptom |
| RTS, S/AS02A | Safety: Occurrence of SAEs | Anaemia | 1.2 % of subjects reporting symptom |
| RTS, S/AS02A | Safety: Occurrence of SAEs | Meningitis | 1.2 % of subjects reporting symptom |
| RTS, S/AS02A | Safety: Occurrence of SAEs | Encephalitis | 1.2 % of subjects reporting symptom |
| RTS, S/AS02A | Safety: Occurrence of SAEs | Peptic Ulcer Haemorrhage | 1.2 % of subjects reporting symptom |
| RTS, S/AS02A | Safety: Occurrence of SAEs | Pleural Effusion | 0.0 % of subjects reporting symptom |
| RTS, S/AS02A | Safety: Occurrence of SAEs | Osteoarthritis | 1.2 % of subjects reporting symptom |
| RTS, S/AS02A | Safety: Occurrence of SAEs | Wound Necrosis | 1.2 % of subjects reporting symptom |
| RTS, S/AS02A | Safety: Occurrence of SAEs | Haemoptysis | 1.2 % of subjects reporting symptom |
| RTS, S/AS02A | Safety: Occurrence of SAEs | Trichomoniasis | 1.2 % of subjects reporting symptom |
| RTS, S/AS02A | Safety: Occurrence of SAEs | Abscess Limb | 0.0 % of subjects reporting symptom |
| RTS, S/AS02A | Safety: Occurrence of SAEs | Cardiac Failure | 0.0 % of subjects reporting symptom |
| RTS, S/AS02A | Safety: Occurrence of SAEs | Pulmonary Tuberculosis | 0.0 % of subjects reporting symptom |
| RTS, S/AS02A | Safety: Occurrence of SAEs | Disseminated Tuberculosis | 1.2 % of subjects reporting symptom |
| RTS, S/AS01B | Safety: Occurrence of SAEs | Trichomoniasis | 0.0 % of subjects reporting symptom |
| RTS, S/AS01B | Safety: Occurrence of SAEs | Anaemia | 0.0 % of subjects reporting symptom |
| RTS, S/AS01B | Safety: Occurrence of SAEs | Cardiac Failure | 0.0 % of subjects reporting symptom |
| RTS, S/AS01B | Safety: Occurrence of SAEs | Cataract | 0.0 % of subjects reporting symptom |
| RTS, S/AS01B | Safety: Occurrence of SAEs | Peptic Ulcer Haemorrhage | 0.0 % of subjects reporting symptom |
| RTS, S/AS01B | Safety: Occurrence of SAEs | Wound Necrosis | 0.0 % of subjects reporting symptom |
| RTS, S/AS01B | Safety: Occurrence of SAEs | Abscess Limb | 0.0 % of subjects reporting symptom |
| RTS, S/AS01B | Safety: Occurrence of SAEs | Disseminated Tuberculosis | 0.0 % of subjects reporting symptom |
| RTS, S/AS01B | Safety: Occurrence of SAEs | HIV Infection | 0.0 % of subjects reporting symptom |
| RTS, S/AS01B | Safety: Occurrence of SAEs | Lobar Pneumonia | 0.0 % of subjects reporting symptom |
| RTS, S/AS01B | Safety: Occurrence of SAEs | Malaria | 1.2 % of subjects reporting symptom |
| RTS, S/AS01B | Safety: Occurrence of SAEs | Meningitis | 0.0 % of subjects reporting symptom |
| RTS, S/AS01B | Safety: Occurrence of SAEs | Meningitis Cryptococcal | 0.0 % of subjects reporting symptom |
| RTS, S/AS01B | Safety: Occurrence of SAEs | Pneumocystis Jiroveci Pheumonia | 0.0 % of subjects reporting symptom |
| RTS, S/AS01B | Safety: Occurrence of SAEs | Pneumonia | 0.0 % of subjects reporting symptom |
| RTS, S/AS01B | Safety: Occurrence of SAEs | Pulmonary Tuberculosis | 0.0 % of subjects reporting symptom |
| RTS, S/AS01B | Safety: Occurrence of SAEs | Pericardial Effusion | 0.0 % of subjects reporting symptom |
| RTS, S/AS01B | Safety: Occurrence of SAEs | Osteoarthritis | 0.0 % of subjects reporting symptom |
| RTS, S/AS01B | Safety: Occurrence of SAEs | Encephalitis | 0.0 % of subjects reporting symptom |
| RTS, S/AS01B | Safety: Occurrence of SAEs | Abortion | 0.0 % of subjects reporting symptom |
| RTS, S/AS01B | Safety: Occurrence of SAEs | Haemoptysis | 0.0 % of subjects reporting symptom |
| RTS, S/AS01B | Safety: Occurrence of SAEs | Pleural Effusion | 0.0 % of subjects reporting symptom |
| Rabipur (Rabies) Vaccine | Safety: Occurrence of SAEs | Pneumonia | 0.0 % of subjects reporting symptom |
| Rabipur (Rabies) Vaccine | Safety: Occurrence of SAEs | Abscess Limb | 1.2 % of subjects reporting symptom |
| Rabipur (Rabies) Vaccine | Safety: Occurrence of SAEs | Abortion | 0.0 % of subjects reporting symptom |
| Rabipur (Rabies) Vaccine | Safety: Occurrence of SAEs | Pulmonary Tuberculosis | 1.2 % of subjects reporting symptom |
| Rabipur (Rabies) Vaccine | Safety: Occurrence of SAEs | Wound Necrosis | 0.0 % of subjects reporting symptom |
| Rabipur (Rabies) Vaccine | Safety: Occurrence of SAEs | Anaemia | 0.0 % of subjects reporting symptom |
| Rabipur (Rabies) Vaccine | Safety: Occurrence of SAEs | Trichomoniasis | 0.0 % of subjects reporting symptom |
| Rabipur (Rabies) Vaccine | Safety: Occurrence of SAEs | Peptic Ulcer Haemorrhage | 0.0 % of subjects reporting symptom |
| Rabipur (Rabies) Vaccine | Safety: Occurrence of SAEs | Pleural Effusion | 1.2 % of subjects reporting symptom |
| Rabipur (Rabies) Vaccine | Safety: Occurrence of SAEs | Osteoarthritis | 0.0 % of subjects reporting symptom |
| Rabipur (Rabies) Vaccine | Safety: Occurrence of SAEs | Cataract | 1.2 % of subjects reporting symptom |
| Rabipur (Rabies) Vaccine | Safety: Occurrence of SAEs | Malaria | 0.0 % of subjects reporting symptom |
| Rabipur (Rabies) Vaccine | Safety: Occurrence of SAEs | Haemoptysis | 0.0 % of subjects reporting symptom |
| Rabipur (Rabies) Vaccine | Safety: Occurrence of SAEs | Meningitis | 1.2 % of subjects reporting symptom |
| Rabipur (Rabies) Vaccine | Safety: Occurrence of SAEs | Lobar Pneumonia | 0.0 % of subjects reporting symptom |
| Rabipur (Rabies) Vaccine | Safety: Occurrence of SAEs | Encephalitis | 0.0 % of subjects reporting symptom |
| Rabipur (Rabies) Vaccine | Safety: Occurrence of SAEs | Meningitis Cryptococcal | 1.2 % of subjects reporting symptom |
| Rabipur (Rabies) Vaccine | Safety: Occurrence of SAEs | HIV Infection | 3.5 % of subjects reporting symptom |
| Rabipur (Rabies) Vaccine | Safety: Occurrence of SAEs | Cardiac Failure | 1.2 % of subjects reporting symptom |
| Rabipur (Rabies) Vaccine | Safety: Occurrence of SAEs | Pneumocystis Jiroveci Pheumonia | 0.0 % of subjects reporting symptom |
| Rabipur (Rabies) Vaccine | Safety: Occurrence of SAEs | Disseminated Tuberculosis | 0.0 % of subjects reporting symptom |
| Rabipur (Rabies) Vaccine | Safety: Occurrence of SAEs | Pericardial Effusion | 1.2 % of subjects reporting symptom |
Secondary
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
Population: Number of subjects with at least one administered dose
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RTS, S/AS02A | Safety: Occurrence of SAEs | Wound Necrosis | 1.4 % of subjects |
| RTS, S/AS02A | Safety: Occurrence of SAEs | Cardiac Failure | 0.0 % of subjects |
| RTS, S/AS02A | Safety: Occurrence of SAEs | Pericardial Effusion | 0.0 % of subjects |
| RTS, S/AS02A | Safety: Occurrence of SAEs | Cataract | 0.0 % of subjects |
| RTS, S/AS02A | Safety: Occurrence of SAEs | Anaemia | 1.4 % of subjects |
| RTS, S/AS02A | Safety: Occurrence of SAEs | Abscess Limb | 0.0 % of subjects |
| RTS, S/AS02A | Safety: Occurrence of SAEs | HIV Infection | 1.4 % of subjects |
| RTS, S/AS02A | Safety: Occurrence of SAEs | Lobar Pneumonia | 1.4 % of subjects |
| RTS, S/AS02A | Safety: Occurrence of SAEs | Malaria | 0.0 % of subjects |
| RTS, S/AS02A | Safety: Occurrence of SAEs | Meningitis | 1.4 % of subjects |
| RTS, S/AS02A | Safety: Occurrence of SAEs | Pneumonia | 1.4 % of subjects |
| RTS, S/AS02A | Safety: Occurrence of SAEs | Pulmonary Tuberculosis | 0.0 % of subjects |
| RTS, S/AS02A | Safety: Occurrence of SAEs | Trichomoniasis | 1.4 % of subjects |
| RTS, S/AS02A | Safety: Occurrence of SAEs | Abortion | 1.4 % of subjects |
| RTS, S/AS02A | Safety: Occurrence of SAEs | Haemoptysis | 2.4 % of subjects |
| RTS, S/AS02A | Safety: Occurrence of SAEs | Pleural Effusion | 0.0 % of subjects |
| RTS, S/AS01B | Safety: Occurrence of SAEs | Abscess Limb | 0.0 % of subjects |
| RTS, S/AS01B | Safety: Occurrence of SAEs | HIV Infection | 0.0 % of subjects |
| RTS, S/AS01B | Safety: Occurrence of SAEs | Lobar Pneumonia | 0.0 % of subjects |
| RTS, S/AS01B | Safety: Occurrence of SAEs | Abortion | 0.0 % of subjects |
| RTS, S/AS01B | Safety: Occurrence of SAEs | Malaria | 1.3 % of subjects |
| RTS, S/AS01B | Safety: Occurrence of SAEs | Meningitis | 0.0 % of subjects |
| RTS, S/AS01B | Safety: Occurrence of SAEs | Pleural Effusion | 0.0 % of subjects |
| RTS, S/AS01B | Safety: Occurrence of SAEs | Pneumonia | 0.0 % of subjects |
| RTS, S/AS01B | Safety: Occurrence of SAEs | Anaemia | 0.0 % of subjects |
| RTS, S/AS01B | Safety: Occurrence of SAEs | Haemoptysis | 0.0 % of subjects |
| RTS, S/AS01B | Safety: Occurrence of SAEs | Cardiac Failure | 0.0 % of subjects |
| RTS, S/AS01B | Safety: Occurrence of SAEs | Pulmonary Tuberculosis | 0.0 % of subjects |
| RTS, S/AS01B | Safety: Occurrence of SAEs | Pericardial Effusion | 0.0 % of subjects |
| RTS, S/AS01B | Safety: Occurrence of SAEs | Cataract | 0.0 % of subjects |
| RTS, S/AS01B | Safety: Occurrence of SAEs | Wound Necrosis | 0.0 % of subjects |
| RTS, S/AS01B | Safety: Occurrence of SAEs | Trichomoniasis | 0.0 % of subjects |
| Rabipur (Rabies) Vaccine | Safety: Occurrence of SAEs | Pneumonia | 0.0 % of subjects |
| Rabipur (Rabies) Vaccine | Safety: Occurrence of SAEs | Abscess Limb | 1.3 % of subjects |
| Rabipur (Rabies) Vaccine | Safety: Occurrence of SAEs | Trichomoniasis | 0.0 % of subjects |
| Rabipur (Rabies) Vaccine | Safety: Occurrence of SAEs | Pericardial Effusion | 1.3 % of subjects |
| Rabipur (Rabies) Vaccine | Safety: Occurrence of SAEs | HIV Infection | 1.3 % of subjects |
| Rabipur (Rabies) Vaccine | Safety: Occurrence of SAEs | Pleural Effusion | 1.3 % of subjects |
| Rabipur (Rabies) Vaccine | Safety: Occurrence of SAEs | Anaemia | 0.0 % of subjects |
| Rabipur (Rabies) Vaccine | Safety: Occurrence of SAEs | Lobar Pneumonia | 0.0 % of subjects |
| Rabipur (Rabies) Vaccine | Safety: Occurrence of SAEs | Pulmonary Tuberculosis | 1.3 % of subjects |
| Rabipur (Rabies) Vaccine | Safety: Occurrence of SAEs | Wound Necrosis | 0.0 % of subjects |
| Rabipur (Rabies) Vaccine | Safety: Occurrence of SAEs | Malaria | 0.0 % of subjects |
| Rabipur (Rabies) Vaccine | Safety: Occurrence of SAEs | Abortion | 0.0 % of subjects |
| Rabipur (Rabies) Vaccine | Safety: Occurrence of SAEs | Cardiac Failure | 1.3 % of subjects |
| Rabipur (Rabies) Vaccine | Safety: Occurrence of SAEs | Meningitis | 1.3 % of subjects |
| Rabipur (Rabies) Vaccine | Safety: Occurrence of SAEs | Cataract | 1.3 % of subjects |
| Rabipur (Rabies) Vaccine | Safety: Occurrence of SAEs | Haemoptysis | 0.0 % of subjects |
Other Pre-specified
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
Population: Efficacy (According to protocol (ATP) Cohort): 228 subjects (74 RTS,S/AS01B, 79 RTS,S/AS02A, 75 rabies vaccine).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RTS, S/AS02A | Efficacy: Vaccine Efficacy Against P. Falciparum Infection | 28 participants |
| RTS, S/AS01B | Efficacy: Vaccine Efficacy Against P. Falciparum Infection | 28 participants |
| Rabipur (Rabies) Vaccine | Efficacy: Vaccine Efficacy Against P. Falciparum Infection | 37 participants |
Other Pre-specified
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)
Population: The ATP Cohort includes all evaluable subjects for whom data were available. For GMTs by infection status arms have been combined.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| RTS, S/AS02A | Geometric Mean Antibody Titers (GMTs) for Anti-CS Antibodies by Infection Status PII (D60) | Infected: PII(D60) | 11.9 titers |
| RTS, S/AS02A | Geometric Mean Antibody Titers (GMTs) for Anti-CS Antibodies by Infection Status PII (D60) | Non-infected: PII(D60) | 33.9 titers |
Other Pre-specified
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)
Population: The ATP Cohort includes all evaluable subjects for whom data were available. For GMTs by infection status arms have been combined.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| RTS, S/AS02A | Geometric Mean Antibody Titers (GMTs) for Anti-CS Antibodies by Infection Status PIII (D90) | Infected: PIII(D90) | 18.3 titers |
| RTS, S/AS02A | Geometric Mean Antibody Titers (GMTs) for Anti-CS Antibodies by Infection Status PIII (D90) | Non-infected: PIII(D90) | 40.1 titers |
Other Pre-specified
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)
Population: The ATP Cohort includes all evaluable subjects for whom data were available. For GMTs by infection status arms have been combined.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| RTS, S/AS02A | Geometric Mean Antibody Titers (GMTs) for Anti-CS Antibodies by Infection Status PIII (M6.5) | Infected: PIII(M6.5) | 9.9 titers |
| RTS, S/AS02A | Geometric Mean Antibody Titers (GMTs) for Anti-CS Antibodies by Infection Status PIII (M6.5) | Non-infected: PIII(M6.5) | 25.1 titers |
Other Pre-specified
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
Population: The ATP Cohort includes all evaluable subjects for whom data were available. For GMTs by infection status arms have been combined.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| RTS, S/AS02A | Geometric Mean Antibody Titers (GMTs) for Anti-CS Antibodies by Infection Status PRE | Infected: PRE | 1.2 titers |
| RTS, S/AS02A | Geometric Mean Antibody Titers (GMTs) for Anti-CS Antibodies by Infection Status PRE | Non-infected: PRE | 2.0 titers |
Other Pre-specified
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
Population: Subjects with available results
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RTS, S/AS02A | Geometric Mean Antibody Titers (GMTs) for Anti-HBs Antibodies by Vaccine Group PRE | 11.1 titers |
| RTS, S/AS01B | Geometric Mean Antibody Titers (GMTs) for Anti-HBs Antibodies by Vaccine Group PRE | 18.3 titers |
| Rabipur (Rabies) Vaccine | Geometric Mean Antibody Titers (GMTs) for Anti-HBs Antibodies by Vaccine Group PRE | 23.6 titers |
Other Pre-specified
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
Population: Efficacy (According to protocol (ATP) Cohort): 228 subjects (74 RTS,S/AS01B, 79 RTS,S/AS02A, 75 rabies vaccine).
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RTS, S/AS02A | Geometric Mean Antibody Titers (GMTs) of Asexual P. Falciparum Parasitemia | 1122 titers |
| RTS, S/AS01B | Geometric Mean Antibody Titers (GMTs) of Asexual P. Falciparum Parasitemia | 342 titers |
| Rabipur (Rabies) Vaccine | Geometric Mean Antibody Titers (GMTs) of Asexual P. Falciparum Parasitemia | 711 titers |
Other Pre-specified
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
Population: Immunogenicity (According to protocol (ATP) Cohort): 222 subjects (75 RTS,S/AS01B, 74 RTS,S/AS02A, 73 rabies vaccine)
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RTS, S/AS02A | Geometric Mean Titers (GMTs) for Anti-CS Antibodies up to Month 12 by Vaccine Group PII (D60) | 31.6 titers |
| RTS, S/AS01B | Geometric Mean Titers (GMTs) for Anti-CS Antibodies up to Month 12 by Vaccine Group PII (D60) | 16.7 titers |
| Rabipur (Rabies) Vaccine | Geometric Mean Titers (GMTs) for Anti-CS Antibodies up to Month 12 by Vaccine Group PII (D60) | 1.8 titers |
Other Pre-specified
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
Population: Immunogenicity (According to protocol (ATP) Cohort): 213 subjects (72 RTS,S/AS01B, 72 RTS,S/AS02A, 69 rabies vaccine)
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RTS, S/AS02A | Geometric Mean Titers (GMTs) for Anti-CS Antibodies up to Month 12 by Vaccine Group PIII (D90) | 41.4 titers |
| RTS, S/AS01B | Geometric Mean Titers (GMTs) for Anti-CS Antibodies up to Month 12 by Vaccine Group PIII (D90) | 21.4 titers |
| Rabipur (Rabies) Vaccine | Geometric Mean Titers (GMTs) for Anti-CS Antibodies up to Month 12 by Vaccine Group PIII (D90) | 1.1 titers |
Other Pre-specified
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
Population: Immunogenicity (According to protocol (ATP) Cohort): 189 subjects (61 RTS,S/AS01B, 62 RTS,S/AS02A, 66 rabies vaccine)
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RTS, S/AS02A | Geometric Mean Titers (GMTs) for Anti-CS Antibodies up to Month 12 by Vaccine Group PIII (M12) | 14.2 titers |
| RTS, S/AS01B | Geometric Mean Titers (GMTs) for Anti-CS Antibodies up to Month 12 by Vaccine Group PIII (M12) | 7.3 titers |
| Rabipur (Rabies) Vaccine | Geometric Mean Titers (GMTs) for Anti-CS Antibodies up to Month 12 by Vaccine Group PIII (M12) | 1.7 titers |
Other Pre-specified
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
Population: Immunogenicity (According to protocol (ATP) Cohort): 207 subjects (69 RTS,S/AS01B, 69 RTS,S/AS02A, 69 rabies vaccine)
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RTS, S/AS02A | Geometric Mean Titers (GMTs) for Anti-CS Antibodies up to Month 12 by Vaccine Group PIII (M6.5) | 23.1 titers |
| RTS, S/AS01B | Geometric Mean Titers (GMTs) for Anti-CS Antibodies up to Month 12 by Vaccine Group PIII (M6.5) | 13.1 titers |
| Rabipur (Rabies) Vaccine | Geometric Mean Titers (GMTs) for Anti-CS Antibodies up to Month 12 by Vaccine Group PIII (M6.5) | 1.5 titers |
Other Pre-specified
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
Population: Immunogenicity (According to protocol (ATP) Cohort): 222 subjects (75 RTS,S/AS01B, 74 RTS,S/AS02A, 73 rabies vaccine)
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RTS, S/AS02A | Geometric Mean Titers (GMTs) for Anti-CS Antibodies up to Month 12 by Vaccine Group PRE | 2.2 titers |
| RTS, S/AS01B | Geometric Mean Titers (GMTs) for Anti-CS Antibodies up to Month 12 by Vaccine Group PRE | 1.2 titers |
| Rabipur (Rabies) Vaccine | Geometric Mean Titers (GMTs) for Anti-CS Antibodies up to Month 12 by Vaccine Group PRE | 1.9 titers |
Other Pre-specified
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
Population: The Total Vaccinated Cohort includes all vaccinated subjects for whom data were available. For GMTs by infection status arms have been combined.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| RTS, S/AS02A | Geometric Mean Titers (GMTs) for Anti-HBs Antibodies by Infection Status PIII (D90) | Non-infected: PIII(D90) | 1558.3 titer |
| RTS, S/AS02A | Geometric Mean Titers (GMTs) for Anti-HBs Antibodies by Infection Status PIII (D90) | Infected: PIII(D90) | 1532.6 titer |
Other Pre-specified
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
Population: The Total Vaccinated Cohort includes all vaccinated subjects for whom data were available. For GMTs by infection status arms have been combined.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| RTS, S/AS02A | Geometric Mean Titers (GMTs) for Anti-HBs Antibodies by Infection Status PIII (M12) | Non-infected: PIII(M12) | 765.8 titer |
| RTS, S/AS02A | Geometric Mean Titers (GMTs) for Anti-HBs Antibodies by Infection Status PIII (M12) | Infected: PIII(M12) | 499.0 titer |
Other Pre-specified
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
Population: The Total Vaccinated Cohort includes all vaccinated subjects for whom data were available. For GMTs by infection status arms have been combined.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| RTS, S/AS02A | Geometric Mean Titers (GMTs) for Anti-HBs Antibodies by Infection Status PRE | Non-infected: PRE | 11.1 titer |
| RTS, S/AS02A | Geometric Mean Titers (GMTs) for Anti-HBs Antibodies by Infection Status PRE | Infected: PRE | 13.5 titer |
Other Pre-specified
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
Population: Subjects with available results
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RTS, S/AS02A | Geometric Mean Titers (GMTs) for Anti-HBs Antibodies by Vaccine Group PIII (D90) | 1434.9 titers |
| RTS, S/AS01B | Geometric Mean Titers (GMTs) for Anti-HBs Antibodies by Vaccine Group PIII (D90) | 1714.3 titers |
| Rabipur (Rabies) Vaccine | Geometric Mean Titers (GMTs) for Anti-HBs Antibodies by Vaccine Group PIII (D90) | 31.7 titers |
Other Pre-specified
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
Population: Subjects with available results
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RTS, S/AS02A | Geometric Mean Titers (GMTs) for Anti-HBs Antibodies by Vaccine Group PIII (M12) | 593.7 titers |
| RTS, S/AS01B | Geometric Mean Titers (GMTs) for Anti-HBs Antibodies by Vaccine Group PIII (M12) | 635.8 titers |
| Rabipur (Rabies) Vaccine | Geometric Mean Titers (GMTs) for Anti-HBs Antibodies by Vaccine Group PIII (M12) | 28.6 titers |
Other Pre-specified
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RTS, S/AS02A | Percentage of Participants With Positive and Negative Parasite Density | Parasite Density: % of Negative Subjects | 91.4 % of subjects |
| RTS, S/AS02A | Percentage of Participants With Positive and Negative Parasite Density | Parasite Density: % of Positive Subjects | 8.6 % of subjects |
| RTS, S/AS01B | Percentage of Participants With Positive and Negative Parasite Density | Parasite Density: % of Negative Subjects | 93.2 % of subjects |
| RTS, S/AS01B | Percentage of Participants With Positive and Negative Parasite Density | Parasite Density: % of Positive Subjects | 6.8 % of subjects |
| Rabipur (Rabies) Vaccine | Percentage of Participants With Positive and Negative Parasite Density | Parasite Density: % of Negative Subjects | 95.8 % of subjects |
| Rabipur (Rabies) Vaccine | Percentage of Participants With Positive and Negative Parasite Density | Parasite Density: % of Positive Subjects | 4.2 % of subjects |
Other Pre-specified
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)
Population: The ATP Cohort includes all evaluable subjects for whom data were available. For seropositivity rates by infection status arms have been combined.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RTS, S/AS02A | Seropositivity Rates for Anti-CS Antibodies by Infection Status PII (D60) | % of Infected: PII(D60) | 98.2 percentage of participants |
| RTS, S/AS02A | Seropositivity Rates for Anti-CS Antibodies by Infection Status PII (D60) | % of Non-infected: PII(D60) | 100 percentage of participants |
Other Pre-specified
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)
Population: The ATP Cohort includes all evaluable subjects for whom data were available. For seropositivity rates by infection status arms have been combined.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RTS, S/AS02A | Seropositivity Rates for Anti-CS Antibodies by Infection Status PIII (D90) | % of Infected: PIII(D90) | 98.2 percentage of participants |
| RTS, S/AS02A | Seropositivity Rates for Anti-CS Antibodies by Infection Status PIII (D90) | % of Non-infected: PIII(D90) | 100 percentage of participants |
Other Pre-specified
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)
Population: The ATP Cohort includes all evaluable subjects for whom data were available. For seropositivity rates by infection status arms have been combined.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RTS, S/AS02A | Seropositivity Rates for Anti-CS Antibodies by Infection Status PIII (M6.5) | % of Infected: PIII(M6.5) | 98.1 percentage of participants |
| RTS, S/AS02A | Seropositivity Rates for Anti-CS Antibodies by Infection Status PIII (M6.5) | % of Non-infected: PIII(M6.5) | 98.9 percentage of participants |
Other Pre-specified
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
Population: The ATP Cohort includes all evaluable subjects for whom data were available. For seropositivity rates by infection status arms have been combined.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RTS, S/AS02A | Seropositivity Rates for Anti-CS Antibodies by Infection Status PRE | % of Infected: PRE | 76.8 percentage of participants |
| RTS, S/AS02A | Seropositivity Rates for Anti-CS Antibodies by Infection Status PRE | % of Non-infected: PRE | 83.5 percentage of participants |
Other Pre-specified
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
Population: Immunogenicity (According to protocol (ATP) Cohort): 222 subjects (75 RTS,S/AS01B, 74 RTS,S/AS02A, 73 rabies vaccine)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RTS, S/AS02A | Seropositivity Rates for Anti-CS Antibodies by Vaccine Group PII (D60) | 98.7 percentage of participants |
| RTS, S/AS01B | Seropositivity Rates for Anti-CS Antibodies by Vaccine Group PII (D60) | 100 percentage of participants |
| Rabipur (Rabies) Vaccine | Seropositivity Rates for Anti-CS Antibodies by Vaccine Group PII (D60) | 84.9 percentage of participants |
Other Pre-specified
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
Population: Immunogenicity (According to protocol (ATP) Cohort): 213 subjects (72 RTS,S/AS01B, 72 RTS,S/AS02A, 69 rabies vaccine)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RTS, S/AS02A | Seropositivity Rates for Anti-CS Antibodies by Vaccine Group PIII (D90) | 98.6 percentage of participants |
| RTS, S/AS01B | Seropositivity Rates for Anti-CS Antibodies by Vaccine Group PIII (D90) | 100 percentage of participants |
| Rabipur (Rabies) Vaccine | Seropositivity Rates for Anti-CS Antibodies by Vaccine Group PIII (D90) | 82.6 percentage of participants |
Other Pre-specified
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
Population: Immunogenicity (According to protocol (ATP) Cohort): 189 subjects (61 RTS,S/AS01B, 62 RTS,S/AS02A, 66 rabies vaccine)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RTS, S/AS02A | Seropositivity Rates for Anti-CS Antibodies by Vaccine Group PIII (M12) | 100 percentage of participants |
| RTS, S/AS01B | Seropositivity Rates for Anti-CS Antibodies by Vaccine Group PIII (M12) | 95.2 percentage of participants |
| Rabipur (Rabies) Vaccine | Seropositivity Rates for Anti-CS Antibodies by Vaccine Group PIII (M12) | 80.3 percentage of participants |
Other Pre-specified
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
Population: Immunogenicity (According to protocol (ATP) Cohort): 207 subjects (69 RTS,S/AS01B, 69 RTS,S/AS02A, 69 rabies vaccine)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RTS, S/AS02A | Seropositivity Rates for Anti-CS Antibodies by Vaccine Group PIII (M6.5) | 98.6 percentage of participants |
| RTS, S/AS01B | Seropositivity Rates for Anti-CS Antibodies by Vaccine Group PIII (M6.5) | 98.6 percentage of participants |
| Rabipur (Rabies) Vaccine | Seropositivity Rates for Anti-CS Antibodies by Vaccine Group PIII (M6.5) | 79.7 percentage of participants |
Other Pre-specified
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
Population: Immunogenicity (ATP Cohort): 222 subjects (75 RTS,S/AS01B, 74 RTS,S/AS02A, 73 rabies vaccine)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RTS, S/AS02A | Seropositivity Rates for Anti-CS Antibodies by Vaccine Group PRE | 86.7 percentage of participants |
| RTS, S/AS01B | Seropositivity Rates for Anti-CS Antibodies by Vaccine Group PRE | 75.7 percentage of participants |
| Rabipur (Rabies) Vaccine | Seropositivity Rates for Anti-CS Antibodies by Vaccine Group PRE | 84.9 percentage of participants |
Other Pre-specified
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
Population: The Total Vaccinated Cohort includes all vaccinated subjects for whom data were available. For seropositivity rates by infection status arms have been combined.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RTS, S/AS02A | Seropositivity Rates for Anti-HBs Antibodies by Infection Status PIII(D90) | % of Non-infected: PIII(D90) | 96.5 percentage of participants |
| RTS, S/AS02A | Seropositivity Rates for Anti-HBs Antibodies by Infection Status PIII(D90) | % of Infected: PIII(D90) | 93.7 percentage of participants |
| RTS, S/AS01B | Seropositivity Rates for Anti-HBs Antibodies by Infection Status PIII(D90) | % of Non-infected: PIII(D90) | 93.0 percentage of participants |
| RTS, S/AS01B | Seropositivity Rates for Anti-HBs Antibodies by Infection Status PIII(D90) | % of Infected: PIII(D90) | 91.6 percentage of participants |
Other Pre-specified
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
Population: The Total Vaccinated Cohort includes all vaccinated subjects for whom data were available. For seropositivity rates by infection status arms have been combined.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RTS, S/AS02A | Seropositivity Rates for Anti-HBs Antibodies by Infection Status PIII(M12) | % of Non-infected: PIII(M12) | 97.9 percentage of participants |
| RTS, S/AS02A | Seropositivity Rates for Anti-HBs Antibodies by Infection Status PIII(M12) | % of Infected: PIII(M12) | 92.9 percentage of participants |
| RTS, S/AS01B | Seropositivity Rates for Anti-HBs Antibodies by Infection Status PIII(M12) | % of Non-infected: PIII(M12) | 91.5 percentage of participants |
| RTS, S/AS01B | Seropositivity Rates for Anti-HBs Antibodies by Infection Status PIII(M12) | % of Infected: PIII(M12) | 90.6 percentage of participants |
Other Pre-specified
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
Population: The Total Vaccinated Cohort includes all vaccinated subjects for whom data were available. For seropositivity rates by infection status arms have been combined.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RTS, S/AS02A | Seropositivity Rates for Anti-HBs Antibodies by Infection Status PRE | % of Non-infected | 38.8 percentage of participants |
| RTS, S/AS02A | Seropositivity Rates for Anti-HBs Antibodies by Infection Status PRE | % of Infected | 50.0 percentage of participants |
| RTS, S/AS01B | Seropositivity Rates for Anti-HBs Antibodies by Infection Status PRE | % of Non-infected | 37.3 percentage of participants |
| RTS, S/AS01B | Seropositivity Rates for Anti-HBs Antibodies by Infection Status PRE | % of Infected | 44.8 percentage of participants |
Other Pre-specified
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
Population: Subjects with available results
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RTS, S/AS02A | Seropositivity Rates for Anti-HBs Antibodies by Vaccine Group PIII(D90) | 68 Participants |
| RTS, S/AS01B | Seropositivity Rates for Anti-HBs Antibodies by Vaccine Group PIII(D90) | 68 Participants |
| Rabipur (Rabies) Vaccine | Seropositivity Rates for Anti-HBs Antibodies by Vaccine Group PIII(D90) | 37 Participants |
Other Pre-specified
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
Population: Subjects with available results
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RTS, S/AS02A | Seropositivity Rates for Anti-HBs Antibodies by Vaccine Group PIII(M12) | 57 Participants |
| RTS, S/AS01B | Seropositivity Rates for Anti-HBs Antibodies by Vaccine Group PIII(M12) | 59 Participants |
| Rabipur (Rabies) Vaccine | Seropositivity Rates for Anti-HBs Antibodies by Vaccine Group PIII(M12) | 40 Participants |
Other Pre-specified
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
Population: Subject with available results
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RTS, S/AS02A | Seropositivity Rates for Anti-HBs Antibodies by Vaccine Group PRE | 31 Participants |
| RTS, S/AS01B | Seropositivity Rates for Anti-HBs Antibodies by Vaccine Group PRE | 38 Participants |
| Rabipur (Rabies) Vaccine | Seropositivity Rates for Anti-HBs Antibodies by Vaccine Group PRE | 35 Participants |
Other Pre-specified
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
Population: Subject with available results
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RTS, S/AS02A | Seroprotection Rates for Anti-HBs Antibodies by Vaccine Group PIII (D90) | 65 Participants |
| RTS, S/AS01B | Seroprotection Rates for Anti-HBs Antibodies by Vaccine Group PIII (D90) | 67 Participants |
| Rabipur (Rabies) Vaccine | Seroprotection Rates for Anti-HBs Antibodies by Vaccine Group PIII (D90) | 33 Participants |
Other Pre-specified
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
Population: Subjects with available results
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RTS, S/AS02A | Seroprotection Rates for Anti-HBs Antibodies by Vaccine Group PIII (M12) | 55 Participants |
| RTS, S/AS01B | Seroprotection Rates for Anti-HBs Antibodies by Vaccine Group PIII (M12) | 57 Participants |
| Rabipur (Rabies) Vaccine | Seroprotection Rates for Anti-HBs Antibodies by Vaccine Group PIII (M12) | 33 Participants |
Other Pre-specified
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
Population: Subjects with available results
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RTS, S/AS02A | Seroprotection Rates for Anti-HBs Antibodies by Vaccine Group PRE | 29 Participants |
| RTS, S/AS01B | Seroprotection Rates for Anti-HBs Antibodies by Vaccine Group PRE | 34 Participants |
| Rabipur (Rabies) Vaccine | Seroprotection Rates for Anti-HBs Antibodies by Vaccine Group PRE | 33 Participants |