Malaria, Falciparum
Conditions
Keywords
Plasmodium, falciparum, malaria, vaccine, AS02A adjuvant, FMP1, Merozoite surface protein-1
Brief summary
This trial is currently evaluating one candidate malaria vaccine, FMP1/AS02A. This candidate malaria vaccine is being developed for the routine immunization of infants and children living in malaria-endemic areas. This vaccine would offer protection against malaria disease due to the parasite Plasmodium falciparum. Prior to the start of this study, FMP1/AS02A had been given to approximately 60 malaria-naïve adults and 40 adults and 90 children living in malaria-endemic regions. This study will investigate whether the candidate vaccine prevents malaria disease for 6 months post-vaccination. One half of the enrolled subjects will receive FMP1/AS02A and the other half rabies vaccine (RabAvert).
Detailed description
Field trial of a candidate antigen/adjuvant conducted at one study center with 12 outlying (satellite) field stations. Subjects were screened no more than 45 days prior to the first inoculation and were randomized on the first day of vaccination 1:1 between two arms (FMP1/AS02A and rabies vaccine). The planned immunization schedule was 0, 1, and 2 months for both study arms; however, the 4-week intervals between doses could be extended for up to 2 additional weeks if temporary suspension was deemed advisable due to serious adverse events (SAEs) or other concerns. Vaccinations were administered intramuscularly (IM) in the left anterolateral thigh muscle unless a compelling reason for using an alternate injection site was evident. Each subject participated in the study approximately 14 months with 7-day follow-up for solicited adverse events (five visits: vaccination day plus post-vaccination days 1, 2, 3, and 6) and 30-day follow-up for unsolicited events (vaccination day plus 29 subsequent days). Follow-up of SAEs continued for study duration. Active case detection occurred during the Efficacy Follow-up Period (169 days, starting 14 days after the third vaccination (Day 71)), active case detection commenced with visits approximately every 28 days to the Walter Reed Project Kombewa clinic and terminated after 6 months (approximately Day 240). The primary study analysis for all endpoints was completed on the cleaned Efficacy Follow-up Period database after a data-lock-point. The Addendum Efficacy Follow-up Period (125 days) started with the end of the Efficacy Follow-up Period (approximately Day 240) and active case detection commenced with visits approximately every 28 days to the Walter Reed Project Kombewa Clinic and terminated after 10 months (approximately Day 364). The study addendum analysis for all endpoints was completed after the Addendum Efficacy Follow-up Period database after a data-lock-point. Malaria cases were detected actively and passively. Active case detection was handled through scheduled (1) facilitated participant visits to the Kombewa Clinic and (2) field worker visits to participant homes. Passive case detection was handled through unscheduled, self-presentation of participants to the Kombewa Clinic. At scheduled clinic visits, blood samples were taken from all subjects to determine parasite density and hemoglobin levels. At home visits, subjects with fever or other illness within the 24 hours were transported to the clinic for collection of blood samples.
Interventions
BIOLOGICALFMP1/AS02A
FMP1/AS02A candidate malaria vaccine
BIOLOGICALRabAvert
RabAvert rabies vaccine
Sponsors
The PATH Malaria Vaccine Initiative (MVI)
United States Agency for International Development (USAID)
GlaxoSmithKline
Kenya Medical Research Institute
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
DOUBLE (Subject, Investigator)
Masking description
Both study participants and those investigators responsible for evaluation of the endpoints will be blinded as to who receives the test article versus the comparator. On vaccination days, the comparator vaccine will be in the same package as received from the manufacturer. After agitation it will appear clear and pink. The FMP1 antigen and the AS02A adjuvant will be packaged separately. The reconstituted FMPI antigen in the AS02A adjuvant/diluent will have a milky white appearance. Because the vaccines will have a markedly different appearance, contents of the syringe will be concealed as described later in this section. The two vaccine preparation teams, consisting of the study pharmacist, pharmacy assistants, and drug manager (an experienced nurse, clinician, or pharmacist), will be responsible for vaccine preparation. They will also verify that the proper vaccine and vaccine dose is prepared and delivered to each subject.
Intervention model description
Subjects were screened no more than 45 days prior to the first inoculation and were randomized on the first day of vaccination 1:1 between two arms (FMP1/AS02A and rabies vaccine (RabAvert)).
Eligibility
Sex/Gender
ALL
Age
12 Months to 47 Months
Healthy volunteers
Yes
Inclusion criteria
All subjects must satisfy the following criteria at study entry: * A healthy male or female child, 12 to 47 months of age on the day of screening * Written informed consent obtained from at least one parent/guardian before study start * Available to participate for the study duration (about 14 months)
Exclusion criteria
* Acute disease at the time of entry into the study that in the opinion of the investigator may pose a threat to the subject * Prior receipt of a rabies vaccine or any investigational vaccine * Use of any investigational drug or vaccine other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use up to 30 days after the third dose * Administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying drugs within six months of vaccination. (For corticosteroids, this will mean prednisone, or equivalent, greater than or equal to 0.5 mg/kg/day. Inhaled and topical steroids are allowed) * Administration or anticipated administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine(s) with the exception of tetanus toxoid * Previous vaccination with a vaccine containing MPL or QS21 (e.g., RTS,S/AS02A) * Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. (No HIV test will be performed as part of this study.) * History of allergic reactions or anaphylaxis to immunizations or to any vaccine components, such as eggs * History of surgical splenectomy * Administration of immunoglobulins, blood transfusions, or any other blood products within the six months preceding the first dose of study vaccine or planned administration during the study period * Simultaneous participation in any other clinical trial * Acute or chronic cardiovascular, pulmonary, hepatic, or renal condition that in the opinion of the PI, may increase the risk to the subject from participating in the study * Any other condition or circumstance that in the opinion of the investigator may pose a threat to the subject
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjects Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - Intent to Treat (ITT) Population | starting 14 days after the 3rd vaccination (day 71), every 28 days and ending on day 240 | Days to first clinical episode of P falciparum malaria during the efficacy f/u period for ITT population Time at Risk adjusted for: SA= study absence MT= malaria treatment SA MT= study absence and malaria treatment Case Definitions: Primary = \>37.5°C with presence of a density of asexual stage P. falciparum \>50K parasites/µL blood Secondary (200) = \>37.5°C with presence of a density of asexual stage P. falciparum \>200K parasites/µL blood Secondary (100) = \>37.5°C with presence of a density of asexual stage P. falciparum \>100K parasites/µL blood Secondary (10) = \>37.5°C with presence of a density of asexual stage P. falciparum \>10K parasites/µL blood Secondary (0) = \>37.5°C with presence of a density of asexual stage P. falciparum \>0 parasites/µL blood Secondary (0\*) = \>37.5°C OR history of fever in the last 24 hrs with presence of a density of asexual stage P. falciparum \>0 parasites/µL blood |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - Intent to Treat (ITT) Population | vaccination day plus post-vaccination days 1, 2, 3, and 6 | Each subject participated in the study approximately 14 months with 7-day follow-up for solicited adverse events (five visits: vaccination day plus post-vaccination days 1, 2, 3, and 6). I1 = Immunization 1 I2 = Immunization 2 I3 = Immunization 3 |
| Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - According to Protocol (ATP) Population | vaccination day plus post-vaccination days 1, 2, 3, and 6 | Each subject participated in the study approximately 14 months with 7-day follow-up for solicited adverse events (five visits: vaccination day plus post-vaccination days 1, 2, 3, and 6). I1 = Immunization 1 I2 = Immunization 2 I3 = Immunization 3 |
| Vaccine-Related Unsolicited Adverse Events by Immunization - Intent to Treat (ITT) Population | vaccination day and 29 subsequent days | Each subject participated in the study approximately 14 months with 7-day follow-up for solicited adverse events (five visits: vaccination day plus post-vaccination days 1, 2, 3, and 6) and 30-day follow-up for unsolicited events (vaccination day plus 29 subsequent days). I1 = Immunization 1 I2 = Immunization 2 I3 = Immunization 3 |
| Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - According to Protocol (ATP) Population | starting 14 days after the 3rd vaccination (day 71), every 28 days and ending on day 240 | Days to first clinical episode of P falciparum malaria during the efficacy f/u period for ATP population Time at Risk adjusted for: SA= study absence MT= malaria treatment SA MT= study absence and malaria treatment Case Definitions: Primary = \>37.5°C with presence of a density of asexual stage P. falciparum \>50K parasites/µL blood Secondary (200) = \>37.5°C with presence of a density of asexual stage P. falciparum \>200K parasites/µL blood Secondary (100) = \>37.5°C with presence of a density of asexual stage P. falciparum \>100K parasites/µL blood Secondary (10) = \>37.5°C with presence of a density of asexual stage P. falciparum \>10K parasites/µL blood Secondary (0) = \>37.5°C with presence of a density of asexual stage P. falciparum \>0 parasites/µL blood Secondary (0\*) = \>37.5°C OR history of fever in the last 24 hrs with presence of a density of asexual stage P. falciparum \>0 parasites/µL blood |
| Number of Patients Who Showed Symptoms, Unsolicited Adverse Events, and Serious Adverse Events by Immunization | vaccination day plus post-vaccine days 1, 2, 3, and 6; 30 day follow-up for unsolicited events and follow-up for SAEs to continue for duration of study (364 days) | Each subject participated in the study approximately 14 months with 7-day follow-up for solicited adverse events (five visits: vaccination day plus post-vaccination days 1, 2, 3, and 6) and 30-day follow-up for unsolicited events (vaccination day plus 29 subsequent days). Follow-up of SAEs continued for study duration (364 days) |
| Vaccine-Related Local and Systemic Solicited Adverse Events by Immunization - According to Protocol (ATP) | vaccination day plus 29 subsequent days | Each subject participated in the study approximately 14 months with 7-day follow-up for solicited adverse events (five visits: vaccination day plus post-vaccination days 1, 2, 3, and 6) and 30-day follow-up for unsolicited events (vaccination day plus 29 subsequent days). I1 = Immunization 1 I2 = Immunization 2 I3 = Immunization 3 |
| Vaccine-Related Local and Systemic Solicited Adverse Events by Immunization - Intent to Treat (ITT) | vaccination day plus 29 subsequent days | Each subject participated in the study approximately 14 months with 7-day follow-up for solicited adverse events (five visits: vaccination day plus post-vaccination days 1, 2, 3, and 6) and 30-day follow-up for unsolicited events (vaccination day plus 29 subsequent days). I1 = Immunization 1 I2 = Immunization 2 I3 = Immunization 3 |
| Vaccine-Related Unsolicited Adverse Events by Immunization - According to Protocol (ATP) Population | vaccination day and 29 subsequent days | Each subject participated in the study approximately 14 months with 7-day follow-up for solicited adverse events (five visits: vaccination day plus post-vaccination days 1, 2, 3, and 6) and 30-day follow-up for unsolicited events (vaccination day plus 29 subsequent days). I1 = Immunization 1 I2 = Immunization 2 I3 = Immunization 3 |
Countries
Kenya
Participant flow
Recruitment details
Subjects were screened no more than 45 days prior to the first inoculation and were randomized on the first day of vaccination 1:1 between two arms (FMP1/AS02A and rabies vaccine) at the Walter Reed Project Kombewa Clinic in Kombewa Division, Kisumu District, Nyanze Province, Western Kenya (and 12 small field stations within Kombewa Division).
Participants by arm
| Arm | Count |
|---|---|
| FMP1/AS02A FMP1/AS02A candidate malaria vaccine was administered IM in the left anterolateral thigh muscle at 0, 1, and 2 months
FMP1/AS02A: FMP1/AS02A candidate malaria vaccine | 200 |
| RabAvert (Rabies Vaccine) RabAvert vaccine was administered IM in the left anterolateral thigh muscle at 0, 1, and 2 months
RabAvert: RabAvert rabies vaccine | 200 |
| Total | 400 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Moved from area | 2 | 1 |
| Overall Study | Withdrawal by Subject | 4 | 8 |
Baseline characteristics
| Characteristic | FMP1/AS02A | RabAvert (Rabies Vaccine) | Total |
|---|---|---|---|
| Age, Continuous Abol Field Station | 34.3 Months STANDARD_DEVIATION 9.7 | 28.9 Months STANDARD_DEVIATION 10 | 31.6 Months STANDARD_DEVIATION 10 |
| Age, Continuous Bar-Korwa Field Station | 22.0 Months STANDARD_DEVIATION 6.2 | 32.8 Months STANDARD_DEVIATION 5.9 | 26.6 Months STANDARD_DEVIATION 8 |
| Age, Continuous Got-Aglu Field Station | 29.1 Months STANDARD_DEVIATION 11.8 | 25.0 Months STANDARD_DEVIATION 8.6 | 26.8 Months STANDARD_DEVIATION 10.2 |
| Age, Continuous Kitare Field Station | 30.2 Months STANDARD_DEVIATION 10.7 | 29.9 Months STANDARD_DEVIATION 10 | 30.1 Months STANDARD_DEVIATION 10.2 |
| Age, Continuous Kuoyo-Kowe Field Station | 31.1 Months STANDARD_DEVIATION 9.3 | 31.7 Months STANDARD_DEVIATION 9.4 | 31.4 Months STANDARD_DEVIATION 9.2 |
| Age, Continuous Manyanda Field Station | 30.6 Months STANDARD_DEVIATION 6.4 | 31.1 Months STANDARD_DEVIATION 8.2 | 30.9 Months STANDARD_DEVIATION 7 |
| Age, Continuous Mirieri Field Station | 30.3 Months STANDARD_DEVIATION 10 | 26.5 Months STANDARD_DEVIATION 10.1 | 28.8 Months STANDARD_DEVIATION 10 |
| Age, Continuous Nduru Field Station | 26.1 Months STANDARD_DEVIATION 10.2 | 34.6 Months STANDARD_DEVIATION 10.2 | 30.9 Months STANDARD_DEVIATION 10.9 |
| Age, Continuous Oruga Field Station | 30.5 Months STANDARD_DEVIATION 9.5 | 33.1 Months STANDARD_DEVIATION 9.6 | 31.8 Months STANDARD_DEVIATION 9.5 |
| Age, Continuous Osewre Field Station | 31.1 Months STANDARD_DEVIATION 11.3 | 30.7 Months STANDARD_DEVIATION 8.4 | 30.9 Months STANDARD_DEVIATION 9.8 |
| Age, Continuous Ranen Field Station | 26.2 Months STANDARD_DEVIATION 10.9 | 32.2 Months STANDARD_DEVIATION 11.2 | 29.5 Months STANDARD_DEVIATION 11.2 |
| Age, Continuous Reru Field Station | 26.9 Months STANDARD_DEVIATION 11 | 30.3 Months STANDARD_DEVIATION 10.8 | 28.9 Months STANDARD_DEVIATION 10.7 |
| Age, Continuous Walter Reed Project Field Station | 28.6 Months STANDARD_DEVIATION 10.6 | 29.2 Months STANDARD_DEVIATION 10.9 | 28.9 Months STANDARD_DEVIATION 10.7 |
| Alpha-Thalassemia - WRAIR Field Station Hetero | 17 Participants | 20 Participants | 37 Participants |
| Alpha-Thalassemia - WRAIR Field Station Homo | 3 Participants | 1 Participants | 4 Participants |
| Alpha-Thalassemia - WRAIR Field Station Normal | 21 Participants | 20 Participants | 41 Participants |
| Baseline Alpha-Thalassemia - Abol Field Station Hetero | 6 Participants | 3 Participants | 9 Participants |
| Baseline Alpha-Thalassemia - Abol Field Station Homo | 1 Participants | 1 Participants | 2 Participants |
| Baseline Alpha-Thalassemia - Abol Field Station Normal | 7 Participants | 8 Participants | 15 Participants |
| Baseline Alpha-Thalassemia- Bar-Korwa Field Station Hetero | 0 Participants | 2 Participants | 2 Participants |
| Baseline Alpha-Thalassemia- Bar-Korwa Field Station Homo | 1 Participants | 0 Participants | 1 Participants |
| Baseline Alpha-Thalassemia- Bar-Korwa Field Station Normal | 6 Participants | 3 Participants | 9 Participants |
| Baseline Alpha-Thalassemia - Got-Aglu Field Station Hetero | 9 Participants | 10 Participants | 19 Participants |
| Baseline Alpha-Thalassemia - Got-Aglu Field Station Homo | 1 Participants | 1 Participants | 2 Participants |
| Baseline Alpha-Thalassemia - Got-Aglu Field Station Normal | 4 Participants | 6 Participants | 10 Participants |
| Baseline Alpha-Thalassemia - Kitare Field Station Hetero | 9 Participants | 10 Participants | 19 Participants |
| Baseline Alpha-Thalassemia - Kitare Field Station Homo | 3 Participants | 1 Participants | 4 Participants |
| Baseline Alpha-Thalassemia - Kitare Field Station Normal | 7 Participants | 6 Participants | 13 Participants |
| Baseline Alpha-Thalassemia - Kuoyo-Kowe Field Station Hetero | 3 Participants | 8 Participants | 11 Participants |
| Baseline Alpha-Thalassemia - Kuoyo-Kowe Field Station Homo | 1 Participants | 3 Participants | 4 Participants |
| Baseline Alpha-Thalassemia - Kuoyo-Kowe Field Station Normal | 13 Participants | 7 Participants | 20 Participants |
| Baseline Alpha-Thalassemia - Manyanda Field Station Hetero | 3 Participants | 1 Participants | 4 Participants |
| Baseline Alpha-Thalassemia - Manyanda Field Station Homo | 0 Participants | 0 Participants | 0 Participants |
| Baseline Alpha-Thalassemia - Manyanda Field Station Normal | 5 Participants | 6 Participants | 11 Participants |
| Baseline Alpha-Thalassemia - Mirieri Field Station Hetero | 8 Participants | 6 Participants | 14 Participants |
| Baseline Alpha-Thalassemia - Mirieri Field Station Homo | 2 Participants | 1 Participants | 3 Participants |
| Baseline Alpha-Thalassemia - Mirieri Field Station Normal | 8 Participants | 4 Participants | 12 Participants |
| Baseline Alpha-Thalassemia - Nduru Kadero Field Station Hetero | 5 Participants | 10 Participants | 15 Participants |
| Baseline Alpha-Thalassemia - Nduru Kadero Field Station Homo | 1 Participants | 1 Participants | 2 Participants |
| Baseline Alpha-Thalassemia - Nduru Kadero Field Station Normal | 4 Participants | 2 Participants | 6 Participants |
| Baseline Alpha-Thalassemia - Oruga Field Station Hetero | 4 Participants | 7 Participants | 11 Participants |
| Baseline Alpha-Thalassemia - Oruga Field Station Homo | 5 Participants | 2 Participants | 7 Participants |
| Baseline Alpha-Thalassemia - Oruga Field Station Normal | 10 Participants | 9 Participants | 19 Participants |
| Baseline Alpha-Thalassemia - Osewre Field Station Hetero | 3 Participants | 5 Participants | 8 Participants |
| Baseline Alpha-Thalassemia - Osewre Field Station Homo | 0 Participants | 1 Participants | 1 Participants |
| Baseline Alpha-Thalassemia - Osewre Field Station Normal | 8 Participants | 3 Participants | 11 Participants |
| Baseline Alpha-Thalassemia - Ranen Field Station Hetero | 6 Participants | 5 Participants | 11 Participants |
| Baseline Alpha-Thalassemia - Ranen Field Station Homo | 2 Participants | 1 Participants | 3 Participants |
| Baseline Alpha-Thalassemia - Ranen Field Station Normal | 2 Participants | 6 Participants | 8 Participants |
| Baseline Alpha-Thalassemia - Reru Field Station Hetero | 4 Participants | 5 Participants | 9 Participants |
| Baseline Alpha-Thalassemia - Reru Field Station Homo | 1 Participants | 1 Participants | 2 Participants |
| Baseline Alpha-Thalassemia - Reru Field Station Normal | 2 Participants | 4 Participants | 6 Participants |
| Baseline Density (par-µL blood)- Abol Field Station | 1509.6 par/µL blood STANDARD_DEVIATION 2816.8 | 303.5 par/µL blood STANDARD_DEVIATION 754.7 | 963.0 par/µL blood STANDARD_DEVIATION 2180 |
| Baseline Hemoglobin (g/dL) - Bar-Korwa Field Station | 10.24 g/dL STANDARD_DEVIATION 0.91 | 10.28 g/dL STANDARD_DEVIATION 0.84 | 10.26 g/dL STANDARD_DEVIATION 0.84 |
| Baseline Hemoglobin (g/dL) - Got-Aglu Field Station | 10.42 g/dL STANDARD_DEVIATION 1.36 | 10.30 g/dL STANDARD_DEVIATION 1.38 | 10.35 g/dL STANDARD_DEVIATION 1.35 |
| Baseline Hemoglobin (g/dL) - Kitare Field Station | 10.42 g/dL STANDARD_DEVIATION 1.1 | 9.96 g/dL STANDARD_DEVIATION 0.94 | 10.20 g/dL STANDARD_DEVIATION 1.04 |
| Baseline Hemoglobin (g/dL) - Kuoyo-Kowe Field Station | 10.75 g/dL STANDARD_DEVIATION 1.2 | 10.19 g/dL STANDARD_DEVIATION 1.28 | 10.46 g/dL STANDARD_DEVIATION 1.25 |
| Baseline Hemoglobin (g/dL) - Manyanda Field Station | 10.34 g/dL STANDARD_DEVIATION 1.29 | 10.46 g/dL STANDARD_DEVIATION 7.67 | 10.39 g/dL STANDARD_DEVIATION 1.42 |
| Baseline Hemoglobin (g/dL) - Mirieri Field Station | 11.10 g/dL STANDARD_DEVIATION 0.97 | 10.48 g/dL STANDARD_DEVIATION 1.38 | 10.87 g/dL STANDARD_DEVIATION 1.16 |
| Baseline Hemoglobin (g/dL) - Nduru Kadero Field Station | 10.48 g/dL STANDARD_DEVIATION 1.18 | 10.78 g/dL STANDARD_DEVIATION 1.28 | 10.66 g/dL STANDARD_DEVIATION 1.21 |
| Baseline Hemoglobin (g/dL) - Oruga Field Station | 10.57 g/dL STANDARD_DEVIATION 1 | 9.96 g/dL STANDARD_DEVIATION 1.23 | 10.27 g/dL STANDARD_DEVIATION 1.15 |
| Baseline Hemoglobin (g/dL) - Osewre Field Station | 10.06 g/dL STANDARD_DEVIATION 1.62 | 10.18 g/dL STANDARD_DEVIATION 1.08 | 10.12 g/dL STANDARD_DEVIATION 1.37 |
| Baseline Hemoglobin (g/dL) - Ranen Field Station | 10.01 g/dL STANDARD_DEVIATION 1.03 | 10.34 g/dL STANDARD_DEVIATION 1.24 | 10.19 g/dL STANDARD_DEVIATION 1.14 |
| Baseline Hemoglobin (g/dL) - Reru Field Station | 10.44 g/dL STANDARD_DEVIATION 1.57 | 10.14 g/dL STANDARD_DEVIATION 1.03 | 10.26 g/dL STANDARD_DEVIATION 1.24 |
| Baseline Malaria Prevention - Bar-Korwa Field Station Always sleep under mosquito net | 7 Participants | 5 Participants | 12 Participants |
| Baseline Malaria Prevention - Bar-Korwa Field Station Other | 0 Participants | 0 Participants | 0 Participants |
| Baseline Malaria Prevention - Bar-Korwa Field Station Use moquito coils or sprays | 0 Participants | 1 Participants | 1 Participants |
| Baseline Malaria Prevention - Bar-Korwa Field Station Use topical mosquito repellents | 0 Participants | 0 Participants | 0 Participants |
| Baseline Malaria Prevention - Got-Aglu Field Station Always sleep under mosquito net | 8 Participants | 8 Participants | 16 Participants |
| Baseline Malaria Prevention - Got-Aglu Field Station Other | 0 Participants | 0 Participants | 0 Participants |
| Baseline Malaria Prevention - Got-Aglu Field Station Use mosquito coils or sprays | 4 Participants | 7 Participants | 11 Participants |
| Baseline Malaria Prevention - Got-Aglu Field Station Use topical mosquito repellents | 1 Participants | 0 Participants | 1 Participants |
| Baseline Malaria Prevention - Kuoyo-Kowe Field Station Always sleep under mosquito net | 9 Participants | 12 Participants | 21 Participants |
| Baseline Malaria Prevention - Kuoyo-Kowe Field Station Other | 1 Participants | 0 Participants | 1 Participants |
| Baseline Malaria Prevention - Kuoyo-Kowe Field Station Use mosquito coils or sprays | 3 Participants | 4 Participants | 7 Participants |
| Baseline Malaria Prevention - Kuoyo-Kowe Field Station Use topical mosquito repellents | 0 Participants | 0 Participants | 0 Participants |
| Baseline Malaria Prevention - Manyanda Field Station Always sleep under mosquito net | 7 Participants | 6 Participants | 13 Participants |
| Baseline Malaria Prevention - Manyanda Field Station Other | 0 Participants | 0 Participants | 0 Participants |
| Baseline Malaria Prevention - Manyanda Field Station Use mosquito coils or sprays | 2 Participants | 1 Participants | 3 Participants |
| Baseline Malaria Prevention - Manyanda Field Station Use topical mosquito repellents | 0 Participants | 0 Participants | 0 Participants |
| Baseline Malaria Prevention - Mirieri Field Station Always sleep under mosquito net | 10 Participants | 6 Participants | 16 Participants |
| Baseline Malaria Prevention - Mirieri Field Station Other | 0 Participants | 0 Participants | 0 Participants |
| Baseline Malaria Prevention - Mirieri Field Station Use mosquito coils or sprays | 1 Participants | 3 Participants | 4 Participants |
| Baseline Malaria Prevention - Mirieri Field Station Use topical mosquito repellents | 0 Participants | 0 Participants | 0 Participants |
| Baseline Malaria Prevention - Nduru Kadero Field Station Always sleep under mosquito net | 5 Participants | 8 Participants | 13 Participants |
| Baseline Malaria Prevention - Nduru Kadero Field Station Other | 0 Participants | 0 Participants | 0 Participants |
| Baseline Malaria Prevention - Nduru Kadero Field Station Use mosquito coils or sprays | 5 Participants | 2 Participants | 7 Participants |
| Baseline Malaria Prevention - Nduru Kadero Field Station Use topical mosquito repellents | 1 Participants | 0 Participants | 1 Participants |
| Baseline Malaria Prevention - Oruga Field Station Alwasy sleep under mosquito net | 15 Participants | 12 Participants | 27 Participants |
| Baseline Malaria Prevention - Oruga Field Station Other | 0 Participants | 0 Participants | 0 Participants |
| Baseline Malaria Prevention - Oruga Field Station Use mosquito coils or sprays | 1 Participants | 3 Participants | 4 Participants |
| Baseline Malaria Prevention - Oruga Field Station Use topical mosquito repellents | 0 Participants | 0 Participants | 0 Participants |
| Baseline Malaria Prevention - Osewre Field Station Always sleep under mosquito net | 8 Participants | 6 Participants | 14 Participants |
| Baseline Malaria Prevention - Osewre Field Station Other | 0 Participants | 0 Participants | 0 Participants |
| Baseline Malaria Prevention - Osewre Field Station Use mosquito coils or sprays | 2 Participants | 1 Participants | 3 Participants |
| Baseline Malaria Prevention - Osewre Field Station Use topical mosquito repellents | 0 Participants | 0 Participants | 0 Participants |
| Baseline Malaria Prevention - Ranen Field Station Always sleep under mosquito net | 5 Participants | 12 Participants | 17 Participants |
| Baseline Malaria Prevention - Ranen Field Station Other | 0 Participants | 0 Participants | 0 Participants |
| Baseline Malaria Prevention - Ranen Field Station Use mosquito coils or sprays | 3 Participants | 0 Participants | 3 Participants |
| Baseline Malaria Prevention - Ranen Field Station Use topical mosquito repellents | 0 Participants | 0 Participants | 0 Participants |
| Baseline Malaria Prevention - Reru Field Station Always sleep under mosquito net | 3 Participants | 7 Participants | 10 Participants |
| Baseline Malaria Prevention - Reru Field Station Other | 0 Participants | 0 Participants | 0 Participants |
| Baseline Malaria Prevention - Reru Field Station Use mosquito coils or sprays | 3 Participants | 5 Participants | 8 Participants |
| Baseline Malaria Prevention - Reru Field Station Use topical mosquito repellents | 0 Participants | 0 Participants | 0 Participants |
| Baseline Malarie Prevention - Kitare Field Station Always sleep under mosquito net | 17 Participants | 16 Participants | 33 Participants |
| Baseline Malarie Prevention - Kitare Field Station Other | 0 Participants | 0 Participants | 0 Participants |
| Baseline Malarie Prevention - Kitare Field Station Use mosquito coils or sprays | 0 Participants | 1 Participants | 1 Participants |
| Baseline Malarie Prevention - Kitare Field Station Use topical mosquito repellents | 1 Participants | 0 Participants | 1 Participants |
| Baseline Parasite Density (par/µL blood) - Bar-Korwa Field Station | 1481.1 par/µL STANDARD_DEVIATION 3918.5 | 1679.0 par/µL STANDARD_DEVIATION 2907.7 | 1563.5 par/µL STANDARD_DEVIATION 3385.3 |
| Baseline Parasite Density (par/µL blood) - Got-Aglu Field Station | 2427.1 par/µL STANDARD_DEVIATION 6899.7 | 3932.5 par/µL STANDARD_DEVIATION 7509.3 | 3252.7 par/µL STANDARD_DEVIATION 7161.3 |
| Baseline Parasite Density (par/µL blood) - Kitare Field Station | 1645.5 par/µL STANDARD_DEVIATION 4375.6 | 550.1 par/µL STANDARD_DEVIATION 1416.7 | 1144.8 par/µL STANDARD_DEVIATION 3355.7 |
| Baseline Parasite Density (par/µL blood) - Kuoyo-Kowe Field Station | 1073.0 par/µL | 1185.0 par/µL STANDARD_DEVIATION 4230.4 | 1130.6 par/µL STANDARD_DEVIATION 3502.5 |
| Baseline Parasite Density (par/µL blood) - Manyanda Field Station | 148.9 par/µL STANDARD_DEVIATION 330.1 | 2441.0 par/µL STANDARD_DEVIATION 4236.4 | 1218.5 par/µL STANDARD_DEVIATION 3024.4 |
| Baseline Parasite Density (par/µL blood) - Mirieri Field Station | 1669.4 par/µL STANDARD_DEVIATION 3848.2 | 15775 par/µL STANDARD_DEVIATION 51756.8 | 7019.6 par/µL STANDARD_DEVIATION 31662.4 |
| Baseline Parasite Density (par/µL blood) - Nduru Kadero Field Station | 1676.5 par/µL STANDARD_DEVIATION 5123.2 | 6749.7 par/µL STANDARD_DEVIATION 20674.1 | 4543.9 par/µL STANDARD_DEVIATION 15826.8 |
| Baseline Parasite Density (par/µL blood) - Oruga Field Station | 1481.6 par/µL blood STANDARD_DEVIATION 3068.2 | 3034.9 par/µL blood STANDARD_DEVIATION 5151.7 | 2237.3 par/µL blood STANDARD_DEVIATION 4226 |
| Baseline Parasite Density (par/µL blood) - Osewre Field Station | 5288.3 par/µL blood STANDARD_DEVIATION 10961.1 | 1129.7 par/µL blood STANDARD_DEVIATION 2548.3 | 3416.9 par/µL blood STANDARD_DEVIATION 8394.9 |
| Baseline Parasite Density (par/µL blood) - Ranen Field Station | 3734.0 par/µL blood STANDARD_DEVIATION 11675.1 | 5906.4 par/µL blood STANDARD_DEVIATION 14161.9 | 4871.9 par/µL blood STANDARD_DEVIATION 12761.4 |
| Baseline Parasite Density (par/µL blood) - Reru Field Station | 823.5 par/µL blood STANDARD_DEVIATION 1490.1 | 5377.5 par/µL blood STANDARD_DEVIATION 13315.9 | 3502.3 par/µL blood STANDARD_DEVIATION 10291.2 |
| Baseline Sick Cell Status - Manyanda Field Station AA | 6 Participants | 4 Participants | 10 Participants |
| Baseline Sick Cell Status - Manyanda Field Station AD | 0 Participants | 0 Participants | 0 Participants |
| Baseline Sick Cell Status - Manyanda Field Station A+ Hb Kenya | 0 Participants | 0 Participants | 0 Participants |
| Baseline Sick Cell Status - Manyanda Field Station AS | 2 Participants | 3 Participants | 5 Participants |
| Baseline Sick Cell Status - Manyanda Field Station G6PD deficient | 0 Participants | 0 Participants | 0 Participants |
| Baseline Sickle Cell Status - Bar-Korwa Field Station AA | 3 Participants | 4 Participants | 7 Participants |
| Baseline Sickle Cell Status - Bar-Korwa Field Station AD | 0 Participants | 0 Participants | 0 Participants |
| Baseline Sickle Cell Status - Bar-Korwa Field Station A+ Hb Kenya | 0 Participants | 0 Participants | 0 Participants |
| Baseline Sickle Cell Status - Bar-Korwa Field Station AS | 4 Participants | 1 Participants | 5 Participants |
| Baseline Sickle Cell Status - Bar-Korwa Field Station G6PD deficient | 0 Participants | 1 Participants | 1 Participants |
| Baseline Sickle Cell Status - Got-Aglu Field Station AA | 8 Participants | 14 Participants | 22 Participants |
| Baseline Sickle Cell Status - Got-Aglu Field Station AD | 1 Participants | 0 Participants | 1 Participants |
| Baseline Sickle Cell Status - Got-Aglu Field Station A+ Hb Kenya | 0 Participants | 0 Participants | 0 Participants |
| Baseline Sickle Cell Status - Got-Aglu Field Station AS | 5 Participants | 3 Participants | 8 Participants |
| Baseline Sickle Cell Status - Got-Aglu Field Station G6PD deficient | 2 Participants | 3 Participants | 5 Participants |
| Baseline Sickle Cell Status - Kitare Field Station AA | 14 Participants | 10 Participants | 24 Participants |
| Baseline Sickle Cell Status - Kitare Field Station AD | 0 Participants | 0 Participants | 0 Participants |
| Baseline Sickle Cell Status - Kitare Field Station A+ Hb Kenya | 0 Participants | 0 Participants | 0 Participants |
| Baseline Sickle Cell Status - Kitare Field Station AS | 5 Participants | 7 Participants | 12 Participants |
| Baseline Sickle Cell Status - Kitare Field Station G6PD deficient | 1 Participants | 2 Participants | 3 Participants |
| Baseline Sickle Cell Status - Kuoyo-Kowe Field Station AA | 13 Participants | 16 Participants | 29 Participants |
| Baseline Sickle Cell Status - Kuoyo-Kowe Field Station AD | 0 Participants | 0 Participants | 0 Participants |
| Baseline Sickle Cell Status - Kuoyo-Kowe Field Station A+ Hb Kenya | 0 Participants | 0 Participants | 0 Participants |
| Baseline Sickle Cell Status - Kuoyo-Kowe Field Station AS | 4 Participants | 2 Participants | 6 Participants |
| Baseline Sickle Cell Status - Kuoyo-Kowe Field Station G6PD deficient | 5 Participants | 2 Participants | 7 Participants |
| Baseline Sickle Cell Status - Mirieri Field Station AA | 16 Participants | 8 Participants | 24 Participants |
| Baseline Sickle Cell Status - Mirieri Field Station AD | 0 Participants | 0 Participants | 0 Participants |
| Baseline Sickle Cell Status - Mirieri Field Station A+ Hb Kenya | 0 Participants | 0 Participants | 0 Participants |
| Baseline Sickle Cell Status - Mirieri Field Station AS | 2 Participants | 3 Participants | 5 Participants |
| Baseline Sickle Cell Status - Mirieri Field Station G6PD deficient | 3 Participants | 0 Participants | 3 Participants |
| Baseline Sickle Cell Status - Nduru Kadero Field Station AA | 9 Participants | 11 Participants | 20 Participants |
| Baseline Sickle Cell Status - Nduru Kadero Field Station AD | 0 Participants | 0 Participants | 0 Participants |
| Baseline Sickle Cell Status - Nduru Kadero Field Station A+ Hb Kenya | 0 Participants | 0 Participants | 0 Participants |
| Baseline Sickle Cell Status - Nduru Kadero Field Station AS | 1 Participants | 2 Participants | 3 Participants |
| Baseline Sickle Cell Status - Nduru Kadero Field Station G6PD deficient | 0 Participants | 1 Participants | 1 Participants |
| Baseline Sickle Cell Status - Oruga Field Station AA | 15 Participants | 16 Participants | 31 Participants |
| Baseline Sickle Cell Status - Oruga Field Station AD | 0 Participants | 0 Participants | 0 Participants |
| Baseline Sickle Cell Status - Oruga Field Station A+ Hb Kenya | 1 Participants | 0 Participants | 1 Participants |
| Baseline Sickle Cell Status - Oruga Field Station AS | 3 Participants | 2 Participants | 5 Participants |
| Baseline Sickle Cell Status - Oruga Field Station G6PD deficient | 2 Participants | 2 Participants | 4 Participants |
| Baseline Sickle Cell Status - Osewre Field Station AA | 11 Participants | 9 Participants | 20 Participants |
| Baseline Sickle Cell Status - Osewre Field Station AD | 0 Participants | 0 Participants | 0 Participants |
| Baseline Sickle Cell Status - Osewre Field Station A+ Hb Kenya | 0 Participants | 0 Participants | 0 Participants |
| Baseline Sickle Cell Status - Osewre Field Station AS | 0 Participants | 0 Participants | 0 Participants |
| Baseline Sickle Cell Status - Osewre Field Station G6PD deficient | 0 Participants | 2 Participants | 2 Participants |
| Baseline Sickle Cell Status - Ranen Field Station AA | 9 Participants | 9 Participants | 18 Participants |
| Baseline Sickle Cell Status - Ranen Field Station AD | 0 Participants | 0 Participants | 0 Participants |
| Baseline Sickle Cell Status - Ranen Field Station A+ Hb Kenya | 0 Participants | 0 Participants | 0 Participants |
| Baseline Sickle Cell Status - Ranen Field Station AS | 1 Participants | 3 Participants | 4 Participants |
| Baseline Sickle Cell Status - Ranen Field Station G6PD deficient | 1 Participants | 1 Participants | 2 Participants |
| Baseline Sickle Cell Status - Reru Field Station AA | 5 Participants | 8 Participants | 13 Participants |
| Baseline Sickle Cell Status - Reru Field Station AD | 0 Participants | 0 Participants | 0 Participants |
| Baseline Sickle Cell Status - Reru Field Station A+ Hb Kenya | 0 Participants | 0 Participants | 0 Participants |
| Baseline Sickle Cell Status - Reru Field Station AS | 2 Participants | 2 Participants | 4 Participants |
| Baseline Sickle Cell Status - Reru Field Station G6PD deficient | 2 Participants | 2 Participants | 4 Participants |
| Hemoglobin, g/dL - Abol Field Station | 10.69 g/dL STANDARD_DEVIATION 0.7 | 9.99 g/dL STANDARD_DEVIATION 1.13 | 10.37 g/dL STANDARD_DEVIATION 0.98 |
| Hemoglobin, g/dL - WRAIR Field Station | 1.16 g/dL STANDARD_DEVIATION 1.377 | 10.53 g/dL STANDARD_DEVIATION 1.18 | 10.40 g/dL STANDARD_DEVIATION 1.29 |
| Malaria Prevention - Abol Field Station Always sleep under mosquito net | 11 Participants | 11 Participants | 22 Participants |
| Malaria Prevention - Abol Field Station Other | 0 Participants | 0 Participants | 0 Participants |
| Malaria Prevention - Abol Field Station Use mosquito coils or sprays | 1 Participants | 1 Participants | 2 Participants |
| Malaria Prevention - Abol Field Station Use topical mosquito repellents | 0 Participants | 0 Participants | 0 Participants |
| Malaria Prevention - WRAIR Field Station Always sleep under mosquito net | 34 Participants | 31 Participants | 65 Participants |
| Malaria Prevention - WRAIR Field Station Other | 0 Participants | 0 Participants | 0 Participants |
| Malaria Prevention - WRAIR Field Station Use mosquito coils or sprays | 6 Participants | 7 Participants | 13 Participants |
| Malaria Prevention - WRAIR Field Station Use topical mosquito repellents | 0 Participants | 0 Participants | 0 Participants |
| Parasite Density (par/µL blood) - WRAIR Field Station | 5045.3 par/µL blood STANDARD_DEVIATION 13280 | 5716.3 par/µL blood STANDARD_DEVIATION 24832.9 | 5380.8 par/µL blood STANDARD_DEVIATION 19792.3 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Kenya | 200 Participants | 200 Participants | 400 Participants |
| Sex: Female, Male Abol Field Station Female | 7 Participants | 4 Participants | 11 Participants |
| Sex: Female, Male Abol Field Station Male | 7 Participants | 8 Participants | 15 Participants |
| Sex: Female, Male Bar-Korwa Field Station Female | 3 Participants | 3 Participants | 6 Participants |
| Sex: Female, Male Bar-Korwa Field Station Male | 4 Participants | 2 Participants | 6 Participants |
| Sex: Female, Male Got-Aglu Field Station Female | 6 Participants | 6 Participants | 12 Participants |
| Sex: Female, Male Got-Aglu Field Station Male | 8 Participants | 11 Participants | 19 Participants |
| Sex: Female, Male Kitare Field Station Female | 10 Participants | 5 Participants | 15 Participants |
| Sex: Female, Male Kitare Field Station Male | 9 Participants | 12 Participants | 21 Participants |
| Sex: Female, Male Kuoyo-Kowe Field Station Female | 8 Participants | 7 Participants | 15 Participants |
| Sex: Female, Male Kuoyo-Kowe Field Station Male | 9 Participants | 11 Participants | 20 Participants |
| Sex: Female, Male Manyanda Field Station Female | 5 Participants | 5 Participants | 10 Participants |
| Sex: Female, Male Manyanda Field Station Male | 3 Participants | 2 Participants | 5 Participants |
| Sex: Female, Male Mirieri Field Station Female | 13 Participants | 3 Participants | 16 Participants |
| Sex: Female, Male Mirieri Field Station Male | 5 Participants | 8 Participants | 13 Participants |
| Sex: Female, Male Nduru Kadero Field Station Female | 8 Participants | 5 Participants | 13 Participants |
| Sex: Female, Male Nduru Kadero Field Station Male | 2 Participants | 8 Participants | 10 Participants |
| Sex: Female, Male Oruga Field Station Female | 7 Participants | 7 Participants | 14 Participants |
| Sex: Female, Male Oruga Field Station Male | 12 Participants | 11 Participants | 23 Participants |
| Sex: Female, Male Osewre Field Station Female | 3 Participants | 6 Participants | 9 Participants |
| Sex: Female, Male Osewre Field Station Male | 8 Participants | 3 Participants | 11 Participants |
| Sex: Female, Male Ranen Field Station Female | 6 Participants | 5 Participants | 11 Participants |
| Sex: Female, Male Ranen Field Station Male | 4 Participants | 7 Participants | 11 Participants |
| Sex: Female, Male Reru Field Station Female | 5 Participants | 5 Participants | 10 Participants |
| Sex: Female, Male Reru Field Station Male | 2 Participants | 5 Participants | 7 Participants |
| Sex: Female, Male WRAIR Field Station Female | 16 Participants | 17 Participants | 33 Participants |
| Sex: Female, Male WRAIR Field Station Male | 25 Participants | 24 Participants | 49 Participants |
| Sickle Cell Status - Abol Field Station AA | 12 Participants | 7 Participants | 19 Participants |
| Sickle Cell Status - Abol Field Station AD | 0 Participants | 0 Participants | 0 Participants |
| Sickle Cell Status - Abol Field Station A+ Hb Kenya | 0 Participants | 1 Participants | 1 Participants |
| Sickle Cell Status - Abol Field Station AS | 2 Participants | 4 Participants | 6 Participants |
| Sickle Cell Status - Abol Field Station G6PD deficient | 0 Participants | 1 Participants | 1 Participants |
| Sickle Cell Status - WRAIR Field Station AA | 37 Participants | 36 Participants | 73 Participants |
| Sickle Cell Status - WRAIR Field Station AD | 0 Participants | 0 Participants | 0 Participants |
| Sickle Cell Status - WRAIR Field Station A+ Hb Kenya | 1 Participants | 0 Participants | 1 Participants |
| Sickle Cell Status - WRAIR Field Station AS | 3 Participants | 5 Participants | 8 Participants |
| Sickle Cell Status - WRAIR Field Station G6PD deficient | 4 Participants | 6 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 200 | 0 / 200 |
| other Total, other adverse events | 197 / 200 | 197 / 200 |
| serious Total, serious adverse events | 15 / 200 | 8 / 200 |
Outcome results
Primary
Subjects Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - Intent to Treat (ITT) Population
Days to first clinical episode of P falciparum malaria during the efficacy f/u period for ITT population Time at Risk adjusted for: SA= study absence MT= malaria treatment SA MT= study absence and malaria treatment Case Definitions: Primary = \>37.5°C with presence of a density of asexual stage P. falciparum \>50K parasites/µL blood Secondary (200) = \>37.5°C with presence of a density of asexual stage P. falciparum \>200K parasites/µL blood Secondary (100) = \>37.5°C with presence of a density of asexual stage P. falciparum \>100K parasites/µL blood Secondary (10) = \>37.5°C with presence of a density of asexual stage P. falciparum \>10K parasites/µL blood Secondary (0) = \>37.5°C with presence of a density of asexual stage P. falciparum \>0 parasites/µL blood Secondary (0\*) = \>37.5°C OR history of fever in the last 24 hrs with presence of a density of asexual stage P. falciparum \>0 parasites/µL blood
Time frame: starting 14 days after the 3rd vaccination (day 71), every 28 days and ending on day 240
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FMP1/AS02A | Subjects Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - Intent to Treat (ITT) Population | SA: Primary | 107 events |
| FMP1/AS02A | Subjects Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - Intent to Treat (ITT) Population | SA: Secondary (200) | 25 events |
| FMP1/AS02A | Subjects Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - Intent to Treat (ITT) Population | SA: Secondary (100) | 68 events |
| FMP1/AS02A | Subjects Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - Intent to Treat (ITT) Population | SA: Secondary (10) | 130 events |
| FMP1/AS02A | Subjects Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - Intent to Treat (ITT) Population | SA: Secondary (0) | 158 events |
| FMP1/AS02A | Subjects Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - Intent to Treat (ITT) Population | SA: Secondary (0*) | 185 events |
| FMP1/AS02A | Subjects Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - Intent to Treat (ITT) Population | MT: Primary | 105 events |
| FMP1/AS02A | Subjects Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - Intent to Treat (ITT) Population | MT: Secondary (200) | 23 events |
| FMP1/AS02A | Subjects Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - Intent to Treat (ITT) Population | MT: Secondary (100) | 64 events |
| FMP1/AS02A | Subjects Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - Intent to Treat (ITT) Population | MT: Secondary (10) | 130 events |
| FMP1/AS02A | Subjects Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - Intent to Treat (ITT) Population | MT: Secondary (0) | 156 events |
| FMP1/AS02A | Subjects Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - Intent to Treat (ITT) Population | MT: Secondary (0*) | 186 events |
| FMP1/AS02A | Subjects Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - Intent to Treat (ITT) Population | SA MT: Primary | 101 events |
| FMP1/AS02A | Subjects Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - Intent to Treat (ITT) Population | SA MT: Secondary (200) | 22 events |
| FMP1/AS02A | Subjects Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - Intent to Treat (ITT) Population | SA MT: Secondary (100) | 60 events |
| FMP1/AS02A | Subjects Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - Intent to Treat (ITT) Population | SA MT: Secondary (10) | 125 events |
| FMP1/AS02A | Subjects Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - Intent to Treat (ITT) Population | SA MT: Secondary (0) | 151 events |
| FMP1/AS02A | Subjects Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - Intent to Treat (ITT) Population | SA MT: Secondary (0*) | 183 events |
| RabAvert (Rabies Vaccine) | Subjects Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - Intent to Treat (ITT) Population | SA MT: Secondary (200) | 27 events |
| RabAvert (Rabies Vaccine) | Subjects Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - Intent to Treat (ITT) Population | SA: Primary | 121 events |
| RabAvert (Rabies Vaccine) | Subjects Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - Intent to Treat (ITT) Population | MT: Secondary (10) | 138 events |
| RabAvert (Rabies Vaccine) | Subjects Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - Intent to Treat (ITT) Population | SA: Secondary (200) | 29 events |
| RabAvert (Rabies Vaccine) | Subjects Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - Intent to Treat (ITT) Population | SA MT: Secondary (0*) | 182 events |
| RabAvert (Rabies Vaccine) | Subjects Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - Intent to Treat (ITT) Population | SA: Secondary (100) | 80 events |
| RabAvert (Rabies Vaccine) | Subjects Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - Intent to Treat (ITT) Population | MT: Secondary (0) | 161 events |
| RabAvert (Rabies Vaccine) | Subjects Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - Intent to Treat (ITT) Population | SA: Secondary (10) | 143 events |
| RabAvert (Rabies Vaccine) | Subjects Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - Intent to Treat (ITT) Population | SA MT: Secondary (100) | 76 events |
| RabAvert (Rabies Vaccine) | Subjects Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - Intent to Treat (ITT) Population | SA: Secondary (0) | 165 events |
| RabAvert (Rabies Vaccine) | Subjects Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - Intent to Treat (ITT) Population | MT: Secondary (0*) | 182 events |
| RabAvert (Rabies Vaccine) | Subjects Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - Intent to Treat (ITT) Population | SA: Secondary (0*) | 182 events |
| RabAvert (Rabies Vaccine) | Subjects Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - Intent to Treat (ITT) Population | SA MT: Secondary (0) | 160 events |
| RabAvert (Rabies Vaccine) | Subjects Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - Intent to Treat (ITT) Population | MT: Primary | 116 events |
| RabAvert (Rabies Vaccine) | Subjects Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - Intent to Treat (ITT) Population | SA MT: Primary | 113 events |
| RabAvert (Rabies Vaccine) | Subjects Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - Intent to Treat (ITT) Population | MT: Secondary (200) | 27 events |
| RabAvert (Rabies Vaccine) | Subjects Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - Intent to Treat (ITT) Population | SA MT: Secondary (10) | 138 events |
| RabAvert (Rabies Vaccine) | Subjects Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - Intent to Treat (ITT) Population | MT: Secondary (100) | 76 events |
Secondary
Number of Patients Who Showed Symptoms, Unsolicited Adverse Events, and Serious Adverse Events by Immunization
Each subject participated in the study approximately 14 months with 7-day follow-up for solicited adverse events (five visits: vaccination day plus post-vaccination days 1, 2, 3, and 6) and 30-day follow-up for unsolicited events (vaccination day plus 29 subsequent days). Follow-up of SAEs continued for study duration (364 days)
Time frame: vaccination day plus post-vaccine days 1, 2, 3, and 6; 30 day follow-up for unsolicited events and follow-up for SAEs to continue for duration of study (364 days)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FMP1/AS02A | Number of Patients Who Showed Symptoms, Unsolicited Adverse Events, and Serious Adverse Events by Immunization | Any solicited symptom | 195 Number of Participants |
| FMP1/AS02A | Number of Patients Who Showed Symptoms, Unsolicited Adverse Events, and Serious Adverse Events by Immunization | Any unsolicited AE | 197 Number of Participants |
| FMP1/AS02A | Number of Patients Who Showed Symptoms, Unsolicited Adverse Events, and Serious Adverse Events by Immunization | Any serious adverse event | 16 Number of Participants |
| FMP1/AS02A | Number of Patients Who Showed Symptoms, Unsolicited Adverse Events, and Serious Adverse Events by Immunization | Red blood cell | 176 Number of Participants |
| FMP1/AS02A | Number of Patients Who Showed Symptoms, Unsolicited Adverse Events, and Serious Adverse Events by Immunization | Resistance mechanism | 167 Number of Participants |
| FMP1/AS02A | Number of Patients Who Showed Symptoms, Unsolicited Adverse Events, and Serious Adverse Events by Immunization | Body as a whole general | 174 Number of Participants |
| FMP1/AS02A | Number of Patients Who Showed Symptoms, Unsolicited Adverse Events, and Serious Adverse Events by Immunization | Skin and appendages | 132 Number of Participants |
| FMP1/AS02A | Number of Patients Who Showed Symptoms, Unsolicited Adverse Events, and Serious Adverse Events by Immunization | Gastroentestinal | 128 Number of Participants |
| FMP1/AS02A | Number of Patients Who Showed Symptoms, Unsolicited Adverse Events, and Serious Adverse Events by Immunization | Application site | 176 Number of Participants |
| FMP1/AS02A | Number of Patients Who Showed Symptoms, Unsolicited Adverse Events, and Serious Adverse Events by Immunization | Respiratory | 61 Number of Participants |
| FMP1/AS02A | Number of Patients Who Showed Symptoms, Unsolicited Adverse Events, and Serious Adverse Events by Immunization | Vision | 36 Number of Participants |
| FMP1/AS02A | Number of Patients Who Showed Symptoms, Unsolicited Adverse Events, and Serious Adverse Events by Immunization | Psychiatric | 30 Number of Participants |
| FMP1/AS02A | Number of Patients Who Showed Symptoms, Unsolicited Adverse Events, and Serious Adverse Events by Immunization | Liver and biliary | 10 Number of Participants |
| FMP1/AS02A | Number of Patients Who Showed Symptoms, Unsolicited Adverse Events, and Serious Adverse Events by Immunization | Central and peripheral nervous system | 12 Number of Participants |
| FMP1/AS02A | Number of Patients Who Showed Symptoms, Unsolicited Adverse Events, and Serious Adverse Events by Immunization | White cell and reticuloendothelial | 6 Number of Participants |
| FMP1/AS02A | Number of Patients Who Showed Symptoms, Unsolicited Adverse Events, and Serious Adverse Events by Immunization | Urinary | 6 Number of Participants |
| FMP1/AS02A | Number of Patients Who Showed Symptoms, Unsolicited Adverse Events, and Serious Adverse Events by Immunization | Platelet bleeding and clotting | 1 Number of Participants |
| FMP1/AS02A | Number of Patients Who Showed Symptoms, Unsolicited Adverse Events, and Serious Adverse Events by Immunization | Musculoskeletal | 1 Number of Participants |
| FMP1/AS02A | Number of Patients Who Showed Symptoms, Unsolicited Adverse Events, and Serious Adverse Events by Immunization | Hearing and vestibular | 1 Number of Participants |
| FMP1/AS02A | Number of Patients Who Showed Symptoms, Unsolicited Adverse Events, and Serious Adverse Events by Immunization | Endocrine | 0 Number of Participants |
| FMP1/AS02A | Number of Patients Who Showed Symptoms, Unsolicited Adverse Events, and Serious Adverse Events by Immunization | Reproductive | 2 Number of Participants |
| RabAvert (Rabies Vaccine) | Number of Patients Who Showed Symptoms, Unsolicited Adverse Events, and Serious Adverse Events by Immunization | Vision | 35 Number of Participants |
| RabAvert (Rabies Vaccine) | Number of Patients Who Showed Symptoms, Unsolicited Adverse Events, and Serious Adverse Events by Immunization | Any solicited symptom | 85 Number of Participants |
| RabAvert (Rabies Vaccine) | Number of Patients Who Showed Symptoms, Unsolicited Adverse Events, and Serious Adverse Events by Immunization | Hearing and vestibular | 2 Number of Participants |
| RabAvert (Rabies Vaccine) | Number of Patients Who Showed Symptoms, Unsolicited Adverse Events, and Serious Adverse Events by Immunization | Any unsolicited AE | 197 Number of Participants |
| RabAvert (Rabies Vaccine) | Number of Patients Who Showed Symptoms, Unsolicited Adverse Events, and Serious Adverse Events by Immunization | Psychiatric | 3 Number of Participants |
| RabAvert (Rabies Vaccine) | Number of Patients Who Showed Symptoms, Unsolicited Adverse Events, and Serious Adverse Events by Immunization | Any serious adverse event | 8 Number of Participants |
| RabAvert (Rabies Vaccine) | Number of Patients Who Showed Symptoms, Unsolicited Adverse Events, and Serious Adverse Events by Immunization | Platelet bleeding and clotting | 4 Number of Participants |
| RabAvert (Rabies Vaccine) | Number of Patients Who Showed Symptoms, Unsolicited Adverse Events, and Serious Adverse Events by Immunization | Red blood cell | 167 Number of Participants |
| RabAvert (Rabies Vaccine) | Number of Patients Who Showed Symptoms, Unsolicited Adverse Events, and Serious Adverse Events by Immunization | Liver and biliary | 12 Number of Participants |
| RabAvert (Rabies Vaccine) | Number of Patients Who Showed Symptoms, Unsolicited Adverse Events, and Serious Adverse Events by Immunization | Resistance mechanism | 160 Number of Participants |
| RabAvert (Rabies Vaccine) | Number of Patients Who Showed Symptoms, Unsolicited Adverse Events, and Serious Adverse Events by Immunization | Reproductive | 0 Number of Participants |
| RabAvert (Rabies Vaccine) | Number of Patients Who Showed Symptoms, Unsolicited Adverse Events, and Serious Adverse Events by Immunization | Body as a whole general | 115 Number of Participants |
| RabAvert (Rabies Vaccine) | Number of Patients Who Showed Symptoms, Unsolicited Adverse Events, and Serious Adverse Events by Immunization | Central and peripheral nervous system | 9 Number of Participants |
| RabAvert (Rabies Vaccine) | Number of Patients Who Showed Symptoms, Unsolicited Adverse Events, and Serious Adverse Events by Immunization | Skin and appendages | 132 Number of Participants |
| RabAvert (Rabies Vaccine) | Number of Patients Who Showed Symptoms, Unsolicited Adverse Events, and Serious Adverse Events by Immunization | Musculoskeletal | 3 Number of Participants |
| RabAvert (Rabies Vaccine) | Number of Patients Who Showed Symptoms, Unsolicited Adverse Events, and Serious Adverse Events by Immunization | Gastroentestinal | 116 Number of Participants |
| RabAvert (Rabies Vaccine) | Number of Patients Who Showed Symptoms, Unsolicited Adverse Events, and Serious Adverse Events by Immunization | White cell and reticuloendothelial | 10 Number of Participants |
| RabAvert (Rabies Vaccine) | Number of Patients Who Showed Symptoms, Unsolicited Adverse Events, and Serious Adverse Events by Immunization | Application site | 15 Number of Participants |
| RabAvert (Rabies Vaccine) | Number of Patients Who Showed Symptoms, Unsolicited Adverse Events, and Serious Adverse Events by Immunization | Endocrine | 2 Number of Participants |
| RabAvert (Rabies Vaccine) | Number of Patients Who Showed Symptoms, Unsolicited Adverse Events, and Serious Adverse Events by Immunization | Respiratory | 69 Number of Participants |
| RabAvert (Rabies Vaccine) | Number of Patients Who Showed Symptoms, Unsolicited Adverse Events, and Serious Adverse Events by Immunization | Urinary | 4 Number of Participants |
Secondary
Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - According to Protocol (ATP) Population
Days to first clinical episode of P falciparum malaria during the efficacy f/u period for ATP population Time at Risk adjusted for: SA= study absence MT= malaria treatment SA MT= study absence and malaria treatment Case Definitions: Primary = \>37.5°C with presence of a density of asexual stage P. falciparum \>50K parasites/µL blood Secondary (200) = \>37.5°C with presence of a density of asexual stage P. falciparum \>200K parasites/µL blood Secondary (100) = \>37.5°C with presence of a density of asexual stage P. falciparum \>100K parasites/µL blood Secondary (10) = \>37.5°C with presence of a density of asexual stage P. falciparum \>10K parasites/µL blood Secondary (0) = \>37.5°C with presence of a density of asexual stage P. falciparum \>0 parasites/µL blood Secondary (0\*) = \>37.5°C OR history of fever in the last 24 hrs with presence of a density of asexual stage P. falciparum \>0 parasites/µL blood
Time frame: starting 14 days after the 3rd vaccination (day 71), every 28 days and ending on day 240
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FMP1/AS02A | Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - According to Protocol (ATP) Population | SA: Primary | 85 events |
| FMP1/AS02A | Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - According to Protocol (ATP) Population | SA: Secondary (200) | 17 events |
| FMP1/AS02A | Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - According to Protocol (ATP) Population | SA: Secondary (100) | 49 events |
| FMP1/AS02A | Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - According to Protocol (ATP) Population | SA: Secondary (10) | 103 events |
| FMP1/AS02A | Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - According to Protocol (ATP) Population | SA: Secondary (0) | 130 events |
| FMP1/AS02A | Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - According to Protocol (ATP) Population | SA: Secondary (0*) | 171 events |
| FMP1/AS02A | Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - According to Protocol (ATP) Population | MT: Primary | 80 events |
| FMP1/AS02A | Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - According to Protocol (ATP) Population | MT: Secondary (200) | 16 events |
| FMP1/AS02A | Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - According to Protocol (ATP) Population | MT: Secondary (100) | 46 events |
| FMP1/AS02A | Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - According to Protocol (ATP) Population | MT: Secondary (10) | 100 events |
| FMP1/AS02A | Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - According to Protocol (ATP) Population | MT: Secondary (0) | 127 events |
| FMP1/AS02A | Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - According to Protocol (ATP) Population | MT: Secondary (0*) | 173 events |
| FMP1/AS02A | Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - According to Protocol (ATP) Population | SA MT: Primary | 78 events |
| FMP1/AS02A | Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - According to Protocol (ATP) Population | SA MT: Secondary (200) | 15 events |
| FMP1/AS02A | Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - According to Protocol (ATP) Population | SA MT: Secondary (100) | 44 events |
| FMP1/AS02A | Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - According to Protocol (ATP) Population | SA MT: Secondary (10) | 96 events |
| FMP1/AS02A | Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - According to Protocol (ATP) Population | SA MT: Secondary (0) | 122 events |
| FMP1/AS02A | Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - According to Protocol (ATP) Population | SA MT: Secondary (0*) | 168 events |
| RabAvert (Rabies Vaccine) | Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - According to Protocol (ATP) Population | SA MT: Secondary (200) | 12 events |
| RabAvert (Rabies Vaccine) | Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - According to Protocol (ATP) Population | SA: Primary | 86 events |
| RabAvert (Rabies Vaccine) | Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - According to Protocol (ATP) Population | MT: Secondary (10) | 101 events |
| RabAvert (Rabies Vaccine) | Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - According to Protocol (ATP) Population | SA: Secondary (200) | 13 events |
| RabAvert (Rabies Vaccine) | Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - According to Protocol (ATP) Population | SA MT: Secondary (0*) | 168 events |
| RabAvert (Rabies Vaccine) | Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - According to Protocol (ATP) Population | SA: Secondary (100) | 50 events |
| RabAvert (Rabies Vaccine) | Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - According to Protocol (ATP) Population | MT: Secondary (0) | 131 events |
| RabAvert (Rabies Vaccine) | Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - According to Protocol (ATP) Population | SA: Secondary (10) | 107 events |
| RabAvert (Rabies Vaccine) | Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - According to Protocol (ATP) Population | SA MT: Secondary (100) | 47 events |
| RabAvert (Rabies Vaccine) | Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - According to Protocol (ATP) Population | SA: Secondary (0) | 138 events |
| RabAvert (Rabies Vaccine) | Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - According to Protocol (ATP) Population | MT: Secondary (0*) | 168 events |
| RabAvert (Rabies Vaccine) | Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - According to Protocol (ATP) Population | SA: Secondary (0*) | 168 events |
| RabAvert (Rabies Vaccine) | Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - According to Protocol (ATP) Population | SA MT: Secondary (0) | 131 events |
| RabAvert (Rabies Vaccine) | Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - According to Protocol (ATP) Population | MT: Primary | 79 events |
| RabAvert (Rabies Vaccine) | Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - According to Protocol (ATP) Population | SA MT: Primary | 76 events |
| RabAvert (Rabies Vaccine) | Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - According to Protocol (ATP) Population | MT: Secondary (200) | 12 events |
| RabAvert (Rabies Vaccine) | Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - According to Protocol (ATP) Population | SA MT: Secondary (10) | 100 events |
| RabAvert (Rabies Vaccine) | Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - According to Protocol (ATP) Population | MT: Secondary (100) | 47 events |
Secondary
Vaccine-Related Local and Systemic Solicited Adverse Events by Immunization - According to Protocol (ATP)
Each subject participated in the study approximately 14 months with 7-day follow-up for solicited adverse events (five visits: vaccination day plus post-vaccination days 1, 2, 3, and 6) and 30-day follow-up for unsolicited events (vaccination day plus 29 subsequent days). I1 = Immunization 1 I2 = Immunization 2 I3 = Immunization 3
Time frame: vaccination day plus 29 subsequent days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FMP1/AS02A | Vaccine-Related Local and Systemic Solicited Adverse Events by Immunization - According to Protocol (ATP) | I1 - Local | 139 adverse events |
| FMP1/AS02A | Vaccine-Related Local and Systemic Solicited Adverse Events by Immunization - According to Protocol (ATP) | I2 - Systemic | 62 adverse events |
| FMP1/AS02A | Vaccine-Related Local and Systemic Solicited Adverse Events by Immunization - According to Protocol (ATP) | I2 - Any symptom | 131 adverse events |
| FMP1/AS02A | Vaccine-Related Local and Systemic Solicited Adverse Events by Immunization - According to Protocol (ATP) | I3 - Any symptom | 76 adverse events |
| FMP1/AS02A | Vaccine-Related Local and Systemic Solicited Adverse Events by Immunization - According to Protocol (ATP) | I1 - Systemic | 82 adverse events |
| FMP1/AS02A | Vaccine-Related Local and Systemic Solicited Adverse Events by Immunization - According to Protocol (ATP) | I3 - Local | 66 adverse events |
| FMP1/AS02A | Vaccine-Related Local and Systemic Solicited Adverse Events by Immunization - According to Protocol (ATP) | I2 - Local | 113 adverse events |
| FMP1/AS02A | Vaccine-Related Local and Systemic Solicited Adverse Events by Immunization - According to Protocol (ATP) | I3 - Systemic | 21 adverse events |
| FMP1/AS02A | Vaccine-Related Local and Systemic Solicited Adverse Events by Immunization - According to Protocol (ATP) | I1 - Any symptom | 157 adverse events |
| RabAvert (Rabies Vaccine) | Vaccine-Related Local and Systemic Solicited Adverse Events by Immunization - According to Protocol (ATP) | I3 - Systemic | 9 adverse events |
| RabAvert (Rabies Vaccine) | Vaccine-Related Local and Systemic Solicited Adverse Events by Immunization - According to Protocol (ATP) | I1 - Any symptom | 22 adverse events |
| RabAvert (Rabies Vaccine) | Vaccine-Related Local and Systemic Solicited Adverse Events by Immunization - According to Protocol (ATP) | I1 - Local | 9 adverse events |
| RabAvert (Rabies Vaccine) | Vaccine-Related Local and Systemic Solicited Adverse Events by Immunization - According to Protocol (ATP) | I1 - Systemic | 16 adverse events |
| RabAvert (Rabies Vaccine) | Vaccine-Related Local and Systemic Solicited Adverse Events by Immunization - According to Protocol (ATP) | I2 - Any symptom | 10 adverse events |
| RabAvert (Rabies Vaccine) | Vaccine-Related Local and Systemic Solicited Adverse Events by Immunization - According to Protocol (ATP) | I2 - Local | 5 adverse events |
| RabAvert (Rabies Vaccine) | Vaccine-Related Local and Systemic Solicited Adverse Events by Immunization - According to Protocol (ATP) | I2 - Systemic | 6 adverse events |
| RabAvert (Rabies Vaccine) | Vaccine-Related Local and Systemic Solicited Adverse Events by Immunization - According to Protocol (ATP) | I3 - Any symptom | 10 adverse events |
| RabAvert (Rabies Vaccine) | Vaccine-Related Local and Systemic Solicited Adverse Events by Immunization - According to Protocol (ATP) | I3 - Local | 1 adverse events |
Secondary
Vaccine-Related Local and Systemic Solicited Adverse Events by Immunization - Intent to Treat (ITT)
Each subject participated in the study approximately 14 months with 7-day follow-up for solicited adverse events (five visits: vaccination day plus post-vaccination days 1, 2, 3, and 6) and 30-day follow-up for unsolicited events (vaccination day plus 29 subsequent days). I1 = Immunization 1 I2 = Immunization 2 I3 = Immunization 3
Time frame: vaccination day plus 29 subsequent days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FMP1/AS02A | Vaccine-Related Local and Systemic Solicited Adverse Events by Immunization - Intent to Treat (ITT) | I1 - Local | 142 adverse events |
| FMP1/AS02A | Vaccine-Related Local and Systemic Solicited Adverse Events by Immunization - Intent to Treat (ITT) | I2 - Systemic | 62 adverse events |
| FMP1/AS02A | Vaccine-Related Local and Systemic Solicited Adverse Events by Immunization - Intent to Treat (ITT) | I2 - Any symptom | 131 adverse events |
| FMP1/AS02A | Vaccine-Related Local and Systemic Solicited Adverse Events by Immunization - Intent to Treat (ITT) | I3 - Any symptom | 76 adverse events |
| FMP1/AS02A | Vaccine-Related Local and Systemic Solicited Adverse Events by Immunization - Intent to Treat (ITT) | I1 - Systemic | 83 adverse events |
| FMP1/AS02A | Vaccine-Related Local and Systemic Solicited Adverse Events by Immunization - Intent to Treat (ITT) | I3 - Local | 66 adverse events |
| FMP1/AS02A | Vaccine-Related Local and Systemic Solicited Adverse Events by Immunization - Intent to Treat (ITT) | I2 - Local | 113 adverse events |
| FMP1/AS02A | Vaccine-Related Local and Systemic Solicited Adverse Events by Immunization - Intent to Treat (ITT) | I3 - Systemic | 21 adverse events |
| FMP1/AS02A | Vaccine-Related Local and Systemic Solicited Adverse Events by Immunization - Intent to Treat (ITT) | I1 - Any symptom | 160 adverse events |
| RabAvert (Rabies Vaccine) | Vaccine-Related Local and Systemic Solicited Adverse Events by Immunization - Intent to Treat (ITT) | I3 - Systemic | 9 adverse events |
| RabAvert (Rabies Vaccine) | Vaccine-Related Local and Systemic Solicited Adverse Events by Immunization - Intent to Treat (ITT) | I1 - Any symptom | 24 adverse events |
| RabAvert (Rabies Vaccine) | Vaccine-Related Local and Systemic Solicited Adverse Events by Immunization - Intent to Treat (ITT) | I1 - Local | 10 adverse events |
| RabAvert (Rabies Vaccine) | Vaccine-Related Local and Systemic Solicited Adverse Events by Immunization - Intent to Treat (ITT) | I1 - Systemic | 17 adverse events |
| RabAvert (Rabies Vaccine) | Vaccine-Related Local and Systemic Solicited Adverse Events by Immunization - Intent to Treat (ITT) | I2 - Any symptom | 11 adverse events |
| RabAvert (Rabies Vaccine) | Vaccine-Related Local and Systemic Solicited Adverse Events by Immunization - Intent to Treat (ITT) | I2 - Local | 5 adverse events |
| RabAvert (Rabies Vaccine) | Vaccine-Related Local and Systemic Solicited Adverse Events by Immunization - Intent to Treat (ITT) | I2 - Systemic | 7 adverse events |
| RabAvert (Rabies Vaccine) | Vaccine-Related Local and Systemic Solicited Adverse Events by Immunization - Intent to Treat (ITT) | I3 - Any symptom | 10 adverse events |
| RabAvert (Rabies Vaccine) | Vaccine-Related Local and Systemic Solicited Adverse Events by Immunization - Intent to Treat (ITT) | I3 - Local | 1 adverse events |
Secondary
Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - According to Protocol (ATP) Population
Each subject participated in the study approximately 14 months with 7-day follow-up for solicited adverse events (five visits: vaccination day plus post-vaccination days 1, 2, 3, and 6). I1 = Immunization 1 I2 = Immunization 2 I3 = Immunization 3
Time frame: vaccination day plus post-vaccination days 1, 2, 3, and 6
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| FMP1/AS02A | Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - According to Protocol (ATP) Population | I1 - Pain | 137 Participants |
| FMP1/AS02A | Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - According to Protocol (ATP) Population | I1 - Swelling | 50 Participants |
| FMP1/AS02A | Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - According to Protocol (ATP) Population | I1 - Fever | 61 Participants |
| FMP1/AS02A | Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - According to Protocol (ATP) Population | I1 - Drowsiness | 1 Participants |
| FMP1/AS02A | Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - According to Protocol (ATP) Population | I1 - Loss of appetite | 27 Participants |
| FMP1/AS02A | Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - According to Protocol (ATP) Population | I1 - Irritability/fussiness | 13 Participants |
| FMP1/AS02A | Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - According to Protocol (ATP) Population | I2 - Pain | 113 Participants |
| FMP1/AS02A | Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - According to Protocol (ATP) Population | I2 - Swelling | 28 Participants |
| FMP1/AS02A | Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - According to Protocol (ATP) Population | I2 - Fever | 46 Participants |
| FMP1/AS02A | Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - According to Protocol (ATP) Population | I2 - Drowsiness | 1 Participants |
| FMP1/AS02A | Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - According to Protocol (ATP) Population | I2 - Loss of appetite | 21 Participants |
| FMP1/AS02A | Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - According to Protocol (ATP) Population | I2 - Irritability/fussiness | 7 Participants |
| FMP1/AS02A | Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - According to Protocol (ATP) Population | I3 - Pain | 66 Participants |
| FMP1/AS02A | Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - According to Protocol (ATP) Population | I3 - Swelling | 15 Participants |
| FMP1/AS02A | Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - According to Protocol (ATP) Population | I3 - Fever | 17 Participants |
| FMP1/AS02A | Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - According to Protocol (ATP) Population | I3 - Drowsiness | 0 Participants |
| FMP1/AS02A | Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - According to Protocol (ATP) Population | I3 - Loss of appetite | 5 Participants |
| FMP1/AS02A | Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - According to Protocol (ATP) Population | I3 - Irritability/fussiness | 3 Participants |
| RabAvert (Rabies Vaccine) | Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - According to Protocol (ATP) Population | I3 - Swelling | 1 Participants |
| RabAvert (Rabies Vaccine) | Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - According to Protocol (ATP) Population | I1 - Pain | 8 Participants |
| RabAvert (Rabies Vaccine) | Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - According to Protocol (ATP) Population | I2 - Drowsiness | 0 Participants |
| RabAvert (Rabies Vaccine) | Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - According to Protocol (ATP) Population | I1 - Swelling | 1 Participants |
| RabAvert (Rabies Vaccine) | Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - According to Protocol (ATP) Population | I3 - Irritability/fussiness | 0 Participants |
| RabAvert (Rabies Vaccine) | Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - According to Protocol (ATP) Population | I1 - Fever | 10 Participants |
| RabAvert (Rabies Vaccine) | Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - According to Protocol (ATP) Population | I2 - Loss of appetite | 3 Participants |
| RabAvert (Rabies Vaccine) | Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - According to Protocol (ATP) Population | I1 - Drowsiness | 0 Participants |
| RabAvert (Rabies Vaccine) | Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - According to Protocol (ATP) Population | I3 - Fever | 6 Participants |
| RabAvert (Rabies Vaccine) | Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - According to Protocol (ATP) Population | I1 - Loss of appetite | 6 Participants |
| RabAvert (Rabies Vaccine) | Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - According to Protocol (ATP) Population | I2 - Irritability/fussiness | 0 Participants |
| RabAvert (Rabies Vaccine) | Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - According to Protocol (ATP) Population | I1 - Irritability/fussiness | 1 Participants |
| RabAvert (Rabies Vaccine) | Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - According to Protocol (ATP) Population | I3 - Loss of appetite | 3 Participants |
| RabAvert (Rabies Vaccine) | Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - According to Protocol (ATP) Population | I2 - Pain | 5 Participants |
| RabAvert (Rabies Vaccine) | Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - According to Protocol (ATP) Population | I3 - Pain | 1 Participants |
| RabAvert (Rabies Vaccine) | Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - According to Protocol (ATP) Population | I2 - Swelling | 0 Participants |
| RabAvert (Rabies Vaccine) | Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - According to Protocol (ATP) Population | I3 - Drowsiness | 0 Participants |
| RabAvert (Rabies Vaccine) | Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - According to Protocol (ATP) Population | I2 - Fever | 3 Participants |
Secondary
Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - Intent to Treat (ITT) Population
Each subject participated in the study approximately 14 months with 7-day follow-up for solicited adverse events (five visits: vaccination day plus post-vaccination days 1, 2, 3, and 6). I1 = Immunization 1 I2 = Immunization 2 I3 = Immunization 3
Time frame: vaccination day plus post-vaccination days 1, 2, 3, and 6
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FMP1/AS02A | Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - Intent to Treat (ITT) Population | I1 - Pain | 140 participants |
| FMP1/AS02A | Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - Intent to Treat (ITT) Population | I1 - Swelling | 51 participants |
| FMP1/AS02A | Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - Intent to Treat (ITT) Population | I1 - Fever | 61 participants |
| FMP1/AS02A | Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - Intent to Treat (ITT) Population | I1 - Drowsiness | 1 participants |
| FMP1/AS02A | Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - Intent to Treat (ITT) Population | I1 - Loss of appetite | 27 participants |
| FMP1/AS02A | Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - Intent to Treat (ITT) Population | I1 - Irritability/fussiness | 14 participants |
| FMP1/AS02A | Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - Intent to Treat (ITT) Population | I2 - Pain | 113 participants |
| FMP1/AS02A | Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - Intent to Treat (ITT) Population | I2 - Swelling | 28 participants |
| FMP1/AS02A | Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - Intent to Treat (ITT) Population | I2 - Fever | 46 participants |
| FMP1/AS02A | Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - Intent to Treat (ITT) Population | I2 - Drowsiness | 1 participants |
| FMP1/AS02A | Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - Intent to Treat (ITT) Population | I2 - Loss of appetite | 21 participants |
| FMP1/AS02A | Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - Intent to Treat (ITT) Population | I2 - Irritability/fussiness | 7 participants |
| FMP1/AS02A | Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - Intent to Treat (ITT) Population | I3 - Pain | 66 participants |
| FMP1/AS02A | Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - Intent to Treat (ITT) Population | I3 - Swelling | 16 participants |
| FMP1/AS02A | Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - Intent to Treat (ITT) Population | I3 - Fever | 17 participants |
| FMP1/AS02A | Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - Intent to Treat (ITT) Population | I3 - Drowsiness | 0 participants |
| FMP1/AS02A | Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - Intent to Treat (ITT) Population | I3 - Loss of appetite | 5 participants |
| FMP1/AS02A | Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - Intent to Treat (ITT) Population | I3 - Irritability/fussiness | 3 participants |
| RabAvert (Rabies Vaccine) | Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - Intent to Treat (ITT) Population | I3 - Swelling | 1 participants |
| RabAvert (Rabies Vaccine) | Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - Intent to Treat (ITT) Population | I1 - Pain | 9 participants |
| RabAvert (Rabies Vaccine) | Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - Intent to Treat (ITT) Population | I2 - Drowsiness | 0 participants |
| RabAvert (Rabies Vaccine) | Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - Intent to Treat (ITT) Population | I1 - Swelling | 1 participants |
| RabAvert (Rabies Vaccine) | Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - Intent to Treat (ITT) Population | I3 - Irritability/fussiness | 0 participants |
| RabAvert (Rabies Vaccine) | Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - Intent to Treat (ITT) Population | I1 - Fever | 11 participants |
| RabAvert (Rabies Vaccine) | Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - Intent to Treat (ITT) Population | I2 - Loss of appetite | 4 participants |
| RabAvert (Rabies Vaccine) | Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - Intent to Treat (ITT) Population | I1 - Drowsiness | 0 participants |
| RabAvert (Rabies Vaccine) | Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - Intent to Treat (ITT) Population | I3 - Fever | 6 participants |
| RabAvert (Rabies Vaccine) | Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - Intent to Treat (ITT) Population | I1 - Loss of appetite | 6 participants |
| RabAvert (Rabies Vaccine) | Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - Intent to Treat (ITT) Population | I2 - Irritability/fussiness | 0 participants |
| RabAvert (Rabies Vaccine) | Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - Intent to Treat (ITT) Population | I1 - Irritability/fussiness | 1 participants |
| RabAvert (Rabies Vaccine) | Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - Intent to Treat (ITT) Population | I3 - Loss of appetite | 3 participants |
| RabAvert (Rabies Vaccine) | Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - Intent to Treat (ITT) Population | I2 - Pain | 6 participants |
| RabAvert (Rabies Vaccine) | Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - Intent to Treat (ITT) Population | I3 - Pain | 1 participants |
| RabAvert (Rabies Vaccine) | Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - Intent to Treat (ITT) Population | I2 - Swelling | 0 participants |
| RabAvert (Rabies Vaccine) | Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - Intent to Treat (ITT) Population | I3 - Drowsiness | 0 participants |
| RabAvert (Rabies Vaccine) | Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - Intent to Treat (ITT) Population | I2 - Fever | 3 participants |
Secondary
Vaccine-Related Unsolicited Adverse Events by Immunization - According to Protocol (ATP) Population
Each subject participated in the study approximately 14 months with 7-day follow-up for solicited adverse events (five visits: vaccination day plus post-vaccination days 1, 2, 3, and 6) and 30-day follow-up for unsolicited events (vaccination day plus 29 subsequent days). I1 = Immunization 1 I2 = Immunization 2 I3 = Immunization 3
Time frame: vaccination day and 29 subsequent days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FMP1/AS02A | Vaccine-Related Unsolicited Adverse Events by Immunization - According to Protocol (ATP) Population | I1 - Body as a whole general | 13 adverse events |
| FMP1/AS02A | Vaccine-Related Unsolicited Adverse Events by Immunization - According to Protocol (ATP) Population | I2 - Body as a whole general | 7 adverse events |
| FMP1/AS02A | Vaccine-Related Unsolicited Adverse Events by Immunization - According to Protocol (ATP) Population | I3 - Body as a whole general | 4 adverse events |
| FMP1/AS02A | Vaccine-Related Unsolicited Adverse Events by Immunization - According to Protocol (ATP) Population | I1 - History of Fever | 12 adverse events |
| FMP1/AS02A | Vaccine-Related Unsolicited Adverse Events by Immunization - According to Protocol (ATP) Population | I2 - History of Fever | 7 adverse events |
| FMP1/AS02A | Vaccine-Related Unsolicited Adverse Events by Immunization - According to Protocol (ATP) Population | I3 - History ofFever | 4 adverse events |
| FMP1/AS02A | Vaccine-Related Unsolicited Adverse Events by Immunization - According to Protocol (ATP) Population | I1 - Fever | 1 adverse events |
| FMP1/AS02A | Vaccine-Related Unsolicited Adverse Events by Immunization - According to Protocol (ATP) Population | I2 - Fever | 0 adverse events |
| FMP1/AS02A | Vaccine-Related Unsolicited Adverse Events by Immunization - According to Protocol (ATP) Population | I3 - Fever | 0 adverse events |
| FMP1/AS02A | Vaccine-Related Unsolicited Adverse Events by Immunization - According to Protocol (ATP) Population | I1 - Rash maculo-papular | 0 adverse events |
| FMP1/AS02A | Vaccine-Related Unsolicited Adverse Events by Immunization - According to Protocol (ATP) Population | I2 - Rash maculo-papular | 0 adverse events |
| FMP1/AS02A | Vaccine-Related Unsolicited Adverse Events by Immunization - According to Protocol (ATP) Population | I3 - Rash maculo-papular | 1 adverse events |
| FMP1/AS02A | Vaccine-Related Unsolicited Adverse Events by Immunization - According to Protocol (ATP) Population | I1 - Gastroenteritis | 0 adverse events |
| FMP1/AS02A | Vaccine-Related Unsolicited Adverse Events by Immunization - According to Protocol (ATP) Population | I2 - Gastroenteritis | 0 adverse events |
| FMP1/AS02A | Vaccine-Related Unsolicited Adverse Events by Immunization - According to Protocol (ATP) Population | I3 - Gastroenteritis | 0 adverse events |
| FMP1/AS02A | Vaccine-Related Unsolicited Adverse Events by Immunization - According to Protocol (ATP) Population | I1 - Headache | 0 adverse events |
| FMP1/AS02A | Vaccine-Related Unsolicited Adverse Events by Immunization - According to Protocol (ATP) Population | I2 - Headache | 0 adverse events |
| FMP1/AS02A | Vaccine-Related Unsolicited Adverse Events by Immunization - According to Protocol (ATP) Population | I3 - Headache | 1 adverse events |
| FMP1/AS02A | Vaccine-Related Unsolicited Adverse Events by Immunization - According to Protocol (ATP) Population | I1 - Injection site inflammation | 0 adverse events |
| FMP1/AS02A | Vaccine-Related Unsolicited Adverse Events by Immunization - According to Protocol (ATP) Population | I2 - Injection site inflammation | 0 adverse events |
| FMP1/AS02A | Vaccine-Related Unsolicited Adverse Events by Immunization - According to Protocol (ATP) Population | I3 - Injection site inflammation | 0 adverse events |
| RabAvert (Rabies Vaccine) | Vaccine-Related Unsolicited Adverse Events by Immunization - According to Protocol (ATP) Population | I2 - Rash maculo-papular | 0 adverse events |
| RabAvert (Rabies Vaccine) | Vaccine-Related Unsolicited Adverse Events by Immunization - According to Protocol (ATP) Population | I1 - Body as a whole general | 6 adverse events |
| RabAvert (Rabies Vaccine) | Vaccine-Related Unsolicited Adverse Events by Immunization - According to Protocol (ATP) Population | I1 - Injection site inflammation | 0 adverse events |
| RabAvert (Rabies Vaccine) | Vaccine-Related Unsolicited Adverse Events by Immunization - According to Protocol (ATP) Population | I2 - Body as a whole general | 2 adverse events |
| RabAvert (Rabies Vaccine) | Vaccine-Related Unsolicited Adverse Events by Immunization - According to Protocol (ATP) Population | I3 - Rash maculo-papular | 0 adverse events |
| RabAvert (Rabies Vaccine) | Vaccine-Related Unsolicited Adverse Events by Immunization - According to Protocol (ATP) Population | I3 - Body as a whole general | 0 adverse events |
| RabAvert (Rabies Vaccine) | Vaccine-Related Unsolicited Adverse Events by Immunization - According to Protocol (ATP) Population | I2 - Headache | 0 adverse events |
| RabAvert (Rabies Vaccine) | Vaccine-Related Unsolicited Adverse Events by Immunization - According to Protocol (ATP) Population | I1 - History of Fever | 6 adverse events |
| RabAvert (Rabies Vaccine) | Vaccine-Related Unsolicited Adverse Events by Immunization - According to Protocol (ATP) Population | I1 - Gastroenteritis | 1 adverse events |
| RabAvert (Rabies Vaccine) | Vaccine-Related Unsolicited Adverse Events by Immunization - According to Protocol (ATP) Population | I2 - History of Fever | 2 adverse events |
| RabAvert (Rabies Vaccine) | Vaccine-Related Unsolicited Adverse Events by Immunization - According to Protocol (ATP) Population | I3 - Injection site inflammation | 1 adverse events |
| RabAvert (Rabies Vaccine) | Vaccine-Related Unsolicited Adverse Events by Immunization - According to Protocol (ATP) Population | I3 - History ofFever | 0 adverse events |
| RabAvert (Rabies Vaccine) | Vaccine-Related Unsolicited Adverse Events by Immunization - According to Protocol (ATP) Population | I2 - Gastroenteritis | 0 adverse events |
| RabAvert (Rabies Vaccine) | Vaccine-Related Unsolicited Adverse Events by Immunization - According to Protocol (ATP) Population | I1 - Fever | 0 adverse events |
| RabAvert (Rabies Vaccine) | Vaccine-Related Unsolicited Adverse Events by Immunization - According to Protocol (ATP) Population | I3 - Headache | 0 adverse events |
| RabAvert (Rabies Vaccine) | Vaccine-Related Unsolicited Adverse Events by Immunization - According to Protocol (ATP) Population | I2 - Fever | 0 adverse events |
| RabAvert (Rabies Vaccine) | Vaccine-Related Unsolicited Adverse Events by Immunization - According to Protocol (ATP) Population | I3 - Gastroenteritis | 0 adverse events |
| RabAvert (Rabies Vaccine) | Vaccine-Related Unsolicited Adverse Events by Immunization - According to Protocol (ATP) Population | I3 - Fever | 0 adverse events |
| RabAvert (Rabies Vaccine) | Vaccine-Related Unsolicited Adverse Events by Immunization - According to Protocol (ATP) Population | I2 - Injection site inflammation | 0 adverse events |
| RabAvert (Rabies Vaccine) | Vaccine-Related Unsolicited Adverse Events by Immunization - According to Protocol (ATP) Population | I1 - Rash maculo-papular | 0 adverse events |
| RabAvert (Rabies Vaccine) | Vaccine-Related Unsolicited Adverse Events by Immunization - According to Protocol (ATP) Population | I1 - Headache | 0 adverse events |
Secondary
Vaccine-Related Unsolicited Adverse Events by Immunization - Intent to Treat (ITT) Population
Each subject participated in the study approximately 14 months with 7-day follow-up for solicited adverse events (five visits: vaccination day plus post-vaccination days 1, 2, 3, and 6) and 30-day follow-up for unsolicited events (vaccination day plus 29 subsequent days). I1 = Immunization 1 I2 = Immunization 2 I3 = Immunization 3
Time frame: vaccination day and 29 subsequent days
Population: withdrawals
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FMP1/AS02A | Vaccine-Related Unsolicited Adverse Events by Immunization - Intent to Treat (ITT) Population | I1 - Body as a whole general | 14 adverse events |
| FMP1/AS02A | Vaccine-Related Unsolicited Adverse Events by Immunization - Intent to Treat (ITT) Population | I2 - Body as a whole general | 7 adverse events |
| FMP1/AS02A | Vaccine-Related Unsolicited Adverse Events by Immunization - Intent to Treat (ITT) Population | I3 - Body as a whole general | 4 adverse events |
| FMP1/AS02A | Vaccine-Related Unsolicited Adverse Events by Immunization - Intent to Treat (ITT) Population | I1 - History of fever | 13 adverse events |
| FMP1/AS02A | Vaccine-Related Unsolicited Adverse Events by Immunization - Intent to Treat (ITT) Population | I2 - History of fever | 7 adverse events |
| FMP1/AS02A | Vaccine-Related Unsolicited Adverse Events by Immunization - Intent to Treat (ITT) Population | I3 - History of fever | 4 adverse events |
| FMP1/AS02A | Vaccine-Related Unsolicited Adverse Events by Immunization - Intent to Treat (ITT) Population | I1 - Fever | 1 adverse events |
| FMP1/AS02A | Vaccine-Related Unsolicited Adverse Events by Immunization - Intent to Treat (ITT) Population | I2 - Fever | 0 adverse events |
| FMP1/AS02A | Vaccine-Related Unsolicited Adverse Events by Immunization - Intent to Treat (ITT) Population | I3 - Fever | 0 adverse events |
| FMP1/AS02A | Vaccine-Related Unsolicited Adverse Events by Immunization - Intent to Treat (ITT) Population | I1 - Rash maculo-papular | 0 adverse events |
| FMP1/AS02A | Vaccine-Related Unsolicited Adverse Events by Immunization - Intent to Treat (ITT) Population | I2 - Rash maculo-papular | 0 adverse events |
| FMP1/AS02A | Vaccine-Related Unsolicited Adverse Events by Immunization - Intent to Treat (ITT) Population | I3 - Rash maculo-papular | 1 adverse events |
| FMP1/AS02A | Vaccine-Related Unsolicited Adverse Events by Immunization - Intent to Treat (ITT) Population | I1 - Gastroenteritis | 0 adverse events |
| FMP1/AS02A | Vaccine-Related Unsolicited Adverse Events by Immunization - Intent to Treat (ITT) Population | I2 - Gastroenteritis | 0 adverse events |
| FMP1/AS02A | Vaccine-Related Unsolicited Adverse Events by Immunization - Intent to Treat (ITT) Population | I3 - Gastroenteritis | 0 adverse events |
| FMP1/AS02A | Vaccine-Related Unsolicited Adverse Events by Immunization - Intent to Treat (ITT) Population | I1 - Headache | 0 adverse events |
| FMP1/AS02A | Vaccine-Related Unsolicited Adverse Events by Immunization - Intent to Treat (ITT) Population | I2 - Headache | 0 adverse events |
| FMP1/AS02A | Vaccine-Related Unsolicited Adverse Events by Immunization - Intent to Treat (ITT) Population | I3 - Headache | 1 adverse events |
| FMP1/AS02A | Vaccine-Related Unsolicited Adverse Events by Immunization - Intent to Treat (ITT) Population | I1 - Injection site inflammation | 0 adverse events |
| FMP1/AS02A | Vaccine-Related Unsolicited Adverse Events by Immunization - Intent to Treat (ITT) Population | I2 - Injection site inflammation | 0 adverse events |
| FMP1/AS02A | Vaccine-Related Unsolicited Adverse Events by Immunization - Intent to Treat (ITT) Population | I3 - Injection site inflammation | 0 adverse events |
| RabAvert (Rabies Vaccine) | Vaccine-Related Unsolicited Adverse Events by Immunization - Intent to Treat (ITT) Population | I2 - Rash maculo-papular | 0 adverse events |
| RabAvert (Rabies Vaccine) | Vaccine-Related Unsolicited Adverse Events by Immunization - Intent to Treat (ITT) Population | I1 - Body as a whole general | 7 adverse events |
| RabAvert (Rabies Vaccine) | Vaccine-Related Unsolicited Adverse Events by Immunization - Intent to Treat (ITT) Population | I1 - Injection site inflammation | 0 adverse events |
| RabAvert (Rabies Vaccine) | Vaccine-Related Unsolicited Adverse Events by Immunization - Intent to Treat (ITT) Population | I2 - Body as a whole general | 3 adverse events |
| RabAvert (Rabies Vaccine) | Vaccine-Related Unsolicited Adverse Events by Immunization - Intent to Treat (ITT) Population | I3 - Rash maculo-papular | 0 adverse events |
| RabAvert (Rabies Vaccine) | Vaccine-Related Unsolicited Adverse Events by Immunization - Intent to Treat (ITT) Population | I3 - Body as a whole general | 0 adverse events |
| RabAvert (Rabies Vaccine) | Vaccine-Related Unsolicited Adverse Events by Immunization - Intent to Treat (ITT) Population | I2 - Headache | 0 adverse events |
| RabAvert (Rabies Vaccine) | Vaccine-Related Unsolicited Adverse Events by Immunization - Intent to Treat (ITT) Population | I1 - History of fever | 7 adverse events |
| RabAvert (Rabies Vaccine) | Vaccine-Related Unsolicited Adverse Events by Immunization - Intent to Treat (ITT) Population | I1 - Gastroenteritis | 1 adverse events |
| RabAvert (Rabies Vaccine) | Vaccine-Related Unsolicited Adverse Events by Immunization - Intent to Treat (ITT) Population | I2 - History of fever | 3 adverse events |
| RabAvert (Rabies Vaccine) | Vaccine-Related Unsolicited Adverse Events by Immunization - Intent to Treat (ITT) Population | I3 - Injection site inflammation | 1 adverse events |
| RabAvert (Rabies Vaccine) | Vaccine-Related Unsolicited Adverse Events by Immunization - Intent to Treat (ITT) Population | I3 - History of fever | 0 adverse events |
| RabAvert (Rabies Vaccine) | Vaccine-Related Unsolicited Adverse Events by Immunization - Intent to Treat (ITT) Population | I2 - Gastroenteritis | 0 adverse events |
| RabAvert (Rabies Vaccine) | Vaccine-Related Unsolicited Adverse Events by Immunization - Intent to Treat (ITT) Population | I1 - Fever | 0 adverse events |
| RabAvert (Rabies Vaccine) | Vaccine-Related Unsolicited Adverse Events by Immunization - Intent to Treat (ITT) Population | I3 - Headache | 0 adverse events |
| RabAvert (Rabies Vaccine) | Vaccine-Related Unsolicited Adverse Events by Immunization - Intent to Treat (ITT) Population | I2 - Fever | 0 adverse events |
| RabAvert (Rabies Vaccine) | Vaccine-Related Unsolicited Adverse Events by Immunization - Intent to Treat (ITT) Population | I3 - Gastroenteritis | 0 adverse events |
| RabAvert (Rabies Vaccine) | Vaccine-Related Unsolicited Adverse Events by Immunization - Intent to Treat (ITT) Population | I3 - Fever | 0 adverse events |
| RabAvert (Rabies Vaccine) | Vaccine-Related Unsolicited Adverse Events by Immunization - Intent to Treat (ITT) Population | I2 - Injection site inflammation | 0 adverse events |
| RabAvert (Rabies Vaccine) | Vaccine-Related Unsolicited Adverse Events by Immunization - Intent to Treat (ITT) Population | I1 - Rash maculo-papular | 0 adverse events |
| RabAvert (Rabies Vaccine) | Vaccine-Related Unsolicited Adverse Events by Immunization - Intent to Treat (ITT) Population | I1 - Headache | 0 adverse events |