Malaria
Conditions
Brief summary
The purpose of this study is to determine whether an investigational malaria vaccine is safe and induces an immune response against malaria when tested in adults living in the United States.
Detailed description
Study is to evaluate the safety, reactogenicity, and immunogenicity fo the candidate Plasmodium falciparum malaria protein 10 (FMP010). Malaria-experienced adults will be enrolled and randomized into 2 groups. Subjects will receive full dose FMP010 antigen (approximately 50 μg) in 0.5 mL AS01B adjuvant or licensed rabies vaccine Rabipur (by Novartis) supplied in single dose vials containing lyophilized antigen with 1.0 mL of diluent (sterile water) for injection.
Interventions
Vaccine antigen is a recombinant protein based on merozoite surface protein-1 (MSP-1) of FVO strain of Plasmodium falciparum, and adjuvant AS01B is a proprietary adjuvant of GSK
BIOLOGICALRabipur
Rabipur is a licensed rabies vaccine.
Sponsors
GlaxoSmithKline
United States Agency for International Development (USAID)
Walter Reed Army Institute of Research (WRAIR)
Kenya Medical Research Institute
U.S. Army Medical Research and Development Command
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* • A male or non-lactating female 18 to 50 years of age (inclusive) at the time of screening * Free of significant health problems as established by medical history and clinical examination before entering into the study * Available to participate for duration of study (approximately seven months) If the subject is female, she must be of non-childbearing potential (either surgically sterilized or one year post-menopausal) or, if of childbearing potential, she must have a negative pregnancy test at the time of vaccination, be capable of preventing pregnancy for at least one month prior to determination of eligibility (to include abstinence or contraceptives (for example intrauterine contraceptive device; oral contraceptives; Norplant® or Depo-Provera® ), and must agree to continue such precautions for two months after completion of the vaccination series. Written informed consent must be obtained from the subject before screening procedures.
Exclusion criteria
* • Prior receipt of any investigational malaria vaccine * Prior receipt of a vaccine containing either QS-21, MPL or AS02A or AS01B * Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period * Administration of chronic (defined as more than 14 days) immunosuppressants or other immune modifying drugs within six months of vaccination. For corticosteroids, this is defined as prednisone, or equivalent, 0.5 mg/kg/day. Inhaled and topical steroids are allowed. * Planned administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of the study vaccine. * Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection * A family history of congenital or hereditary immunodeficiency * Chronic or active neurologic disease including seizure disorder * History of splenectomy * Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or abnormal baseline laboratory screening tests * ALT above normal range * Creatinine above normal range * Hemoglobin below normal range * Platelet count below normal range * Total white cell count below normal * Acute disease at the time of enrollment (acute disease is defined as the presence of a moderate or severe illness with or without fever). All vaccines can be administered to persons with a minor illness, such as diarrhea or mild upper respiratory infection without fever, i.e. Oral temperature \< 37.5°C. * Hepatomegaly, right upper quadrant abdominal pain or tenderness * Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period * Pregnant or lactating female * Suspected or known current alcohol abuse/drug abuse as obtained by history and physical examination * Female who is willing or intends to become pregnant during the study * Any history of allergic reaction or anaphylaxis to previous vaccination * Unwilling to allow blood samples to be stored for future use * Inability to make follow up visits * Allergy to kanamycin, nickel, or imidazole * Any other significant finding that in the opinion of the investigator would increase the risk of having an adverse outcome from participating in this study * Previous allergy to Rabies Vaccine * Allergy to chicken and chicken products
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | After each vaccination (Day 0), follow-up visits were scheduled on Days 1, 2, 3, and 7 | Vaccinations were given at 0-, 1-, 2-month interval, occurrence and intensity of solicited symptoms on day of vaccination (Day 0) and Days 1-7 after each vaccination Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe |
| Number of Subjects With Unsolicited Adverse Events at Specified Grades | After each vaccination (Day 0), 30 day f/u period post vaccination | Vaccinations were given at 0-, 1-, 2-month interval, number of subjects reporting unsolicited symptoms at specified grades over a 30-day follow-up period (day of vaccination and 29 subsequent days) after each vaccination Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe |
| Number of Subjects With the Occurrence of Serious Adverse Events | After each vaccination (Day 0), follow-up visits were scheduled on Days 1, 2, 3, and 7 post vaccination | Vaccinations were given at 0-, 1-, 2-month interval, number of subjects with the occurrence of serious adverse events at days 0-7 post vaccination |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | After each vaccination, blood draws performed on Days 0, 14, 28, 42, 56, 70 and 112 | Antibody concentrations will be presented by reporting the summarized Geometric Mean Titer (GMT) values with 95% Confidence Interval (CI) (not presented in results), at each time point at which blood samples are taken for serology. Peak responses (Day 70) will be compared by Student's T test on data normalized by log transformation to ascertain presence or absence of significant dose response difference. GMTs are presented without CI data. |
| Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group | After each vaccination, blood draws performed on Days 0, 14, 28, 42, 56, 70 and 112 | Antibody concentrations will be presented by reporting the summarized Geometric Mean Titer (GMT) values with 95% Confidence Interval (CI) at each time point at which blood samples are taken for serology. Peak responses (Day 70) will be compared by Student's T test on data normalized by log transformation to ascertain presence or absence of significant dose response difference. GMTs are presented without CI data. |
Participant flow
Recruitment details
30 healthy, malaria-experienced adults were enrolled and randomized into 2 groups at Walter Reed Project/Kenya Medical Research Institute (KEMRI) Kisumu, Kenya.
Participants by arm
| Arm | Count |
|---|---|
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant Plasmodium falciparum Malaria Protein 010 (FMP010): Vaccine antigen is a recombinant protein based on merozoite surface protein-1 (MSP-1) of FVO strain of Plasmodium falciparum, and adjuvant AS01B is a proprietary adjuvant of GSK | 20 |
| Rabies Vaccine Rabipur Rabipur: Rabipur is a licensed rabies vaccine. | 10 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Rabies Vaccine Rabipur | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 10 Participants | 30 Participants |
| Race/Ethnicity, Customized Black | 20 Participants | 10 Participants | 30 Participants |
| Race/Ethnicity, Customized Lulya | 2 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Luo | 18 Participants | 9 Participants | 27 Participants |
| Region of Enrollment Kenya | 20 participants | 10 participants | 30 participants |
| Sex: Female, Male Female | 8 Participants | 5 Participants | 13 Participants |
| Sex: Female, Male Male | 12 Participants | 5 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 10 |
| other Total, other adverse events | 19 / 20 | 10 / 10 |
| serious Total, serious adverse events | 0 / 20 | 0 / 10 |
Outcome results
Primary
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Vaccinations were given at 0-, 1-, 2-month interval, occurrence and intensity of solicited symptoms on day of vaccination (Day 0) and Days 1-7 after each vaccination Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe
Time frame: After each vaccination (Day 0), follow-up visits were scheduled on Days 1, 2, 3, and 7
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 1: Local pain | Grade 3 | 0 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 1: Fever | Grade 2 | 0 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 1: Fever | Grade 3 | 0 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 1: Fever | No experiences | 20 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 1: Fatigue | Grade 1 | 2 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 1: Fatigue | Grade 2 | 3 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 1: Fatigue | Grade 3 | 0 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 1: Fatigue | No experiences | 15 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 1: Gastrointestinal (nausea) | Grade 1 | 3 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 1: Gastrointestinal (nausea) | Grade 2 | 0 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 1: Gastrointestinal (nausea) | Grade 3 | 0 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 1: Gastrointestinal (nausea) | No experiences | 17 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 1: Headache | Grade 1 | 8 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 1: Headache | Grade 2 | 4 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 1: Headache | Grade 3 | 0 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 1: Headache | No experiences | 8 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 1: Malaise | Grade 1 | 2 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 1: Malaise | Grade 2 | 1 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 1: Malaise | Grade 3 | 0 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 1: Malaise | No experiences | 17 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 1: Myalgia | Grade 1 | 1 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 1: Myalgia | Grade 2 | 0 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 1: Myalgia | Grade 3 | 0 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 1: Myalgia | No experiences | 19 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 1: Joint pain | Grade 1 | 2 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 1: Joint pain | Grade 2 | 1 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 1: Joint pain | Grade 3 | 0 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 1: Joint pain | No experiences | 17 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 1: Local pain | Grade 1 | 14 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 1: Local pain | Grade 2 | 6 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 1: Fever | Grade 1 | 0 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 1: Local pain | No experiences | 0 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization: Local redness | Grade 1 | 1 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization: Local redness | Grade 2 | 0 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization: Local redness | Grade 3 | 0 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization: Local redness | No experiences | 19 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 1: Local swelling | Grade 1 | 6 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 1: Local swelling | Grade 2 | 0 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 1: Local swelling | Grade 3 | 0 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 1: Local swelling | No experiences | 14 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Fever | Grade 1 | 1 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Fever | Grade 2 | 0 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Fever | Grade 3 | 0 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Fever | No experiences | 19 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Fatigue | Grade 1 | 1 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Fatigue | Grade 2 | 1 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Fatigue | Grade 3 | 0 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Fatigue | No experiences | 18 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Gastrointestinal (nausea) | Grade 1 | 0 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Gastrointestinal (nausea) | Grade 2 | 1 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Gastrointestinal (nausea) | Grade 3 | 0 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Gastrointestinal (nausea) | No experiences | 19 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Headache | Grade 1 | 3 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Headache | Grade 2 | 0 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Headache | Grade 3 | 1 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Headache | No experiences | 16 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Malaise | Grade 1 | 2 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Malaise | Grade 2 | 3 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Malaise | Grade 3 | 0 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Malaise | No experiences | 15 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Myalgia | Grade 1 | 1 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Myalgia | Grade 2 | 2 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Myalgia | Grade 3 | 0 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Myalgia | No experiences | 17 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Joint pain | Grade 1 | 1 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Joint pain | Grade 2 | 2 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Joint pain | Grade 3 | 0 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Joint pain | No experiences | 17 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Local pain | Grade 1 | 12 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Local pain | Grade 2 | 7 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Local pain | Grade 3 | 0 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Local pain | No experiences | 1 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Local redness | Grade 1 | 3 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Local redness | Grade 2 | 0 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Local redness | Grade 3 | 0 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Local redness | No experiences | 17 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Local swelling | Grade 1 | 3 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Local swelling | Grade 2 | 0 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Local swelling | Grade 3 | 0 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Local swelling | No experiences | 17 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Fever | Grade 1 | 1 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Fever | Grade 2 | 0 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Fever | Grade 3 | 0 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Fever | No experiences | 19 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Fatigue | Grade 1 | 2 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Fatigue | Grade 2 | 0 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Fatigue | Grade 3 | 0 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Fatigue | No experiences | 18 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Gastrointestinal (nausea) | Grade 1 | 0 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Gastrointestinal (nausea) | Grade 2 | 0 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Gastrointestinal (nausea) | Grade 3 | 0 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Gastrointestinal (nausea) | No experiences | 20 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Headache | Grade 1 | 4 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Headache | Grade 2 | 2 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Headache | Grade 3 | 0 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Headache | No experiences | 14 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Malaise | Grade 1 | 1 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Malaise | Grade 2 | 1 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Malaise | Grade 3 | 0 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Malaise | No experiences | 18 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Myalgia | Grade 1 | 1 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Myalgia | Grade 2 | 0 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Myalgia | Grade 3 | 0 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Myalgia | No experiences | 19 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Joint pain | Grade 1 | 1 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Joint pain | Grade 2 | 0 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Joint pain | Grade 3 | 0 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Joint pain | No experiences | 19 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Local pain | Grade 1 | 10 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Local pain | Grade 2 | 4 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Local pain | Grade 3 | 0 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Local pain | No experiences | 6 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Local redness | Grade 1 | 0 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Local redness | Grade 2 | 0 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Local redness | Grade 3 | 1 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Local redness | No experiences | 19 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Local swelling | Grade 1 | 1 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Local swelling | Grade 2 | 0 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Local swelling | Grade 3 | 1 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Local swelling | No experiences | 18 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Local redness | Grade 1 | 0 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 1: Fever | Grade 1 | 0 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Myalgia | Grade 1 | 0 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 1: Fever | Grade 2 | 0 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Gastrointestinal (nausea) | Grade 3 | 0 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 1: Fever | Grade 3 | 0 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Myalgia | Grade 2 | 0 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 1: Fever | No experiences | 10 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Joint pain | Grade 2 | 0 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 1: Fatigue | Grade 1 | 1 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Myalgia | Grade 3 | 0 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 1: Fatigue | Grade 2 | 0 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Gastrointestinal (nausea) | No experiences | 10 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 1: Fatigue | Grade 3 | 0 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Myalgia | No experiences | 10 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 1: Fatigue | No experiences | 9 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Local swelling | Grade 1 | 1 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 1: Gastrointestinal (nausea) | Grade 1 | 1 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Joint pain | Grade 1 | 0 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 1: Gastrointestinal (nausea) | Grade 2 | 0 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Headache | Grade 1 | 0 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 1: Gastrointestinal (nausea) | Grade 3 | 0 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Joint pain | Grade 2 | 0 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 1: Gastrointestinal (nausea) | No experiences | 9 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Joint pain | Grade 3 | 0 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 1: Headache | Grade 1 | 1 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Joint pain | Grade 3 | 0 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 1: Headache | Grade 2 | 0 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Headache | Grade 2 | 1 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 1: Headache | Grade 3 | 0 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Joint pain | No experiences | 10 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 1: Headache | No experiences | 9 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Local redness | Grade 2 | 0 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 1: Malaise | Grade 1 | 0 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Local pain | Grade 1 | 5 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 1: Malaise | Grade 2 | 0 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Headache | Grade 3 | 0 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 1: Malaise | Grade 3 | 0 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Local pain | Grade 2 | 5 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 1: Malaise | No experiences | 10 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Joint pain | No experiences | 9 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 1: Myalgia | Grade 1 | 1 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Local pain | Grade 3 | 0 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 1: Myalgia | Grade 2 | 0 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Headache | No experiences | 9 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 1: Myalgia | Grade 3 | 0 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Local pain | No experiences | 0 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 1: Myalgia | No experiences | 9 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Local swelling | Grade 3 | 0 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 1: Joint pain | Grade 1 | 1 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Local redness | Grade 1 | 2 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 1: Joint pain | Grade 2 | 0 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Malaise | Grade 1 | 0 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 1: Joint pain | Grade 3 | 0 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Local redness | Grade 2 | 0 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 1: Joint pain | No experiences | 9 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Local pain | Grade 1 | 4 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 1: Local pain | Grade 1 | 6 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Local redness | Grade 3 | 0 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 1: Local pain | Grade 2 | 0 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Malaise | Grade 2 | 0 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 1: Local pain | Grade 3 | 0 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Local redness | No experiences | 8 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 1: Local pain | No experiences | 4 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Local redness | Grade 3 | 0 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization: Local redness | Grade 1 | 0 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Local swelling | Grade 1 | 2 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization: Local redness | Grade 2 | 0 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Malaise | Grade 3 | 0 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization: Local redness | Grade 3 | 0 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Local swelling | Grade 2 | 0 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization: Local redness | No experiences | 10 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Local pain | Grade 2 | 0 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 1: Local swelling | Grade 1 | 2 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Local swelling | Grade 3 | 0 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 1: Local swelling | Grade 2 | 0 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Malaise | No experiences | 10 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 1: Local swelling | Grade 3 | 0 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Local swelling | No experiences | 8 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 1: Local swelling | No experiences | 8 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Local swelling | Grade 2 | 0 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Fever | Grade 1 | 0 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Fever | Grade 1 | 0 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Fever | Grade 2 | 0 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Myalgia | Grade 1 | 0 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Fever | Grade 3 | 0 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Fever | Grade 2 | 0 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Fever | No experiences | 10 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Local pain | Grade 3 | 0 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Fatigue | Grade 1 | 1 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Fever | Grade 3 | 0 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Fatigue | Grade 2 | 0 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Myalgia | Grade 2 | 0 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Fatigue | Grade 3 | 0 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Fever | No experiences | 10 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Fatigue | No experiences | 9 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Local redness | No experiences | 10 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Gastrointestinal (nausea) | Grade 1 | 0 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Fatigue | Grade 1 | 0 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Gastrointestinal (nausea) | Grade 2 | 0 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Myalgia | Grade 3 | 0 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Gastrointestinal (nausea) | Grade 3 | 0 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Fatigue | Grade 2 | 0 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Gastrointestinal (nausea) | No experiences | 10 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Local pain | No experiences | 6 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Headache | Grade 1 | 0 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Fatigue | Grade 3 | 0 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Headache | Grade 2 | 0 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Myalgia | No experiences | 10 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Headache | Grade 3 | 0 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Fatigue | No experiences | 10 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Headache | No experiences | 10 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Local swelling | No experiences | 9 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Malaise | Grade 1 | 0 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Gastrointestinal (nausea) | Grade 1 | 0 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Malaise | Grade 2 | 0 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Joint pain | Grade 1 | 1 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Malaise | Grade 3 | 0 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 3: Gastrointestinal (nausea) | Grade 2 | 0 Participants |
| Rabies Vaccine Rabipur | Number of Participants With Solicited Adverse Events With Each Vaccination by Grade | Immunization 2: Malaise | No experiences | 10 Participants |
Primary
Number of Subjects With the Occurrence of Serious Adverse Events
Vaccinations were given at 0-, 1-, 2-month interval, number of subjects with the occurrence of serious adverse events at days 0-7 post vaccination
Time frame: After each vaccination (Day 0), follow-up visits were scheduled on Days 1, 2, 3, and 7 post vaccination
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Subjects With the Occurrence of Serious Adverse Events | 0 Participants |
| Rabies Vaccine Rabipur | Number of Subjects With the Occurrence of Serious Adverse Events | 0 Participants |
Primary
Number of Subjects With Unsolicited Adverse Events at Specified Grades
Vaccinations were given at 0-, 1-, 2-month interval, number of subjects reporting unsolicited symptoms at specified grades over a 30-day follow-up period (day of vaccination and 29 subsequent days) after each vaccination Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe
Time frame: After each vaccination (Day 0), 30 day f/u period post vaccination
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Subjects With Unsolicited Adverse Events at Specified Grades | Grade 2 | 15 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Subjects With Unsolicited Adverse Events at Specified Grades | Grade 1 | 20 Participants |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Number of Subjects With Unsolicited Adverse Events at Specified Grades | Grade 3 | 1 Participants |
| Rabies Vaccine Rabipur | Number of Subjects With Unsolicited Adverse Events at Specified Grades | Grade 1 | 10 Participants |
| Rabies Vaccine Rabipur | Number of Subjects With Unsolicited Adverse Events at Specified Grades | Grade 2 | 9 Participants |
| Rabies Vaccine Rabipur | Number of Subjects With Unsolicited Adverse Events at Specified Grades | Grade 3 | 1 Participants |
Secondary
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Antibody concentrations will be presented by reporting the summarized Geometric Mean Titer (GMT) values with 95% Confidence Interval (CI) (not presented in results), at each time point at which blood samples are taken for serology. Peak responses (Day 70) will be compared by Student's T test on data normalized by log transformation to ascertain presence or absence of significant dose response difference. GMTs are presented without CI data.
Time frame: After each vaccination, blood draws performed on Days 0, 14, 28, 42, 56, 70 and 112
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 12612: Day0 | 1852.4 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 00423: Day0 | 44720.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 00423: Day14 | 54644.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 00423: Day28 | 51390.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 00423: Day42 | 97930.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 00423: Day56 | 90560.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 00423: Day70 | 99530.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 00423: Day112 | 91040.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 00906: Day0 | 7055.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 00906: Day14 | 7961.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 00906: Day28 | 11322.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 00906: Day42 | 36532.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 00906: Day56 | 21780.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 00906: Day70 | 36438.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 00906: Day112 | 14994.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 02507: Day0 | 84830.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 02507: Day14 | 261320.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 02507: Day28 | 172340.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 02507: Day42 | 224560.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 02507: Day56 | 396580.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 02507: Day70 | 275580.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 02507: Day 112 | 240330.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 02708: Day0 | 4905.9 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 02708: Day14 | 7577.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 02708: Day28 | 10519.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 02708: Day42 | 61350.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 02708: Day56 | 40838.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subect 02708: Day70 | 66650.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 02708: Day112 | 57170.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 03401: Day0 | 2215.7 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 03401: Day14 | 10186.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 03401: Day28 | 6060.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 03401: Day42 | 62353.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 03401: Day56 | 30647.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 03401: Day70 | 70680.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 03401: Day112 | 45400.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 03814: Day0 | 15190.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 03814: Day14 | 45280.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 03814: Day28 | 44100.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 03814: Day42 | 83150.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 03814: Day56 | 137740.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 03814: Day70 | 80160.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 03814: Day112 | 99760.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 05029: Day0 | 4151.5 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 05029: Day14 | 15949.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 05029: Day28 | 21873.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 05029: Day42 | 92010.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 05029: Day56 | 58170.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 05029: Day70 | 74950.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 05029: Day112 | 41140.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 06020: Day0 | 45960.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 06020: Day14 | 45690.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 06020: Day28 | 48483.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 06020: Day42 | 65830.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 06020: Day56 | 79880.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 06020: Day70 | 68280.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 06020: Day112 | 54958.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 06627: Day0 | 3926.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 06627: Day14 | 10662.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 06627: Day28 | 8919.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 06627: Day42 | 12677.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 06627: Day56 | 10673.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 06627: Day70 | 12201.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 06627: Day112 | NA Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 07722: Day0 | 399.6 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 07722: Day14 | 1500.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 07722: Day28 | 970.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 07722: Day42 | 55140.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 07722: Day56 | 39952.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 07722: Day70 | 127770.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 07722: Day112 | 40950.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 08904: Day0 | 1751.8 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 08904: Day14 | 2656.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 08904: Day28 | 2176.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 08904: Day42 | 19760.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 08904: Day56 | 11798.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 08904: Day70 | 16158.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 08904: Day112 | 13393.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 09105: Day0 | 37.7 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 09105: Day14 | 567.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 09105: Day28 | 1318.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 09105: Day42 | 132810.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 09105: Day56 | 37366.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 09105: Day70 | 121030.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 09105: Day112 | 30260.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 09621: Day0 | 6147.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 09621: Day14 | 15889.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 09621: Day28 | 15213.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 09621: Day42 | 32252.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 09621: Day56 | 19676.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 09621: Day70 | 53608.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 09621: Day112 | 26482.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 09913: Day0 | 29480.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 09913: Day14 | 32260.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 09913: Day28 | 27302.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 09913: Day42 | 80040.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 09913: Day56 | NA Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 09913: Day72 | 76470.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 09913: Day112 | 114600.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 10015: Day0 | 2007.5 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 10015: Day14 | 6241.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 10015: Day28 | 6617.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 10015: Day42 | 53650.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 10015: Day56 | 311250.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 10015: Day70 | 205460.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 10015: Day112 | 149250.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 10916: Day0 | 28200.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 10916: Day14 | 53252.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 10916: Day28 | 61407.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 10916: Day42 | 68040.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 10916: Day56 | 71610.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 10916: Day70 | 60950.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 10916: Day112 | 81650.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 12217: Day0 | 6603.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 12217: Day14 | 11804.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 12217: Day28 | 10355.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 12217: Day42 | 48342.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 12217: Day56 | 24537.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 12217: Day70 | 78190.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 12217: Day112 | 45929.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 12518: Day0 | 2051.6 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 12518: Day14 | 4403.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 12518: Day28 | 2214.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 12518: Day42 | 78680.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 12518: Day56 | 27675.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 12518: Day70 | 126160.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 12518: Day112 | 38900.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 12612: Day14 | 1545.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 12612: Day28 | 979.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 12612: Day42 | 7536.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 12612: Day56 | 4067.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 12612: Day70 | 23216.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 12612: Day112 | 11960.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 13209: Day0 | 940.8 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 13209: Day14 | 2506.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 13209: Day28 | 2988.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 13209: Day42 | 153550.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 13209: Day 56 | 900000.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 13209: Day70 | 110650.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group | Subject 13209: Day112 | 38390.0 Geometric Mean Titers |
Secondary
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group
Antibody concentrations will be presented by reporting the summarized Geometric Mean Titer (GMT) values with 95% Confidence Interval (CI) at each time point at which blood samples are taken for serology. Peak responses (Day 70) will be compared by Student's T test on data normalized by log transformation to ascertain presence or absence of significant dose response difference. GMTs are presented without CI data.
Time frame: After each vaccination, blood draws performed on Days 0, 14, 28, 42, 56, 70 and 112
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group | Subject 04026: Day28 | 109.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group | Subject 04328: Day28 | 4560.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group | Subject 01603: Day0 | 20580.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group | Subject 01603: Day14 | 23707.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group | Subject 01603: Day28 | 22537.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group | Subject 01603: Day42 | 24090.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group | Subject 01603: Day56 | 42005.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group | Subject 01603: Day70 | 43723.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group | Subject 01603: Day112 | 32104.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group | Subject 01702: Day0 | 71.5 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group | Subject 01702: Day14 | 84.3 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group | Subject 01702: Day28 | 53.2 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group | Subject 01702: Day42 | 57.8 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group | Subject 01702: Day56 | 65.1 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group | Subject 01702: Day70 | 73.6 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group | Subject 01702: Day112 | 42.1 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group | Subject 04026: Day0 | 122.6 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group | Subject 04026: Day14 | 103.2 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group | Subject 04026: Day42 | 77.5 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group | Subject 04026: Day56 | 1000.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group | Subject 04026: Day70 | 544.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group | Subject 04026: Day112 | 125.8 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group | Subject 04328: Day0 | 5226.3 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group | Subject 04328: Day14 | 3782.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group | Subject 04328: Day42 | 3788.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group | Subject 04328: Day56 | 2914.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group | Subject 04328: Day70 | 1920.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group | Subject 04328: Day112 | 1802.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group | Subject 08725: Day0 | 27240.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group | Subject 08725: Day14 | 29477.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group | Subject 08725: Day28 | 26786.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group | Subject 08725: Day42 | 17866.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group | Subject 08725: Day56 | 13819.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group | Subject 08725: Day70 | 9601.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group | Subject 08725: Day112 | 9898.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group | Subject 09211: Day0 | 2347.1 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group | Subject 09211: Day14 | 2250.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group | Subject 09211: Day28 | 2794.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group | Subject 09211: Day42 | 1952.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group | Subject 09211: Day56 | 1378.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group | Subject 09211: Day70 | 1232.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group | Subject 09211: Day112 | 1991.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group | Subject 10324: Day0 | 3970.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group | Subject 10324: Day14 | 4493.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group | Subject 10324: Day28 | 3781.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group | Subject 10324: Day42 | 2891.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group | Subject 10324: Day56 | 3849.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group | Subject 10324: Day70 | 1901.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group | Subject 10324: Day112 | 1381.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group | Subject 10810: Day0 | 49410.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group | Subject 10810: Day14 | 41500.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group | Subject 10810: Day28 | 45920.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group | Subject 10810: Day42 | 49386.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group | Subject 10810: Day56 | 32158.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group | Subject 10810: Day70 | 39979.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group | Subject 10810: Day112 | 36962.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group | Subject 11819: Day0 | 9669.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group | Subject 11819: Day14 | 11155.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group | Subject 11819: Day28 | 10008.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group | Subject 11819: Day42 | 9381.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group | Subject 11819: Day56 | 6355.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group | Subject 11819: Day70 | 5276.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group | Subject 11819: Day112 | 5921.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group | Subject 12330: Day0 | 1117.6 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group | Subject 12330: Day14 | 1291.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group | Subject 12330: Day28 | 1392.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group | Subject 12330: Day42 | 1105.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group | Subject 12330: Day56 | 734.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group | Subject 12330: Day70 | 858.0 Geometric Mean Titers |
| 50 ug of FMP010 Antigen in 0.5 mL AS01B Adjuvant | Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group | Subject 12330: Day112 | 852.0 Geometric Mean Titers |