Plasmodium Falciparum Malaria
Conditions
Keywords
Vaccine, Phase 1, Plasmodium falciparum, Malaria, Merozoite surface protein-1, MSP-1, Falciparum malaria protein 1, FMP-1, AS02A
Brief summary
To assess the safety and reactogenicity of the FMP-1/AS02A malaria vaccine in malaria-exposed children living in western Kenya and aged 12-47 months
Detailed description
Study consists of 3 cohorts (12 to 23 months, 24 to 35 months, and 36 to 47 months). Within each cohort subjects were randomized in a 2:1 ration to receive one of three dose levels of FMP1/AS02A (Cohort A, 10 ug; Cohort B, 25 ug; Cohort C, 50 ug) or Imovax Rabies vaccine. Immunization was staggered among dose cohorts; subjects in Cohort B received their first immunization only after the Local Medical Monitor and Data Safety Monitoring Board reviewed Cohort A safety data for the eight-day follow-up period following their first immunization. The same procedure was followed for the immunization of Cohort C. This will be conducted in western Kenya a the Walter Reed Project Lumbewa Clinic.
Interventions
BIOLOGICALFMP1/AS02A Malaria vaccine
Subjects vaccinated with FMP1/AS02 vaccine
BIOLOGICALImovax Rabies vaccine
Subjects vaccinated on corresponding FMP1/AS02A vaccination days
Sponsors
Kenya Medical Research Institute
Walter Reed Army Institute of Research (WRAIR)
The PATH Malaria Vaccine Initiative (MVI)
United States Agency for International Development (USAID)
GlaxoSmithKline
U.S. Army Medical Research and Development Command
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Months to 47 Months
Healthy volunteers
Yes
Inclusion criteria
* A healthy male or female child, 12 to 47 months of age at the time of screening. * Written informed consent obtained from at least one parent before study start. * Available to participate for the duration of the study (12 months).
Exclusion criteria
* Acute disease at the time of entry into the study * Axillary temperature of 37.5 degrees C * Respiratory rate 50 * Serum ALT 45 IU/l (i.e., \> 1.5 X ULN) * Decreased renal function: serum creatinine levels \> 92.2 mM/l (\> 1.1 mg/dl). * Significant anemia (Hgb \<8 gm/dL). * Thrombocytopenia (Platelets \< 100,000 per mm3) * Impaired immunity: (Absolute lymphocyte count \[ALC\] for 1 year olds \< 4.0 x 103/mm3; for 2 year olds \< 3.0 x 103/mm3; for 3 year olds \< 2.0 103/mm3. * History of homozygous sickle cell disease (SS). * Malnutrition (Z score; Malnutrition = Weight for height \< - 3 z scores) * Blood transfusion or use of blood-based product in previous 6 months. * Prior receipt of a rabies vaccine or an investigational malaria vaccine. * Use of any investigational drug or vaccine other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use up to 30 days after the third dose. * Administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying drugs within six months of vaccination. (For cortico-steroids, this will mean prednisone, or equivalent, greater than or equal to 0.5 mg/kg/day. Inhaled and topical steroids are allowed). * Administration or anticipated administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine(s) with the exception of tetanus toxoid. * Previous vaccination with a vaccine containing MPL or QS21 (e.g., RTS,S). * Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. (No HIV testing will be undertaken as part of this study.) * History of allergic reactions or anaphylaxis to immunizations or to any vaccine components. * History of surgical splenectomy. * Administration of immunoglobulins or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period. * Simultaneous participation in any other clinical trial. * Acute or chronic cardiovascular, pulmonary, hepatic or renal condition, which in the opinion of the PI may increase the risk to the subject from participating in the study. * Any other condition or circumstance that in the opinion of the investigator may pose a threat to the subject.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | 40 days | Occurrence of any, local, or general solicited symptoms during the 8 day follow-up period |
| Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | 90 days | Occurrence of unsolicited symptoms during a 30 day follow-up period after each vaccination (day of vaccination and the 29 subsequent days) |
| Occurrence of Serious Adverse Events During an 8 Month Follow-up Period Following the First Dose of Study Vaccine | 8 months | Occurrence of solicited and unsolicited serious adverse events during an 8 month follow-up period following the first dose of study vaccine |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anti-FMP1 Antibody Titer Responses | 364 days | Antibody responses to FMP1 by ELISA following immunization with the study vaccine through 364 days following the first dose of study vaccine |
Countries
Kenya
Participant flow
Recruitment details
Subject were randomized in a 2:1 ratio between the FMP1/AS02A and Imovax vaccine groups.
Participants by arm
| Arm | Count |
|---|---|
| FMP1/AS02A Malaria Vaccine 10ug (Cohort A) Subject vaccinated with 10 ug of FMP1/AS02A on days 0, 29 and 57
FMP1/AS02A Malaria vaccine: Subjects vaccinated with FMP1/AS02 vaccine | 29 |
| Imovax (Cohort A) Subject vaccinated with Imovax Rabies Vaccine on corresponding FMP1/AS021 vaccination days | 15 |
| FMP1/AS02A Malaria Vaccine 25 ug (Cohort B) Subject vaccinated with 25 ug of FMP1/AS02A on days 14, 42, and 70
FMP1/AS02A Malaria vaccine: Subjects vaccinated with FMP1/AS02 vaccine | 30 |
| Imovax (Cohort B) Subject vaccinated with Imovax Rabies Vaccine on corresponding FMP1/AS021 vaccination days | 15 |
| FMP1/AS02A Malaria Vaccine 50 ug (Cohort C) Subject vaccinated with 50 ug of FMP1/AS02A on days 28, 56 and 84
FMP1/AS02A Malaria vaccine: Subjects vaccinated with FMP1/AS02 vaccine | 30 |
| Imovax (Cohort C) Subject vaccinated with Imovax Rabies Vaccine on corresponding FMP1/AS021 vaccination days
Imovax Rabies vaccine: Subjects vaccinated on corresponding FMP1/AS02A vaccination days | 15 |
| Total | 134 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Death | 1 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Other | 0 | 2 | 0 | 0 | 0 | 0 |
| Overall Study | Relocation | 1 | 0 | 1 | 1 | 5 | 2 |
| Overall Study | Withdrawal by Subject | 2 | 1 | 2 | 1 | 3 | 1 |
Baseline characteristics
| Characteristic | FMP1/AS02A Malaria Vaccine 10ug (Cohort A) | Imovax (Cohort A) | FMP1/AS02A Malaria Vaccine 25 ug (Cohort B) | Imovax (Cohort B) | FMP1/AS02A Malaria Vaccine 50 ug (Cohort C) | Imovax (Cohort C) | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 28.5 Months STANDARD_DEVIATION 9.6 | 28.8 Months STANDARD_DEVIATION 9.7 | 29.5 Months STANDARD_DEVIATION 10.9 | 29.9 Months STANDARD_DEVIATION 11.2 | 29.0 Months STANDARD_DEVIATION 9.9 | 29.2 Months STANDARD_DEVIATION 10.9 | 29.0 Months STANDARD_DEVIATION 10.1 |
| Diastolic blood pressure (mmHg) | 55.8 mmHg STANDARD_DEVIATION 11 | 54.5 mmHg STANDARD_DEVIATION 11.5 | 51.3 mmHg STANDARD_DEVIATION 7.5 | 53.3 mmHg STANDARD_DEVIATION 10.1 | 53.5 mmHg STANDARD_DEVIATION 10.2 | 52.0 mmHg STANDARD_DEVIATION 8 | 53.5 mmHg STANDARD_DEVIATION 9.7 |
| Height (cm) | 84.7 cm STANDARD_DEVIATION 7 | 84.3 cm STANDARD_DEVIATION 6.7 | 84.8 cm STANDARD_DEVIATION 9 | 85.7 cm STANDARD_DEVIATION 9.2 | 83.1 cm STANDARD_DEVIATION 6.9 | 81.2 cm STANDARD_DEVIATION 8.3 | 84.2 cm STANDARD_DEVIATION 7.6 |
| Pulse (bpm) | 111.8 beats per minute (bpm) STANDARD_DEVIATION 21.4 | 102.7 beats per minute (bpm) STANDARD_DEVIATION 24.4 | 108.8 beats per minute (bpm) STANDARD_DEVIATION 14.1 | 116.5 beats per minute (bpm) STANDARD_DEVIATION 18 | 102.9 beats per minute (bpm) STANDARD_DEVIATION 17.3 | 119.7 beats per minute (bpm) STANDARD_DEVIATION 19 | 107.8 beats per minute (bpm) STANDARD_DEVIATION 18 |
| Region of Enrollment Kenya | 29 participants | 15 participants | 30 participants | 15 participants | 30 participants | 15 participants | 134 participants |
| Respiratory rate (bpm) | 31.5 breaths per minute (bpm) STANDARD_DEVIATION 5.3 | 30.9 breaths per minute (bpm) STANDARD_DEVIATION 5.5 | 31.1 breaths per minute (bpm) STANDARD_DEVIATION 5.3 | 29.9 breaths per minute (bpm) STANDARD_DEVIATION 2.8 | 31.6 breaths per minute (bpm) STANDARD_DEVIATION 5.2 | 32.8 breaths per minute (bpm) STANDARD_DEVIATION 5.4 | 31.4 breaths per minute (bpm) STANDARD_DEVIATION 5.2 |
| Sex: Female, Male Female | 17 Participants | 8 Participants | 19 Participants | 9 Participants | 13 Participants | 10 Participants | 76 Participants |
| Sex: Female, Male Male | 12 Participants | 7 Participants | 11 Participants | 6 Participants | 17 Participants | 5 Participants | 58 Participants |
| Systolic blood pressure (mmHg) | 96.6 mmHg STANDARD_DEVIATION 9.2 | 96.4 mmHg STANDARD_DEVIATION 14.5 | 95.2 mmHg STANDARD_DEVIATION 9.6 | 96.1 mmHg STANDARD_DEVIATION 11.8 | 97.3 mmHg STANDARD_DEVIATION 11.7 | 94.4 mmHg STANDARD_DEVIATION 14.1 | 96.4 mmHg STANDARD_DEVIATION 10.1 |
| Temperature (celcius) | 36.36 Celcius STANDARD_DEVIATION 0.42 | 36.30 Celcius STANDARD_DEVIATION 36.49 | 36.49 Celcius STANDARD_DEVIATION 0.57 | 36.46 Celcius STANDARD_DEVIATION 0.51 | 36.50 Celcius STANDARD_DEVIATION 0.62 | 36.85 Celcius STANDARD_DEVIATION 0.65 | 36.45 Celcius STANDARD_DEVIATION 0.54 |
| Weight (kg) | 12.23 kg STANDARD_DEVIATION 1.97 | 11.97 kg STANDARD_DEVIATION 2.1 | 12.04 kg STANDARD_DEVIATION 2.52 | 12.51 kg STANDARD_DEVIATION 3.11 | 11.73 kg STANDARD_DEVIATION 1.93 | 11.04 kg STANDARD_DEVIATION 2.17 | 12.00 kg STANDARD_DEVIATION 2.14 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 90 | 0 / 45 |
| other Total, other adverse events | 87 / 90 | 10 / 45 |
| serious Total, serious adverse events | 3 / 90 | 2 / 45 |
Outcome results
Primary
Occurrence of Serious Adverse Events During an 8 Month Follow-up Period Following the First Dose of Study Vaccine
Occurrence of solicited and unsolicited serious adverse events during an 8 month follow-up period following the first dose of study vaccine
Time frame: 8 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FMP1/AS02A Malaria Vaccine | Occurrence of Serious Adverse Events During an 8 Month Follow-up Period Following the First Dose of Study Vaccine | Cohort B: Imm 3 | 0 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Serious Adverse Events During an 8 Month Follow-up Period Following the First Dose of Study Vaccine | Cohort B: Any SAE | 0 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Serious Adverse Events During an 8 Month Follow-up Period Following the First Dose of Study Vaccine | Cohort A: Any SAE | 2 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Serious Adverse Events During an 8 Month Follow-up Period Following the First Dose of Study Vaccine | Cohort C: Any SAE | 1 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Serious Adverse Events During an 8 Month Follow-up Period Following the First Dose of Study Vaccine | Cohort A: Imm 2 | 1 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Serious Adverse Events During an 8 Month Follow-up Period Following the First Dose of Study Vaccine | Cohort A: Imm 1 | 0 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Serious Adverse Events During an 8 Month Follow-up Period Following the First Dose of Study Vaccine | Cohort A: Imm 3 | 1 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Serious Adverse Events During an 8 Month Follow-up Period Following the First Dose of Study Vaccine | Cohort B: Imm 2 | 0 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Serious Adverse Events During an 8 Month Follow-up Period Following the First Dose of Study Vaccine | Cohort C: Imm 1 | 0 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Serious Adverse Events During an 8 Month Follow-up Period Following the First Dose of Study Vaccine | Cohort C: Imm 2 | 1 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Serious Adverse Events During an 8 Month Follow-up Period Following the First Dose of Study Vaccine | Cohort B: Imm 1 | 0 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Serious Adverse Events During an 8 Month Follow-up Period Following the First Dose of Study Vaccine | Cohort C: Imm 3 | 0 events |
| Imovax Rabies Vaccine | Occurrence of Serious Adverse Events During an 8 Month Follow-up Period Following the First Dose of Study Vaccine | Cohort A: Imm 1 | 0 events |
| Imovax Rabies Vaccine | Occurrence of Serious Adverse Events During an 8 Month Follow-up Period Following the First Dose of Study Vaccine | Cohort B: Imm 3 | 0 events |
| Imovax Rabies Vaccine | Occurrence of Serious Adverse Events During an 8 Month Follow-up Period Following the First Dose of Study Vaccine | Cohort C: Any SAE | 0 events |
| Imovax Rabies Vaccine | Occurrence of Serious Adverse Events During an 8 Month Follow-up Period Following the First Dose of Study Vaccine | Cohort C: Imm 2 | 0 events |
| Imovax Rabies Vaccine | Occurrence of Serious Adverse Events During an 8 Month Follow-up Period Following the First Dose of Study Vaccine | Cohort C: Imm 3 | 0 events |
| Imovax Rabies Vaccine | Occurrence of Serious Adverse Events During an 8 Month Follow-up Period Following the First Dose of Study Vaccine | Cohort A: Any SAE | 1 events |
| Imovax Rabies Vaccine | Occurrence of Serious Adverse Events During an 8 Month Follow-up Period Following the First Dose of Study Vaccine | Cohort A: Imm 2 | 0 events |
| Imovax Rabies Vaccine | Occurrence of Serious Adverse Events During an 8 Month Follow-up Period Following the First Dose of Study Vaccine | Cohort A: Imm 3 | 1 events |
| Imovax Rabies Vaccine | Occurrence of Serious Adverse Events During an 8 Month Follow-up Period Following the First Dose of Study Vaccine | Cohort B: Any SAE | 0 events |
| Imovax Rabies Vaccine | Occurrence of Serious Adverse Events During an 8 Month Follow-up Period Following the First Dose of Study Vaccine | Cohort B: Imm 1 | 0 events |
| Imovax Rabies Vaccine | Occurrence of Serious Adverse Events During an 8 Month Follow-up Period Following the First Dose of Study Vaccine | Cohort B: Imm 2 | 0 events |
| Imovax Rabies Vaccine | Occurrence of Serious Adverse Events During an 8 Month Follow-up Period Following the First Dose of Study Vaccine | Cohort C: Imm 1 | 0 events |
| Overall | Occurrence of Serious Adverse Events During an 8 Month Follow-up Period Following the First Dose of Study Vaccine | Cohort B: Imm 3 | 0 events |
| Overall | Occurrence of Serious Adverse Events During an 8 Month Follow-up Period Following the First Dose of Study Vaccine | Cohort B: Any SAE | 0 events |
| Overall | Occurrence of Serious Adverse Events During an 8 Month Follow-up Period Following the First Dose of Study Vaccine | Cohort C: Imm 2 | 1 events |
| Overall | Occurrence of Serious Adverse Events During an 8 Month Follow-up Period Following the First Dose of Study Vaccine | Cohort A: Imm 2 | 1 events |
| Overall | Occurrence of Serious Adverse Events During an 8 Month Follow-up Period Following the First Dose of Study Vaccine | Cohort B: Imm 1 | 0 events |
| Overall | Occurrence of Serious Adverse Events During an 8 Month Follow-up Period Following the First Dose of Study Vaccine | Cohort C: Any SAE | 1 events |
| Overall | Occurrence of Serious Adverse Events During an 8 Month Follow-up Period Following the First Dose of Study Vaccine | Cohort C: Imm 1 | 0 events |
| Overall | Occurrence of Serious Adverse Events During an 8 Month Follow-up Period Following the First Dose of Study Vaccine | Cohort A: Imm 1 | 0 events |
| Overall | Occurrence of Serious Adverse Events During an 8 Month Follow-up Period Following the First Dose of Study Vaccine | Cohort A: Any SAE | 3 events |
| Overall | Occurrence of Serious Adverse Events During an 8 Month Follow-up Period Following the First Dose of Study Vaccine | Cohort B: Imm 2 | 0 events |
| Overall | Occurrence of Serious Adverse Events During an 8 Month Follow-up Period Following the First Dose of Study Vaccine | Cohort A: Imm 3 | 2 events |
| Overall | Occurrence of Serious Adverse Events During an 8 Month Follow-up Period Following the First Dose of Study Vaccine | Cohort C: Imm 3 | 0 events |
Primary
Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination
Occurrence of any, local, or general solicited symptoms during the 8 day follow-up period
Time frame: 40 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FMP1/AS02A Malaria Vaccine | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort A: Any Imm - Local | 15 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort C: Any Imm - Any Symptom | 28 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort A: Imm 1 - Local | 9 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort A: Imm 1 - Any Symptom | 16 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort B: Imm 3 - General | 7 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort A: Any Imm - Any Symptom | 24 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort B: Imm 2 - General | 8 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort A: Imm 2 - General | 10 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort A: Imm 3 - General | 4 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort B: Imm 2 - Local | 12 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort A: Imm 3 - Any Symptom | 4 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort A: Any Imm - General | 18 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort B: Imm 2 - Any Symptom | 15 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort A: Imm 3 - Local | 1 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort B: Imm 1 - General | 12 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort B: Any Imm - Local | 24 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort C: Imm 1 - General | 15 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort B: Imm 1 - Local | 14 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort B: Any Imm - General | 18 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort B: Any Imm - Any Symptom | 28 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort B: Imm 1 - Any Symptom | 21 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort A: Imm 1 - General | 11 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort C: Imm 3 - General | 10 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort B: Imm 3 - Any Symptom | 15 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort C: Imm 2 - Local | 17 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort C: Imm 1 - Local | 18 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort B: Imm 3 - Local | 11 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort A: Imm 2 - Any Symptom | 13 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort C: Imm 2 - General | 10 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort C: Imm 1 - Any Symptom | 24 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort C: Imm 3 - Any Symptom | 22 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort C: Imm 2 - Any Symptom | 19 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort C: Any Imm - General | 20 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort C: Imm 3 - Local | 19 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort A: Imm 2 - Local | 5 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort C: Any Imm - Local | 26 events |
| Imovax Rabies Vaccine | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort C: Imm 1 - General | 3 events |
| Imovax Rabies Vaccine | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort A: Any Imm - Local | 2 events |
| Imovax Rabies Vaccine | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort A: Any Imm - General | 10 events |
| Imovax Rabies Vaccine | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort A: Imm 1 - Any Symptom | 7 events |
| Imovax Rabies Vaccine | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort A: Imm 1 - General | 7 events |
| Imovax Rabies Vaccine | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort A: Imm 2 - Any Symptom | 6 events |
| Imovax Rabies Vaccine | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort A: Imm 3 - Local | 0 events |
| Imovax Rabies Vaccine | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort A: Imm 3 - General | 2 events |
| Imovax Rabies Vaccine | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort B: Any Imm - Any Symptom | 10 events |
| Imovax Rabies Vaccine | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort B: Imm 1 - Any Symptom | 6 events |
| Imovax Rabies Vaccine | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort B: Imm 3 - Any Symptom | 4 events |
| Imovax Rabies Vaccine | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort B: Imm 3 - Local | 0 events |
| Imovax Rabies Vaccine | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort C: Imm 2 - General | 3 events |
| Imovax Rabies Vaccine | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort C: Imm 3 - Any Symptom | 2 events |
| Imovax Rabies Vaccine | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort A: Any Imm - Any Symptom | 11 events |
| Imovax Rabies Vaccine | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort A: Imm 1 - Local | 0 events |
| Imovax Rabies Vaccine | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort A: Imm 2 - Local | 2 events |
| Imovax Rabies Vaccine | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort A: Imm 2 - General | 4 events |
| Imovax Rabies Vaccine | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort A: Imm 3 - Any Symptom | 2 events |
| Imovax Rabies Vaccine | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort B: Any Imm - Local | 1 events |
| Imovax Rabies Vaccine | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort B: Any Imm - General | 10 events |
| Imovax Rabies Vaccine | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort B: Imm 1 - Local | 0 events |
| Imovax Rabies Vaccine | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort B: Imm 1 - General | 6 events |
| Imovax Rabies Vaccine | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort B: Imm 2 - Any Symptom | 5 events |
| Imovax Rabies Vaccine | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort B: Imm 2 - Local | 1 events |
| Imovax Rabies Vaccine | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort B: Imm 2 - General | 5 events |
| Imovax Rabies Vaccine | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort B: Imm 3 - General | 4 events |
| Imovax Rabies Vaccine | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort C: Any Imm - Any Symptom | 8 events |
| Imovax Rabies Vaccine | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort C: Any Imm - Local | 2 events |
| Imovax Rabies Vaccine | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort C: Any Imm - General | 6 events |
| Imovax Rabies Vaccine | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort C: Imm 1 - Any Symptom | 4 events |
| Imovax Rabies Vaccine | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort C: Imm 1 - Local | 1 events |
| Imovax Rabies Vaccine | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort C: Imm 2 - Any Symptom | 4 events |
| Imovax Rabies Vaccine | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort C: Imm 2 - Local | 1 events |
| Imovax Rabies Vaccine | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort C: Imm 3 - Local | 0 events |
| Imovax Rabies Vaccine | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort C: Imm 3 - General | 2 events |
| Overall | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort C: Imm 3 - Local | 19 events |
| Overall | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort B: Imm 2 - General | 13 events |
| Overall | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort B: Imm 3 - Local | 11 events |
| Overall | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort A: Imm 1 - Local | 9 events |
| Overall | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort C: Imm 2 - Any Symptom | 23 events |
| Overall | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort B: Imm 3 - General | 11 events |
| Overall | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort A: Imm 1 - Any Symptom | 23 events |
| Overall | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort A: Imm 1 - General | 18 events |
| Overall | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort C: Any Imm - Any Symptom | 36 events |
| Overall | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort A: Any Imm - Any Symptom | 35 events |
| Overall | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort A: Any Imm - Local | 17 events |
| Overall | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort C: Any Imm - Local | 28 events |
| Overall | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort C: Imm 1 - Any Symptom | 28 events |
| Overall | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort C: Imm 3 - Any Symptom | 24 events |
| Overall | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort C: Imm 2 - Local | 18 events |
| Overall | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort C: Any Imm - General | 26 events |
| Overall | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort C: Imm 2 - General | 13 events |
| Overall | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort A: Any Imm - General | 29 events |
| Overall | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort B: Imm 3 - Any Symptom | 19 events |
| Overall | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort C: Imm 3 - General | 12 events |
| Overall | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort C: Imm 1 - Local | 19 events |
| Overall | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort B: Any Imm - General | 28 events |
| Overall | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort B: Imm 1 - Any Symptom | 27 events |
| Overall | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort B: Any Imm - Local | 25 events |
| Overall | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort A: Imm 3 - General | 6 events |
| Overall | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort B: Imm 1 - Local | 14 events |
| Overall | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort B: Any Imm - Any Symptom | 38 events |
| Overall | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort A: Imm 3 - Local | 1 events |
| Overall | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort B: Imm 1 - General | 18 events |
| Overall | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort A: Imm 3 - Any Symptom | 6 events |
| Overall | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort C: Imm 1 - General | 18 events |
| Overall | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort B: Imm 2 - Any Symptom | 20 events |
| Overall | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort A: Imm 2 - General | 14 events |
| Overall | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort A: Imm 2 - Any Symptom | 19 events |
| Overall | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort B: Imm 2 - Local | 13 events |
| Overall | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination | Cohort A: Imm 2 - Local | 7 events |
Primary
Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination
Occurrence of unsolicited symptoms during a 30 day follow-up period after each vaccination (day of vaccination and the 29 subsequent days)
Time frame: 90 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FMP1/AS02A Malaria Vaccine | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Application Site | 0 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Vision | 7 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Body as a Whole: General | 4 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Unclassified | 0 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Liver and Biliary System | 0 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Urinary System | 1 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Red Blood Cells | 1 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Red Blood Cells | 0 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Central and Peripheral Nervous | 0 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Unclassified | 1 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Vision | 0 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Gastrointestinal System | 6 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Resistance Mechanism | 18 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Body as a Whole: General | 5 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Parasitic Infection | 14 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Musculoskeletal System | 1 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Unclassified | 1 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Red Blood Cells | 0 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Respiratory System | 11 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Liver and Biliary System | 1 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Body as a Whole: General | 8 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Parasitic Infection | 14 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Gastrointestinal System | 7 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Hearing and Vestibular | 1 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Parasitic Infection | 19 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Vision | 1 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Skin and Appendages | 9 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Gastrointestinal System | 2 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Urinary System | 0 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Respiratory System | 10 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Central and Peripheral Nervous | 0 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Skin and Appedages | 11 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Urinary System | 0 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Respiratory System | 10 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Resistance Mechanism | 13 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Resistance Mechnism | 14 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Skin and appendages | 7 events |
| FMP1/AS02A Malaria Vaccine | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Hearing and Vestibular | 0 events |
| Imovax Rabies Vaccine | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Vision | 4 events |
| Imovax Rabies Vaccine | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Skin and appendages | 14 events |
| Imovax Rabies Vaccine | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Urinary System | 0 events |
| Imovax Rabies Vaccine | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Vision | 1 events |
| Imovax Rabies Vaccine | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Body as a Whole: General | 4 events |
| Imovax Rabies Vaccine | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Gastrointestinal System | 6 events |
| Imovax Rabies Vaccine | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Resistance Mechanism | 18 events |
| Imovax Rabies Vaccine | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Gastrointestinal System | 8 events |
| Imovax Rabies Vaccine | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Parasitic Infection | 15 events |
| Imovax Rabies Vaccine | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Urinary System | 0 events |
| Imovax Rabies Vaccine | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Hearing and Vestibular | 1 events |
| Imovax Rabies Vaccine | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Unclassified | 0 events |
| Imovax Rabies Vaccine | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Hearing and Vestibular | 0 events |
| Imovax Rabies Vaccine | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Red Blood Cells | 0 events |
| Imovax Rabies Vaccine | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Central and Peripheral Nervous | 1 events |
| Imovax Rabies Vaccine | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Parasitic Infection | 14 events |
| Imovax Rabies Vaccine | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Resistance Mechanism | 18 events |
| Imovax Rabies Vaccine | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Skin and Appedages | 13 events |
| Imovax Rabies Vaccine | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Vision | 7 events |
| Imovax Rabies Vaccine | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Application Site | 1 events |
| Imovax Rabies Vaccine | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Red Blood Cells | 1 events |
| Imovax Rabies Vaccine | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Respiratory System | 13 events |
| Imovax Rabies Vaccine | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Liver and Biliary System | 1 events |
| Imovax Rabies Vaccine | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Body as a Whole: General | 6 events |
| Imovax Rabies Vaccine | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Red Blood Cells | 1 events |
| Imovax Rabies Vaccine | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Musculoskeletal System | 1 events |
| Imovax Rabies Vaccine | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Gastrointestinal System | 9 events |
| Imovax Rabies Vaccine | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Central and Peripheral Nervous | 0 events |
| Imovax Rabies Vaccine | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Liver and Biliary System | 0 events |
| Imovax Rabies Vaccine | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Urinary System | 0 events |
| Imovax Rabies Vaccine | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Body as a Whole: General | 4 events |
| Imovax Rabies Vaccine | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Parasitic Infection | 11 events |
| Imovax Rabies Vaccine | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Skin and Appendages | 12 events |
| Imovax Rabies Vaccine | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Resistance Mechnism | 15 events |
| Imovax Rabies Vaccine | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Respiratory System | 8 events |
| Imovax Rabies Vaccine | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Respiratory System | 1 events |
| Imovax Rabies Vaccine | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Unclassified | 2 events |
| Imovax Rabies Vaccine | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Unclassified | 1 events |
| Overall | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Vision | 4 events |
| Overall | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Liver and Biliary System | 3 events |
| Overall | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Central and Peripheral Nervous | 0 events |
| Overall | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Red Blood Cells | 0 events |
| Overall | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Unclassified | 2 events |
| Overall | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Musculoskeletal System | 1 events |
| Overall | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Parasitic Infection | 12 events |
| Overall | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Skin and Appedages | 5 events |
| Overall | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Respiratory System | 5 events |
| Overall | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Body as a Whole: General | 3 events |
| Overall | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Red Blood Cells | 2 events |
| Overall | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Hearing and Vestibular | 0 events |
| Overall | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Central and Peripheral Nervous | 0 events |
| Overall | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Urinary System | 0 events |
| Overall | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Parasitic Infection | 8 events |
| Overall | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Skin and Appendages | 2 events |
| Overall | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Body as a Whole: General | 3 events |
| Overall | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Unclassified | 1 events |
| Overall | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Vision | 1 events |
| Overall | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Unclassified | 3 events |
| Overall | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Red Blood Cells | 0 events |
| Overall | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Urinary System | 1 events |
| Overall | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Parasitic Infection | 13 events |
| Overall | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Gastrointestinal System | 5 events |
| Overall | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Resistance Mechanism | 14 events |
| Overall | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Liver and Biliary System | 0 events |
| Overall | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Skin and appendages | 11 events |
| Overall | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Application Site | 0 events |
| Overall | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Respiratory System | 4 events |
| Overall | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Respiratory System | 4 events |
| Overall | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Gastrointestinal System | 4 events |
| Overall | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Body as a Whole: General | 2 events |
| Overall | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Vision | 2 events |
| Overall | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Resistance Mechanism | 10 events |
| Overall | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Urinary System | 1 events |
| Overall | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Resistance Mechnism | 13 events |
| Overall | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Gastrointestinal System | 5 events |
| Overall | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Hearing and Vestibular | 0 events |
| FMP1/AS02A Any Imm | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Vision | 11 events |
| FMP1/AS02A Any Imm | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Respiratory System | 18 events |
| FMP1/AS02A Any Imm | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Vision | 6 events |
| FMP1/AS02A Any Imm | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Vision | 8 events |
| FMP1/AS02A Any Imm | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Application Site | 1 events |
| FMP1/AS02A Any Imm | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Parasitic Infection | 17 events |
| FMP1/AS02A Any Imm | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Urinary System | 0 events |
| FMP1/AS02A Any Imm | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Central and Peripheral Nervous | 0 events |
| FMP1/AS02A Any Imm | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Resistance Mechanism | 25 events |
| FMP1/AS02A Any Imm | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Resistance Mechanism | 28 events |
| FMP1/AS02A Any Imm | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Respiratory System | 20 events |
| FMP1/AS02A Any Imm | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Hearing and Vestibular | 1 events |
| FMP1/AS02A Any Imm | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Gastrointestinal System | 17 events |
| FMP1/AS02A Any Imm | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Skin and Appedages | 20 events |
| FMP1/AS02A Any Imm | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Parasitic Infection | 25 events |
| FMP1/AS02A Any Imm | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Musculoskeletal System | 3 events |
| FMP1/AS02A Any Imm | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Unclassified | 3 events |
| FMP1/AS02A Any Imm | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Red Blood Cells | 0 events |
| FMP1/AS02A Any Imm | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Gastrointestinal System | 13 events |
| FMP1/AS02A Any Imm | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Urinary System | 2 events |
| FMP1/AS02A Any Imm | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Gastrointestinal System | 12 events |
| FMP1/AS02A Any Imm | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Skin and appendages | 20 events |
| FMP1/AS02A Any Imm | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Red Blood Cells | 1 events |
| FMP1/AS02A Any Imm | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Liver and Biliary System | 4 events |
| FMP1/AS02A Any Imm | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Central and Peripheral Nervous | 1 events |
| FMP1/AS02A Any Imm | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Urinary System | 1 events |
| FMP1/AS02A Any Imm | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Hearing and Vestibular | 1 events |
| FMP1/AS02A Any Imm | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Resistance Mechnism | 24 events |
| FMP1/AS02A Any Imm | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Red Blood Cells | 4 events |
| FMP1/AS02A Any Imm | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Body as a Whole: General | 10 events |
| FMP1/AS02A Any Imm | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Body as a Whole: General | 10 events |
| FMP1/AS02A Any Imm | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Unclassified | 6 events |
| FMP1/AS02A Any Imm | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Skin and Appendages | 17 events |
| FMP1/AS02A Any Imm | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Parasitic Infection | 27 events |
| FMP1/AS02A Any Imm | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Respiratory System | 12 events |
| FMP1/AS02A Any Imm | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Liver and Biliary System | 1 events |
| FMP1/AS02A Any Imm | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Body as a Whole: General | 12 events |
| FMP1/AS02A Any Imm | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Unclassified | 2 events |
| Imovax Imm 1 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Body as a Whole: General | 1 events |
| Imovax Imm 1 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Urinary System | 0 events |
| Imovax Imm 1 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Resistance Mechanism | 5 events |
| Imovax Imm 1 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Body as a Whole: General | 1 events |
| Imovax Imm 1 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Respiratory System | 7 events |
| Imovax Imm 1 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Red Blood Cells | 0 events |
| Imovax Imm 1 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Skin and appendages | 8 events |
| Imovax Imm 1 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Skin and Appendages | 5 events |
| Imovax Imm 1 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Hearing and Vestibular | 0 events |
| Imovax Imm 1 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Respiratory System | 5 events |
| Imovax Imm 1 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Musculoskeletal System | 0 events |
| Imovax Imm 1 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Gastrointestinal System | 0 events |
| Imovax Imm 1 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Application Site | 1 events |
| Imovax Imm 1 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Parasitic Infection | 10 events |
| Imovax Imm 1 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Hearing and Vestibular | 0 events |
| Imovax Imm 1 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Unclassified | 2 events |
| Imovax Imm 1 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Central and Peripheral Nervous | 1 events |
| Imovax Imm 1 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Body as a Whole: General | 2 events |
| Imovax Imm 1 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Vision | 2 events |
| Imovax Imm 1 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Resistance Mechnism | 7 events |
| Imovax Imm 1 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Vision | 2 events |
| Imovax Imm 1 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Gastrointestinal System | 2 events |
| Imovax Imm 1 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Resistance Mechanism | 8 events |
| Imovax Imm 1 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Red Blood Cells | 0 events |
| Imovax Imm 1 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Respiratory System | 5 events |
| Imovax Imm 1 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Vision | 2 events |
| Imovax Imm 1 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Liver and Biliary System | 0 events |
| Imovax Imm 1 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Skin and Appedages | 5 events |
| Imovax Imm 1 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Urinary System | 0 events |
| Imovax Imm 1 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Red Blood Cells | 1 events |
| Imovax Imm 1 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Central and Peripheral Nervous | 0 events |
| Imovax Imm 1 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Urinary System | 0 events |
| Imovax Imm 1 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Gastrointestinal System | 3 events |
| Imovax Imm 1 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Unclassified | 1 events |
| Imovax Imm 1 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Liver and Biliary System | 1 events |
| Imovax Imm 1 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Unclassified | 1 events |
| Imovax Imm 1 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Parasitic Infection | 9 events |
| Imovax Imm 1 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Parasitic Infection | 9 events |
| Imovax Imm 2 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Body as a Whole: General | 2 events |
| Imovax Imm 2 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Unclassified | 0 events |
| Imovax Imm 2 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Resistance Mechnism | 11 events |
| Imovax Imm 2 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Skin and Appedages | 5 events |
| Imovax Imm 2 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Gastrointestinal System | 1 events |
| Imovax Imm 2 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Unclassified | 0 events |
| Imovax Imm 2 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Musculoskeletal System | 0 events |
| Imovax Imm 2 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Skin and Appendages | 4 events |
| Imovax Imm 2 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Respiratory System | 3 events |
| Imovax Imm 2 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Body as a Whole: General | 1 events |
| Imovax Imm 2 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Vision | 2 events |
| Imovax Imm 2 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Unclassified | 0 events |
| Imovax Imm 2 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Central and Peripheral Nervous | 0 events |
| Imovax Imm 2 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Parasitic Infection | 5 events |
| Imovax Imm 2 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Resistance Mechanism | 7 events |
| Imovax Imm 2 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Skin and appendages | 5 events |
| Imovax Imm 2 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Respiratory System | 7 events |
| Imovax Imm 2 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Gastrointestinal System | 3 events |
| Imovax Imm 2 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Vision | 1 events |
| Imovax Imm 2 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Red Blood Cells | 0 events |
| Imovax Imm 2 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Application Site | 0 events |
| Imovax Imm 2 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Urinary System | 0 events |
| Imovax Imm 2 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Parasitic Infection | 7 events |
| Imovax Imm 2 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Respiratory System | 5 events |
| Imovax Imm 2 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Body as a Whole: General | 1 events |
| Imovax Imm 2 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Vision | 2 events |
| Imovax Imm 2 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Liver and Biliary System | 1 events |
| Imovax Imm 2 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Red Blood Cells | 2 events |
| Imovax Imm 2 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Central and Peripheral Nervous | 1 events |
| Imovax Imm 2 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Hearing and Vestibular | 0 events |
| Imovax Imm 2 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Urinary System | 1 events |
| Imovax Imm 2 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Resistance Mechanism | 7 events |
| Imovax Imm 2 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Parasitic Infection | 10 events |
| Imovax Imm 2 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Gastrointestinal System | 2 events |
| Imovax Imm 2 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Hearing and Vestibular | 0 events |
| Imovax Imm 2 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Red Blood Cells | 0 events |
| Imovax Imm 2 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Liver and Biliary System | 0 events |
| Imovax Imm 2 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Urinary System | 0 events |
| Imovax Imm 3 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Parasitic Infection | 6 events |
| Imovax Imm 3 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Gastrointestinal System | 5 events |
| Imovax Imm 3 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Urinary System | 0 events |
| Imovax Imm 3 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Vision | 0 events |
| Imovax Imm 3 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Gastrointestinal System | 6 events |
| Imovax Imm 3 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Body as a Whole: General | 2 events |
| Imovax Imm 3 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Urinary System | 0 events |
| Imovax Imm 3 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Respiratory System | 3 events |
| Imovax Imm 3 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Skin and Appendages | 4 events |
| Imovax Imm 3 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Musculoskeletal System | 0 events |
| Imovax Imm 3 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Parasitic Infection | 7 events |
| Imovax Imm 3 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Unclassified | 1 events |
| Imovax Imm 3 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Body as a Whole: General | 1 events |
| Imovax Imm 3 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Hearing and Vestibular | 1 events |
| Imovax Imm 3 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Hearing and Vestibular | 0 events |
| Imovax Imm 3 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Gastrointestinal System | 3 events |
| Imovax Imm 3 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Skin and Appedages | 4 events |
| Imovax Imm 3 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Respiratory System | 4 events |
| Imovax Imm 3 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Red Blood Cells | 0 events |
| Imovax Imm 3 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Application Site | 0 events |
| Imovax Imm 3 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Respiratory System | 2 events |
| Imovax Imm 3 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Body as a Whole: General | 3 events |
| Imovax Imm 3 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Resistance Mechnism | 7 events |
| Imovax Imm 3 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Central and Peripheral Nervous | 0 events |
| Imovax Imm 3 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Skin and appendages | 4 events |
| Imovax Imm 3 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Red Blood Cells | 0 events |
| Imovax Imm 3 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Urinary System | 0 events |
| Imovax Imm 3 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Vision | 1 events |
| Imovax Imm 3 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Resistance Mechanism | 4 events |
| Imovax Imm 3 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Liver and Biliary System | 0 events |
| Imovax Imm 3 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Liver and Biliary System | 0 events |
| Imovax Imm 3 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Parasitic Infection | 8 events |
| Imovax Imm 3 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Red Blood Cells | 0 events |
| Imovax Imm 3 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Resistance Mechanism | 8 events |
| Imovax Imm 3 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Vision | 1 events |
| Imovax Imm 3 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Unclassified | 1 events |
| Imovax Imm 3 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Unclassified | 0 events |
| Imovax Imm 3 | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Central and Peripheral Nervous | 0 events |
| Imovax Any Imm | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Liver and Biliary System | 2 events |
| Imovax Any Imm | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Gastrointestinal System | 6 events |
| Imovax Any Imm | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Respiratory System | 8 events |
| Imovax Any Imm | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Vision | 4 events |
| Imovax Any Imm | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Hearing and Vestibular | 0 events |
| Imovax Any Imm | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Skin and Appedages | 8 events |
| Imovax Any Imm | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Urinary System | 1 events |
| Imovax Any Imm | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Application Site | 1 events |
| Imovax Any Imm | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Red Blood Cells | 0 events |
| Imovax Any Imm | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Resistance Mechanism | 13 events |
| Imovax Any Imm | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Gastrointestinal System | 7 events |
| Imovax Any Imm | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Liver and Biliary System | 0 events |
| Imovax Any Imm | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Parasitic Infection | 13 events |
| Imovax Any Imm | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Respiratory System | 11 events |
| Imovax Any Imm | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Skin and Appendages | 10 events |
| Imovax Any Imm | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Skin and appendages | 11 events |
| Imovax Any Imm | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Resistance Mechanism | 10 events |
| Imovax Any Imm | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Respiratory System | 10 events |
| Imovax Any Imm | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Parasitic Infection | 13 events |
| Imovax Any Imm | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Unclassified | 2 events |
| Imovax Any Imm | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Body as a Whole: General | 4 events |
| Imovax Any Imm | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Gastrointestinal System | 8 events |
| Imovax Any Imm | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Body as a Whole: General | 3 events |
| Imovax Any Imm | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Vision | 4 events |
| Imovax Any Imm | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Unclassified | 3 events |
| Imovax Any Imm | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Hearing and Vestibular | 1 events |
| Imovax Any Imm | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Urinary System | 0 events |
| Imovax Any Imm | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Red Blood Cells | 1 events |
| Imovax Any Imm | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Parasitic Infection | 13 events |
| Imovax Any Imm | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Resistance Mechnism | 15 events |
| Imovax Any Imm | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort C: Central and Peripheral Nervous | 0 events |
| Imovax Any Imm | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Urinary System | 0 events |
| Imovax Any Imm | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Musculoskeletal System | 0 events |
| Imovax Any Imm | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Central and Peripheral Nervous | 1 events |
| Imovax Any Imm | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Vision | 5 events |
| Imovax Any Imm | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort A: Unclassified | 1 events |
| Imovax Any Imm | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Red Blood Cells | 2 events |
| Imovax Any Imm | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination | Cohort B: Body as a Whole: General | 4 events |
Secondary
Anti-FMP1 Antibody Titer Responses
Antibody responses to FMP1 by ELISA following immunization with the study vaccine through 364 days following the first dose of study vaccine
Time frame: 364 days
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| FMP1/AS02A Malaria Vaccine | Anti-FMP1 Antibody Titer Responses | Pre-Imm 3 | 4534 titers |
| FMP1/AS02A Malaria Vaccine | Anti-FMP1 Antibody Titer Responses | Day 180 | 5354 titers |
| FMP1/AS02A Malaria Vaccine | Anti-FMP1 Antibody Titer Responses | Day 74 | 10151 titers |
| FMP1/AS02A Malaria Vaccine | Anti-FMP1 Antibody Titer Responses | Pre-Imm 1 | 2141 titers |
| FMP1/AS02A Malaria Vaccine | Anti-FMP1 Antibody Titer Responses | Day 44 | 4438 titers |
| FMP1/AS02A Malaria Vaccine | Anti-FMP1 Antibody Titer Responses | Pre-Imm 2 | 2440 titers |
| FMP1/AS02A Malaria Vaccine | Anti-FMP1 Antibody Titer Responses | Day 14 | 2711 titers |
| FMP1/AS02A Malaria Vaccine | Anti-FMP1 Antibody Titer Responses | Day 364 | 4115 titers |
| FMP1/AS02A Malaria Vaccine | Anti-FMP1 Antibody Titer Responses | Day 270 | 6190 titers |
| FMP1/AS02A Malaria Vaccine | Anti-FMP1 Antibody Titer Responses | Day 90 | 10332 titers |
| Imovax Rabies Vaccine | Anti-FMP1 Antibody Titer Responses | Day 44 | 2562 titers |
| Imovax Rabies Vaccine | Anti-FMP1 Antibody Titer Responses | Pre-Imm 1 | 2814 titers |
| Imovax Rabies Vaccine | Anti-FMP1 Antibody Titer Responses | Pre-Imm 3 | 2013 titers |
| Imovax Rabies Vaccine | Anti-FMP1 Antibody Titer Responses | Day 74 | 1529 titers |
| Imovax Rabies Vaccine | Anti-FMP1 Antibody Titer Responses | Day 90 | 1768 titers |
| Imovax Rabies Vaccine | Anti-FMP1 Antibody Titer Responses | Day 270 | 1877 titers |
| Imovax Rabies Vaccine | Anti-FMP1 Antibody Titer Responses | Day 364 | 2238 titers |
| Imovax Rabies Vaccine | Anti-FMP1 Antibody Titer Responses | Day 14 | 2857 titers |
| Imovax Rabies Vaccine | Anti-FMP1 Antibody Titer Responses | Pre-Imm 2 | 2829 titers |
| Imovax Rabies Vaccine | Anti-FMP1 Antibody Titer Responses | Day 180 | 1788 titers |
| Overall | Anti-FMP1 Antibody Titer Responses | Day 44 | 8390 titers |
| Overall | Anti-FMP1 Antibody Titer Responses | Day 14 | 4784 titers |
| Overall | Anti-FMP1 Antibody Titer Responses | Pre-Imm 2 | 2777 titers |
| Overall | Anti-FMP1 Antibody Titer Responses | Day 74 | 43399 titers |
| Overall | Anti-FMP1 Antibody Titer Responses | Pre-Imm 3 | 10240 titers |
| Overall | Anti-FMP1 Antibody Titer Responses | Day 270 | 14839 titers |
| Overall | Anti-FMP1 Antibody Titer Responses | Pre-Imm 1 | 2737 titers |
| Overall | Anti-FMP1 Antibody Titer Responses | Day 364 | 12043 titers |
| Overall | Anti-FMP1 Antibody Titer Responses | Day 90 | 27189 titers |
| Overall | Anti-FMP1 Antibody Titer Responses | Day 180 | 13496 titers |
| FMP1/AS02A Any Imm | Anti-FMP1 Antibody Titer Responses | Day 364 | 4005 titers |
| FMP1/AS02A Any Imm | Anti-FMP1 Antibody Titer Responses | Pre-Imm 1 | 3226 titers |
| FMP1/AS02A Any Imm | Anti-FMP1 Antibody Titer Responses | Day 14 | 2520 titers |
| FMP1/AS02A Any Imm | Anti-FMP1 Antibody Titer Responses | Day 180 | 4318 titers |
| FMP1/AS02A Any Imm | Anti-FMP1 Antibody Titer Responses | Pre-Imm 2 | 4282 titers |
| FMP1/AS02A Any Imm | Anti-FMP1 Antibody Titer Responses | Pre-Imm 3 | 2258 titers |
| FMP1/AS02A Any Imm | Anti-FMP1 Antibody Titer Responses | Day 270 | 6020 titers |
| FMP1/AS02A Any Imm | Anti-FMP1 Antibody Titer Responses | Day 44 | 3593 titers |
| FMP1/AS02A Any Imm | Anti-FMP1 Antibody Titer Responses | Day 90 | 2909 titers |
| FMP1/AS02A Any Imm | Anti-FMP1 Antibody Titer Responses | Day 74 | 3368 titers |
| Imovax Imm 1 | Anti-FMP1 Antibody Titer Responses | Day 270 | 15380 titers |
| Imovax Imm 1 | Anti-FMP1 Antibody Titer Responses | Day 90 | 34657 titers |
| Imovax Imm 1 | Anti-FMP1 Antibody Titer Responses | Day 180 | 14840 titers |
| Imovax Imm 1 | Anti-FMP1 Antibody Titer Responses | Day 44 | 10791 titers |
| Imovax Imm 1 | Anti-FMP1 Antibody Titer Responses | Day 364 | 8807 titers |
| Imovax Imm 1 | Anti-FMP1 Antibody Titer Responses | Day 74 | 50166 titers |
| Imovax Imm 1 | Anti-FMP1 Antibody Titer Responses | Day 14 | 5729 titers |
| Imovax Imm 1 | Anti-FMP1 Antibody Titer Responses | Pre-Imm 2 | 4705 titers |
| Imovax Imm 1 | Anti-FMP1 Antibody Titer Responses | Pre-Imm 1 | 2301 titers |
| Imovax Imm 1 | Anti-FMP1 Antibody Titer Responses | Pre-Imm 3 | 10631 titers |
| Imovax Imm 2 | Anti-FMP1 Antibody Titer Responses | Pre-Imm 2 | 1041 titers |
| Imovax Imm 2 | Anti-FMP1 Antibody Titer Responses | Day 44 | 1105 titers |
| Imovax Imm 2 | Anti-FMP1 Antibody Titer Responses | Day 364 | 1295 titers |
| Imovax Imm 2 | Anti-FMP1 Antibody Titer Responses | Day 270 | 1970 titers |
| Imovax Imm 2 | Anti-FMP1 Antibody Titer Responses | Day 74 | 790 titers |
| Imovax Imm 2 | Anti-FMP1 Antibody Titer Responses | Pre-Imm 3 | 1034 titers |
| Imovax Imm 2 | Anti-FMP1 Antibody Titer Responses | Day 90 | 1039 titers |
| Imovax Imm 2 | Anti-FMP1 Antibody Titer Responses | Pre-Imm 1 | 1041 titers |
| Imovax Imm 2 | Anti-FMP1 Antibody Titer Responses | Day 14 | 944 titers |
| Imovax Imm 2 | Anti-FMP1 Antibody Titer Responses | Day 180 | 999 titers |