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| ID | Type | Description | Link |
|---|---|---|---|
| S-12-07 | Other Identifier | Sponsor | |
| NMRC.2012.0005 | Other Identifier | Naval Medical Research Center Institutional Review Board | |
| 1924 | Other Identifier | Walter Reed Army Institute of Research Institutional Review Board |
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The purpose of the study is to determine if immunization with a chimeric E. coli protein, dsc14CfaE-sCT2/LTB5, is safe and immunogenic when administered by vaccination under the skin.
The purpose of the study is to evaluate the safety and immunogenicity of dsc14cfaEsCTA2/LTB5 (Chimera) and dscCfaE administered with and without LTR192G by intradermal (ID) immunization and to gather additional data on the administration of dsCfaE and LTR192G via transcutaneous immunization (TCI) route. If vaccines are found to be safe and adequately immunogenic in humans, a down-selection would occur and a phase 2b vaccination/challenge study would be undertaken to further evaluate vaccine safety and allow a preliminary assessment of efficacy of one of these candidates by the ID or TCI route. With favorable evidence for safety, immunogenicity, efficacy, complemented by advances in standard methodology to combine multiple adhesins with an appropriate LT enterotoxoid form, a multivalent vaccine would be constructed and evaluated for further clinical development.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A-1 | Experimental | Recombinant fimbrial adhesin dscCfaE: 1 ug of dscCfaE ID on study days 0, 21 and 42 |
|
| Group A-2 | Experimental | Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5: 2.6 ug of Chimera ID on study days 0, 21 and 42 |
|
| Group A-3 | Experimental | Modified E. coli heat labile enterotoxin LTR192G: 100 ng of LTR192G ID on study days 0, 21 and 42 |
|
| Group B-1 | Experimental | Recombinant fimbrial adhesin dscCfaE and Modified E. coli heat labile enterotoxin LTR192G: 1 ug of dscCfaE + 100 ng of LTR192G ID on study days 0, 21 and 42 |
|
| Group B-2 | Experimental | Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5 and Modified E. coli heat labile enterotoxin LTR192G: 2.6 ug of Chimera + 100 ng of LTR192G ID on study days 0, 21 and 42 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5 | Biological |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety - Occurrence of Adverse Events | Occurrence of related and unrelated to vaccine AE's | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Immune Responses to Vaccine Antigens | Number of participants with immune responses to vaccine antigens from baseline. Peripheral blood mononuclear cells (PBMCs) were collected to determine IgA antibody secreting cells (ASC) responses to dscCfaE and LTB. For each antigen, pre-and post-dosing samples were tested for total and vaccine-specific numbers of IgA-ASCs using the ELISPOT assay. A positive IgA-ASC response was defined as a > 2-fold increase over the baseline value of the ASC per 10^6 PBMC, when the number of ASC was >0.5 per 10^6 in the baseline sample. When the number of baseline ASCs was less than 0.5 per 10 PBMC, a subject was considered a responder if the post-vaccination value was greater than 1.0 per 10^6 PBMC. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ramiro L. Gutierrez, MD, MPH | Enteric Diseases Department, Naval Medical Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Walter Reed Army Institute of Research Clinical trial Center | Silver Spring | Maryland | 20910 | United States |
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57 subjects were enrolled. An additional 2 subjects per cohort for Cohorts A-C and 2 subjects per group in Cohort D were included as alternates.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A-1 | Recombinant fimbrial adhesin dscCfaE: 1 ug of dscCfaE ID on study days 0, 21 and 42 Recombinant fimbrial adhesin dscCfaE |
| FG001 | Group A-2 | Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5: 2.6 ug of Chimera ID on study days 0, 21 and 42 Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5 |
| FG002 | Group A-3 | Modified E. coli heat labile enterotoxin LTR192G: 100 ng of LTR192G ID on study days 0, 21 and 42 Modified E. coli heat labile enterotoxin LTR192G |
| FG003 | Group B-1 | Recombinant fimbrial adhesin dscCfaE and Modified E. coli heat labile enterotoxin LTR192G: 1 ug of dscCfaE + 100 ng of LTR192G ID on study days 0, 21 and 42 Recombinant fimbrial adhesin dscCfaE Modified E. coli heat labile enterotoxin LTR192G |
| FG004 | Group B-2 | Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5 and Modified E. coli heat labile enterotoxin LTR192G: 2.6 ug of Chimera + 100 ng of LTR192G ID on study days 0, 21 and 42 Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5 Modified E. coli heat labile enterotoxin LTR192G |
| FG005 | Group C-1 | Recombinant fimbrial adhesin dscCfaE and Modified E. coli heat labile enterotoxin LTR192G: 5 ug of dscCfaE + 100 ng of LTR192G ID on study days 0, 21 and 42 Recombinant fimbrial adhesin dscCfaE Modified E. coli heat labile enterotoxin LTR192G |
| FG006 | Group C-2 | Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5 and Modified E. coli heat labile enterotoxin LTR192G: 12.9 ug of Chimera + 100 ng of LTR192G ID on study days 0, 21 and 42 Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5 Modified E. coli heat labile enterotoxin LTR192G |
| FG007 | Group D-1 | Recombinant fimbrial adhesin dscCfaE and Modified E. coli heat labile enterotoxin LTR192G: 25 ug dscCfaE + 100 ng LTR192G ID on study days 0, 21 and 42 Recombinant fimbrial adhesin dscCfaE Modified E. coli heat labile enterotoxin LTR192G |
| FG008 | Group D-2 | Recombinant fimbrial adhesin dscCfaE and Modified E. coli heat labile enterotoxin LTR192G: TBD ug dscCfaE + 50 ng LTR192G TCI on study days 0, 21 and 42 Recombinant fimbrial adhesin dscCfaE Modified E. coli heat labile enterotoxin LTR192G |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Demographics within Final Clinical Study Report were not broken out by groups or cohorts. No randomization was presented to detail which subject was in which group or cohort. Data is presented as it was detailed in the FCSR. No explanation was given as to why groups were combined to report demographic data.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Cohorts | Baseline data within Final Clinical Study Report was not broken out by groups or cohorts. No randomization was presented to detail which subject was in which group or cohort. Data is presented as it was detailed in the FCSR. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Safety - Occurrence of Adverse Events | Occurrence of related and unrelated to vaccine AE's | Posted | Number | Number of Adverse Events | 1 year |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group A-1 | Recombinant fimbrial adhesin dscCfaE: 1 ug of dscCfaE ID on study days 0, 21 and 42 Recombinant fimbrial adhesin dscCfaE |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment | Related to vaccine |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ramiro L. Gutierrez, MD, MPH | Enteric Diseases Department, Naval Medical Research Center | 301-319-3193 | ramiro.gutierrez@med.navy.mil |
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| ID | Term |
|---|---|
| D004927 | Escherichia coli Infections |
| ID | Term |
|---|---|
| D004756 | Enterobacteriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| Group C-1 | Experimental | Recombinant fimbrial adhesin dscCfaE and Modified E. coli heat labile enterotoxin LTR192G: 5 ug of dscCfaE + 100 ng of LTR192G ID on study days 0, 21 and 42 |
|
| Group C-2 | Experimental | Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5 and Modified E. coli heat labile enterotoxin LTR192G: 12.9 ug of Chimera + 100 ng of LTR192G ID on study days 0, 21 and 42 |
|
| Group D-1 | Experimental | Recombinant fimbrial adhesin dscCfaE and Modified E. coli heat labile enterotoxin LTR192G: 25 ug dscCfaE + 100 ng LTR192G ID on study days 0, 21 and 42 |
|
| Group D-2 | Experimental | Recombinant fimbrial adhesin dscCfaE and Modified E. coli heat labile enterotoxin LTR192G: 1250 ug dscCfaE + 50 ng LTR192G TCI on study days 0, 21 and 42 |
|
| Recombinant fimbrial adhesin dscCfaE | Biological |
|
|
| Modified E. coli heat labile enterotoxin LTR192G | Biological |
|
|
| baseline and post dose |
| Antigen-Specific IgA Geometric Mean Titers | Antigen-Specific IgA Geometric Mean Titers as defined by Fecal IgA. Final Clinical Study Report (FCSR) highlighted titer numbers only; no numbers for measure of dispersion/precision were given; no explanation as to why standard deviation information is not present in the FCSR. | Day 0, 21,42, 56, 70 |
| Lost to Follow-up |
|
| Family emergency |
|
| Relocation |
|
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Modified E. coli heat labile enterotoxin LTR192G: 100 ng of LTR192G ID on study days 0, 21 and 42
Modified E. coli heat labile enterotoxin LTR192G
| OG003 | Group B-1 | Recombinant fimbrial adhesin dscCfaE and Modified E. coli heat labile enterotoxin LTR192G: 1 ug of dscCfaE + 100 ng of LTR192G ID on study days 0, 21 and 42 Recombinant fimbrial adhesin dscCfaE Modified E. coli heat labile enterotoxin LTR192G |
| OG004 | Group B-2 | Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5 and Modified E. coli heat labile enterotoxin LTR192G: 2.6 ug of Chimera + 100 ng of LTR192G ID on study days 0, 21 and 42 Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5 Modified E. coli heat labile enterotoxin LTR192G |
| OG005 | Group C-1 | Recombinant fimbrial adhesin dscCfaE and Modified E. coli heat labile enterotoxin LTR192G: 5 ug of dscCfaE + 100 ng of LTR192G ID on study days 0, 21 and 42 Recombinant fimbrial adhesin dscCfaE Modified E. coli heat labile enterotoxin LTR192G |
| OG006 | Group C-2 | Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5 and Modified E. coli heat labile enterotoxin LTR192G: 12.9 ug of Chimera + 100 ng of LTR192G ID on study days 0, 21 and 42 Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5 Modified E. coli heat labile enterotoxin LTR192G |
| OG007 | Group D-1 | Recombinant fimbrial adhesin dscCfaE and Modified E. coli heat labile enterotoxin LTR192G: 25 ug dscCfaE + 100 ng LTR192G ID on study days 0, 21 and 42 Recombinant fimbrial adhesin dscCfaE Modified E. coli heat labile enterotoxin LTR192G |
| OG008 | Group D-2 | Recombinant fimbrial adhesin dscCfaE and Modified E. coli heat labile enterotoxin LTR192G: TBD ug dscCfaE + 50 ng LTR192G TCI on study days 0, 21 and 42 Recombinant fimbrial adhesin dscCfaE Modified E. coli heat labile enterotoxin LTR192G |
|
|
| Secondary | Number of Participants With Immune Responses to Vaccine Antigens | Number of participants with immune responses to vaccine antigens from baseline. Peripheral blood mononuclear cells (PBMCs) were collected to determine IgA antibody secreting cells (ASC) responses to dscCfaE and LTB. For each antigen, pre-and post-dosing samples were tested for total and vaccine-specific numbers of IgA-ASCs using the ELISPOT assay. A positive IgA-ASC response was defined as a > 2-fold increase over the baseline value of the ASC per 10^6 PBMC, when the number of ASC was >0.5 per 10^6 in the baseline sample. When the number of baseline ASCs was less than 0.5 per 10 PBMC, a subject was considered a responder if the post-vaccination value was greater than 1.0 per 10^6 PBMC. | A total of 55 subjects across cohorts received the minimum required 2 doses of investigation product(s) and were evaluable for the immunology analysis per protocol. | Posted | Count of Participants | Participants | baseline and post dose |
|
|
|
| Secondary | Antigen-Specific IgA Geometric Mean Titers | Antigen-Specific IgA Geometric Mean Titers as defined by Fecal IgA. Final Clinical Study Report (FCSR) highlighted titer numbers only; no numbers for measure of dispersion/precision were given; no explanation as to why standard deviation information is not present in the FCSR. | Only subjects receiving at least 2 vaccine doses were included in this assessment. Final Clinical Study Report (FCSR) highlighted titer numbers only; no numbers for measure of dispersion/precision were given; no explanation on not presenting standard deviation information is present in the FCSR. | Posted | Geometric Mean | Standard Deviation | Geometric Mean Titers | Day 0, 21,42, 56, 70 |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 5 |
| 5 |
| EG001 | Group A-2 | Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5: 2.6 ug of Chimera ID on study days 0, 21 and 42 Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5 | 0 | 5 | 0 | 5 | 5 | 5 |
| EG002 | Group A-3 | Modified E. coli heat labile enterotoxin LTR192G: 100 ng of LTR192G ID on study days 0, 21 and 42 Modified E. coli heat labile enterotoxin LTR192G | 0 | 5 | 0 | 5 | 5 | 5 |
| EG003 | Group B-1 | Recombinant fimbrial adhesin dscCfaE and Modified E. coli heat labile enterotoxin LTR192G: 1 ug of dscCfaE + 100 ng of LTR192G ID on study days 0, 21 and 42 Recombinant fimbrial adhesin dscCfaE Modified E. coli heat labile enterotoxin LTR192G | 0 | 5 | 0 | 5 | 5 | 5 |
| EG004 | Group B-2 | Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5 and Modified E. coli heat labile enterotoxin LTR192G: 2.6 ug of Chimera + 100 ng of LTR192G ID on study days 0, 21 and 42 Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5 Modified E. coli heat labile enterotoxin LTR192G | 0 | 5 | 0 | 5 | 5 | 5 |
| EG005 | Group C-1 | Recombinant fimbrial adhesin dscCfaE and Modified E. coli heat labile enterotoxin LTR192G: 5 ug of dscCfaE + 100 ng of LTR192G ID on study days 0, 21 and 42 Recombinant fimbrial adhesin dscCfaE Modified E. coli heat labile enterotoxin LTR192G | 0 | 7 | 0 | 7 | 7 | 7 |
| EG006 | Group C-2 | Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5 and Modified E. coli heat labile enterotoxin LTR192G: 12.9 ug of Chimera + 100 ng of LTR192G ID on study days 0, 21 and 42 Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5 Modified E. coli heat labile enterotoxin LTR192G | 0 | 7 | 0 | 7 | 7 | 7 |
| EG007 | Group D-1 | Recombinant fimbrial adhesin dscCfaE and Modified E. coli heat labile enterotoxin LTR192G: 25 ug dscCfaE + 100 ng LTR192G ID on study days 0, 21 and 42 Recombinant fimbrial adhesin dscCfaE Modified E. coli heat labile enterotoxin LTR192G | 0 | 10 | 0 | 10 | 10 | 10 |
| EG008 | Group D-2 | Recombinant fimbrial adhesin dscCfaE and Modified E. coli heat labile enterotoxin LTR192G: TBD ug dscCfaE + 50 ng LTR192G TCI on study days 0, 21 and 42 Recombinant fimbrial adhesin dscCfaE Modified E. coli heat labile enterotoxin LTR192G | 0 | 8 | 0 | 8 | 8 | 8 |
|
| Fever | General disorders | MedDRA (Unspecified) | Non-systematic Assessment | Related to vaccine |
|
| GI symptoms | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment | Related to vaccine |
|
| Headache | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment | Related to vaccine |
|
| Hemoglobin decrease | Investigations | MedDRA (Unspecified) | Non-systematic Assessment | Related to vaccine |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment | Related to vaccine |
|
| Loose stools | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment | Related to vaccine |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment | Related to vaccine |
|
| Malaise | General disorders | MedDRA (Unspecified) | Non-systematic Assessment | Related to vaccine |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment | Related to vaccine |
|
| Right axillary pain | General disorders | MedDRA (Unspecified) | Non-systematic Assessment | Related to vaccine |
|
| Right knee pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment | Related to vaccine |
|
| Sleepiness | Psychiatric disorders | MedDRA (Unspecified) | Non-systematic Assessment | Related to vaccine |
|
| Tegaderm reaction | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment | Related to vaccine |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment | Related to vaccine |
|
| Vaccine site pain | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment | Related to vaccine |
|
| Vaccine site pruritus | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment | Related to vaccine |
|
| Vaccine site reaction | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment | Related to vaccine |
|
| Vaccine site swelling | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment | Related to vaccine |
|
| Vaccine site tenderness | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment | Related to vaccine |
|
| Vaccine site warmth | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment | Related to vaccine |
|
| Allergic rhinitis | Immune system disorders | MedDRA (Unspecified) | Non-systematic Assessment | Unrelated to vaccine |
|
| ALT elevation | Investigations | MedDRA (Unspecified) | Non-systematic Assessment | Unrelated to vaccine |
|
| Anemia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment | Unrelated to vaccine |
|
| Ankle trauma, left | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment | Unrelated to vaccine |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment | Unrelated to vaccine |
|
| AST elevation | Investigations | MedDRA (Unspecified) | Non-systematic Assessment | Unrelated to vaccine |
|
| Bilateral bicep strain | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment | Unrelated to vaccine |
|
| BP elevation | Investigations | MedDRA (Unspecified) | Non-systematic Assessment | Unrelated to vaccine |
|
| Constipation | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment | Unrelated to vaccine |
|
| Creatinine elevation | Investigations | MedDRA (Unspecified) | Non-systematic Assessment | Unrelated to vaccine |
|
| Dorsal foot pain | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment | Unrelated to vaccine |
|
| Eosinophilia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment | Unrelated to vaccine |
|
| Fever | General disorders | MedDRA (Unspecified) | Non-systematic Assessment | Unrelated to vaccine |
|
| Gastroenteritis | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment | Unrelated to vaccine |
|
| Generalized eruption, truncal proximal UE | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment | Unrelated to vaccine |
|
| Headache | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment | Unrelated to vaccine |
|
| Hemoglobin decrease | Investigations | MedDRA (Unspecified) | Non-systematic Assessment | Unrelated to vaccine |
|
| Hemorrhoids | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment | Unrelated to vaccine |
|
| Hyperglycemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment | Unrelated to vaccine |
|
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment | Unrelated to vaccine |
|
| Hypertension | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment | Unrelated to vaccine |
|
| Hypoglycemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment | Unrelated to vaccine |
|
| Calf soreness, left | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment | Unrelated to vaccine |
|
| Facial trauma, left eye | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment | Unrelated to vaccine |
|
| Left metatarsal stress fracture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment | Unrelated to vaccine |
|
| Left upper groin wound | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment | Unrelated to vaccine |
|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment | Unrelated to vaccine |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment | Unrelated to vaccine |
|
| Loose stools | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment | Unrelated to vaccine |
|
| Lower back pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment | Unrelated to vaccine |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment | Unrelated to vaccine |
|
| Malaise | General disorders | MedDRA (Unspecified) | Non-systematic Assessment | Unrelated to vaccine |
|
| Menstrual cramps | Reproductive system and breast disorders | MedDRA (Unspecified) | Non-systematic Assessment | Unrelated to vaccine |
|
| Mental disorder NOS | Psychiatric disorders | MedDRA (Unspecified) | Non-systematic Assessment | Unrelated to vaccine |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment | Unrelated to vaccine |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment | Unrelated to vaccine |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment | Unrelated to vaccine |
|
| Neutrophilia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment | Unrelated to vaccine |
|
| Platelet decrease | Investigations | MedDRA (Unspecified) | Non-systematic Assessment | Unrelated to vaccine |
|
| Ankel sprain, right | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment | Unrelated to vaccine |
|
| Knee hyperflexion, right | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment | Unrelated to vaccine |
|
| RUE Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment | Unrelated to vaccine |
|
| Scalp folliculitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment | Unrelated to vaccine |
|
| Allergies, seasonal | Immune system disorders | MedDRA (Unspecified) | Non-systematic Assessment | Unrelated to vaccine |
|
| Sore throat | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment | Unrelated to vaccine |
|
| Subsurface blood clot, left calf | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment | Unrelated to vaccine |
|
| Tachycardia | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment | Unrelated to vaccine |
|
| Tegaderm reaction | Immune system disorders | MedDRA (Unspecified) | Non-systematic Assessment | Unrelated to vaccine |
|
| Upper respiratory infection | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment | Unrelated to vaccine |
|
| Vasovagal episode | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment | Unrelated to vaccine |
|
| Viral syndrome | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment | Unrelated to vaccine |
|
Not provided
Not provided
| D007239 | Infections |
| Serum IgG (aLT) - >4-fold rise in baseline titer |
|
| Serum IgA (aCfaE) - >4-fold rise in baseline titer |
|
| Serum IgA (aLT) - >4-fold risein baseline titer |
|
| IgA ASC (aCfaE) - >2-fold increase over baseline |
|
| IgA ASC (aLT) - >2-fold increase over baseline |
|
| Day 21 - Anti-CfaE |
|
| Day 42 - Anti-CfaE |
|
| Day 56 - Anti-CfaE |
|
| Day 70 - Anti-CfaE |
|
| Day 0 - Anti-LT |
|
| Day 21 - Anti-LT |
|
| Day 42 - Anti-LT |
|
| Day 56 - Anti-LT |
|
| Day 70 - Anti-LT |
|