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| ID | Type | Description | Link |
|---|---|---|---|
| B1971004 | Other Identifier | Alias Study Number |
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The purpose of this study is to evaluate the safety and tolerability of an investigational meningococcal B rLP2086 vaccine in healthy adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | rLP2086 vaccine 60 mcg |
|
| 2 | Experimental | rLP2086 vaccine 120 mcg |
|
| 3 | Experimental | rLP2086 vaccine 200 mcg |
|
| 4 | Active Comparator | Tdap vaccine - normal saline - normal saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rLP2086 vaccine or control | Biological | intra-muscular vaccine (solution), 0.5 mL, 3 doses, schedule: 0, 2, 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With at Least One Adverse Event (AE) | Baseline up to Month 7 | |
| Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Alanine Aminotransferase [ALT]) | Baseline up to Month 7 | |
| Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Aspartate Aminotransferase [AST]) | Baseline up to Month 7 | |
| Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Total Protein) | Baseline up to Month 7 | |
| Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Albumin) | Baseline up to Month 7 | |
| Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Alkaline Phosphatase [ALP]) | Baseline up to Month 7 | |
| Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Total Bilirubin) | Baseline up to Month 7 | |
| Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Creatine Phosphokinase [CPK]) | Baseline up to Month 7 | |
| Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Prothrombin Time [PT]) |
| Measure | Description | Time Frame |
|---|---|---|
| Meningococcal Immunoglobulin G (IgG) Geometric Mean Titers (GMT) | Before Dose 1, 1 month after Dose 2, before Dose 3, 1 month after Dose 3 |
Not provided
Inclusion Criteria:
A subject must meet the following inclusion criteria at screening (visit 1) and at randomization (visit 2) to be considered for enrollment in the study:
In addition a subject must meet the following inclusion criteria at randomization (visit 2) to be considered for enrollment in the study. The referred blood and urinalysis tests (inclusion criterion 5) will be performed on a blood and urine sample taken at visit 1:
Exclusion Criteria:
None
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miami Research Associates, Inc. | South Miami | Florida | 33143 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35164991 | Derived | Beeslaar J, Mather S, Absalon J, Eiden JJ, York LJ, Crowther G, Maansson R, Maguire JD, Peyrani P, Perez JL. Safety data from the MenB-FHbp clinical development program in healthy individuals aged 10 years and older. Vaccine. 2022 Mar 15;40(12):1872-1878. doi: 10.1016/j.vaccine.2022.01.046. Epub 2022 Feb 11. | |
| 22832260 | Derived |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Of the 189 participants who signed informed consent form, 134 were screen failures (mainly because of laboratory abnormalities) and 7 participants withdrew before the first vaccination. Total 48 participants were randomized into 4 groups.
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| ID | Title | Description |
|---|---|---|
| FG000 | rLP2086 60mcg | Given on a 0, 2-, 6- month schedule |
| FG001 | rLP2086 120 mcg | Given on a 0, 2-, 6- month schedule |
| FG002 | rLP2086 200 mcg | Given on a 0, 2-, 6- month schedule |
| FG003 | Tdap/Normal Saline (Control) | Tdap was given at month 0 and Saline was given at Month 2 and 6 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety population included all randomized participants who received at least 1 vaccination.
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| ID | Title | Description |
|---|---|---|
| BG000 | rLP2086 60mcg | Given on a 0, 2-, 6- month schedule |
| BG001 | rLP2086 120 mcg | Given on a 0, 2-, 6- month schedule |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Percentage of Participants With at Least One Adverse Event (AE) | Posted | Number | percentage of participants | Baseline up to Month 7 |
|
Baseline up to Month 7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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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 | rLP2086 60mcg | Given on a 0, 2-, 6- month schedule |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tachycardia | Cardiac disorders | MedDRA | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D008585 | Meningitis, Meningococcal |
| ID | Term |
|---|---|
| D016920 | Meningitis, Bacterial |
| D020806 | Central Nervous System Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| rLP2086 vaccine or control | Biological | intra-muscular vaccine (solution), 0.5 mL, 3 doses, schedule: 0, 2, 6 months |
|
| rLP2086 vaccine or control | Biological | intra-muscular vaccine (solution), 0.5 mL, 3 doses, schedule: 0, 2, 6 months |
|
| rLP2086 vaccine or control | Biological | intra-muscular vaccine (solution), 0.5 mL, 3 doses, schedule: 0, 2, 6 months |
|
| Baseline up to Month 7 |
| Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Partial Thromboplastin Time [PTT]) | Baseline up to Month 7 |
| Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Fibrinogen) | Baseline up to Month 7 |
| Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Hemoglobin) | Baseline up to Month 7 |
| Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (White Blood Cell [WBC]) | Baseline up to Month 7 |
| Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Lymphocytes) | Baseline up to Month 7 |
| Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Neutrophils) | Baseline up to Month 7 |
| Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Eosinophils) | Baseline up to Month 7 |
| Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Platelet Count) | Baseline up to Month 7 |
| Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Sodium). | Baseline up to Month 7 |
| Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Potassium). | Baseline up to Month 7 |
| Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Blood Urea Nitrogen [BUN]). | Baseline up to Month 7 |
| Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Serum Creatinine). | Baseline up to Month 7 |
| Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Urine Red Blood Cells [RBC]). | Baseline up to Month 7 |
| Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Urine Protein). | Baseline up to Month 7 |
| Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Urine Glucose). | Baseline up to Month 7 |
| Sheldon EA, Schwartz H, Jiang Q, Giardina PC, Perez JL. A phase 1, randomized, open-label, active-controlled trial to assess the safety of a meningococcal serogroup B bivalent rLP2086 vaccine in healthy adults. Hum Vaccin Immunother. 2012 Jul;8(7):888-95. doi: 10.4161/hv.19983. Epub 2012 Jul 1. |
| Lost to Follow-up |
|
| Participant Failed to Return |
|
| Withdrawal by Subject |
|
| Physician Decision |
|
| Other |
|
| BG002 |
| rLP2086 200 mcg |
Given on a 0, 2-, 6- month schedule |
| BG003 | Tdap/Normal Saline (Control) | Tdap was given at month 0 and Saline was given at Month 2 and 6 |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Tdap was given at month 0 and Saline was given at Month 2 and 6 |
|
|
| Primary | Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Alanine Aminotransferase [ALT]) | Posted | Number | percentage of participants | Baseline up to Month 7 |
|
|
|
| Primary | Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Aspartate Aminotransferase [AST]) | Posted | Number | percentage of participants | Baseline up to Month 7 |
|
|
|
| Primary | Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Total Protein) | Posted | Number | percentage of participants | Baseline up to Month 7 |
|
|
|
| Primary | Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Albumin) | Posted | Number | percentage of participants | Baseline up to Month 7 |
|
|
|
| Primary | Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Alkaline Phosphatase [ALP]) | Posted | Number | percentage of participants | Baseline up to Month 7 |
|
|
|
| Primary | Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Total Bilirubin) | Posted | Number | percentage of participants | Baseline up to Month 7 |
|
|
|
| Primary | Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Creatine Phosphokinase [CPK]) | Posted | Number | percentage of participants | Baseline up to Month 7 |
|
|
|
| Primary | Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Prothrombin Time [PT]) | Posted | Number | percentage of participants | Baseline up to Month 7 |
|
|
|
| Primary | Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Partial Thromboplastin Time [PTT]) | Posted | Number | percentage of participants | Baseline up to Month 7 |
|
|
|
| Primary | Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Fibrinogen) | Posted | Number | percentage of participants | Baseline up to Month 7 |
|
|
|
| Primary | Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Hemoglobin) | Posted | Number | percentage of participants | Baseline up to Month 7 |
|
|
|
| Primary | Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (White Blood Cell [WBC]) | Posted | Number | percentage of participants | Baseline up to Month 7 |
|
|
|
| Primary | Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Lymphocytes) | Posted | Number | percentage of participants | Baseline up to Month 7 |
|
|
|
| Primary | Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Neutrophils) | Posted | Number | percentage of participants | Baseline up to Month 7 |
|
|
|
| Primary | Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Eosinophils) | Posted | Number | percentage of participants | Baseline up to Month 7 |
|
|
|
| Primary | Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Platelet Count) | Posted | Number | percentage of participants | Baseline up to Month 7 |
|
|
|
| Primary | Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Sodium). | Posted | Number | percentage of participants | Baseline up to Month 7 |
|
|
|
| Primary | Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Potassium). | Posted | Number | percentage of participants | Baseline up to Month 7 |
|
|
|
| Primary | Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Blood Urea Nitrogen [BUN]). | Posted | Number | percentage of participants | Baseline up to Month 7 |
|
|
|
| Primary | Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Serum Creatinine). | Posted | Number | percentage of participants | Baseline up to Month 7 |
|
|
|
| Primary | Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Urine Red Blood Cells [RBC]). | Posted | Number | percentage of participants | Baseline up to Month 7 |
|
|
|
| Primary | Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Urine Protein). | Posted | Number | percentage of participants | Baseline up to Month 7 |
|
|
|
| Primary | Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Urine Glucose). | Posted | Number | percentage of participants | Baseline up to Month 7 |
|
|
|
| Secondary | Meningococcal Immunoglobulin G (IgG) Geometric Mean Titers (GMT) | Posted | Geometric Mean | 95% Confidence Interval | titers | Before Dose 1, 1 month after Dose 2, before Dose 3, 1 month after Dose 3 |
|
|
|
| 0 |
| 12 |
| 11 |
| 12 |
| EG001 | rLP2086 120 mcg | Given on a 0, 2-, 6- month schedule | 0 | 12 | 11 | 12 |
| EG002 | rLP2086 200 mcg | Given on a 0, 2-, 6- month schedule | 0 | 12 | 11 | 12 |
| EG003 | Tdap/Normal Saline (Control) | Tdap was given at month 0 and Saline was given at Month 2 and 6 | 0 | 12 | 11 | 12 |
| Abdominal pain | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Induration | General disorders | MedDRA | Non-systematic Assessment |
|
| Injection site induration | General disorders | MedDRA | Non-systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA | Non-systematic Assessment |
|
| Injection site rash | General disorders | MedDRA | Non-systematic Assessment |
|
| Food allergy | Immune system disorders | MedDRA | Non-systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Tooth infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Joint sprain | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Activated partial thromboplastin time prolonged | Investigations | MedDRA | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA | Non-systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA | Non-systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA | Non-systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA | Non-systematic Assessment |
|
| Blood fibrinogen decreased | Investigations | MedDRA | Non-systematic Assessment |
|
| Blood fibrinogen increased | Investigations | MedDRA | Non-systematic Assessment |
|
| Blood potassium increased | Investigations | MedDRA | Non-systematic Assessment |
|
| Blood sodium increased | Investigations | MedDRA | Non-systematic Assessment |
|
| Eosinophil count increased | Investigations | MedDRA | Non-systematic Assessment |
|
| Fibrin D dimer increased | Investigations | MedDRA | Non-systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA | Non-systematic Assessment |
|
| Haematocrit decreased | Investigations | MedDRA | Non-systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA | Non-systematic Assessment |
|
| Haemoglobin increased | Investigations | MedDRA | Non-systematic Assessment |
|
| International normalised ratio increased | Investigations | MedDRA | Non-systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA | Non-systematic Assessment |
|
| Mean cell haemoglobin concentration decreased | Investigations | MedDRA | Non-systematic Assessment |
|
| Mean cell haemoglobin decreased | Investigations | MedDRA | Non-systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA | Non-systematic Assessment |
|
| Neutrophil count increased | Investigations | MedDRA | Non-systematic Assessment |
|
| Platelet count increased | Investigations | MedDRA | Non-systematic Assessment |
|
| Protein urine | Investigations | MedDRA | Non-systematic Assessment |
|
| Prothrombin time prolonged | Investigations | MedDRA | Non-systematic Assessment |
|
| Red blood cell count decreased | Investigations | MedDRA | Non-systematic Assessment |
|
| Red blood cells urine | Investigations | MedDRA | Non-systematic Assessment |
|
| Red blood cells urine positive | Investigations | MedDRA | Non-systematic Assessment |
|
| Red cell distribution width increased | Investigations | MedDRA | Non-systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA | Non-systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Hidradenitis | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D007239 | Infections |
| D008589 | Meningococcal Infections |
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D002494 | Central Nervous System Infections |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008581 | Meningitis |
| D000090862 | Neuroinflammatory Diseases |
| Baseline: Normal, Post-Baseline: Mild |
|
| Baseline: Normal, Post-Baseline: Mild |
|
| Baseline: Normal, Post-Baseline: Moderate |
|
| Baseline:Normal,Post Baseline:Mild/Moderate/Severe |
|
| Baseline:Normal,Post Baseline:Mild/Moderate/Severe |
|
| Baseline: Normal, Post-Baseline: Mild |
|
| Baseline: Normal, Post-Baseline: Moderate |
|
| Baseline: Normal, Post-Baseline: Grade 4 |
|
| Baseline: Normal, Post-Baseline: Mild |
|
| Baseline: Normal, Post-Baseline: Moderate |
|
| Baseline: Normal, Post-Baseline: Grade 4 |
|
| Baseline: Normal, Post-Baseline: Moderate |
|
| Baseline: Normal, Post-Baseline: Mild |
|
| Baseline: Normal, Post-Baseline: Moderate |
|
| Baseline: Normal, Post-Baseline: Mild+ |
|
| Baseline: Normal, Post-Baseline: Moderate+ |
|
| Baseline: Normal, Post-Baseline: Mild- |
|
| Baseline: Normal, Post-Baseline: Mild |
|
| Baseline: Normal, Post-Baseline: Moderate |
|
| Baseline: Normal, Post-Baseline: Mild+ |
|
| Baseline: Normal, Post-Baseline: Moderate+ |
|
| Baseline: Normal, Post-Baseline: Mild- |
|
| Baseline: Normal, Post-Baseline: Moderate |
|
| Baseline: Normal, Post-Baseline: Severe |
|
| Baseline: Normal, Post-Baseline: Mild |
|
| Baseline:Normal,Post Baseline:Mild/Moderate/Severe |
|
| Baseline: Normal, Post-Baseline: Mild+ |
|
| Baseline: Normal, Post-Baseline: Moderate+ |
|
| Baseline: Normal, Post-Baseline: Severe+ |
|
| Baseline: Normal, Post-Baseline: Grade 4 increase |
|
| Baseline: Normal, Post-Baseline: Mild+ |
|
| Baseline: Normal, Post-Baseline: Grade 4 increase |
|
| Baseline:Normal,Post Baseline:Mild/Moderate/Severe |
|
| Baseline:Normal,Post Baseline:Mild/Moderate/Severe |
|
| Baseline: Normal, Post-Baseline: Mild |
|
| Baseline: Normal, Post-Baseline: Moderate |
|
| Baseline: Normal, Post-Baseline: Mild |
|
| Baseline: Normal, Post-Baseline: Moderate |
|
| Baseline: Normal, Post-Baseline: Grade 4 |
|
| Baseline:Normal,Post Baseline:Mild/Moderate/Severe |
|
| Subfamily A: 1 Month After Dose2 (N=10, 12, 11, 9) |
|
| Subfamily A: Before Dose 3 (N=10, 11, 11, 7) |
|
| Subfamily A: 1 Month After Dose 3 (N=8, 10, 9, 7) |
|
| Subfamily B: Before Dose 1 (N=12, 12, 12, 12) |
|
| Subfamily B: 1 Month After Dose2 (N=10, 12, 11, 9) |
|
| Subfamily B: Before Dose3 (N=10, 11, 11, 7) |
|
| Subfamily B: 1 Month After dose 3 (N=8, 10, 9, 7) |
|