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Phase I Study to Assess the Safety and Immunology of a COVID-19 Vaccine With GRAd-COV2 Vaccine

A Phase 1, Dosage-Escalation Study to Assess the Safety and Immunogenicity of a COVID-19 Vaccine GRAd-COV2 in Healthy Adults and Elderly Subjects

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04528641
Enrollment
98
Registered
2020-08-27
Start date
2020-08-10
Completion date
2021-05-19
Last updated
2022-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Brief summary

RT-CoV-2 is a Phase I, open-label, dose escalation multicenter clinical trial to assess safety and immunogenicity of the candidate Coronavirus disease (COVID-19) vaccine GRAd-COV2 in Italian healthy volunteers aged 18-55 years and 65-85 years inclusive. GRAd-COV2 is based on a novel replication defective Gorilla Adenovirus and encodes for SARS-COV-2 Spike protein.

Detailed description

RT-CoV-2 is a Phase I, open-label, dose escalation multicenter clinical trial to assess safety and immunogenicity of the candidate Coronavirus disease (COVID-19) vaccine GRAd-COV2 in Italian healthy volunteers aged 18-55 years and 65-85 years inclusive. GRAd-COV2 is based on a novel replication defective Gorilla Adenovirus and encodes for SARS-COV-2 full length prefusion stabilized Spike protein. GRAd-COV2 is developed and manufactured by ReiThera Srl. This study will evaluate a singular intramuscular administration of GRAd-COV2 at 3 dose levels: 5e10, 1e11, 2e11viral particles (vp). There will be 6 study arms for a total of 90 healthy volunteers, divided into 2 cohorts of age, 18-55y and 65-85y, respectively. Participants will be followed up for 24 weeks after vaccination. Follow up includes safety and immunogenicity assessment. Follow up visits will occur at day2, then 1, 2, 4, 8, 12, 24 weeks after vaccination. The primary objective is to evaluate the safety and reactogenicity of a single dose vaccination schedule of GRAd-COV2 across 3 dosages in healthy younger and older adults. The secondary objective is to evaluate humoral and cellular immunogenicity.

Interventions

BIOLOGICALGRAd-COV2

Single intramuscular administration.

Sponsors

Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani IRCCS
CollaboratorNETWORK
ReiThera Srl
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Phase I, open-label, dose escalation, clinical trial to assess the safety and immunogenicity of the candidate GRAd-COV2 vaccine in 90 healthy volunteers aged 18-55 years and elderly volunteers aged 65-85 years. The vaccine will be administered intramuscularly once in time.

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes

Inclusion criteria

A subject must meet all of the following criteria to be eligible to participate in this study: 1. Provides written informed consent prior to initiation of any study procedures. 2. Be able to understand and agrees to comply with planned study procedures and be available for all study visits. 3. Agrees to the collection of venous blood per protocol. 4. Confirms to have not donated blood three months before the study 5. Agrees to refrain from blood during the study and until the three months after the end of the study. 6. Body Mass Index 18-29 kg/m2, inclusive, at screening. 7. Premenopausal women must agree to use one acceptable primary form of contraception. 8. Premenopausal women must have a negative urine pregnancy test the day of vaccination and are routinely using - and willing to use up to six months from vaccine administration - an effective method of birth control resulting in a low failure rate (i.e., hormonal contraception, condoms in combination with a spermicidal cream, male partner sterilization-vasectomy or total sexual abstinence). 9. Oral temperature ≤37.0 degrees Celsius the day of the administration of the vaccine 10. Pulse no greater than 100 beats per minute. 11. Systolic blood pressure (BP) is 85 to 139 mmHg, inclusive the day of vaccination. 12. Should not show laboratory values outside the normal range which may have clinical significance even in absence of specific signs or symptoms.

Exclusion criteria

A subject who meets any of the following criteria will be excluded from participation in this study: 1. Positive serology for anti-HIV-Ab 2. Positive HbBsAg 3. Positive anti-HCV-Ab 4. Positive for SARS-CoV-2 (either anti-S-Ab or anti-N-Ab) 5. Acute illness, as determined by the site PI or appropriate sub-investigator, the day of vaccination. 6. Breastfeeding women 7. Autoimmune and hyper-inflammatory condition 8. History of atopy (or any IgE associated condition) who had required treatment over the last 6 months; 9. History of hypersensitivity or severe allergic reaction (e.g., anaphylaxis, generalized urticaria, angioedema, other significant reaction) to any previous licensed or unlicensed vaccines; 10. Assumption of any immunomodulatory medication over the last 4 months (including, but not limited to, systemic corticosteroids, allergy injections, immunoglobulin, interferon, immunomodulators, cytotoxic drugs, or other similar or toxic drugs). The use of low dose topical, ophthalmic, inhaled, and intranasal steroid preparations will be permitted. 11. Presence of self-reported or medically documented significant medical condition 12. Presence of self-reported or medically documented significant psychiatric condition 13. Significant cardiovascular disease needing therapy or history of myocarditis or pericarditis or heart surgery. Patients in treatment with Sartans or ACE-Inhibitors and good response to therapy may be included. 14. Neurological or neurodevelopmental conditions (e.g., history of migraines in the past 5 years, epilepsy, stroke, seizures in the last 3 years, encephalopathy, focal neurologic deficits, Guillain-Barré syndrome, encephalomyelitis or transverse myelitis). 15. Ongoing malignancy or recent diagnosis of malignancy in the last five years excluding basal cell and squamous cell carcinoma of the skin, which are allowed. 16. Primary or secondary immunodeficiency of any cause. 17. Participated in another investigational study involving vaccination of biologic compounds in the last 12 months. 18. Currently enrolled in or plans to participate in another clinical trial with an investigational agent that will be received during the study-reporting period. 19. Administration of immunoglobulins and/or any blood or blood products within the 4 months before the first vaccine administration or at any time during the study. 20. Has any significant disorder of coagulation. 21. Has any chronic liver disease, including fatty liver. 22. Has a history of alcohol abuse or other recreational drug use within 6 months before the first vaccine administration. 23. Has any abnormality or permanent body art (e.g., tattoo) that would interfere with the ability to observe local reactions at the injection site (deltoid region). 24. Received or plans to receive additional vaccination within 4 weeks before or after each vaccination. 25. Has been reported as a case (confirmed or probable) of COVID-19 from the regional health system 26. Has any clinical conditions that, in the opinion of the site PI or appropriate sub-investigator, precludes study participation, this includes any acute, subacute, intermittent or chronic medical disease or condition that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of this trial

Design outcomes

Primary

MeasureTime frameDescription
Change in Urea Nitrogen From Baselineweek 1,2,4,8,12, and 24—
Change in Bilirubin From Baselineweek 1,2,4,8,12, and 24—
Change in Albumin Form Baselineweek 1,2,4,8,12, and 24—
Change in Creatinine Form Baselineweek 1,2,4,8,12, and 24—
Change in Lactate Dehydrogenase From Baselineweek 1,2,4,8,12, and 24—
Occurrence of Solicited Local AE Signs and Symptoms 7 Days Following the Vaccination7 days following the vaccinationParticipants were monitored for 7 days post-vaccination and the occurrence of solicited local AE signs and symptoms were collected.
Occurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the Vaccination7 days following the vaccinationParticipants were monitored for 7 days post-vaccination and the occurrence of solicited systemic AE signs and symptoms were collected.
Occurrence of Unsolicited AE 28 Days Following the Vaccination28 days following the vaccinationOccurrence of unsolicited AEs: unsolicited AEs were collected using the patient Diary and reported as Any AE occurring 28 days following the vaccination.
Occurrence of Serious AE 24 Weeks Following the Vaccination24 weeks following the vaccinationOccurrence of any treatment - emergent serious AE and treatment - emergent SAE related to study drug was monitored during the study period (24 weeks following vaccination)
Change in Leucocytes From Baselinebaseline, Weeks 1,2,4,8,12, and 24—
Change in Basophils From BaselineWeeks 1,2,4,8,12, and 24—
Change in Eosinophils From BaselineWeeks 1,2,4,8,12, and 24—
Change in Neutrophils From BaselineWeeks 1,2,4,8,12, and 24Change from baseline was calculated as the value at each week minus the value at the baseline.
Change in Monocytes From BaselineWeeks 1,2,4,8,12, and 24—
Change in Lymphocytes From BaselineWeeks 1,2,4,8,12, and 24—
Change in Erythrocytes From BaselineWeeks 1,2,4,8,12, and 24—
Change in Hematocrit From BaselineWeeks 1,2,4,8,12, and 24—
Change in Platelets From BaselineWeeks 1,2,4,8,12, and 24—
Change in Hemoglobin From BaselineWeeks 1,2,4,8,12, and 24—
Change in Sodium From Baselineweek 1,2,4,8,12, and 24—
Change in Potassium From Baselineweek 1,2,4,8,12, and 24—
Change in Alkaline Phosphatase From Baselineweek 1,2,4,8,12, and 24—
Change in Alanine Aminotransferase From Baselineweek 1,2,4,8,12, and 24—
Change in Aspartate Aminotransferase From Baselineweek 1,2,4,8,12, and 24—
Change in Direct Bilirubin Form Baselineweek 1,2,4,8,12, and 24—

Secondary

MeasureTime frameDescription
Number of Participants With Positive, Negative Anti-n Antibodyweek 1, 2, 4, 8, 12 and 24To assess the cellular and humoral immune response to SARS-CoV2 elicited by the vaccine cellular and humoral immune parameters evaluated: anti-N Antibody Interpretation: n. of subjects positive, negative at week 1, 2, 4, 8, 12 and 24 compared to baseline
Number of Participants With Positive, Negative for Micro Neutralization Testweek 4 and week 24To assess the cellular and humoral immune response to SARS-CoV2 elicited by the vaccine cellular and humoral immune parameters evaluated: Micro Neutralization test Interpretation: n. of positive and negative subjects at week 4 and week 24 by evaluating geometric mean titer change from baseline
Immunogenicity - T-cell Responsebaseline, week 2, week 4, week 8, week 12, week 24To assess the cellular and humoral immune response to SARS-CoV2 elicited by the vaccine cellular and humoral immune parameters evaluated. T-cells were evaluated on frozen and fresh (week2) samples Within-cohort comparisons to assess the difference in immune response according to different doses in the same population Across-the-cohort comparison to assess whether elderlies and adults have a different pattern of immune response after vaccination at different endpoints Unit: spot-forming cells \[SFC\]/1 × 10\^6 peripheral blood mononuclear cell \[PBMC\] Interpretation: values higher than at baseline are indicative of a persistent spike-specific memory T-cell establishment.
Number of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 1, 2, 4, 8, 12, and 24To assess the cellular and humoral immune response to SARS-CoV2 elicited by the vaccine Immunogenicity Result: Seroconversion for Anti-S Antibody Interpretation: n. of subjects positive, negative or indeterminate at week 1, 2, 4, 8, 12, and 24 after vaccination.

Countries

Italy

Participant flow

Pre-assignment details

a total of 180 subjects were screened and 98 subjects were enrolled in the study. seven out of 98 enrolled subjects were not administered vaccine because of withdrawal by subjects (3 subjects) and because the protocol allowed Screening period 21 days passed (4 subjects). a total of 91 subjects were administered vaccine.

Participants by arm

ArmCount
Arm 1 - Low Dose
Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15 GRAd-COV2: Single intramuscular administration.
15
Arm 2 - Intermediate Dose
Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15 GRAd-COV2: Single intramuscular administration.
15
Arm 3 - High Dose
Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15 GRAd-COV2: Single intramuscular administration.
15
Arm 4 - Low Dose
Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=16 GRAd-COV2: Single intramuscular administration.
16
Arm 5 - Intermediate Dose
Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15 GRAd-COV2: Single intramuscular administration.
15
Arm 6 - High Dose
Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15 GRAd-COV2: Single intramuscular administration.
15
Total91

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004FG005
Overall StudyWithdrawal by Subject000101

Baseline characteristics

CharacteristicArm 1 - Low DoseArm 2 - Intermediate DoseArm 3 - High DoseArm 4 - Low DoseArm 5 - Intermediate DoseArm 6 - High DoseTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants16 Participants15 Participants15 Participants46 Participants
Age, Categorical
Between 18 and 65 years
15 Participants15 Participants15 Participants0 Participants0 Participants0 Participants45 Participants
Age, Continuous33.9 years
STANDARD_DEVIATION 9.1
37.0 years
STANDARD_DEVIATION 10.2
36.2 years
STANDARD_DEVIATION 11.1
69.5 years
STANDARD_DEVIATION 4.6
70.8 years
STANDARD_DEVIATION 5.6
70.0 years
STANDARD_DEVIATION 3.5
53.1 years
STANDARD_DEVIATION 18.9
Demographic - BMI24.514 Kg/m^2
STANDARD_DEVIATION 2.5747
23.367 Kg/m^2
STANDARD_DEVIATION 3.0412
23.332 Kg/m^2
STANDARD_DEVIATION 2.7751
24.767 Kg/m^2
STANDARD_DEVIATION 3.0552
24.574 Kg/m^2
STANDARD_DEVIATION 2.5569
25.035 Kg/m^2
STANDARD_DEVIATION 2.2006
24.514 Kg/m^2
STANDARD_DEVIATION 2.5747
Demographic - Height173.3 cm
STANDARD_DEVIATION 9.82
171.9 cm
STANDARD_DEVIATION 10.93
173.8 cm
STANDARD_DEVIATION 10.21
169.0 cm
STANDARD_DEVIATION 9.01
168.1 cm
STANDARD_DEVIATION 11.3
169.7 cm
STANDARD_DEVIATION 9.47
170.9 cm
STANDARD_DEVIATION 10.12
Demographic - weight73.9 kg
STANDARD_DEVIATION 12.172
69.7 kg
STANDARD_DEVIATION 14.91
70.9 kg
STANDARD_DEVIATION 13.49
73.61 kg
STANDARD_DEVIATION 12.874
70.37 kg
STANDARD_DEVIATION 10.181
70.9 kg
STANDARD_DEVIATION 10.54
71.59 kg
STANDARD_DEVIATION 12.224
Race/Ethnicity, Customized
Hispanic or Latino
0 participants1 participants0 participants0 participants0 participants0 participants1 participants
Race/Ethnicity, Customized
Not Hispanic or Latino
15 participants14 participants15 participants16 participants15 participants15 participants90 participants
Region of Enrollment
Italy
15 participants15 participants15 participants16 participants15 participants15 participants91 participants
Sex: Female, Male
Female
7 Participants5 Participants6 Participants5 Participants5 Participants5 Participants33 Participants
Sex: Female, Male
Male
8 Participants10 Participants9 Participants11 Participants10 Participants10 Participants58 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
deaths
Total, all-cause mortality
0 / 150 / 150 / 150 / 160 / 150 / 15
other
Total, other adverse events
12 / 1514 / 1514 / 1513 / 169 / 159 / 15
serious
Total, serious adverse events
0 / 150 / 150 / 150 / 160 / 150 / 15

Outcome results

Primary

Change in Alanine Aminotransferase From Baseline

Time frame: week 1,2,4,8,12, and 24

ArmMeasureGroupValue (MEAN)Dispersion
Arm 1 - Low DoseChange in Alanine Aminotransferase From Baselineweek 11.3 U/LStandard Deviation 6.69
Arm 1 - Low DoseChange in Alanine Aminotransferase From Baselineweek 22.7 U/LStandard Deviation 16.39
Arm 1 - Low DoseChange in Alanine Aminotransferase From Baselineweek 41.1 U/LStandard Deviation 10.91
Arm 1 - Low DoseChange in Alanine Aminotransferase From Baselineweek 81.2 U/LStandard Deviation 12.13
Arm 1 - Low DoseChange in Alanine Aminotransferase From Baselineweek 126.9 U/LStandard Deviation 12.59
Arm 1 - Low DoseChange in Alanine Aminotransferase From Baselineweek 24-0.7 U/LStandard Deviation 11.81
Arm 2 - Intermediate DoseChange in Alanine Aminotransferase From Baselineweek 22.0 U/LStandard Deviation 5.13
Arm 2 - Intermediate DoseChange in Alanine Aminotransferase From Baselineweek 84.1 U/LStandard Deviation 6.08
Arm 2 - Intermediate DoseChange in Alanine Aminotransferase From Baselineweek 241.2 U/LStandard Deviation 4.2
Arm 2 - Intermediate DoseChange in Alanine Aminotransferase From Baselineweek 12.3 U/LStandard Deviation 6.33
Arm 2 - Intermediate DoseChange in Alanine Aminotransferase From Baselineweek 42.9 U/LStandard Deviation 3.81
Arm 2 - Intermediate DoseChange in Alanine Aminotransferase From Baselineweek 124.9 U/LStandard Deviation 6.33
Arm 3 - High DoseChange in Alanine Aminotransferase From Baselineweek 240.3 U/LStandard Deviation 10.26
Arm 3 - High DoseChange in Alanine Aminotransferase From Baselineweek 123.9 U/LStandard Deviation 9.84
Arm 3 - High DoseChange in Alanine Aminotransferase From Baselineweek 80.1 U/LStandard Deviation 5.46
Arm 3 - High DoseChange in Alanine Aminotransferase From Baselineweek 40.9 U/LStandard Deviation 6.65
Arm 3 - High DoseChange in Alanine Aminotransferase From Baselineweek 1-0.2 U/LStandard Deviation 2.91
Arm 3 - High DoseChange in Alanine Aminotransferase From Baselineweek 22.5 U/LStandard Deviation 5.25
Arm 4 - Low DoseChange in Alanine Aminotransferase From Baselineweek 8-1.4 U/LStandard Deviation 5.26
Arm 4 - Low DoseChange in Alanine Aminotransferase From Baselineweek 2-1.1 U/LStandard Deviation 3.26
Arm 4 - Low DoseChange in Alanine Aminotransferase From Baselineweek 40.9 U/LStandard Deviation 3.96
Arm 4 - Low DoseChange in Alanine Aminotransferase From Baselineweek 2410. U/LStandard Deviation 3.38
Arm 4 - Low DoseChange in Alanine Aminotransferase From Baselineweek 12-0.5 U/LStandard Deviation 8.22
Arm 4 - Low DoseChange in Alanine Aminotransferase From Baselineweek 1-1.8 U/LStandard Deviation 2.44
Arm 5 - Intermediate DoseChange in Alanine Aminotransferase From Baselineweek 14.3 U/LStandard Deviation 20.3
Arm 5 - Intermediate DoseChange in Alanine Aminotransferase From Baselineweek 120.4 U/LStandard Deviation 3.76
Arm 5 - Intermediate DoseChange in Alanine Aminotransferase From Baselineweek 22.6 U/LStandard Deviation 3.98
Arm 5 - Intermediate DoseChange in Alanine Aminotransferase From Baselineweek 40.1 U/LStandard Deviation 3.84
Arm 5 - Intermediate DoseChange in Alanine Aminotransferase From Baselineweek 80.8 U/LStandard Deviation 7.02
Arm 5 - Intermediate DoseChange in Alanine Aminotransferase From Baselineweek 24-0.3 U/LStandard Deviation 6.31
Arm 6 - High DoseChange in Alanine Aminotransferase From Baselineweek 8-0.1 U/LStandard Deviation 2.99
Arm 6 - High DoseChange in Alanine Aminotransferase From Baselineweek 40.7 U/LStandard Deviation 4.43
Arm 6 - High DoseChange in Alanine Aminotransferase From Baselineweek 12-1.1 U/LStandard Deviation 3.23
Arm 6 - High DoseChange in Alanine Aminotransferase From Baselineweek 24-0.9 U/LStandard Deviation 3.83
Arm 6 - High DoseChange in Alanine Aminotransferase From Baselineweek 20.9 U/LStandard Deviation 3.68
Arm 6 - High DoseChange in Alanine Aminotransferase From Baselineweek 10.2 U/LStandard Deviation 3.55
Primary

Change in Albumin Form Baseline

Time frame: week 1,2,4,8,12, and 24

ArmMeasureGroupValue (MEAN)Dispersion
Arm 1 - Low DoseChange in Albumin Form Baselineweek 24-0.62 g/LStandard Deviation 2.155
Arm 1 - Low DoseChange in Albumin Form Baselineweek 2-0.01 g/LStandard Deviation 2.334
Arm 1 - Low DoseChange in Albumin Form Baselineweek 40.62 g/LStandard Deviation 3.15
Arm 1 - Low DoseChange in Albumin Form Baselineweek 8-0.23 g/LStandard Deviation 2.666
Arm 1 - Low DoseChange in Albumin Form Baselineweek 12-0.86 g/LStandard Deviation 2.442
Arm 1 - Low DoseChange in Albumin Form Baselineweek 1-2.45 g/LStandard Deviation 2.989
Arm 2 - Intermediate DoseChange in Albumin Form Baselineweek 1-0.65 g/LStandard Deviation 2.37
Arm 2 - Intermediate DoseChange in Albumin Form Baselineweek 4-159 g/LStandard Deviation 2.035
Arm 2 - Intermediate DoseChange in Albumin Form Baselineweek 24-2.56 g/LStandard Deviation 2.201
Arm 2 - Intermediate DoseChange in Albumin Form Baselineweek 8-2.07 g/LStandard Deviation 2.587
Arm 2 - Intermediate DoseChange in Albumin Form Baselineweek 2-0.83 g/LStandard Deviation 3.253
Arm 2 - Intermediate DoseChange in Albumin Form Baselineweek 12-1.68 g/LStandard Deviation 2.815
Arm 3 - High DoseChange in Albumin Form Baselineweek 1-1.70 g/LStandard Deviation 2.6376
Arm 3 - High DoseChange in Albumin Form Baselineweek 12-0.25 g/LStandard Deviation 2.167
Arm 3 - High DoseChange in Albumin Form Baselineweek 4-0.08 g/LStandard Deviation 2.486
Arm 3 - High DoseChange in Albumin Form Baselineweek 80.71 g/LStandard Deviation 2.619
Arm 3 - High DoseChange in Albumin Form Baselineweek 2-1.37 g/LStandard Deviation 2.943
Arm 3 - High DoseChange in Albumin Form Baselineweek 24-1.59 g/LStandard Deviation 2.63
Arm 4 - Low DoseChange in Albumin Form Baselineweek 8-1.47 g/LStandard Deviation 2.587
Arm 4 - Low DoseChange in Albumin Form Baselineweek 2-1.03 g/LStandard Deviation 1.1885
Arm 4 - Low DoseChange in Albumin Form Baselineweek 1-1.67 g/LStandard Deviation 2.775
Arm 4 - Low DoseChange in Albumin Form Baselineweek 4-1.00 g/LStandard Deviation 2.055
Arm 4 - Low DoseChange in Albumin Form Baselineweek 24-1.21 g/LStandard Deviation 2.811
Arm 4 - Low DoseChange in Albumin Form Baselineweek 12-0.64 g/LStandard Deviation 2.2143
Arm 5 - Intermediate DoseChange in Albumin Form Baselineweek 2-0.73 g/LStandard Deviation 2.504
Arm 5 - Intermediate DoseChange in Albumin Form Baselineweek 8-2.43 g/LStandard Deviation 2.88
Arm 5 - Intermediate DoseChange in Albumin Form Baselineweek 24-0.07 g/LStandard Deviation 3.501
Arm 5 - Intermediate DoseChange in Albumin Form Baselineweek 12-0.93 g/LStandard Deviation 1.617
Arm 5 - Intermediate DoseChange in Albumin Form Baselineweek 10.03 g/LStandard Deviation 2.343
Arm 5 - Intermediate DoseChange in Albumin Form Baselineweek 4-1.53 g/LStandard Deviation 2.707
Arm 6 - High DoseChange in Albumin Form Baselineweek 241.21 g/LStandard Deviation 2.598
Arm 6 - High DoseChange in Albumin Form Baselineweek 2-1.61 g/LStandard Deviation 1.739
Arm 6 - High DoseChange in Albumin Form Baselineweek 4-0.87 g/LStandard Deviation 2.408
Arm 6 - High DoseChange in Albumin Form Baselineweek 8-0.45 g/LStandard Deviation 2.77
Arm 6 - High DoseChange in Albumin Form Baselineweek 12-0.13 g/LStandard Deviation 1.848
Arm 6 - High DoseChange in Albumin Form Baselineweek 1-0.64 g/LStandard Deviation 2.346
Primary

Change in Alkaline Phosphatase From Baseline

Time frame: week 1,2,4,8,12, and 24

ArmMeasureGroupValue (MEAN)Dispersion
Arm 1 - Low DoseChange in Alkaline Phosphatase From Baselineweek 12.1 U/LStandard Deviation 7.52
Arm 1 - Low DoseChange in Alkaline Phosphatase From Baselineweek 20.5 U/LStandard Deviation 7.06
Arm 1 - Low DoseChange in Alkaline Phosphatase From Baselineweek 41.3 U/LStandard Deviation 9.62
Arm 1 - Low DoseChange in Alkaline Phosphatase From Baselineweek 85.0 U/LStandard Deviation 6.31
Arm 1 - Low DoseChange in Alkaline Phosphatase From Baselineweek 122.7 U/LStandard Deviation 11.92
Arm 1 - Low DoseChange in Alkaline Phosphatase From Baselineweek 241.7 U/LStandard Deviation 8.17
Arm 2 - Intermediate DoseChange in Alkaline Phosphatase From Baselineweek 22.0 U/LStandard Deviation 6.63
Arm 2 - Intermediate DoseChange in Alkaline Phosphatase From Baselineweek 82.5 U/LStandard Deviation 5.36
Arm 2 - Intermediate DoseChange in Alkaline Phosphatase From Baselineweek 245.3 U/LStandard Deviation 9.49
Arm 2 - Intermediate DoseChange in Alkaline Phosphatase From Baselineweek 10.7 U/LStandard Deviation 4.92
Arm 2 - Intermediate DoseChange in Alkaline Phosphatase From Baselineweek 4-0.4 U/LStandard Deviation 5.74
Arm 2 - Intermediate DoseChange in Alkaline Phosphatase From Baselineweek 123.2 U/LStandard Deviation 5.91
Arm 3 - High DoseChange in Alkaline Phosphatase From Baselineweek 243.3 U/LStandard Deviation 9.5
Arm 3 - High DoseChange in Alkaline Phosphatase From Baselineweek 123.9 U/LStandard Deviation 7.81
Arm 3 - High DoseChange in Alkaline Phosphatase From Baselineweek 81.1 U/LStandard Deviation 6.35
Arm 3 - High DoseChange in Alkaline Phosphatase From Baselineweek 43.6 U/LStandard Deviation 7.52
Arm 3 - High DoseChange in Alkaline Phosphatase From Baselineweek 1-3.7 U/LStandard Deviation 6.52
Arm 3 - High DoseChange in Alkaline Phosphatase From Baselineweek 2-4.7 U/LStandard Deviation 6.43
Arm 4 - Low DoseChange in Alkaline Phosphatase From Baselineweek 8-2.4 U/LStandard Deviation 5.94
Arm 4 - Low DoseChange in Alkaline Phosphatase From Baselineweek 2-1.8 U/LStandard Deviation 5.39
Arm 4 - Low DoseChange in Alkaline Phosphatase From Baselineweek 4-2.4 U/LStandard Deviation 6.31
Arm 4 - Low DoseChange in Alkaline Phosphatase From Baselineweek 24-1.7 U/LStandard Deviation 7.01
Arm 4 - Low DoseChange in Alkaline Phosphatase From Baselineweek 12-1.1 U/LStandard Deviation 5.48
Arm 4 - Low DoseChange in Alkaline Phosphatase From Baselineweek 1-4.9 U/LStandard Deviation 4.89
Arm 5 - Intermediate DoseChange in Alkaline Phosphatase From Baselineweek 1-0.7 U/LStandard Deviation 6.76
Arm 5 - Intermediate DoseChange in Alkaline Phosphatase From Baselineweek 12-2.1 U/LStandard Deviation 10.02
Arm 5 - Intermediate DoseChange in Alkaline Phosphatase From Baselineweek 2-4.3 U/LStandard Deviation 5.61
Arm 5 - Intermediate DoseChange in Alkaline Phosphatase From Baselineweek 4-2.7 U/LStandard Deviation 6.6
Arm 5 - Intermediate DoseChange in Alkaline Phosphatase From Baselineweek 83.5 U/LStandard Deviation 6.24
Arm 5 - Intermediate DoseChange in Alkaline Phosphatase From Baselineweek 242.1 U/LStandard Deviation 11.48
Arm 6 - High DoseChange in Alkaline Phosphatase From Baselineweek 84.1 U/LStandard Deviation 5.65
Arm 6 - High DoseChange in Alkaline Phosphatase From Baselineweek 43.2 U/LStandard Deviation 4.21
Arm 6 - High DoseChange in Alkaline Phosphatase From Baselineweek 120.1 U/LStandard Deviation 6.02
Arm 6 - High DoseChange in Alkaline Phosphatase From Baselineweek 242.3 U/LStandard Deviation 8.48
Arm 6 - High DoseChange in Alkaline Phosphatase From Baselineweek 20.3 U/LStandard Deviation 7.62
Arm 6 - High DoseChange in Alkaline Phosphatase From Baselineweek 10.9 U/LStandard Deviation 6.94
Primary

Change in Aspartate Aminotransferase From Baseline

Time frame: week 1,2,4,8,12, and 24

ArmMeasureGroupValue (MEAN)Dispersion
Arm 1 - Low DoseChange in Aspartate Aminotransferase From Baselineweek 1-1.60 U/LStandard Deviation 4.982
Arm 1 - Low DoseChange in Aspartate Aminotransferase From Baselineweek 29.07 U/LStandard Deviation 32.288
Arm 1 - Low DoseChange in Aspartate Aminotransferase From Baselineweek 4-0.13 U/LStandard Deviation 4.518
Arm 1 - Low DoseChange in Aspartate Aminotransferase From Baselineweek 81.07 U/LStandard Deviation 4.48
Arm 1 - Low DoseChange in Aspartate Aminotransferase From Baselineweek 122.73 U/LStandard Deviation 6.147
Arm 1 - Low DoseChange in Aspartate Aminotransferase From Baselineweek 240.33 U/LStandard Deviation 6.091
Arm 2 - Intermediate DoseChange in Aspartate Aminotransferase From Baselineweek 20.29 U/LStandard Deviation 3.106
Arm 2 - Intermediate DoseChange in Aspartate Aminotransferase From Baselineweek 81.20 U/LStandard Deviation 5.735
Arm 2 - Intermediate DoseChange in Aspartate Aminotransferase From Baselineweek 240.87 U/LStandard Deviation 2.774
Arm 2 - Intermediate DoseChange in Aspartate Aminotransferase From Baselineweek 10.40 U/LStandard Deviation 4.768
Arm 2 - Intermediate DoseChange in Aspartate Aminotransferase From Baselineweek 42.53 U/LStandard Deviation 3.067
Arm 2 - Intermediate DoseChange in Aspartate Aminotransferase From Baselineweek 122.47 U/LStandard Deviation 4.533
Arm 3 - High DoseChange in Aspartate Aminotransferase From Baselineweek 240.07 U/LStandard Deviation 5.391
Arm 3 - High DoseChange in Aspartate Aminotransferase From Baselineweek 122.20 U/LStandard Deviation 4.109
Arm 3 - High DoseChange in Aspartate Aminotransferase From Baselineweek 81.13 U/LStandard Deviation 3.623
Arm 3 - High DoseChange in Aspartate Aminotransferase From Baselineweek 40.87 U/LStandard Deviation 4.015
Arm 3 - High DoseChange in Aspartate Aminotransferase From Baselineweek 1-0.40 U/LStandard Deviation 2.898
Arm 3 - High DoseChange in Aspartate Aminotransferase From Baselineweek 22.27 U/LStandard Deviation 3.262
Arm 4 - Low DoseChange in Aspartate Aminotransferase From Baselineweek 8-2.50 U/LStandard Deviation 4.487
Arm 4 - Low DoseChange in Aspartate Aminotransferase From Baselineweek 2-2.44 U/LStandard Deviation 5.151
Arm 4 - Low DoseChange in Aspartate Aminotransferase From Baselineweek 40.69 U/LStandard Deviation 4.191
Arm 4 - Low DoseChange in Aspartate Aminotransferase From Baselineweek 24-1.53 U/LStandard Deviation 4.357
Arm 4 - Low DoseChange in Aspartate Aminotransferase From Baselineweek 12.194 U/LStandard Deviation 4.106
Arm 4 - Low DoseChange in Aspartate Aminotransferase From Baselineweek 1-1.38 U/LStandard Deviation 4.53
Arm 5 - Intermediate DoseChange in Aspartate Aminotransferase From Baselineweek 13.93 U/LStandard Deviation 11.738
Arm 5 - Intermediate DoseChange in Aspartate Aminotransferase From Baselineweek 12-0.20 U/LStandard Deviation 3.986
Arm 5 - Intermediate DoseChange in Aspartate Aminotransferase From Baselineweek 20.07 U/LStandard Deviation 3.15
Arm 5 - Intermediate DoseChange in Aspartate Aminotransferase From Baselineweek 41.47 U/LStandard Deviation 3.72
Arm 5 - Intermediate DoseChange in Aspartate Aminotransferase From Baselineweek 81.13 U/LStandard Deviation 4.34
Arm 5 - Intermediate DoseChange in Aspartate Aminotransferase From Baselineweek 244.27 U/LStandard Deviation 18.763
Arm 6 - High DoseChange in Aspartate Aminotransferase From Baselineweek 8-0.93 U/LStandard Deviation 3.411
Arm 6 - High DoseChange in Aspartate Aminotransferase From Baselineweek 4-0.93 U/LStandard Deviation 3.24
Arm 6 - High DoseChange in Aspartate Aminotransferase From Baselineweek 120.13 U/LStandard Deviation 3.739
Arm 6 - High DoseChange in Aspartate Aminotransferase From Baselineweek 24-0.29 U/LStandard Deviation 3.384
Arm 6 - High DoseChange in Aspartate Aminotransferase From Baselineweek 2-0.80 U/LStandard Deviation 3.649
Arm 6 - High DoseChange in Aspartate Aminotransferase From Baselineweek 1-1.33 U/LStandard Deviation 2.38
Primary

Change in Basophils From Baseline

Time frame: Weeks 1,2,4,8,12, and 24

ArmMeasureGroupValue (MEAN)Dispersion
Arm 1 - Low DoseChange in Basophils From Baselineweek 1-0.002 10^9 basophils/LStandard Deviation 0.0094
Arm 1 - Low DoseChange in Basophils From Baselineweek 20.001 10^9 basophils/LStandard Deviation 0.0122
Arm 1 - Low DoseChange in Basophils From Baselineweek 120.002 10^9 basophils/LStandard Deviation 0.0142
Arm 1 - Low DoseChange in Basophils From Baselineweek 8-0.001 10^9 basophils/LStandard Deviation 0.0122
Arm 1 - Low DoseChange in Basophils From Baselineweek 24-0.004 10^9 basophils/LStandard Deviation 0.0135
Arm 1 - Low DoseChange in Basophils From Baselineweek 4-0.004 10^9 basophils/LStandard Deviation 0.0118
Arm 2 - Intermediate DoseChange in Basophils From Baselineweek 40.0 10^9 basophils/LStandard Deviation 0.012
Arm 2 - Intermediate DoseChange in Basophils From Baselineweek 240.004 10^9 basophils/LStandard Deviation 0.0112
Arm 2 - Intermediate DoseChange in Basophils From Baselineweek 20.007 10^9 basophils/LStandard Deviation 0.0129
Arm 2 - Intermediate DoseChange in Basophils From Baselineweek 1-0.002 10^9 basophils/LStandard Deviation 0.0147
Arm 2 - Intermediate DoseChange in Basophils From Baselineweek 80.001 10^9 basophils/LStandard Deviation 0.0133
Arm 2 - Intermediate DoseChange in Basophils From Baselineweek 120.003 10^9 basophils/LStandard Deviation 0.0159
Arm 3 - High DoseChange in Basophils From Baselineweek 2-0.002 10^9 basophils/LStandard Deviation 0.0142
Arm 3 - High DoseChange in Basophils From Baselineweek 1-0.010 10^9 basophils/LStandard Deviation 0.0169
Arm 3 - High DoseChange in Basophils From Baselineweek 120.0 10^9 basophils/LStandard Deviation 0.0108
Arm 3 - High DoseChange in Basophils From Baselineweek 4-0.003 10^9 basophils/LStandard Deviation 0.15
Arm 3 - High DoseChange in Basophils From Baselineweek 8-0.001 10^9 basophils/LStandard Deviation 0.0119
Arm 3 - High DoseChange in Basophils From Baselineweek 24-0.001 10^9 basophils/LStandard Deviation 0.0146
Arm 4 - Low DoseChange in Basophils From Baselineweek 8-0.002 10^9 basophils/LStandard Deviation 0.0164
Arm 4 - Low DoseChange in Basophils From Baselineweek 1-0.001 10^9 basophils/LStandard Deviation 0.0141
Arm 4 - Low DoseChange in Basophils From Baselineweek 40.001 10^9 basophils/LStandard Deviation 0.054
Arm 4 - Low DoseChange in Basophils From Baselineweek 20.004 10^9 basophils/LStandard Deviation 0.011
Arm 4 - Low DoseChange in Basophils From Baselineweek 120.0 10^9 basophils/LStandard Deviation 0.0121
Arm 4 - Low DoseChange in Basophils From Baselineweek 24-0.003 10^9 basophils/LStandard Deviation 0.0168
Arm 5 - Intermediate DoseChange in Basophils From Baselineweek 120.0 10^9 basophils/LStandard Deviation 0.0156
Arm 5 - Intermediate DoseChange in Basophils From Baselineweek 1-0.009 10^9 basophils/LStandard Deviation 0.0113
Arm 5 - Intermediate DoseChange in Basophils From Baselineweek 24-0.004 10^9 basophils/LStandard Deviation 0.014
Arm 5 - Intermediate DoseChange in Basophils From Baselineweek 4-0.003 10^9 basophils/LStandard Deviation 0.0129
Arm 5 - Intermediate DoseChange in Basophils From Baselineweek 20.003 10^9 basophils/LStandard Deviation 0.0272
Arm 5 - Intermediate DoseChange in Basophils From Baselineweek 8-0.005 10^9 basophils/LStandard Deviation 0.0092
Arm 6 - High DoseChange in Basophils From Baselineweek 24-0.001 10^9 basophils/LStandard Deviation 0.0141
Arm 6 - High DoseChange in Basophils From Baselineweek 1-0.001 10^9 basophils/LStandard Deviation 0.0162
Arm 6 - High DoseChange in Basophils From Baselineweek 20.004 10^9 basophils/LStandard Deviation 0.0124
Arm 6 - High DoseChange in Basophils From Baselineweek 40.004 10^9 basophils/LStandard Deviation 0.0199
Arm 6 - High DoseChange in Basophils From Baselineweek 120.002 10^9 basophils/LStandard Deviation 0.0142
Arm 6 - High DoseChange in Basophils From Baselineweek 80.003 10^9 basophils/LStandard Deviation 0.0116
Primary

Change in Bilirubin From Baseline

Time frame: week 1,2,4,8,12, and 24

ArmMeasureGroupValue (MEAN)Dispersion
Arm 1 - Low DoseChange in Bilirubin From Baselineweek 10.3534 umol/LStandard Deviation 3.7254
Arm 1 - Low DoseChange in Bilirubin From Baselineweek 21.1286 umol/LStandard Deviation 3.4315
Arm 1 - Low DoseChange in Bilirubin From Baselineweek 4-0.7068 umol/LStandard Deviation 3.0527
Arm 1 - Low DoseChange in Bilirubin From Baselineweek 82.1546 umol/LStandard Deviation 3.7037
Arm 1 - Low DoseChange in Bilirubin From Baselineweek 121.9038 umol/LStandard Deviation 6.9092
Arm 1 - Low DoseChange in Bilirubin From Baselineweek 24-0.7524 umol/LStandard Deviation 2.8223
Arm 2 - Intermediate DoseChange in Bilirubin From Baselineweek 2-0.1938 umol/LStandard Deviation 3.5435
Arm 2 - Intermediate DoseChange in Bilirubin From Baselineweek 80.2280 umol/LStandard Deviation 3.282
Arm 2 - Intermediate DoseChange in Bilirubin From Baselineweek 240.05586 umol/LStandard Deviation 3.9258
Arm 2 - Intermediate DoseChange in Bilirubin From Baselineweek 1-1.1970 umol/LStandard Deviation 3.7725
Arm 2 - Intermediate DoseChange in Bilirubin From Baselineweek 41.0146 umol/LStandard Deviation 3.526
Arm 2 - Intermediate DoseChange in Bilirubin From Baselineweek 120.3078 umol/LStandard Deviation 3.7354
Arm 3 - High DoseChange in Bilirubin From Baselineweek 2423.9286 umol/LStandard Deviation 91.7547
Arm 3 - High DoseChange in Bilirubin From Baselineweek 12-0.6954 umol/LStandard Deviation 5.6701
Arm 3 - High DoseChange in Bilirubin From Baselineweek 80.2052 umol/LStandard Deviation 7.1427
Arm 3 - High DoseChange in Bilirubin From Baselineweek 4-0.2736 umol/LStandard Deviation 6.4174
Arm 3 - High DoseChange in Bilirubin From Baselineweek 10.1048 umol/LStandard Deviation 5.4294
Arm 3 - High DoseChange in Bilirubin From Baselineweek 2-0.1824 umol/LStandard Deviation 4.4841
Arm 4 - Low DoseChange in Bilirubin From Baselineweek 80.0534 umol/LStandard Deviation 3.9465
Arm 4 - Low DoseChange in Bilirubin From Baselineweek 2-0.4275 umol/LStandard Deviation 2.54871
Arm 4 - Low DoseChange in Bilirubin From Baselineweek 40.1176 umol/LStandard Deviation 2.9557
Arm 4 - Low DoseChange in Bilirubin From Baselineweek 24-0.0114 umol/LStandard Deviation 3.467
Arm 4 - Low DoseChange in Bilirubin From Baselineweek 12-1.1222 umol/LStandard Deviation 2.5108
Arm 4 - Low DoseChange in Bilirubin From Baselineweek 10.0641 umol/LStandard Deviation 4.2155
Arm 5 - Intermediate DoseChange in Bilirubin From Baselineweek 1-0.0228 umol/LStandard Deviation 3.5705
Arm 5 - Intermediate DoseChange in Bilirubin From Baselineweek 12-2.6220 umol/LStandard Deviation 2.896
Arm 5 - Intermediate DoseChange in Bilirubin From Baselineweek 2-0.7980 umol/LStandard Deviation 1.7181
Arm 5 - Intermediate DoseChange in Bilirubin From Baselineweek 4-0.0456 umol/LStandard Deviation 2.7064
Arm 5 - Intermediate DoseChange in Bilirubin From Baselineweek 8-0.5244 umol/LStandard Deviation 3.0702
Arm 5 - Intermediate DoseChange in Bilirubin From Baselineweek 24-0.3078 umol/LStandard Deviation 4.4235
Arm 6 - High DoseChange in Bilirubin From Baselineweek 8-0.3192 umol/LStandard Deviation 1.9269
Arm 6 - High DoseChange in Bilirubin From Baselineweek 4-0.6954 umol/LStandard Deviation 2.9706
Arm 6 - High DoseChange in Bilirubin From Baselineweek 12-0.3420 umol/LStandard Deviation 3.1431
Arm 6 - High DoseChange in Bilirubin From Baselineweek 24-0.1954 umol/LStandard Deviation 2.9227
Arm 6 - High DoseChange in Bilirubin From Baselineweek 2-0.7069 umol/LStandard Deviation 2.5436
Arm 6 - High DoseChange in Bilirubin From Baselineweek 10.5586 umol/LStandard Deviation 2.8697
Primary

Change in Creatinine Form Baseline

Time frame: week 1,2,4,8,12, and 24

ArmMeasureGroupValue (MEAN)Dispersion
Arm 1 - Low DoseChange in Creatinine Form Baselineweek 1-0.6483 umol/LStandard Deviation 5.2878
Arm 1 - Low DoseChange in Creatinine Form Baselineweek 21.5323 umol/LStandard Deviation 5.3404
Arm 1 - Low DoseChange in Creatinine Form Baselineweek 4-2.3575 umol/LStandard Deviation 4.4284
Arm 1 - Low DoseChange in Creatinine Form Baselineweek 82.2116 umol/LStandard Deviation 6.3904
Arm 1 - Low DoseChange in Creatinine Form Baselineweek 120.5893 umol/LStandard Deviation 6.861
Arm 1 - Low DoseChange in Creatinine Form Baselineweek 24-4.9504 umol/LStandard Deviation 5.6088
Arm 2 - Intermediate DoseChange in Creatinine Form Baselineweek 2-2.1805 umol/LStandard Deviation 4.9992
Arm 2 - Intermediate DoseChange in Creatinine Form Baselineweek 8-0.3536 umol/LStandard Deviation 5.6088
Arm 2 - Intermediate DoseChange in Creatinine Form Baselineweek 24-2.0037 umol/LStandard Deviation 4.6112
Arm 2 - Intermediate DoseChange in Creatinine Form Baselineweek 1-2.9467 umol/LStandard Deviation 5.8701
Arm 2 - Intermediate DoseChange in Creatinine Form Baselineweek 4-4.2432 umol/LStandard Deviation 4.7511
Arm 2 - Intermediate DoseChange in Creatinine Form Baselineweek 12-2.8288 umol/LStandard Deviation 5.5929
Arm 3 - High DoseChange in Creatinine Form Baselineweek 24-0.11799 umol/LStandard Deviation 5.382
Arm 3 - High DoseChange in Creatinine Form Baselineweek 121.1787 umol/LStandard Deviation 3.268
Arm 3 - High DoseChange in Creatinine Form Baselineweek 82.4163 umol/LStandard Deviation 3.0889
Arm 3 - High DoseChange in Creatinine Form Baselineweek 41.6501 umol/LStandard Deviation 5.2284
Arm 3 - High DoseChange in Creatinine Form Baselineweek 11.4733 umol/LStandard Deviation 3.9908
Arm 3 - High DoseChange in Creatinine Form Baselineweek 22.1216 umol/LStandard Deviation 37176
Arm 4 - Low DoseChange in Creatinine Form Baselineweek 8-3.228 umol/LStandard Deviation 8.9278
Arm 4 - Low DoseChange in Creatinine Form Baselineweek 20.3315 umol/LStandard Deviation 7.9125
Arm 4 - Low DoseChange in Creatinine Form Baselineweek 4-2.4310 umol/LStandard Deviation 8.96
Arm 4 - Low DoseChange in Creatinine Form Baselineweek 24-4.2432 umol/LStandard Deviation 9.2244
Arm 4 - Low DoseChange in Creatinine Form Baselineweek 12-3.0940 umol/LStandard Deviation 10.4097
Arm 4 - Low DoseChange in Creatinine Form Baselineweek 1-4.0333 umol/LStandard Deviation 8.5827
Arm 5 - Intermediate DoseChange in Creatinine Form Baselineweek 11.2963 umol/LStandard Deviation 9.553
Arm 5 - Intermediate DoseChange in Creatinine Form Baselineweek 12-4.4789 umol/LStandard Deviation 6.7279
Arm 5 - Intermediate DoseChange in Creatinine Form Baselineweek 20.3536 umol/LStandard Deviation 5.9657
Arm 5 - Intermediate DoseChange in Creatinine Form Baselineweek 4-1.8959 umol/LStandard Deviation 6.6394
Arm 5 - Intermediate DoseChange in Creatinine Form Baselineweek 8-1.5912 umol/LStandard Deviation 4.6442
Arm 5 - Intermediate DoseChange in Creatinine Form Baselineweek 24-3.1824 umol/LStandard Deviation 5.9751
Arm 6 - High DoseChange in Creatinine Form Baselineweek 8-2.1216 umol/LStandard Deviation 5.4779
Arm 6 - High DoseChange in Creatinine Form Baselineweek 4-1.7680 umol/LStandard Deviation 5.9017
Arm 6 - High DoseChange in Creatinine Form Baselineweek 12-3.2413 umol/LStandard Deviation 5.6175
Arm 6 - High DoseChange in Creatinine Form Baselineweek 24-1.6417 umol/LStandard Deviation 7.1888
Arm 6 - High DoseChange in Creatinine Form Baselineweek 2-1.3555 umol/LStandard Deviation 6.7561
Arm 6 - High DoseChange in Creatinine Form Baselineweek 1-0.5304 umol/LStandard Deviation 7.3491
Primary

Change in Direct Bilirubin Form Baseline

Time frame: week 1,2,4,8,12, and 24

ArmMeasureGroupValue (MEAN)Dispersion
Arm 1 - Low DoseChange in Direct Bilirubin Form Baselineweek 10.1026 umol/LStandard Deviation 0.9712
Arm 1 - Low DoseChange in Direct Bilirubin Form Baselineweek 20.4140 umol/LStandard Deviation 0.8857
Arm 1 - Low DoseChange in Direct Bilirubin Form Baselineweek 40.1140 umol/LStandard Deviation 0.7907
Arm 1 - Low DoseChange in Direct Bilirubin Form Baselineweek 80.6498 umol/LStandard Deviation 0.8155
Arm 1 - Low DoseChange in Direct Bilirubin Form Baselineweek 120.4789 umol/LStandard Deviation 1.4059
Arm 1 - Low DoseChange in Direct Bilirubin Form Baselineweek 240.0114 umol/LStandard Deviation 0.861
Arm 2 - Intermediate DoseChange in Direct Bilirubin Form Baselineweek 24.5942 umol/LStandard Deviation 17.862
Arm 2 - Intermediate DoseChange in Direct Bilirubin Form Baselineweek 80.2394 umol/LStandard Deviation 0.9362
Arm 2 - Intermediate DoseChange in Direct Bilirubin Form Baselineweek 240.0689 umol/LStandard Deviation 0.9883
Arm 2 - Intermediate DoseChange in Direct Bilirubin Form Baselineweek 1-0.3420 umol/LStandard Deviation 0.995
Arm 2 - Intermediate DoseChange in Direct Bilirubin Form Baselineweek 40.3762 umol/LStandard Deviation 0.9053
Arm 2 - Intermediate DoseChange in Direct Bilirubin Form Baselineweek 120.1938 umol/LStandard Deviation 0.9209
Arm 3 - High DoseChange in Direct Bilirubin Form Baselineweek 24-0.1482 umol/LStandard Deviation 2.1081
Arm 3 - High DoseChange in Direct Bilirubin Form Baselineweek 12-0.3534 umol/LStandard Deviation 1.3718
Arm 3 - High DoseChange in Direct Bilirubin Form Baselineweek 8-0.1026 umol/LStandard Deviation 1.8449
Arm 3 - High DoseChange in Direct Bilirubin Form Baselineweek 4-0.1710 umol/LStandard Deviation 1.6503
Arm 3 - High DoseChange in Direct Bilirubin Form Baselineweek 1-0.2622 umol/LStandard Deviation 1.5375
Arm 3 - High DoseChange in Direct Bilirubin Form Baselineweek 2-0.1482 umol/LStandard Deviation 1.1559
Arm 4 - Low DoseChange in Direct Bilirubin Form Baselineweek 80.0962 umol/LStandard Deviation 1.1945
Arm 4 - Low DoseChange in Direct Bilirubin Form Baselineweek 2-0.1603 umol/LStandard Deviation 0.6767
Arm 4 - Low DoseChange in Direct Bilirubin Form Baselineweek 4-0.0107 umol/LStandard Deviation 0.7835
Arm 4 - Low DoseChange in Direct Bilirubin Form Baselineweek 240.1254 umol/LStandard Deviation 0.9531
Arm 4 - Low DoseChange in Direct Bilirubin Form Baselineweek 12-0.1603 umol/LStandard Deviation 0.8365
Arm 4 - Low DoseChange in Direct Bilirubin Form Baselineweek 1-0.0214 umol/LStandard Deviation 1.0992
Arm 5 - Intermediate DoseChange in Direct Bilirubin Form Baselineweek 10.2280 umol/LStandard Deviation 0.8878
Arm 5 - Intermediate DoseChange in Direct Bilirubin Form Baselineweek 12-0.6270 umol/LStandard Deviation 0.772
Arm 5 - Intermediate DoseChange in Direct Bilirubin Form Baselineweek 2-0.0684 umol/LStandard Deviation 0.0504
Arm 5 - Intermediate DoseChange in Direct Bilirubin Form Baselineweek 40.0570 umol/LStandard Deviation 0.7331
Arm 5 - Intermediate DoseChange in Direct Bilirubin Form Baselineweek 80.0570 umol/LStandard Deviation 0.8783
Arm 5 - Intermediate DoseChange in Direct Bilirubin Form Baselineweek 24-0.0342 umol/LStandard Deviation 1.2181
Arm 6 - High DoseChange in Direct Bilirubin Form Baselineweek 80.1140 umol/LStandard Deviation 0.6452
Arm 6 - High DoseChange in Direct Bilirubin Form Baselineweek 4-0.1254 umol/LStandard Deviation 0.8802
Arm 6 - High DoseChange in Direct Bilirubin Form Baselineweek 12-0.0228 umol/LStandard Deviation 0.8547
Arm 6 - High DoseChange in Direct Bilirubin Form Baselineweek 240.1710 umol/LStandard Deviation 0.6938
Arm 6 - High DoseChange in Direct Bilirubin Form Baselineweek 2-0.0570 umol/LStandard Deviation 0.7129
Arm 6 - High DoseChange in Direct Bilirubin Form Baselineweek 10.2280 umol/LStandard Deviation 0.8419
Primary

Change in Eosinophils From Baseline

Time frame: Weeks 1,2,4,8,12, and 24

ArmMeasureGroupValue (MEAN)Dispersion
Arm 1 - Low DoseChange in Eosinophils From Baselineweek 20.014 10^9 eosinophils /LStandard Deviation 0.037
Arm 1 - Low DoseChange in Eosinophils From Baselineweek 12-0.004 10^9 eosinophils /LStandard Deviation 0.084
Arm 1 - Low DoseChange in Eosinophils From Baselineweek 8-0.023 10^9 eosinophils /LStandard Deviation 0.0716
Arm 1 - Low DoseChange in Eosinophils From Baselineweek 24-0.051 10^9 eosinophils /LStandard Deviation 0.0907
Arm 1 - Low DoseChange in Eosinophils From Baselineweek 4-0.013 10^9 eosinophils /LStandard Deviation 0.0873
Arm 1 - Low DoseChange in Eosinophils From Baselineweek 10.009 10^9 eosinophils /LStandard Deviation 0.0478
Arm 2 - Intermediate DoseChange in Eosinophils From Baselineweek 4-0.003 10^9 eosinophils /LStandard Deviation 0.0603
Arm 2 - Intermediate DoseChange in Eosinophils From Baselineweek 24-0.013 10^9 eosinophils /LStandard Deviation 0.0807
Arm 2 - Intermediate DoseChange in Eosinophils From Baselineweek 20.029 10^9 eosinophils /LStandard Deviation 0.0644
Arm 2 - Intermediate DoseChange in Eosinophils From Baselineweek 1-0.017 10^9 eosinophils /LStandard Deviation 0.0649
Arm 2 - Intermediate DoseChange in Eosinophils From Baselineweek 8-0.002 10^9 eosinophils /LStandard Deviation 0.1202
Arm 2 - Intermediate DoseChange in Eosinophils From Baselineweek 12-0.017 10^9 eosinophils /LStandard Deviation 0.077
Arm 3 - High DoseChange in Eosinophils From Baselineweek 12-0.013 10^9 eosinophils /LStandard Deviation 0.1085
Arm 3 - High DoseChange in Eosinophils From Baselineweek 20.024 10^9 eosinophils /LStandard Deviation 0.0697
Arm 3 - High DoseChange in Eosinophils From Baselineweek 240.008 10^9 eosinophils /LStandard Deviation 0.1239
Arm 3 - High DoseChange in Eosinophils From Baselineweek 1-0.007 10^9 eosinophils /LStandard Deviation 0.0555
Arm 3 - High DoseChange in Eosinophils From Baselineweek 8-0.033 10^9 eosinophils /LStandard Deviation 0.0979
Arm 3 - High DoseChange in Eosinophils From Baselineweek 4-0.003 10^9 eosinophils /LStandard Deviation 0.0471
Arm 4 - Low DoseChange in Eosinophils From Baselineweek 80.010 10^9 eosinophils /LStandard Deviation 0.0732
Arm 4 - Low DoseChange in Eosinophils From Baselineweek 4-0.008 10^9 eosinophils /LStandard Deviation 0.068
Arm 4 - Low DoseChange in Eosinophils From Baselineweek 20.046 10^9 eosinophils /LStandard Deviation 0.0574
Arm 4 - Low DoseChange in Eosinophils From Baselineweek 10.031 10^9 eosinophils /LStandard Deviation 0.0483
Arm 4 - Low DoseChange in Eosinophils From Baselineweek 12-0.001 10^9 eosinophils /LStandard Deviation 0.0804
Arm 4 - Low DoseChange in Eosinophils From Baselineweek 240.012 10^9 eosinophils /LStandard Deviation 0.0914
Arm 5 - Intermediate DoseChange in Eosinophils From Baselineweek 120.007 10^9 eosinophils /LStandard Deviation 0.0707
Arm 5 - Intermediate DoseChange in Eosinophils From Baselineweek 240.015 10^9 eosinophils /LStandard Deviation 0.0635
Arm 5 - Intermediate DoseChange in Eosinophils From Baselineweek 40.001 10^9 eosinophils /LStandard Deviation 0.0442
Arm 5 - Intermediate DoseChange in Eosinophils From Baselineweek 20.037 10^9 eosinophils /LStandard Deviation 0.0743
Arm 5 - Intermediate DoseChange in Eosinophils From Baselineweek 80.006 10^9 eosinophils /LStandard Deviation 0.0617
Arm 5 - Intermediate DoseChange in Eosinophils From Baselineweek 10.009 10^9 eosinophils /LStandard Deviation 0.0674
Arm 6 - High DoseChange in Eosinophils From Baselineweek 240.018 10^9 eosinophils /LStandard Deviation 0.0477
Arm 6 - High DoseChange in Eosinophils From Baselineweek 10.006 10^9 eosinophils /LStandard Deviation 0.0467
Arm 6 - High DoseChange in Eosinophils From Baselineweek 20.021 10^9 eosinophils /LStandard Deviation 0.0439
Arm 6 - High DoseChange in Eosinophils From Baselineweek 40.027 10^9 eosinophils /LStandard Deviation 0.087
Arm 6 - High DoseChange in Eosinophils From Baselineweek 120.02 10^9 eosinophils /LStandard Deviation 0.0728
Arm 6 - High DoseChange in Eosinophils From Baselineweek 80.021 10^9 eosinophils /LStandard Deviation 0.0935
Primary

Change in Erythrocytes From Baseline

Time frame: Weeks 1,2,4,8,12, and 24

ArmMeasureGroupValue (MEAN)Dispersion
Arm 1 - Low DoseChange in Erythrocytes From Baselineweek 1-0.091 10^12 Erythrocytes /LStandard Deviation 0.1603
Arm 1 - Low DoseChange in Erythrocytes From Baselineweek 20.001 10^12 Erythrocytes /LStandard Deviation 0.01757
Arm 1 - Low DoseChange in Erythrocytes From Baselineweek 4-0.065 10^12 Erythrocytes /LStandard Deviation 0.2011
Arm 1 - Low DoseChange in Erythrocytes From Baselineweek 80.026 10^12 Erythrocytes /LStandard Deviation 0.2133
Arm 1 - Low DoseChange in Erythrocytes From Baselineweek 120.054 10^12 Erythrocytes /LStandard Deviation 0.1722
Arm 1 - Low DoseChange in Erythrocytes From Baselineweek 240.007 10^12 Erythrocytes /LStandard Deviation 0.2073
Arm 2 - Intermediate DoseChange in Erythrocytes From Baselineweek 2-0.093 10^12 Erythrocytes /LStandard Deviation 0.22
Arm 2 - Intermediate DoseChange in Erythrocytes From Baselineweek 80.002 10^12 Erythrocytes /LStandard Deviation 0.232
Arm 2 - Intermediate DoseChange in Erythrocytes From Baselineweek 24-0.046 10^12 Erythrocytes /LStandard Deviation 0.2601
Arm 2 - Intermediate DoseChange in Erythrocytes From Baselineweek 1-0.067 10^12 Erythrocytes /LStandard Deviation 0.2342
Arm 2 - Intermediate DoseChange in Erythrocytes From Baselineweek 4-0.059 10^12 Erythrocytes /LStandard Deviation 0.2081
Arm 2 - Intermediate DoseChange in Erythrocytes From Baselineweek 12-0.036 10^12 Erythrocytes /LStandard Deviation 0.326
Arm 3 - High DoseChange in Erythrocytes From Baselineweek 240.001 10^12 Erythrocytes /LStandard Deviation 0.2936
Arm 3 - High DoseChange in Erythrocytes From Baselineweek 120.027 10^12 Erythrocytes /LStandard Deviation 0.3375
Arm 3 - High DoseChange in Erythrocytes From Baselineweek 80.047 10^12 Erythrocytes /LStandard Deviation 0.3186
Arm 3 - High DoseChange in Erythrocytes From Baselineweek 4-0.039 10^12 Erythrocytes /LStandard Deviation 0.2599
Arm 3 - High DoseChange in Erythrocytes From Baselineweek 1-0.037 10^12 Erythrocytes /LStandard Deviation 0.1574
Arm 3 - High DoseChange in Erythrocytes From Baselineweek 2-0.037 10^12 Erythrocytes /LStandard Deviation 0.2251
Arm 4 - Low DoseChange in Erythrocytes From Baselineweek 8-0.024 10^12 Erythrocytes /LStandard Deviation 0.2767
Arm 4 - Low DoseChange in Erythrocytes From Baselineweek 2-0.084 10^12 Erythrocytes /LStandard Deviation 0.166
Arm 4 - Low DoseChange in Erythrocytes From Baselineweek 4-0.059 10^12 Erythrocytes /LStandard Deviation 0.2024
Arm 4 - Low DoseChange in Erythrocytes From Baselineweek 240.018 10^12 Erythrocytes /LStandard Deviation 0.2453
Arm 4 - Low DoseChange in Erythrocytes From Baselineweek 12-0.013 10^12 Erythrocytes /LStandard Deviation 0.2587
Arm 4 - Low DoseChange in Erythrocytes From Baselineweek 1-0.0158 10^12 Erythrocytes /LStandard Deviation 0.2014
Arm 5 - Intermediate DoseChange in Erythrocytes From Baselineweek 1-0.066 10^12 Erythrocytes /LStandard Deviation 0.2763
Arm 5 - Intermediate DoseChange in Erythrocytes From Baselineweek 12-0.045 10^12 Erythrocytes /LStandard Deviation 0.268
Arm 5 - Intermediate DoseChange in Erythrocytes From Baselineweek 2-0.073 10^12 Erythrocytes /LStandard Deviation 0.2447
Arm 5 - Intermediate DoseChange in Erythrocytes From Baselineweek 4-0.119 10^12 Erythrocytes /LStandard Deviation 0.2456
Arm 5 - Intermediate DoseChange in Erythrocytes From Baselineweek 8-0.061 10^12 Erythrocytes /LStandard Deviation 0.3035
Arm 5 - Intermediate DoseChange in Erythrocytes From Baselineweek 24-0.058 10^12 Erythrocytes /LStandard Deviation 0.2505
Arm 6 - High DoseChange in Erythrocytes From Baselineweek 8-0.034 10^12 Erythrocytes /LStandard Deviation 0.1874
Arm 6 - High DoseChange in Erythrocytes From Baselineweek 4-0.079 10^12 Erythrocytes /LStandard Deviation 0.1122
Arm 6 - High DoseChange in Erythrocytes From Baselineweek 12-0.070 10^12 Erythrocytes /LStandard Deviation 0.1488
Arm 6 - High DoseChange in Erythrocytes From Baselineweek 24-0.062 10^12 Erythrocytes /LStandard Deviation 0.1691
Arm 6 - High DoseChange in Erythrocytes From Baselineweek 2-0.149 10^12 Erythrocytes /LStandard Deviation 0.0896
Arm 6 - High DoseChange in Erythrocytes From Baselineweek 1-0.074 10^12 Erythrocytes /LStandard Deviation 0.1644
Primary

Change in Hematocrit From Baseline

Time frame: Weeks 1,2,4,8,12, and 24

ArmMeasureGroupValue (MEAN)Dispersion
Arm 1 - Low DoseChange in Hematocrit From Baselineweek 240.21 percentage of TotalStandard Deviation 1.758
Arm 1 - Low DoseChange in Hematocrit From Baselineweek 1-1.16 percentage of TotalStandard Deviation 1.446
Arm 1 - Low DoseChange in Hematocrit From Baselineweek 120.31 percentage of TotalStandard Deviation 1.594
Arm 1 - Low DoseChange in Hematocrit From Baselineweek 2-0.19 percentage of TotalStandard Deviation 1.552
Arm 1 - Low DoseChange in Hematocrit From Baselineweek 4-0.59 percentage of TotalStandard Deviation 1.492
Arm 1 - Low DoseChange in Hematocrit From Baselineweek 80.26 percentage of TotalStandard Deviation 1.95
Arm 2 - Intermediate DoseChange in Hematocrit From Baselineweek 4-0.41 percentage of TotalStandard Deviation 2.004
Arm 2 - Intermediate DoseChange in Hematocrit From Baselineweek 8.047 percentage of TotalStandard Deviation 2.132
Arm 2 - Intermediate DoseChange in Hematocrit From Baselineweek 1-0.50 percentage of TotalStandard Deviation 2.429
Arm 2 - Intermediate DoseChange in Hematocrit From Baselineweek 12-0.32 percentage of TotalStandard Deviation 3.175
Arm 2 - Intermediate DoseChange in Hematocrit From Baselineweek 2-0.49 percentage of TotalStandard Deviation 2.086
Arm 2 - Intermediate DoseChange in Hematocrit From Baselineweek 24-0.29 percentage of TotalStandard Deviation 2.534
Arm 3 - High DoseChange in Hematocrit From Baselineweek 80.85 percentage of TotalStandard Deviation 2.857
Arm 3 - High DoseChange in Hematocrit From Baselineweek 240.62 percentage of TotalStandard Deviation 2.02
Arm 3 - High DoseChange in Hematocrit From Baselineweek 2-0.33 percentage of TotalStandard Deviation 1.991
Arm 3 - High DoseChange in Hematocrit From Baselineweek 120.61 percentage of TotalStandard Deviation 2.312
Arm 3 - High DoseChange in Hematocrit From Baselineweek 40.15 percentage of TotalStandard Deviation 2.091
Arm 3 - High DoseChange in Hematocrit From Baselineweek 1-0.35 percentage of TotalStandard Deviation 1.28
Arm 4 - Low DoseChange in Hematocrit From Baselineweek 4-0.41 percentage of TotalStandard Deviation 2.339
Arm 4 - Low DoseChange in Hematocrit From Baselineweek 12-0.13 percentage of TotalStandard Deviation 2.819
Arm 4 - Low DoseChange in Hematocrit From Baselineweek 8-0.04 percentage of TotalStandard Deviation 2.79
Arm 4 - Low DoseChange in Hematocrit From Baselineweek 1-1.81 percentage of TotalStandard Deviation 2.05
Arm 4 - Low DoseChange in Hematocrit From Baselineweek 2-0.52 percentage of TotalStandard Deviation 2.004
Arm 4 - Low DoseChange in Hematocrit From Baselineweek 240.32 percentage of TotalStandard Deviation 2.511
Arm 5 - Intermediate DoseChange in Hematocrit From Baselineweek 1-1.38 percentage of TotalStandard Deviation 2.155
Arm 5 - Intermediate DoseChange in Hematocrit From Baselineweek 2-0.80 percentage of TotalStandard Deviation 2.267
Arm 5 - Intermediate DoseChange in Hematocrit From Baselineweek 12-0.49 percentage of TotalStandard Deviation 2.511
Arm 5 - Intermediate DoseChange in Hematocrit From Baselineweek 4-1.26 percentage of TotalStandard Deviation 2.16
Arm 5 - Intermediate DoseChange in Hematocrit From Baselineweek 24-0.81 percentage of TotalStandard Deviation 2.255
Arm 5 - Intermediate DoseChange in Hematocrit From Baselineweek 8-0.91 percentage of TotalStandard Deviation 2.775
Arm 6 - High DoseChange in Hematocrit From Baselineweek 24-0.79 percentage of TotalStandard Deviation 1.389
Arm 6 - High DoseChange in Hematocrit From Baselineweek 1-0.59 percentage of TotalStandard Deviation 1.499
Arm 6 - High DoseChange in Hematocrit From Baselineweek 2-1.47 percentage of TotalStandard Deviation 0.647
Arm 6 - High DoseChange in Hematocrit From Baselineweek 4-0.78 percentage of TotalStandard Deviation 0.986
Arm 6 - High DoseChange in Hematocrit From Baselineweek 12-0.59 percentage of TotalStandard Deviation 1.47
Arm 6 - High DoseChange in Hematocrit From Baselineweek 80.05 percentage of TotalStandard Deviation 2.017
Primary

Change in Hemoglobin From Baseline

Time frame: Weeks 1,2,4,8,12, and 24

ArmMeasureGroupValue (MEAN)Dispersion
Arm 1 - Low DoseChange in Hemoglobin From Baselineweek 1-3.6 g/LStandard Deviation 5.21
Arm 1 - Low DoseChange in Hemoglobin From Baselineweek 2-0.8 g/LStandard Deviation 5.54
Arm 1 - Low DoseChange in Hemoglobin From Baselineweek 4-2.3 g/LStandard Deviation 5.86
Arm 1 - Low DoseChange in Hemoglobin From Baselineweek 83.5 g/LStandard Deviation 6.15
Arm 1 - Low DoseChange in Hemoglobin From Baselineweek 12-2.0 g/LStandard Deviation 4.93
Arm 1 - Low DoseChange in Hemoglobin From Baselineweek 24-0.8 g/LStandard Deviation 6.13
Arm 2 - Intermediate DoseChange in Hemoglobin From Baselineweek 2-2.6 g/LStandard Deviation 6.33
Arm 2 - Intermediate DoseChange in Hemoglobin From Baselineweek 8-2.9 g/LStandard Deviation 6.61
Arm 2 - Intermediate DoseChange in Hemoglobin From Baselineweek 24-3.1 g/LStandard Deviation 7.55
Arm 2 - Intermediate DoseChange in Hemoglobin From Baselineweek 1-2.1 g/LStandard Deviation 6.31
Arm 2 - Intermediate DoseChange in Hemoglobin From Baselineweek 4-4.8 g/LStandard Deviation 6.05
Arm 2 - Intermediate DoseChange in Hemoglobin From Baselineweek 12-2.6 g/LStandard Deviation 8.94
Arm 3 - High DoseChange in Hemoglobin From Baselineweek 240.1 g/LStandard Deviation 8.09
Arm 3 - High DoseChange in Hemoglobin From Baselineweek 120.1 g/LStandard Deviation 8.71
Arm 3 - High DoseChange in Hemoglobin From Baselineweek 8-0.9 g/LStandard Deviation 8.2
Arm 3 - High DoseChange in Hemoglobin From Baselineweek 4-5.8 g/LStandard Deviation 6.66
Arm 3 - High DoseChange in Hemoglobin From Baselineweek 1-2.3 g/LStandard Deviation 4.89
Arm 3 - High DoseChange in Hemoglobin From Baselineweek 2-2.8 g/LStandard Deviation 6.14
Arm 4 - Low DoseChange in Hemoglobin From Baselineweek 80.3 g/LStandard Deviation 7.84
Arm 4 - Low DoseChange in Hemoglobin From Baselineweek 2-3.3 g/LStandard Deviation 5.51
Arm 4 - Low DoseChange in Hemoglobin From Baselineweek 4-1.6 g/LStandard Deviation 6.55
Arm 4 - Low DoseChange in Hemoglobin From Baselineweek 242.8 g/LStandard Deviation 6.97
Arm 4 - Low DoseChange in Hemoglobin From Baselineweek 121.8 g/LStandard Deviation 8.07
Arm 4 - Low DoseChange in Hemoglobin From Baselineweek 1-4.5 g/LStandard Deviation 5.7
Arm 5 - Intermediate DoseChange in Hemoglobin From Baselineweek 1-1.7 g/LStandard Deviation 7.07
Arm 5 - Intermediate DoseChange in Hemoglobin From Baselineweek 120.6 g/LStandard Deviation 7.89
Arm 5 - Intermediate DoseChange in Hemoglobin From Baselineweek 2-2.1 g/LStandard Deviation 7.45
Arm 5 - Intermediate DoseChange in Hemoglobin From Baselineweek 4-1.9 g/LStandard Deviation 7.52
Arm 5 - Intermediate DoseChange in Hemoglobin From Baselineweek 8-1.6 g/LStandard Deviation 9.45
Arm 5 - Intermediate DoseChange in Hemoglobin From Baselineweek 24-0.2 g/LStandard Deviation 7.88
Arm 6 - High DoseChange in Hemoglobin From Baselineweek 82.4 g/LStandard Deviation 4.87
Arm 6 - High DoseChange in Hemoglobin From Baselineweek 41.5 g/LStandard Deviation 5.01
Arm 6 - High DoseChange in Hemoglobin From Baselineweek 120.3 g/LStandard Deviation 5.74
Arm 6 - High DoseChange in Hemoglobin From Baselineweek 24-0.1 g/LStandard Deviation 5.45
Arm 6 - High DoseChange in Hemoglobin From Baselineweek 2-3.0 g/LStandard Deviation 3.25
Arm 6 - High DoseChange in Hemoglobin From Baselineweek 1-2.2 g/LStandard Deviation 4.44
Primary

Change in Lactate Dehydrogenase From Baseline

Time frame: week 1,2,4,8,12, and 24

ArmMeasureGroupValue (MEAN)Dispersion
Arm 1 - Low DoseChange in Lactate Dehydrogenase From Baselineweek 1-3.5 U/LStandard Deviation 12.69
Arm 1 - Low DoseChange in Lactate Dehydrogenase From Baselineweek 28.4 U/LStandard Deviation 35.25
Arm 1 - Low DoseChange in Lactate Dehydrogenase From Baselineweek 4-3.0 U/LStandard Deviation 16.46
Arm 1 - Low DoseChange in Lactate Dehydrogenase From Baselineweek 8-4.3 U/LStandard Deviation 10.31
Arm 1 - Low DoseChange in Lactate Dehydrogenase From Baselineweek 12-9.1 U/LStandard Deviation 13.48
Arm 1 - Low DoseChange in Lactate Dehydrogenase From Baselineweek 24-9.4 U/LStandard Deviation 18.26
Arm 2 - Intermediate DoseChange in Lactate Dehydrogenase From Baselineweek 21.4 U/LStandard Deviation 21.89
Arm 2 - Intermediate DoseChange in Lactate Dehydrogenase From Baselineweek 8-2.4 U/LStandard Deviation 16.82
Arm 2 - Intermediate DoseChange in Lactate Dehydrogenase From Baselineweek 24-3.3 U/LStandard Deviation 20.58
Arm 2 - Intermediate DoseChange in Lactate Dehydrogenase From Baselineweek 10.5 U/LStandard Deviation 20
Arm 2 - Intermediate DoseChange in Lactate Dehydrogenase From Baselineweek 4-1.7 U/LStandard Deviation 18.67
Arm 2 - Intermediate DoseChange in Lactate Dehydrogenase From Baselineweek 12-3.8 U/LStandard Deviation 20.23
Arm 3 - High DoseChange in Lactate Dehydrogenase From Baselineweek 24-2.1 U/LStandard Deviation 12.06
Arm 3 - High DoseChange in Lactate Dehydrogenase From Baselineweek 121.3 U/LStandard Deviation 16.86
Arm 3 - High DoseChange in Lactate Dehydrogenase From Baselineweek 814.2 U/LStandard Deviation 24.4
Arm 3 - High DoseChange in Lactate Dehydrogenase From Baselineweek 45.1 U/LStandard Deviation 15.34
Arm 3 - High DoseChange in Lactate Dehydrogenase From Baselineweek 16.5 U/LStandard Deviation 15.62
Arm 3 - High DoseChange in Lactate Dehydrogenase From Baselineweek 27.3 U/LStandard Deviation 17.99
Arm 4 - Low DoseChange in Lactate Dehydrogenase From Baselineweek 8-11.2 U/LStandard Deviation 17.86
Arm 4 - Low DoseChange in Lactate Dehydrogenase From Baselineweek 2-7.0 U/LStandard Deviation 20.64
Arm 4 - Low DoseChange in Lactate Dehydrogenase From Baselineweek 42.1 U/LStandard Deviation 12.37
Arm 4 - Low DoseChange in Lactate Dehydrogenase From Baselineweek 24-10.0 U/LStandard Deviation 19.42
Arm 4 - Low DoseChange in Lactate Dehydrogenase From Baselineweek 12-10.1 U/LStandard Deviation 17.55
Arm 4 - Low DoseChange in Lactate Dehydrogenase From Baselineweek 1-10.8 U/LStandard Deviation 17.09
Arm 5 - Intermediate DoseChange in Lactate Dehydrogenase From Baselineweek 1-2.6 U/LStandard Deviation 19.82
Arm 5 - Intermediate DoseChange in Lactate Dehydrogenase From Baselineweek 12-8.9 U/LStandard Deviation 15.95
Arm 5 - Intermediate DoseChange in Lactate Dehydrogenase From Baselineweek 2-10.9 U/LStandard Deviation 13.17
Arm 5 - Intermediate DoseChange in Lactate Dehydrogenase From Baselineweek 41.3 U/LStandard Deviation 17.54
Arm 5 - Intermediate DoseChange in Lactate Dehydrogenase From Baselineweek 83.7 U/LStandard Deviation 37.19
Arm 5 - Intermediate DoseChange in Lactate Dehydrogenase From Baselineweek 24-3.1 U/LStandard Deviation 22.96
Arm 6 - High DoseChange in Lactate Dehydrogenase From Baselineweek 8-4.2 U/LStandard Deviation 17.31
Arm 6 - High DoseChange in Lactate Dehydrogenase From Baselineweek 4-3.9 U/LStandard Deviation 19.78
Arm 6 - High DoseChange in Lactate Dehydrogenase From Baselineweek 12-3.4 U/LStandard Deviation 23.85
Arm 6 - High DoseChange in Lactate Dehydrogenase From Baselineweek 242.4 U/LStandard Deviation 25.13
Arm 6 - High DoseChange in Lactate Dehydrogenase From Baselineweek 2-5.7 U/LStandard Deviation 16.18
Arm 6 - High DoseChange in Lactate Dehydrogenase From Baselineweek 10.9 U/LStandard Deviation 14.11
Primary

Change in Leucocytes From Baseline

Time frame: baseline, Weeks 1,2,4,8,12, and 24

ArmMeasureGroupValue (MEAN)Dispersion
Arm 1 - Low DoseChange in Leucocytes From Baselineweek 20.218 10^9 leucocytes /LStandard Deviation 1.354
Arm 1 - Low DoseChange in Leucocytes From Baselineweek 4-0.230 10^9 leucocytes /LStandard Deviation 1.2881
Arm 1 - Low DoseChange in Leucocytes From Baselineweek 24-0.695 10^9 leucocytes /LStandard Deviation 1.199
Arm 1 - Low DoseChange in Leucocytes From Baselineweek 12-0.045 10^9 leucocytes /LStandard Deviation 1.0228
Arm 1 - Low DoseChange in Leucocytes From Baselineweek 80.154 10^9 leucocytes /LStandard Deviation 0.8825
Arm 1 - Low DoseChange in Leucocytes From Baselineweek 1-0.033 10^9 leucocytes /LStandard Deviation 1.285
Arm 2 - Intermediate DoseChange in Leucocytes From Baselineweek 1-0.199 10^9 leucocytes /LStandard Deviation 1.3799
Arm 2 - Intermediate DoseChange in Leucocytes From Baselineweek 24-0.125 10^9 leucocytes /LStandard Deviation 1.0887
Arm 2 - Intermediate DoseChange in Leucocytes From Baselineweek 20.091 10^9 leucocytes /LStandard Deviation 1.2248
Arm 2 - Intermediate DoseChange in Leucocytes From Baselineweek 40.472 10^9 leucocytes /LStandard Deviation 1.2324
Arm 2 - Intermediate DoseChange in Leucocytes From Baselineweek 80.094 10^9 leucocytes /LStandard Deviation 1.2006
Arm 2 - Intermediate DoseChange in Leucocytes From Baselineweek 120.409 10^9 leucocytes /LStandard Deviation 1.762
Arm 3 - High DoseChange in Leucocytes From Baselineweek 1-0.265 10^9 leucocytes /LStandard Deviation 0.5758
Arm 3 - High DoseChange in Leucocytes From Baselineweek 4-0.286 10^9 leucocytes /LStandard Deviation 0.6787
Arm 3 - High DoseChange in Leucocytes From Baselineweek 8-0.029 10^9 leucocytes /LStandard Deviation 1.0882
Arm 3 - High DoseChange in Leucocytes From Baselineweek 24-0.263 10^9 leucocytes /LStandard Deviation 0.8854
Arm 3 - High DoseChange in Leucocytes From Baselineweek 120.133 10^9 leucocytes /LStandard Deviation 1.1654
Arm 3 - High DoseChange in Leucocytes From Baselineweek 2-0.099 10^9 leucocytes /LStandard Deviation 0.6808
Arm 4 - Low DoseChange in Leucocytes From Baselineweek 1-0.159 10^9 leucocytes /LStandard Deviation 0.7563
Arm 4 - Low DoseChange in Leucocytes From Baselineweek 20.158 10^9 leucocytes /LStandard Deviation 0.9098
Arm 4 - Low DoseChange in Leucocytes From Baselineweek 24-0.310 10^9 leucocytes /LStandard Deviation 1.0615
Arm 4 - Low DoseChange in Leucocytes From Baselineweek 8-0.013 10^9 leucocytes /LStandard Deviation 0.8416
Arm 4 - Low DoseChange in Leucocytes From Baselineweek 12-0.060 10^9 leucocytes /LStandard Deviation 0.9897
Arm 4 - Low DoseChange in Leucocytes From Baselineweek 4-0.261 10^9 leucocytes /LStandard Deviation 1.0477
Arm 5 - Intermediate DoseChange in Leucocytes From Baselineweek 40.186 10^9 leucocytes /LStandard Deviation 1.0368
Arm 5 - Intermediate DoseChange in Leucocytes From Baselineweek 240.196 10^9 leucocytes /LStandard Deviation 0.7996
Arm 5 - Intermediate DoseChange in Leucocytes From Baselineweek 120.357 10^9 leucocytes /LStandard Deviation 0.8966
Arm 5 - Intermediate DoseChange in Leucocytes From Baselineweek 20.329 10^9 leucocytes /LStandard Deviation 0.7771
Arm 5 - Intermediate DoseChange in Leucocytes From Baselineweek 80.080 10^9 leucocytes /LStandard Deviation 0.5862
Arm 5 - Intermediate DoseChange in Leucocytes From Baselineweek 1-0.019 10^9 leucocytes /LStandard Deviation 0.4475
Arm 6 - High DoseChange in Leucocytes From Baselineweek 240.199 10^9 leucocytes /LStandard Deviation 0.8817
Arm 6 - High DoseChange in Leucocytes From Baselineweek 10.055 10^9 leucocytes /LStandard Deviation 0.6884
Arm 6 - High DoseChange in Leucocytes From Baselineweek 20.190 10^9 leucocytes /LStandard Deviation 0.6531
Arm 6 - High DoseChange in Leucocytes From Baselineweek 40.186 10^9 leucocytes /LStandard Deviation 1.1456
Arm 6 - High DoseChange in Leucocytes From Baselineweek 8-0.087 10^9 leucocytes /LStandard Deviation 0.6728
Arm 6 - High DoseChange in Leucocytes From Baselineweek 12-0.175 10^9 leucocytes /LStandard Deviation 0.7302
Primary

Change in Lymphocytes From Baseline

Time frame: Weeks 1,2,4,8,12, and 24

ArmMeasureGroupValue (MEAN)Dispersion
Arm 1 - Low DoseChange in Lymphocytes From Baselineweek 10.209 10^9 Lymphocytes /LStandard Deviation 0.5808
Arm 1 - Low DoseChange in Lymphocytes From Baselineweek 20.247 10^9 Lymphocytes /LStandard Deviation 0.3868
Arm 1 - Low DoseChange in Lymphocytes From Baselineweek 40.077 10^9 Lymphocytes /LStandard Deviation 0.4069
Arm 1 - Low DoseChange in Lymphocytes From Baselineweek 8-0.012 10^9 Lymphocytes /LStandard Deviation 0.349
Arm 1 - Low DoseChange in Lymphocytes From Baselineweek 120.115 10^9 Lymphocytes /LStandard Deviation 0.4083
Arm 1 - Low DoseChange in Lymphocytes From Baselineweek 24-0.219 10^9 Lymphocytes /LStandard Deviation 0.3293
Arm 2 - Intermediate DoseChange in Lymphocytes From Baselineweek 20.257 10^9 Lymphocytes /LStandard Deviation 0.3913
Arm 2 - Intermediate DoseChange in Lymphocytes From Baselineweek 80.063 10^9 Lymphocytes /LStandard Deviation 0.3991
Arm 2 - Intermediate DoseChange in Lymphocytes From Baselineweek 240.027 10^9 Lymphocytes /LStandard Deviation 0.5038
Arm 2 - Intermediate DoseChange in Lymphocytes From Baselineweek 1-0.060 10^9 Lymphocytes /LStandard Deviation 0.4455
Arm 2 - Intermediate DoseChange in Lymphocytes From Baselineweek 4-0.023 10^9 Lymphocytes /LStandard Deviation 0.3568
Arm 2 - Intermediate DoseChange in Lymphocytes From Baselineweek 12-0.045 10^9 Lymphocytes /LStandard Deviation 0.3655
Arm 3 - High DoseChange in Lymphocytes From Baselineweek 24-0.097 10^9 Lymphocytes /LStandard Deviation 0.2514
Arm 3 - High DoseChange in Lymphocytes From Baselineweek 120.015 10^9 Lymphocytes /LStandard Deviation 0.2884
Arm 3 - High DoseChange in Lymphocytes From Baselineweek 8-0.058 10^9 Lymphocytes /LStandard Deviation 0.2627
Arm 3 - High DoseChange in Lymphocytes From Baselineweek 40.013 10^9 Lymphocytes /LStandard Deviation 0.2528
Arm 3 - High DoseChange in Lymphocytes From Baselineweek 10.077 10^9 Lymphocytes /LStandard Deviation 0.205
Arm 3 - High DoseChange in Lymphocytes From Baselineweek 20.169 10^9 Lymphocytes /LStandard Deviation 0.4038
Arm 4 - Low DoseChange in Lymphocytes From Baselineweek 8-0.039 10^9 Lymphocytes /LStandard Deviation 0.2856
Arm 4 - Low DoseChange in Lymphocytes From Baselineweek 20.109 10^9 Lymphocytes /LStandard Deviation 0.249
Arm 4 - Low DoseChange in Lymphocytes From Baselineweek 40.010 10^9 Lymphocytes /LStandard Deviation 0.3045
Arm 4 - Low DoseChange in Lymphocytes From Baselineweek 240.072 10^9 Lymphocytes /LStandard Deviation 0.2427
Arm 4 - Low DoseChange in Lymphocytes From Baselineweek 12-0.046 10^9 Lymphocytes /LStandard Deviation 0.32
Arm 4 - Low DoseChange in Lymphocytes From Baselineweek 10.179 10^9 Lymphocytes /LStandard Deviation 0.2565
Arm 5 - Intermediate DoseChange in Lymphocytes From Baselineweek 10.115 10^9 Lymphocytes /LStandard Deviation 0.2064
Arm 5 - Intermediate DoseChange in Lymphocytes From Baselineweek 120.135 10^9 Lymphocytes /LStandard Deviation 0.2941
Arm 5 - Intermediate DoseChange in Lymphocytes From Baselineweek 20.249 10^9 Lymphocytes /LStandard Deviation 0.2813
Arm 5 - Intermediate DoseChange in Lymphocytes From Baselineweek 40.03 10^9 Lymphocytes /LStandard Deviation 0.2146
Arm 5 - Intermediate DoseChange in Lymphocytes From Baselineweek 80.077 10^9 Lymphocytes /LStandard Deviation 0.2252
Arm 5 - Intermediate DoseChange in Lymphocytes From Baselineweek 240.064 10^9 Lymphocytes /LStandard Deviation 0.2607
Arm 6 - High DoseChange in Lymphocytes From Baselineweek 80.062 10^9 Lymphocytes /LStandard Deviation 0.2502
Arm 6 - High DoseChange in Lymphocytes From Baselineweek 40.103 10^9 Lymphocytes /LStandard Deviation 0.1823
Arm 6 - High DoseChange in Lymphocytes From Baselineweek 120.031 10^9 Lymphocytes /LStandard Deviation 0.2214
Arm 6 - High DoseChange in Lymphocytes From Baselineweek 240.049 10^9 Lymphocytes /LStandard Deviation 0.3324
Arm 6 - High DoseChange in Lymphocytes From Baselineweek 20.184 10^9 Lymphocytes /LStandard Deviation 0.3094
Arm 6 - High DoseChange in Lymphocytes From Baselineweek 10.179 10^9 Lymphocytes /LStandard Deviation 0.2516
Primary

Change in Monocytes From Baseline

Time frame: Weeks 1,2,4,8,12, and 24

ArmMeasureGroupValue (MEAN)Dispersion
Arm 1 - Low DoseChange in Monocytes From Baselineweek 1-0.0040 10^9 Monocytes /LStandard Deviation 0.0733
Arm 1 - Low DoseChange in Monocytes From Baselineweek 20.0733 10^9 Monocytes /LStandard Deviation 0.1011
Arm 1 - Low DoseChange in Monocytes From Baselineweek 4-0.0220 10^9 Monocytes /LStandard Deviation 0.0668
Arm 1 - Low DoseChange in Monocytes From Baselineweek 80.0073 10^9 Monocytes /LStandard Deviation 0.0612
Arm 1 - Low DoseChange in Monocytes From Baselineweek 12-0.0004 10^9 Monocytes /LStandard Deviation 0.0797
Arm 1 - Low DoseChange in Monocytes From Baselineweek 24-0.0427 10^9 Monocytes /LStandard Deviation 0.0707
Arm 2 - Intermediate DoseChange in Monocytes From Baselineweek 20.0427 10^9 Monocytes /LStandard Deviation 0.1353
Arm 2 - Intermediate DoseChange in Monocytes From Baselineweek 80.0113 10^9 Monocytes /LStandard Deviation 0.1336
Arm 2 - Intermediate DoseChange in Monocytes From Baselineweek 24-0.0107 10^9 Monocytes /LStandard Deviation 0.1163
Arm 2 - Intermediate DoseChange in Monocytes From Baselineweek 1-0.0227 10^9 Monocytes /LStandard Deviation 0.11218
Arm 2 - Intermediate DoseChange in Monocytes From Baselineweek 4-0.0327 10^9 Monocytes /LStandard Deviation 0.1142
Arm 2 - Intermediate DoseChange in Monocytes From Baselineweek 120.0007 10^9 Monocytes /LStandard Deviation 0.1331
Arm 3 - High DoseChange in Monocytes From Baselineweek 24-0.0233 10^9 Monocytes /LStandard Deviation 0.1271
Arm 3 - High DoseChange in Monocytes From Baselineweek 12-0.0240 10^9 Monocytes /LStandard Deviation 0.0662
Arm 3 - High DoseChange in Monocytes From Baselineweek 8-0.0380 10^9 Monocytes /LStandard Deviation 0.0927
Arm 3 - High DoseChange in Monocytes From Baselineweek 4-0.0287 10^9 Monocytes /LStandard Deviation 0.0666
Arm 3 - High DoseChange in Monocytes From Baselineweek 1-0.0353 10^9 Monocytes /LStandard Deviation 0.0689
Arm 3 - High DoseChange in Monocytes From Baselineweek 20.0227 10^9 Monocytes /LStandard Deviation 0.1109
Arm 4 - Low DoseChange in Monocytes From Baselineweek 8-0.0431 10^9 Monocytes /LStandard Deviation 0.0624
Arm 4 - Low DoseChange in Monocytes From Baselineweek 20.0144 10^9 Monocytes /LStandard Deviation 0.0999
Arm 4 - Low DoseChange in Monocytes From Baselineweek 4-0.0556 10^9 Monocytes /LStandard Deviation 0.0909
Arm 4 - Low DoseChange in Monocytes From Baselineweek 24-0.0227 10^9 Monocytes /LStandard Deviation 0.096
Arm 4 - Low DoseChange in Monocytes From Baselineweek 12-0.0475 10^9 Monocytes /LStandard Deviation 0.0772
Arm 4 - Low DoseChange in Monocytes From Baselineweek 1-0.0525 10^9 Monocytes /LStandard Deviation 0.0668
Arm 5 - Intermediate DoseChange in Monocytes From Baselineweek 10.0100 10^9 Monocytes /LStandard Deviation 0.086
Arm 5 - Intermediate DoseChange in Monocytes From Baselineweek 120.0453 10^9 Monocytes /LStandard Deviation 0.0856
Arm 5 - Intermediate DoseChange in Monocytes From Baselineweek 20.0520 10^9 Monocytes /LStandard Deviation 0.0844
Arm 5 - Intermediate DoseChange in Monocytes From Baselineweek 40.0400 10^9 Monocytes /LStandard Deviation 0.111
Arm 5 - Intermediate DoseChange in Monocytes From Baselineweek 80.0253 10^9 Monocytes /LStandard Deviation 0.0801
Arm 5 - Intermediate DoseChange in Monocytes From Baselineweek 240.0493 10^9 Monocytes /LStandard Deviation 0.1127
Arm 6 - High DoseChange in Monocytes From Baselineweek 8-0.0227 10^9 Monocytes /LStandard Deviation 0.0849
Arm 6 - High DoseChange in Monocytes From Baselineweek 4-0.0193 10^9 Monocytes /LStandard Deviation 0.0656
Arm 6 - High DoseChange in Monocytes From Baselineweek 12-0.0387 10^9 Monocytes /LStandard Deviation 0.0605
Arm 6 - High DoseChange in Monocytes From Baselineweek 24-0.0021 10^9 Monocytes /LStandard Deviation 0.0567
Arm 6 - High DoseChange in Monocytes From Baselineweek 20.0280 10^9 Monocytes /LStandard Deviation 0.082
Arm 6 - High DoseChange in Monocytes From Baselineweek 1-0.0307 10^9 Monocytes /LStandard Deviation 0.0694
Primary

Change in Neutrophils From Baseline

Change from baseline was calculated as the value at each week minus the value at the baseline.

Time frame: Weeks 1,2,4,8,12, and 24

ArmMeasureGroupValue (MEAN)Dispersion
Arm 1 - Low DoseChange in Neutrophils From Baselineweek 4-0.273 10^9 Neutrophils /LStandard Deviation 1.3001
Arm 1 - Low DoseChange in Neutrophils From Baselineweek 2-0.115 10^9 Neutrophils /LStandard Deviation 1.1387
Arm 1 - Low DoseChange in Neutrophils From Baselineweek 1-0.241 10^9 Neutrophils /LStandard Deviation 1.1183
Arm 1 - Low DoseChange in Neutrophils From Baselineweek 24-0.376 10^9 Neutrophils /LStandard Deviation 1.1492
Arm 1 - Low DoseChange in Neutrophils From Baselineweek 12-0.159 10^9 Neutrophils /LStandard Deviation 0.8592
Arm 1 - Low DoseChange in Neutrophils From Baselineweek 8-0.131 10^9 Neutrophils /LStandard Deviation 0.8082
Arm 2 - Intermediate DoseChange in Neutrophils From Baselineweek 4-0.417 10^9 Neutrophils /LStandard Deviation 1.0814
Arm 2 - Intermediate DoseChange in Neutrophils From Baselineweek 1-0.105 10^9 Neutrophils /LStandard Deviation 1.3346
Arm 2 - Intermediate DoseChange in Neutrophils From Baselineweek 2-0.254 10^9 Neutrophils /LStandard Deviation 1.0089
Arm 2 - Intermediate DoseChange in Neutrophils From Baselineweek 80.008 10^9 Neutrophils /LStandard Deviation 1.1261
Arm 2 - Intermediate DoseChange in Neutrophils From Baselineweek 120.458 10^9 Neutrophils /LStandard Deviation 1.8931
Arm 2 - Intermediate DoseChange in Neutrophils From Baselineweek 24-0.141 10^9 Neutrophils /LStandard Deviation 0.8632
Arm 3 - High DoseChange in Neutrophils From Baselineweek 24-0.151 10^9 Neutrophils /LStandard Deviation 0.6475
Arm 3 - High DoseChange in Neutrophils From Baselineweek 2-0.313 10^9 Neutrophils /LStandard Deviation 0.4109
Arm 3 - High DoseChange in Neutrophils From Baselineweek 80.097 10^9 Neutrophils /LStandard Deviation 0.932
Arm 3 - High DoseChange in Neutrophils From Baselineweek 4-0.273 10^9 Neutrophils /LStandard Deviation 0.467
Arm 3 - High DoseChange in Neutrophils From Baselineweek 1-0.296 10^9 Neutrophils /LStandard Deviation 0.5781
Arm 3 - High DoseChange in Neutrophils From Baselineweek 120.153 10^9 Neutrophils /LStandard Deviation 1.0128
Arm 4 - Low DoseChange in Neutrophils From Baselineweek 2-0.014 10^9 Neutrophils /LStandard Deviation 0.8032
Arm 4 - Low DoseChange in Neutrophils From Baselineweek 4-0.208 10^9 Neutrophils /LStandard Deviation 1.0731
Arm 4 - Low DoseChange in Neutrophils From Baselineweek 1-0.391 10^9 Neutrophils /LStandard Deviation 0.7397
Arm 4 - Low DoseChange in Neutrophils From Baselineweek 24-0.378 10^9 Neutrophils /LStandard Deviation 0.9802
Arm 4 - Low DoseChange in Neutrophils From Baselineweek 80.054 10^9 Neutrophils /LStandard Deviation 0.7545
Arm 4 - Low DoseChange in Neutrophils From Baselineweek 120.027 10^9 Neutrophils /LStandard Deviation 0.9118
Arm 5 - Intermediate DoseChange in Neutrophils From Baselineweek 8-0.025 10^9 Neutrophils /LStandard Deviation 0.4139
Arm 5 - Intermediate DoseChange in Neutrophils From Baselineweek 240.073 10^9 Neutrophils /LStandard Deviation 0.6629
Arm 5 - Intermediate DoseChange in Neutrophils From Baselineweek 2-0.015 10^9 Neutrophils /LStandard Deviation 0.5966
Arm 5 - Intermediate DoseChange in Neutrophils From Baselineweek 120.165 10^9 Neutrophils /LStandard Deviation 0.6483
Arm 5 - Intermediate DoseChange in Neutrophils From Baselineweek 40.116 10^9 Neutrophils /LStandard Deviation 0.8245
Arm 5 - Intermediate DoseChange in Neutrophils From Baselineweek 1-0.147 10^9 Neutrophils /LStandard Deviation 0.3939
Arm 6 - High DoseChange in Neutrophils From Baselineweek 2-0.044 10^9 Neutrophils /LStandard Deviation 0.4523
Arm 6 - High DoseChange in Neutrophils From Baselineweek 240.147 10^9 Neutrophils /LStandard Deviation 0.7146
Arm 6 - High DoseChange in Neutrophils From Baselineweek 40.011 10^9 Neutrophils /LStandard Deviation 1.082
Arm 6 - High DoseChange in Neutrophils From Baselineweek 1-0.092 10^9 Neutrophils /LStandard Deviation 0.556
Arm 6 - High DoseChange in Neutrophils From Baselineweek 8-0.148 10^9 Neutrophils /LStandard Deviation 0.5358
Arm 6 - High DoseChange in Neutrophils From Baselineweek 12-0.180 10^9 Neutrophils /LStandard Deviation 0.6024
Primary

Change in Platelets From Baseline

Time frame: Weeks 1,2,4,8,12, and 24

ArmMeasureGroupValue (MEAN)Dispersion
Arm 1 - Low DoseChange in Platelets From Baselineweek 17.7 10^9 Platelets /LStandard Deviation 19.56
Arm 1 - Low DoseChange in Platelets From Baselineweek 217.4 10^9 Platelets /LStandard Deviation 25.92
Arm 1 - Low DoseChange in Platelets From Baselineweek 44.3 10^9 Platelets /LStandard Deviation 22.9
Arm 1 - Low DoseChange in Platelets From Baselineweek 811.0 10^9 Platelets /LStandard Deviation 22.9
Arm 1 - Low DoseChange in Platelets From Baselineweek 1215.9 10^9 Platelets /LStandard Deviation 31.26
Arm 1 - Low DoseChange in Platelets From Baselineweek 2411.3 10^9 Platelets /LStandard Deviation 30.27
Arm 2 - Intermediate DoseChange in Platelets From Baselineweek 210.5 10^9 Platelets /LStandard Deviation 33.06
Arm 2 - Intermediate DoseChange in Platelets From Baselineweek 88.2 10^9 Platelets /LStandard Deviation 31.41
Arm 2 - Intermediate DoseChange in Platelets From Baselineweek 2411.3 10^9 Platelets /LStandard Deviation 36.34
Arm 2 - Intermediate DoseChange in Platelets From Baselineweek 1-0.1 10^9 Platelets /LStandard Deviation 24.38
Arm 2 - Intermediate DoseChange in Platelets From Baselineweek 4-0.2 10^9 Platelets /LStandard Deviation 22.27
Arm 2 - Intermediate DoseChange in Platelets From Baselineweek 126.0 10^9 Platelets /LStandard Deviation 30.25
Arm 3 - High DoseChange in Platelets From Baselineweek 245.9 10^9 Platelets /LStandard Deviation 18.3
Arm 3 - High DoseChange in Platelets From Baselineweek 1213.3 10^9 Platelets /LStandard Deviation 27.51
Arm 3 - High DoseChange in Platelets From Baselineweek 814.2 10^9 Platelets /LStandard Deviation 23.86
Arm 3 - High DoseChange in Platelets From Baselineweek 46.1 10^9 Platelets /LStandard Deviation 24.28
Arm 3 - High DoseChange in Platelets From Baselineweek 11.5 10^9 Platelets /LStandard Deviation 27.38
Arm 3 - High DoseChange in Platelets From Baselineweek 220.3 10^9 Platelets /LStandard Deviation 24.62
Arm 4 - Low DoseChange in Platelets From Baselineweek 8-3.8 10^9 Platelets /LStandard Deviation 24.07
Arm 4 - Low DoseChange in Platelets From Baselineweek 24.6 10^9 Platelets /LStandard Deviation 17.77
Arm 4 - Low DoseChange in Platelets From Baselineweek 4-0.1 10^9 Platelets /LStandard Deviation 22.93
Arm 4 - Low DoseChange in Platelets From Baselineweek 24-2.7 10^9 Platelets /LStandard Deviation 31.25
Arm 4 - Low DoseChange in Platelets From Baselineweek 12-7.1 10^9 Platelets /LStandard Deviation 21.05
Arm 4 - Low DoseChange in Platelets From Baselineweek 1-3.2 10^9 Platelets /LStandard Deviation 16.2
Arm 5 - Intermediate DoseChange in Platelets From Baselineweek 1-8.1 10^9 Platelets /LStandard Deviation 12.15
Arm 5 - Intermediate DoseChange in Platelets From Baselineweek 12-6.3 10^9 Platelets /LStandard Deviation 16.19
Arm 5 - Intermediate DoseChange in Platelets From Baselineweek 22.7 10^9 Platelets /LStandard Deviation 16.23
Arm 5 - Intermediate DoseChange in Platelets From Baselineweek 4-1.8 10^9 Platelets /LStandard Deviation 17.76
Arm 5 - Intermediate DoseChange in Platelets From Baselineweek 82.0 10^9 Platelets /LStandard Deviation 14.11
Arm 5 - Intermediate DoseChange in Platelets From Baselineweek 241.9 10^9 Platelets /LStandard Deviation 19.3
Arm 6 - High DoseChange in Platelets From Baselineweek 89.4 10^9 Platelets /LStandard Deviation 28.11
Arm 6 - High DoseChange in Platelets From Baselineweek 46.2 10^9 Platelets /LStandard Deviation 16.23
Arm 6 - High DoseChange in Platelets From Baselineweek 120.1 10^9 Platelets /LStandard Deviation 17.94
Arm 6 - High DoseChange in Platelets From Baselineweek 24-4.4 10^9 Platelets /LStandard Deviation 24.42
Arm 6 - High DoseChange in Platelets From Baselineweek 26.5 10^9 Platelets /LStandard Deviation 14.79
Arm 6 - High DoseChange in Platelets From Baselineweek 12.3 10^9 Platelets /LStandard Deviation 21.86
Primary

Change in Potassium From Baseline

Time frame: week 1,2,4,8,12, and 24

ArmMeasureGroupValue (MEAN)Dispersion
Arm 1 - Low DoseChange in Potassium From Baselineweek 10.125 mmol/LStandard Deviation 0.307
Arm 1 - Low DoseChange in Potassium From Baselineweek 40.036 mmol/LStandard Deviation 0.3004
Arm 1 - Low DoseChange in Potassium From Baselineweek 120.040 mmol/LStandard Deviation 0.4153
Arm 1 - Low DoseChange in Potassium From Baselineweek 8-0.028 mmol/LStandard Deviation 0.3874
Arm 1 - Low DoseChange in Potassium From Baselineweek 20.057 mmol/LStandard Deviation 0.2369
Arm 1 - Low DoseChange in Potassium From Baselineweek 240.061 mmol/LStandard Deviation 0.2474
Arm 2 - Intermediate DoseChange in Potassium From Baselineweek 2-0.037 mmol/LStandard Deviation 0.2778
Arm 2 - Intermediate DoseChange in Potassium From Baselineweek 80.045 mmol/LStandard Deviation 0.368
Arm 2 - Intermediate DoseChange in Potassium From Baselineweek 4-0.195 mmol/LStandard Deviation 0.2952
Arm 2 - Intermediate DoseChange in Potassium From Baselineweek 1-0.007 mmol/LStandard Deviation 0.3696
Arm 2 - Intermediate DoseChange in Potassium From Baselineweek 240.161 mmol/LStandard Deviation 0.2367
Arm 2 - Intermediate DoseChange in Potassium From Baselineweek 12-0.205 mmol/LStandard Deviation 0.4556
Arm 3 - High DoseChange in Potassium From Baselineweek 40.113 mmol/LStandard Deviation 0.34446
Arm 3 - High DoseChange in Potassium From Baselineweek 80.241 mmol/LStandard Deviation 0.3395
Arm 3 - High DoseChange in Potassium From Baselineweek 10.189 mmol/LStandard Deviation 0.4025
Arm 3 - High DoseChange in Potassium From Baselineweek 20.064 mmol/LStandard Deviation 0.29
Arm 3 - High DoseChange in Potassium From Baselineweek 120.217 mmol/LStandard Deviation 0.2773
Arm 3 - High DoseChange in Potassium From Baselineweek 240.324 mmol/LStandard Deviation 0.2924
Arm 4 - Low DoseChange in Potassium From Baselineweek 2-0.049 mmol/LStandard Deviation 0.4433
Arm 4 - Low DoseChange in Potassium From Baselineweek 40.023 mmol/LStandard Deviation 0.4688
Arm 4 - Low DoseChange in Potassium From Baselineweek 10.036 mmol/LStandard Deviation 0.3269
Arm 4 - Low DoseChange in Potassium From Baselineweek 120.072 mmol/LStandard Deviation 0.3896
Arm 4 - Low DoseChange in Potassium From Baselineweek 8-0.008 mmol/LStandard Deviation 0.4328
Arm 4 - Low DoseChange in Potassium From Baselineweek 240.023 mmol/LStandard Deviation 0.2988
Arm 5 - Intermediate DoseChange in Potassium From Baselineweek 10.239 mmol/LStandard Deviation 0.5699
Arm 5 - Intermediate DoseChange in Potassium From Baselineweek 240.253 mmol/LStandard Deviation 0.41
Arm 5 - Intermediate DoseChange in Potassium From Baselineweek 2-0.137 mmol/LStandard Deviation 0.4979
Arm 5 - Intermediate DoseChange in Potassium From Baselineweek 120.089 mmol/LStandard Deviation 0.2322
Arm 5 - Intermediate DoseChange in Potassium From Baselineweek 80.271 mmol/LStandard Deviation 0.3383
Arm 5 - Intermediate DoseChange in Potassium From Baselineweek 4-0.023 mmol/LStandard Deviation 0.4196
Arm 6 - High DoseChange in Potassium From Baselineweek 1-0.158 mmol/LStandard Deviation 0.3481
Arm 6 - High DoseChange in Potassium From Baselineweek 24-0.190 mmol/LStandard Deviation 0.3313
Arm 6 - High DoseChange in Potassium From Baselineweek 2-0.089 mmol/LStandard Deviation 0.3626
Arm 6 - High DoseChange in Potassium From Baselineweek 8-0.209 mmol/LStandard Deviation 0.3582
Arm 6 - High DoseChange in Potassium From Baselineweek 4-0.227 mmol/LStandard Deviation 0.309
Arm 6 - High DoseChange in Potassium From Baselineweek 12-0.110 mmol/LStandard Deviation 0.2961
Primary

Change in Sodium From Baseline

Time frame: week 1,2,4,8,12, and 24

ArmMeasureGroupValue (MEAN)Dispersion
Arm 1 - Low DoseChange in Sodium From Baselineweek 1-0.1 mmol/LStandard Deviation 1.33
Arm 1 - Low DoseChange in Sodium From Baselineweek 20.6 mmol/LStandard Deviation 1.72
Arm 1 - Low DoseChange in Sodium From Baselineweek 40.5 mmol/LStandard Deviation 1.36
Arm 1 - Low DoseChange in Sodium From Baselineweek 80.0 mmol/LStandard Deviation 1.56
Arm 1 - Low DoseChange in Sodium From Baselineweek 12-0.2 mmol/LStandard Deviation 1.37
Arm 1 - Low DoseChange in Sodium From Baselineweek 240.8 mmol/LStandard Deviation 1.86
Arm 2 - Intermediate DoseChange in Sodium From Baselineweek 20.4 mmol/LStandard Deviation 2.32
Arm 2 - Intermediate DoseChange in Sodium From Baselineweek 8-0.5 mmol/LStandard Deviation 1.81
Arm 2 - Intermediate DoseChange in Sodium From Baselineweek 24-0.3 mmol/LStandard Deviation 2.19
Arm 2 - Intermediate DoseChange in Sodium From Baselineweek 10.6 mmol/LStandard Deviation 2.06
Arm 2 - Intermediate DoseChange in Sodium From Baselineweek 4-1.6 mmol/LStandard Deviation 1.96
Arm 2 - Intermediate DoseChange in Sodium From Baselineweek 12-0.9 mmol/LStandard Deviation 1.25
Arm 3 - High DoseChange in Sodium From Baselineweek 241.8 mmol/LStandard Deviation 2.01
Arm 3 - High DoseChange in Sodium From Baselineweek 121.1 mmol/LStandard Deviation 2.31
Arm 3 - High DoseChange in Sodium From Baselineweek 8-0.1 mmol/LStandard Deviation 2.03
Arm 3 - High DoseChange in Sodium From Baselineweek 40.1 mmol/LStandard Deviation 1.39
Arm 3 - High DoseChange in Sodium From Baselineweek 10.3 mmol/LStandard Deviation 2.29
Arm 3 - High DoseChange in Sodium From Baselineweek 20.3 mmol/LStandard Deviation 1.79
Arm 4 - Low DoseChange in Sodium From Baselineweek 8-0.7 mmol/LStandard Deviation 182
Arm 4 - Low DoseChange in Sodium From Baselineweek 20.3 mmol/LStandard Deviation 221
Arm 4 - Low DoseChange in Sodium From Baselineweek 4-1.1 mmol/LStandard Deviation 1.18
Arm 4 - Low DoseChange in Sodium From Baselineweek 240.1 mmol/LStandard Deviation 1.85
Arm 4 - Low DoseChange in Sodium From Baselineweek 12-0.8 mmol/LStandard Deviation 1.84
Arm 4 - Low DoseChange in Sodium From Baselineweek 10.3 mmol/LStandard Deviation 1.65
Arm 5 - Intermediate DoseChange in Sodium From Baselineweek 10.6 mmol/LStandard Deviation 1.92
Arm 5 - Intermediate DoseChange in Sodium From Baselineweek 12-0.2 mmol/LStandard Deviation 2.11
Arm 5 - Intermediate DoseChange in Sodium From Baselineweek 2-0.5 mmol/LStandard Deviation 1.85
Arm 5 - Intermediate DoseChange in Sodium From Baselineweek 40.6 mmol/LStandard Deviation 1.92
Arm 5 - Intermediate DoseChange in Sodium From Baselineweek 80.5 mmol/LStandard Deviation 2.07
Arm 5 - Intermediate DoseChange in Sodium From Baselineweek 240.9 mmol/LStandard Deviation 1.85
Arm 6 - High DoseChange in Sodium From Baselineweek 80.3 mmol/LStandard Deviation 2.26
Arm 6 - High DoseChange in Sodium From Baselineweek 40.8 mmol/LStandard Deviation 2.21
Arm 6 - High DoseChange in Sodium From Baselineweek 121.8 mmol/LStandard Deviation 1.47
Arm 6 - High DoseChange in Sodium From Baselineweek 242.1 mmol/LStandard Deviation 2.14
Arm 6 - High DoseChange in Sodium From Baselineweek 21.5 mmol/LStandard Deviation 1.96
Arm 6 - High DoseChange in Sodium From Baselineweek 11.8 mmol/LStandard Deviation 1.97
Primary

Change in Urea Nitrogen From Baseline

Time frame: week 1,2,4,8,12, and 24

ArmMeasureGroupValue (MEAN)Dispersion
Arm 1 - Low DoseChange in Urea Nitrogen From Baselineweek 24-0.0619 mmol/LStandard Deviation 1.7148
Arm 1 - Low DoseChange in Urea Nitrogen From Baselineweek 20.2951 mmol/LStandard Deviation 1.9132
Arm 1 - Low DoseChange in Urea Nitrogen From Baselineweek 8-0.4522 mmol/LStandard Deviation 2.0612
Arm 1 - Low DoseChange in Urea Nitrogen From Baselineweek 12-0.0143 mmol/LStandard Deviation 1.8835
Arm 1 - Low DoseChange in Urea Nitrogen From Baselineweek 40.1571 mmol/LStandard Deviation 2.2931
Arm 1 - Low DoseChange in Urea Nitrogen From Baselineweek 10.0571 mmol/LStandard Deviation 1.9802
Arm 2 - Intermediate DoseChange in Urea Nitrogen From Baselineweek 10.0524 mmol/LStandard Deviation 1.5732
Arm 2 - Intermediate DoseChange in Urea Nitrogen From Baselineweek 120.1000 mmol/LStandard Deviation 2.1727
Arm 2 - Intermediate DoseChange in Urea Nitrogen From Baselineweek 20.5284 mmol/LStandard Deviation 2.2289
Arm 2 - Intermediate DoseChange in Urea Nitrogen From Baselineweek 4-0.1856 mmol/LStandard Deviation 1.6149
Arm 2 - Intermediate DoseChange in Urea Nitrogen From Baselineweek 240.2667 mmol/LStandard Deviation 2.8833
Arm 2 - Intermediate DoseChange in Urea Nitrogen From Baselineweek 8-0.0286 mmol/LStandard Deviation 1.5584
Arm 3 - High DoseChange in Urea Nitrogen From Baselineweek 24-0.5331 mmol/LStandard Deviation 2.3939
Arm 3 - High DoseChange in Urea Nitrogen From Baselineweek 8-0.0952 mmol/LStandard Deviation 2.322
Arm 3 - High DoseChange in Urea Nitrogen From Baselineweek 4-0.1428 mmol/LStandard Deviation 2.3668
Arm 3 - High DoseChange in Urea Nitrogen From Baselineweek 12-0.6045 mmol/LStandard Deviation 2.6703
Arm 3 - High DoseChange in Urea Nitrogen From Baselineweek 2-0.9377 mmol/LStandard Deviation 3.3246
Arm 3 - High DoseChange in Urea Nitrogen From Baselineweek 1-0.5712 mmol/LStandard Deviation 2.7988
Arm 4 - Low DoseChange in Urea Nitrogen From Baselineweek 2-0.2365 mmol/LStandard Deviation 2.2977
Arm 4 - Low DoseChange in Urea Nitrogen From Baselineweek 8-0.0759 mmol/LStandard Deviation 2.3484
Arm 4 - Low DoseChange in Urea Nitrogen From Baselineweek 4-0.3570 mmol/LStandard Deviation 2.0358
Arm 4 - Low DoseChange in Urea Nitrogen From Baselineweek 120.3525 mmol/LStandard Deviation 2.3561
Arm 4 - Low DoseChange in Urea Nitrogen From Baselineweek 240.5379 mmol/LStandard Deviation 2.391
Arm 4 - Low DoseChange in Urea Nitrogen From Baselineweek 10.1428 mmol/LStandard Deviation 2.0927
Arm 5 - Intermediate DoseChange in Urea Nitrogen From Baselineweek 4-0.6474 mmol/LStandard Deviation 1.829
Arm 5 - Intermediate DoseChange in Urea Nitrogen From Baselineweek 1-0.4712 mmol/LStandard Deviation 1.5268
Arm 5 - Intermediate DoseChange in Urea Nitrogen From Baselineweek 20.7854 mmol/LStandard Deviation 1.2804
Arm 5 - Intermediate DoseChange in Urea Nitrogen From Baselineweek 8-1.0900 mmol/LStandard Deviation 2.3572
Arm 5 - Intermediate DoseChange in Urea Nitrogen From Baselineweek 12-0.4667 mmol/LStandard Deviation 2.1063
Arm 5 - Intermediate DoseChange in Urea Nitrogen From Baselineweek 24-0.2999 mmol/LStandard Deviation 1.5902
Arm 6 - High DoseChange in Urea Nitrogen From Baselineweek 80.3237 mmol/LStandard Deviation 2.1001
Arm 6 - High DoseChange in Urea Nitrogen From Baselineweek 4-0.5807 mmol/LStandard Deviation 2.3925
Arm 6 - High DoseChange in Urea Nitrogen From Baselineweek 2-0.6378 mmol/LStandard Deviation 2.4125
Arm 6 - High DoseChange in Urea Nitrogen From Baselineweek 1-0.3237 mmol/LStandard Deviation 2.457
Arm 6 - High DoseChange in Urea Nitrogen From Baselineweek 24-0.1989 mmol/LStandard Deviation 2.9145
Arm 6 - High DoseChange in Urea Nitrogen From Baselineweek 12-0.6426 mmol/LStandard Deviation 1.9342
Primary

Occurrence of Serious AE 24 Weeks Following the Vaccination

Occurrence of any treatment - emergent serious AE and treatment - emergent SAE related to study drug was monitored during the study period (24 weeks following vaccination)

Time frame: 24 weeks following the vaccination

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Arm 1 - Low DoseOccurrence of Serious AE 24 Weeks Following the VaccinationAny treatment-emergent SAE related to study drug0 Participants
Arm 1 - Low DoseOccurrence of Serious AE 24 Weeks Following the VaccinationAny treatment-emergent SAE0 Participants
Arm 2 - Intermediate DoseOccurrence of Serious AE 24 Weeks Following the VaccinationAny treatment-emergent SAE related to study drug0 Participants
Arm 2 - Intermediate DoseOccurrence of Serious AE 24 Weeks Following the VaccinationAny treatment-emergent SAE0 Participants
Arm 3 - High DoseOccurrence of Serious AE 24 Weeks Following the VaccinationAny treatment-emergent SAE related to study drug0 Participants
Arm 3 - High DoseOccurrence of Serious AE 24 Weeks Following the VaccinationAny treatment-emergent SAE0 Participants
Arm 4 - Low DoseOccurrence of Serious AE 24 Weeks Following the VaccinationAny treatment-emergent SAE related to study drug0 Participants
Arm 4 - Low DoseOccurrence of Serious AE 24 Weeks Following the VaccinationAny treatment-emergent SAE0 Participants
Arm 5 - Intermediate DoseOccurrence of Serious AE 24 Weeks Following the VaccinationAny treatment-emergent SAE related to study drug0 Participants
Arm 5 - Intermediate DoseOccurrence of Serious AE 24 Weeks Following the VaccinationAny treatment-emergent SAE0 Participants
Arm 6 - High DoseOccurrence of Serious AE 24 Weeks Following the VaccinationAny treatment-emergent SAE related to study drug0 Participants
Arm 6 - High DoseOccurrence of Serious AE 24 Weeks Following the VaccinationAny treatment-emergent SAE0 Participants
Primary

Occurrence of Solicited Local AE Signs and Symptoms 7 Days Following the Vaccination

Participants were monitored for 7 days post-vaccination and the occurrence of solicited local AE signs and symptoms were collected.

Time frame: 7 days following the vaccination

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Arm 1 - Low DoseOccurrence of Solicited Local AE Signs and Symptoms 7 Days Following the VaccinationInjection site pain10 Participants
Arm 1 - Low DoseOccurrence of Solicited Local AE Signs and Symptoms 7 Days Following the VaccinationInjection site Haematoma0 Participants
Arm 1 - Low DoseOccurrence of Solicited Local AE Signs and Symptoms 7 Days Following the VaccinationInjection site erythema1 Participants
Arm 1 - Low DoseOccurrence of Solicited Local AE Signs and Symptoms 7 Days Following the VaccinationInjection site swelling0 Participants
Arm 2 - Intermediate DoseOccurrence of Solicited Local AE Signs and Symptoms 7 Days Following the VaccinationInjection site swelling0 Participants
Arm 2 - Intermediate DoseOccurrence of Solicited Local AE Signs and Symptoms 7 Days Following the VaccinationInjection site pain12 Participants
Arm 2 - Intermediate DoseOccurrence of Solicited Local AE Signs and Symptoms 7 Days Following the VaccinationInjection site Haematoma0 Participants
Arm 2 - Intermediate DoseOccurrence of Solicited Local AE Signs and Symptoms 7 Days Following the VaccinationInjection site erythema2 Participants
Arm 3 - High DoseOccurrence of Solicited Local AE Signs and Symptoms 7 Days Following the VaccinationInjection site erythema2 Participants
Arm 3 - High DoseOccurrence of Solicited Local AE Signs and Symptoms 7 Days Following the VaccinationInjection site pain10 Participants
Arm 3 - High DoseOccurrence of Solicited Local AE Signs and Symptoms 7 Days Following the VaccinationInjection site swelling1 Participants
Arm 3 - High DoseOccurrence of Solicited Local AE Signs and Symptoms 7 Days Following the VaccinationInjection site Haematoma0 Participants
Arm 4 - Low DoseOccurrence of Solicited Local AE Signs and Symptoms 7 Days Following the VaccinationInjection site pain2 Participants
Arm 4 - Low DoseOccurrence of Solicited Local AE Signs and Symptoms 7 Days Following the VaccinationInjection site Haematoma0 Participants
Arm 4 - Low DoseOccurrence of Solicited Local AE Signs and Symptoms 7 Days Following the VaccinationInjection site swelling0 Participants
Arm 4 - Low DoseOccurrence of Solicited Local AE Signs and Symptoms 7 Days Following the VaccinationInjection site erythema0 Participants
Arm 5 - Intermediate DoseOccurrence of Solicited Local AE Signs and Symptoms 7 Days Following the VaccinationInjection site erythema0 Participants
Arm 5 - Intermediate DoseOccurrence of Solicited Local AE Signs and Symptoms 7 Days Following the VaccinationInjection site pain1 Participants
Arm 5 - Intermediate DoseOccurrence of Solicited Local AE Signs and Symptoms 7 Days Following the VaccinationInjection site swelling0 Participants
Arm 5 - Intermediate DoseOccurrence of Solicited Local AE Signs and Symptoms 7 Days Following the VaccinationInjection site Haematoma1 Participants
Arm 6 - High DoseOccurrence of Solicited Local AE Signs and Symptoms 7 Days Following the VaccinationInjection site erythema1 Participants
Arm 6 - High DoseOccurrence of Solicited Local AE Signs and Symptoms 7 Days Following the VaccinationInjection site pain4 Participants
Arm 6 - High DoseOccurrence of Solicited Local AE Signs and Symptoms 7 Days Following the VaccinationInjection site Haematoma0 Participants
Arm 6 - High DoseOccurrence of Solicited Local AE Signs and Symptoms 7 Days Following the VaccinationInjection site swelling1 Participants
Primary

Occurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the Vaccination

Participants were monitored for 7 days post-vaccination and the occurrence of solicited systemic AE signs and symptoms were collected.

Time frame: 7 days following the vaccination

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Arm 1 - Low DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationAbdominal Pain1 Participants
Arm 1 - Low DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationMyalgia1 Participants
Arm 1 - Low DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationTooth abscess0 Participants
Arm 1 - Low DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationNeutropeonia1 Participants
Arm 1 - Low DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationNausea2 Participants
Arm 1 - Low DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationHyperkalaemia0 Participants
Arm 1 - Low DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationLymphadenopathy1 Participants
Arm 1 - Low DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationEcchymosis0 Participants
Arm 1 - Low DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationOropharyngeal pain0 Participants
Arm 1 - Low DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationHeadache5 Participants
Arm 1 - Low DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationChills1 Participants
Arm 1 - Low DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationDyspnoea0 Participants
Arm 1 - Low DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationTooth fracture0 Participants
Arm 1 - Low DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationMuscle strain0 Participants
Arm 1 - Low DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationMuscle injury0 Participants
Arm 1 - Low DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationFatigue8 Participants
Arm 1 - Low DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationHot flush1 Participants
Arm 1 - Low DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationFaeces Soft0 Participants
Arm 1 - Low DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationCough0 Participants
Arm 1 - Low DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationPyrexia3 Participants
Arm 1 - Low DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationChalazion0 Participants
Arm 1 - Low DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationBack Pain0 Participants
Arm 1 - Low DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationArthralgia0 Participants
Arm 1 - Low DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationDiarrhoea1 Participants
Arm 2 - Intermediate DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationFatigue7 Participants
Arm 2 - Intermediate DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationTooth fracture0 Participants
Arm 2 - Intermediate DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationHeadache6 Participants
Arm 2 - Intermediate DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationPyrexia4 Participants
Arm 2 - Intermediate DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationMyalgia5 Participants
Arm 2 - Intermediate DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationChills1 Participants
Arm 2 - Intermediate DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationNausea2 Participants
Arm 2 - Intermediate DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationNeutropeonia1 Participants
Arm 2 - Intermediate DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationAbdominal Pain4 Participants
Arm 2 - Intermediate DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationDiarrhoea3 Participants
Arm 2 - Intermediate DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationArthralgia0 Participants
Arm 2 - Intermediate DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationBack Pain0 Participants
Arm 2 - Intermediate DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationCough0 Participants
Arm 2 - Intermediate DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationFaeces Soft0 Participants
Arm 2 - Intermediate DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationHot flush0 Participants
Arm 2 - Intermediate DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationHyperkalaemia0 Participants
Arm 2 - Intermediate DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationMuscle injury0 Participants
Arm 2 - Intermediate DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationMuscle strain0 Participants
Arm 2 - Intermediate DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationDyspnoea0 Participants
Arm 2 - Intermediate DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationOropharyngeal pain1 Participants
Arm 2 - Intermediate DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationEcchymosis1 Participants
Arm 2 - Intermediate DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationTooth abscess0 Participants
Arm 2 - Intermediate DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationChalazion0 Participants
Arm 2 - Intermediate DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationLymphadenopathy0 Participants
Arm 3 - High DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationMyalgia4 Participants
Arm 3 - High DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationCough0 Participants
Arm 3 - High DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationOropharyngeal pain0 Participants
Arm 3 - High DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationAbdominal Pain0 Participants
Arm 3 - High DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationHeadache10 Participants
Arm 3 - High DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationFatigue10 Participants
Arm 3 - High DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationDiarrhoea0 Participants
Arm 3 - High DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationFaeces Soft1 Participants
Arm 3 - High DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationDyspnoea0 Participants
Arm 3 - High DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationLymphadenopathy0 Participants
Arm 3 - High DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationChills6 Participants
Arm 3 - High DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationPyrexia11 Participants
Arm 3 - High DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationChalazion0 Participants
Arm 3 - High DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationHot flush0 Participants
Arm 3 - High DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationTooth abscess0 Participants
Arm 3 - High DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationNeutropeonia2 Participants
Arm 3 - High DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationBack Pain0 Participants
Arm 3 - High DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationHyperkalaemia0 Participants
Arm 3 - High DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationArthralgia0 Participants
Arm 3 - High DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationTooth fracture1 Participants
Arm 3 - High DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationNausea3 Participants
Arm 3 - High DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationEcchymosis0 Participants
Arm 3 - High DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationMuscle strain0 Participants
Arm 3 - High DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationMuscle injury0 Participants
Arm 4 - Low DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationDiarrhoea0 Participants
Arm 4 - Low DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationArthralgia0 Participants
Arm 4 - Low DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationMuscle strain0 Participants
Arm 4 - Low DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationOropharyngeal pain0 Participants
Arm 4 - Low DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationHeadache6 Participants
Arm 4 - Low DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationTooth fracture0 Participants
Arm 4 - Low DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationDyspnoea0 Participants
Arm 4 - Low DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationNausea1 Participants
Arm 4 - Low DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationBack Pain1 Participants
Arm 4 - Low DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationNeutropeonia1 Participants
Arm 4 - Low DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationMyalgia5 Participants
Arm 4 - Low DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationMuscle injury0 Participants
Arm 4 - Low DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationCough0 Participants
Arm 4 - Low DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationChills4 Participants
Arm 4 - Low DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationTooth abscess1 Participants
Arm 4 - Low DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationFaeces Soft0 Participants
Arm 4 - Low DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationAbdominal Pain0 Participants
Arm 4 - Low DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationFatigue7 Participants
Arm 4 - Low DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationHot flush0 Participants
Arm 4 - Low DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationChalazion0 Participants
Arm 4 - Low DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationHyperkalaemia0 Participants
Arm 4 - Low DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationPyrexia4 Participants
Arm 4 - Low DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationEcchymosis0 Participants
Arm 4 - Low DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationLymphadenopathy0 Participants
Arm 5 - Intermediate DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationTooth abscess0 Participants
Arm 5 - Intermediate DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationAbdominal Pain0 Participants
Arm 5 - Intermediate DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationPyrexia4 Participants
Arm 5 - Intermediate DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationDiarrhoea1 Participants
Arm 5 - Intermediate DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationArthralgia0 Participants
Arm 5 - Intermediate DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationBack Pain0 Participants
Arm 5 - Intermediate DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationCough0 Participants
Arm 5 - Intermediate DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationFatigue2 Participants
Arm 5 - Intermediate DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationLymphadenopathy0 Participants
Arm 5 - Intermediate DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationFaeces Soft0 Participants
Arm 5 - Intermediate DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationHot flush0 Participants
Arm 5 - Intermediate DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationHyperkalaemia1 Participants
Arm 5 - Intermediate DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationChalazion0 Participants
Arm 5 - Intermediate DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationMuscle injury1 Participants
Arm 5 - Intermediate DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationHeadache3 Participants
Arm 5 - Intermediate DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationMuscle strain0 Participants
Arm 5 - Intermediate DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationTooth fracture0 Participants
Arm 5 - Intermediate DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationDyspnoea0 Participants
Arm 5 - Intermediate DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationOropharyngeal pain0 Participants
Arm 5 - Intermediate DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationEcchymosis0 Participants
Arm 5 - Intermediate DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationMyalgia1 Participants
Arm 5 - Intermediate DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationChills4 Participants
Arm 5 - Intermediate DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationNausea3 Participants
Arm 5 - Intermediate DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationNeutropeonia1 Participants
Arm 6 - High DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationChalazion1 Participants
Arm 6 - High DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationMuscle injury0 Participants
Arm 6 - High DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationHeadache2 Participants
Arm 6 - High DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationHyperkalaemia0 Participants
Arm 6 - High DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationPyrexia4 Participants
Arm 6 - High DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationDiarrhoea0 Participants
Arm 6 - High DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationMyalgia5 Participants
Arm 6 - High DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationEcchymosis0 Participants
Arm 6 - High DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationFaeces Soft0 Participants
Arm 6 - High DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationCough1 Participants
Arm 6 - High DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationAbdominal Pain0 Participants
Arm 6 - High DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationChills6 Participants
Arm 6 - High DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationFatigue4 Participants
Arm 6 - High DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationHot flush0 Participants
Arm 6 - High DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationBack Pain0 Participants
Arm 6 - High DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationTooth abscess0 Participants
Arm 6 - High DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationNeutropeonia2 Participants
Arm 6 - High DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationDyspnoea1 Participants
Arm 6 - High DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationNausea2 Participants
Arm 6 - High DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationLymphadenopathy0 Participants
Arm 6 - High DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationTooth fracture0 Participants
Arm 6 - High DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationMuscle strain1 Participants
Arm 6 - High DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationArthralgia1 Participants
Arm 6 - High DoseOccurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the VaccinationOropharyngeal pain0 Participants
Primary

Occurrence of Unsolicited AE 28 Days Following the Vaccination

Occurrence of unsolicited AEs: unsolicited AEs were collected using the patient Diary and reported as Any AE occurring 28 days following the vaccination.

Time frame: 28 days following the vaccination

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Arm 1 - Low DoseOccurrence of Unsolicited AE 28 Days Following the Vaccinationweek 3 - Any AE: mild4 Participants
Arm 1 - Low DoseOccurrence of Unsolicited AE 28 Days Following the Vaccinationweek 3 - any AE: moderate0 Participants
Arm 1 - Low DoseOccurrence of Unsolicited AE 28 Days Following the Vaccinationweek 1 - any AE : Moderate3 Participants
Arm 1 - Low DoseOccurrence of Unsolicited AE 28 Days Following the Vaccinationweek 2 - any AE: moderate0 Participants
Arm 1 - Low DoseOccurrence of Unsolicited AE 28 Days Following the Vaccinationweek 4 - any AE: severe0 Participants
Arm 1 - Low DoseOccurrence of Unsolicited AE 28 Days Following the Vaccinationweek 1 - any AE : Severe0 Participants
Arm 1 - Low DoseOccurrence of Unsolicited AE 28 Days Following the Vaccinationweek 4 - any AE: moderate0 Participants
Arm 1 - Low DoseOccurrence of Unsolicited AE 28 Days Following the Vaccinationweek 2 - any AE: mild5 Participants
Arm 1 - Low DoseOccurrence of Unsolicited AE 28 Days Following the Vaccinationweek 1 - any AE : Mild9 Participants
Arm 1 - Low DoseOccurrence of Unsolicited AE 28 Days Following the Vaccinationweek 4 - any AE: mild1 Participants
Arm 1 - Low DoseOccurrence of Unsolicited AE 28 Days Following the Vaccinationweek 2 - any AE: severe0 Participants
Arm 1 - Low DoseOccurrence of Unsolicited AE 28 Days Following the Vaccinationweek 3 - any AE: severe0 Participants
Arm 2 - Intermediate DoseOccurrence of Unsolicited AE 28 Days Following the Vaccinationweek 1 - any AE : Mild9 Participants
Arm 2 - Intermediate DoseOccurrence of Unsolicited AE 28 Days Following the Vaccinationweek 3 - Any AE: mild3 Participants
Arm 2 - Intermediate DoseOccurrence of Unsolicited AE 28 Days Following the Vaccinationweek 2 - any AE: moderate1 Participants
Arm 2 - Intermediate DoseOccurrence of Unsolicited AE 28 Days Following the Vaccinationweek 4 - any AE: moderate0 Participants
Arm 2 - Intermediate DoseOccurrence of Unsolicited AE 28 Days Following the Vaccinationweek 3 - any AE: severe0 Participants
Arm 2 - Intermediate DoseOccurrence of Unsolicited AE 28 Days Following the Vaccinationweek 3 - any AE: moderate1 Participants
Arm 2 - Intermediate DoseOccurrence of Unsolicited AE 28 Days Following the Vaccinationweek 2 - any AE: severe0 Participants
Arm 2 - Intermediate DoseOccurrence of Unsolicited AE 28 Days Following the Vaccinationweek 2 - any AE: mild5 Participants
Arm 2 - Intermediate DoseOccurrence of Unsolicited AE 28 Days Following the Vaccinationweek 4 - any AE: severe0 Participants
Arm 2 - Intermediate DoseOccurrence of Unsolicited AE 28 Days Following the Vaccinationweek 4 - any AE: mild2 Participants
Arm 2 - Intermediate DoseOccurrence of Unsolicited AE 28 Days Following the Vaccinationweek 1 - any AE : Moderate5 Participants
Arm 2 - Intermediate DoseOccurrence of Unsolicited AE 28 Days Following the Vaccinationweek 1 - any AE : Severe0 Participants
Arm 3 - High DoseOccurrence of Unsolicited AE 28 Days Following the Vaccinationweek 1 - any AE : Moderate6 Participants
Arm 3 - High DoseOccurrence of Unsolicited AE 28 Days Following the Vaccinationweek 4 - any AE: moderate1 Participants
Arm 3 - High DoseOccurrence of Unsolicited AE 28 Days Following the Vaccinationweek 3 - any AE: severe0 Participants
Arm 3 - High DoseOccurrence of Unsolicited AE 28 Days Following the Vaccinationweek 1 - any AE : Severe0 Participants
Arm 3 - High DoseOccurrence of Unsolicited AE 28 Days Following the Vaccinationweek 2 - any AE: mild0 Participants
Arm 3 - High DoseOccurrence of Unsolicited AE 28 Days Following the Vaccinationweek 2 - any AE: moderate0 Participants
Arm 3 - High DoseOccurrence of Unsolicited AE 28 Days Following the Vaccinationweek 3 - Any AE: mild0 Participants
Arm 3 - High DoseOccurrence of Unsolicited AE 28 Days Following the Vaccinationweek 1 - any AE : Mild13 Participants
Arm 3 - High DoseOccurrence of Unsolicited AE 28 Days Following the Vaccinationweek 3 - any AE: moderate2 Participants
Arm 3 - High DoseOccurrence of Unsolicited AE 28 Days Following the Vaccinationweek 4 - any AE: mild0 Participants
Arm 3 - High DoseOccurrence of Unsolicited AE 28 Days Following the Vaccinationweek 4 - any AE: severe0 Participants
Arm 3 - High DoseOccurrence of Unsolicited AE 28 Days Following the Vaccinationweek 2 - any AE: severe0 Participants
Arm 4 - Low DoseOccurrence of Unsolicited AE 28 Days Following the Vaccinationweek 1 - any AE : Severe1 Participants
Arm 4 - Low DoseOccurrence of Unsolicited AE 28 Days Following the Vaccinationweek 1 - any AE : Moderate1 Participants
Arm 4 - Low DoseOccurrence of Unsolicited AE 28 Days Following the Vaccinationweek 1 - any AE : Mild9 Participants
Arm 4 - Low DoseOccurrence of Unsolicited AE 28 Days Following the Vaccinationweek 2 - any AE: mild5 Participants
Arm 4 - Low DoseOccurrence of Unsolicited AE 28 Days Following the Vaccinationweek 2 - any AE: moderate0 Participants
Arm 4 - Low DoseOccurrence of Unsolicited AE 28 Days Following the Vaccinationweek 2 - any AE: severe0 Participants
Arm 4 - Low DoseOccurrence of Unsolicited AE 28 Days Following the Vaccinationweek 3 - Any AE: mild3 Participants
Arm 4 - Low DoseOccurrence of Unsolicited AE 28 Days Following the Vaccinationweek 3 - any AE: moderate1 Participants
Arm 4 - Low DoseOccurrence of Unsolicited AE 28 Days Following the Vaccinationweek 3 - any AE: severe0 Participants
Arm 4 - Low DoseOccurrence of Unsolicited AE 28 Days Following the Vaccinationweek 4 - any AE: mild0 Participants
Arm 4 - Low DoseOccurrence of Unsolicited AE 28 Days Following the Vaccinationweek 4 - any AE: moderate0 Participants
Arm 4 - Low DoseOccurrence of Unsolicited AE 28 Days Following the Vaccinationweek 4 - any AE: severe0 Participants
Arm 5 - Intermediate DoseOccurrence of Unsolicited AE 28 Days Following the Vaccinationweek 2 - any AE: moderate1 Participants
Arm 5 - Intermediate DoseOccurrence of Unsolicited AE 28 Days Following the Vaccinationweek 1 - any AE : Severe0 Participants
Arm 5 - Intermediate DoseOccurrence of Unsolicited AE 28 Days Following the Vaccinationweek 1 - any AE : Mild6 Participants
Arm 5 - Intermediate DoseOccurrence of Unsolicited AE 28 Days Following the Vaccinationweek 4 - any AE: severe0 Participants
Arm 5 - Intermediate DoseOccurrence of Unsolicited AE 28 Days Following the Vaccinationweek 4 - any AE: moderate0 Participants
Arm 5 - Intermediate DoseOccurrence of Unsolicited AE 28 Days Following the Vaccinationweek 2 - any AE: mild1 Participants
Arm 5 - Intermediate DoseOccurrence of Unsolicited AE 28 Days Following the Vaccinationweek 1 - any AE : Moderate2 Participants
Arm 5 - Intermediate DoseOccurrence of Unsolicited AE 28 Days Following the Vaccinationweek 3 - any AE: severe0 Participants
Arm 5 - Intermediate DoseOccurrence of Unsolicited AE 28 Days Following the Vaccinationweek 3 - Any AE: mild1 Participants
Arm 5 - Intermediate DoseOccurrence of Unsolicited AE 28 Days Following the Vaccinationweek 4 - any AE: mild1 Participants
Arm 5 - Intermediate DoseOccurrence of Unsolicited AE 28 Days Following the Vaccinationweek 3 - any AE: moderate1 Participants
Arm 5 - Intermediate DoseOccurrence of Unsolicited AE 28 Days Following the Vaccinationweek 2 - any AE: severe0 Participants
Arm 6 - High DoseOccurrence of Unsolicited AE 28 Days Following the Vaccinationweek 3 - any AE: moderate0 Participants
Arm 6 - High DoseOccurrence of Unsolicited AE 28 Days Following the Vaccinationweek 2 - any AE: moderate0 Participants
Arm 6 - High DoseOccurrence of Unsolicited AE 28 Days Following the Vaccinationweek 3 - any AE: severe0 Participants
Arm 6 - High DoseOccurrence of Unsolicited AE 28 Days Following the Vaccinationweek 2 - any AE: mild0 Participants
Arm 6 - High DoseOccurrence of Unsolicited AE 28 Days Following the Vaccinationweek 4 - any AE: severe0 Participants
Arm 6 - High DoseOccurrence of Unsolicited AE 28 Days Following the Vaccinationweek 4 - any AE: mild0 Participants
Arm 6 - High DoseOccurrence of Unsolicited AE 28 Days Following the Vaccinationweek 1 - any AE : Severe1 Participants
Arm 6 - High DoseOccurrence of Unsolicited AE 28 Days Following the Vaccinationweek 1 - any AE : Moderate2 Participants
Arm 6 - High DoseOccurrence of Unsolicited AE 28 Days Following the Vaccinationweek 4 - any AE: moderate0 Participants
Arm 6 - High DoseOccurrence of Unsolicited AE 28 Days Following the Vaccinationweek 3 - Any AE: mild0 Participants
Arm 6 - High DoseOccurrence of Unsolicited AE 28 Days Following the Vaccinationweek 1 - any AE : Mild7 Participants
Arm 6 - High DoseOccurrence of Unsolicited AE 28 Days Following the Vaccinationweek 2 - any AE: severe0 Participants
Secondary

Immunogenicity - T-cell Response

To assess the cellular and humoral immune response to SARS-CoV2 elicited by the vaccine cellular and humoral immune parameters evaluated. T-cells were evaluated on frozen and fresh (week2) samples Within-cohort comparisons to assess the difference in immune response according to different doses in the same population Across-the-cohort comparison to assess whether elderlies and adults have a different pattern of immune response after vaccination at different endpoints Unit: spot-forming cells \[SFC\]/1 × 10\^6 peripheral blood mononuclear cell \[PBMC\] Interpretation: values higher than at baseline are indicative of a persistent spike-specific memory T-cell establishment.

Time frame: baseline, week 2, week 4, week 8, week 12, week 24

Population: number of subjects analyzed is calculated based on number of subjects with non missing observation thus numbers of subjects analyzed may vary between the observation period.

ArmMeasureGroupValue (MEDIAN)
Arm 1 - Low DoseImmunogenicity - T-cell ResponseT-cell response week 24538.0 SFC/1x10^6 PBMC
Arm 1 - Low DoseImmunogenicity - T-cell ResponseT-cell response week 12570.0 SFC/1x10^6 PBMC
Arm 1 - Low DoseImmunogenicity - T-cell ResponseT-cell response week 2 (frozen samples)1214.0 SFC/1x10^6 PBMC
Arm 1 - Low DoseImmunogenicity - T-cell ResponseT-cell response week 2 (fresh samples)1161.0 SFC/1x10^6 PBMC
Arm 1 - Low DoseImmunogenicity - T-cell ResponseT-cell response baseline54 SFC/1x10^6 PBMC
Arm 1 - Low DoseImmunogenicity - T-cell ResponseT-cell response week 8720.0 SFC/1x10^6 PBMC
Arm 1 - Low DoseImmunogenicity - T-cell ResponseT-cell response week 4788.0 SFC/1x10^6 PBMC
Arm 2 - Intermediate DoseImmunogenicity - T-cell ResponseT-cell response week 41120.0 SFC/1x10^6 PBMC
Arm 2 - Intermediate DoseImmunogenicity - T-cell ResponseT-cell response week 8948.0 SFC/1x10^6 PBMC
Arm 2 - Intermediate DoseImmunogenicity - T-cell ResponseT-cell response week 12655.0 SFC/1x10^6 PBMC
Arm 2 - Intermediate DoseImmunogenicity - T-cell ResponseT-cell response week 24500.0 SFC/1x10^6 PBMC
Arm 2 - Intermediate DoseImmunogenicity - T-cell ResponseT-cell response baseline88.0 SFC/1x10^6 PBMC
Arm 2 - Intermediate DoseImmunogenicity - T-cell ResponseT-cell response week 2 (fresh samples)2857.0 SFC/1x10^6 PBMC
Arm 2 - Intermediate DoseImmunogenicity - T-cell ResponseT-cell response week 2 (frozen samples)1095.0 SFC/1x10^6 PBMC
Arm 3 - High DoseImmunogenicity - T-cell ResponseT-cell response week 41330.0 SFC/1x10^6 PBMC
Arm 3 - High DoseImmunogenicity - T-cell ResponseT-cell response week 2 (fresh samples)2272.0 SFC/1x10^6 PBMC
Arm 3 - High DoseImmunogenicity - T-cell ResponseT-cell response baseline128.0 SFC/1x10^6 PBMC
Arm 3 - High DoseImmunogenicity - T-cell ResponseT-cell response week 81172.0 SFC/1x10^6 PBMC
Arm 3 - High DoseImmunogenicity - T-cell ResponseT-cell response week 12856.0 SFC/1x10^6 PBMC
Arm 3 - High DoseImmunogenicity - T-cell ResponseT-cell response week 24798.0 SFC/1x10^6 PBMC
Arm 3 - High DoseImmunogenicity - T-cell ResponseT-cell response week 2 (frozen samples)905.0 SFC/1x10^6 PBMC
Arm 4 - Low DoseImmunogenicity - T-cell ResponseT-cell response week 12898.0 SFC/1x10^6 PBMC
Arm 4 - Low DoseImmunogenicity - T-cell ResponseT-cell response week 2 (frozen samples)1258.0 SFC/1x10^6 PBMC
Arm 4 - Low DoseImmunogenicity - T-cell ResponseT-cell response week 24740.5 SFC/1x10^6 PBMC
Arm 4 - Low DoseImmunogenicity - T-cell ResponseT-cell response baseline320.0 SFC/1x10^6 PBMC
Arm 4 - Low DoseImmunogenicity - T-cell ResponseT-cell response week 2 (fresh samples)1917.0 SFC/1x10^6 PBMC
Arm 4 - Low DoseImmunogenicity - T-cell ResponseT-cell response week 41153.0 SFC/1x10^6 PBMC
Arm 4 - Low DoseImmunogenicity - T-cell ResponseT-cell response week 8898.0 SFC/1x10^6 PBMC
Arm 5 - Intermediate DoseImmunogenicity - T-cell ResponseT-cell response week 12835.0 SFC/1x10^6 PBMC
Arm 5 - Intermediate DoseImmunogenicity - T-cell ResponseT-cell response week 24643.0 SFC/1x10^6 PBMC
Arm 5 - Intermediate DoseImmunogenicity - T-cell ResponseT-cell response week 8888.0 SFC/1x10^6 PBMC
Arm 5 - Intermediate DoseImmunogenicity - T-cell ResponseT-cell response week 2 (frozen samples)1363.0 SFC/1x10^6 PBMC
Arm 5 - Intermediate DoseImmunogenicity - T-cell ResponseT-cell response week 2 (fresh samples)2262.0 SFC/1x10^6 PBMC
Arm 5 - Intermediate DoseImmunogenicity - T-cell ResponseT-cell response week 41258.0 SFC/1x10^6 PBMC
Arm 5 - Intermediate DoseImmunogenicity - T-cell ResponseT-cell response baseline165.0 SFC/1x10^6 PBMC
Arm 6 - High DoseImmunogenicity - T-cell ResponseT-cell response week 121435.0 SFC/1x10^6 PBMC
Arm 6 - High DoseImmunogenicity - T-cell ResponseT-cell response week 2 (frozen samples)1618.0 SFC/1x10^6 PBMC
Arm 6 - High DoseImmunogenicity - T-cell ResponseT-cell response week 241223.0 SFC/1x10^6 PBMC
Arm 6 - High DoseImmunogenicity - T-cell ResponseT-cell response week 2 (fresh samples)3142.0 SFC/1x10^6 PBMC
Arm 6 - High DoseImmunogenicity - T-cell ResponseT-cell response baseline425.0 SFC/1x10^6 PBMC
Arm 6 - High DoseImmunogenicity - T-cell ResponseT-cell response week 41645.0 SFC/1x10^6 PBMC
Arm 6 - High DoseImmunogenicity - T-cell ResponseT-cell response week 82133.0 SFC/1x10^6 PBMC
Secondary

Number of Participants With Positive, Negative Anti-n Antibody

To assess the cellular and humoral immune response to SARS-CoV2 elicited by the vaccine cellular and humoral immune parameters evaluated: anti-N Antibody Interpretation: n. of subjects positive, negative at week 1, 2, 4, 8, 12 and 24 compared to baseline

Time frame: week 1, 2, 4, 8, 12 and 24

Population: * One subject in arm-1 low dose (adult cohort) had an asymptomatic infection around the time of vaccination. This was discovered post hoc, and this subject was excluded from all Immunogenicity Analysis Set(IAS).~* One subject in Arm-4 low dose (elderly cohort) had a suspicious non-specific reactivity to the tests and was excluded from the IAS.~* Other specification: % = Calculated as nr. of subjects within category divided by nr. of subjects with non-missing observation at each time point.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Arm 1 - Low DoseNumber of Participants With Positive, Negative Anti-n Antibodyweek 4positive0 Participants
Arm 1 - Low DoseNumber of Participants With Positive, Negative Anti-n Antibodyweek 2positive0 Participants
Arm 1 - Low DoseNumber of Participants With Positive, Negative Anti-n Antibodyweek 1negative14 Participants
Arm 1 - Low DoseNumber of Participants With Positive, Negative Anti-n Antibodyweek 4negative14 Participants
Arm 1 - Low DoseNumber of Participants With Positive, Negative Anti-n Antibodyweek 12positive0 Participants
Arm 1 - Low DoseNumber of Participants With Positive, Negative Anti-n Antibodyweek 24positive0 Participants
Arm 1 - Low DoseNumber of Participants With Positive, Negative Anti-n Antibodyweek 8negative14 Participants
Arm 1 - Low DoseNumber of Participants With Positive, Negative Anti-n Antibodyweek 2negative14 Participants
Arm 1 - Low DoseNumber of Participants With Positive, Negative Anti-n Antibodyweek 24negative14 Participants
Arm 1 - Low DoseNumber of Participants With Positive, Negative Anti-n Antibodyweek 1positive0 Participants
Arm 1 - Low DoseNumber of Participants With Positive, Negative Anti-n Antibodyweek 8positive0 Participants
Arm 1 - Low DoseNumber of Participants With Positive, Negative Anti-n Antibodyweek 12negative14 Participants
Arm 2 - Intermediate DoseNumber of Participants With Positive, Negative Anti-n Antibodyweek 8positive0 Participants
Arm 2 - Intermediate DoseNumber of Participants With Positive, Negative Anti-n Antibodyweek 4positive0 Participants
Arm 2 - Intermediate DoseNumber of Participants With Positive, Negative Anti-n Antibodyweek 24negative13 Participants
Arm 2 - Intermediate DoseNumber of Participants With Positive, Negative Anti-n Antibodyweek 24positive0 Participants
Arm 2 - Intermediate DoseNumber of Participants With Positive, Negative Anti-n Antibodyweek 1negative15 Participants
Arm 2 - Intermediate DoseNumber of Participants With Positive, Negative Anti-n Antibodyweek 12negative15 Participants
Arm 2 - Intermediate DoseNumber of Participants With Positive, Negative Anti-n Antibodyweek 12positive0 Participants
Arm 2 - Intermediate DoseNumber of Participants With Positive, Negative Anti-n Antibodyweek 2positive0 Participants
Arm 2 - Intermediate DoseNumber of Participants With Positive, Negative Anti-n Antibodyweek 1positive0 Participants
Arm 2 - Intermediate DoseNumber of Participants With Positive, Negative Anti-n Antibodyweek 8negative15 Participants
Arm 2 - Intermediate DoseNumber of Participants With Positive, Negative Anti-n Antibodyweek 2negative15 Participants
Arm 2 - Intermediate DoseNumber of Participants With Positive, Negative Anti-n Antibodyweek 4negative15 Participants
Arm 3 - High DoseNumber of Participants With Positive, Negative Anti-n Antibodyweek 1negative15 Participants
Arm 3 - High DoseNumber of Participants With Positive, Negative Anti-n Antibodyweek 1positive0 Participants
Arm 3 - High DoseNumber of Participants With Positive, Negative Anti-n Antibodyweek 2positive0 Participants
Arm 3 - High DoseNumber of Participants With Positive, Negative Anti-n Antibodyweek 2negative15 Participants
Arm 3 - High DoseNumber of Participants With Positive, Negative Anti-n Antibodyweek 4positive0 Participants
Arm 3 - High DoseNumber of Participants With Positive, Negative Anti-n Antibodyweek 4negative15 Participants
Arm 3 - High DoseNumber of Participants With Positive, Negative Anti-n Antibodyweek 8positive0 Participants
Arm 3 - High DoseNumber of Participants With Positive, Negative Anti-n Antibodyweek 8negative15 Participants
Arm 3 - High DoseNumber of Participants With Positive, Negative Anti-n Antibodyweek 12positive0 Participants
Arm 3 - High DoseNumber of Participants With Positive, Negative Anti-n Antibodyweek 12negative14 Participants
Arm 3 - High DoseNumber of Participants With Positive, Negative Anti-n Antibodyweek 24positive0 Participants
Arm 3 - High DoseNumber of Participants With Positive, Negative Anti-n Antibodyweek 24negative13 Participants
Arm 4 - Low DoseNumber of Participants With Positive, Negative Anti-n Antibodyweek 12negative15 Participants
Arm 4 - Low DoseNumber of Participants With Positive, Negative Anti-n Antibodyweek 2positive0 Participants
Arm 4 - Low DoseNumber of Participants With Positive, Negative Anti-n Antibodyweek 24negative12 Participants
Arm 4 - Low DoseNumber of Participants With Positive, Negative Anti-n Antibodyweek 1negative15 Participants
Arm 4 - Low DoseNumber of Participants With Positive, Negative Anti-n Antibodyweek 12positive0 Participants
Arm 4 - Low DoseNumber of Participants With Positive, Negative Anti-n Antibodyweek 2negative15 Participants
Arm 4 - Low DoseNumber of Participants With Positive, Negative Anti-n Antibodyweek 4positive0 Participants
Arm 4 - Low DoseNumber of Participants With Positive, Negative Anti-n Antibodyweek 24positive0 Participants
Arm 4 - Low DoseNumber of Participants With Positive, Negative Anti-n Antibodyweek 4negative15 Participants
Arm 4 - Low DoseNumber of Participants With Positive, Negative Anti-n Antibodyweek 1positive0 Participants
Arm 4 - Low DoseNumber of Participants With Positive, Negative Anti-n Antibodyweek 8negative15 Participants
Arm 4 - Low DoseNumber of Participants With Positive, Negative Anti-n Antibodyweek 8positive0 Participants
Arm 5 - Intermediate DoseNumber of Participants With Positive, Negative Anti-n Antibodyweek 4negative15 Participants
Arm 5 - Intermediate DoseNumber of Participants With Positive, Negative Anti-n Antibodyweek 1positive0 Participants
Arm 5 - Intermediate DoseNumber of Participants With Positive, Negative Anti-n Antibodyweek 8positive0 Participants
Arm 5 - Intermediate DoseNumber of Participants With Positive, Negative Anti-n Antibodyweek 2positive0 Participants
Arm 5 - Intermediate DoseNumber of Participants With Positive, Negative Anti-n Antibodyweek 8negative15 Participants
Arm 5 - Intermediate DoseNumber of Participants With Positive, Negative Anti-n Antibodyweek 12positive0 Participants
Arm 5 - Intermediate DoseNumber of Participants With Positive, Negative Anti-n Antibodyweek 1negative15 Participants
Arm 5 - Intermediate DoseNumber of Participants With Positive, Negative Anti-n Antibodyweek 12negative15 Participants
Arm 5 - Intermediate DoseNumber of Participants With Positive, Negative Anti-n Antibodyweek 24negative13 Participants
Arm 5 - Intermediate DoseNumber of Participants With Positive, Negative Anti-n Antibodyweek 24positive0 Participants
Arm 5 - Intermediate DoseNumber of Participants With Positive, Negative Anti-n Antibodyweek 4positive0 Participants
Arm 5 - Intermediate DoseNumber of Participants With Positive, Negative Anti-n Antibodyweek 2negative15 Participants
Arm 6 - High DoseNumber of Participants With Positive, Negative Anti-n Antibodyweek 12negative15 Participants
Arm 6 - High DoseNumber of Participants With Positive, Negative Anti-n Antibodyweek 1positive0 Participants
Arm 6 - High DoseNumber of Participants With Positive, Negative Anti-n Antibodyweek 2negative15 Participants
Arm 6 - High DoseNumber of Participants With Positive, Negative Anti-n Antibodyweek 2positive0 Participants
Arm 6 - High DoseNumber of Participants With Positive, Negative Anti-n Antibodyweek 24positive0 Participants
Arm 6 - High DoseNumber of Participants With Positive, Negative Anti-n Antibodyweek 4negative15 Participants
Arm 6 - High DoseNumber of Participants With Positive, Negative Anti-n Antibodyweek 12positive0 Participants
Arm 6 - High DoseNumber of Participants With Positive, Negative Anti-n Antibodyweek 4positive0 Participants
Arm 6 - High DoseNumber of Participants With Positive, Negative Anti-n Antibodyweek 24negative13 Participants
Arm 6 - High DoseNumber of Participants With Positive, Negative Anti-n Antibodyweek 1negative15 Participants
Arm 6 - High DoseNumber of Participants With Positive, Negative Anti-n Antibodyweek 8negative15 Participants
Arm 6 - High DoseNumber of Participants With Positive, Negative Anti-n Antibodyweek 8positive0 Participants
Secondary

Number of Participants With Positive, Negative for Micro Neutralization Test

To assess the cellular and humoral immune response to SARS-CoV2 elicited by the vaccine cellular and humoral immune parameters evaluated: Micro Neutralization test Interpretation: n. of positive and negative subjects at week 4 and week 24 by evaluating geometric mean titer change from baseline

Time frame: week 4 and week 24

Population: number of subjects analyzed is calculated based on number of subjects with non missing observation thus numbers of subjects analyzed may vary between the observation period.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Arm 1 - Low DoseNumber of Participants With Positive, Negative for Micro Neutralization Testpositive week 46 Participants
Arm 1 - Low DoseNumber of Participants With Positive, Negative for Micro Neutralization TestNegative week 2412 Participants
Arm 1 - Low DoseNumber of Participants With Positive, Negative for Micro Neutralization TestPositive week 242 Participants
Arm 1 - Low DoseNumber of Participants With Positive, Negative for Micro Neutralization TestNegative week 48 Participants
Arm 2 - Intermediate DoseNumber of Participants With Positive, Negative for Micro Neutralization TestNegative week 249 Participants
Arm 2 - Intermediate DoseNumber of Participants With Positive, Negative for Micro Neutralization TestNegative week 45 Participants
Arm 2 - Intermediate DoseNumber of Participants With Positive, Negative for Micro Neutralization Testpositive week 410 Participants
Arm 2 - Intermediate DoseNumber of Participants With Positive, Negative for Micro Neutralization TestPositive week 244 Participants
Arm 3 - High DoseNumber of Participants With Positive, Negative for Micro Neutralization Testpositive week 49 Participants
Arm 3 - High DoseNumber of Participants With Positive, Negative for Micro Neutralization TestPositive week 245 Participants
Arm 3 - High DoseNumber of Participants With Positive, Negative for Micro Neutralization TestNegative week 46 Participants
Arm 3 - High DoseNumber of Participants With Positive, Negative for Micro Neutralization TestNegative week 248 Participants
Arm 4 - Low DoseNumber of Participants With Positive, Negative for Micro Neutralization TestNegative week 2410 Participants
Arm 4 - Low DoseNumber of Participants With Positive, Negative for Micro Neutralization TestNegative week 43 Participants
Arm 4 - Low DoseNumber of Participants With Positive, Negative for Micro Neutralization TestPositive week 242 Participants
Arm 4 - Low DoseNumber of Participants With Positive, Negative for Micro Neutralization Testpositive week 412 Participants
Arm 5 - Intermediate DoseNumber of Participants With Positive, Negative for Micro Neutralization TestNegative week 45 Participants
Arm 5 - Intermediate DoseNumber of Participants With Positive, Negative for Micro Neutralization Testpositive week 410 Participants
Arm 5 - Intermediate DoseNumber of Participants With Positive, Negative for Micro Neutralization TestPositive week 244 Participants
Arm 5 - Intermediate DoseNumber of Participants With Positive, Negative for Micro Neutralization TestNegative week 249 Participants
Arm 6 - High DoseNumber of Participants With Positive, Negative for Micro Neutralization TestNegative week 247 Participants
Arm 6 - High DoseNumber of Participants With Positive, Negative for Micro Neutralization Testpositive week 411 Participants
Arm 6 - High DoseNumber of Participants With Positive, Negative for Micro Neutralization TestNegative week 44 Participants
Arm 6 - High DoseNumber of Participants With Positive, Negative for Micro Neutralization TestPositive week 246 Participants
Secondary

Number of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibody

To assess the cellular and humoral immune response to SARS-CoV2 elicited by the vaccine Immunogenicity Result: Seroconversion for Anti-S Antibody Interpretation: n. of subjects positive, negative or indeterminate at week 1, 2, 4, 8, 12, and 24 after vaccination.

Time frame: week 1, 2, 4, 8, 12, and 24

Population: * One subject in arm-1 low dose (adult cohort) had an asymptomatic infection around the time of vaccination. This was discovered post hoc, and this subject was excluded from all Immunogenicity Analysis Set(IAS).~* One subject in Arm-4 low dose (elderly cohort) had a suspicious non-specific reactivity to the tests and was excluded from the IAS.~* Other specification: % = Calculated as nr. of subjects within category divided by nr. of subjects with non-missing observation at each time point.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Arm 1 - Low DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 24negative4 Participants
Arm 1 - Low DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 12negative1 Participants
Arm 1 - Low DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 4indeterminate0 Participants
Arm 1 - Low DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 24positive10 Participants
Arm 1 - Low DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 4positive13 Participants
Arm 1 - Low DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 24indeterminate0 Participants
Arm 1 - Low DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 4negative1 Participants
Arm 1 - Low DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 12indeterminate0 Participants
Arm 1 - Low DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 12positive13 Participants
Arm 1 - Low DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 1negative14 Participants
Arm 1 - Low DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 8negative1 Participants
Arm 1 - Low DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 1indeterminate0 Participants
Arm 1 - Low DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 1positive0 Participants
Arm 1 - Low DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 2positive8 Participants
Arm 1 - Low DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 8indeterminate0 Participants
Arm 1 - Low DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 8positive13 Participants
Arm 1 - Low DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 2negative6 Participants
Arm 1 - Low DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 2indeterminate0 Participants
Arm 2 - Intermediate DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 4positive14 Participants
Arm 2 - Intermediate DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 2indeterminate1 Participants
Arm 2 - Intermediate DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 24negative4 Participants
Arm 2 - Intermediate DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 1indeterminate0 Participants
Arm 2 - Intermediate DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 24positive7 Participants
Arm 2 - Intermediate DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 8indeterminate0 Participants
Arm 2 - Intermediate DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 1positive0 Participants
Arm 2 - Intermediate DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 24indeterminate2 Participants
Arm 2 - Intermediate DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 8positive14 Participants
Arm 2 - Intermediate DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 12negative2 Participants
Arm 2 - Intermediate DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 2negative7 Participants
Arm 2 - Intermediate DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 4negative0 Participants
Arm 2 - Intermediate DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 2positive7 Participants
Arm 2 - Intermediate DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 8negative1 Participants
Arm 2 - Intermediate DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 12indeterminate0 Participants
Arm 2 - Intermediate DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 4indeterminate1 Participants
Arm 2 - Intermediate DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 1negative15 Participants
Arm 2 - Intermediate DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 12positive13 Participants
Arm 3 - High DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 24positive11 Participants
Arm 3 - High DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 1positive0 Participants
Arm 3 - High DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 12positive13 Participants
Arm 3 - High DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 12negative1 Participants
Arm 3 - High DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 24negative1 Participants
Arm 3 - High DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 1negative15 Participants
Arm 3 - High DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 1indeterminate0 Participants
Arm 3 - High DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 2positive8 Participants
Arm 3 - High DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 2negative6 Participants
Arm 3 - High DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 4positive13 Participants
Arm 3 - High DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 2indeterminate1 Participants
Arm 3 - High DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 8indeterminate0 Participants
Arm 3 - High DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 4negative2 Participants
Arm 3 - High DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 4indeterminate0 Participants
Arm 3 - High DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 24indeterminate1 Participants
Arm 3 - High DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 8positive14 Participants
Arm 3 - High DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 12indeterminate0 Participants
Arm 3 - High DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 8negative0 Participants
Arm 4 - Low DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 8negative3 Participants
Arm 4 - Low DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 4indeterminate0 Participants
Arm 4 - Low DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 12negative4 Participants
Arm 4 - Low DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 12indeterminate1 Participants
Arm 4 - Low DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 2positive4 Participants
Arm 4 - Low DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 24indeterminate0 Participants
Arm 4 - Low DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 1positive0 Participants
Arm 4 - Low DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 8positive10 Participants
Arm 4 - Low DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 1indeterminate0 Participants
Arm 4 - Low DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 12positive10 Participants
Arm 4 - Low DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 1negative15 Participants
Arm 4 - Low DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 24negative6 Participants
Arm 4 - Low DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 8indeterminate2 Participants
Arm 4 - Low DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 4negative1 Participants
Arm 4 - Low DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 4positive14 Participants
Arm 4 - Low DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 24positive6 Participants
Arm 4 - Low DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 2indeterminate1 Participants
Arm 4 - Low DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 2negative10 Participants
Arm 5 - Intermediate DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 1positive0 Participants
Arm 5 - Intermediate DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 1negative15 Participants
Arm 5 - Intermediate DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 1indeterminate0 Participants
Arm 5 - Intermediate DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 2positive5 Participants
Arm 5 - Intermediate DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 2negative7 Participants
Arm 5 - Intermediate DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 2indeterminate3 Participants
Arm 5 - Intermediate DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 4positive14 Participants
Arm 5 - Intermediate DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 4negative1 Participants
Arm 5 - Intermediate DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 4indeterminate0 Participants
Arm 5 - Intermediate DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 8positive12 Participants
Arm 5 - Intermediate DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 8negative3 Participants
Arm 5 - Intermediate DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 8indeterminate0 Participants
Arm 5 - Intermediate DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 12positive11 Participants
Arm 5 - Intermediate DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 12negative4 Participants
Arm 5 - Intermediate DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 12indeterminate0 Participants
Arm 5 - Intermediate DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 24positive5 Participants
Arm 5 - Intermediate DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 24negative6 Participants
Arm 5 - Intermediate DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 24indeterminate2 Participants
Arm 6 - High DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 8positive13 Participants
Arm 6 - High DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 4indeterminate0 Participants
Arm 6 - High DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 24negative3 Participants
Arm 6 - High DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 12indeterminate0 Participants
Arm 6 - High DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 4negative1 Participants
Arm 6 - High DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 4positive14 Participants
Arm 6 - High DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 2indeterminate1 Participants
Arm 6 - High DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 1indeterminate0 Participants
Arm 6 - High DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 24positive10 Participants
Arm 6 - High DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 2negative9 Participants
Arm 6 - High DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 2positive5 Participants
Arm 6 - High DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 1positive0 Participants
Arm 6 - High DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 1negative15 Participants
Arm 6 - High DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 12positive13 Participants
Arm 6 - High DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 24indeterminate0 Participants
Arm 6 - High DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 12negative2 Participants
Arm 6 - High DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 8indeterminate1 Participants
Arm 6 - High DoseNumber of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibodyweek 8negative1 Participants

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026