Clinical Assessment of Pharmacokinetics, Efficacy, and Safety of 10% IVIg in PID Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 7 February 2022
• Main ID: NCT03961009
• Date of registration: 21/05/2019
• Prospective Registration: No
• Primary sponsor: Kedrion S.p.A.
• Public title: Clinical Assessment of Pharmacokinetics, Efficacy, and Safety of 10% IVIg in PID Patients CARES10
• Scientific title: A Phase III, Open-label, Prospective, Multicenter Study to Assess Efficacy, Safety and Pharmacokinetics of Kedrion Intravenous Immunoglobulin (IVIg) 10% in Primary Immunodeficiency Disease (PID) Patients
• Date of first enrolment: April 30, 2019
• Target sample size: 47
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03961009
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Canada, United States

Contacts

• Name: Medical Director
• Affiliation: Kedrion SpA

Key inclusion & exclusion criteria

Inclusion Criteria:

- Written informed consent/assent obtained from participant/participant's parent(s) or
legally acceptable representative indicating that they understand the purpose of and
procedures required for the study and are willing to participate in it.

- Confirmed clinical diagnosis of a PID, requiring treatment with IVIg and have
documented agammaglobulinemia (defined as the total absence of one or more classes of
antibodies) or hypogammaglobulinemia (defined as low levels of one or more classes
[that is at least 2 standard deviations under the mean level per age])

- Male or female, ages 2 to 70 years at screening

- Received 200 to 800 mg/kg of a commercially available IVIg therapy in the range of 21-
or 28-day intervals (±3 days or ±4 days, respectively) for at least 3 infusion cycles
prior to screening

- At least 2 documented IgG trough levels while receiving an IVIg, of greater than or
equals to (>=) 6 gram per liter (g/L) obtained at 2 infusion cycles within 12 months
(1 must be within 6 months) prior to Informed Consent Form (ICF) signature

- Participant is willing to comply all requirements of the protocol.

- Females of child-bearing potential with a negative urine pregnancy test and who agree
to employ adequate birth control measures during the study

- Authorization to access personal health information

- Participant previously participating in a clinical trial with another experimental
IVIg may be enrolled if they have received stable commercially available IVIg therapy
for at least 3 infusion cycles (21 or 28 days) prior to screening

- Participant currently on treatment with any subcutaneous immunoglobulin (SCIG) can be
enrolled if they are switched to stable commercially available IVIg therapy for at
least 3 infusion cycles (21 or 28 days) prior to screening

Exclusion Criteria:

- Newly diagnosed PID and and naïve to IgG replacement therapy

- Dysgammaglobulinemia (defined as a deficiency in one or more classes of antibodies,
but not severe enough to require substitutive therapy) or isolated IgG subclass
deficiency or profound primary T-cell deficiency (defined as the absence or severe
reduction of T lymphocytes [CD3+ <300 cells per cubic millimeter (cell/mm3)] and an
absent or particularly low proliferative response [10% of the lower normal range] to
phytohaemagglutinin P [PHA])

- Has history of severe or serious reactions or hypersensitivity to IVIg or other
injectable forms of IgG

- Has history of thrombotic events (including deep vein thrombosis, cerebrovascular
accident, pulmonary embolism, transient ischemic attacks, or myocardial infarction),
as defined by at least 1 event in participant's lifetime

- Has IgA deficiency with documented antibodies to IgA

- Have received blood products that have not undergone viral inactivation measures
within 12 months prior to Informed Consent Form (ICF) signature

- Has significant protein losing enteropathy, nephrotic syndrome, or lymphangiectasia

- Has an acute infection as documented by culture or diagnostic imaging and/or a body
temperature >= 38 degree Celsius (°C) (>=100.4 degree Fahrenheit (°F) within 7 days
prior to screening

- Has acquired immunodeficiency syndrome (AIDS) and/or hepatitis B/C active disease at
ICF signature

- Has levels of Alanine aminotransferase (ALT) or aspartate aminotransferase (AST), 2.5
times of the upper limit of normal for the laboratory designated for the study

- Using an implanted venous access device

- Has profound anemia (haemoglobin less than10 gram per deciliter [g/dl]) or persistent
severe neutropenia (<= 1000 neutrophils per millimeter cube (mm^3) or lymphopenia of
less than 500 cells per microliter

- Have severe chronic condition such as renal failure (creatinine concentration > 2.0
times the upper limit of normal) with proteinuria, congestive heart failure (New York
Heart Association III/IV), cardiomyopathy, cardiac arrhythmia associated with
thromboembolic events (e.g., atrial fibrillation), unstable or advanced ischemic heart
disease, hyper viscosity, or any other condition that the Investigator believes is
likely to interfere with evaluation of the study drug or with satisfactory conduct of
the trial. Normal values for serum creatinine are the following: a) Female (18+
years): 45 - 84 micromole per liter (mcmol/L) or 0.51 - 0.95 milligrams per deciliter
(mg/dl); b) Male (18+ years): 59 - 103 mcmol/L or 0.67 - 1.17 mg/dl

- Has history of a malignant disease other than properly treated carcinoma in situ of
the cervix or basal cell or squamous cell carcinoma of the skin within 24 months prior
to ICF signature

- Has history of pharmacoresistant epilepsy or multiple episodes of migraine (defined as
at least 1 episode within 6 months of ICF signature) not completely controlled by
medication

- Participants must not be receiving steroids (oral or parenteral daily dose of >= 0.15
milligram per kilogram per day (mg/kg/day) of prednisone or equivalent) or other
immunosuppressive drugs or chemotherapy

- Females who are pregnant, breast feeding or planning a pregnancy during the course of
the study. Women who become pregnant during the study will be withdrawn from the study

- Has participated in another clinical study within 3 weeks prior to study ICF signature

- Has history of drug or alcohol abuse within the 6 months before screening

- Has Employed or a direct relative of an employee of the CRO, the study site, or the
Sponsor

- Previously treated under this protocol

- Unable to provide informed consent or provide informed consent by a legally authorized
representative



Age minimum: 2 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Primary Immunodeficiency Disease

Intervention(s)

Biological: Kedrion IVIG 10%

Primary Outcome(s)

Incidence Rate of Acute Serious Bacterial Infections (ABSIs) [Time Frame: Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)]

Secondary Outcome(s)

Anti-Tetanus Toxoid Antibody Levels [Time Frame: Baseline, Weeks 16, 32 and 48 (28-day dosing schedule); Weeks 18, 30, 48 (21-day dosing schedule)]

Area Under the Serum Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Antigen-Specific Tetanus Toxoid Antibodies [Time Frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Antigen-Specific Tetanus Toxoid Antibodies [Time Frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

Duration of Missed School/Work/Other Major Activities Due to Infections [Time Frame: Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)]

Elimination Rate Constant (Kel) of Antigen-Specific Tetanus Toxoid Antibodies [Time Frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

Incidence Rate of Any Infection Other Than Acute Serious Bacterial Infections [Time Frame: Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)]

Incidence Rate of Fever Episodes [Time Frame: Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)]

Number of Participants With Total Immunoglobulin G (IgG) Trough Levels Less Than or Equal to (<=) 6 Grams/Liter (g/L) Criteria [Time Frame: Up to 12 months]

Percentage Peak Trough Fluctuation of Antigen-Specific Tetanus Toxoid Antibodies [Time Frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

Anti-Haemophilus Influenza Type B Antibody Levels [Time Frame: Baseline, Weeks 16, 32 and 48 (28 -day dosing schedule); Weeks 18, 30, 48 (21-day dosing schedule)]

Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes) [Time Frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

Duration of Any Infection Other Than Acute Serious Bacterial Infections [Time Frame: Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)]

Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Antigen-Specific Haemophilus Influenza Type B Antibodies [Time Frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Total IgG [Time Frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

Anti-Measles Antibody Levels [Time Frame: Baseline, Weeks 16, 32 and 48 (28-day dosing schedule); Weeks 18, 30, 48 (21-day dosing schedule)]

Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Antigen-Specific Tetanus Toxoid Antibodies [Time Frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

Area Under the Serum Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes) [Time Frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

Volume of Distribution (Vd) of Antigen-Specific Haemophilus Influenza Type B Antibodies [Time Frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

Anti-Pneumococcal Capsular Polysaccharide Antibody Levels [Time Frame: Baseline, Weeks 16, 32 and 48 (28-day dosing schedule); Weeks 18, 30, 48 (21-day dosing schedule)]

Area Under the Serum Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Total IgG [Time Frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

Area Under the Serum Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Antigen-Specific Haemophilus Influenza Type B Antibodies [Time Frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Total IgG [Time Frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

Average Concentration of Total IgG Over the Dosing Interval (Cavg) [Time Frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

Elimination Half-Life (t1/2) of Total IgG [Time Frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes) [Time Frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

Duration of Fever Episodes in Participants [Time Frame: Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)]

Volume of Distribution (Vd) of Total IgG [Time Frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

Duration of Participants on Antibiotics for Treatment of Any Kind of Infection [Time Frame: Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)]

Average Concentration of Antigen-Specific Haemophilus Influenza Type B Antibodies Over the Dosing Interval (Cavg) [Time Frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

Immunoglobulin G (IgG) Subclasses Levels (IgG1, IgG2, IgG3, IgG4) [Time Frame: At baseline, Weeks 16, 32 and 48 (28-day dosing schedule); Weeks 18, 30, 48 (21-day dosing schedule)]

Duration of Overall Participants Hospitalization [Time Frame: Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)]

Incidence Rate of Antibiotics Episodes for Treatment of Any Kind of Infections [Time Frame: Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)]

Elimination Half-Life (t1/2) of Antigen-Specific Tetanus Toxoid Antibodies [Time Frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

Duration of Participants Hospitalization Due to Infection [Time Frame: Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)]

Maximum Observed Serum Concentration (Cmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes) [Time Frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

Maximum Observed Serum Concentration (Cmax) of Antigen-Specific Tetanus Toxoid Antibodies [Time Frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

Elimination Half-Life (t1/2) of Antigen-Specific Haemophilus Influenza Type B Antibodies [Time Frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

Number of Drug Related Infusion Adverse Events (AEs) [Time Frame: Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)]

Maximum Observed Serum Concentration (Cmax) of Total Immunoglobulin G (IgG) [Time Frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

Average Concentration of Anti-pneumococcal Capsular Polysaccharide the Dosing Interval (Cavg) (Overall SP Serotypes) [Time Frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

Number of Infusions With One or More Infusion Associated Adverse Events (AEs) [Time Frame: Baseline up to Week 52]

Number of Participants With Abnormal Plasma-free Haemoglobin Level [Time Frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule)]

Minimum Observed Serum Concentration (Cmin) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes) [Time Frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

Number of Participants With Abnormal Serum Haptoglobin Level [Time Frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule)]

Elimination Rate Constant (Kel) of Antigen-Specific Haemophilus Influenza Type B Antibodies [Time Frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

Elimination Rate Constant (Kel) of Total IgG [Time Frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

Number of Participants With Clinically Significant Changes From Baseline in Physical Examinations [Time Frame: Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)]

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs [Time Frame: Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)]

Pediatric Quality of Life Inventory (PedsQL) Score [Time Frame: Baseline, Week 24 (21-day dosing schedule and 28-day dosing schedule), Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)]

Elimination Rate Constant (Kel) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes) [Time Frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

Minimum Observed Serum Concentration (Cmin) of Antigen-Specific Haemophilus Influenza Type B Antibodies [Time Frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

Time to Reach the Maximum Serum Concentration (Tmax) of Antigen-Specific Tetanus Toxoid Antibodies [Time Frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

Number of TEAEs and Serious TEAEs [Time Frame: Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)]

Time to Reach the Maximum Serum Concentration (Tmax) of Antigen-Specific Haemophilus Influenza Type B Antibodies [Time Frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

Minimum Observed Serum Concentration (Cmin) of Antigen-Specific Tetanus Toxoid Antibodies [Time Frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

Time to Reach the Maximum Serum Concentration (Tmax) of Total IgG [Time Frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

Number of Participants With Positive Coomb's Test at Week 16 (28-day Dosing Schedule) and Week 18 (21-day Dosing Schedule) [Time Frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule)]

Volume of Distribution (Vd) of of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes) [Time Frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

Number of Participants With Positive Urine Hemosiderin Test [Time Frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule)]

Steady State Clearance (CLss) of Anti-pneumococcal Capsular Polysaccharide Antibodies (Overall SP Serotypes) [Time Frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

Steady State Clearance (CLss) of Total IgG [Time Frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

Percentage Peak Trough Fluctuation of Total IgG [Time Frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

Steady State Clearance (CLss) of Antigen-Specific Haemophilus Influenza Type B Antibodies [Time Frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

Steady State Clearance (CLss) of Antigen-Specific Tetanus Toxoid Antibodies [Time Frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Antigen-Specific Haemophilus Influenza Type B Antibodies [Time Frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

Average Concentration of Antigen-Specific Tetanus Toxoid Antibodies Over the Dosing Interval (Cavg) [Time Frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

Elimination Half-Life (t1/2) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes) [Time Frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

Maximum Observed Serum Concentration (Cmax) of Antigen-Specific Haemophilus Influenza Type B Antibodies [Time Frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

Minimum Observed Serum Concentration (Cmin) of Total IgG [Time Frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

Number of Infusions With Decreased Infusion Rate Due to Adverse Events (AEs) [Time Frame: Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)]

Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameters [Time Frame: Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)]

Number of Participants With Clinically Significant Changes From Baseline in Vital Signs [Time Frame: Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)]

Percentage of Participants Who Experienced at Least One Drug Related Infusion Adverse Events (AEs) [Time Frame: Baseline up to Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)]

Percentage Peak Trough Fluctuation of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes) [Time Frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

Percentage Peak Trough Fluctuation of Antigen-Specific Haemophilus Influenza Type B Antibodies [Time Frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

Serum Immunoglobulin G (IgG) Trough Levels [Time Frame: At baseline, Week 51 (21-day dosing schedule) and Week 52 (28-day dosing schedule)]

Time to Reach the Maximum Serum Concentration (Tmax) of Anti-pneumococcal Capsular Polysaccharide (Overall SP Serotypes) [Time Frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

Volume of Distribution (Vd) of Antigen-Specific Tetanus Toxoid Antibodies [Time Frame: At Week 16 (28-day dosing schedule) and Week 18 (21-day dosing schedule), 10 to 30 minutes pre-infusion, 30 minutes, 2, 24, 72, 168, 336, 504, 672 hours post infusion]

Secondary ID(s)

KIG10_US3_PID01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 27/01/2022
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03961009