Trial Outcomes & Findings for Continuation Study of Long-term Safety, Tolerability, Pharmacokinetics and Efficacy of Recifercept in Achondroplasia (NCT NCT05116046)
NCT ID: NCT05116046
Last Updated: 2024-02-08
Results Overview
An AE was any untoward medical occurrence that did not necessarily have a causal relationship with study treatment. TEAE was an AE that occurred after initiation of study treatment that was not present at the time of treatment start or an AE that increased in severity after the initiation of medication, if the event was present at the time of treatment start emerges. SAE was an AE resulting in any of the following outcomes or considered medically significant: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or birth defect. Severe AEs were AEs that were medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated disabling, limiting self-care activities of daily living.
TERMINATED
PHASE2
35 participants
From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
2024-02-08
Participant Flow
Eligible participants aged greater than or equal to (\>=)15 months to 12 years (inclusive) diagnosed with achondroplasia from study C4181005 (NCT04638153) were enrolled in this extension study.
A total of 35 participants were enrolled and assigned to study treatment.
Participant milestones
| Measure |
Recifercept 1 Milligram Per Kilogram (mg/kg) Once Weekly
Participants with achondroplasia who completed study C4181005 (NCT04638153) received recifercept 1 mg/kg once weekly via the subcutaneous route for up to 24 months.
|
Recifercept 2 mg/kg Twice Weekly
Participants with achondroplasia who completed study C4181005 (NCT04638153) received recifercept 2 mg/kg twice weekly via the subcutaneous route for up to 24 months.
|
Recifercept 1.5 mg/kg Once Daily
Participants with achondroplasia who completed study C4181005 (NCT04638153) received recifercept 1.5 mg/kg once daily via the subcutaneous route for up to 24 months.
|
|---|---|---|---|
|
Overall Study
STARTED
|
16
|
17
|
2
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
16
|
17
|
2
|
Reasons for withdrawal
| Measure |
Recifercept 1 Milligram Per Kilogram (mg/kg) Once Weekly
Participants with achondroplasia who completed study C4181005 (NCT04638153) received recifercept 1 mg/kg once weekly via the subcutaneous route for up to 24 months.
|
Recifercept 2 mg/kg Twice Weekly
Participants with achondroplasia who completed study C4181005 (NCT04638153) received recifercept 2 mg/kg twice weekly via the subcutaneous route for up to 24 months.
|
Recifercept 1.5 mg/kg Once Daily
Participants with achondroplasia who completed study C4181005 (NCT04638153) received recifercept 1.5 mg/kg once daily via the subcutaneous route for up to 24 months.
|
|---|---|---|---|
|
Overall Study
Withdrawal by parent/guardian
|
2
|
1
|
1
|
|
Overall Study
Study terminated by sponsor
|
14
|
16
|
1
|
Baseline Characteristics
Continuation Study of Long-term Safety, Tolerability, Pharmacokinetics and Efficacy of Recifercept in Achondroplasia
Baseline characteristics by cohort
| Measure |
Recifercept 1 Milligram Per Kilogram (mg/kg) Once Weekly
n=16 Participants
Participants with achondroplasia who completed study C4181005 (NCT04638153) received recifercept 1 mg/kg once weekly via the subcutaneous route for up to 24 months.
|
Recifercept 2 mg/kg Twice Weekly
n=17 Participants
Participants with achondroplasia who completed study C4181005 (NCT04638153) received recifercept 2 mg/kg twice weekly via the subcutaneous route for up to 24 months.
|
Recifercept 1.5 mg/kg Once Daily
n=2 Participants
Participants with achondroplasia who completed study C4181005 (NCT04638153) received recifercept 1.5 mg/kg once daily via the subcutaneous route for up to 24 months.
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
7.5 Years
STANDARD_DEVIATION 2.66 • n=93 Participants
|
6.6 Years
STANDARD_DEVIATION 2.50 • n=4 Participants
|
9.5 Years
STANDARD_DEVIATION 0.71 • n=27 Participants
|
7.2 Years
STANDARD_DEVIATION 2.56 • n=483 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
20 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
15 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
32 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
33 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)Population: FAS consisted of all participants who received at least one dose of recifercept. Participants were analyzed according to the dose they actually received.
An AE was any untoward medical occurrence that did not necessarily have a causal relationship with study treatment. TEAE was an AE that occurred after initiation of study treatment that was not present at the time of treatment start or an AE that increased in severity after the initiation of medication, if the event was present at the time of treatment start emerges. SAE was an AE resulting in any of the following outcomes or considered medically significant: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or birth defect. Severe AEs were AEs that were medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated disabling, limiting self-care activities of daily living.
Outcome measures
| Measure |
Recifercept 1 Milligram Per Kilogram (mg/kg) Once Weekly
n=16 Participants
Participants with achondroplasia who completed study C4181005 (NCT04638153) received recifercept 1 mg/kg once weekly via the subcutaneous route for up to 24 months.
|
Recifercept 2 mg/kg Twice Weekly
n=17 Participants
Participants with achondroplasia who completed study C4181005 (NCT04638153) received recifercept 2 mg/kg twice weekly via the subcutaneous route for up to 24 months.
|
Recifercept 1.5 mg/kg Once Daily
n=2 Participants
Participants with achondroplasia who completed study C4181005 (NCT04638153) received recifercept 1.5 mg/kg once daily via the subcutaneous route for up to 24 months.
|
|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Severe AEs
AEs
|
9 Participants
|
11 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Severe AEs
SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 24Population: Data was not collected as study was terminated based on sponsor discretion due to lack of efficacy at any of the tested doses. The decision to terminate the study was not related to a safety concern.
Height was measured using anthropometric measurements. Anthropometric data was collected by appropriately trained individuals at the trial site and in accordance with the anthropometric measurement manual.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Predose on Day 91, 181, 271, 361 and 451.Population: Data was not collected as study was terminated based on sponsor discretion due to lack of efficacy at any of the tested doses. The decision to terminate the study was not related to a safety concern.
Clearance of a drug was a measure of the rate at which a drug is metabolised or eliminated by normal biological processes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Months 3, 6, 9Population: Data was not collected as study was terminated based on sponsor discretion due to lack of efficacy at any of the tested doses. The decision to terminate the study was not related to a safety concern.
Sitting height to standing height ratio was calculated based upon the anthropometric measurements. Anthropometric data was collected by appropriately trained individuals at the trial site and in accordance with the anthropometric measurement manual.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Months 3, 6, 9Population: Data was not collected as study was terminated based on sponsor discretion due to lack of efficacy at any of the tested doses. The decision to terminate the study was not related to a safety concern.
Height and length difference was calculated with anthropometric measurements. Anthropometric data was collected by appropriately trained individuals at the trial site and in accordance with the anthropometric measurement manual.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Months 3, 6, 9Population: Data was not collected as study was terminated based on sponsor discretion due to lack of efficacy at any of the tested doses. The decision to terminate the study was not related to a safety concern.
Knee height was defined as the distance from the sole of the foot to the most anterior surface of the femoral condyles of the thigh (medial being more anterior), with the ankle and knee each flexed to a 90-degree angle. Lower segment of the leg included tibia and foot height
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Months 3, 6, 9Population: Data was not collected as study was terminated based on sponsor discretion due to lack of efficacy at any of the tested doses. The decision to terminate the study was not related to a safety concern.
Occipito-frontal circumference was measured by anthropometric measurements. It was measured over the most prominent part on the back of the head (occiput) and just above the eyebrows (supraorbital ridges).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Months 3, 6, 9Population: Data was not collected as study was terminated based on sponsor discretion due to lack of efficacy at any of the tested doses. The decision to terminate the study was not related to a safety concern.
Occipito-frontal circumference was measured by anthropometric measurements. Anthropometric data was collected by appropriately trained individuals at the trial site and in accordance with the anthropometric measurement manual.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Months 3, 6, 9Population: Data was not collected as study was terminated based on sponsor discretion due to lack of efficacy at any of the tested doses. The decision to terminate the study was not related to a safety concern.
The Z-score described how many standard deviations a given measurement lies above or below a size or age-specific population mean. A Z-score above the population mean indicates a positive value, whereas a Z-score below the population mean indicates a negative value. The greater the deviation of the Z-score from zero (in a positive or negative direction), the greater the magnitude of deviation from the mean.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Months 3, 6, 9Population: Data was not collected as study was terminated based on sponsor discretion due to lack of efficacy at any of the tested doses. The decision to terminate the study was not related to a safety concern.
Fixed Flexion Angles was measured by anthropometric measurements. Anthropometric data was collected by appropriately trained individuals at the trial site and in accordance with the anthropometric measurement manual.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Months 3, 6, 9Population: Data was not collected as study was terminated based on sponsor discretion due to lack of efficacy at any of the tested doses. The decision to terminate the study was not related to a safety concern.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Months 3, 6, 9Population: Data was not collected as study was terminated based on sponsor discretion due to lack of efficacy at any of the tested doses. The decision to terminate the study was not related to a safety concern.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From baseline up to end of study/early termination (for a maximum duration of 11 months)Population: FAS included all participants who were planned to receive at least one dose of recifercept. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.'
Laboratory parameters that were assessed included lymphocytes, neutrophils, eosinophils, monocytes and potassium. Clinically significant abnormal laboratory findings were determined based on investigator's decision.
Outcome measures
| Measure |
Recifercept 1 Milligram Per Kilogram (mg/kg) Once Weekly
n=15 Participants
Participants with achondroplasia who completed study C4181005 (NCT04638153) received recifercept 1 mg/kg once weekly via the subcutaneous route for up to 24 months.
|
Recifercept 2 mg/kg Twice Weekly
n=16 Participants
Participants with achondroplasia who completed study C4181005 (NCT04638153) received recifercept 2 mg/kg twice weekly via the subcutaneous route for up to 24 months.
|
Recifercept 1.5 mg/kg Once Daily
n=2 Participants
Participants with achondroplasia who completed study C4181005 (NCT04638153) received recifercept 1.5 mg/kg once daily via the subcutaneous route for up to 24 months.
|
|---|---|---|---|
|
Number of Participants With Clinically Meaningful Findings in Laboratory Test Parameters Through the Study
Hematology: Lymphocytes
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Meaningful Findings in Laboratory Test Parameters Through the Study
Hematology: Neutrophils
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Meaningful Findings in Laboratory Test Parameters Through the Study
Hematology: Eosinophils
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With Clinically Meaningful Findings in Laboratory Test Parameters Through the Study
Hematology: Monocytes
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Meaningful Findings in Laboratory Test Parameters Through the Study
Chemistry: Potassium
|
2 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From baseline up to end of study/early termination (for a maximum duration of 11 months)Population: FAS included all participants who were planned to receive at least one dose of recifercept.
Absolute values and changes from baseline in supine systolic and diastolic blood pressure, oral temperature, and pulse rate were planned to be summarized by treatment in accordance with the sponsor reporting standards. Clinically significant abnormal laboratory findings were those which were not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
Outcome measures
| Measure |
Recifercept 1 Milligram Per Kilogram (mg/kg) Once Weekly
n=16 Participants
Participants with achondroplasia who completed study C4181005 (NCT04638153) received recifercept 1 mg/kg once weekly via the subcutaneous route for up to 24 months.
|
Recifercept 2 mg/kg Twice Weekly
n=17 Participants
Participants with achondroplasia who completed study C4181005 (NCT04638153) received recifercept 2 mg/kg twice weekly via the subcutaneous route for up to 24 months.
|
Recifercept 1.5 mg/kg Once Daily
n=2 Participants
Participants with achondroplasia who completed study C4181005 (NCT04638153) received recifercept 1.5 mg/kg once daily via the subcutaneous route for up to 24 months.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Findings in Vital Signs Through the Study
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From baseline up to end of study/early termination (for a maximum duration of 11 months)Population: FAS included all participants who were planned to receive at least one dose of recifercept.
A complete physical examination included cardiovascular, respiratory, gastrointestinal systems, and skin. Height and weight will also be measured and recorded as part of the anthropometric measurements collected. Anthropometric data was collected by appropriately trained individuals at the trial site and in accordance with the anthropometric measurement manual.
Outcome measures
| Measure |
Recifercept 1 Milligram Per Kilogram (mg/kg) Once Weekly
n=16 Participants
Participants with achondroplasia who completed study C4181005 (NCT04638153) received recifercept 1 mg/kg once weekly via the subcutaneous route for up to 24 months.
|
Recifercept 2 mg/kg Twice Weekly
n=17 Participants
Participants with achondroplasia who completed study C4181005 (NCT04638153) received recifercept 2 mg/kg twice weekly via the subcutaneous route for up to 24 months.
|
Recifercept 1.5 mg/kg Once Daily
n=2 Participants
Participants with achondroplasia who completed study C4181005 (NCT04638153) received recifercept 1.5 mg/kg once daily via the subcutaneous route for up to 24 months.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Findings in Physical Examination Through the Study
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Month 3 up to end of study/early termination (up to Month 11)Population: FAS included all participants who were planned to receive at least one dose of recifercept.
Outcome measures
| Measure |
Recifercept 1 Milligram Per Kilogram (mg/kg) Once Weekly
n=16 Participants
Participants with achondroplasia who completed study C4181005 (NCT04638153) received recifercept 1 mg/kg once weekly via the subcutaneous route for up to 24 months.
|
Recifercept 2 mg/kg Twice Weekly
n=17 Participants
Participants with achondroplasia who completed study C4181005 (NCT04638153) received recifercept 2 mg/kg twice weekly via the subcutaneous route for up to 24 months.
|
Recifercept 1.5 mg/kg Once Daily
n=2 Participants
Participants with achondroplasia who completed study C4181005 (NCT04638153) received recifercept 1.5 mg/kg once daily via the subcutaneous route for up to 24 months.
|
|---|---|---|---|
|
Number of Participants With Positive Anti-Drug Antibodies (ADA)
|
12 Participants
|
15 Participants
|
2 Participants
|
Adverse Events
Recifercept 1 mg/kg Once Weekly
Recifercept 2 mg/kg Twice Weekly
Recifercept 1.5 mg/kg Once Daily
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Recifercept 1 mg/kg Once Weekly
n=16 participants at risk
Participants with achondroplasia who completed study C4181005 (NCT04638153) received recifercept 1 mg/kg once weekly via the subcutaneous route for up to 24 months.
|
Recifercept 2 mg/kg Twice Weekly
n=17 participants at risk
Participants with achondroplasia who completed study C4181005 (NCT04638153) received recifercept 2 mg/kg twice weekly via the subcutaneous route for up to 24 months.
|
Recifercept 1.5 mg/kg Once Daily
n=2 participants at risk
Participants with achondroplasia who completed study C4181005 (NCT04638153) received recifercept 1.5 mg/kg once daily via the subcutaneous route for up to 24 months.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/16 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
5.9%
1/17 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
0.00%
0/2 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/16 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
5.9%
1/17 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
0.00%
0/2 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
|
Vascular disorders
Haematoma
|
0.00%
0/16 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
11.8%
2/17 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
0.00%
0/2 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
|
Nervous system disorders
Nystagmus
|
6.2%
1/16 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
0.00%
0/17 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
0.00%
0/2 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/16 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
5.9%
1/17 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
0.00%
0/2 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
|
Respiratory, thoracic and mediastinal disorders
Catarrh
|
0.00%
0/16 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
5.9%
1/17 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
0.00%
0/2 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.8%
3/16 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
0.00%
0/17 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
0.00%
0/2 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/16 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
5.9%
1/17 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
0.00%
0/2 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/16 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
5.9%
1/17 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
0.00%
0/2 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
|
Ear and labyrinth disorders
Eustachian tube dysfunction
|
0.00%
0/16 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
5.9%
1/17 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
0.00%
0/2 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
|
Ear and labyrinth disorders
Tympanic membrane perforation
|
0.00%
0/16 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
5.9%
1/17 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
0.00%
0/2 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/16 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
5.9%
1/17 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
0.00%
0/2 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
|
Gastrointestinal disorders
Toothache
|
6.2%
1/16 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
5.9%
1/17 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
0.00%
0/2 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/16 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
5.9%
1/17 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
0.00%
0/2 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
|
General disorders
Fatigue
|
0.00%
0/16 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
5.9%
1/17 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
0.00%
0/2 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
|
General disorders
Injection site rash
|
6.2%
1/16 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
0.00%
0/17 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
0.00%
0/2 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
|
General disorders
Pyrexia
|
6.2%
1/16 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
5.9%
1/17 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
0.00%
0/2 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/16 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
5.9%
1/17 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
0.00%
0/2 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
|
Infections and infestations
COVID-19
|
12.5%
2/16 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
0.00%
0/17 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
0.00%
0/2 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
|
Infections and infestations
Conjunctivitis
|
6.2%
1/16 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
0.00%
0/17 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
0.00%
0/2 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
|
General disorders
Injection site haematoma
|
6.2%
1/16 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
0.00%
0/17 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
0.00%
0/2 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
|
Infections and infestations
Ear infection
|
6.2%
1/16 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
5.9%
1/17 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
0.00%
0/2 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
|
Infections and infestations
Gastroenteritis viral
|
6.2%
1/16 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
0.00%
0/17 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
0.00%
0/2 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
|
Infections and infestations
Influenza
|
12.5%
2/16 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
5.9%
1/17 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
0.00%
0/2 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
|
Infections and infestations
Nasopharyngiti
|
18.8%
3/16 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
5.9%
1/17 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
0.00%
0/2 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
|
Infections and infestations
Oral herpes
|
0.00%
0/16 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
5.9%
1/17 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
0.00%
0/2 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
|
Infections and infestations
Otitis externa
|
0.00%
0/16 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
5.9%
1/17 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
0.00%
0/2 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
|
Infections and infestations
Otitis media
|
6.2%
1/16 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
5.9%
1/17 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
0.00%
0/2 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
|
Infections and infestations
Otitis media acute
|
6.2%
1/16 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
0.00%
0/17 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
0.00%
0/2 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
|
Infections and infestations
Rhinitis
|
6.2%
1/16 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
23.5%
4/17 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
0.00%
0/2 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
|
Infections and infestations
Skin candida
|
6.2%
1/16 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
0.00%
0/17 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
0.00%
0/2 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
|
Infections and infestations
Upper respiratory tract infection
|
6.2%
1/16 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
0.00%
0/17 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
0.00%
0/2 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
|
Infections and infestations
Viral infection
|
0.00%
0/16 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
5.9%
1/17 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
0.00%
0/2 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/16 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
5.9%
1/17 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
0.00%
0/2 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
6.2%
1/16 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
5.9%
1/17 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
0.00%
0/2 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
|
Investigations
Blood phosphorous increased
|
6.2%
1/16 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
0.00%
0/17 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
0.00%
0/2 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
|
Investigations
Blood urea increase
|
6.2%
1/16 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
0.00%
0/17 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
0.00%
0/2 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
|
Investigations
Platelet count increased
|
6.2%
1/16 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
5.9%
1/17 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
0.00%
0/2 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.2%
1/16 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
5.9%
1/17 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
0.00%
0/2 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/16 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
5.9%
1/17 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
0.00%
0/2 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
|
Nervous system disorders
Headache
|
0.00%
0/16 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
5.9%
1/17 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
0.00%
0/2 • From first dose of study drug up to 28 days after last dose of study drug (maximum up to 11 months)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER