Clinical Trial Results:
A Phase 3, Single-arm Trial to Evaluate the Safety and Immunogenicity of a 20-Valent Pneumococcal Conjugate Vaccine in Healthy Children 15 Months Through 17 Years of Age
Summary
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EudraCT number |
2019-003308-11 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
06 Apr 2022
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Results information
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Results version number |
v2(current) |
This version publication date |
06 Mar 2024
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First version publication date |
24 Sep 2022
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Other versions |
v1 |
Version creation reason |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
B7471014
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT04642079 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Pfizer Inc.
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Sponsor organisation address |
235 E 42nd Street, New York, United States, NY 10017
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Public contact |
Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
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Scientific contact |
Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
Yes
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EMA paediatric investigation plan number(s) |
EMEA-002330-PIP01-18 | ||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
07 Jul 2022
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
06 Apr 2022
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To describe the safety profile of 20-valent pneumococcal conjugate (20vPnC).
Cohort 1 (subjects aged >=15 to <24 months) and Cohort 2 (subjects aged >=2 to <5 years): To demonstrate that the serotype-specific immunoglobulin G (IgG) concentrations for the 7 additional serotypes 1 month after 20-valent pneumococcal conjugate (20vPnC) are superior to the corresponding IgG concentrations before 20vPnC.
Cohort 3 (subjects aged >=5 to <10 years) and Cohort 4 (subjects aged >=10 to <18 years): To demonstrate that the serotype-specific opsonophagocytic activity (OPA) titers for the 7 additional serotypes 1 month after 20vPnC are superior to the corresponding OPA titers before 20vPnC.
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Protection of trial subjects |
The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonisation (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
04 Dec 2020
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United States: 839
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Worldwide total number of subjects |
839
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EEA total number of subjects |
0
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
210
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Children (2-11 years) |
473
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Adolescents (12-17 years) |
156
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
- | |||||||||||||||||||||||||||||||||||||||||||||
Pre-assignment
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Screening details |
A total of 839 subjects were enrolled and assigned to receive a single dose of 20vPnC of which 8 subjects were not vaccinated and 831 were vaccinated with 20vPnC. | |||||||||||||||||||||||||||||||||||||||||||||
Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | |||||||||||||||||||||||||||||||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | |||||||||||||||||||||||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Cohort 1: 20vPnC: >=15 to <24 Months | |||||||||||||||||||||||||||||||||||||||||||||
Arm description |
Subjects aged >=15 months to <24 months who have been previously vaccinated with at least 3 doses of 13vPnC, were administered a single dose of 0.5 millilitre (mL) 20vPnC intramuscularly on Day 1. | |||||||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
20-Valent Pneumococcal Conjugate Vaccine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Suspension for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Subjects were administered a single 0.5 mL dose of 20vPnC intramuscularly on Day 1.
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Arm title
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Cohort 2: 20vPnC: >=2 to <5 Years | |||||||||||||||||||||||||||||||||||||||||||||
Arm description |
Subjects aged >=2 to <5 years who have been previously vaccinated with at least 3 doses of 13vPnC, were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1. | |||||||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
20-Valent Pneumococcal Conjugate Vaccine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Suspension for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Subjects were administered a single 0.5 mL dose of 20vPnC intramuscularly on Day 1.
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Arm title
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Cohort 3: 20vPnC: >=5 to <10 Years | |||||||||||||||||||||||||||||||||||||||||||||
Arm description |
Subjects aged >=5 to <10 years regardless of previous vaccination status with 7vPnC or 13vPnC, were administered a single dose of 0.5 mL 20vPnC intramuscularly into the left arm on Day 1. | |||||||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
20-Valent Pneumococcal Conjugate Vaccine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Suspension for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Subjects were administered a single 0.5 mL dose of 20vPnC intramuscularly on Day 1.
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Arm title
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Cohort 4: 20vPnC: >=10 to <18 Years | |||||||||||||||||||||||||||||||||||||||||||||
Arm description |
Subjects aged >=10 to <18 years regardless of previous vaccination status with 7vPnC or 13vPnC, were administered a single dose of 0.5 mL 20vPnC intramuscularly into the left arm on Day 1. | |||||||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
20-Valent Pneumococcal Conjugate Vaccine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Suspension for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Subjects were administered a single 0.5 mL dose of 20vPnC intramuscularly on Day 1.
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Baseline characteristics reporting groups
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Reporting group title |
Cohort 1: 20vPnC: >=15 to <24 Months
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Reporting group description |
Subjects aged >=15 months to <24 months who have been previously vaccinated with at least 3 doses of 13vPnC, were administered a single dose of 0.5 millilitre (mL) 20vPnC intramuscularly on Day 1. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Cohort 2: 20vPnC: >=2 to <5 Years
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Reporting group description |
Subjects aged >=2 to <5 years who have been previously vaccinated with at least 3 doses of 13vPnC, were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Cohort 3: 20vPnC: >=5 to <10 Years
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Reporting group description |
Subjects aged >=5 to <10 years regardless of previous vaccination status with 7vPnC or 13vPnC, were administered a single dose of 0.5 mL 20vPnC intramuscularly into the left arm on Day 1. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Cohort 4: 20vPnC: >=10 to <18 Years
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Reporting group description |
Subjects aged >=10 to <18 years regardless of previous vaccination status with 7vPnC or 13vPnC, were administered a single dose of 0.5 mL 20vPnC intramuscularly into the left arm on Day 1. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Cohort 1: 20vPnC: >=15 to <24 Months
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Reporting group description |
Subjects aged >=15 months to <24 months who have been previously vaccinated with at least 3 doses of 13vPnC, were administered a single dose of 0.5 millilitre (mL) 20vPnC intramuscularly on Day 1. | ||
Reporting group title |
Cohort 2: 20vPnC: >=2 to <5 Years
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Reporting group description |
Subjects aged >=2 to <5 years who have been previously vaccinated with at least 3 doses of 13vPnC, were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1. | ||
Reporting group title |
Cohort 3: 20vPnC: >=5 to <10 Years
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Reporting group description |
Subjects aged >=5 to <10 years regardless of previous vaccination status with 7vPnC or 13vPnC, were administered a single dose of 0.5 mL 20vPnC intramuscularly into the left arm on Day 1. | ||
Reporting group title |
Cohort 4: 20vPnC: >=10 to <18 Years
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Reporting group description |
Subjects aged >=10 to <18 years regardless of previous vaccination status with 7vPnC or 13vPnC, were administered a single dose of 0.5 mL 20vPnC intramuscularly into the left arm on Day 1. |
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End point title |
Percentage of Subjects Reporting Prompted Local Reactions Within 7 Days After Vaccination [1] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Local reactions included pain at injection site, redness and swelling recorded by parent’s/legal guardian’s of subjects in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. One measuring device unit =0.5 centimetre (cm). Redness and swelling were graded as mild: greater than (>) 0.0 to 2.0 cm, moderate: >2.0 to 7.0 cm and severe: >7.0 cm. Pain at injection site was graded as mild: hurt if gently touched (cohort 1) and did not interfere with activity (cohort 2-4); moderate: hurt if gently touched with crying (cohort 1) and interfered with daily activity (cohort 2-4) and; severe: limited limb movement (cohort 1) and prevented daily activity (cohort 2-4). 95 percent (%) confidence interval (CI) was based on Clopper and Pearson method. Safety population included all subjects who received 20vPnC and had safety follow-up after vaccination. Here, “Number of Subjects Analysed” signifies subjects evaluable for this endpoint.
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End point type |
Primary
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End point timeframe |
Within 7 days after vaccination
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analysis were performed. |
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No statistical analyses for this end point |
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End point title |
Percentage of Subjects Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohort 1 [2] [3] | ||||||||||||||||||||||||||||||||||||||||||
End point description |
Systemic events for Cohort 1 were recorded by parents/legal guardians of subject’s using an e-diary. Fever was defined as temperature greater than or equal to (>=) 38.0 degree Celsius (C) and categorised as >=38.0 to 38.4 degree C, >38.4 to 38.9 degree C, >38.9 to 40.0 degree C and >40.0 degree C. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). 95% CI was based on Clopper and Pearson method. Safety population included all subjects who received 20vPnC and had safety follow-up after vaccination. “Number of Subjects Analysed” = subjects evaluable for this endpoint.
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End point type |
Primary
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End point timeframe |
Within 7 days after vaccination
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Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms. [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint was planned to be analysed only for the specified reporting arms. |
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No statistical analyses for this end point |
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End point title |
Percentage of Subjects Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4 [4] [5] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Systemic events for Cohort 2-4 included fever, fatigue, headache, muscle pain and joint pain, recorded by parents/legal guardians of subject’s using an e-diary. Fever was defined as temperature >=38.0 degree C and categorised as >=38.0 to 38.4 degree C,>38.4 to 38.9 degree C,>38.9 to 40.0 degree C and >40.0 degree C. Fatigue, headache, muscle pain and joint pain were graded as mild (no interference with activity), moderate (some interference with activity) and severe (prevents daily routine activity). 95% CI was based on Clopper and Pearson method. Safety population included all subjects who received 20vPnC and had safety follow-up after vaccination. “Number of Subjects Analysed” = subjects evaluable for this endpoint.
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End point type |
Primary
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End point timeframe |
Within 7 days after vaccination
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Notes [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analysis were performed. [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint was planned to be analysed only for the specified reporting arms. |
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No statistical analyses for this end point |
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End point title |
Percentage of Subjects Reporting Serious Adverse Events (SAEs) up to 6 Months After Vaccination [6] | ||||||||||||||||||||
End point description |
An SAE was any untoward medical occurrence that occurred, at any dose: resulted in death; required inpatient hospitalisation or prolongation of existing hospitalisation; was life-threatening; resulted in persistent or significant disability/ incapacity; was a congenital anomaly/birth defect and other important medical events. 95% CI was based on the Clopper and Pearson method. Safety population included all subjects who received 20vPnC and had safety follow-up after vaccination.
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End point type |
Primary
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End point timeframe |
From Day 1 of vaccination up to 6 months after vaccination
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Notes [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analysis were performed. |
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No statistical analyses for this end point |
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End point title |
Percentage of Subjects Reporting Adverse Events (AEs) up to 1 Month After Vaccination [7] | ||||||||||||||||||||
End point description |
An AE was any untoward medical occurrence in a subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment. 95% CI was based on the Clopper and Pearson method. Safety population included all subjects who received 20vPnC and had safety follow-up after vaccination.
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End point type |
Primary
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End point timeframe |
From Day 1 of vaccination up to 1 month after vaccination
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Notes [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analysis were performed. |
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No statistical analyses for this end point |
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End point title |
Geometric Mean Fold Rises (GMFRs) of Pneumococcal Serotype-Specific Immunoglobulin G (IgG) Concentrations for the 7 Additional Serotypes From Before to 1 Month After 20vPnC Vaccination: Cohort 1 and 2 [8] [9] | |||||||||||||||||||||||||||||||||
End point description |
Pneumococcal serotype-specific IgG concentrations were measured from serum samples for 7 additional 20vPnC serotypes: 8, 10A, 11A, 12F, 15B, 22F and 33F. GMFR=geometric mean of fold rise from before vaccination on Day 1 to 1 month after vaccination with 20vPnC. GMFRs and corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of titres or fold rises and the corresponding CIs (based on Student t distribution). Superiority of IgG concentration 1 month after 20vPnC to before vaccination for each serotype was demonstrated if the 95% lower CI of GMFR was >1. Evaluable immunogenicity population (EIP) included all subjects who were eligible; received 20vPnC; at least 1 valid immunogenicity result from 1 month after vaccination collected within 27 to 56 days after vaccination for Cohorts 1-2; no other major protocol deviations. Number of Subjects Analysed=subjects included in the EIP and n=subjects with valid assay results at both timepoints for the specified serotype.
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End point type |
Primary
|
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End point timeframe |
Before vaccination to 1 month after vaccination
|
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Notes [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms. [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint was planned to be analysed only for the specified reporting arms. |
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No statistical analyses for this end point |
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End point title |
Percentage of Subjects Reporting Newly Diagnosed Chronic Medical Conditions (NDCMCs) up to 6 Months After Vaccination [10] | ||||||||||||||||||||
End point description |
An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long-lasting in its effects. 95% CI was based on the Clopper and Pearson method. Safety population included all subjects who received 20vPnC and had safety follow-up after vaccination.
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End point type |
Primary
|
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End point timeframe |
From Day 1 of vaccination up to 6 months after vaccination
|
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Notes [10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analysis were performed. |
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No statistical analyses for this end point |
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End point title |
GMFRs of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titres for the 7 Additional Serotypes From Before to 1 Month After 20PnC Vaccination: Cohort 3 and 4 [11] [12] | |||||||||||||||||||||||||||||||||
End point description |
Pneumococcal serotype-specific OPA titers were measured from serum samples for 7 additional 20vPnC serotypes: 8, 10A, 11A, 12F, 15B, 22F and 33F. GMFR was calculated as geometric mean of fold rise from before vaccination on Day 1 to 1 month after vaccination with 20vPnC. GMFRs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titres or fold rises and the corresponding CIs (based on the Student t distribution). Superiority of OPA titers 1 month after 20vPnC to before vaccination for each serotype was demonstrated if the 95% lower CI of the GMFR was >1. EIP included all subjects who were eligible; received 20vPnC; at least 1 valid immunogenicity result from 1 month after vaccination collected within 27 to 49 days after vaccination for Cohorts 3-4; no other major protocol deviations. Here, Number of Subjects Analysed=subjects included in the EIP and n=subjects with valid assay results at both timepoints for the specified serotype.
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End point type |
Primary
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End point timeframe |
Before vaccination to 1 month after vaccination
|
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Notes [11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms. [12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint was planned to be analysed only for the specified reporting arms. |
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No statistical analyses for this end point |
|
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End point title |
Percentage of Subjects With Predefined Levels of Pneumococcal Serotype-Specific IgG Concentrations for the 7 Additional Serotypes at 1 Month After Vaccination in Cohort 1 Only [13] | ||||||||||||||||||||||
End point description |
Pneumococcal serotype-specific IgG concentrations were measured from serum samples for 7 additional 20vPnC serotypes: 8, 10A, 11A, 12F, 15B, 22F and 33F. Percentage of subjects with predefined level (>=0.35 micrograms per millilitre (mcg/mL) of IgG concentration for the 7 additional 20vPnC serotypes was presented. 95% CI was based on Clopper and Pearson method. EIP included all subjects who were eligible; received 20vPnC; at least 1 valid immunogenicity result from 1 month after vaccination collected within 27 to 56 days after vaccination for Cohort 1; no other major protocol deviations. Here, “Number of Subjects Analysed” signifies subjects included in the EIP with valid assay results.
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End point type |
Secondary
|
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End point timeframe |
At 1 Month after vaccination
|
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Notes [13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint was planned to be analysed only for the specified reporting arms. |
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No statistical analyses for this end point |
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End point title |
Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Pneumococcal serotype-specific IgG concentrations were measured for serum samples for 13vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F; and 7 additional 20vPnC serotypes: 8, 10A, 11A, 12F, 15B, 22F and 33F. GMCs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). EIP included all subjects who were eligible; received 20vPnC; at least 1 valid immunogenicity result from 1 month after vaccination collected within 27 to 56 days or within 27 to 49 days after vaccination for Cohorts 1-2 or Cohorts 3-4, respectively; no other major protocol deviations. Here, “Number of Subjects Analysed” signifies subjects included in the EIP and n=subjects with valid IgG concentrations at the specified timepoint.
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End point type |
Secondary
|
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End point timeframe |
Before vaccination (Vacc.) and 1 month after vaccination (1M after Vacc.)
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No statistical analyses for this end point |
|
||||||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 1 and 2 [14] | |||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Pneumococcal serotype-specific IgG concentrations were measured from serum samples for 13vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F. GMFR was calculated as geometric mean of fold rise from before vaccination on Day 1 to 1 month after vaccination with 20vPnC. GMFRs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titres or fold rises and the corresponding CIs (based on the Student t distribution). EIP included all subjects who were eligible; received 20vPnC; at least 1 valid immunogenicity result from 1 month after vaccination collected within 27 to 56 days after vaccination for Cohorts 1-2; no other major protocol deviations. Here, “Number of Subjects Analysed” signifies subjects included in the EIP and n=subjects with valid assay results at both timepoints for the specified serotype.
|
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End point type |
Secondary
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
Before vaccination to 1 month after vaccination
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
Notes [14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint was planned to be analysed only for the specified reporting arms. |
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No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 3 and 4 [15] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Pneumococcal serotype-specific IgG concentrations were measured from serum samples for 13vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F; and 7 additional 20vPnC serotypes: 8, 10A, 11A, 12F, 15B, 22F and 33F. GMFR was calculated as geometric mean of fold rise from before vaccination on Day 1 to 1 month after vaccination with 20vPnC. GMFRs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titres or fold rises and the corresponding CIs (based on the Student t distribution). EIP included all subjects who were eligible; received 20vPnC; at least 1 valid immunogenicity result from 1 month after vaccination collected within 27 to 49 days after vaccination for Cohorts 3-4; no other major protocol deviations. Here, “Number of Subjects Analysed” signifies subjects included in the EIP and n= subjects with valid assay results at both timepoints for the specified serotype.
|
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End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
Before vaccination to 1 month after vaccination
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Notes [15] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint was planned to be analysed only for the specified reporting arms. |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||
End point title |
Percentage of Subjects With >=4-fold Rise in Pneumococcal Serotype-Specific OPA Titres for the 7 Additional Serotypes From Before to 1 Month After Vaccination: Cohorts 2, 3, and 4 Only [16] | ||||||||||||||||||||||||||||||||||||||||||||
End point description |
Pneumococcal serotype-specific OPA titres were measured from serum samples for 7 additional 20vPnC serotypes: 8, 10A, 11A, 12F, 15B, 22F and 33F. Percentage of subjects with >=4 fold rise in serotype-specific OPA titres from before vaccination to 1 month after vaccination with 20vPnC and the associated 2-sided 95% CI based on the Clopper and Pearson method was presented. EIP included all subjects who were eligible; received 20vPnC; at least 1 valid immunogenicity result from 1 month after vaccination collected within 27 to 56 days or 27 to 49 days after vaccination for Cohort 2 or Cohorts 3-4, respectively; no other major protocol deviations. Here, “Number of Subjects Analysed” signifies subjects included in the EIP and n=subjects with valid assay results at both timepoints for the specified serotype.
|
||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
Before vaccination to 1 month after vaccination
|
||||||||||||||||||||||||||||||||||||||||||||
Notes [16] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint was planned to be analysed only for the specified reporting arms. |
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|
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No statistical analyses for this end point |
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|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Pneumococcal serotype-specific OPA titres were measured from serum samples for 13vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F; and 7 additional 20vPnC serotypes: 8, 10A, 11A, 12F, 15B, 22F and 33F. GMTs and 2-sided CIs were calculated by exponentiating the mean logarithm of the titres and the corresponding CIs (based on the Student t distribution). EIP included all subjects who were eligible; received 20vPnC; at least 1 valid immunogenicity result from 1 month after vaccination collected within 27 to 56 days or 27 to 49 days after vaccination for Cohorts 1-2 or Cohorts 3-4,respectively; no other major protocol deviations. Here, “Number of Subjects Analysed” signifies subjects included in the EIP and n=subjects with valid OPA titres at the specified timepoint.
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End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
Before vaccination (Vacc.) and 1 month after vaccination (1M after Vacc.)
|
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No statistical analyses for this end point |
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|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
GMFRs of Pneumococcal Serotype-Specific OPA Titres for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 1 and 2 [17] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Pneumococcal serotype-specific OPA titres were measured from serum samples for 13vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F; and 7 additional 20vPnC serotypes: 8, 10A, 11A, 12F, 15B, 22F and 33F. GMFR was calculated as geometric mean of fold rise from before vaccination on Day 1 to 1 month after vaccination with 20vPnC. GMFRs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titres or fold rises and the corresponding CIs (based on the Student t distribution). EIP included all subjects who were eligible; received 20vPnC; at least 1 valid immunogenicity result from 1 month after vaccination collected within 27 to 56 days after vaccination for Cohorts 1-2; no other major protocol deviations. Here, 'Number of Subjects Analysed' signifies subjects included in the EIP and n=subjects with valid assay results at both timepoints for the specified serotype.
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End point type |
Secondary
|
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End point timeframe |
Before vaccination to 1 month after vaccination
|
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Notes [17] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint was planned to be analysed only for the specified reporting arms. |
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No statistical analyses for this end point |
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End point title |
GMFRs of Pneumococcal Serotype-Specific OPA Titres for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 3 and 4 [18] | |||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Pneumococcal serotype-specific OPA titres were measured for 13vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F. GMFR was calculated as geometric mean of fold rise from before vaccination on Day 1 to 1 month after vaccination with 20vPnC. GMFRs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titres or fold rises and the corresponding CIs (based on the Student t distribution). EIP included all subjects who were eligible; received 20vPnC; at least 1 valid immunogenicity result from 1 month after vaccination collected within 27 to 49 days after vaccination for Cohorts 3-4; no other major protocol deviations. Here, “Number of Subjects Analysed” signifies subjects included in the EIP and n=subjects with valid assay results at both timepoints for the specified serotype.
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End point type |
Secondary
|
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End point timeframe |
Before vaccination to 1 month after vaccination
|
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Notes [18] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint was planned to be analysed only for the specified reporting arms. |
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No statistical analyses for this end point |
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Adverse events information
|
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Timeframe for reporting adverse events |
Local reactions and systemic events (systematic assessment): within 7 days after vaccination; SAEs (non-systematic assessment): from Day1 up to 6 months after vaccination and other AEs (non-systematic assessment): from Day1 up to 1 month after vaccination
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Adverse event reporting additional description |
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
24.1
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Reporting groups
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Reporting group title |
Cohort 1: 20vPnC: >=15 to <24 Months
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Reporting group description |
Subjects aged >=15 months to <24 months who have been previously vaccinated with at least 3 doses of 13vPnC, were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Cohort 2: 20vPnC: >=2 to <5 Years
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Reporting group description |
Subjects aged >=2 to <5 years who have been previously vaccinated with at least 3 doses of 13vPnC, were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Cohort 3: 20vPnC: >=5 to <10 Years
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Reporting group description |
Subjects aged >=5 to <10 years regardless of previous vaccination status with 7vPnC or 13vPnC, were administered a single dose of 0.5 mL 20vPnC intramuscularly into the left arm on Day 1. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Cohort 4: 20vPnC: >=10 to <18 Years
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Reporting group description |
Subjects aged >=10 to <18 years regardless of previous vaccination status with 7vPnC or 13vPnC, were administered a single dose of 0.5 mL 20vPnC intramuscularly into the left arm on Day 1. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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18 Oct 2021 |
-To be consistent with the European PIP modification
approved in August 2021 added 2 secondary
immunogenicity endpoints.
-Added 2 exploratory immunogenicity endpoints for
additional description of the immune response.
- Clarified that the primary immunogenicity endpoints
and the additional secondary endpoints are
addressing consistencies with the approved European
PIP modification. |
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |