Clinical Trial Results:
A Phase 4, Open-Label, Single-Arm, Multicenter Study to Describe the Safety of 13-Valent Pneumococcal Conjugate Vaccine in Children 6 to 17 Years of Age in India
Summary
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EudraCT number |
2019-000890-21 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
17 Apr 2019
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Results information
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Results version number |
v1(current) |
This version publication date |
01 Nov 2019
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First version publication date |
01 Nov 2019
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Other versions |
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 |
B1851190
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT03777865 | ||
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 18007181021, ClinicalTrials.gov_Inquiries@pfizer.com
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Scientific contact |
Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 18007181021, 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) |
No
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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 |
09 Sep 2019
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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 |
17 Apr 2019
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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 13-Valent Pneumococcal Conjugate (13vPnC) in pediatric subjects 6 to 17 years of age.
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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 Harmonization (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 |
14 Dec 2018
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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 |
India: 100
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Worldwide total number of subjects |
100
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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) |
0
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Children (2-11 years) |
73
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Adolescents (12-17 years) |
27
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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 |
The study was conducted in 1 country from 14 December 2018 to 17 April 2019. A total of 100 subjects were enrolled. | ||||||
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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Arm title
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13-Valent Pneumococcal Conjugate (13vPnC) Vaccine | ||||||
Arm description |
Subjects received a single dose of 0.5 milliliter (mL) 13vPnC vaccine, intramuscularly on Day 1. | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
13-valent Pneumococcal Conjugate Vaccine
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Investigational medicinal product code |
13vPnC
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Subjects received a single dose of 0.5 mL of 13vPnC vaccine as intramuscularly on Day 1.
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Baseline characteristics reporting groups
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Reporting group title |
13-Valent Pneumococcal Conjugate (13vPnC) Vaccine
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Reporting group description |
Subjects received a single dose of 0.5 milliliter (mL) 13vPnC vaccine, intramuscularly on Day 1. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
13-Valent Pneumococcal Conjugate (13vPnC) Vaccine
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Reporting group description |
Subjects received a single dose of 0.5 milliliter (mL) 13vPnC vaccine, intramuscularly on Day 1. |
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End point title |
Percentage of Subjects Reporting Local Reactions by Severity Within 7 Days After Vaccination [1] | ||||||||||||||||||||||||||||||||
End point description |
Local reactions (redness, swelling and pain [tenderness]) at the 13vPnC injection site were monitored daily for 7 days after vaccination. Redness and swelling were measured and recorded in a measuring device units. 1 measuring device unit=0.5 centimeter (cm). Redness and swelling were graded as; any (any redness or swelling at the injection site), mild (1 to 4 measuring device units = 0.5 to 2.0 cm), moderate (5 to 14 measuring device units = 2.5 to 7.0 cm) and severe (greater than [>]14 measuring device units = >7.0 cm). Pain (tenderness) at injection site was categorized as; any: any pain at the injection site, mild: did not interfere with activity, moderate: interfered with activity and severe: prevented daily activity. The safety population included all subjects who received 1 dose of an investigational product. Here, “Number of Subjects Analyzed”(N)=subjects evaluable for this end point and “n”=subjects evaluable at specific rows.
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End point type |
Primary
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End point timeframe |
Within 7 days after vaccination on Day 1 (up to Day 7)
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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: Only descriptive data was analyzed for this endpoint. |
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No statistical analyses for this end point |
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End point title |
Percentage of Subjects Reporting Systemic Events by Severity Within 7 Days After Vaccination [2] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Systemic events included fever, fatigue(tiredness), headache, muscle pain, joint pain, vomiting and diarrhea. Fever: greater than or equal to (>=) 38.0 degrees Celsius (C), >=38.0 degrees C to <=38.4 degrees C, >=38.5 to <=38.9 degrees C, 39.0 to 40.0 degrees C, > 40.0 degrees C. Fatigue, headache, muscle pain and joint pain graded as any (any fatigue, headache, muscle pain, joint pain), mild(did not interfere with activity), moderate(some interference with activity) or severe(prevented daily routine activity). Vomiting was graded as any (any vomiting), mild (1-2 times in 24 hours [hrs.]), moderate(>2 times in 24 hrs.) or severe (required intravenous hydration). Diarrhea was graded as any(any diarrhea), mild (2-3 loose stools in 24 hrs.), moderate(4-5 loose stools in 24 hrs.) or severe(>=6 loose stools in 24 hrs.). The safety population=all subjects who received 1 dose of an investigational product. “N”=subjects evaluable for this end point; “n”=subjects evaluable at specific rows.
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End point type |
Primary
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End point timeframe |
Within 7 days after vaccination on Day 1 (up to Day 7)
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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: Only descriptive data was analyzed for this endpoint. |
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No statistical analyses for this end point |
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End point title |
Percentage of Subjects With Treatment Emergent Adverse Events (AEs) and Serious adverse events (SAEs) [3] | ||||||||||||
End point description |
An AE was any untoward medical occurrence in a subject who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or that was considered to be an important medical event. Treatment-emergent were events between first dose of study drug and up to 1 month that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious AEs. The safety population included all subjects who received 1 dose of an investigational product. Here, “n”=subjects evaluable at specific rows.
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End point type |
Primary
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End point timeframe |
up to 1 month after vaccination on Day 1
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Notes [3] - 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: Only descriptive data was analyzed for this endpoint. |
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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 |
up to 1 month after vaccination on Day 1
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Adverse event reporting additional description |
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 subject and as nonserious in another subject or 1 subject may have experienced both serious and nonserious event during study.
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
22.0
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Reporting groups
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Reporting group title |
13-Valent Pneumococcal Conjugate (13vPnC) Vaccine
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Reporting group description |
Subjects received a single dose of 0.5 mL dose of 13vPnC vaccine, intramuscularly injection on Day 1. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Notes [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. [8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. [9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. [10] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. |
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
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 |