Clinical Trial Results:
A phase III, open, controlled, multi-centric study to evaluate the immunogenicity, safety and reactogenicity of GSK Biologicals' 10-valent pneumococcal conjugate vaccine when administered to children aged between 2 to17 years who are at an increased risk of pneumococcal infection and to an age-matched control group of healthy children aged 24 to 59 months.
Due to the EudraCT – Results system being out of service between 31 July 2015 and 12 January 2016, these results have been published in compliance with revised timelines.
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Summary
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EudraCT number |
2011-006013-34 |
Trial protocol |
Outside EU/EEA PL |
Global end of trial date |
29 Jun 2015
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Results information
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Results version number |
v1 |
This version publication date |
04 Feb 2016
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First version publication date |
04 Feb 2016
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Other versions |
v2 , v3 |
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 |
115884
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01746108 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
GlaxoSmithKline Biologicals
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Sponsor organisation address |
Rue de l’Institut 89, Rixensart, Belgium, B-1330
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Public contact |
Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.com
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Scientific contact |
Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.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-000673-PIP01-09 | ||
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 |
Interim
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Date of interim/final analysis |
01 Dec 2015
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
29 Jun 2015
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Global end of trial reached? |
Yes
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Global end of trial date |
29 Jun 2015
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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 assess the immunogenicity of GSK Biologicals’ 10Pn-PD-DiT vaccine when administered to at-risk children aged between 2-17 years, either as a 2-dose catch-up vaccination in unprimed children or as a single dose in primed children.
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Protection of trial subjects |
All subjects were supervised closely for at least 30 minutes following vaccination with appropriate medical treatment readily available. Vaccines were administered by qualified and trained personnel. Only eligible subjects that had no contraindications to any components of the vaccines were vaccinated. Subjects were followed-up after each vaccination.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
18 Jun 2013
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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 |
Poland: 15
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Country: Number of subjects enrolled |
Russian Federation: 37
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Worldwide total number of subjects |
52
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EEA total number of subjects |
15
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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) |
35
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Adolescents (12-17 years) |
17
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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 |
No Healthy primed subjects, aged 2-4 years (age-matched to the 2-4 years primed subjects in At risk group - see enrolment process for healthy subjects, as described for HE-Un-2-4Y Group; who had to receive 1 dose of 10Pn-PD-DiT because vaccinated with at least 1 dose of a pneumococcal conjugate vaccine before enrolment) were enrolled in the study. | ||||||||||||||||||||||||||||||||
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Pre-assignment
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Screening details |
- | ||||||||||||||||||||||||||||||||
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Pre-assignment period milestones
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Number of subjects started |
52 | ||||||||||||||||||||||||||||||||
Number of subjects completed |
52 | ||||||||||||||||||||||||||||||||
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Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | ||||||||||||||||||||||||||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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AR-Pr-2-17Y Group | ||||||||||||||||||||||||||||||||
Arm description |
Primed subjects aged between 24 months and 17 years, who were at an increased risk of pneumococcal infection*, receiving 1 dose of 10Pn-PD-DiT vaccine: Primed groups included subjects who have been previously vaccinated with at least one dose of a pneumococcal conjugate vaccine, i.e. either Synflorix (10Pn-PD-DiT), Prevenar or Prevenar13 or with plain polysaccharide pneumococcal vaccine more than 2 years (24 months) and less than 5 years (60 months) before enrolment. *An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D. | ||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Synflorix
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Investigational medicinal product code |
GSK1024850A
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Other name |
10Pn-PD-DiT, 10Pn
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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 received 1 dose of Synflorix™ vaccine (Month 0). Pneumococcal vaccine dose was administered intramuscularly into the non-dominant deltoid for Children ≥ 12 months of age if the muscle size is adequate or in the thigh for the other subjects.
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Arm title
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AR-Un-2-17Y Group | ||||||||||||||||||||||||||||||||
Arm description |
Unprimed subjects aged between 24 months and 17 years, who were at an increased risk of pneumococcal infection*, receiving 2 doses of 10Pn-PD-DiT vaccine: Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, Synflorix (10Pn-PD-DiT), Prevenar or Prevenar13. * An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D. | ||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Synflorix
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Investigational medicinal product code |
GSK1024850A
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Other name |
10Pn-PD-DiT, 10Pn
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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 received 2 doses of Synflorix™ vaccine (Month 0 and Month 2). Pneumococcal vaccine doses were administered intramuscularly into the non-dominant deltoid for Children ≥ 12 months of age if the muscle size is adequate or in the thigh for the other subjects.
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Arm title
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HE-Un-2-4Y Group | ||||||||||||||||||||||||||||||||
Arm description |
Healthy (HE) unprimed subjects, aged between 24 and 59 months of age (age-matched to the subjects aged 24-59 months in the At risk groups), receiving 2 doses of 10Pn-PD-DiT vaccine. Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, Synflorix (10Pn-PD-DiT), Prevenar or Prevenar13. For each enrolled at-risk subject aged between 24-59 months, a healthy subject of the same age expressed in years from the same country should be enrolled regardless of the priming status. In other words, a healthy subject could be enrolled only once if he/she could be matched with an unmatched at-risk subject of the same age and country. | ||||||||||||||||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Synflorix
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Investigational medicinal product code |
GSK1024850A
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Other name |
10Pn-PD-DiT, 10Pn
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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 received 2 doses of Synflorix™ vaccine (Month 0 and Month 2). Pneumococcal vaccine doses were administered intramuscularly into the non-dominant deltoid for Children ≥ 12 months of age if the muscle size is adequate or in the thigh for the other subjects.
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Baseline characteristics reporting groups
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Reporting group title |
AR-Pr-2-17Y Group
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Reporting group description |
Primed subjects aged between 24 months and 17 years, who were at an increased risk of pneumococcal infection*, receiving 1 dose of 10Pn-PD-DiT vaccine: Primed groups included subjects who have been previously vaccinated with at least one dose of a pneumococcal conjugate vaccine, i.e. either Synflorix (10Pn-PD-DiT), Prevenar or Prevenar13 or with plain polysaccharide pneumococcal vaccine more than 2 years (24 months) and less than 5 years (60 months) before enrolment. *An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
AR-Un-2-17Y Group
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Reporting group description |
Unprimed subjects aged between 24 months and 17 years, who were at an increased risk of pneumococcal infection*, receiving 2 doses of 10Pn-PD-DiT vaccine: Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, Synflorix (10Pn-PD-DiT), Prevenar or Prevenar13. * An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
HE-Un-2-4Y Group
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Reporting group description |
Healthy (HE) unprimed subjects, aged between 24 and 59 months of age (age-matched to the subjects aged 24-59 months in the At risk groups), receiving 2 doses of 10Pn-PD-DiT vaccine. Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, Synflorix (10Pn-PD-DiT), Prevenar or Prevenar13. For each enrolled at-risk subject aged between 24-59 months, a healthy subject of the same age expressed in years from the same country should be enrolled regardless of the priming status. In other words, a healthy subject could be enrolled only once if he/she could be matched with an unmatched at-risk subject of the same age and country. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
AR-Pr-2-17Y Group
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Reporting group description |
Primed subjects aged between 24 months and 17 years, who were at an increased risk of pneumococcal infection*, receiving 1 dose of 10Pn-PD-DiT vaccine: Primed groups included subjects who have been previously vaccinated with at least one dose of a pneumococcal conjugate vaccine, i.e. either Synflorix (10Pn-PD-DiT), Prevenar or Prevenar13 or with plain polysaccharide pneumococcal vaccine more than 2 years (24 months) and less than 5 years (60 months) before enrolment. *An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D. | ||
Reporting group title |
AR-Un-2-17Y Group
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Reporting group description |
Unprimed subjects aged between 24 months and 17 years, who were at an increased risk of pneumococcal infection*, receiving 2 doses of 10Pn-PD-DiT vaccine: Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, Synflorix (10Pn-PD-DiT), Prevenar or Prevenar13. * An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D. | ||
Reporting group title |
HE-Un-2-4Y Group
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Reporting group description |
Healthy (HE) unprimed subjects, aged between 24 and 59 months of age (age-matched to the subjects aged 24-59 months in the At risk groups), receiving 2 doses of 10Pn-PD-DiT vaccine. Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, Synflorix (10Pn-PD-DiT), Prevenar or Prevenar13. For each enrolled at-risk subject aged between 24-59 months, a healthy subject of the same age expressed in years from the same country should be enrolled regardless of the priming status. In other words, a healthy subject could be enrolled only once if he/she could be matched with an unmatched at-risk subject of the same age and country. | ||
Subject analysis set title |
AR-PR-2-4Y Group
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
subset of the AR-PR-2-17Y Group including subjects aged between 24 and 59 months.
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Subject analysis set title |
AR-Un-2-4Y Group
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
subset of the AR-UN-2-17Y Group including subjects aged between 24 and 59 months.
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Subject analysis set title |
AR-PR-5-17Y Group
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
subset of the AR-PR-2-17Y Group including subjects aged between 5 and 17 years.
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Subject analysis set title |
AR- UN-5-17Y Group
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
subset of the AR- UN-5-17Y Group including subjects aged between 5 and 17 years.
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End point title |
Concentrations of antibodies against Vaccine Pneumococcal Serotypes. [1] | ||||||||||||||||||||
End point description |
Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per millilitre (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 µg/mL. Antibody concentrations < 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation. Primary results are the results presented for the At-risk groups. Results were not available at the time of the posting and are entered as equal to “9” (placeholder values), the numbers of subjects in each group are entered as equal to the numbers of subjects who completed the study.
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End point type |
Primary
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End point timeframe |
One month after Dose 1 (At Month 1 for primed subjects) or after Dose 2 (At Month 3 for unprimed subjects)
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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: The intent of this endpoint was descriptive, no comparison of groups was performed |
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| No statistical analyses for this end point | |||||||||||||||||||||
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End point title |
Number of subjects with any and severe (grade 3) solicited local Adverse Events (AEs) after dose 1 for subjects aged between 2 to 4 years. [2] | ||||||||||||||||||||||||||||||||||||
End point description |
Solicited local AEs assessed were pain, redness and swelling. Any = incidence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimetre. Primed subjects received one dose and Unprimed subjects received two doses.
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End point type |
Secondary
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End point timeframe |
During the 4-day (Days 0-3) after dose 1
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| Notes [2] - 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: The endpoint concerns only subjects aged between 2 to 4 years (subset of the population). |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||
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End point title |
Number of subjects with any and severe (grade 3) solicited local Adverse Events (AEs) after dose 2 for subjects aged between 2 to 4 years. [3] | |||||||||||||||||||||||||||
End point description |
Solicited local AEs assessed were pain, redness and swelling. Any = incidence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimetre. Primed subjects received one dose and Unprimed subjects received two doses.
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End point type |
Secondary
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End point timeframe |
During the 4-day (Days 0-3) after dose 2
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| Notes [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: Since all the groups didn't receive dose 2, there are no results to be analyzed for that timeframe for those groups. Moreover the endpoint concerns only subjects aged between 2 to 4 years. |
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| No statistical analyses for this end point | ||||||||||||||||||||||||||||
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End point title |
Number of subjects with any and severe (grade 3) solicited local Adverse Events (AEs) after dose 1 for subjects aged between 5 to 17 years. | |||||||||||||||||||||||||||
End point description |
Solicited local AEs assessed were pain, redness and swelling. Any = incidence of any local symptom regardless of intensity grade. Grade 3 pain =Significant pain at rest. Prevented normal every day activities. Grade 3 redness/swelling = redness/swelling above 50 millimetre. Primed subjects received one dose and Unprimed subjects received two doses.
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End point type |
Secondary
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End point timeframe |
During the 4-day (Days 0-3) after dose 1
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| No statistical analyses for this end point | ||||||||||||||||||||||||||||
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End point title |
Number of subjects with any and severe (grade 3) solicited local Adverse Events (AEs) after dose 2 for subjects aged between 5 to 17 years. | ||||||||||||||||||
End point description |
Solicited local AEs assessed were pain, redness and swelling. Any = incidence of any local symptom regardless of intensity grade. Grade 3 pain = Significant pain at rest. Prevented normal every day activities. Grade 3 redness/swelling = redness/swelling above 50 millimetre. Primed subjects received one dose and Unprimed subjects received two doses.
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End point type |
Secondary
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End point timeframe |
During the 4-day (Days 0-3) after dose 2
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Number of subjects with any, severe (grade 3) and related solicited general Adverse Events (AEs) after dose 1 for subjects aged between 2 to 4 years. [4] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
General AEs = drowsiness, irritability, loss of appetite (loss of appet) and fever (axillary ≥ 37.5 degrees Celsius). Any= Incidence of any solicited general symptom regardless of intensity grade or relationship to vaccination. Grade 3: drowsiness = prevented normal activity; irritability = crying that could not be comforted/ prevented normal activity; loss of appetite = not eating at all; fever > 39.5°C. Related = symptom assessed by the investigator as related to the vaccination. Primed subjects received one dose and Unprimed subjects received two doses.
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End point type |
Secondary
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End point timeframe |
During the 4-day (Days 0-3) after dose 1
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| Notes [4] - 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: The endpoint concerns only subjects aged between 2 to 4 years (subset of the population). |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End point title |
Number of subjects with any, severe (grade 3) and related solicited general Adverse Events (AEs) after dose 2 for subjects aged between 2 to 4 years. [5] | |||||||||||||||||||||||||||||||||||||||||||||
End point description |
General AEs = drowsiness, irritability, loss of appetite (loss of appet) and fever (axillary ≥ 37.5 degrees Celsius). Any= Incidence of any solicited general symptom regardless of intensity grade or relationship to vaccination. Grade 3: drowsiness = prevented normal activity; irritability = crying that could not be comforted/ prevented normal activity; loss of appetite = not eating at all; fever > 39.5°C. Related = symptom assessed by the investigator as related to the vaccination. Primed subjects received one dose and Unprimed subjects received two doses.
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End point type |
Secondary
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End point timeframe |
During the 4-day (Days 0-3) after dose 2
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| Notes [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: Since all the groups didn't receive dose 2, there are no results to be analyzed for that timeframe for those groups. Moreover the endpoint concerns only subjects aged between 2 to 4 years. |
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| No statistical analyses for this end point | ||||||||||||||||||||||||||||||||||||||||||||||
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End point title |
Number of subjects with any, severe (grade 3) and related solicited general Adverse Events (AEs) after dose 1 for subjects aged between 5 to 17 years.. | |||||||||||||||||||||||||||||||||||||||||||||
End point description |
General AEs = headache, fatigue, gastrointestinal symptoms (gastro symp) (nausea, vomiting, diarrhoea and/or abdominal pain) and fever (axillary ≥ 37.5 degrees Celsius). Any= Incidence of any solicited general symptom regardless of intensity grade or relationship to vaccination. Grade 3: headache, fatigue and gastrointestinal symptoms = symptoms that prevented normal activity; Fever > 39.5°C. Related = symptom assessed by the investigator as related to the vaccination. Primed subjects received one dose and Unprimed subjects received two doses.
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End point type |
Secondary
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End point timeframe |
During the 4-day (Days 0-3) after dose 1
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| No statistical analyses for this end point | ||||||||||||||||||||||||||||||||||||||||||||||
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End point title |
Number of subjects with any, severe (grade 3) and related solicited general Adverse Events (AEs) after dose 2 for subjects aged between 5 to 17 years. | ||||||||||||||||||||||||||||||
End point description |
General AEs = headache, fatigue, gastrointestinal symptoms (gastro symp) (nausea, vomiting, diarrhoea and/or abdominal pain) and fever (axillary ≥ 37.5 degrees Celsius). Any= Incidence of any solicited general symptom regardless of intensity grade or relationship to vaccination. Grade 3: headache, fatigue and gastrointestinal symptoms = symptoms that prevented normal activity; Fever > 39.5°C. Related = symptom assessed by the investigator as related to the vaccination. Primed subjects received one dose and Unprimed subjects received two doses.
|
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End point type |
Secondary
|
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End point timeframe |
During the 4-day (Days 0-3) after dose 2
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||
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End point title |
Number of subjects with unsolicited AEs. | ||||||||||||||||
End point description |
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
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End point type |
Secondary
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End point timeframe |
Within the 31-day (Days 0-30) post- vaccination period
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Number of subjects with Serious Adverse Events (SAEs). | ||||||||||||||||
End point description |
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of study subjects.
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End point type |
Secondary
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End point timeframe |
From Dose 1 at Month 0 up to study end at Month 1 for primed subjects and at Month 3 for unprimed subjects.
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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 |
SAEs: from Month 0 up to Study end, Solicited and Unsolicited AEs: within the 31-day post- vaccination period.
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
18.1
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Reporting groups
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Reporting group title |
AR-Pr-2-17Y
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Reporting group description |
Primed subjects aged between 24 months and 17 years, who were at an increased risk of pneumococcal infection*, receiving 1 dose of 10Pn-PD-DiT vaccine: Primed groups included subjects who have been previously vaccinated with at least one dose of a pneumococcal conjugate vaccine, i.e. either Synflorix (10Pn-PD-DiT), Prevenar or Prevenar13 or with plain polysaccharide pneumococcal vaccine more than 2 years (24 months) and less than 5 years (60 months) before enrolment. *An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
AR-Un-2-17Y
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Reporting group description |
Unprimed subjects aged between 24 months and 17 years, who were at an increased risk of pneumococcal infection*, receiving 2 doses of 10Pn-PD-DiT vaccine: Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, Synflorix (10Pn-PD-DiT), Prevenar or Prevenar13. * An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
HE-Un-2-4Y
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Reporting group description |
Healthy (HE) unprimed subjects, aged between 24 and 59 months of age (age-matched to the subjects aged 24-59 months in the At risk groups), receiving 2 doses of 10Pn-PD-DiT vaccine. Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, Synflorix (10Pn-PD-DiT), Prevenar or Prevenar13. For each enrolled at-risk subject aged between 24-59 months, a healthy subject of the same age expressed in years from the same country should be enrolled regardless of the priming status. In other words, a healthy subject could be enrolled only once if he/she could be matched with an unmatched at-risk subject of the same age and country. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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 |
||
22 Nov 2012 |
As requested by the Committee for Medicinal Products for Human Use (CHMP), the definition of priming status has been further clarified to consider for inclusion in the primed groups children who have been previously vaccinated with at least one dose of a pneumococcal conjugate vaccine (i.e. either Synflorix (10Pn-PD-DiT), Prevenar or Prevenar13) and/or with plain polysaccharide pneumococcal vaccine more than 2 years (24 months) and less than 5 years (60 months) before enrolment. Children who have not been previously vaccinated with any pneumococcal vaccine (i.e. either plain polysaccharide pneumococcal vaccine, Synflorix (10Pn-PD-DiT), Prevenar or Prevenar13) will be considered for inclusion in the unprimed groups.
In addition clarifications have been made to the definition of at-risk subjects and recording of pneumococcal vaccination history of primed subjects.
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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 | |||
