| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Active immunization against disease caused by Streptococcus pneumoniae in children 2-17 years of age who are at increased risk of pneumococcal infection. |
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| E.1.1.1 | Medical condition in easily understood language |
| Immunization against certain infections caused by the Streptococcus pneumoniae bacterium. This bacterium can cause ear infection, lung infection or meningitis |
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| E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 14.1 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10042197 |
| E.1.2 | Term | Streptococcus pneumoniae septicaemia |
| E.1.2 | System Organ Class | 100000004862 |
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| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 14.1 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10042195 |
| E.1.2 | Term | Streptococcus pneumoniae pneumonia |
| E.1.2 | System Organ Class | 100000004862 |
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| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 14.1 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10054642 |
| E.1.2 | Term | Streptococcus pneumoniae septicemia |
| E.1.2 | System Organ Class | 100000004862 |
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| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 15.1 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10035648 |
| E.1.2 | Term | Pneumococcal pneumonia [Streptococcus pneumoniae pneumonia] |
| E.1.2 | System Organ Class | 100000004862 |
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| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | 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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| E.2.2 | Secondary objectives of the trial |
To assess the immunogenicity of GSK Biologicals’ 10Pn-PD-DiT vaccine administered to healthy children aged between 24-59 months, either as a 2-dose catch-up vaccination in unprimed children or as a single dose in primed children.
To assess the safety and reactogenicity of GSK Biologicals’ 10Pn-PD-DiT vaccine when administered to children aged between 2-17 years, either as 2-dose catch-up vaccination in unprimed children or as a single dose in primed children.
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| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol (e.g. completion of the diary cards).
Written informed consent obtained from the parent(s)/LAR(s) of the subject and informed assent obtained from the subject, if appropriate, prior to enrolment.
Female subjects of non-childbearing potential may be enrolled in the study. (Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy or ovariectomy).
Please refer to the GLOSSARY OF TERMS for the definition of menarche.
Female subjects of childbearing potential may be enrolled in the study, if the subject:
-has practiced adequate contraception for 30 days prior to vaccination, and
-has a negative pregnancy test on the day of vaccination, and
-has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.
Priming status:
- 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.
- 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
* with plain polysaccharide pneumococcal vaccine more than 2 years and less than 5 years before enrolment.
will be considered for inclusion in the primed groups.
Additional inclusion criteria for the At-risk groups:
A male or female aged between, and including, 2 and 17 years at the time of first vaccination.
For the purpose of this study, at-risk subject is a subject with:
-Congenital or acquired asplenia such as anatomic, surgical or functional asplenia or
-Splenic dysfunction, chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc or
Note: All individuals who are diagnosed by the investigator as with splenic dysfunction are eligible for enrolment in the At-risk group. When available, investigator will collect medical documentation for reduced splenic function diagnosed with an appropriate technique (e.g. scintiscan, pitted erythrocyte counting or Howell-Jolly body detection) in the At-risk subject’s medical records. No further assessment will be necessary. A maximum of 35 individuals with sickle-cell disease can be enrolled in the At-risk group. These subjects do not require assessment of the splenic function as sickle-cell disease is invariably associated with severe splenic dysfunction [Pearson, 1969].
-Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D.
For all subjects defined as At-risk the Investigator will make all efforts to collect information from the subject/subject’s parent(s)/LAR(s) during the interview and/or from previously available medical documentation on the date and conditions which have made a child at-risk of pneumococcal infection and/or the results of tests determining spleen dysfunction or complement deficiency. This should be documented in the medical records of the At-risk subject. No originals/copies of medical documentation are needed.
Additional inclusion criteria for the Healthy group:
A male or female matched (for age and country) to a subject aged 24-59 months from the At-risk group.
Healthy subjects as established by medical history and clinical examination before entering into the study. |
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| E.4 | Principal exclusion criteria |
Child in care.
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting 30 days before each dose of vaccine(s) and ending 30 days after*
* In case an emergency mass vaccination for an unforeseen public health threat (e.g.: a pandemic) is organised by the public health authorities, outside the routine immunization program, vaccines can be administered at any time during the study period provided it is licensed and used according to its Summary of Product Characteristics or Prescribing Information and according to the local governmental recommendations and that a written approval of the Sponsor is provided. Vaccines that are recommended for subjects with an increased risk of bacterial infection (for example meningococcal, Hib vaccines, etc, except a pneumococcal vaccine), can be administered at any time to the subjects enrolled in the At-risk group.
Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
History of any neurological disorders or seizures.
Acute disease and/or fever at the time of enrolment.
-Fever is defined as temperature ≥ 37.5°C on oral, axillary or tympanic setting, or ≥ 38.0°C on rectal setting. The preferred route for recording temperature in this study will be axillary.
-Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.
History of chronic alcohol consumption and/or drug abuse.
Any confirmed or suspected Human Immunodeficiency virus (HIV) infection, based on medical history and physical examination (no laboratory testing required).
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
Pregnant or lactating female.
Female planning to become pregnant or planning to discontinue contraceptive precautions.
Major congenital defects except medical conditions that define an At-risk subject (see section 1.3).
Previous vaccination against pneumococcal infection with pneumococcal conjugate vaccine within the last 8 weeks.
Previous vaccination against pneumococcal infection with plain polysaccharide (e.g. Pneumovax) vaccine within the last 2 years.
Additional exclusion criteria for the Healthy group:
Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. (For corticosteroids, this will mean prednisone 0.5 mg/kg/day with an upper limit of 20 mg/day, or equivalent). Inhaled and topical steroids are allowed.
Serious chronic illness.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
Family history of congenital or hereditary immunodeficiency.
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| E.5 End points |
| E.5.1 | Primary end point(s) |
Evaluation of immune responses to components of the investigational vaccine one month after one dose and/or two vaccine doses in the At-risk groups:
-Concentrations of antibodies against pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F.
-Opsonophagocytic activity against pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F.
-Concentrations of antibodies against protein D.
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| E.5.1.1 | Timepoint(s) of evaluation of this end point |
one month after one dose and/or two vaccine doses in the At-risk groups:
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| E.5.2 | Secondary end point(s) |
1) Evaluation of immune responses to components of the investigational vaccine one month after one dose and/or two vaccine doses in the Healthy groups:
-Concentrations of antibodies against pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F.
-Opsonophagocytic activity against pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F.
-Concentrations of antibodies against protein D.
2) Solicited local and general symptoms.
-Occurrence of solicited local symptoms (any and grade 3) within 4 days (Day 0 - Day 3) after each vaccination.
-Occurrence of solicited general symptoms (any, related and grade 3) within 4 days (Day 0 - Day after each vaccination.
3) Unsolicited adverse events.
-Occurrence of unsolicited AEs within 31 days (Day 0 - Day 30) after each vaccination.
4) Serious adverse events.
-Occurrence of serious adverse events from within 31 days (Day 0 - Day 30) after each vaccination.
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| E.5.2.1 | Timepoint(s) of evaluation of this end point |
1) ELISA and OPA:one month after one dose and/or two vaccine doses in the Healthy groups.
2) within 4 days (Day 0 - Day 3) after each vaccination.
3) within 31 days (Day 0 - Day 30) after each vaccination.
4) within 31 days (Day 0 - Day 30) after each vaccination.
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| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | No |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | No |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | Yes |
| E.6.13.1 | Other scope of the trial description |
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| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | No |
| E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | No |
| E.8.1.2 | Open | Yes |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | No |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | No |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | Yes |
| E.8.2.3.1 | Comparator description |
| Age matched healthy subjects |
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| E.8.2.4 | Number of treatment arms in the trial | 4 |
| E.8.3 |
Will this trial be conducted at a single site globally?
| No |
| E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.2 | Trial being conducted completely outside of the EEA | No |
| E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
| Poland |
| Russian Federation |
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| E.8.7 | Trial has a data monitoring committee | No |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.2 | In all countries concerned by the trial years | 0 |
| E.8.9.2 | In all countries concerned by the trial months | 3 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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