| 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 from 8 weeks up to 2 years of age. |
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| E.1.1.1 | Medical condition in easily understood language |
| Immunization against certain types of 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 | 17.1 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10061190 |
| E.1.2 | Term | Haemophilus infection |
| E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 17.1 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10061353 |
| E.1.2 | Term | Pneumococcal infection |
| E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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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’ 10-valent pneumococcal conjugate vaccine when co-administered with DTPw-HBV/Hib and OPV vaccines in children with sickle cell disease, one month after completion of the 3-dose primary vaccination course before 6 months of age |
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| E.2.2 | Secondary objectives of the trial |
| •Immunogenicity of 10Pn-PD-DiT vaccine given as 3-dose or 2-dose catch-up vaccination.•Persistence of antibodies against 10Pn-PD-DiT vaccine co-administered with DTPw-HBV/Hib and OPV vaccines after the completion of 3-dose primary vaccination.•One month post-booster vaccination immunogenicity of 10Pn-PD-DiT vaccine co-administered with DTPw-HBV/Hib and OPV vaccines.•One month and 5-6 months post primary vaccination and one month post-booster, immunogenicity of DTPw-HBV/Hib co-administered with 10Pn-PD-DiT vaccine and OPV.•Safety and reactogenicity of 10Pn-PD-DiT vaccine co-administered with DTPw-HBV/Hib and OPV vaccines as 3-dose primary vaccination and as booster dose.•Persistence of antibodies against 10Pn-PD-DiT vaccine after completion of the 2-dose primary vaccination.•Persistence of antibodies against 10Pn-PD-DiT vaccine 2-4 months after the first dose.•Safety and reactogenicity of 10Pn-PD-DiT vaccine when administered as 3-dose or 2-dose catch-up vaccination. |
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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
•A male or female between, and including: 8 and 11 weeks of age at the time of the first vaccination for subjects in the <6S and <6NS groups or 7 and 11 months at the time of the first vaccination for subjects in the 7-11S and 7-11NS groups or 12 and 23 months at the time of first vaccination for subjects in the 12-23S and 12-23NS groups (Note the second dose should be administered at 23 Months of age at the latest to allow, if needed, compliance with the National Recommendations on administration of the 23-valent polysaccharide pneumococcal vaccine in children with SCD as of 24 months of age).
•Written informed consent, signed or thumb printed, obtained from the parent(s)/LAR(s) of the subject. Where parent(s)/LAR(s) are illiterate, the consent form will be countersigned by a witness.
Additional inclusion criteria for children with SCD (<6S, 7-11S and 12-23S groups):
•Children with neonatal diagnosis of sickle cell disease [homozygous sickle cell disease (hemoglobin SS disease), double heterozygous sickle hemoglobin C disease (hemoglobin SC disease) and the sickle ß-thalassemias] and confirmed haemoglobin status by haemoglobin chromatography and electrophoresis(<6S group) or electrophoresis (7-11S and 12-23S groups).
•Free of any other known or suspected health problems (as established by medical history and clinical examination before entering into the study), that would contraindicate the initiation of routine immunizations outside a clinical trial context
Additional inclusion criteria for healthy children (<6NS, 7-11NS and
12-23NS groups):
•Healthy subjects as established by medical history and clinical examination before entering into the study.
•Children with negative neonatal diagnosis of sickle cell disease and confirmed hemoglobin status by hemoglobin chromatography and/or electrophoresis. |
|
| 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.
•Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone equal or more than 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
•Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of study vaccines and ending 30 days after. Locally recommended vaccines (recommended through the EPI program or through national immunization campaigns) for example inactivated influenza vaccine are always allowed with the exception of DTP-HBV/Hib in the <6S group and <6NS group, even if concomitantly administered with the study vaccines, but should be documented in the eCRF.
•Subjects being heterozygous or carriers of abnormal haemoglobin (e.g. haemoglobin S, Haemoglobin C) who are not considered to have SCD.
Additional exclusion criteria for children of the <6S and <6NS group:
•Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B and Haemophilus influenzae type b.
•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).
•Previous vaccination or planned vaccination during the study with any pneumococcal vaccine.
•History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
•Major congenital malformations.
•History of any neurological disorders or seizures.
•Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
•Birth weight below 1500g.
•Serious chronic illness other than SCD.
•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 tympanic. Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.
Additional exclusion criteria for children with SCD (<6S, 7-11S and 12-23S groups):
•Any confirmed or suspected immunosuppressive or immunodeficient condition, (including human immunodeficiency virus (HIV) infection) other than SCD related conditions, based on medical history and physical examination (no laboratory testing required).
Additional exclusion criteria for healthy children (<6 NS, 7-11NS and
12-23NS groups):
•Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection, based on medical history and physical examination (no laboratory testing required).
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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 (<6S and <6NS groups) |
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| E.5.1.1 | Timepoint(s) of evaluation of this end point |
| One month after primary vaccination |
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| E.5.2 | Secondary end point(s) |
| Evaluation of the immune responses to components of the investigational vaccine, for additional parameters. Evaluation of immune responses to components of the co-administered vaccine. Occurrence of each solicited adverse event. Occurrence of unsolicited adverse events. Occurrence of serious adverse events |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
| Antibodies against pneumococcal vaccine components: prior to and one month after primary vaccination and prior to and one month after booster dose (<6S, 7-11S, <6NS and 7-11NS groups), one month after second dose (12-23S and 12-23NS groups). Antibodies against co-administered vaccine:prior to and one month after primary vaccination, prior to, and one month after booster vaccination (<6S and <6NS). Solicited and unsolicited adverse events: within 4 and 31 days after each vaccination. Serious adverse events during the entire study period. |
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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 | Yes |
| 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 |
| =<6NS, 7-11NS and 12-23NS groups |
|
| E.8.2.4 | Number of treatment arms in the trial | 6 |
| E.8.3 |
Will this trial be conducted at a single site globally?
| Yes |
| E.8.4 | Will this trial be conducted at multiple sites globally? | No |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
| E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
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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 | 1 |
| E.8.9.2 | In all countries concerned by the trial months | 9 |
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