| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Booster vaccination against Streptococcus pneumoniae in children 12 to 18 months old. |
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| MedDRA Classification |
| 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 demonstrate that a booster dose of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine is non-inferior to Prevenar, both co-administered with DTPa-HBV-IPV/Hib vaccine, in terms of post-immunization febrile reactions with rectal fever > 39.0°C.
Criteria for safety:
Non-inferiority will be demonstrated if the upper limit of the 95% CI of the difference (10Pn-10Pn group minus 7Pn-7Pn group), in terms of percentage of subjects with rectal fever >39.0°C, is lower than 10%.
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| E.2.2 | Secondary objectives of the trial |
• To assess the safety, reactogenicity and immunogenicity of a booster dose of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine, when co-administered with DTPa-HBV-IPV/Hib vaccine at 12-18 months of age.
• To assess the immunogenicity of a booster dose of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine following a 3-dose primary vaccination with Prevenar co-administered with DTPa-HBV-IPV/Hib vaccine.
• To assess the antibody persistence induced by GSK Biologicals’ 10-valent pneumococcal conjugate vaccine or Prevenar, 8-14 months after completion of the 3-dose immunization course in study 10PN-PD-DIT-001.
• To assess the immunogenicity, safety and reactogenicity of a booster dose of DTPa-HBV-IPV/Hib vaccine when co-administered with GSK Biologicals’ 10-valent pneumococcal conjugate vaccine or Prevenar at 12-18 months of age.
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| E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
| E.3 | Principal inclusion criteria |
All subjects must satisfy the following criteria at study entry:
• Male or female between, and including, 12-18 months of age at the time of vaccination.
• Subjects who previously participated in the study 10PN-PD-DIT-001 and received at least one dose of pneumococcal conjugate vaccine during the primary study.
• Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visit).
• Written informed consent obtained from the parent or guardian of the subject.
• Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Specific for France:
A subject will be eligible for inclusion in this study if he /her is either affiliated to or beneficiary of a social security category.
It is the investigator’s responsibility to ensure and to document (in source document - patient notes) that the patient is either affiliated to or beneficiary of a social security category.
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| E.4 | Principal exclusion criteria |
The following criteria should be checked at the time of study entry. If any apply, the subject must not be included in the study:
• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the entire study period (active phase and extended safety follow-up).
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the dose of vaccine(s). (For corticosteroids, this will mean prednisone, or equivalent, ≥ 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
• Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before the dose of vaccine(s) up to Visit 2.
• Administration of any additional pneumococcal vaccine or DTPa-combined vaccine since end of 10PN-PD-DIT-001 study.
• Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing required).
• A family history of congenital or hereditary immunodeficiency.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
• Major congenital defects or serious chronic illness.
• History of seizures (subjects who have had a single, uncomplicated febrile convulsion in the past can be included) or progressive neurological disease.
• Administration of immunoglobulins and/or any blood products since birth or planned administration during the active phase of the study.
• Anaphylactic reaction following the administration of vaccine(s).
• Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea or mild upper respiratory infections with or without low-grade fever, i.e oral/axillary/tympanic temperature <37.5°C / rectal temperature <38.0°C).
• Febrile illness defined as oral, axillary or tympanic temperature ≥37.5°C, rectal temperature ≥38.0°C. A temperature greater than or equal to these cut-offs warrants deferral of the vaccination pending recovery of the subject.
Prevenar
Absolute contraindications:
• Hypersensitivity to any component of the vaccine, including diphtheria toxoid.
Precautions:
Precautions include ‘moderate to severe illness, with or without fever is a reason to defer routine immunization with most vaccines’. The decision to delay vaccination depends on the severity and aetiology of the underlying disease.
DTPa-HBV-IPV/Hib vaccine
The following adverse events constitute absolute contraindications to administration of DTPa-HBV-IPV/Hib; if any of these adverse events occur during the study, the investigator must decide which vaccine to give to the subject for these antigens:
• DTPa-HBV-IPV/Hib should not be administered to subjects with known hypersensitivity after previous administration of diphtheria, tetanus, pertussis, hepatitis B, polio and Hib vaccines or to any component of the vaccines.
• DTPa-HBV-IPV/Hib are contra-indicated if the infant has experienced an encephalopathy, defined as an acute, severe central nervous system disorder occurring within 7 days following pertussis vaccination and generally consisting of major alterations in consciousness, unresponsiveness, generalized or focal seizures that persist more than a few hours, with failure to recover within 24 hours.
• As with other vaccines, administration of DTPa-HBV-IPV/Hib should be postponed in subjects suffering from acute moderate or severe illness. The presence of a mild acute illness is not a contra-indication.
The following adverse events constitute precautions specific to DTPa-HBV-IPV/Hib vaccine administration. If any of these adverse experiences occurs, the subject may be withdrawn at the discretion of the investigator.
• Fever of ≥ 40.5°C (rectal temperature) or ≥ 40.0°C (oral, axillary or tympanic temperature) within 48 hours of vaccination.
• Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours of vaccination.
• Persistent, inconsolable crying occurring within 48 hours of vaccination and lasting ≥ 3 hours.
• Convulsions with or without fever occurring within 3 days of vaccination.
N.B. Contraindication to the administration of the DTPa-HBV-IPV/Hib vaccine does not constitute contraindication to the administration of the pneumococcal vaccine. Children who will not receive the DTPa-HBV-IPV/Hib vaccine may still receive the study pneumococcal vaccine: the decision is left to the discretion of the investigator.
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| E.5 End points |
| E.5.1 | Primary end point(s) |
Safety
• Occurrence of rectal fever >39.0°C within 4 days (day 0-day 3) after the booster 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 | Yes |
| E.6.3 | Therapy | No |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| 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 | Information not present in EudraCT |
| 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 | No |
| E.8.1.3 | Single blind | Yes |
| 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 | Yes |
| E.8.1.7.1 | Other trial design description |
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| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | Yes |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | No |
| E.8.3 |
The trial involves single site in the Member State concerned
| No |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | No |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
| E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
| 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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| Last contact, last subject. |
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| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | |
| E.8.9.1 | In the Member State concerned months | 9 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial months | 9 |
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