E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
A single dose of Sanofi Pasteur MSD’s unconjugated 23-valent polysaccharide pneumococcal vaccine (Pneumovax™23) to healthy children who were previously primed with the full three doses of GSK Biologicals’ 10-valent conjugate pneumococcal vaccine or Prevenar™ in the primary vaccination study 10PN-PD-DIT-003. Children will be 11-14 months old at the time of enrolment in this study and will receive concomitantly their booster dose of Infanrix™hexa according to national recommendations.
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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 assess the immunological memory following primary vaccination with either GSK Biologicals’ 10-valent conjugate vaccine or Prevenar™, through the administration of a single booster dose of unconjugated 23-valent pneumococcal polysaccharide vaccine (Pneumovax™23) in children 11-14 months of age.
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E.2.2 | Secondary objectives of the trial |
To assess the persistence of antibodies induced by either GSK Biologicals’ 10-valent conjugate vaccine or Prevenar™ 7 to 10 months after completion of the 3-dose primary immunization course in study 10PN-PD-DIT-003.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
All subjects must satisfy the following criteria at study entry: • Male or female between, and including, 11-14 months of age at the time of vaccination. • 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 visits). • A male or female who previously participated in study 10PN-PD-DIT-003 and received the full three doses of pneumococcal conjugate vaccine. • 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.
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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(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) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent, greater or equal to 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 first dose of vaccine(s) and during the entire study period; with the exception of GSK Biologicals’ DTPa-HBV-IPV/Hib vaccine (Infanrix™ hexa) which may be administered concomitantly to Pneumovax™ 23 at 11-14 months of age. • Administration of any pneumococcal vaccine other than the study vaccines from study 10PN-PD-DIT-003. • 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. • Anaphylactic reaction following the administration of the vaccine or history of allergic disease or reactions likely to be exacerbated by any component of the vaccine. • 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. • 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 diarrhea or mild upper respiratory infections with or without low-grade febrile illness, i.e oral/axillary/tympanic temperature <37.5°C / rectal temperature <38.0°C). • History of invasive pneumococcal diseases. • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. • Febrile illness defined as oral, axillary or tympanic temperature greater or equal to 37.5°C, rectal temperature greater or equal to 38.0°C. A temperature greater than or equal to these cut-offs warrants deferral of the vaccination pending recovery of the subject. Pneumovax™ 23 Hypersensitivity to any component of the vaccine. In the case of fever, acute disease, or relapse of chronic disease, it is preferable to postpone vaccination. 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 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 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 vaccine administration. If any of these adverse experiences occurs, the subject may be vaccinated at a later date, within the time window specified in the protocol, or withdrawn at the discretion of the investigator. Fever greater or equal to 40.5°C (rectal temperature) or greater or equal to 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 or more. Seizures 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) |
One month after the administration of the single dose of unconjugated 23-valent pneumococcal polysaccharide vaccine (Pneumovax™ 23): anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations greater or equal to 0.2 micrograms/mL. |
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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 | Yes |
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) | 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.8.4.1 | Number of sites anticipated in Member State concerned | 32 |
E.8.5 | The trial involves multiple Member States | No |
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 | 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.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 3 |