| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| A single dose booster vaccination against Streptococcus pneumoniae of healthy children between 12-15 months of age who were previously primed with three doses of GSK Biologicals’10-valent conjugate pneumococcal vaccine in the primary vaccination study 10PN-PD-DIT-010 and a first single dose vaccination against meningococcal disease due to serogroups A, C, W-135, or Y, of pneumococcal vaccine unprimed healthy children of 12-15 months of age. |
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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 determine the percentage reduction in febrile reactions (rectal temperature >=38.0°C or oral/axillary/tympanic >=37.5°C) when prophylactic antipyretic treatment is administered compared to no prophylactic antipyretic treatment, after booster vaccination with GSK Biologicals’ 10-valent pneumococcal conjugate vaccine and routine DTPa-HBV-IPV/Hib (Infanrix hexa) vaccination in children at 12-15 months of age. |
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| E.2.2 | Secondary objectives of the trial |
Safety of booster dose of 10-valent pneumococ conj vaccine and co-adm DTPa-HBV-IPV/Hib with/without prophylactic antipyretic treatment at 12-15 months of age
7 to 10 months post dose 3 of primary vaccination and prior to booster dose persistence of antibodies induced by 10-valent pneumococ conj vaccine
1 month post-booster immunogenicity of 10-valent pneumococ conj vaccine
12 to 15 months after booster dose persistence of antibodies induced by 10-valent pneumococ conj vaccine
Impact of 10-valent pneumococcal conj. vaccine on reducing the nasopharyngeal carriage of S. pneumoniae (vaccine serotypes+others) and H. influenzae
One month post vaccine dose immunogenicity of all antigens included in MenACWY-TT conj vaccine and in co-adm DTPa-HBV-IPV/Hib
12 to 15 months post vaccine dose, persistence of meningococ A, C, W, Y antibodies induced by MenACWY-TT conj vaccine and persistence of hep B and polio antibodies induced by co-adm DTPa-HBV-IPV/Hib
Safety of MenACWY-TT conj vaccine |
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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:
•Subjects who 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) should be enrolled in the study.
•A male or female between, and including, 12-15 months of age at the time of the booster vaccination.
•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.
Subjects in the primed antipyretic and primed non-antipyretic group:
•A male or female who previously participated in study 10PN-PD-DIT-010 and received three doses of pneumococcal conjugate vaccine.
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| E.4 | Principal exclusion criteria |
For all subjects:
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).
Indication, other than specified in the protocol, for prophylactic antipyretic treatment.
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within one month (30 days) preceding the dose of study vaccines, or planned use during the entire study period.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the dose of study vaccines. (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 (30 days) before the dose of study vaccines (Visit 1) and up to one month after the dose of study vaccines (Visit 2).
History of, or intercurrent, diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b disease.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
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, defined as the presence of a mild, moderate or severe illness with or without fever.
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.
Major congenital defects or serious chronic illness.
Administration of immunoglobulins and/or any blood products within three months preceding dose of study vaccines or planned administration during the study period.
Subjects of which both parents have a history of atopia (polinosis, asthma, atopic eczema).
The following conditions are temporary or self-limiting and a subject may be included in the study and/or vaccinated once the condition has resolved and no other exclusion criteria are met:
Subject has received systemic antibiotic therapy for acute illness within 24 hours prior to the vaccination.
Subject is likely to receive antipyretic treatment as a result of a concomitant illness or has been treated with paracetamol within the past 24 hours.
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.
Known hypersensitivity after previous administration of diphtheria, tetanus, pertussis, polio, hepatitis B and Hib vaccines or to any component of the vaccines.
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 mild, moderate or severe illness.
N.B. Contraindication to the administration of the DTPa-HBV-IPV/Hib vaccine does not constitute contraindication to the administration of the pneumococcal vaccine.
For subjects in the primed antipyretic and non-antipyretic groups:
Administration of any pneumococcal, diphtheria, tetanus, pertussis, polio, hepatitis B and/or Haemophilus influenzae type b vaccines other than allowed and used in study 10PN-PD-DIT-010.
For subjects in the primed antipyretic group continuing antipyretic treatment:
Subject with any contraindication to treatment with paracetamol (e.g. known sensitivity to paracetamol or other components of the suppositories, functional impairment of the liver or kidney, Gilbert Syndrome, or current treatment with medication that interferes with paracetamol as described in the paracetamol summary of product characteristics [SPC]).
For subjects in the unprimed group:
Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C, W-135 and/or Y.
Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroups A, C, W-135 and/or Y.
Previous vaccination with tetanus toxoid containing vaccines including T, DTP, DT, DTP-IPV, DTP-HBV-IPV and Hib-TT vaccines six months prior to study entry.
History of meningococcal disease due to serogroup A, C, W, or Y.
Full vaccination history since birth not available.
Administration of any pneumococcal vaccine since birth.
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| E.5 End points |
| E.5.1 | Primary end point(s) |
•Occurrence of core fever >=38°C(rectal temperature) within 4 days (days 0 to 3) after the administration of the vaccine dose in subjects of the primed group.
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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) | No |
| 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 | 10 |
| 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 | 1 |
| 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 years | 1 |
| E.8.9.2 | In all countries concerned by the trial months | 3 |
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