E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Cellular immune response(long term memory) after following the infant immunisation programme with a pneumococcal conjugate vaccine (Prevenar). |
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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 development of the cellular immune response (plasma B cells and memory B-cells), immediately before and after the booster of the 3+1 Prevenar® vaccination schedule at 11 months of age and before and after the challenge vaccination at 24 months of age |
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E.2.2 | Secondary objectives of the trial |
To determine development of the immune response by looking at antibody concentrations, avidity and opsonophagocytoses immediately before and after the booster of the 3+1 Prevenar® vaccination schedule at 11 months of age and before and after the challenge vaccination at 24 months of age |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•The children have to be of normal health (same health criteria apply as used in well-baby clinics when a child receives a vaccination, e.g. also children with small increases in temperature or cold are seen as children with normal health) •They have to be willing and able to participate in the trial according to procedure •Presence of a signed informed consent (the parents/legally representatives have given written informed consent after receiving oral and written information) •The children have received or will receive the Prevenar® vaccinations according to the 3+1 schedule of the Dutch NIP
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E.4 | Principal exclusion criteria |
•Previous vaccinations with Prevenar® using a schedule that differs from the Dutch 3+1 schedule •Previous vaccinations with other pneumoccocal vaccines •Presence of a serious disease that requires medical care that can interfere with the results of the study •Known or expected allergy/hypersensitivity against one of the vaccine ingredients (anamnestic, be alert if the child has had medical complaints after previous Prevenar® vaccinations) •Known or suspected immunological disorder •Previously administration of plasma products (including immunoglobulin), within three months of study enrolment •Bleeding disorders
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E.5 End points |
E.5.1 | Primary end point(s) |
Main study parameter/endpoint Cellular immune respons (Plasma B cells and memory B cells)
Secondary study parameters/endpoints Antibody titers, avidity and opsonophagocytoses
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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 | No |
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 |
Defining cellular immune response |
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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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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 | 8 |
E.8.9.1 | In the Member State concerned days | 0 |