E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
This study investigates the influence of the Prevenar® vaccination schedule in the NIP on colonisation with vaccine- and non-vaccine serotypes in the third year after implementation of Prevenar® in the NIP. We also determine the impact on other nasopharyngeal colonising bacteria. |
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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 trends in vaccine- and nonvaccine-serotype S. pneumoniae colonisation in 11-month-old and 24-month-old infants who have been immunized according to the Dutch NIP with pneumococcal conjugate vaccinations Prevenar® in the third year after implementation of PCV-7 ( Prevenar®) in the Dutch NIP. |
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E.2.2 | Secondary objectives of the trial |
• To determine vaccine- and nonvaccine-serotype pneumococcal colonisation in one parent of 24-month-old children • To determine the influence of altered vaccine- and nonvaccine- serotype composition on other colonising bacteria like S.aureus, H. influenzae, M. catarrhalis in children and parents
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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 the Prevenar® vaccinations according to the 3+1 schedule of the Dutch NIP Parents •Parents are included when their children fulfil inclusion criteria
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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 •Previous vaccinations of older brother(s) and/or sister(s) and/or parents with a pneumococcal conjugate vaccine (e.g. brother(s) and/or sister(s) that participated in the MINOES trial) •Chromosomal abnormalities or craniofacial abnormalities (like Trisomy 21 or schisis), known or suspected immunodeficiency disease or other medical conditions that will severely affect immunological responses to vaccinations or nasopharyngeal carriage rates. •Coagulation disorder/anticoagulant medication
Parents are excluded •when they have a bleeding disorder/ anticoagulant medication (because of the transnasal swab)
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E.5 End points |
E.5.1 | Primary end point(s) |
The percentage of the (the seven) vaccine and non-vaccines pneumococcal serotypes found in the NP swabs from children at 11 and 24 months of age and parents of the 24-month-old children. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Information not present in EudraCT |
E.6.5 | Efficacy | Information not present in EudraCT |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Influence of Prevenar® vaccination on nasopharyngeal pneumococcal carriage |
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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 | |