E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Pneumococcal carriership in children having previously received Prevenar vaccination (7-valent pneumococcal conjugate vaccine) according to the 3+1 vaccination schedule used in the Dutch National Immunization Program (NIP).
Comparison will be done to the 2+1 schedule group of the MINOES trial (ISRCNTN25571720). |
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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 NP vaccine type (VT) pneumococcal colonisation (seven vaccine serotypes together) of infants aged 12 months, who previously received 4 (3+1) pneumococcal conjugate vaccinations Prevenar® in the Dutch NIP and to compare this data to NP colonisation data of infants from the MINOES study that received 3 (2+1) Prevenar® vaccinations. |
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E.2.2 | Secondary objectives of the trial |
To compare pneumococcal replacement by non-vaccine type (NVT) pneumococcal serotypes after a 3+1 and 2+1 doses scheme
To compare the influence on other NP colonising bacteria like S. aureus, H. influenzae, M. catarrhalis and P. aeruginosa after a 3+1 and 2+1 doses scheme
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
These criteria are derived from the related MINOES study, in order to increase comparability
• 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
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E.4 | Principal exclusion criteria |
These criteria are derived from the related MINOES study, in order to increase comparability
• 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)
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E.5 End points |
E.5.1 | Primary end point(s) |
The overall percentage of the seven VT pneumococcal serotypes found in the NP swabs at 12 months of age
The percentage of NVT pneumococcal serotypes found in the NP swabs at 12 months The percentage of children positive for S.aureus, H. influenzae, M. catarrhalis and P. aeruginosa
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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 |
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) | 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 | 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 | Yes |
E.8.2.3.1 | Comparator description |
the 2+1 vaccination schedule group of the MINOES study (ISRCNTN255717) will be used |
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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 | 10 |
E.8.9.1 | In the Member State concerned days | |