E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The study investigates the presence of nasopharyngeal vaccine- and non-vaccine pneumococcal serotypes in 11- and 24-month-old infants and parents, 6.5 years after implementation of a pneumococcal vaccine in the National Immunization Program. We also determine nasopharyngeal colonising of respiratory non-pneumococcal bacteria and of virusses. |
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E.1.1.1 | Medical condition in easily understood language |
Nasopharyngeal colonisation of respiratory bacteria and virusses in infants and parents |
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E.1.1.2 | Therapeutic area | Body processes [G] - Biological Phenomena [G16] |
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 nasopharyngeal colonization with total vaccine- and non-vaccine serotypes of S. pneumoniae in healthy 11-month-old and 24-month-old infants who have been immunized according to the Dutch National Immunization Program 6.5 years after implementation of PCV7 and 1.5 years after implementation of PCV10. |
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E.2.2 | Secondary objectives of the trial |
To determine trends in nasopharyngeal pneumococcal colonization with total vaccine- and non-vaccine serotypes in the parents of 24-month-old infants.
To determine trends in colonization of other respiratory pathogens like S. aureus, H. influenzae, M. catarrhalis in infants and parents of 24-month-old infants.
To determine trends in individual serotype colonization in healthy 11-month-old and 24-month-old infants who have been immunized according to the Dutch NIP as well as in parents of 24-month-old infants.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Infants:
The infants have to be of normal health (same health criteria apply as used in well-baby clinics when an infant receives a vaccination, e.g. also infants with small increases in temperature or cold are seen as infants with normal health)
The parents have to be willing and able to participate in the trial according to procedure
The infant is 11 or 24 months old (± 4 weeks) dependent on the group
The infant has been vaccinated according to the Dutch 3+1 schedule and received 3 pneumococcal vaccinations before the age of 6 months (11-month-old infant) and the 11 month booster (24-month-old infant).
Presence of a signed informed consent signed by both parents/legal representatives.
Parents:
Parents are included when their 24 month-old infant fulfils the inclusion criteria. |
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E.4 | Principal exclusion criteria |
Infants:
Previous vaccinations with pneumococcal vaccine using a schedule that differs from the Dutch 3+1 schedule
Previous vaccinations with other pneumoccocal vaccines than Synflorix (11-month-old infant) or Prevenar-7 (24-month-old infant)
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:
Chromosomal abnormalities or craniofacial abnormalities, known or suspected immunodeficiency disease or other medical conditions that will severely affect immunological responses
Coagulation disorder/anticoagulant medication |
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E.5 End points |
E.5.1 | Primary end point(s) |
The percentage of total vaccine- and non-vaccine pneumococcal serotypes found in the nasopharyngeal swabs from infants at 11 and 24 months of age by conventional culture. Serotyping is performed at single colony level by Quellung reaction as in previous surveillance studies. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
11 month timepoint before the 11 month booster (11-month-old infant)
24 month timepoint (24-month-old infant and parent) |
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E.5.2 | Secondary end point(s) |
The percentage of total vaccine- and non-vaccine pneumococcal serotypes found in the nasopharyngeal swabs from parents of the 24-month-old infants as determined by culture and Quellung.
The percentage of infants and parents with nasopharyngeal swabs positive for S. aureus, H. influenzae and M. catarrhalis as determined by culture.
The percentage of individual pneumococcal serotypes found in the nasopharyngeal swabs from infants at 11 and 24 months of age and parents of the 24-month-old infants as determined by culture and Quellung.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
11 month timepoint before the 11 month booster (11-month-old infant)
24 month timepoint (24-month-old infant and parent) |
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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 |
Nasopharyngeal pneumococcal colonization and of respiratory non-pneumococcal bacteria and of virusses |
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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) | 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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | No |
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 | 0 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 5 |
E.8.9.2 | In all countries concerned by the trial days | 0 |