E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Immunity and immune memory after pneumococcal vaccination against S. pneumoniae serotypes present in either Synflorix or Prevenar-13 |
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E.1.1.1 | Medical condition in easily understood language |
Immunity and immunological memory after pneumococcal vaccination |
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E.1.1.2 | Therapeutic area | Body processes [G] - Immune system processes [G12] |
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 compare immunogenicity (humoral and cellular) induced by PCV10 and PCV13 after the booster dose of a complete vaccination series (3+1, the current NIP schedule) |
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E.2.2 | Secondary objectives of the trial |
To compare immunogenicity (humoral) induced by PCV10 and PCV13 at 5, 8, 11 and 12 months of a complete vaccination series (3+1, the current NIP schedule)
To investigate the possible influence of the pneumococcal vaccination on the serological responses of other vaccine components of the NIP which are administered simultaneously in the other limb (DTaP-Hib)
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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 (≤38.5 °C) or cold are seen as children with normal health)
• The parents/legally representatives have to be willing and able to allow their child to participate in the trial according to the described procedures
• Presence of a signed informed consent (the parents/legally representatives have given written informed consent after receiving oral and written information)
• Group 1: The children are 2 months old (± 2 weeks), have not received any vaccinations and will receive all vaccinations (DTaP-IPV-Hib-HepB and PCV13) by the study team
• Group 2: The children are 4-6 months old and have received three DTaP-IPV-Hib-HepB and PCV10 vaccinations according to the 3+1 schedule of the Dutch NIP*.
*The Dutch NIP 3+1 schedule: All children born as of August 1st 2011 will receive Synflorix (PCV10) and DTaP-IPV-Hib-HepB vaccinations, at the age of 2, 3 4 and 11 months of age. |
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E.4 | Principal exclusion criteria |
Exclusion criteria
• Group 1: Previous vaccinations with PCV7 or PCV10
• Group 2: Previous vaccinations with PCV7 of PCV13
• Vaccinations using a schedule that differs from the Dutch 3+1 schedule
• 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 pneumococcal vaccinations)
• Known or suspected immunological disorder
• Previously administration of plasma products (including immunoglobulin), within three months of study enrolment
• Presence of bleeding disorders
• Communication problems that interfere with the trial
• Prematurity (<37 weeks after gestation) |
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E.5 End points |
E.5.1 | Primary end point(s) |
Pneumococcal serotypes
• Cellular immune response (Plasma B cells and memory B cells) immediately before and 7-9 days after the booster at 11-months of age
• Humoral immune response (antibody concentrations and geometric mean concentrations (GMT)) at 12 months of age |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Cellular: at 11 months and 7-9 days after 11 months vaccination
Humoral: at 12 months |
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E.5.2 | Secondary end point(s) |
Pneumococcal serotypes
• Opsonophagocytoses immediately before and 7-9 days after the booster at 11-months of age
• Avidity at 5, 8, immediately before and 7-9 days after the booster at 11-months and at 12 months of age
• Antibody concentrations and geometric mean concentrations (GMT) at 5, 8, immediately before and 7-9 days after the booster at 11-months and at 12 months of age
• Kinetics of antibody concentrations and geometric mean concentrations (GMT) over time (at 5, 8, 11 and 12 months of age)
DTaP-HIb
• Antibody concentrations and geometric mean concentrations (GMT) at 5, 8, 11 and 12 months of age |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Humoral: at 5, 8, 11, 7-9 days after 11 months vaccination and 12 months
Opsonophagocytoses: immediately before and 7-9 days after the booster at 11-months of age
Avidity: at 5, 8, immediately before and 7-9 days after the booster at 11-months and at 12 months of age
DTaP-Hib, humoral: at 5, 8, 11 and 12 months of age |
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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 |
immunity and immune memory after pneumococcal vaccination |
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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 | 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 | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 0 |
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 | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |