E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
healthy volunteer
(immunological response to early extra measles immunization) |
gezonde vrijwilliger (immuun response op vroege extra mazelen vaccinatie) |
|
E.1.1.1 | Medical condition in easily understood language |
Measles immunization |
Mazelen vaccinatie |
|
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 assess the effect of an early extra measles immunization between 6 and 12 months of age on the development of humoral and cell-mediated immunity against measles following routine MMR immunization at 14 months of age. |
Effect bepalen van vroege extra mazelen vaccinatie (gegeven tussen 6-12 maanden leeftijd) op humorale en cellulaire immuun response tegen mazelen volgend op de routine BMR vaccinatie gegeven op 14 maanden leeftijd |
|
E.2.2 | Secondary objectives of the trial |
Determine effect of early extra measles immunization on the immunogenicity against other infant vaccines of the NIP
Determine the influence of maternal measles antibodies on the infants’ immune response to measles immunization
Determine the rate of measles (neutralizing) antibody decline between 6 weeks and 1 year after routine MMR immunization at 14 months of age
|
Bepalen van effect van vroege extra mazelen vaccinatie op de immuniteit van de andere kindervaccinaties in het Rijksvaccinatie Programma
Bepalen van de invloed van maternale mazelen antistoffen op de immuunreactie van het kind op de mazelen vaccinatie
Bepalen van de snelheid van afname van (neutraliserende) mazelen antistoffen tussen 6 weken en 1 jaar na de routine BMR-1 vaccinatie op 14 maanden leeftijd |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Group 1: infants receiving (or having received) MMR-0 between 6-12 months of age and who are about to receive the MMR-1 at 14 months of age
Group 2: infants not receiving MMR-0 and who are about to receive the MMR-1 at 14 months of age
|
Groep 1: kinderen die BMR-0 ontvangen of gaan ontvangen tussen de leeftijd van 6-12 maanden en die BMR-1 gaan ontvangen op 14 maanden leeftijd
Groep 2: kinderen die geen BMR-0 ontvangen en die wel de BMR-1 gaan ontvangen op 14 maanden leeftijd |
|
E.4 | Principal exclusion criteria |
Encountered measles infection earlier in life
Receiving immunosuppressive medication
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
Known or suspected immunological disorder
Bleeding disorders |
Doorgemaakte mazelen infectie
Ontvangen van immuunsuppresieve medicatie
Aanwezigheid van een ernstige ziekte die medische zorg vereist die de resultaten van de studie kan beinvloeden
Bekende of vermoedd allergie of overgevoeligheid tegen een van de vaccin componenten
bekende of vermoede immunologische ziekte
bloedingsziekte |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Measles specific B- and T-cell immunogenicity
Measles specific serum IgG antibody concentrations, avidity (Luminex), and functional antibody characteristics with plaque neutralisation (PRN) |
Mazelen specifieke B- en T-cell
Mazelen specifieke serum IgG antistof concentraties, aviditeit (Luminex) en functionele antistoffen met plaque neutralisatie (PRN) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
immediately before and 7-9 days, 6 weeks and one year post MMR-1 |
direct voor en 7-9 dagen, 6 weken en 1 jaar na BMR-1 |
|
E.5.2 | Secondary end point(s) |
Serum IgG antibody concentrations against other vaccines of the NIP (mumps, rubella, MenC, diphtheria, tetanus, pertussis antigens (Ptx, FHA and PRN), Hib, HepB, and pneumococcal serotypes present in PCV10 (Luminex)
Measles, mumps and rubella antibody concentrations in DBS collected at 6 days of age, to monitor the concentrations of maternal antibodies delivered at birth (and to predict the concentrations at the time of MMR-0)
|
Serum IgG antistof concentraties tegen andere RVP vaccines (bof, rode hond, MenC, difterie, tetanus, kinkhoest (Ptx, FHA en PRN), Hib, HepB en pneumokokken serotypen in PCV10 (Luminex)
Mazelen, bof en rode hond antistof concentraties in droge bloed spots op de hielprik kaartjes die zijn verzameld op de leeftijd van 6 dagen, om de concentraties van maternale antistoffen die bij geboorte zijn meegegeven te bepalen (en om de concentraties op het tijdstip van BMR-0 te voorspellen) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
immediately before and 7-9 days, 6 weeks and one year post MMR-1 |
direct voor en 7-9 dagen, 6 weken en 1 jaar na BMR-1 |
|
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 |
immune response to early extra measles vaccination |
immuun reactie op vroege extra mazelen vaccinatie |
|
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 | 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 |
kinderen die geen vroege extra BMR-0 vaccinatie hebben gehad |
children who have not received the extra early MMR-0 immunization |
|
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
|
LVLS |
Laatste bezoek laatste deelnemer |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | |