E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
This study is going to focus on the immunisation against pertussis disease in previous healthy participants (adults and children), but the disease itself is not going to be studied. |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Body processes [G] - Immune system processes [G12] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10034738 |
E.1.2 | Term | Pertussis |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10047976 |
E.1.2 | Term | Whooping cough due to bordetella pertussis (B. pertussis) |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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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 investigate the effects of acellular pertussis booster vaccination on the immune response to Bordetella pertussis in children, young adults and the elderly in three European countries with a different epidemiological background and with different primary vaccination schedule for pertussis (whole cell pertussis vaccination only, mixed whole cell and acellular vaccination or only acellular pertussis vaccination).
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E.2.2 | Secondary objectives of the trial |
• To assess the antibody response to the vaccine 1 year after vaccination. • To measure other pertussis specific immunological responses before vaccination, and after vaccination at different time points. • Collection and biobanking of biological samples for identifying the persistence of immunity to Pertussis. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Normal general health • Within the right age group for the cohort • Received all regular vaccines for their age group according to the Dutch NIP, UK NIP or Finnish NIP • Provision of written informed consent • Willing to adhere to the protocol and be available during the study period |
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E.4 | Principal exclusion criteria |
• Present evidence of serious disease(s) within the last 3 months before inclusion requiring immunosuppressive or immune modulating medical treatment, such as systemic corticosteroids, that might interfere with the results of the study; • Chronic infection • Known or suspected immune deficiency; • History of any neurologic disorder, including epilepsy; • Previous administration of serum products (including immunoglobulins) within 6 months before vaccination and blood sampling; • Known and/or suspected allergy to any of the vaccine components (by medical history); • Occurrence of a serious adverse events (SAEs) after primary DTwP-IPV vaccination, DTaP-IPV vaccination or any other vaccination (by medical history); • Vaccination with any other pertussis vaccine other than those described in the inclusion criteria (i.e. only according to NIP) • Vaccination with any other DT-IPV vaccine in the last 5 years, a DT-IPV vaccination according to NIP in cohort B is not an exclusion criterion; • Children between 8 and 10 years of age eligible for cohort A in the Netherlands who have already received the diphtheria and tetanus toxoid vaccine (DT)-IPV booster vaccination according to Dutch NIP around 9 years of age; • Mixed wP and aP priming within a participant, cohort B; • Pregnancy. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The main study parameter is the specific IgG antibody level against PT at T4 using the isolated serum fraction. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The main study parameter is the specific IgG antibody level against PT at T4 using the isolated serum fraction. |
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E.5.2 | Secondary end point(s) |
- Specific IgG-levels to other pertussis vaccine antigens (FHA; Prn and Fim2,3), as well as to non-pertussis antigens (diphtheria toxoid and tetanus toxoid) will be determined at T0, T4 and T5, using a PERISCOPE serological multiplex immunoassay.
- Functional pertussis-specific antibody levels will be determined in serum samples at T0, T4 and T5, using PERISCOPE core assays as described in section 8.3.4. Differences in levels of functional antibodies will be measured before and after vaccination. Functional antibody assays include bacterial adherence inhibition (BAI), PT neutralisation (PTNA), serum bactericidal activity (SBA), and bacterial opsonophagocytosis assay (OPA). Other serological parameters such as avidity, subclass distribution (IgA, IgM) are optional in serum samples.
- Antigen-specific memory B cell responses at time points T0, T2, T4 and T5 will be measured to determine the effects of aP booster vaccination in children, young adults and elderly, using PERISCOPE B cell core assay. Characterisation of the effect of an aP booster on the specific T cell immune response, both early after the boost and later on, in different age groups, vaccinated initially either with a whole cell or an acellular vaccine.
- Characterisation of novel biomarkers of lasting memory and waning immunity by the use of novel exploratory immunoassays and for possible bridging to other pertussis vaccine studies.in samples storage on the Periscope biobank. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Please see section 23-2 above. |
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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 | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 3 |
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 | Yes |
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 | 3 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 28 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 9 |
E.8.9.2 | In all countries concerned by the trial days | 28 |