E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The vaccine administered in this study is used to prevent pertussis caused by the bacterium Bordetella pertussis |
Het toegediende vaccin in deze studie wordt gebruikt om kinkhoest, veroorzaakt door de bacterie Bordetella pertussis, te voorkomen |
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E.1.1.1 | Medical condition in easily understood language |
Whooping Cough - pertussis |
Kinkhoest |
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E.1.1.2 | Therapeutic area | Health Care [N] - Environment and Public Health [N06] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The main purpose of this study is to investigate the longitudinal effects of an aP booster vaccination in adults, on long-term humoral (T0-T5)and cellular (T0-T4) memory immunity against B. pertussis. By measuring antibody levels against the various pertussis proteins (, antibody kinetics in serum (T0-T5) and saliva (T0-T4) can be determined. |
Het doel van deze studie is de longitudinale effecten van een aP booster vaccinatie bij volwassenen onderzoeken, op de lange-termijn humorale (T0-T5) en cellulaire geheugen immuniteit (T0-T4) tegen B. pertussis. Door het meten van antistof niveau's tegen de verschillende pertussis antigenen, kan de antistof kinetiek in serum (T0-T5) en speeksel (T0-T4) worden bepaald. |
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E.2.2 | Secondary objectives of the trial |
See E.5.2 Secondary end points |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
In order to be eligible to participate in this study, participants must meet all of the following criteria: • Good general health; • 25-29 years of age; • Vaccinated with DTwP-IPV (RIVM) at 3, 4, 5, and 11 months of age; • Received all other regular vaccines according to the Dutch NIP; • Provision of written informed consent; • Adherent to protocol and available during the study period. |
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E.4 | Principal exclusion criteria |
Any of the following criteria will exclude a participant from this study: • Antibiotic use within 14 days of enrollment; • Present evidence of serious disease(s) demanding immunosuppressive medical treatment, like corticosteroids, that might interfere with the results of the study within the last 3 months; • Known or suspected allergy to any of the vaccine components (by medical history); • Occurrence of serious adverse event after primary DTwP-IPV vaccination or other vaccination (by medical history); • 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/ saliva sampling; • Vaccination with any other pertussis vaccine than those described in the inclusion criteria; • No DT or DT-IPV vaccination at least 5 years before enrollment; • Vaccination within a month before enrollment; • Pregnant at start of study (when vaccination is administered);
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E.5 End points |
E.5.1 | Primary end point(s) |
The main purpose of this study is to investigate the longitudinal effects of an aP booster vaccination in adults, on long-term humoral (T0-T5) and cellular memory (T0-T4) immunity against B. pertussis. By measuring antibody levels against the various pertussis proteins, antibody kinetics in serum (T0-T5) and saliva (T0-T4) can be determined. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
T0: First visit (Informed consent, blood sample, saliva sample and vaccination) T1: Second visit, 14 days after T0 (blood sample and saliva sample) T2: Third visit, 28 days after T0 (blood sample and saliva sample) T3: Fourth visit, 1 year after T0 (blood sample and saliva sample) T4: Fifth visit, 2 years after T0 (blood sample and saliva sample) T5: Sixth visit, 6 years after T0 (blood sample) |
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E.5.2 | Secondary end point(s) |
• To determine pertussis specific IgG-subclasses and –avidity in serum (T0-T4); • To determine pertussis specific IgG-antibodies in saliva (T0-T4); • To measure serum specific IgG-antibodies (T0-T5), and memory B- and T-cell responses (T0-T4) against the other components (Diphtheria and Tetanus) of the booster vaccine; • To measure pertussis specific IgA antibodies in serum and saliva (T0-T4).
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
T0: First visit (Informed consent, blood sample, saliva sample and vaccination) T1: Second visit, 14 days after T0 (blood sample and saliva sample) T2: Third visit, 28 days after T0 (blood sample and saliva sample) T3: Fourth visit, 1 year after T0 (blood sample and saliva sample) T4: Fifth visit, 2 years after T0 (blood sample and saliva sample) T5: Sixth visit, 6 years after T0 (blood sample) |
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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 |
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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 | 6 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |