Clinical trial • Phase IV • Infectious Disease

DIPHTHERIA TOXOID, TETANUS TOXOID, PERTUSSIS TOXOID, PERTUSSIS FILAMENTOUS HAEMAGGLUTININ, PERTUSSIS PERTACTIN, POLIOVIRUS (INACTIVATED) TYPE 3 (SAUKETT STRAIN), POLIOVIRUS (INACTIVATED) TYPE 2 (MEF-1 STRAIN), PERTUSSIS FIMBRIAL AGGLUTINOGENS (FIM) 2 AND 3, POLIOVIRUS (INACTIVATED) TYPE 1 (MAHONEY STRAIN) for Pertussis

Phase IV trial of DIPHTHERIA TOXOID, TETANUS TOXOID, PERTUSSIS TOXOID, PERTUSSIS FILAMENTOUS HAEMAGGLUTININ, PERTUSSIS PERTACTIN, POLIOVIRUS (INACTIVATED)…

Overview

Trial Therapeutic Area
Infectious Disease
Trial Disease
Pertussis
Trial Stage
Phase IV
Drug Modality
Vaccine|Small molecule

Key dates

Initial CTIS Submission Date
23-02-2024
First CTIS Authorization Date
04-06-2024

Trial design

Randomised, td-ipv comparator (revaxis). product: revaxis suspension for injection in pre-filled syringe; reported dose 0.5 ml (maxdailydoseamount 0.5 ml), route: injection; used as td-ipv control group. Phase IV trial across 1 site in Netherlands.

Randomised
Yes
Comparator
Td-IPV comparator (REVAXIS). Product: REVAXIS suspension for injection in pre-filled syringe; reported dose 0.5 ml (maxDailyDoseAmount 0.5 ml), route: injection; used as Td-IPV control group.
Target Sample Size
99
Trial Duration For Participant
28

Eligibility

Recruits 99 No vulnerable populations selected (isVulnerablePopulationSelected=false). Participants are healthy adult volunteers; informed consent is obtained (Subject information and informed consent form document present). Participants must be fully conversant in Dutch..

Pregnancy Exclusion
For female participants: pregnancy, lactation or intention to become pregnant during the study. Female volunteers are required to use an effective form of contraception during this study
Vulnerable Population
No vulnerable populations selected (isVulnerablePopulationSelected=false). Participants are healthy adult volunteers; informed consent is obtained (Subject information and informed consent form document present). Participants must be fully conversant in Dutch.

Inclusion criteria

  • {"criterion_text":"- Participant is born before 1-9-2004 and < 50 years old on the day of screening (Visit 1; V1)\n- Participant has received all primary pertussis vaccines during childhood\n- Participant is able to answer all questions of the pre-consent questionnaire correctly\n- Participant is fully conversant in the Dutch language\n- Participant is able to arrive within 1h at the Radboudumc from his/her home address. The participant must have a home address and live in the Netherlands\n- Participant is able to arrive within 3h at the Radboudumc at any time between Bp inoculation (V6) until the day 28 post challenge visit (V12)\n- Participant is willing to take an antibiotic regimen after inoculation with Bp according to the study protocol"}

Exclusion criteria

  • {"criterion_text":"- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g., anaphylaxis) to any component of the study intervention\n- Smoking: Any smoking event in the last month, including (e-)cigarette, joint, cigar and pipe\n- Individuals who have a history of receiving pertussis vaccination in the last 5 years\n- Receipt of any non-study vaccine within 14 days, before and after receiving the study vaccine (V2) or Bp inoculation (V6)\n- For female participants: pregnancy, lactation or intention to become pregnant during the study. Female volunteers are required to use an effective form of contraception during this study\n- Individuals who have inviolable commitments within the study period from V6 until V12 (28 days in total) to make contact with: •\tinfants aged < 1 year •\tunimmunized children aged < 4 years •\tpregnant women >32 weeks who have not received pertussis vaccination at least a week prior to contact •\tchronically ill patients (e.g. asthma, COPD, heart diseases)\n- Individuals who have household contacts working with •\tinfants aged < 1 year •\tpregnant women\n- A confirmed diagnosis of pertussis in the last two years and/or Serum IgG anti-FHA >55.9 IU/mL"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Bp colonisation rate in Tdap-IPV and Td-IPV vaccination groups, with Bp colonisation defined as any positive Bp culture from nasal wash samples at any time point between Day 3 and Day 28 after challenge","definition_or_measurement_approach":"Bp colonisation defined as any positive Bp culture from nasal wash samples at any time point between Day 3 and Day 28 after challenge"}
  • {"endpoint_text":"- Bp colonisation rate in Tdap-IPV vaccination groups, with Bp colonisation defined as any positive Bp culture from nasal wash samples at any time point between Day 3 and Day 28 after challenge","definition_or_measurement_approach":"Bp colonisation defined as any positive Bp culture from nasal wash samples at any time point between Day 3 and Day 28 after challenge"}

Recruitment

Planned Sample Size
99
Recruitment Window Months
24
Consent Approach
Informed consent obtained from adult participants using a Subject Information and Informed Consent Form (document: L1_SIS and ICF description_for publication). Participants must be fully conversant in Dutch; no assent procedures (no minors included).

Geography

Total Number Of Sites
1
Total Number Of Participants
99

Netherlands

Earliest CTIS Part Ii Submission Date
15-05-2024
Latest Decision Or Authorization Date
26-01-2026
Processing Time Days
621
Number Of Sites
1
Number Of Participants
99

Sites

Site Name
Radboud universitair medisch centrum / RADBOUDUMC
Department Name
Laboratory Medical Immunology
Contact Person Name
Dimitri Diavatopoulos

Sponsor

Primary sponsor

Full Name
Stichting Radboud University Medical Center
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Netherlands

Investigational products

Investigational Product Name
REPEVAX, suspension for injection, in pre-filled syringe Diphtheria, Tetanus, Pertussis (acellular, component) and Poliomyelitis (inactivated) Vaccine (adsorbed, reduced antigen(s) content)
Active Substance
DIPHTHERIA TOXOID, TETANUS TOXOID, PERTUSSIS TOXOID, PERTUSSIS FILAMENTOUS HAEMAGGLUTININ, PERTUSSIS PERTACTIN, POLIOVIRUS (INACTIVATED) TYPE 3 (SAUKETT STRAIN), POLIOVIRUS (INACTIVATED) TYPE 2 (MEF-1 STRAIN), PERTUSSIS FIMBRIAL AGGLUTINOGENS (FIM) 2 AND 3, POLIOVIRUS (INACTIVATED) TYPE 1 (MAHONEY STRAIN)
Modality
Vaccine
Routes Of Administration
Injection
Route
Injection
Authorisation Status
Authorised
Starting Dose
0.5 ml
Dose Levels
0.5 ml
Frequency
Single dose
Maximum Dose
0.5 ml
Investigational Product Name
REVAXIS Suspensie voor injectie in voorgevulde spuit. Difterie, tetanus en poliomyelitis (geïnactiveerd) vaccin, geadsorbeerd, beperkte hoeveelheid antigen(en).
Active Substance
DIPHTHERIA TOXOID, TETANUS TOXOID, POLIOVIRUS TYPE 1 (INACTIVATED), POLIOVIRUS TYPE 2 (INACTIVATED), POLIOVIRUS TYPE 3 (INACTIVATED)
Modality
Vaccine
Routes Of Administration
Injection
Route
Injection
Authorisation Status
Authorised
Starting Dose
0.5 ml
Dose Levels
0.5 ml
Frequency
Single dose
Maximum Dose
0.5 ml
Investigational Product Name
Azitromycine 500 mg Teva, filmomhulde tabletten.
Active Substance
AZITHROMYCIN
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
Authorised
Starting Dose
500 mg
Dose Levels
500 mg
Frequency
Once daily (max daily dose 500 mg; max treatment period 3 days)
Maximum Dose
1500 mg

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