ONE OR TWO DOSES OF A NEW VACCINE AGAINST WHOOPING COUGH?

Switzerland (ICTRP)

ID di studio ICTRP
NCT05193734 (ICTRP)

Titolo ufficiale (approvato dal comitato etico)
Safety and Immunogenicity of 2 Doses Versus 1 Dose of Acellular Pertussis Vaccines Containing Genetically-detoxified Pertussis Toxin in Young Adults Previously Primed With Acellular Pertussis Vaccines (Pertagen2x) (BASEC)

Titolo accademico
A Phase II/III Randomized, Double-blind Controlled Study to Compare the Safety and Immunogenicity of 1 or 2 Doses of Acellular Pertussis Vaccines Containing Genetically-detoxified Pertussis Toxin in Young Adults Previously Primed With Acellular Pertussis Vaccines (ICTRP)

Titolo pubblico
Safety and Immunogenicity of 2 Doses Versus 1 Dose of Acellular Pertussis Vaccines Containing Genetically-detoxified Pertussis Toxin in Young Adults Previously Primed With Acellular Pertussis Vaccines (ICTRP)

Malattie studiate
Pertussis
Vaccine-Preventable Diseases
(ICTRP)

Intervento studiato
Drug: Pertagen®
Drug: Revaxis®
(ICTRP)

Tipo di studio
Interventional (ICTRP)

Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Triple (Participant, Investigator, Outcomes Assessor). (ICTRP)

Criteri di inclusione/esclusione

Inclusion Criteria:

- Has provided written informed consent;

- Male or female, ages 18 to 30 years (inclusive) at the time of enrollment;

- With documented history of acellular pertussis immunization (5 doses);

- Free of clinically significant health problems, as determined by pertinent medical
history and clinical examination at study screening;

- Non-pregnant, non-lactating females :

- Able to attend all scheduled visits during one year and to understand and comply with
the study procedures;

Exclusion Criteria:

- Prior dTpa immunization within the last 5 years or prior dT immunization within the
last 2 years, or any other investigational vaccine likely to impact on interpretation
of the trial data

- Suspected or confirmed pertussis infection within the last 10 years or documented
pertussis infection in a household member within the last 10 years;

- History of severe local or systemic reactions to any vaccination;

- Known hypersensitivity or allergy to diphtheria, tetanus, or pertussis-containing
vaccines (including excipients);

- Receipt of investigational product up to 30 days prior to enrollment or ongoing
participation in another interventional clinical trial;

- Receipt of licensed vaccines within 30 days of planned study immunization or ongoing
participation in another clinical interventional trial likely to interfere with study
results;

- Acute or chronic, clinically significant psychiatric, hematologic, pulmonary,
cardiovascular, or hepatic or renal functional abnormality as determined by the
Investigator based on medical history and physical exam;

- Any confirmed or suspected immunosuppressive or immunodeficient condition, including
human immunodeficiency virus (HIV) infection, asplenia, cytotoxic therapy in the
previous 5 years, and/or diabetes;

- Has a known history of vaccine-induced Guillain-Barré Syndrome;

- Has an active malignancy or recent (<10 years) history of metastatic or hematologic
malignancy;

- Suspected or known alcohol and/or illicit drug abuse within the past 5 years;

- Pregnant or lactating female, or female intending to becoming pregnant during the
study period;

- Administration of immunoglobulins within the 120 days preceding study entry or planned
administration during the study period;

- History of blood donation (at least 450 ml) within 30 days of enrollment or plans to
donate within the 30 days following and preceding each blood draw;

- Receipt of chronic (>14 days) immunosuppressants or other immune-modifying drugs
within 6 months of study entry:

- Any other significant finding that, in the opinion of the investigator, would increase
the risk of the individual's having an adverse outcome by participating in this study.
(ICTRP)

non disponibile

Endpoint primari e secondari
Immunogenicity of two doses compared to a single dose of an acellular pertussis vaccine
(ICTRP)

Incidence of Treatment-Emergent Adverse Events OBJECTIVE
Humoral immune response
Cellular immune response
(ICTRP)

Data di registrazione
23.11.2021 (ICTRP)

Inclusione del primo partecipante
07.02.2022 (ICTRP)

Sponsor secondari
non disponibile

Contatti aggiuntivi
BLANCHARD ROHNER Geraldine, MD, University of Geneva (ICTRP)

ID secondari
PERTAGEN2x (ICTRP)

Risultati-Dati individuali dei partecipanti
non disponibile

Ulteriori informazioni sullo studio
https://trialsearch.who.int/Trial2.aspx?TrialID=NCT05193734 (ICTRP)