Immunogenicity of a Combined Diphtheria-Tetanus-recombinant Acellular Pertussis (DTaP) Vaccine in… (NCT07213089) | Clinical Trial Compass
CompletedPhase 2/3
Immunogenicity of a Combined Diphtheria-Tetanus-recombinant Acellular Pertussis (DTaP) Vaccine in Healthy Toddlers
Thailand290 participantsStarted 2020-07-13
Plain-language summary
Recombinant acellular pertussis vaccines containing genetically detoxified Pertussis Toxin (PTgen) have been used for booster immunisation in children, adolescents and adults including pregnant women in Thailand. Three vaccines have been licensed in Thailand, a monovalent (aPgen) and two vaccines combined with tetanus and reduced diphtheria dose vaccines (TdaPgen and Tdapgen). To address the need for improved vaccines in younger children, a new recombinant pediatric DTaP vaccine (DTaPgen) containing 5 µg genetically detoxified Pertussis Toxin (PTgen) and 10 µg Filamentous Hemagglutinin (FHA) was developed and found safe and immunogenic in a phase II trial in children aged 3 years onwards.
The purpose of this study is to assess the immunogenicity and safety of this new pediatric formulation DTaPgen given as the first booster dose in healthy toddlers aged 15 to 36 months compared to a commercially available vaccine in Thailand.
Who can participate
Age range15 Years – 36 Years
SexALL
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Inclusion criteria
✓. 15 to 36 months of age at the time of vaccination.
✓. Having completed the 3-dose DTwP or 3-dose DTaP vaccination (no interchange of DTwP and DTaP during primary immunization).
✓. The parents or legal guardians of the participant are able to read and write.
✓. The parents or legal guardians can provide written informed consent.
✓. Healthy, as established by pertinent medical history and physical examination.
Exclusion criteria
✕. History of any significant medical illness such as, but not limited to, immune deficiency, renal, hepatic, cardiovascular, or endocrine disorder as determined by the investigator based on medical history and physical examination.
✕. History of allergy or hypersensitivity to any vaccine (including its component).
✕. History of any serious adverse event or neurological adverse event after vaccination.
. Having received only 1 or 2 doses of DTwP or DTaP (incomplete primary immunization) after birth until the study enrollment.
✕. Having received the 4th dose DTwP or DTaP vaccination.
✕. Having experienced a physician diagnosed diphtheria or tetanus or pertussis illness within 1 year prior to recruitment.
✕. Receipt of any vaccine within 28 days prior to enrollment (3 months for live-attenuated vaccines).
✕. Planning to receive tetanus, diphtheria, pertussis or planning to participate in another clinical trial during the study period (approximately 1 year).