A Randomized, Open-label, Controlled Clinical Study to Evaluate the Safety and Immunogenicity of Adsorbed Acellular Diphtheria, Tetanus and Pertussis Combined Vaccine Administered at Different Injection Sites in Healthy Infants and Young Children

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2026
INTERVENTION: Trial group:Trial group inoculation site and route: anterior lateral thigh, intramuscular injection.;Control group:Control group inoculation site and route: lateral aspect of the upper arm deltoid muscle, intramuscular injection.; CONDITION: Diphtheria, Tetanus, Pertussis PRIMARY OUTCOME: Seroconversion rates and geometric mean concentrations (GMCs) of each antibody 30 days after completion of the full primary immunization series; SECONDARY OUTCOME: Incidence of adverse events within 30 days following each vaccine dose;Incidence of serious adverse events within 6 months after completion of the full primary immunization series;Geometric Mean Fold Increases (GMFIs) of each antibody at Day 30 after completion of the full primary immunization series; INCLUSION CRITERIA: 1.Permanent healthy subjects aged 3 to 6 months; 2.Consent obtained from the volunteer’s guardian with a signed informed consent form; 3.The volunteer and their guardian are able to comply with the requirements of the clinical trial protocol; 4.No prior vaccination with diphtheria, tetanus and pertussis vaccine or combination vaccines containing its components; 5.Axillary temperature <= 37.0?;
Epistemonikos ID: ab08c0b9ddedd0144bf508bb4c1d4c641cfcc223
First added on: Oct 08, 2026