A Phase III, Single Center, Randomized, Blind, and Positive Control Clinical Trial to Evaluate the Immunogenicity and Safety of Diphtheria, Tetanus and Acellular Pertussis (Component) Combined Vaccine (Adsorbed) in 3-month-old Infants

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The purpose of this study is to evaluate the safety and immunogenicity of the DTaP in 3-month-old infants.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 3 months
Maximum Age: 3 months
Healthy Volunteers: t
View:

• Basic immune stage:

‣ 3-month-old infants who can provide valid identification documents;

⁃ Infants should be born following a 37-42 weeks of pregnancy and have a birth weight that meets the standard (2500g ≤ body weight ≤ 4500g);

⁃ The legal guardian of the subject voluntarily agrees to their child's participation in the trial and signs a written informed consent form;

⁃ The legal guardian of the subject has the ability to understand the trial procedure and participate in all planned follow-up visits;

⁃ Has not received a vaccine containing the active ingredients of pertussis, diphtheria, tetanus combined vaccine;

⁃ Active control group 2 has not been vaccinated with any vaccine containing the active ingredients of poliomyelitis vaccine or haemophilus influenzae vaccine;

• Enhanced immunity stage:

‣ Infants and young children aged 18-24 months who have been enrolled in this clinical trial at the age of 3 months;

⁃ Basic immunization has been completed in this clinical trial;

⁃ According to the researcher's opinion, the subjects and their legal guardians are able to comply with the requirements of the clinical trial protocol.

Locations
Other Locations
China
Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention
RECRUITING
Nanning
Contact Information
Primary
Wenjian Fang
fangwenjian@zhifeishengwu.com
+86-18611630252
Time Frame
Start Date: 2023-12-21
Estimated Completion Date: 2028-12-25
Participants
Target number of participants: 1584
Treatments
Experimental: DTaP vaccine
Diphtheria, tetanus and acellular pertussis (component) combined vaccine (adsorbed), 0.5ml/vial, injection.
Active_comparator: Active comparator 1: DTaP vaccine
Diphtheria, tetanus and acellular pertussis combined vaccine (adsorbed), 0.5ml/tube; injection.
Active_comparator: Active comparator 2: DTaP-IPV//PRP-T vaccine
Diphtheria, tetanus, pertussis (acellular, component), poliomyelitis (inactivated) vaccine (adsorbed) and Haemophilus influenzae type b conjugate vaccine, 0.5ml/tube; injection.
Sponsors
Leads: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

This content was sourced from clinicaltrials.gov