Extended Study on the Safety and Immunogenicity of DTaP-IPV/Hib Pentavalent Vaccine in Chinese 2-month-old Infants: a Randomized, Prospective, Open Clinical Study
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The main purpose of this study is to evaluate immune persistence at 30 and 36 Months of Age and Pertussis Breakthrough Infections between 19 and 36 Months of Age following two regiments of DTaP-IPV/Hib Pentavalent Vaccine in Healthy 2-Month-Old Infants and Children in China.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 1
Healthy Volunteers: t
View:
• \- (1)Received 4 doses of DTaP-IPV/Hib pentavalent vaccines (2) Obtained consent from the participant's caregiver and sign an informed consent form
Locations
Other Locations
China
Jingsu Provincial Centre of Disease Control and Prevention
RECRUITING
Nanjing
Contact Information
Primary
Jingxin Li
jingxin42102209@126.com
+8613813865838
Time Frame
Start Date: 2024-09-05
Estimated Completion Date: 2026-02
Participants
Target number of participants: 785
Treatments
Experimental: Intervention group
Intervention group: 1 dose of DTaP-IPV/Hib Pentavalent Vaccine at 2, 4 and 6 months of age, and 1 dose of enhanced vaccine at 18 months of age.
Active_comparator: Control group
Control group: 1 dose of DTaP-IPV/Hib Pentavalent Vaccine at 2, 3 and 4 months of age, and 1 dose of enhanced vaccine at 18 months of age.
Related Therapeutic Areas
Sponsors
Leads: Jiangsu Province Centers for Disease Control and Prevention