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Safety and Immunogenicity of DTaP-IPV/Hib Pentavalent Vaccine in Chinese 2-month-old Infants
Sponsor: Jiangsu Province Centers for Disease Control and Prevention
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.
Official title: 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
Key Details
Gender
All
Age Range
19 Months - 22 Months
Study Type
INTERVENTIONAL
Enrollment
785
Start Date
2024-09-05
Completion Date
2026-02
Last Updated
2024-09-20
Healthy Volunteers
Yes
Interventions
Different immunization regiments with DTaP-IPV/Hib Pentavalent Vaccine
The test vaccine in this study was Pentaxim®, a pentavalent vaccine produced by Sanofi Pasteur, France.This vaccine is a combination vaccine consisting of adsorbed acellular DTP and inactivated polio vaccine (DTaP-IPV) and Haemophilus influenzae type b conjugate vaccine (Hib). 1. Intervention group: 1 dose of experimental vaccine at 2, 4 and 6 months of age, and 1 dose of enhanced vaccine at 18 months of age. 2. Control group: 1 dose of experimental vaccine at 2, 3 and 4 months of age, and 1 dose of enhanced vaccine at 18 months of age.
Locations (1)
Jingsu Provincial Centre of Disease Control and Prevention
Nanjing, Jiangsu, China