RecruitingNot Applicable

Safety and Immunogenicity of DTaP-IPV/Hib Pentavalent Vaccine in Chinese 2-month-old Infants

China785 participantsStarted 2024-09-05

Plain-language 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.

Who can participate

Age range19 Months – 22 Months

SexALL

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Exclusion criteria

✕(1) Diagnosed by a physician with a coagulation abnormality (e.g., coagulation factor deficiency, coagulopathy, platelet abnormality) (2) Any other factor considered to make participation in the trial unsuitable.

What they're measuring

Anti-pertussis toxin, anti-pertussis filamentous hemagglutinin, anti-pertussis adhesin, anti-pertussis FIM2, anti-pertussis FIM3 .Anti-diphtheria, anti-tetanus, anti-HIB PRP and anti-type 1, 2 and 3 poliomyelitis antibody levels .

Timeframe: 30 months of age

Timeframe: 36 months of age

Trial details

NCT IDNCT06605755

SponsorJiangsu Province Centers for Disease Control and Prevention

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2025-12

Contact for this trial

Jingxin Li

+8613813865838 jingxin42102209@126.com

View on ClinicalTrials.gov More Pertussis trials