Evaluating a new vaccine for infants against multiple infections
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
This study is testing a new vaccine for healthy 2-month-old infants to see how well it protects them from multiple infections and how long that protection lasts.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 785 (estimated) |
| Ages | 19 Months to 22 Months |
| Sex | All |
| Sponsor | Jiangsu Province Centers for Disease Control and Prevention Research network |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT06605755 on ClinicalTrials.gov |
What this trial studies
This study assesses the safety and immune response of the DTaP-IPV/Hib Pentavalent Vaccine in healthy 2-month-old infants in China. It involves two groups receiving different vaccination schedules and aims to monitor immune persistence and the occurrence of pertussis breakthrough infections up to 36 months of age. Participants will be followed from 2 to 19 months, with data collected on their health and vaccination responses. The study is randomized and prospective, ensuring a robust evaluation of the vaccine's effectiveness.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy infants aged 2 months who can receive the DTaP-IPV/Hib pentavalent vaccine.
Not a fit: Patients with coagulation abnormalities or other medical conditions that make participation unsuitable will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance vaccination strategies and improve immunity against serious infections in infants.
How similar studies have performed: Other studies have shown positive outcomes with similar vaccination approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: \- (1)Received 4 doses of DTaP-IPV/Hib pentavalent vaccines (2) Obtained consent from the participant's caregiver and sign an informed consent form 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.
Where this trial is running
Nanjing, Jiangsu
- Jingsu Provincial Centre of Disease Control and Prevention — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Jingxin Li
- Email: jingxin42102209@126.com
- Phone: +8613813865838
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.