Immunogenicity and Safety of Diphtheria, Tetanus, Pertussis (DTaP) Vaccine in 3-month-old Infants
Recruiting
Phase 3
Interventional Study
Healthy Volunteers
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 3 Months – 3 Months
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 1,584 (estimated)
- Sponsor
- Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd · Industry
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About This Trial
The purpose of this study is to evaluate the safety and immunogenicity of the DTaP in 3-month-old infants.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Basic immune stage:
1. 3-month-old infants who can provide valid identification documents;
2. Infants should be born following a 37-42 weeks of pregnancy and have a birth weight that meets the standard (2500g ≤ body weight ≤ 4500g);
3. The legal guardian of the subject …
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