Evaluating the DTaP vaccine in 3-month-old infants

A Phase III, Single Center, Randomized, Blind, and Positive Control Clinical Trial to Evaluate the Immunogenicity and Safety of Diphtheria, Tetanus and Acellular Pertussis (Component) Combined Vaccine (Adsorbed) in 3-month-old Infants

This study is testing the safety and effectiveness of the DTaP vaccine in healthy 3-month-old babies to see how well it works.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1584 (estimated)
• Ages: 3 Months to 3 Months
• Sex: All
• Sponsor: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd (Industry-sponsored)
• Drugs / interventions: prednisone
• Locations: 1 site (Nanning, Guangxi)
• Trial ID: NCT06344065 on ClinicalTrials.gov

What this trial studies

This Phase III clinical trial aims to assess the safety and immunogenicity of the Diphtheria, Tetanus, and Acellular Pertussis (DTaP) vaccine in infants aged 3 months. Conducted in Guangxi Province, China, the study will enroll 1584 healthy infants, who will be randomly assigned to different groups receiving either the DTaP vaccine or control vaccines. The trial will also include a follow-up subset of 200 infants to evaluate the persistence of immunological response. The study is designed to provide critical data on the vaccine's effectiveness and safety profile in this age group.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy infants aged 3 months who meet specific birth weight and gestational age criteria.

Not a fit: Patients who have previously received any vaccine containing the active ingredients of the DTaP vaccine will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the understanding of DTaP vaccine safety and efficacy in infants, leading to improved vaccination strategies.

How similar studies have performed: Previous studies on the DTaP vaccine have shown positive outcomes regarding safety and immunogenicity, indicating that this approach is supported by existing evidence.

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 voluntarily agrees to their child's participation in the trial and signs a written informed consent form;
  4. The legal guardian of the subject has the ability to understand the trial procedure and participate in all planned follow-up visits;
  5. Has not received a vaccine containing the active ingredients of pertussis, diphtheria, tetanus combined vaccine;
  6. Active control group 2 has not been vaccinated with any vaccine containing the active ingredients of poliomyelitis vaccine or haemophilus influenzae vaccine;
* Enhanced immunity stage:

  1. Infants and young children aged 18-24 months who have been enrolled in this clinical trial at the age of 3 months;
  2. Basic immunization has been completed in this clinical trial;
  3. According to the researcher's opinion, the subjects and their legal guardians are able to comply with the requirements of the clinical trial protocol.

Exclusion Criteria:

* Basic immune stage:

  1. Has a history of pertussis, diphtheria, or tetanus;
  2. Has any history of severe allergies to vaccination in the past;
  3. Allergy to any component of the experimental vaccine;
  4. Has a history or family history of epilepsy, convulsions, encephalopathy, mental illness;
  5. Individuals with thrombocytopenia, any coagulation dysfunction, or undergoing anticoagulant therapy that may cause contraindications for subcutaneous injection;
  6. Suffering from serious congenital malformations or serious diseases that may interfere with the conduct or completion of the trial including but not limited to: infant wheezing, Down syndrome, severe thalassemia, heart disease, liver disease, kidney disease, diabetes, hereditary allergies, Guillain Barre syndrome, severe skin diseases, congenital or acquired immune defects (repeated perianal abscess), etc;
  7. Has the history of severe abnormal production process, suffocation rescue, neurological damage, and current pathological jaundice;
  8. Suffering from infectious diseases with clinical or serological evidence, such as tuberculosis, hepatitis B, hepatitis C, or HIV infection confirmed by parents;
  9. Within 3 months before to enrollment, has received systemic corticosteroid treatment (any route of administration, ≥ 2mg/kg/day) for ≥ 14 days, such as prednisone, inhaled steroids such as budesonide, and fluticasone; Or being using other immunosuppressants such as cyclosporine, tacrolimus, etc. before enrollment;
  10. Within 3 months before enrollment，has received treatment with immunoglobulin and/or any blood products (except hepatitis B immunoglobulin) ;
  11. Participating in or planning to participate in clinical trials of other drugs in the near future;
  12. According to the researcher's judgment, there are any other factors that are not suitable for the subjects to participate in the clinical trial.
* Enhanced immunity stage:

  1. Newly discovered severe allergic history to any previous vaccination;
  2. Individuals with thrombocytopenia, any coagulation dysfunction, or undergoing anticoagulant therapy that may cause contraindications for subcutaneous injection;
  3. Suffering from serious congenital malformations or serious diseases that may interfere with the conduct or completion of the test, including but not limited to: infant wheezing, Down syndrome, severe thalassemia, heart disease, liver disease, kidney disease, diabetes, hereditary allergies, Guillain Barre syndrome, severe skin diseases, congenital or acquired immune defects (repeated perianal abscess), etc;
  4. After completing basic immunization, subjects were vaccinated with other vaccine containing the active ingredients of pertussis, diphtheria, tetanus combined vaccine before booster immunization;
  5. Participating in or planning to participate in clinical trials of other drugs in the near future;
  6. According to the researcher's judgment, there are any other factors that are not suitable for the subjects to participate in the clinical trial.

Where this trial is running

Nanning, Guangxi

• Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention — Nanning, Guangxi, China (Recruiting)

Study contacts

• Study coordinator: Wenjian Fang

Conditions Healthy Volunteers; DTaP