Immunogenicity and Safety of Diphtheria, Tetanus, Pertussis (DTaP) Vaccine in 3-month-old Infants

Recruiting now · Phase 3

Conditions studied: Healthy Volunteers

In brief

The purpose of this study is to evaluate the safety and immunogenicity of the DTaP in 3-month-old infants.

Key facts

Study ID

NCT06344065

Run by

Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

People needed

1584

Starts

2023-12-21

Expected to finish

2028-12-25

Last updated by the study team

2024-04-03

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Basic immune stage:
• 3-month-old infants who can provide valid identification documents;
• Infants should be born following a 37-42 weeks of pregnancy and have a birth weight that meets the standard (2500g ≤ body weight ≤ 4500g);
• The legal guardian of the subject voluntarily agrees to their child's participation in the trial and signs a written informed consent form;
• The legal guardian of the subject has the ability to understand the trial procedure and participate in all planned follow-up visits;
• Has not received a vaccine containing the active ingredients of pertussis, diphtheria, tetanus combined vaccine;
• 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:
• Infants and young children aged 18-24 months who have been enrolled in this clinical trial at the age of 3 months;
• Basic immunization has been completed in this clinical trial;
• According to the researcher's opinion, the subjects and their legal guardians are able to comply with the requirements of the clinical trial protocol.

You may not qualify if…

• Basic immune stage:
• Has a history of pertussis, diphtheria, or tetanus;
• Has any history of severe allergies to vaccination in the past;
• Allergy to any component of the experimental vaccine;
• Has a history or family history of epilepsy, convulsions, encephalopathy, mental illness;
• Individuals with thrombocytopenia, any coagulation dysfunction, or undergoing anticoagulant therapy that may cause contraindications for subcutaneous injection;
• 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;
• Has the history of severe abnormal production process, suffocation rescue, neurological damage, and current pathological jaundice;
• Suffering from infectious diseases with clinical or serological evidence, such as tuberculosis, hepatitis B, hepatitis C, or HIV infection confirmed by parents;
• 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;
• Within 3 months before enrollment，has received treatment with immunoglobulin and/or any blood products (except hepatitis B immunoglobulin) ;
• Participating in or planning to participate in clinical trials of other drugs in the near future;
• 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:
• Newly discovered severe allergic history to any previous vaccination;
• Individuals with thrombocytopenia, any coagulation dysfunction, or undergoing anticoagulant therapy that may cause contraindications for subcutaneous injection;
• 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;
• After completing basic immunization, subjects were vaccinated with other vaccine containing the active ingredients of pertussis, diphtheria, tetanus combined vaccine before booster immunization;
• Participating in or planning to participate in clinical trials of other drugs in the near future;
• 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 it is running

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

Full record on ClinicalTrials.gov

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