RecruitingPhase 3

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

China1,584 participantsStarted 2023-12-21

Plain-language summary

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

Age range3 Months – 3 Months

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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;
✓. 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;

✕. 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;

Immunogenicity results of experimental group and active control group (DTaP)

Timeframe: 30 days after basic immunization

Immunogenicity results of experimental group and active control group (DTaP-IPV//PRP-T)

Timeframe: 30 days after basic immunization

Immunogenicity results of experimental group

Timeframe: 30 days after basic immunization

NCT IDNCT06344065

SponsorBeijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-05-25

Wenjian Fang

Who can participate

Age range3 Months – 3 Months

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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;
✓. 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;

✕. 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;

What they're measuring

Immunogenicity results of experimental group and active control group (DTaP)

Timeframe: 30 days after basic immunization

Immunogenicity results of experimental group and active control group (DTaP-IPV//PRP-T)

Timeframe: 30 days after basic immunization

Immunogenicity results of experimental group

Timeframe: 30 days after basic immunization