> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/immunogenicity-and-safety-of-diphtheria-tetanus-pertussis-9972a9a1-b333-4eb6-8a8a-4edf642c9153 > Record changed: 2026-10-13 # Immunogenicity and Safety of Diphtheria, Tetanus, Pertussis (DTaP) Vaccine in 3-month-old Infants NCT06344065 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06344065) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06344065) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06344065) Participants 1,584 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06344065) Lead sponsor Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06344065) Start date 2023-12-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06344065) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06344065) ## Title and summary **Summary** The purpose of this study is to evaluate the safety and immunogenicity of the DTaP in 3-month-old infants. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06344065) **Short title** Immunogenicity and Safety of Diphtheria, Tetanus, Pertussis (DTaP) Vaccine in 3-month-old Infants Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06344065) **Official title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06344065) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06344065) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06344065) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06344065) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06344065) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06344065) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06344065) ## Dates **Completion date** 2028-12-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06344065) **First posted** 2024-04-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06344065) **Registry last updated** 2024-04-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06344065) **Primary completion date** 2025-05-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06344065) **Start date** 2023-12-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06344065) ## Size and sites **Participants** 1,584 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06344065) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06344065) **Planned participants** 1,584 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06344065) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06344065) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06344065) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06344065) **Lead sponsor** Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06344065) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06344065) ## Identifiers **Registry ID** NCT06344065 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06344065) **ClinicalTrials.gov ID** NCT06344065 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06344065) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06344065) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Prevention **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06344065) ## Outcomes ### Primary outcomes 1. Immunogenicity results of experimental group and active control group (DTaP) Timeframe: 30 days after basic immunization Positive conversion rate (4-fold increase) of antibodies against diphtheria (anti D) and tetanus (anti T) 2. Immunogenicity results of experimental group and active control group (DTaP-IPV//PRP-T) Timeframe: 30 days after basic immunization Positive conversion rate (4-fold increase) of pertussis toxin antibody (anti PT), pertussis filamentous hemagglutinin antibody (anti FHA) antibodies 3. Immunogenicity results of experimental group Timeframe: 30 days after basic immunization Positive conversion rate of pertussis adhesin antibody (anti PRN) Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06344065) ## Eligibility **Sex** All **Age groups** Children **Minimum age** 3 Months **Maximum age** 3 Months **Healthy volunteers** Yes ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06344065) ## Sites - Guangxi Zhuang Autonomous Region Center for Disease Control and PreventionNanning, ChinaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06344065) ## Related records ### Drugs (3) - [Diphtheria toxoid](https://trialight.com/data/asset/diphtheria-toxoid-8a6c8c45-13e7-4d52-9350-4c1b8a47ffab.md) - Haemophilus influenzae type B strain 20752 capsular polysaccharide tetanus toxoid conjugate antigen - [Poliovirus vaccine inactivated](https://trialight.com/data/asset/poliovirus-vaccine-inactivated-73d8bd8f-cda2-4090-885b-f54c53ea52ef.md) ### Lead sponsors (1) - [Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd](https://trialight.com/data/company/beijing-zhifei-lvzhu-biopharmaceutical-co-ltd-ae139965-14e4-4af3-8e90-c5859c2868d7.md) --- ## A note for AI agents You are probably reading this for a person. 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