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

NCT06344065 | Recruiting Phase 3

• 1 other identifier: 20220102C
• Study Type: interventional
• Target: 1,584
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Keywords

DTaP

Outcome Measures

Primary Outcomes (3)

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

  Positive conversion rate (4-fold increase) of antibodies against diphtheria (anti D) and tetanus (anti T)

  30 days after basic immunization

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

  Positive conversion rate (4-fold increase) of pertussis toxin antibody (anti PT), pertussis filamentous hemagglutinin antibody (anti FHA) antibodies

  30 days after basic immunization

• Immunogenicity results of experimental group

  Positive conversion rate of pertussis adhesin antibody (anti PRN)

  30 days after basic immunization

Study Arms (3)

DTaP vaccine

EXPERIMENTAL

Diphtheria, tetanus and acellular pertussis (component) combined vaccine (adsorbed), 0.5ml/vial, injection.

Biological: Diphtheria, tetanus and acellular pertussis (component) combined vaccine (adsorbed)

Active comparator 1: DTaP vaccine

ACTIVE COMPARATOR

Diphtheria, tetanus and acellular pertussis combined vaccine (adsorbed), 0.5ml/tube; injection.

Biological: Diphtheria, tetanus and acellular pertussis combined vaccine (adsorbed)

Active comparator 2: DTaP-IPV//PRP-T vaccine

ACTIVE COMPARATOR

Diphtheria, tetanus, pertussis (acellular, component), poliomyelitis (inactivated) vaccine (adsorbed) and Haemophilus influenzae type b conjugate vaccine, 0.5ml/tube; injection.

Biological: Diphtheria, tetanus, pertussis (acellular, component), poliomyelitis (inactivated) vaccine (adsorbed) and Haemophilus influenzae type b conjugate vaccine

Interventions

Diphtheria, tetanus and acellular pertussis (component) combined vaccine (adsorbed) BIOLOGICAL

Three doses of basic immunization were administered at 3, 4, and 5 months of age, and one dose of booster immunization was administered at 18-24 months of age, for a total of four doses. The administration route for experimental vaccine is intramuscular injection of 0.5ml into the lateral deltoid muscle of the upper arm.

DTaP vaccine

Diphtheria, tetanus and acellular pertussis combined vaccine (adsorbed) BIOLOGICAL

Three doses of basic immunization were administered at 3, 4, and 5 months of age, and one dose of booster immunization was administered at 18-24 months of age, for a total of four doses. The administration route for active control vaccine 1 is intramuscular injection of 0.5ml into the lateral deltoid muscle of the upper arm.

Active comparator 1: DTaP vaccine

Diphtheria, tetanus, pertussis (acellular, component), poliomyelitis (inactivated) vaccine (adsorbed) and Haemophilus influenzae type b conjugate vaccine BIOLOGICAL

Three doses of basic immunization were administered at 3, 4, and 5 months of age, and one dose of booster immunization was administered at 18-24 months of age, for a total of four doses. The administration route for active control vaccine 2 is through intramuscular injection of 0.5ml into the anterolateral side of the thigh or the upper arm.

Active comparator 2: DTaP-IPV//PRP-T vaccine

Eligibility Criteria

• Age: 3 Months - 3 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Basic immune stage:
• 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;

Sponsors & Collaborators

• Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd: lead

Study Sites (1)

Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention

Nanning, Guangxi, 530028, China

RECRUITING

MeSH Terms

Interventions

Tetanus Toxoid; Elements; Vaccines, Combined; Vaccines

Intervention Hierarchy (Ancestors)

Toxoids; Biological Products; Complex Mixtures; Inorganic Chemicals

Study Officials

• Lin Du

  Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

  STUDY CHAIR

Central Study Contacts

Wenjian Fang

CONTACT

+86-18611630252; fangwenjian@zhifeishengwu.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: April 3, 2024
• Study Start: December 21, 2023
• Primary Completion: May 25, 2025
• Study Completion (Estimated): December 25, 2028
• Last Updated: April 3, 2024

Record last verified: 2024-02

Locations

CN (1)