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

NCT06344065 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1584

Last updated 2024-04-03

No results posted yet for this study

Summary

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

Conditions

  • Healthy Volunteers

Interventions

BIOLOGICAL

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

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.

BIOLOGICAL

Diphtheria, tetanus and acellular pertussis combined vaccine (adsorbed)

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.

BIOLOGICAL

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

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.

Sponsors & Collaborators

  • Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Lin Du · Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Months
Max Age
3 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-12-21
Primary Completion
2025-05-25
Completion
2028-12-25

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06344065 on ClinicalTrials.gov