Safety and Immunogenicity of DTaP-IPV/Hib Pentavalent Vaccine in Chinese 2-month-old Infants

NCT06605755 | Recruiting

• 1 other identifier: JSVCT-ZL03
• Study Type: interventional
• Target: 785
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this study is to evaluate immune persistence at 30 and 36 Months of Age and Pertussis Breakthrough Infections between 19 and 36 Months of Age following two regiments of DTaP-IPV/Hib Pentavalent Vaccine in Healthy 2-Month-Old Infants and Children in China.

Conditions

Pertussis; Diphtheria; Tetanus; Haemophilus Influenzae Type B Infection; Polio

Outcome Measures

Primary Outcomes (2)

• Anti-pertussis toxin, anti-pertussis filamentous hemagglutinin, anti-pertussis adhesin, anti-pertussis FIM2, anti-pertussis FIM3 .Anti-diphtheria, anti-tetanus, anti-HIB PRP and anti-type 1, 2 and 3 poliomyelitis antibody levels .

  Measure antibody levels

  30 months of age

• Anti-pertussis toxin, anti-pertussis filamentous hemagglutinin, anti-pertussis adhesin, anti-pertussis FIM2, anti-pertussis FIM3 .Anti-diphtheria, anti-tetanus, anti-HIB PRP and anti-type 1, 2 and 3 poliomyelitis antibody levels .

  Measure antibody levels

  36 months of age

Secondary Outcomes (4)

• The positive rate of anti-pertussis toxin, anti-pertussis filamentous hemagglutinin , anti-pertussis adherin, anti-pertussis FIM2, anti-pertussis FIM3 ,anti-diphtheria , anti-tetanus , anti-HIB PRP and anti-type 1, 2, 3 poliomyelitis antibody

  30 months of age

• The positive rate of anti-pertussis toxin, anti-pertussis filamentous hemagglutinin , anti-pertussis adherin, anti-pertussis FIM2, anti-pertussis FIM3 ,anti-diphtheria , anti-tetanus , anti-HIB PRP and anti-type 1, 2, 3 poliomyelitis antibody

  36 months of age

• To evaluate the pathogen detection rates of ARI in 2-month-old healthy infants in China after different DTaP-IPV/Hib vaccination programs during 19-36 months of age.

  19-36 months of age

• To evaluate the pertussis breakthrough infection rate in healthy infants and young children aged 19 to 36 months after receiving DTaP-IPV/Hib vaccine.

  19-36 months of age

Study Arms (2)

Intervention group

EXPERIMENTAL

Intervention group: 1 dose of DTaP-IPV/Hib Pentavalent Vaccine at 2, 4 and 6 months of age, and 1 dose of enhanced vaccine at 18 months of age.

Procedure: Different immunization regiments with DTaP-IPV/Hib Pentavalent Vaccine

Control group

ACTIVE COMPARATOR

Control group: 1 dose of DTaP-IPV/Hib Pentavalent Vaccine at 2, 3 and 4 months of age, and 1 dose of enhanced vaccine at 18 months of age.

Procedure: Different immunization regiments with DTaP-IPV/Hib Pentavalent Vaccine

Interventions

Different immunization regiments with DTaP-IPV/Hib Pentavalent Vaccine PROCEDURE

The test vaccine in this study was Pentaxim®, a pentavalent vaccine produced by Sanofi Pasteur, France.This vaccine is a combination vaccine consisting of adsorbed acellular DTP and inactivated polio vaccine (DTaP-IPV) and Haemophilus influenzae type b conjugate vaccine (Hib). 1. Intervention group: 1 dose of experimental vaccine at 2, 4 and 6 months of age, and 1 dose of enhanced vaccine at 18 months of age. 2. Control group: 1 dose of experimental vaccine at 2, 3 and 4 months of age, and 1 dose of enhanced vaccine at 18 months of age.

Control group; Intervention group

Eligibility Criteria

• Age: 19 Months - 22 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• \- (1)Received 4 doses of DTaP-IPV/Hib pentavalent vaccines (2) Obtained consent from the participant's caregiver and sign an informed consent form

You may not qualify if:

• (1) Diagnosed by a physician with a coagulation abnormality (e.g., coagulation factor deficiency, coagulopathy, platelet abnormality) (2) Any other factor considered to make participation in the trial unsuitable.

Sponsors & Collaborators

• Jiangsu Province Centers for Disease Control and Prevention: lead

Study Sites (1)

Jingsu Provincial Centre of Disease Control and Prevention

Nanjing, Jiangsu, 210009, China

RECRUITING

MeSH Terms

Conditions

Whooping Cough; Diphtheria; Tetanus; Haemophilus Infections; Poliomyelitis

Condition Hierarchy (Ancestors)

Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Corynebacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Clostridium Infections; Pasteurellaceae Infections; Myelitis; Central Nervous System Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases

Study Officials

• jingxin42102209@126.com Li

  Jingsu Provincial Centre of Disease Control and Prevention

  STUDY DIRECTOR

Central Study Contacts

Jingxin Li

CONTACT

+8613813865838; jingxin42102209@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2024
• First Posted: September 20, 2024
• Study Start: September 5, 2024
• Primary Completion: December 1, 2025
• Study Completion: February 1, 2026
• Last Updated: September 20, 2024

Record last verified: 2024-08

Locations

CN (1)