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

September 18, 2024 updated by: Jiangsu Province Centers for Disease Control and Prevention

Extended Study on the Safety and Immunogenicity of DTaP-IPV/Hib Pentavalent Vaccine in Chinese 2-month-old Infants: a Randomized, Prospective, Open Clinical Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study was based on the DTaP-IPV/Hib Pentavalent Vaccine Basic Immunization Strategy Optimization Study Cohort ("Pentavalent Vaccine Cohort") and the Epidemiological Investigation of Carrying Status of Pathogens Causing Acute Respiratory Infections (ARIs) in Infants and Young Children Cohort ("Pathogen Surveillance Cohort").

DTaP-IPV/Hib vaccine basic immunization strategy optimization study is a single-center, randomized, prospective and open clinical trial. The study was designed for two groups: 2, 3, 4, 18 months of age (control group) and 2, 4, 6, 18 months of age (intervention group). Subjects were randomly assigned to two groups according to the principle of informed consent. Collect basic demographic information of children and their families. The control group received 3 doses of acellular DPT vaccine at 2, 3 and 4 months of age respectively, and 1 dose at 18 months of age; The intervention group received 3 doses of acellular DPT vaccine at 2, 4 and 6 months of age respectively, and 1 dose at 18 months of age. The immunogenicity and safety were observed before and after 28 days of 3 doses of basal immunization, and after 28 days of enhanced immunization at 18 months of age.

The pathogen surveillance team included 2-month-old infants and caregivers with whom they shared a life history. After informed consent, the researchers followed up the subjects from 2 months of age to 19 months of age. The main contents of the visit are sample collection and unified questionnaire survey.

On the basis of the surveillance of ARI aged 2 to 19 months, follow-up was conducted for 17 months. During the follow-up period, ARI telephone visit was conducted twice a week. After ARI was found, pathogen sampling and testing were conducted for them (participants and their caregivers) to monitor the emergence of pertussis infection. Blood samples and throat swabs were collected at 30 and 36 months of age (caregivers were also required to take simultaneous samples), and penta vaccine immunity persistence was observed and multiple respiratory pathogens were monitored.

Study Type

Interventional

Enrollment (Estimated)

785

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Recruiting
        • Jingsu Provincial Centre of Disease Control and Prevention
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

-(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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
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

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.
Active Comparator: Control group
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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 .
Time Frame: 30 months of age
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 .
Time Frame: 36 months of age
Measure antibody levels
36 months of age

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 30 months of age
Measure positive rate of antibody and the growth multiple of GMC
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
Time Frame: 36 months of age
Measure positive rate of antibody and the growth multiple of GMC
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.
Time Frame: 19-36 months of age
The pathogen detection rate was calculated.
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.
Time Frame: 19-36 months of age
To evaluate the pertussis breakthrough infection rate.
19-36 months of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu Province Centers for Disease Control and Prevention

Investigators

  • Study Director: jingxin42102209@126.com Li, Jingsu Provincial Centre of Disease Control and Prevention

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 5, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

September 4, 2024

First Submitted That Met QC Criteria

September 18, 2024

First Posted (Actual)

September 20, 2024

Study Record Updates

Last Update Posted (Actual)

September 20, 2024

Last Update Submitted That Met QC Criteria

September 18, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JSVCT-ZL03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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