Safety and Immunogenicity of DTaP-IPV/Hib Pentavalent Vaccine in Chinese 2-month-old Infants
NCT ID: NCT06605755
Last Updated: 2024-09-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
785 participants
INTERVENTIONAL
2024-09-05
2026-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
19 Months
22 Months
ALL
Yes
Sponsors
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Jiangsu Province Centers for Disease Control and Prevention
NETWORK
Responsible Party
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Principal Investigators
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[email protected] Li
Role: STUDY_DIRECTOR
Jingsu Provincial Centre of Disease Control and Prevention
Locations
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Jingsu Provincial Centre of Disease Control and Prevention
Nanjing, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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JSVCT-ZL03
Identifier Type: -
Identifier Source: org_study_id
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