Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06605755
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-04
Brief Title:
Safety and Immunogenicity of DTaP-IPVHib Pentavalent Vaccine in Chinese 2-month-old Infants
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Extended Study on the Safety and Immunogenicity of DTaP-IPVHib Pentavalent Vaccine in Chinese 2-month-old Infants a Randomized Prospective Open Clinical Study
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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-IPVHib Pentavalent Vaccine in Healthy 2-Month-Old Infants and Children in China
Detailed Description:
This study was based on the DTaP-IPVHib 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-IPVHib 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
DTaP-IPVHib 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None