PertussisNCT06605755
Safety and Immunogenicity of DTaP-IPV/Hib Pentavalent Vaccine in Chinese 2-month-old Infants
A study testing Different immunization regiments with DTaP-IPV/Hib Pentavalent Vaccine in people with Pertussis and Diphtheria, run by Jiangsu Province Centers for Disease Control and Prevention at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 22 monthsHealthy volunteers can take part
- Conditions the study is for
- Pertussis, Diphtheria, Tetanus
- What is being tested?
- Different immunization regiments with DTaP-IPV/Hib Pentavalent Vaccine
- Type of treatment
- Vaccines, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 785 participants
- Where
- 1 siteChina
- Study dates
- 5 Sep 2024to Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 22 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- (1)Received 4 doses of DTaP-IPV/Hib pentavalent vaccines (2) Obtained consent from the participant's caregiver and sign an informed consent form
Who cannot join
- -(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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jingsu Provincial Centre of Disease Control and Prevention
Nanjing, Jiangsu, 210009
Jingxin Li, +8613813865838, jingxin42102209@126.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Pertussis, Diphtheria, Tetanus, Haemophilus Influenzae Type B Infection, Polio
- Being tested
- Different immunization regiments with DTaP-IPV/Hib Pentavalent Vaccine
- Medical subject headings
- Whooping Cough, Diphtheria, Tetanus, Haemophilus Infections, Poliomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Different immunization regiments with DTaP-IPV/Hib Pentavalent VaccineProcedure or surgery
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).
- 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.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Different immunization regiments with DTaP-IPV/Hib Pentavalent Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measure positive rate of antibody and the growth multiple of GMC
Measured: 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
Measure positive rate of antibody and the growth multiple of GMC
Measured: 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.
The pathogen detection rate was calculated.
Measured: 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.
To evaluate the pertussis breakthrough infection rate.
Measured: 19-36 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2024
- Study start5 Sep 2024
- Primary completionDec 2025 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PertussisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 785 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Province Centers for Disease Control and Prevention
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- jingxin42102209@126.com Li, Study director, Jingsu Provincial Centre of Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06605755
- Sponsor's protocol ID
- JSVCT-ZL03
- Status last verified
- Aug 2024
- First submitted
- 4 Sep 2024
- Last updated
- 20 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06605755
- Acronym / sponsor ID
- JSVCT-ZL03
- Conditions
- Pertussis, Diphtheria, Tetanus, Haemophilus Influenzae Type B Infection, Polio
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 785 participants (estimated)
- Lead sponsor
- Jiangsu Province Centers for Disease Control and PreventionResearch network
- Study start
- 5 Sep 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 20 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Procedure: Different immunization regiments with DTaP-IPV/Hib Pentavalent VaccineIntervention 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. |
| Control group | Active comparator | Procedure: Different immunization regiments with DTaP-IPV/Hib Pentavalent VaccineControl 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. |
Who may qualify
- Ages
- 19 to 22 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- (1)Received 4 doses of DTaP-IPV/Hib pentavalent vaccines (2) Obtained consent from the participant's caregiver and sign an informed consent form
Key exclusion criteria (1 listed)
- -(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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Different immunization regiments with DTaP-IPV/Hib Pentavalent VaccineThe 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. | Procedure or surgery | Control group, Intervention group |
Primary outcome
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
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
4 secondary outcomes
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
jingxin42102209@126.com Li study director
Jingsu Provincial Centre of Disease Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Different immunization regiments with DTaP-IPV/Hib Pentavalent Vaccine in people with Pertussis and Diphtheria, run by Jiangsu Province Centers for Disease Control and Prevention at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jingxin Li (+8613813865838, jingxin42102209@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2024.