Vaccination BehaviorNCT07141875
Child Vaccination Scheduling in China
An observational study of Vaccination Behavior, run by Peking University at 1 site in China.
Trial summary
This study aims to optimize pediatric vaccine scheduling in China . The first objective is to gather information on current vaccine schedules in China. The second objective is to evaluate the impact of simultaneous vaccination and combination vaccines on costs and vaccination rates through feedback from caregivers and… Read more about this study
- Who is it for?
- Ages 2 months and olderHealthy volunteers can take part
- Conditions the study is for
- Vaccination Behavior
- Type of treatment
- Vaccines
- How many people
- 6,000 participants
- Where
- 1 siteChina
- Study dates
- 25 Aug 2025to 30 Oct 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 2 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The sample will consist of 6,000 caregivers of children (aged between 2 to 59 months) from 10 representative provinces/municipalities/autonomous regions as well as Vaccination and health care personnel in each study site.
Who may be able to join
- For caregivers of children
- Children aged ≥2 months and ≤59 months
- Caregivers informed consent obtained For vaccination staff
- All vaccination staff currently working at the selected community health service centers or township health clinics on the day of the survey For retrospective analysis
- Children aged 5 years and under; with complete vaccination records. Complete vaccination records refer to a child having received all vaccines required by the NIP for their age group, with accurate dates recorded for each vaccination dose.
Who cannot join
- For caregivers of children
- Caregivers who are unable to participate in the survey due to physical or other objective reasons
- Caregivers with communication barriers
- Caregivers who do not consent to participate in the survey For vaccination staff
- Vaccination staff who do not consent to participate in the survey For retrospective analysis
- Children whose vaccination records are missing or incomplete
- Children whose vaccination has been delayed or not received due to medical contraindications.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking University Health Science Center
Beijing, Beijing Municipality, 100191
About this study
Official title: Optimization Strategies for Pediatric Vaccination Scheduling in China: The Impact of Local Policies, Caregivers, Vaccination Staff, and the Cost-Effectiveness of Simultaneous and Combined Vaccinations
This study aims to optimize pediatric vaccine scheduling in China . The first objective is to gather information on current vaccine schedules in China. The second objective is to evaluate the impact of simultaneous vaccination and combination vaccines on costs and vaccination rates through feedback from caregivers and vaccination staff.
Read the detailed description
The first objective will comprehensively collect vaccination programs for children under 6 years old in all 31 provinces of China (excluding Hong Kong, Macau, and Taiwan), covering both NIP and non-NIP vaccines that are suitable for children. The second objective is to evaluate the impact of simultaneous vaccination and combination vaccines on costs and vaccination rates. This will involve analyzing vaccination coverage for simultaneous vaccines across different regions in China, as well as assessing caregivers' perspectives on simultaneous vaccination, including their willingness, preferences, and factors influencing their vaccination decisions. Additionally, the study will explore vaccination staff attitudes, recommendation behaviors, and their reasons for recommending simultaneous and combination vaccines. For the survey, the sample will consist of caregivers of children (aged between 2 to 59 months) from 10 representative provinces/municipalities/autonomous regions as well as vaccination staff from institutions in the respective regions.
- Conditions
- Vaccination Behavior
- Being tested
- No intervention
- Keywords
- Children vaccine, Simultaneous vaccination, Combination vaccines
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
This is an observational study without any interventions.
| Study group | Role | What they receive |
|---|---|---|
| • Caregiver of Children | Interviewees are parents or grandparents of children aged between 6 to 59 months. Receives: Other: No intervention | |
| Vaccination and health care personnel | Interviewees are vaccination and health care personnel in each study site. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The economic value of optimized vaccination scheduling strategies
This study will comprehensively collect vaccination programs for children under 6 years old in all 31 provinces of China (excluding Hong Kong, Macau, and Taiwan), covering both NIP and non-NIP vaccines that are suitable for children.
The economic value of optimized vaccination scheduling strategies with simultaneous vaccination and combination vaccines will be assessed using a cost-minimization and budget impact model with inputs collected in this study. The optimized vaccination scheduling strategie will be collected in this study through a literature review, a cross-sectional caregiver survey, a survey among vaccination staff, and an observational time and motion chart among the latter population.
Measured: 2025.08-2025.09
Caregivers' willingness to simultaneous vaccination and combined vaccines
To evaluate the acceptance and willingness of different vaccination strategies, the survey will collect caregivers' knowledge, attitudes, and preferences on optimized vaccine scheduling strategies including simultaneous vaccination and combination vaccines, as well as factors influencing their decisions , such as the vaccination status of siblings of other children and elderly family members over 60 years old. The primary outcome variable will be willingness to simultaneous vaccination and combined vaccines, assessed using a 5-point ordinal scale (from "very unwilling" to "very willing").
Measured: 2025.08-2025.09
Immunization records and vaccination coverage
Using data collected from children's immunization records, a retrospective analysis will explore how previous simultaneous vaccination behaviors affect their vaccination rate. By comparing the vaccination rates at different ages between children receiving vaccines concomitantly vs. separately and children who uses combination vaccines vs. single vaccines, the study will evaluate whether the optimized vaccine scheduling strategies including simultaneous vaccination and combination vaccines have an impact on children's vaccination coverage.
Measured: 2025.08-2025.09
Secondary outcomes (2)
Recommendation to simultaneous vaccination and combined vaccines
A survey will be used to evaluate the attitudes and recommendation behaviors among vaccination staff towards optimized vaccine scheduling strategies including simultaneous vaccination and combination vaccines. The outcome variable will be recommendation behavior, assessed on a 5-point Likert scale ranging from "strongly recommend" to "strongly not recommend". To examine the perceived difficulty of vaccine scheduling, the survey will collect potential contributing factors: complexity of immunization schedules, inaccuracy of manual scheduling, limited implementation of simultaneous vaccination strategies, insufficient use of combination vaccines, high demand for catch-up vaccination, and lack of clear guidance for non-NIP vaccines.
Measured: 2025.08-2025.09
Vaccine hesitancy
Questions were designed in the questionnaire to evaluate the degree of vaccine hesitancy of interviewees. Respondents will be asked abound their confidence, convenience and complacency about vaccination of different non-NIP vaccines, so as to further explore the influencing factors of people's vaccination behaviors.
Measured: 2025.08-2025.09
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start25 Aug 2025 (estimated)
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccination BehaviorStudies 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, China, MSD China Holding Co Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07141875
- Sponsor's protocol ID
- IRB00001052-25094
- Status last verified
- Aug 2025
- First submitted
- 15 Aug 2025
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization Strategies for Pediatric Vaccination Scheduling in China: The Impact of Local Policies, Caregivers, Vaccination Staff, and the Cost-Effectiveness of Simultaneous and Combined Vaccinations
- ClinicalTrials.gov ID
- NCT07141875
- Acronym / sponsor ID
- IRB00001052-25094
- Conditions
- Vaccination Behavior
- Keywords
- Children vaccine, Simultaneous vaccination, Combination vaccines
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, China, MSD China Holding Co Ltd
- Study start
- 25 Aug 2025 (estimated)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 26 Aug 2025 (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.
This study aims to optimize pediatric vaccine scheduling in China . The first objective is to gather information on current vaccine schedules in China. The second objective is to evaluate the impact of simultaneous vaccination and combination vaccines on costs and vaccination rates through feedback from caregivers and vaccination staff.
Detailed description
The first objective will comprehensively collect vaccination programs for children under 6 years old in all 31 provinces of China (excluding Hong Kong, Macau, and Taiwan), covering both NIP and non-NIP vaccines that are suitable for children. The second objective is to evaluate the impact of simultaneous vaccination and combination vaccines on costs and vaccination rates. This will involve analyzing vaccination coverage for simultaneous vaccines across different regions in China, as well as assessing caregivers' perspectives on simultaneous vaccination, including their willingness, preferences, and factors influencing their vaccination decisions. Additionally, the study will explore vaccination staff attitudes, recommendation behaviors, and their reasons for recommending simultaneous and combination vaccines. For the survey, the sample will consist of caregivers of children (aged between 2 to 59 months) from 10 representative provinces/municipalities/autonomous regions as well as vaccination staff from institutions in the respective regions.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| • Caregiver of Children | – | Other: No interventionInterviewees are parents or grandparents of children aged between 6 to 59 months. |
| Vaccination and health care personnel | – | Other: No interventionInterviewees are vaccination and health care personnel in each study site. |
Who may qualify
- Ages
- 2 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The sample will consist of 6,000 caregivers of children (aged between 2 to 59 months) from 10 representative provinces/municipalities/autonomous regions as well as Vaccination and health care personnel in each study site.
Key inclusion criteria (5 listed)
- For caregivers of children
- Children aged ≥2 months and ≤59 months
- Caregivers informed consent obtained For vaccination staff
- All vaccination staff currently working at the selected community health service centers or township health clinics on the day of the survey For retrospective analysis
- Children aged 5 years and under; with complete vaccination records. Complete vaccination records refer to a child having received all vaccines required by the NIP for their age group, with accurate dates recorded for each vaccination dose.
Key exclusion criteria (7 listed)
- For caregivers of children
- Caregivers who are unable to participate in the survey due to physical or other objective reasons
- Caregivers with communication barriers
- Caregivers who do not consent to participate in the survey For vaccination staff
- Vaccination staff who do not consent to participate in the survey For retrospective analysis
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 |
|---|---|---|
| No interventionThis is an observational study without any interventions. | Other | Vaccination and health care personnel, • Caregiver of Children |
Primary outcome
The economic value of optimized vaccination scheduling strategies
Time frame: 2025.08-2025.09
This study will comprehensively collect vaccination programs for children under 6 years old in all 31 provinces of China (excluding Hong Kong, Macau, and Taiwan), covering both NIP and non-NIP vaccines that are suitable for children. The economic value of optimized vaccination scheduling strategies with simultaneous vaccination and combination vaccines will be assessed using a cost-minimization and budget impact model with inputs collected in this study. The optimized vaccination scheduling strategie will be collected in this study through a literature review, a cross-sectional caregiver survey, a survey among vaccination staff, and an observational time and motion chart among the latter population.
Caregivers' willingness to simultaneous vaccination and combined vaccines
Time frame: 2025.08-2025.09
To evaluate the acceptance and willingness of different vaccination strategies, the survey will collect caregivers' knowledge, attitudes, and preferences on optimized vaccine scheduling strategies including simultaneous vaccination and combination vaccines, as well as factors influencing their decisions , such as the vaccination status of siblings of other children and elderly family members over 60 years old. The primary outcome variable will be willingness to simultaneous vaccination and combined vaccines, assessed using a 5-point ordinal scale (from "very unwilling" to "very willing").
Immunization records and vaccination coverage
Time frame: 2025.08-2025.09
Using data collected from children's immunization records, a retrospective analysis will explore how previous simultaneous vaccination behaviors affect their vaccination rate. By comparing the vaccination rates at different ages between children receiving vaccines concomitantly vs. separately and children who uses combination vaccines vs. single vaccines, the study will evaluate whether the optimized vaccine scheduling strategies including simultaneous vaccination and combination vaccines have an impact on children's vaccination coverage.
2 secondary outcomes
Recommendation to simultaneous vaccination and combined vaccines
Time frame: 2025.08-2025.09
Vaccine hesitancy
Time frame: 2025.08-2025.09
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vaccination Behavior, run by Peking University 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 5 inclusion and 7 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: opening soon, as of the sponsor's last update on 26 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The economic value of optimized vaccination scheduling strategies (time frame: 2025.08-2025.09). The study lists 3 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 26 Aug 2025.