NCT07141875

Brief 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 vaccination staff.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
6,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2025

Completed
10 days until next milestone

Study Start

First participant enrolled

August 25, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 26, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2025

Completed
Last Updated

August 26, 2025

Status Verified

August 1, 2025

Enrollment Period

2 months

First QC Date

August 15, 2025

Last Update Submit

August 15, 2025

Conditions

Keywords

Children vaccineSimultaneous vaccinationCombination vaccines

Outcome Measures

Primary Outcomes (3)

  • 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.

    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").

    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.

    2025.08-2025.09

Secondary Outcomes (2)

  • Recommendation to simultaneous vaccination and combined vaccines

    2025.08-2025.09

  • Vaccine hesitancy

    2025.08-2025.09

Study Arms (2)

• Caregiver of Children

Interviewees are parents or grandparents of children aged between 6 to 59 months.

Other: No intervention

Vaccination and health care personnel

Interviewees are vaccination and health care personnel in each study site.

Other: No intervention

Interventions

This is an observational study without any interventions.

Vaccination and health care personnel• Caregiver of Children

Eligibility Criteria

Age2 Months+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • \- 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.

You may not qualify if:

  • \- 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Health Science Center

Beijing, Beijing Municipality, 100191, China

Location

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2025

First Posted

August 26, 2025

Study Start

August 25, 2025

Primary Completion

October 30, 2025

Study Completion

October 30, 2025

Last Updated

August 26, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations