NCT04038333

Brief Summary

This trial focuses on influenza vaccination among three recommended groups in China. Data concerning the economic burden of influenza-like illness (ILI), vaccine hesitancy, discrete choice experiment, immunization records and willingness to pay for vaccines will be collected via questionnaires, and the financing strategies of influenza vaccines in China will be further analyzed. Besides, the knowledge, attitude/belief and practice (KAP) of medical staff will also be asked in a supplementary questionnaire.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13,542

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2019

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 30, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

August 1, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2019

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2021

Completed
Last Updated

January 24, 2022

Status Verified

January 1, 2022

Enrollment Period

3 months

First QC Date

July 22, 2019

Last Update Submit

January 7, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • economic burden of influenza-like illness (ILI)

    Questions were designed in the questionnaire to ask the economic burden of influenza-like illness (ILI), including direct and indirect costs. Specifically, direct costs include inpatient cost (both out-of-pocket and reimbursed, range 0-100,000), hospitalization cost (both out-of-pocket and reimbursed, range 0-500,000), drug cost (both out-of-pocket and reimbursed, range 0-100,000), transportation cost (range 0-100,000), accommodation cost range (0-100,000) and food cost (range 0-100,000). Indirect cost include missed working days of the patients and their relatives/friends.

    2019.08-2019.09

  • willingness to pay

    Questions were designed in the questionnaire to ask interviewees' willingness to pay for influenza vaccination. A value between 0 and 150 RMB will be randomly generated, and ask the respondent whether he or she is willing to pay for influenza vaccination. For example, one is asked "Would you like pay 102 for influenza vaccination?" If the answer is "Yes", then he or she will be asked "Would you like pay 112 for influenza vaccination?" If the answer is "No", then he or she will be asked "Would you like pay 92 for influenza vaccination?" The willingness to pay is then settled and recorded. Moreover, the proportion of vaccination cost paid by individuals will be asked (if others will be paid by health insurance and the government).

    2019.08-2019.09

Secondary Outcomes (3)

  • vaccine hesitancy and immunization records

    2019.08-2019.09

  • financing strategies

    2019.08-2019.09

  • discrete choice experiment

    2019.08-2019.09

Study Arms (4)

Children

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

Other: No intervention

Elderly

Interviewees are the elderly aged 60 years old or above.

Other: No intervention

Chronic disease patients

Interviewees are adult patients with chronic diseases aged below 60 years old.

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.

ChildrenChronic disease patientsElderlyVaccination and health care personnel

Eligibility Criteria

Age6 Months+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Three recommended groups for influenza vaccination in China, including children (aged between 6 to 59 months), the elderly (aged 60 years old or above), and adult patients with chronic diseases (aged below 60 years old); Vaccination and health care personnel in each study site.

You may qualify if:

  • (For children group) children aged between 6 to 59 months.
  • (For the elderly group) the elderly aged 60 years old or above.
  • (For chronic disease patient group) adult patients with chronic diseases aged below 60 years old.
  • (For medical staff) general practitioners and vaccination staff.
  • Interviewees with informed consent.

You may not qualify if:

  • Those cannot be surveyed for physical reasons.
  • Those with communication barriers.
  • Those who do not agree to participate in the survey.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Peking University Health Science Center

Beijing, Beijing Municipality, 100191, China

Location

Shandong University

Jinan, Shandong, China

Location

Fudan University

Shanghai, Shanghai Municipality, China

Location

Related Publications (11)

  • Hou Z, Jie Chang, Yue D, Fang H, Meng Q, Zhang Y. Determinants of willingness to pay for self-paid vaccines in China. Vaccine. 2014 Jul 31;32(35):4471-4477. doi: 10.1016/j.vaccine.2014.06.047. Epub 2014 Jun 23.

  • Rajamoorthy Y, Radam A, Taib NM, Rahim KA, Munusamy S, Wagner AL, Mudatsir M, Bazrbachi A, Harapan H. Willingness to pay for hepatitis B vaccination in Selangor, Malaysia: A cross-sectional household survey. PLoS One. 2019 Apr 9;14(4):e0215125. doi: 10.1371/journal.pone.0215125. eCollection 2019.

  • Molinari NA, Ortega-Sanchez IR, Messonnier ML, Thompson WW, Wortley PM, Weintraub E, Bridges CB. The annual impact of seasonal influenza in the US: measuring disease burden and costs. Vaccine. 2007 Jun 28;25(27):5086-96. doi: 10.1016/j.vaccine.2007.03.046. Epub 2007 Apr 20.

  • Putri WCWS, Muscatello DJ, Stockwell MS, Newall AT. Economic burden of seasonal influenza in the United States. Vaccine. 2018 Jun 22;36(27):3960-3966. doi: 10.1016/j.vaccine.2018.05.057. Epub 2018 May 22.

  • Salampessy BH, Veldwijk J, Jantine Schuit A, van den Brekel-Dijkstra K, Neslo RE, Ardine de Wit G, Lambooij MS. The Predictive Value of Discrete Choice Experiments in Public Health: An Exploratory Application. Patient. 2015 Dec;8(6):521-9. doi: 10.1007/s40271-015-0115-2.

  • Guo N, Zhang G, Zhu D, Wang J, Shi L. The effects of convenience and quality on the demand for vaccination: Results from a discrete choice experiment. Vaccine. 2017 May 15;35(21):2848-2854. doi: 10.1016/j.vaccine.2017.04.006. Epub 2017 Apr 12.

  • Wong CKH, Man KKC, Ip P, Kwan M, McGhee SM. Mothers' Preferences and Willingness to Pay for Human Papillomavirus Vaccination for Their Daughters: A Discrete Choice Experiment in Hong Kong. Value Health. 2018 May;21(5):622-629. doi: 10.1016/j.jval.2017.10.012. Epub 2017 Nov 15.

  • Larson HJ, de Figueiredo A, Xiahong Z, Schulz WS, Verger P, Johnston IG, Cook AR, Jones NS. The State of Vaccine Confidence 2016: Global Insights Through a 67-Country Survey. EBioMedicine. 2016 Oct;12:295-301. doi: 10.1016/j.ebiom.2016.08.042. Epub 2016 Sep 13.

  • Larson HJ, Schulz WS, Tucker JD, Smith DM. Measuring vaccine confidence: introducing a global vaccine confidence index. PLoS Curr. 2015 Feb 25;7:ecurrents.outbreaks.ce0f6177bc97332602a8e3fe7d7f7cc4. doi: 10.1371/currents.outbreaks.ce0f6177bc97332602a8e3fe7d7f7cc4.

  • Larson HJ, Jarrett C, Schulz WS, Chaudhuri M, Zhou Y, Dube E, Schuster M, MacDonald NE, Wilson R; SAGE Working Group on Vaccine Hesitancy. Measuring vaccine hesitancy: The development of a survey tool. Vaccine. 2015 Aug 14;33(34):4165-75. doi: 10.1016/j.vaccine.2015.04.037. Epub 2015 Apr 18.

  • Melia M, O'Neill S, Calderon S, Hewitt S, Orlando K, Bithell-Taylor K, Affeln D, Conti C, Wright SB. Development of a flexible, computerized database to prioritize, record, and report influenza vaccination rates for healthcare personnel. Infect Control Hosp Epidemiol. 2009 Apr;30(4):361-9. doi: 10.1086/596043.

MeSH Terms

Conditions

Influenza, HumanBehavior

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Hai Fang, PhD

    Peking University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 22, 2019

First Posted

July 30, 2019

Study Start

August 1, 2019

Primary Completion

October 30, 2019

Study Completion

March 10, 2021

Last Updated

January 24, 2022

Record last verified: 2022-01

Locations