Influenza VaccinesNCT04038333

Financing Strategies of Influenza Vaccination in China

An observational study of Influenza Vaccines and Influenza, Human, run by Peking University at 3 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 6 months and olderHealthy volunteers can take part
Conditions the study is for: Influenza Vaccines, Influenza, Human, Cost of Illness
Type of treatment: Vaccines
How many people: 13,542 participants
Where: 3 sitesChina
Study dates: 1 Aug 2019to 10 Mar 2021
Phase: Observational
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 6 months and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

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.

Who may be able to join

(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.

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

China3 sites

Peking University Health Science Center
Beijing, Beijing Municipality, 100191
Shandong University
Jinan, Shandong
Fudan University
Shanghai, Shanghai Municipality

Other trials in China

About this study

Official title: Influenza Vaccination Among Three Recommended Groups in China: Economic Burden, Vaccine Hesitancy, Discrete Choice Experiment, Immunization Records, Willingness to Pay and Financing Strategies

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.

Read the detailed description

This trial focuses on influenza vaccination among three recommended groups 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).

The questionnaires will collect data on the economic burden of influenza-like illness (ILI), vaccine hesitancy, discrete choice experiment, immunization records and willingness to pay for vaccines, and the financing strategies of influenza vaccines in China will be further analyzed accordingly.

Besides the three recommended groups, vaccination and health care personnel will also be asked about their knowledge, attitude/belief and practice (KAP) in a supplementary questionnaire.

Conditions: Influenza Vaccines, Influenza, Human, Cost of Illness, Health Knowledge, Attitudes, Practice, Immunization Programs
Being tested: No intervention
Medical subject headings: Influenza, Human, Behavior

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 groups in NCT04038333
Study group	Role	What they receive
Children		Interviewees are parents or grandparents of children aged between 6 to 59 months. Receives: Other: No intervention
Elderly		Interviewees are the elderly aged 60 years old or above. Receives: Other: No intervention
Chronic disease patients		Interviewees are adult patients with chronic diseases aged below 60 years old. 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.

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.
Measured: 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).
Measured: 2019.08-2019.09

Secondary outcomes (3)

vaccine hesitancy and immunization records
Immunization records of children were collected. 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 vaccines (include influenza, Hib, PCV, Rota and chickenpox), so as to further explore the influencing factors of people's vaccination behaviors.
Measured: 2019.08-2019.09
financing strategies
Financing strategies will be further discussed according to literature review, government reports, and the results of willingness to pay.
Literature review will be done to learn about the financing strategies of influenza vaccination all over the world. Government reports on basic public health financing will be an important evidence and reference. The results of willingness to pay from the questionnaire estimate the amount (0-150) and proportion (0-100%) an individual is willing to pay for influenza vaccination.
Combining the three information sources, a supply-demand curve can be drawn to decide the optimal financing strategies of influenza vaccine, and the cross-region inequities in China will also be taken into consideration.
Measured: 2019.08-2019.09
discrete choice experiment
An extra questionnaire was specially designed for a small portion of randomly chosen interviewees to conduce discrete choice experiment. In the discrete choice experiment, different packages of vaccine will be given for respondents to choose from. These packages have different characteristics in terms of protection duration, vaccine cost, efficacy, safety and production place. In the experiment, participants are asked to choose one package from 10 pairs of packages (package A and package B) according to their own preferences. Their preferences (protection duration, vaccine cost, efficacy, safety and production place) will be calculated and ranked according to the experiment results.
Measured: 2019.08-2019.09

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 201910 Mar 2021

First posted30 Jul 2019
Study start1 Aug 2019
Primary completion30 Oct 2019
Study completion10 Mar 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (11)Papers the sponsor has linked to this study.
Other trials for Influenza VaccinesStudies of the same condition, open and under way.
More trials run by Peking UniversityThe sponsor's other registered studies.
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: Case only
Time perspective: Cross-sectional
Enrolment: 13,542 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04038333
Sponsor's protocol ID: IRB00001052-19076
Status last verified: Jan 2022
First submitted: 22 Jul 2019
Last updated: 24 Jan 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: It is not yet known if there will be a plan to make IPD available.

Publications

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.
PubMed 24968160
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.
PubMed 30964934
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.
PubMed 17544181
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.
PubMed 29801998
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.
PubMed 25618790
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.
PubMed 28410814
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.
PubMed 29753361
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.
PubMed 27658738
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.
PubMed 25789200
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.
PubMed 25896384
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.
PubMed 19245312

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Not yet recruitingPhase 1
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
RecruitingPhase 1
pH1N1 Blinded Challenge Study
Influenza
RecruitingPhase 3
A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)
Influenza

All Influenza Vaccines trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Influenza Vaccination Among Three Recommended Groups in China: Economic Burden, Vaccine Hesitancy, Discrete Choice Experiment, Immunization Records, Willingness to Pay and Financing Strategies
ClinicalTrials.gov ID: NCT04038333
Acronym / sponsor ID: IRB00001052-19076
Conditions: Influenza Vaccines, Influenza, Human, Cost of Illness, Health Knowledge, Attitudes, Practice, Immunization Programs
Study type: Observational
Recruitment status: Completed
Enrolment: 13,542 participants (actual)
Lead sponsor: Peking UniversityUniversity, hospital or other
Collaborators: Centers for Disease Control and Prevention, China, Fudan University, Shandong University
Study start: 1 Aug 2019 (actual)
Primary completion: 30 Oct 2019 (actual)
Study completion: 10 Mar 2021 (actual)
First posted: 30 Jul 2019 (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.

Detailed description

Besides the three recommended groups, vaccination and health care personnel will also be asked about their knowledge, attitude/belief and practice (KAP) in a supplementary questionnaire.

Study design

Observational model: Case only
Time perspective: Cross-sectional
Number of arms: 4

Arm	Type	Receives
Children	–	Other: No interventionInterviewees are parents or grandparents of children aged between 6 to 59 months.
Elderly	–	Other: No interventionInterviewees are the elderly aged 60 years old or above.
Chronic disease patients	–	Other: No interventionInterviewees are adult patients with chronic diseases aged below 60 years old.
Vaccination and health care personnel	–	Other: No interventionInterviewees are vaccination and health care personnel in each study site.

Who may qualify

Ages: 6 months and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult
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.

Key inclusion criteria (5 listed)

(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.

Key exclusion criteria (3 listed)

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

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	Children, Chronic disease patients, Elderly, Vaccination and health care personnel

Primary outcome

economic burden of influenza-like illness (ILI)
Time frame: 2019.08-2019.09
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.
willingness to pay
Time frame: 2019.08-2019.09
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).

3 secondary outcomes

vaccine hesitancy and immunization records
Time frame: 2019.08-2019.09
financing strategies
Time frame: 2019.08-2019.09
discrete choice experiment
Time frame: 2019.08-2019.09

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2022.
Results publication: PubMed 24968160Hou 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.
Results publication: PubMed 30964934Rajamoorthy 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.
Results publication: PubMed 17544181Molinari 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.
Results publication: PubMed 29801998Putri 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.
Results publication: PubMed 25618790Salampessy 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.
Results publication: PubMed 28410814Guo 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.
Results publication: PubMed 29753361Wong 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.
Results publication: PubMed 27658738Larson 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.
Results publication: PubMed 25789200Larson 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.
Results publication: PubMed 25896384Larson 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.
Results publication: PubMed 19245312Melia 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.
Individual participant dataSharing planned: Undecided. It is not yet known if there will be a plan to make IPD available.

Related trials for Influenza Vaccines

Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Not yet recruitingPhase 1
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
RecruitingPhase 1
pH1N1 Blinded Challenge Study
Influenza
RecruitingPhase 3
A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)
Influenza

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.

Hai Fang, PhD principal investigator

Peking University

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Influenza Vaccines and Influenza, Human, run by Peking University at 3 sites 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 3 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: finished, as of the sponsor's last update on 24 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

economic burden of influenza-like illness (ILI) (time frame: 2019.08-2019.09). 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?

On the ClinicalTrials.gov record for NCT04038333, which also lists 11 linked publications.

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 24 Jan 2022.