InfluenzaNCT01772901
Brief Influenza Vaccine Education to Pregnant Women
A study testing Influenza Vaccine Intervention in people with Influenza and Infectious Disease, run by The University of Hong Kong at 4 sites in Hong Kong.
Trial summary
The investigators will conduct a brief educational intervention to pregnant women who have not yet received the influenza vaccine in this pregnancy to improve the uptake of seasonal influenza vaccine. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Influenza, Infectious Disease, Pregnancy
- What is being tested?
- Influenza Vaccine Intervention
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 321 participants
- Where
- 4 sitesHong Kong
- Study dates
- Oct 2013to Jul 2015
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- singleton pregnancy
- 18 years of age or older
- in at least the second trimester of pregnancy
- Cantonese speaking
- Hong Kong resident
- no serious medical or obstetrical complications
- have not yet received the influenza vaccine in this pregnancy
- staying in Hong Kong for at least two weeks after delivery.
Who cannot join
- not entitled to health benefits in Hong Kong (NEP)
Trial locations and contacts
4 sites in 1 country.
Hong Kong4 sites
Kwong Wah Hospital
Hong Kong
Pamela Youde Nethersole Eastern Hospital
Hong Kong
Queen Mary Hospital
Hong Kong
Tsan Yuk Hospital
Hong Kong
About this study
Official title: A Randomized Controlled Trial of a Brief Educational Intervention to Increase Uptake of Influenza Vaccine Among Pregnant Women
The investigators will conduct a brief educational intervention to pregnant women who have not yet received the influenza vaccine in this pregnancy to improve the uptake of seasonal influenza vaccine.
- Conditions
- Influenza, Infectious Disease, Pregnancy
- Being tested
- Influenza Vaccine Intervention
- Keywords
- influenza, influenza vaccines, infectious disease, pregnancy
- Medical subject headings
- Influenza, Human, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Influenza Vaccine InterventionOther
The intervention will include a brief 5 to 10-minute educational talk by research nurse explaining the facts of influenza and influenza vaccine and answering participant questions. The educational intervention will focus on: (1) Hong Kong government's recommendation regarding influenza vaccine during pregnancy, (2) potential complications associated with influenza during pregnancy and for young infants, (3) safety of influenza vaccine for mother and foetus, and (4) potential benefits of influenza vaccine for mother and infant, and (5) where and how to get the influenza vaccine in Hong Kong.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Usual outpatient antenatal care consists of routine checking of the maternal and foetal health by either clinic midwives or obstetricians along with health education to promote a healthy pregnancy. |
| Influenza Vaccine Intervention | Experimental | The intervention group will receive a brief 5 to 10-minute educational talk by research nurse explaining the facts of influenza and influenza vaccine and answering participant questions. Receives: Other: Influenza Vaccine Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of influenza vaccination
The proportion of influenza vaccination in the control and intervention groups
Measured: 2 weeks postpartum
Secondary outcomes (3)
The influenza and influenza vaccine knowledge of participants
The influenza and influenza vaccine knowledge of participants in the control and intervention groups after receiving the intervention.
Measured: 2 weeks postpartum
the proportion of participants initiating discussion about influenza vaccine with their health care provider
Measured: 2 weeks postpartum
the proportion of participants seeking out influenza vaccine
Measured: 2 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2014
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 321 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Food and Health Bureau, Hong Kong
- Responsible party
- Principal investigator, Marie Tarrant, The University of Hong Kong
- Investigators
- Marie TARRANT, PhD, MPH, RN, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01772901
- Sponsor's protocol ID
- PIV-INT-1
- Status last verified
- Oct 2015
- First submitted
- 17 Jan 2013
- Last updated
- 9 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Wong VWY, Fong DYT, Lok KYW, Wong JYH, Sing C, Choi AY, Yuen CYS, Tarrant M. Brief education to promote maternal influenza vaccine uptake: A randomized controlled trial. Vaccine. 2016 Oct 17;34(44):5243-5250. doi: 10.1016/j.vaccine.2016.09.019. Epub 2016 Sep 22.
PubMed 27667330Wong VW, Fong DY, Tarrant M. Brief education to increase uptake of influenza vaccine among pregnant women: a study protocol for a randomized controlled trial. BMC Pregnancy Childbirth. 2014 Jan 14;14:19. doi: 10.1186/1471-2393-14-19.
PubMed 24423245
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of a Brief Educational Intervention to Increase Uptake of Influenza Vaccine Among Pregnant Women
- ClinicalTrials.gov ID
- NCT01772901
- Acronym / sponsor ID
- PIV-INT-1
- Conditions
- Influenza, Infectious Disease, Pregnancy
- Keywords
- influenza, influenza vaccines, infectious disease, pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 321 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Food and Health Bureau, Hong Kong
- Study start
- Oct 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 21 Jan 2013 (estimated)
- 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 investigators will conduct a brief educational intervention to pregnant women who have not yet received the influenza vaccine in this pregnancy to improve the uptake of seasonal influenza vaccine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Usual outpatient antenatal care consists of routine checking of the maternal and foetal health by either clinic midwives or obstetricians along with health education to promote a healthy pregnancy. |
| Influenza Vaccine Intervention | Experimental | Other: Influenza Vaccine InterventionThe intervention group will receive a brief 5 to 10-minute educational talk by research nurse explaining the facts of influenza and influenza vaccine and answering participant questions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- singleton pregnancy
- 18 years of age or older
- in at least the second trimester of pregnancy
- Cantonese speaking
- Hong Kong resident
Key exclusion criteria (1 listed)
- not entitled to health benefits in Hong Kong (NEP)
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 |
|---|---|---|
| Influenza Vaccine InterventionThe intervention will include a brief 5 to 10-minute educational talk by research nurse explaining the facts of influenza and influenza vaccine and answering participant questions. The educational intervention will focus on: (1) Hong Kong government's recommendation regarding influenza vaccine during pregnancy, (2) potential complications associated with influenza during pregnancy and for young infants, (3) safety of influenza vaccine for mother and foetus, and (4) potential benefits of influenza vaccine for mother and infant, and (5) where and how to get the influenza vaccine in Hong Kong. | Other | Influenza Vaccine Intervention |
Primary outcome
The proportion of influenza vaccination
Time frame: 2 weeks postpartum
The proportion of influenza vaccination in the control and intervention groups
3 secondary outcomes
The influenza and influenza vaccine knowledge of participants
Time frame: 2 weeks postpartum
the proportion of participants initiating discussion about influenza vaccine with their health care provider
Time frame: 2 weeks postpartum
the proportion of participants seeking out influenza vaccine
Time frame: 2 weeks postpartum
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 9 Oct 2015.
- Derived from this study: PubMed 27667330Wong VWY, Fong DYT, Lok KYW, Wong JYH, Sing C, Choi AY, Yuen CYS, Tarrant M. Brief education to promote maternal influenza vaccine uptake: A randomized controlled trial. Vaccine. 2016 Oct 17;34(44):5243-5250. doi: 10.1016/j.vaccine.2016.09.019. Epub 2016 Sep 22.
- Derived from this study: PubMed 24423245Wong VW, Fong DY, Tarrant M. Brief education to increase uptake of influenza vaccine among pregnant women: a study protocol for a randomized controlled trial. BMC Pregnancy Childbirth. 2014 Jan 14;14:19. doi: 10.1186/1471-2393-14-19.
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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.
Marie TARRANT, PhD, MPH, RN principal investigator
The University of Hong Kong
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Influenza Vaccine Intervention in people with Influenza and Infectious Disease, run by The University of Hong Kong at 4 sites in Hong Kong.
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 8 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: finished, as of the sponsor's last update on 9 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Hong Kong. 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?
The proportion of influenza vaccination (time frame: 2 weeks postpartum). 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 NCT01772901, which also lists 2 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 9 Oct 2015.