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CompletedNCT01772901Updated Oct 9, 2015

Brief Influenza Vaccine Education to Pregnant Women

An interventional study of Influenza Vaccine Intervention in Influenza, Infectious Disease and Pregnancy, sponsored by The University of Hong Kong. Completed at 4 sites in Hong Kong. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-10-09.

Sponsored by The University of Hong Kong · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
321
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Influenza
  • Infectious Disease
  • Pregnancy

Keywords

  • influenza
  • influenza vaccines
  • infectious disease
  • pregnancy
03

In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.

This study's enrollment of 321 is above the median of 238 across 1,853 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

The University of Hong Kong is the lead sponsor of 1,262 studies on the registry; 340 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • not entitled to health benefits in Hong Kong (NEP)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
321 participants (actual)

Study arms

  • No intervention
    Control

    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.

  • Experimental
    Influenza Vaccine Intervention

    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.

    Other: Influenza Vaccine Intervention

Interventions

  • OtherInfluenza Vaccine Intervention

    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.

06

What researchers measure

Primary outcomes

  1. The proportion of influenza vaccination

    The proportion of influenza vaccination in the control and intervention groups

    Time frame: 2 weeks postpartum

Secondary outcomes

  1. 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.

    Time frame: 2 weeks postpartum

  2. the proportion of participants initiating discussion about influenza vaccine with their health care provider

    Time frame: 2 weeks postpartum

  3. the proportion of participants seeking out influenza vaccine

    Time frame: 2 weeks postpartum

07

Study locations

4 sites
  • Kwong Wah Hospital
    Hong Kong, Hong Kong
  • Pamela Youde Nethersole Eastern Hospital
    Hong Kong, Hong Kong
  • Queen Mary Hospital
    Hong Kong, Hong Kong
  • Tsan Yuk Hospital
    Hong Kong, Hong Kong
08

References and documents

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 27667330 ↗
  • Wong 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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 9, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01772901
Lead sponsor
The University of Hong Kong
Collaborators
Food and Health Bureau, Hong Kong
Responsible party
Marie Tarrant (Associate Professor, The University of Hong Kong) — Principal investigator
First posted
Jan 21, 2013
Start date
Oct 2013
Primary completion
Dec 2014
Completion
Jul 2015
Last update
Oct 9, 2015

Study contacts

Marie TARRANT, PhD, MPH, RN
principal investigator · The University of Hong Kong

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.

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