Vaccination UptakeNCT06815250
Enhancing Maternal Vaccine Knowledge and Uptake: The InTroDuce-Programme Trial
A study testing Influenza and Tdap Vaccination Educational and Learning Module in people with Vaccination Uptake and Knowledge, run by Universiti Putra Malaysia at 4 sites in Malaysia.
Trial summary
The goal of this InTroDuce-Programme interventional trial aims to test whether a web-based educational program can improve pregnant women's knowledge about Influenza and Tdap vaccinations and increase their intention to get vaccinated in the future. 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
- Vaccination Uptake, Knowledge, Tetanus, Diphtheria and Acellular Pertussis Vaccination
- What is being tested?
- Influenza and Tdap Vaccination Educational and Learning Module
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 351 participants
- Where
- 4 sitesMalaysia
- Study dates
- 13 Jan 2026to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Pregnant women aged 18 years and older
- Before or equal to 32 weeks of gestation as we need to follow-up the patients again at 36 weeks of gestation before delivery occurs.
- Able to understand and consent to participation in the study.
Who cannot join
- Pregnant women with severe anaphylactic or allergic reactions to previous dose of influenza or Tdap vaccination.
- Non-Malaysian
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia4 sites, 4 recruiting
- Recruiting
Klinik Kesihatan Bangi
Bandar Baru Bangi, Selangor, 43650
Dr Siti Rohani Bt Mohamed Alias, Family Med, +60 13-294 5092, ctrohani.alias@moh.gov.my
Dr Siti Rohani Bt Mohamed Alias, Family Med
- Recruiting
Klinik Kesihatan Batu 9
Cheras, Selangor, 43200
Dr Nor Hazlin Bt Talib, Family Med, +60192797330, dr_norhazlin@moh.gov.my
Dr Nor Hazlin Bt Talib, Family Med
- Recruiting
Klinik Kesihatan Balakong
Cheras, Selangor, 43300
Dr Nadiah Binti Md Alwi, Family Med, +60173737637, nadiah.alwi@gmail.com
Dr Nadiah Binti Md Alwi, Family Med
- Recruiting
Klinik Kesihatan Kajang
Kajang, Selangor, 43000
Dr Nur Harnani bt Abdullah, Family Med, +60 17-623 3545, nanee801@yahoo.com
Dr Izzah Hazwani binti Dzulkifli, Family Med, +60 12-392 9950, dr_izzahhazwani@moh.gov.my
About this study
Official title: Effectiveness of the Influenza and Tdap (Tetanus, Diphtheria, Acellular Pertussis) Vaccination Educational and Learning Module (InTroDuce-Programme) in Improving Knowledge and Future Uptake of Vaccination Among Pregnant Mothers in Primary Care Clinics: A Randomised Control Trial Secondary IDs
The goal of this InTroDuce-Programme interventional trial aims to test whether a web-based educational program can improve pregnant women's knowledge about Influenza and Tdap vaccinations and increase their intention to get vaccinated in the future. The main questions it aims to answer are:
Does the InTroDuce-Programme increase knowledge and future intention of pregnant mothers to get vaccinated against Influenza and Tdap? How does demographic factors, attitudes and barriers affect vaccination decisions among pregnant mothers?
Read more
Researchers will compare InTroDuce-Programme to standard care (routine antenatal care) to see if InTroDuce-Programme works to improve knowledge and future intention of pregnant mothers to be vaccinated against Influenza and Tdap. Participants will:
Receive the web-based educational module (InTroDuce-Programme), which covers the importance, safety, and effectiveness of vaccinations, as well as addressing common concerns.
Be followed up one month after the intervention. Answer questionnaires before and after the intervention to measure changes in vaccination knowledge and future intention to get vaccinated
Read the detailed description
1.0 Background and Significance
Maternal vaccination is a crucial public health strategy to protect mothers and infants from infectious diseases like influenza and pertussis. Pregnant women face higher risks of complications due to physiological and immunological changes, with a fourfold increased likelihood of influenza-related hospitalization. Similarly, pertussis is particularly severe in infants under two months. In Malaysia, the Ministry of Health recommends influenza and Tdap vaccines during pregnancy, but uptake remains low due to safety concerns, limited provider recommendations, and access issues. Digital interventions, particularly video-based education, have shown promise in addressing vaccine hesitancy. To tackle these barriers, the InTroDuce-Programme, a comprehensive web-based educational module, has been developed to improve vaccination knowledge and uptake.
2.0 Objective
General objective: To evaluate the effectiveness of the InTroDuce-Programme in improving knowledge and future uptake of influenza and Tdap vaccination among pregnant mothers.
Specific objectives:
- To determine the sociodemographic factors and clinical variables among study population.
- To determine the prevalence of future vaccination uptake following the InTroDuce-Programme.
- To evaluate the level of participants' attitudes and barriers towards future vaccination uptake before and after the InTroDuce-Programme.
- To determine the effectiveness of the InTroDuce-Programme in improving knowledge and future uptake of influenza and Tdap vaccination among pregnant mothers.
- To determine the factors associated with low future uptake of vaccine with socio-demographic factors (age, race, income, education) among pregnant mothers.
3.0 Methodology
3.1 Study Design
This randomised controlled trial (RCT) will be conducted in four primary care clinics in Hulu Langat district which are Klinik Kesihatan Kajang, Klinik Kesihatan Bangi, Klinik Kesihatan Batu 9 and Klinik Kesihatan Balakong. The study duration is 12 months, with recruitment over 6 months. A second follow-up will be conducted one month after providing the InTroDuce-Programme. Two clinics will be randomly assigned to administer the InTroDuce-Programme, while the other two will be provided with standard care, in order to minimise contamination.
Cluster definition based on urban and suburban classification Klinik Kesihatan Kajang and Klinik Kesihatan Bangi are classified as urban, while Klinik Kesihatan Batu 9 and Klinik Kesihatan Balakong are classified as suburban. These clinics were selected due to their geographic and demographic similarity, coupled with variability in socioeconomic, educational, cultural, and attitudinal factors. This selection ensures a balanced representation of diverse populations, enhancing the generalizability and applicability of the study findings. The approach is particularly valuable for comprehensively understanding the factors that influence vaccine knowledge and uptake among pregnant mothers.
Random Allocation of Clinics Random Assignment: One clinic from each category (urban and suburban) will be randomly assigned to either the intervention or control group using an online random number generator. This method ensures unbiased allocation and maintains the balance of geographic representation in both groups.
The rationale for Randomization is to minimise contamination. Randomizing at the clinic level (cluster randomization) rather than at the individual level will help reduce the risk of contamination, where participants in the same clinic may share information or influence each other's behaviour. By assigning entire clinics to either intervention or control, the study ensures that participants within each clinic receive consistent and isolated exposure to the educational materials or standard care.
3.2 Sample Size
The sample size is 351 participants, accounting for a 20% non-response rate. This is based on expected uptake rates of 55% in the intervention group and 36% in the control group.
3.3 Data Collection
A validated, adapted questionnaire will be used in this study to assess vaccine-related knowledge, attitudes, future uptake intentions, and factors influencing vaccination decisions.
3.4 Statistical Analysis
Primary Outcome: Knowledge improvement, analyzed via paired t-tests or Mann-Whitney U tests.
Secondary Outcomes: Logistic regression for factors associated with low uptake intentions.
- Conditions
- Vaccination Uptake, Knowledge, Tetanus, Diphtheria and Acellular Pertussis Vaccination, Influenza, Web Based Intervention, Vaccine Knowledge
- Being tested
- Influenza and Tdap Vaccination Educational and Learning Module
- Keywords
- Influenza vaccination, Tdap vaccination, Educational module, Pregnant mothers, Vaccine knowledge, Vaccine uptake
- Medical subject headings
- Tetanus, Diphtheria, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Influenza and Tdap Vaccination Educational and Learning ModuleBehavioural
Influenza and Tdap learning and educational module delivered via website. The module will cover importance of vaccination for both pregnant women and infant, safety and efficacy of the influenza and TdaP vaccines, timing of vaccination, and addressing common concerns and misconceptions.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Standard antenatal care |
| Intervention | Experimental | Influenza and Tdap Vaccination Web-based Educational and Learning Module (InTroDuce-Programme) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge of Influenza and Tdap Vaccination
knowledge score about the importance, safety, and benefits of vaccination (vaccine literacy) will be assessed through pre- and post-intervention questionnaire
Measured: 1 month post-intervention
Vaccination Future Uptake
Intention of future vaccine uptake of the influenza and Tdap vaccines will be assessed using questionnaire
Measured: 1 month post-intervention
Secondary outcomes (1)
Barriers to vaccination uptake
Identification of barriers to vaccination uptake and socio-demographic factors influencing outcomes.
Measured: 1 month post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start13 Jan 2026
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Vaccination UptakeStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- web-based educational video on Influenza and Tdap vaccine (InTroDuce-Programme)
- Masking
- None (open label)
- Enrolment
- 351 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Putra Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lau Hung Chiun, Universiti Putra Malaysia
- Investigators
- Hung Chiun Lau, Dr Fam Med, Principal investigator, Universiti Putra Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06815250
- Sponsor's protocol ID
- InTroDuce-Programme
- Status last verified
- Apr 2026
- First submitted
- 3 Feb 2025
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
O'Leary ST, Narwaney KJ, Wagner NM, Kraus CR, Omer SB, Glanz JM. Efficacy of a Web-Based Intervention to Increase Uptake of Maternal Vaccines: An RCT. Am J Prev Med. 2019 Oct;57(4):e125-e133. doi: 10.1016/j.amepre.2019.05.018. Epub 2019 Aug 27.
PubMed 31471001Deverall EJ, Gilmore B, Illing S, Peiris-John R. Pertussis vaccination uptake in pregnancy: lessons to be learned from an integrated healthcare approach. N Z Med J. 2018 Apr 13;131(1473):42-47.
PubMed 29649195Dawood FS, Kittikraisak W, Patel A, Rentz Hunt D, Suntarattiwong P, Wesley MG, Thompson MG, Soto G, Mundhada S, Arriola CS, Azziz-Baumgartner E, Brummer T, Cabrera S, Chang HH, Deshmukh M, Ellison D, Florian R, Gonzales O, Kurhe K, Kaoiean S, Rawangban B, Lindstrom S, Llajaruna E, Mott JA, Saha S, Prakash A, Mohanty S, Sinthuwattanawibool C, Tinoco Y. Incidence of influenza during pregnancy and association with pregnancy and perinatal outcomes in three middle-income countries: a multisite prospective longitudinal cohort study. Lancet Infect Dis. 2021 Jan;21(1):97-106. doi: 10.1016/S1473-3099(20)30592-2. Epub 2020 Oct 29.
PubMed 33129424Hong EY, Kulkarni K, Gosavi A, Wong HC, Singh K, Kale AS. Assessment of knowledge and attitude towards influenza and pertussis vaccination in pregnancy and factors affecting vaccine uptake rates: a cross-sectional survey. Singapore Med J. 2023 Aug;64(8):513-516. doi: 10.11622/smedj.2021097. No abstract available.
PubMed 34544209Razai MS, Mansour R, Goldsmith L, Freeman S, Mason-Apps C, Ravindran P, Kooner P, Berendes S, Morris J, Majeed A, Ussher M, Hargreaves S, Oakeshott P. Interventions to increase vaccination against COVID-19, influenza and pertussis during pregnancy: a systematic review and meta-analysis. J Travel Med. 2023 Dec 28;30(8):taad138. doi: 10.1093/jtm/taad138.
PubMed 37934788Kilich E, Dada S, Francis MR, Tazare J, Chico RM, Paterson P, Larson HJ. Factors that influence vaccination decision-making among pregnant women: A systematic review and meta-analysis. PLoS One. 2020 Jul 9;15(7):e0234827. doi: 10.1371/journal.pone.0234827. eCollection 2020.
PubMed 32645112Racicot K, Mor G. Risks associated with viral infections during pregnancy. J Clin Invest. 2017 May 1;127(5):1591-1599. doi: 10.1172/JCI87490. Epub 2017 May 1.
PubMed 28459427Arora M, Lakshmi R. Vaccines - safety in pregnancy. Best Pract Res Clin Obstet Gynaecol. 2021 Oct;76:23-40. doi: 10.1016/j.bpobgyn.2021.02.002. Epub 2021 Feb 19.
PubMed 33773923Merdrignac L, Acosta L, Habington A, Garcia Cenoz M, Pandolfi E, Fabianova K, Jordan I, O'Sullivan N, Navasues A, Tozzi AE, Zavadilova J, Jane M, Cotter S, Pitillas NI, Rizzo C, Krizova P, Hanslik T, Munoz Almagro C, Pastore L, Bacci S, Moren A, Valenciano M; PERTINENT Group. Effectiveness of pertussis vaccination in pregnancy to prevent hospitalisation in infants aged <2 months and effectiveness of both primary vaccination and mother's vaccination in pregnancy in infants aged 2-11 months. Vaccine. 2022 Oct 19;40(44):6374-6382. doi: 10.1016/j.vaccine.2022.09.054. Epub 2022 Sep 29.
PubMed 36182617Razai MS, Mansour R, Ravindran P, Freeman S, Mason-Apps C, Morris J, Majeed A, Ussher M, Hargreaves S, Oakeshott P. Facilitators and barriers to vaccination uptake in pregnancy: A qualitative systematic review. PLoS One. 2024 Apr 19;19(4):e0298407. doi: 10.1371/journal.pone.0298407. eCollection 2024.
PubMed 38640190Razai MS, Chaudhry UAR, Doerholt K, Bauld L, Majeed A. Covid-19 vaccination hesitancy. BMJ. 2021 May 20;373:n1138. doi: 10.1136/bmj.n1138. No abstract available.
PubMed 34016653Parsons J, Griffiths SE, Thomas N, Atherton H. How effective are digital interventions in increasing flu vaccination among pregnant women? A systematic review and meta-analysis. J Public Health (Oxf). 2022 Dec 1;44(4):863-876. doi: 10.1093/pubmed/fdab220.
PubMed 34164686Lau HC, Sekawi Z, Ching SM, Abu Bakar N, Dapari R, Mohamed Alias SR, Talib NH, Dzulkifli IH, Md Alwi N, Abdul Hamid H, Mat Din H. Effectiveness of the influenza and Tdap vaccination educational module (InTroDuce-Programme) on knowledge and intention for antenatal vaccination: A cluster randomised controlled trial protocol among pregnant women in Malaysian primary care clinics. PLoS One. 2026 Mar 12;21(3):e0344651. doi: 10.1371/journal.pone.0344651. eCollection 2026.
PubMed 41818225
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Influenza and Tdap (Tetanus, Diphtheria, Acellular Pertussis) Vaccination Educational and Learning Module (InTroDuce-Programme) in Improving Knowledge and Future Uptake of Vaccination Among Pregnant Mothers in Primary Care Clinics: A Randomised Control Trial Secondary IDs
- ClinicalTrials.gov ID
- NCT06815250
- Acronym / sponsor ID
- InTroDuce-Programme
- Conditions
- Vaccination Uptake, Knowledge, Tetanus, Diphtheria and Acellular Pertussis Vaccination, Influenza, Web Based Intervention, Vaccine Knowledge
- Keywords
- Influenza vaccination, Tdap vaccination, Educational module, Pregnant mothers, Vaccine knowledge, Vaccine uptake
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 351 participants (estimated)
- Lead sponsor
- Universiti Putra MalaysiaUniversity, hospital or other
- Study start
- 13 Jan 2026 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 7 Feb 2025 (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.
The goal of this InTroDuce-Programme interventional trial aims to test whether a web-based educational program can improve pregnant women's knowledge about Influenza and Tdap vaccinations and increase their intention to get vaccinated in the future. The main questions it aims to answer are:
Does the InTroDuce-Programme increase knowledge and future intention of pregnant mothers to get vaccinated against Influenza and Tdap? How does demographic factors, attitudes and barriers affect vaccination decisions among pregnant mothers?
Researchers will compare InTroDuce-Programme to standard care (routine antenatal care) to see if InTroDuce-Programme works to improve knowledge and future intention of pregnant mothers to be vaccinated against Influenza and Tdap. Participants will:
Receive the web-based educational module (InTroDuce-Programme), which covers the importance, safety, and effectiveness of vaccinations, as well as addressing common concerns.
Be followed up one month after the intervention. Answer questionnaires before and after the intervention to measure changes in vaccination knowledge and future intention to get vaccinated
Detailed description
1.0 Background and Significance
Maternal vaccination is a crucial public health strategy to protect mothers and infants from infectious diseases like influenza and pertussis. Pregnant women face higher risks of complications due to physiological and immunological changes, with a fourfold increased likelihood of influenza-related hospitalization. Similarly, pertussis is particularly severe in infants under two months. In Malaysia, the Ministry of Health recommends influenza and Tdap vaccines during pregnancy, but uptake remains low due to safety concerns, limited provider recommendations, and access issues. Digital interventions, particularly video-based education, have shown promise in addressing vaccine hesitancy. To tackle these barriers, the InTroDuce-Programme, a comprehensive web-based educational module, has been developed to improve vaccination knowledge and uptake.
2.0 Objective
General objective: To evaluate the effectiveness of the InTroDuce-Programme in improving knowledge and future uptake of influenza and Tdap vaccination among pregnant mothers.
Specific objectives:
- To determine the sociodemographic factors and clinical variables among study population.
- To determine the prevalence of future vaccination uptake following the InTroDuce-Programme.
- To evaluate the level of participants' attitudes and barriers towards future vaccination uptake before and after the InTroDuce-Programme.
- To determine the effectiveness of the InTroDuce-Programme in improving knowledge and future uptake of influenza and Tdap vaccination among pregnant mothers.
- To determine the factors associated with low future uptake of vaccine with socio-demographic factors (age, race, income, education) among pregnant mothers.
3.0 Methodology
3.1 Study Design
This randomised controlled trial (RCT) will be conducted in four primary care clinics in Hulu Langat district which are Klinik Kesihatan Kajang, Klinik Kesihatan Bangi, Klinik Kesihatan Batu 9 and Klinik Kesihatan Balakong. The study duration is 12 months, with recruitment over 6 months. A second follow-up will be conducted one month after providing the InTroDuce-Programme. Two clinics will be randomly assigned to administer the InTroDuce-Programme, while the other two will be provided with standard care, in order to minimise contamination.
Cluster definition based on urban and suburban classification Klinik Kesihatan Kajang and Klinik Kesihatan Bangi are classified as urban, while Klinik Kesihatan Batu 9 and Klinik Kesihatan Balakong are classified as suburban. These clinics were selected due to their geographic and demographic similarity, coupled with variability in socioeconomic, educational, cultural, and attitudinal factors. This selection ensures a balanced representation of diverse populations, enhancing the generalizability and applicability of the study findings. The approach is particularly valuable for comprehensively understanding the factors that influence vaccine knowledge and uptake among pregnant mothers.
Random Allocation of Clinics Random Assignment: One clinic from each category (urban and suburban) will be randomly assigned to either the intervention or control group using an online random number generator. This method ensures unbiased allocation and maintains the balance of geographic representation in both groups.
The rationale for Randomization is to minimise contamination. Randomizing at the clinic level (cluster randomization) rather than at the individual level will help reduce the risk of contamination, where participants in the same clinic may share information or influence each other's behaviour. By assigning entire clinics to either intervention or control, the study ensures that participants within each clinic receive consistent and isolated exposure to the educational materials or standard care.
3.2 Sample Size
The sample size is 351 participants, accounting for a 20% non-response rate. This is based on expected uptake rates of 55% in the intervention group and 36% in the control group.
3.3 Data Collection
A validated, adapted questionnaire will be used in this study to assess vaccine-related knowledge, attitudes, future uptake intentions, and factors influencing vaccination decisions.
3.4 Statistical Analysis
Primary Outcome: Knowledge improvement, analyzed via paired t-tests or Mann-Whitney U tests.
Secondary Outcomes: Logistic regression for factors associated with low uptake intentions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- web-based educational video on Influenza and Tdap vaccine (InTroDuce-Programme)
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Standard antenatal care |
| Intervention | Experimental | –Influenza and Tdap Vaccination Web-based Educational and Learning Module (InTroDuce-Programme) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pregnant women aged 18 years and older
- Before or equal to 32 weeks of gestation as we need to follow-up the patients again at 36 weeks of gestation before delivery occurs.
- Able to understand and consent to participation in the study.
Key exclusion criteria (2 listed)
- Pregnant women with severe anaphylactic or allergic reactions to previous dose of influenza or Tdap vaccination.
- Non-Malaysian
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 and Tdap Vaccination Educational and Learning ModuleInfluenza and Tdap learning and educational module delivered via website. The module will cover importance of vaccination for both pregnant women and infant, safety and efficacy of the influenza and TdaP vaccines, timing of vaccination, and addressing common concerns and misconceptions. | Behavioural | – |
Primary outcome
Knowledge of Influenza and Tdap Vaccination
Time frame: 1 month post-intervention
knowledge score about the importance, safety, and benefits of vaccination (vaccine literacy) will be assessed through pre- and post-intervention questionnaire
Vaccination Future Uptake
Time frame: 1 month post-intervention
Intention of future vaccine uptake of the influenza and Tdap vaccines will be assessed using questionnaire
1 secondary outcome
Barriers to vaccination uptake
Time frame: 1 month post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Background: PubMed 31471001O'Leary ST, Narwaney KJ, Wagner NM, Kraus CR, Omer SB, Glanz JM. Efficacy of a Web-Based Intervention to Increase Uptake of Maternal Vaccines: An RCT. Am J Prev Med. 2019 Oct;57(4):e125-e133. doi: 10.1016/j.amepre.2019.05.018. Epub 2019 Aug 27.
- Background: PubMed 29649195Deverall EJ, Gilmore B, Illing S, Peiris-John R. Pertussis vaccination uptake in pregnancy: lessons to be learned from an integrated healthcare approach. N Z Med J. 2018 Apr 13;131(1473):42-47.
- Background: PubMed 33129424Dawood FS, Kittikraisak W, Patel A, Rentz Hunt D, Suntarattiwong P, Wesley MG, Thompson MG, Soto G, Mundhada S, Arriola CS, Azziz-Baumgartner E, Brummer T, Cabrera S, Chang HH, Deshmukh M, Ellison D, Florian R, Gonzales O, Kurhe K, Kaoiean S, Rawangban B, Lindstrom S, Llajaruna E, Mott JA, Saha S, Prakash A, Mohanty S, Sinthuwattanawibool C, Tinoco Y. Incidence of influenza during pregnancy and association with pregnancy and perinatal outcomes in three middle-income countries: a multisite prospective longitudinal cohort study. Lancet Infect Dis. 2021 Jan;21(1):97-106. doi: 10.1016/S1473-3099(20)30592-2. Epub 2020 Oct 29.
- Background: PubMed 34544209Hong EY, Kulkarni K, Gosavi A, Wong HC, Singh K, Kale AS. Assessment of knowledge and attitude towards influenza and pertussis vaccination in pregnancy and factors affecting vaccine uptake rates: a cross-sectional survey. Singapore Med J. 2023 Aug;64(8):513-516. doi: 10.11622/smedj.2021097. No abstract available.
- Background: PubMed 37934788Razai MS, Mansour R, Goldsmith L, Freeman S, Mason-Apps C, Ravindran P, Kooner P, Berendes S, Morris J, Majeed A, Ussher M, Hargreaves S, Oakeshott P. Interventions to increase vaccination against COVID-19, influenza and pertussis during pregnancy: a systematic review and meta-analysis. J Travel Med. 2023 Dec 28;30(8):taad138. doi: 10.1093/jtm/taad138.
- Background: PubMed 32645112Kilich E, Dada S, Francis MR, Tazare J, Chico RM, Paterson P, Larson HJ. Factors that influence vaccination decision-making among pregnant women: A systematic review and meta-analysis. PLoS One. 2020 Jul 9;15(7):e0234827. doi: 10.1371/journal.pone.0234827. eCollection 2020.
- Background: PubMed 28459427Racicot K, Mor G. Risks associated with viral infections during pregnancy. J Clin Invest. 2017 May 1;127(5):1591-1599. doi: 10.1172/JCI87490. Epub 2017 May 1.
- Background: PubMed 33773923Arora M, Lakshmi R. Vaccines - safety in pregnancy. Best Pract Res Clin Obstet Gynaecol. 2021 Oct;76:23-40. doi: 10.1016/j.bpobgyn.2021.02.002. Epub 2021 Feb 19.
- Background: PubMed 36182617Merdrignac L, Acosta L, Habington A, Garcia Cenoz M, Pandolfi E, Fabianova K, Jordan I, O'Sullivan N, Navasues A, Tozzi AE, Zavadilova J, Jane M, Cotter S, Pitillas NI, Rizzo C, Krizova P, Hanslik T, Munoz Almagro C, Pastore L, Bacci S, Moren A, Valenciano M; PERTINENT Group. Effectiveness of pertussis vaccination in pregnancy to prevent hospitalisation in infants aged <2 months and effectiveness of both primary vaccination and mother's vaccination in pregnancy in infants aged 2-11 months. Vaccine. 2022 Oct 19;40(44):6374-6382. doi: 10.1016/j.vaccine.2022.09.054. Epub 2022 Sep 29.
- Background: PubMed 38640190Razai MS, Mansour R, Ravindran P, Freeman S, Mason-Apps C, Morris J, Majeed A, Ussher M, Hargreaves S, Oakeshott P. Facilitators and barriers to vaccination uptake in pregnancy: A qualitative systematic review. PLoS One. 2024 Apr 19;19(4):e0298407. doi: 10.1371/journal.pone.0298407. eCollection 2024.
- Background: PubMed 34016653Razai MS, Chaudhry UAR, Doerholt K, Bauld L, Majeed A. Covid-19 vaccination hesitancy. BMJ. 2021 May 20;373:n1138. doi: 10.1136/bmj.n1138. No abstract available.
- Background: PubMed 34164686Parsons J, Griffiths SE, Thomas N, Atherton H. How effective are digital interventions in increasing flu vaccination among pregnant women? A systematic review and meta-analysis. J Public Health (Oxf). 2022 Dec 1;44(4):863-876. doi: 10.1093/pubmed/fdab220.
- PERINATAL CARE MANUAL 4th EDITION. Ministry of Health. 2022Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Not yet recruiting
Tailored Vaccine Messaging for Parents/Caregivers of Adolescents
Vaccine Confidence, Adolescent Vaccination
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.
Hung Chiun Lau, Dr Fam Med principal investigator
Universiti Putra Malaysia
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 and Tdap Vaccination Educational and Learning Module in people with Vaccination Uptake and Knowledge, run by Universiti Putra Malaysia at 4 sites in Malaysia.
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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 1 May 2026. 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 Malaysia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hung Chiun Lau, Dr Fam Med (+60163502549, hungchiun@upm.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge of Influenza and Tdap Vaccination (time frame: 1 month post-intervention). 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 NCT06815250, which also lists 13 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 1 May 2026.