A Phase 4 interventional study of Meningococcal B and High-Dose TIV in Healthy, sponsored by Canadian Immunization Research Network. Completed at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-16.
Sponsored by Canadian Immunization Research Network · Phase 4, Interventional, and Health services research
This project proposes to implement and compare new community pharmacy-based strategies for improving vaccine coverage.
Although there are many safe and effective vaccines for adults, the Public Health Agency of Canada has noted that public perception of vaccination is that it is primarily for infants and children. The National Advisory Committee on Immunization (NACI) recommends adults and adolescents receive the influenza vaccine, tetanus-diphtheria-acellular pertussis vaccine (Tdap), and meningococcal vaccines (MenACWY, 4CMenB). As well, NACI recommends that people 60 years or older receive the herpes zoster vaccine and that Canadians who travel to high-risk areas should consider getting vaccinated to protect themselves against travel-related illnesses, such as Hepatitis A and Typhoid Fever. While NACI makes recommendations, provinces and territories (P/Ts) determine if they will fund and implement vaccine programs. Unlike the childhood immunization programs which tend to be funded by P/Ts, many adult vaccines are unfunded, resulting in poor population uptake. In this project,the investigators propose to implement and compare new community pharmacy-based strategies for improving vaccine coverage.
Patients are typically educated about preventative health care during face-to-face visits with physicians in office settings. The ability to educate and deliver preventative health care is limited by the available provider time during office visits - providers often focus on acute needs and current disease management. New delivery models and a means of extending preventative health care delivery outside of traditional face-to-face office visits are needed.
Pharmacists are in a unique position of being among the most accessible of health professionals. Given their extended operating hours, accessibility, and established trust with patients, pharmacists are well-positioned to improve vaccination rates and health system efficacy through injection administration.
Vaccine coverage rates will be measured using the following:
Intervention communities include Saint John, New Brunswick and New Glasgow/Pictou/Antigonish, Nova Scotia area, which include the smaller towns of Stellarton and Westville, Nova Scotia. Control communities include Moncton, New Brunswick and Kentville/New Minas/Wolfville, Nova Scotia, which include the smaller towns of Canning and Coldbrook, Nova Scotia.
Canadian Immunization Research Network is the lead sponsor of 11 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion criteria:
Exclusion criteria: Not meeting inclusion criteria
There are four communities involved in the study, two in New Brunswick and two in Nova Scotia. All pharmacies in each community will be allocated to one intervention. Interventions include: High-Dose TIV, Meningococcal B Vaccine, Meningococcal ACWY vaccine, Tdap, Herpes Zoster vaccine and Travel Health vaccines (Hepatitis A, Hepatitis B, Typhoid Fever).
Biological: Meningococcal B · Biological: High-Dose TIV · Biological: Tdap (tetanus-diphtheria-acellular pertussis) · Biological: Meningococcal ACWY · Biological: Herpes Zoster · Biological: Travel Health (Hepatitis A, Hepatitis B, Typhoid Fever)
Bexsero is indicated for active immunisation of individuals from 2 months of age and older against invasive meningococcal disease caused by Neisseria meningitidis group B.
Also known as: Bexsero
Fluzone High-Dose is an injectable influenza vaccine made to protect against the flu strains most likely to cause illness for that particular flu season.
Also known as: FluZone
Tdap is a combination vaccine that protects against three potentially life-threatening bacterial diseases: tetanus, diphtheria, and pertussis (whooping cough).
Meningococcal ACWY vaccine is indicated for active immunization of individuals up to 55 years of age against invasive meningococcal diseases caused by Neisseria meningitides serogroups A, C, W-135 and Y.
Herpes zoster vaccine is indicated for the immunization of individuals 50 years of age or older for the prevention of herpes zoster (shingles).
Hepatitis A vaccine is indicated for immunization against infections caused by hepatitis A virus; Hepatitis B vaccine is indicated for immunization against infection caused by hepatitis B virus; and typhoid fever vaccine is indicated for active immunization against Salmonella typhi, the organism which causes typhoid fever.
Number of Vaccines Administered by Participating Pharmacies in the Intervention and Non-intervention Communities Before and During the Intervention.
A 2-year demonstration program was conducted in two Canadian provinces (New Brunswick and Nova Scotia). One community in each province served as the intervention community, where pharmacies were allocated to implement various strategies specifically designed for each of the target vaccines. One community in each province also served as the non-intervention community, where immunization practice continued unchanged. Vaccine uptake was compared using pharmacy-generated reports of the number of vaccine doses administered before (from September 2015 to August 2017) and during (September 2017 to November 2019) the intervention and between non-intervention and intervention pharmacies.
Time frame: At the time of vaccination, 1 day over two years from September 2017 to November 2019.
Compare the Number of Flu Vaccine Recipients Who Were Recruited and Completed the Online AEFI Survey Among Intervention Pharmacies Using Active Recruitment Strategies and the Non-intervention Pharmacies Using Passive Recruitment Strategies.
Recipients of a flu vaccine in the intervention communities were actively recruited to participate in the CANVAS survey by the intervention pharmacists who handed out information sheets and/or pointed to the QR code to sign up for the survey, while flu vaccine recipients in the non-intervention pharmacies were passively recruited through posters with the QR code displayed in waiting areas without telling them about the study. Note: For this secondary outcome, "recruited" means anyone who signed up for the survey but may not have necessarily completed the survey. The number of flu vaccine recipients who were actively recruited in the intervention pharmacies or passively recruited in the non-intervention pharmacies were compared to assess the effectiveness of the active versus passive recruitment approach.
Time frame: At the time of survey recruitment, 1 day over the 5-month period the surveys remained open during the influenza seasons
Determining the Awareness About Pharmacists as Immunizers and Vaccination Behaviours of the Targeted Public Using Pre-intervention and Post-intervention Knowledge, Attitudes, Beliefs and Behaviours (KABB) Surveys
As part of the pre- and post-KABB surveys, participants were asked questions regarding their awareness about pharmacists as immunizers and their vaccination behaviour. Questions related to their awareness about pharmacists as immunizers were "Are you aware that many pharmacists are trained to administer vaccines? (Yes or No)" and "Which of the following vaccines are currently administered by pharmacists in a pharmacy? (Check all that apply)". Questions related to their vaccination behaviour were "Did you get or have you ever received... (the following vaccines)?" \[Note: Those who answered 'Yes' to these yes/no questions are presented below\]
Time frame: At the time of survey administration, 1 day over the 9-month period each of the surveys remained open
Determining the Attitudes and Beliefs of the Targeted Public About Pharmacists as Immunizers Using Pre-intervention and Post-intervention Knowledge, Attitudes, Beliefs, and Behaviours (KABB) Surveys
As part of the pre- and post-KABB surveys, participants were asked to indicate how much they agree/disagree with a list of statements about their attitudes and beliefs about pharmacists as immunizers: "Please indicate how much you agree or disagree with the following statements by clicking the box that best fits your opinion". \[Note: Those who answered 'agree' are presented below\].
Time frame: At the time of survey administration, 1 day over the 9-month period each of the surveys remained open
Determining the Awareness of the National Advisory Committee on Immunization (NACI) Guidelines and the Vaccinating Behaviors of Healthcare Providers Through Pre-intervention and Post-intervention Knowledge, Attitudes, Beliefs and Behaviors (KABB) Surveys
As part of the pre- and post-KABB surveys, healthcare providers were asked about their awareness of NACI recommendations and about their vaccinating behaviour. The questions for their awareness of NACI recommendations were "Are you aware that the Canadian guidelines (NACI) recommends/indicates (the following vaccines)". The questions about their vaccinating behaviour was "Do you offer/discuss/recommend (the following vaccines) according to NACI guidelines?" \[Note: Those who answered 'Yes' to these yes/no questions are presented below\]
Time frame: At the time of survey administration, 1 day over the 9-month period each of the surveys remained open
Determining the Attitudes and Beliefs of Healthcare Providers Regarding Pharmacists as Immunizers Using Pre-intervention and Post-intervention Knowledge, Attitudes, Beliefs, and Behaviours (KABB) Surveys
As part of the pre- and post-KABB surveys, healthcare providers were asked about their attitudes and beliefs about pharmacists as immunizers. The questions were: "Where do you think vaccines should be administered? (Check all that apply)" \[Note: those who selected 'family doctor's office', 'public health clinic', and/or 'pharmacy' as the locations are presented below\]; and "Please indicate how much you agree or disagree with the following statements by clicking the box that best fits your opinion?" \[Note: Those who answered 'agree' are presented below\].
Time frame: At the time of survey administration, 1 day over the 9-month period each of the surveys remained open
Pharmacies were recruited from four communities in Nova Scotia and New Brunswick, Canada. One community in each province served as the intervention community, where community pharmacies were allocated to implement various strategies designed for each of the target vaccines. One community in each province also served as the non-intervention community, where immunization practice continued unchanged. Intervention and non-intervention pharmacies were assigned to each group rather than participants.
| Milestone | Intervention Communities | Non-Intervention Communities |
|---|---|---|
| Started | NA | NA |
| Completed | NA | NA |
| Not completed | NA | NA |
A 2-year demonstration program was conducted in two Canadian provinces (New Brunswick and Nova Scotia). One community in each province served as the intervention community, where pharmacies were allocated to implement various strategies specifically designed for each of the target vaccines. One community in each province also served as the non-intervention community, where immunization practice continued unchanged. Vaccine uptake was compared using pharmacy-generated reports of the number of vaccine doses administered before (from September 2015 to August 2017) and during (September 2017 to November 2019) the intervention and between non-intervention and intervention pharmacies.
| Number of vaccines administered | Intervention Communities | Non-Intervention Communities |
|---|---|---|
| Number of vaccines administered before the intervention (from September 2015 to August 2017) | 3,093 | 5,011 |
| Number of vaccines administered during the intervention (September 2017 to November 2019) | 6,149 | 5,922 |
Recipients of a flu vaccine in the intervention communities were actively recruited to participate in the CANVAS survey by the intervention pharmacists who handed out information sheets and/or pointed to the QR code to sign up for the survey, while flu vaccine recipients in the non-intervention pharmacies were passively recruited through posters with the QR code displayed in waiting areas without telling them about the study. Note: For this secondary outcome, "recruited" means anyone who signed up for the survey but may not have necessarily completed the survey. The number of flu vaccine recipients who were actively recruited in the intervention pharmacies or passively recruited in the non-intervention pharmacies were compared to assess the effectiveness of the active versus passive recruitment approach.
| Participants | Intervention Communities | Non-Intervention Communities |
|---|---|---|
| Compare the Number of Flu Vaccine Recipients Who Were Recruited and Completed the Online AEFI Survey Among Intervention Pharmacies Using Active Recruitment Strategies and the Non-intervention Pharmacies Using Passive Recruitment Strategies. | 221 | 8 |
As part of the pre- and post-KABB surveys, participants were asked questions regarding their awareness about pharmacists as immunizers and their vaccination behaviour. Questions related to their awareness about pharmacists as immunizers were "Are you aware that many pharmacists are trained to administer vaccines? (Yes or No)" and "Which of the following vaccines are currently administered by pharmacists in a pharmacy? (Check all that apply)". Questions related to their vaccination behaviour were "Did you get or have you ever received... (the following vaccines)?" \[Note: Those who answered 'Yes' to these yes/no questions are presented below\]
| Participants | Pre-Intervention Knowledge, Attitudes, Beliefs and Behaviours (KABB) Surveys (Public) | Post-Intervention Knowledge, Attitudes, Beliefs & Behaviours (KABB) Surveys (Public) |
|---|---|---|
| Aware that pharmacists are trained to vaccinate | 850 | 852 |
| Awareness of pharmacists' ability to administer influenza vaccine | 724 | 680 |
| Awareness of pharmacists' ability to administer Tdap vaccine | 166 | 122 |
| Awareness of pharmacists' ability to administer Men ACWY vaccine | 113 | 89 |
| Awareness of pharmacists' ability to administer MenB vaccine | 113 | 86 |
| Awareness of pharmacists' ability to administer travel vaccines (hep A, hep B, typhoid vaccines) | NA | 327 |
| Awareness of pharmacists' ability to administer herpes zoster (shingles) | NA | 249 |
| Get the influenza vaccine | 510 | 610 |
| Ever received Men C or Men ACWY vaccine | 374 | 248 |
| Ever received Men B vaccine (contingency question for participants between 18-24 years old) | 160 | 123 |
| Ever received Tdap vaccine | 765 | 411 |
| Ever received high-dose influenza vaccine (contingency question for participants 65 years or older) | 4 | 12 |
| Ever received vaccines for travel (hep A, hep B, typhoid vaccines) | NA | 530 |
| Ever received herpes zoster (shingles) vaccine (contingency question for participants 50+) | NA | 100 |
| Received all vaccines recommended for adults | 501 | 421 |
| Ever received a vaccination by a pharmacist in a pharmacy | 384 | 557 |
As part of the pre- and post-KABB surveys, participants were asked to indicate how much they agree/disagree with a list of statements about their attitudes and beliefs about pharmacists as immunizers: "Please indicate how much you agree or disagree with the following statements by clicking the box that best fits your opinion". \[Note: Those who answered 'agree' are presented below\].
| Participants | Pre-Intervention Knowledge, Attitudes, Beliefs and Behaviours (KABB) Surveys (Public) | Post-Intervention Knowledge, Attitudes, Beliefs & Behaviours (KABB) Surveys (Public) |
|---|---|---|
| I feel comfortable receiving my vaccines from a pharmacist | 739 | 772 |
| It is convenient for me to receive my vaccines from my pharmacist | 696 | 717 |
| I think pharmacists have enough training to give vaccines | 756 | 780 |
| I would feel more comfortable receiving my vaccines in a pharmacy if my physician recommended it | 458 | 337 |
| I would feel more comfortable receiving my vaccines in a pharmacy if a PH nurse recommended it | 385 | 290 |
| I would get a vaccine if it was recommended by a doctor | NA | 772 |
| I would get a vaccine if it was recommended by a nurse | NA | 738 |
| I would get a vaccine if it was recommended by a pharmacist | NA | 692 |
As part of the pre- and post-KABB surveys, healthcare providers were asked about their awareness of NACI recommendations and about their vaccinating behaviour. The questions for their awareness of NACI recommendations were "Are you aware that the Canadian guidelines (NACI) recommends/indicates (the following vaccines)". The questions about their vaccinating behaviour was "Do you offer/discuss/recommend (the following vaccines) according to NACI guidelines?" \[Note: Those who answered 'Yes' to these yes/no questions are presented below\]
| Participants | Pre-Intervention Knowledge, Attitudes, Beliefs and Behaviours (KABB) Surveys (Healthcare Providers) | Post-Intervention Knowledge, Attitudes, Beliefs & Behaviours (KABB) Surveys (Healthcare Providers) |
|---|---|---|
| Awareness that NACI recommends that adults receive vaccine for protection against influenza | 201 | 163 |
| Awareness that NACI recommends that older adults (65+) receive a high-dose influenza vaccine | 149 | 140 |
| Awareness that NACI recommends healthy adolescents/young adults receive vaccine for MenACWY | 152 | 133 |
| Awareness that NACI indicates that healthy adolescents/young adults may receive vaccine for MenB | 112 | 97 |
| Awareness that NACI recommends that adults receive vaccination for protection against whooping cough | 163 | 143 |
| Awareness that CATMAT recommends adults receive travel vaccines depending on where they travel | NA | 161 |
| Awareness that NACI recommend that adults 50+ receive a vaccine for protection against shingles | NA | 139 |
| Discuss the option of receiving the MenB vaccine with eligible adolescents | 41 | 50 |
| Recommend that all adolescents who did not get the MenACWY vaccine through school get it | 55 | 66 |
| Routinely offer all eligible adults the Tdap vaccine | 79 | 93 |
| Offer all eligible adults travel vaccines (Hep A, Hep B, typhoid) according to CATMAT guidelines | NA | 121 |
| Offer all eligible adults the shingles vaccines | NA | 132 |
As part of the pre- and post-KABB surveys, healthcare providers were asked about their attitudes and beliefs about pharmacists as immunizers. The questions were: "Where do you think vaccines should be administered? (Check all that apply)" \[Note: those who selected 'family doctor's office', 'public health clinic', and/or 'pharmacy' as the locations are presented below\]; and "Please indicate how much you agree or disagree with the following statements by clicking the box that best fits your opinion?" \[Note: Those who answered 'agree' are presented below\].
| Participants | Pre-Intervention Knowledge, Attitudes, Beliefs and Behaviours (KABB) Surveys (Healthcare Providers) | Post-Intervention Knowledge, Attitudes, Beliefs & Behaviours (KABB) Surveys (Healthcare Providers) |
|---|---|---|
| Vaccines should be administered in family doctor's office | 188 | 155 |
| Vaccines should be administered in public health clinic | 197 | 179 |
| Vaccines should be administered in pharmacy | 170 | 136 |
| I support the expansion of pharmacists' scope of practice to include provision of vaccines to adults | 171 | 150 |
| I support the expansion of pharmacist scope of practice to include provision of vaccines to children | 156 | 134 |
| Pharmacists should be allowed to vaccinate children under the age of 5 years old | 66 | 95 |
| Pharmacists have enough training to administer vaccines | 136 | 142 |
| I would refer a patient to receive a vaccine from a pharmacist at a pharmacy (physician/nurses only) | 50 | 75 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention Communities | — | — | — |
| Non-Intervention Communities | — | — | — |
Information on the number of participants is not available (NA) because no participants were assigned to the arms/groups. Instead, pharmacies from the selected community in each province were assigned to each arm/group. Pharmacies were not assessed for these baseline measures; therefore, data were not collected and cannot be reported.
| Age, Continuous | Intervention Communities | Non-Intervention Communities | Total |
|---|
| Sex: Female, Male | Intervention Communities | Non-Intervention Communities | Total |
|---|---|---|---|
| Female | — | — | — |
| Male | — | — | — |
| Race (NIH/OMB) | Intervention Communities | Non-Intervention Communities | Total |
|---|---|---|---|
| American Indian or Alaska Native | — | — | — |
| Asian | — | — | — |
| Native Hawaiian or Other Pacific Islander | — | — | — |
| Black or African American | — | — | — |
| White | — | — | — |
| More than one race | — | — | — |
| Unknown or Not Reported | — | — | — |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Ran from Feb 2017 to primary completion in Jul 2021, 52 months.
Results were first posted in Dec 2024, 3 years 5 months after primary completion.
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Studies of the drug tested here: 4CMenB vaccine
Canadian Immunization Research Network