School-based educational and on-site vaccination among adolescents

ISRCTN ISRCTN18026662
DOI https://doi.org/10.1186/ISRCTN18026662
Secondary identifying numbers 1503/53105
Submission date
01/12/2017
Registration date
05/12/2017
Last edited
25/10/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Despite childhood vaccination programs have been established in many countries around the world, MMR vaccine (Measles-Mumps-Rubella) as well as diphtheria, tetanus, pertussis (whooping cough), and polio rates are not optimal in adolescents. Sometimes vaccinations can be done directly at schools. The “prevention bus” is the first mobile medical practice in Germany and could potentially improve vacation rates in adolecents. The study aims to improve vaccination rates in adolescents with a combination of school-based education classes and on-site vaccination in the "prevention bus" on-site at school.

Who can participate?
Schools in the city center of Berlin, Germany with classes 9 to 11 (students aged 15 and older)

What does the study involve?
Schools are randomly allocated to one of two groups. Those in the first group receive an educational class. Those in the second group receive low-intensity information. In both conditions, the “prevention bus” is delivering vaccine for MMR, diphtheria, tetanus, pertussis, and polio after information or education is delivered by medical staff. Parents are informed in advance and consent is obtained. The effectiveness of the education is primarily assessed by the difference between conditions in the number of pupils who receive vaccination in the bus. Further, differences in vaccination-related knowledge and beliefs are measured. A minimum number of 355 school classes is required to determine effectiveness.

What are the possible benefits and risks of participating?
Potential benefits of this study include the provision of an effective and cost-effective vaccination treatment, which may increase vaccination rates at scale. Further, the educational class may be the basis for a future health and prevention course in German schools. Risks associated with participating in this study are not expected. A reaction to the vaccine given by our physicians is the pre percentage range. Complications (temporarily in need of medical supervision) due to the vaccine is in the per thousand range. Following recommendations by STIKO (vaccination committee at Robert Koch Institut, Germany, Berlin) participants only get vaccinated after receiving medical information on vaccine reaction and possible complications.

Where is the study run from?
Charité - Universitätsmedizin Berlin (Germany)

When is the study starting and how long is it expected to run for?
June 2017 to August 2018

Who is funding the study?
Federal Ministry of Health (BMG) (Germany)

Who is the main contact?
Dr Joachim Seybold (Public)
joachim.seybold@charite.de

Study website

Contact information

Dr Joachim Seybold
Public

The Charité – Universitätsmedizin Berlin
Charitéplatz 1
Berlin
10117
Germany

Phone +49 (0)30 450 670869
Email joachim.seybold@charite.de

Study information

Study designCluster randomized controlled trial (cRCT)
Primary study designInterventional
Secondary study designCluster randomised trial
Study setting(s)School
Study typePrevention
Participant information sheet https://praeventionsbus.charite.de/fileadmin/user_upload/microsites/ohne_AZ/sonstige/praeventionsbus/Aufkl%C3%A4rungsb%C3%B6gen/info_Eltern_homepage.pdf
Scientific titleSchool-based educational and on-site vaccination intervention for the prevention of MMR and Tdap-IPV among adolescents
Study acronymPREV-BUS
Study objectivesThe primary hypothesis tests whether the willingness to participate in on-the-spot vaccinations can be increased in the educational class condition compared to the low-intensity information provision condition. In secondary hypotheses, the group differences in knowledge and vaccination self-efficacy will be tested. Further, post hoc subgroup analyses of the intervention effectiveness will be conducted, e.g., by gender, migration status and socioeconomic background, and type of school. With the prevention bus as an intervention strategy, barriers are identified (feasibility) in the context of the prevention work, to increase the immunization rates at Berlin schools.
Ethics approval(s)Ethics committee of the Charité Berlin, 10/08/2017, ref: EA1/059/17
Health condition(s) or problem(s) studiedMMR vaccine (Measles, Mumps, Rubella)
Tdap-IPV vaccine (Tetanus, Diphteria, Pertussis, Polio)
InterventionThe Prevention Bus will be at each school for approximately one week. Giving all students the possibility to get information and/or vaccination if needed. Besides that, there is an intervention at the classes from 9th to 11th grade (15 years onwards) in high schools and for all apprentices in their teaching facilities. The intervention in schools is held by doctors and nurses and will either be an educational class condition or a low-intensity information condition based on the randomisation. The low-intensity information condition includes an anonymous questionnaire on sociodemographic background and knowledge regarding vaccination. Furthermore, the check of the vaccination card and a guided tour through the Prevention Bus is part of the intervention. In addition to the anonymous questionnaire and the check of the vaccination card, the educational class condition includes a 30 minute class on knowledge, risk communication and enhancing self-efficacy regarding vaccination.
Intervention typeBiological/Vaccine
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)
Primary outcome measureVaccination rate is objectively measured through the number of pupils that get vaccinated, directly after receiving treatment (educational class condition, low-intensity information condition) when pupils visit the Prevention Bus. The primary outcome will be weighted by the number of pupils who are eligible to take part in the study.
Secondary outcome measures1. Health literacy is measured using five items of the HLS-EU Q47 questionnaire addressing prevention and immunization treatment (educational class condition, low intensity information condition) but before pupils visit the bus while they are still in their class room.
2. Health knowledge is measured with six previously developed immunization knowledge items, which psychometric properties were tested in our pilot study after treatment (educational class condition, low intensity information condition) but before pupils visit the bus while they are still in their class room.
Overall study start date01/06/2017
Completion date31/08/2018

Eligibility

Participant type(s)Mixed
Age groupChild
Lower age limit15 Years
SexBoth
Target number of participantsAnticipated sample size of 510 school classes (N=25 per class); a required sample size of 335 school classes was determined a-priori
Key inclusion criteriaSchool level:
1. Centric boroughs within circle line ("Ringbahn" - public Transport Berlin)
2. Summed minimum number of pupils in potential School classes: 230

Participant level:
1. Age (>15 years)
2. Signed informed consent by the parents
Key exclusion criteriaUnder 15 years of age
Date of first enrolment08/12/2017
Date of final enrolment14/07/2018

Locations

Countries of recruitment

  • Germany

Study participating centre

Charité - Universitätsmedizin Berlin
Charitéplatz 1
Berlin
10117
Germany

Sponsor information

Federal Ministery of Health (BMG)
Government

Friedrichstraße 108
Berlin
10117
Germany

Phone +49 (0)30 184410
Email poststelle@bmg.bund.de
Website https://www.bundesgesundheitsministerium.de/
ROR logo "ROR" https://ror.org/05vp4ka74

Funders

Funder type

Government

Bundesministerium für Gesundheit
Government organisation / National government
Alternative name(s)
Federal Ministry of Health, Germany, Federal Ministry of Health, BMG
Location
Germany

Results and Publications

Intention to publish date31/08/2019
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planThe study protocol is planned to be submitted in a peer-reviewed journal before recruitment will be finished. Planned publication of the study results in a high-impact peer reviewed journal within one year after the end of the study.
IPD sharing planFor further questions regarding the data please contact Joachim.seybold@charite.de (principle investigator) and norma.bethke@charite.de (study coordinator).

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 29/01/2019 24/02/2020 Yes No
Interim results article pilot study results 10/01/2022 25/10/2022 Yes No

Editorial Notes

25/10/2022: Publication reference added.
24/02/2020: Publication reference added.
07/12/2017: Internal review.