School-based educational and on-site vaccination among adolescents

• Register: ISRCTN
• Last refreshed on: 7 November 2022
• Main ID: ISRCTN18026662
• Date of registration: 05/12/2017
• Prospective Registration: Yes
• Primary sponsor: Federal Ministery of Health (BMG)
• Public title: School-based educational and on-site vaccination among adolescents
• Scientific title: School-based educational and on-site vaccination intervention for the prevention of MMR and Tdap-IPV among adolescents
• Date of first enrolment: 08/12/2017
• Target sample size: 510
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN18026662
• Study type: Interventional
• Study design: Cluster randomized controlled trial (cRCT) (Prevention)
• Phase: Not Specified

Countries of recruitment

Germany

Contacts

• Name: Joachim Seybold

Key inclusion & exclusion criteria

Inclusion criteria:
School 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

Exclusion criteria: Under 15 years of age

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

MMR vaccine (Measles, Mumps, Rubella) Tdap-IPV vaccine (Tetanus, Diphteria, Pertussis, Polio)
Infections and Infestations
MMR vaccine (Measles, Mumps, Rubella) Tdap-IPV vaccine (Tetanus, Diphteria, Pertussis, Polio)

Intervention(s)

The 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.

Primary Outcome(s)

Vaccination 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(s)

1. 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.

Secondary ID(s)

1503/53105

Source(s) of Monetary Support

Bundesministerium für Gesundheit

Ethics review

Status:
Approval date:
Contact:

Ethics committee of the Charité Berlin, 10/08/2017, ref: EA1/059/17

Results

• Results available: Yes
• Date Completed: 31/08/2018