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NCT01985620 Clinical Trial

The Impact of a Short Intervention During RSV Prophylaxis on Influenza Vaccination Rate.

Influenza Clinical Trial

Official title:
The Impact of a Short Intervention During RSV Prophylaxis on Influenza Vaccination Rate and Morbidity in Infants Born Premature.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01985620
Other study ID # TASMC-13-YS-0503-13-CTIL
Secondary ID 0503-13-TLV
Status Recruiting
Phase N/A
First received November 10, 2013
Last updated June 25, 2014
Start date November 2013

Study information
Verified date November 2013
Source Tel-Aviv Sourasky Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial Summary

Premature infants (born before 34 wk) are routinely vaccinated against RSV but vaccination rate against influenza are low in spite of national programs. Study goal is to evaluate the effectiveness of short intervention during RSV prophylaxis visit, planned to educate parents about the importance of influenza vaccination.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date
Est. primary completion date April 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 6 Months to 2 Years
Eligibility Inclusion Criteria:

- Infants coming for RSV prophylaxis

Exclusion Criteria:

- Already vaccinated against influenza

- Contraindication for influenza vaccination

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Behavioral:
• Educational intervention

Locations
Country Name City State
Israel Sourasky Medical Center Tel-Aviv

Sponsors (1)
Lead Sponsor Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Influenza vaccination rate 5 months No
Secondary respiratory morbidity Upper and lower respiratory tract events during study period 5 months No
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