Phase 4
N=871
A Time-motion Study Comparing Self- to Nurse-vaccination With Influenza Vaccine
Influenza · Vaccination Site Reactions (HT)
Bottom Line
View on ClinicalTrials.gov: NCT01665807 ↗Enrolled (actual)
871
Serious AEs
0.0%
Results posted
Oct 2013
Primary outcome: Primary: Time to Administer Influenza Vaccine (in Seconds) — 90.0; 182.0; 62.6 seconds
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Intanza (Biological); Vaxigrip (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Brenda Coleman
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Administer Influenza Vaccine (in Seconds) |
90.0; 182.0; 62.6 | — |
| SECONDARY Acceptability of Vaccine |
— | — |
| SECONDARY Success Rate |
0; 58; 394 | — |
| SECONDARY Local & Systemic Reactogenicity |
— | — |
| SECONDARY Pain at Injection Site |
— | — |
Summary
The investigators hypothesize that people working in an acute care hospital setting will be able to successfully self-administer the intradermal vaccine (Intanza) in less time than nurse-administration of the regular intramuscular influenza vaccine (Vaxigrip). The investigators also hypothesize that people administering the intradermal vaccine for the second time will take less time to successfully administer than people administering it for the first time.
Eligibility Criteria
Inclusion Criteria
- Medically stable men or women 18 to 69 years of age (inclusive)
- Work in any capacity (including physicians and midwives with admitting privileges), volunteer, or student at participating hospital
- Able to read, understand, and respond to questionnaires
- Able to read, understand, and sign an informed consent form
- Available for follow-up for 8 days post-vaccination
- Participants in Part B (repeat administration) of the study must also have participated in the previous randomized control trial of self- versus nurse-administered intradermal influenza vaccine and must have attempted to self-administer the vaccine
Exclusion Criteria
- Already received 2012-13 influenza vaccine
- History of a severe reaction following influenza vaccination
- Known allergy to components of study vaccines (Intanza® or Vaxigrip®)
- History of Guillain-Barré Syndrome (GBS) within 8 weeks following influenza vaccination
- Acute febrile illness (>37.9ºC orally) within the past 48 hours (participation may be deferred until recovery for these subjects)
Data sourced from ClinicalTrials.gov (NCT01665807). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.