A Time-motion Study Comparing Self- to Nurse-vaccination With Influenza Vaccine

NCT01665807 | Completed Phase 4 Results

• 1 other identifier: SP1203
• Study Type: interventional
• Target: 868
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Influenza; Vaccination Site Reactions (HT)

Keywords

influenza; vaccine; administration

Outcome Measures

Primary Outcomes (1)

• Time to Administer Influenza Vaccine (in Seconds)

  Time required to explain vaccination, obtain consent, administer vaccine, and register vaccination

  Vaccination (Day 0)

Secondary Outcomes (4)

• Acceptability of Vaccine

  Follow up (Day 8)

• Success Rate

  Vaccination (Day 0)

• Local & Systemic Reactogenicity

  Follow up (Day 8)

• Pain at Injection Site

  Follow up (Day 8

Study Arms (3)

Nurse-administered IM

EXPERIMENTAL

Nurse-administered intramuscular influenza vaccine (Vaxigrip, 0.5 mL)

Biological: Vaxigrip

Self-administered intradermal

EXPERIMENTAL

Self-administered intradermal influenza vaccine (Intanza 0.1 mL)

Biological: Intanza

Repeat self-administration intradermal

ACTIVE COMPARATOR

Self-administration of intradermal influenza vaccine (Intanza 0.1 mL) by participants who self-administered an intradermal vaccine in our 2010 study

Biological: Intanza

Interventions

Intanza BIOLOGICAL

Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere

Repeat self-administration intradermal; Self-administered intradermal

Vaxigrip BIOLOGICAL

Influenza vaccine, trivalent, split-virion, inactivated, approved for the 2012-2013 influenza season in the northern hemisphere

Nurse-administered IM

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Brenda Coleman: lead
• Sanofi Pasteur, a Sanofi Company: collaborator

Study Sites (2)

Center for Vaccinology

Halifax, Nova Scotia, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

Location

Related Publications (1)

• Coleman BL, McNeil SA, Langley JM, Halperin SA, McGeer AJ. Differences in efficiency, satisfaction and adverse events between self-administered intradermal and nurse-administered intramuscular influenza vaccines in hospital workers. Vaccine. 2015 Nov 27;33(48):6635-40. doi: 10.1016/j.vaccine.2015.10.095. Epub 2015 Oct 31.

  PMID: 26529074 DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

vaxigrip

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Brenda L. Coleman, PhD,
• Organization: Mount Sinai Hospital, IDERU

bcoleman@mtsinai.on.ca

416-586-4800

Study Officials

• Brenda L Coleman, PhD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

• Melissa Barton

  MOUNT SINAI HOSPITAL

  STUDY DIRECTOR

• Christine Moore

  MOUNT SINAI HOSPITAL

  STUDY DIRECTOR

• Shelly A McNeil, MD

  Canadian Centre for Vaccinology

  PRINCIPAL INVESTIGATOR

• Joanne M Langley, MD

  Canadian Centre for Vaccinology

  STUDY DIRECTOR

• Scott A Halperin, MD

  Canadian Centre for Vaccinology

  STUDY DIRECTOR

• Allison J McGeer, MD, FRCPC

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Scientist

Study Record Dates

• First Submitted: August 13, 2012
• First Posted: August 15, 2012
• Study Start: September 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: April 19, 2017
• Results First Posted: October 1, 2013

Record last verified: 2017-03

Locations

CA (2)