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

NCT ID: NCT01665807

Last Updated: 2017-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 868 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2012-12-31

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.

Detailed Description

Vaccination of healthcare workers has been shown to reduce mortality and morbidity in the patients they care for, as well as reducing illness and absenteeism in the healthcare workers themselves, and healthcare worker vaccination programs have been shown to be cost-effective for hospitals because of the reduced absenteeism. Although influenza vaccination programs based on nurse-administered intramuscular vaccination are effective, easy access to vaccination for hospital staff remains a challenge, in part because of large numbers of staff working evening, night and weekend shifts. In addition, in the Canadian setting, increasing the efficiency of all hospital programs is a priority. If regular recipients of seasonal vaccine became accustomed to the practice, self-administration may significantly improve the efficiency of pandemic mass vaccination campaigns.

Conditions

Influenza; Vaccination Site Reactions (HT)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Nurse-administered IM

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

Group Type: EXPERIMENTAL

Vaxigrip

Intervention Type: BIOLOGICAL

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

Self-administered intradermal

Self-administered intradermal influenza vaccine (Intanza 0.1 mL)

Group Type: EXPERIMENTAL

Intanza

Intervention Type: BIOLOGICAL

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

Repeat self-administration intradermal

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

Group Type: ACTIVE_COMPARATOR

Intanza

Intervention Type: BIOLOGICAL

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

Interventions

Intanza

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

Intervention Type: BIOLOGICAL

Vaxigrip

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

Intervention Type: BIOLOGICAL

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sanofi Pasteur, a Sanofi Company

INDUSTRY

Sponsor Role: collaborator

Brenda Coleman

OTHER

Sponsor Role: lead

Responsible Party

Brenda Coleman

Clinical Scientist

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Brenda L Coleman, PhD

Role: PRINCIPAL_INVESTIGATOR

MOUNT SINAI HOSPITAL

Melissa Barton

Role: STUDY_DIRECTOR

MOUNT SINAI HOSPITAL

Christine Moore

Role: STUDY_DIRECTOR

MOUNT SINAI HOSPITAL

Shelly A McNeil, MD

Role: PRINCIPAL_INVESTIGATOR

Canadian Centre for Vaccinology

Joanne M Langley, MD

Role: STUDY_DIRECTOR

Canadian Centre for Vaccinology

Scott A Halperin, MD

Role: STUDY_DIRECTOR

Canadian Centre for Vaccinology

Allison J McGeer, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

MOUNT SINAI HOSPITAL

Locations

Center for Vaccinology

Halifax, Nova Scotia, Canada

Mount Sinai Hospital

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 26529074 (View on PubMed)

Other Identifiers

SP1203

Identifier Type: -

Identifier Source: org_study_id