Study to Determine a Preference for Fluzone Vaccine Given Intradermally (ID) and Intramuscularly (IM) in Healthy Adults

Influenza Clinical Trial

Official title:

Preference for Fluzone Vaccine Administered Intradermally Versus Intramuscularly in Healthy Adult Subjects 18-49 Years of Age

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00623181
• Other study ID #: FID30
• Status: Completed
• Phase: Phase 2
• First received: February 6, 2008
• Last updated: April 12, 2016
• Start date: January 2008
• Est. completion date: June 2008

Study information

• Verified date: April 2016
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To describe any degree of preference for the route of administration of Fluzone influenza vaccine, ID versus IM, in healthy adult subjects 18-49 years of age.

To collect safety data, injection site reactions, and systemic reactions, through Day 7 post-vaccination; SAEs through day 28 post-vaccination

Description:

The purpose of this clinical trial is to determine, in a relatively small sample of persons 18-49 years of age, if there is a preference trend for a particular route of administration, ID vs IM, when receiving a seasonal influenza vaccine. Uptake of influenza vaccine is disappointingly low in this age group, and there is the perception that aversion to IM injection plays a role in vaccination avoidance. The BD Micro-Injection System to be used in this study may offer a more acceptable alternative to the standard IM injection for influenza immunization and thereby promote wider acceptance of influenza vaccination.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: June 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 49 Years

Eligibility

Inclusion Criteria:

• Healthy male or female subject (can have underlying medical condition, as long as they are stable), greater than or equal to 18 to < 50 years of age on the day of inclusion.

• Informed consent form signed.

• Able to attend both scheduled visits and to comply with all trial procedures.

• For a woman of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to vaccination, until at least 4 weeks after vaccination.

Exclusion Criteria:

• Subject currently breast-feeding.

• Participation in another investigational clinical trial in the 4 weeks preceding and during the trial period.

• Hypersensitivity to egg proteins, chicken proteins, or to any of the vaccine components, or history of a life-threatening reaction to the trial vaccine or a vaccine containing any of the same substances.

• Thrombocytopenia or bleeding disorder contraindicating IM vaccination.

• Any other condition which in the opinion of the Investigator would pose a health risk to the subject or interfere with the evaluation of the vaccine.

• Personal history of Guillain-Barre syndrome.

• Current use of alcohol or recreational drugs that in the opinion of the Investigator might interfere with the subject's ability to comply with trial procedures.

• Febrile illness (oral temperature greater than or equal to 99.5 degrees F) on day of inclusion (temporary deferral).

• Influenza vaccination received this season (2007-2008).

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza

Intervention

Biological:
• Fluzone: Influenza virus vaccine
0.1 mL, Intradermal Right deltoid, 0.5 mL, Intramuscular Left deltoid
• Fluzone: Influenza virus vaccine
0.5 mL, Intramuscular Right deltoid, 0.1 mL, Intradermal Left deltoid

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants Reporting Any Solicited Injection Site Reactions After Vaccine Injection	Solicited injection site reactions: Pain, Pruritus, Erythema, Swelling, Induration, Ecchymosis.; Data for this outcome were combined for responses following a similar type of vaccination route in the entire study population.	Days 0 through 7 post-vaccination	No
Other	Number of Participants Reporting Solicited Systemic Reactions After Vaccine Injection	Solicited systemic reactions: Fever (temperature); Headache; Malaise; and Myalgia.; Data for this outcome were based on the first vaccination type, intradermal or intramuscular.	Days 0 through 7 post-vaccination	No
Primary	Categorical Summary of Pain or Other Discomfort Immediately After Vaccination and on Days 3 and 7 Post-vaccination	Pain or other discomfort was assessed on a scale of 0 to 10 (None = 0; Hardly Any = 1, 2; Mild = 3, 4; Moderate = 5, 6; Severe = 7, 8; Unbearable = 9, 10) according to route of administration: intradermal (ID) as Group 1 and intramuscular (IM) as Group 2.; Data for this outcome were combined for responses following a similar type of vaccination route in the entire study population.	Day 0 and up to 7 days post-vaccination	No
Primary	Continuous Summary of Pain or Other Discomfort Immediately After Vaccination and on Days 3 and 7 Post-vaccination	Numerical scores were assigned to pain by participants on the preference questionnaire as: None = 0; Hardly Any = 1, 2; Mild = 3, 4; Moderate = 5, 6; Severe = 7, 8; or Unbearable = 9, 10.; Data for this outcome were combined for responses following a similar type of vaccination route in the entire study population.	Days 0, 3, and 7 after vaccination	No

External Links

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