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Completed

NCT Number: NCT00623181

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

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

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Grove City, Pennsylvania, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Fluzone: Influenza virus vaccine

Biological

0.1 mL, Intradermal Right deltoid, 0.5 mL, Intramuscular Left deltoid

Other names: Fluzone®

Primary outcomes

  1. Categorical Summary of Pain or Other Discomfort Immediately After Vaccination and on Days 3 and 7 Post-vaccination

    Time frame: Day 0 and up to 7 days 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.

  2. Continuous Summary of Pain or Other Discomfort Immediately After Vaccination and on Days 3 and 7 Post-vaccination

    Time frame: Days 0, 3, and 7 after 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.

Other outcomes

  1. Number of Participants Reporting Any Solicited Injection Site Reactions After Vaccine Injection

    Time frame: Days 0 through 7 post-vaccination

    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.

  2. Number of Participants Reporting Solicited Systemic Reactions After Vaccine Injection

    Time frame: Days 0 through 7 post-vaccination

    Solicited systemic reactions: Fever (temperature); Headache; Malaise; and Myalgia.

    Data for this outcome were based on the first vaccination type, intradermal or intramuscular.

Sponsors and collaborators

Lead sponsor

Sanofi Pasteur, a Sanofi Company

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Feb 25, 2008
Registry last updated
Apr 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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