Influenza
Conditions
Keywords
Influenza, Influenza virus
Brief 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
Detailed 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.
Interventions
BIOLOGICALFluzone: Influenza virus vaccine
0.1 mL, Intradermal Right deltoid, 0.5 mL, Intramuscular Left deltoid
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Categorical Summary of Pain or Other Discomfort Immediately After Vaccination and on Days 3 and 7 Post-vaccination | 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. |
| Continuous Summary of Pain or Other Discomfort Immediately After Vaccination and on Days 3 and 7 Post-vaccination | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting Any Solicited Injection Site Reactions After Vaccine Injection | 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. |
| Number of Participants Reporting Solicited Systemic Reactions After Vaccine Injection | 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. |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled and treated from 25 January 2008 to 11 March 2008 in 1 medical center in the US.
Pre-assignment details
A total of 110 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
Participants by arm
| Arm | Count |
|---|---|
| Fluzone Intradermal First, Then Fluzone Intramuscular Participants who received 1 dose of Fluzone Intradermal (ID) in the right deltoid region, followed by Fluzone Intramuscular (IM) in the left deltoid region on Day 0 | 56 |
| Fluzone Intramuscular First, Then Fluzone Intradermal Participants who received 1 dose of Fluzone Intramuscular in the right deltoid region, followed by Fluzone Intradermal (ID) in the left deltoid region on Day 0 | 54 |
| Total | 110 |
Baseline characteristics
| Characteristic | Fluzone Intramuscular First, Then Fluzone Intradermal | Fluzone Intradermal First, Then Fluzone Intramuscular | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 54 Participants | 56 Participants | 110 Participants |
| Age, Continuous | 31.3 Years STANDARD_DEVIATION 10.58 | 31.2 Years STANDARD_DEVIATION 11.44 | 31.27 Years STANDARD_DEVIATION 10.98 |
| Region of Enrollment United States | 54 participants | 56 participants | 110 participants |
| Sex: Female, Male Female | 24 Participants | 35 Participants | 59 Participants |
| Sex: Female, Male Male | 30 Participants | 21 Participants | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 92 / 110 | 75 / 110 |
| serious Total, serious adverse events | 0 / 56 | 0 / 54 |
Outcome results
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.
Time frame: Day 0 and up to 7 days post-vaccination
Population: Pain or other discomfort was assessed in the Per-Protocol Population. Data were combined for responses following a similar type of vaccination route.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluzone Intradermal Vaccine | Categorical Summary of Pain or Other Discomfort Immediately After Vaccination and on Days 3 and 7 Post-vaccination | Any - Day 3 | 44 Participants |
| Fluzone Intradermal Vaccine | Categorical Summary of Pain or Other Discomfort Immediately After Vaccination and on Days 3 and 7 Post-vaccination | Any - Day 7 | 5 Participants |
| Fluzone Intradermal Vaccine | Categorical Summary of Pain or Other Discomfort Immediately After Vaccination and on Days 3 and 7 Post-vaccination | Severe or Worse - Day 0 | 4 Participants |
| Fluzone Intradermal Vaccine | Categorical Summary of Pain or Other Discomfort Immediately After Vaccination and on Days 3 and 7 Post-vaccination | Severe or Worse - Day 7 | 0 Participants |
| Fluzone Intradermal Vaccine | Categorical Summary of Pain or Other Discomfort Immediately After Vaccination and on Days 3 and 7 Post-vaccination | Severe or Worse - Day 3 | 0 Participants |
| Fluzone Intradermal Vaccine | Categorical Summary of Pain or Other Discomfort Immediately After Vaccination and on Days 3 and 7 Post-vaccination | Any - Day 0 | 85 Participants |
| Fluzone Intramuscular Vaccine | Categorical Summary of Pain or Other Discomfort Immediately After Vaccination and on Days 3 and 7 Post-vaccination | Any - Day 0 | 75 Participants |
| Fluzone Intramuscular Vaccine | Categorical Summary of Pain or Other Discomfort Immediately After Vaccination and on Days 3 and 7 Post-vaccination | Severe or Worse - Day 0 | 2 Participants |
| Fluzone Intramuscular Vaccine | Categorical Summary of Pain or Other Discomfort Immediately After Vaccination and on Days 3 and 7 Post-vaccination | Any - Day 3 | 35 Participants |
| Fluzone Intramuscular Vaccine | Categorical Summary of Pain or Other Discomfort Immediately After Vaccination and on Days 3 and 7 Post-vaccination | Severe or Worse - Day 3 | 0 Participants |
| Fluzone Intramuscular Vaccine | Categorical Summary of Pain or Other Discomfort Immediately After Vaccination and on Days 3 and 7 Post-vaccination | Any - Day 7 | 4 Participants |
| Fluzone Intramuscular Vaccine | Categorical Summary of Pain or Other Discomfort Immediately After Vaccination and on Days 3 and 7 Post-vaccination | Severe or Worse - Day 7 | 0 Participants |
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.
Time frame: Days 0, 3, and 7 after vaccination
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fluzone Intradermal Vaccine | Continuous Summary of Pain or Other Discomfort Immediately After Vaccination and on Days 3 and 7 Post-vaccination | Day 0 | 2.97 Scores on a scale | Standard Deviation 2.13 |
| Fluzone Intradermal Vaccine | Continuous Summary of Pain or Other Discomfort Immediately After Vaccination and on Days 3 and 7 Post-vaccination | Day 3 | 0.79 Scores on a scale | Standard Deviation 1.23 |
| Fluzone Intradermal Vaccine | Continuous Summary of Pain or Other Discomfort Immediately After Vaccination and on Days 3 and 7 Post-vaccination | Day 7 | 0.08 Scores on a scale | Standard Deviation 0.39 |
| Fluzone Intramuscular Vaccine | Continuous Summary of Pain or Other Discomfort Immediately After Vaccination and on Days 3 and 7 Post-vaccination | Day 0 | 2.02 Scores on a scale | Standard Deviation 1.9 |
| Fluzone Intramuscular Vaccine | Continuous Summary of Pain or Other Discomfort Immediately After Vaccination and on Days 3 and 7 Post-vaccination | Day 3 | 0.68 Scores on a scale | Standard Deviation 1.2 |
| Fluzone Intramuscular Vaccine | Continuous Summary of Pain or Other Discomfort Immediately After Vaccination and on Days 3 and 7 Post-vaccination | Day 7 | 0.05 Scores on a scale | Standard Deviation 0.26 |
Other Pre-specified
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.
Time frame: Days 0 through 7 post-vaccination
Population: Safety parameters were assessed in all enrolled and vaccinated participants, intend-to-treat population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluzone Intradermal Vaccine | Number of Participants Reporting Any Solicited Injection Site Reactions After Vaccine Injection | Any Solicited Injection Site Pain | 70 Participants |
| Fluzone Intradermal Vaccine | Number of Participants Reporting Any Solicited Injection Site Reactions After Vaccine Injection | Gr 3 Solicited Injection Site -Pain Incapacitating | 0 Participants |
| Fluzone Intradermal Vaccine | Number of Participants Reporting Any Solicited Injection Site Reactions After Vaccine Injection | Any Solicited Injection Site Pruritus | 39 Participants |
| Fluzone Intradermal Vaccine | Number of Participants Reporting Any Solicited Injection Site Reactions After Vaccine Injection | Gr 3 Solicited Inj. Siite Pruritus -Incapacitating | 1 Participants |
| Fluzone Intradermal Vaccine | Number of Participants Reporting Any Solicited Injection Site Reactions After Vaccine Injection | Any Solicited Injection Site Erythema | 92 Participants |
| Fluzone Intradermal Vaccine | Number of Participants Reporting Any Solicited Injection Site Reactions After Vaccine Injection | Grade 3 Solicited Injection Site Erythema (≥ 5 cm) | 11 Participants |
| Fluzone Intradermal Vaccine | Number of Participants Reporting Any Solicited Injection Site Reactions After Vaccine Injection | Any Solicited Injection Site Swelling | 68 Participants |
| Fluzone Intradermal Vaccine | Number of Participants Reporting Any Solicited Injection Site Reactions After Vaccine Injection | Grade 3 Solicited Injection Site Swelling (≥ 5 cm) | 1 Participants |
| Fluzone Intradermal Vaccine | Number of Participants Reporting Any Solicited Injection Site Reactions After Vaccine Injection | Any Solicited Injection Site Induration | 74 Participants |
| Fluzone Intradermal Vaccine | Number of Participants Reporting Any Solicited Injection Site Reactions After Vaccine Injection | Gr 3 Solicited Injection Site Induration (≥ 5 cm) | 1 Participants |
| Fluzone Intradermal Vaccine | Number of Participants Reporting Any Solicited Injection Site Reactions After Vaccine Injection | Any Solicited Injection Site Ecchymosis | 14 Participants |
| Fluzone Intradermal Vaccine | Number of Participants Reporting Any Solicited Injection Site Reactions After Vaccine Injection | Gr 3 Solicited Injection Site Ecchymosis (≥ 5 cm) | 0 Participants |
| Fluzone Intramuscular Vaccine | Number of Participants Reporting Any Solicited Injection Site Reactions After Vaccine Injection | Any Solicited Injection Site Ecchymosis | 7 Participants |
| Fluzone Intramuscular Vaccine | Number of Participants Reporting Any Solicited Injection Site Reactions After Vaccine Injection | Any Solicited Injection Site Pain | 75 Participants |
| Fluzone Intramuscular Vaccine | Number of Participants Reporting Any Solicited Injection Site Reactions After Vaccine Injection | Any Solicited Injection Site Swelling | 12 Participants |
| Fluzone Intramuscular Vaccine | Number of Participants Reporting Any Solicited Injection Site Reactions After Vaccine Injection | Gr 3 Solicited Injection Site -Pain Incapacitating | 1 Participants |
| Fluzone Intramuscular Vaccine | Number of Participants Reporting Any Solicited Injection Site Reactions After Vaccine Injection | Gr 3 Solicited Injection Site Induration (≥ 5 cm) | 0 Participants |
| Fluzone Intramuscular Vaccine | Number of Participants Reporting Any Solicited Injection Site Reactions After Vaccine Injection | Any Solicited Injection Site Pruritus | 12 Participants |
| Fluzone Intramuscular Vaccine | Number of Participants Reporting Any Solicited Injection Site Reactions After Vaccine Injection | Grade 3 Solicited Injection Site Swelling (≥ 5 cm) | 0 Participants |
| Fluzone Intramuscular Vaccine | Number of Participants Reporting Any Solicited Injection Site Reactions After Vaccine Injection | Gr 3 Solicited Inj. Siite Pruritus -Incapacitating | 0 Participants |
| Fluzone Intramuscular Vaccine | Number of Participants Reporting Any Solicited Injection Site Reactions After Vaccine Injection | Gr 3 Solicited Injection Site Ecchymosis (≥ 5 cm) | 0 Participants |
| Fluzone Intramuscular Vaccine | Number of Participants Reporting Any Solicited Injection Site Reactions After Vaccine Injection | Any Solicited Injection Site Erythema | 15 Participants |
| Fluzone Intramuscular Vaccine | Number of Participants Reporting Any Solicited Injection Site Reactions After Vaccine Injection | Any Solicited Injection Site Induration | 19 Participants |
| Fluzone Intramuscular Vaccine | Number of Participants Reporting Any Solicited Injection Site Reactions After Vaccine Injection | Grade 3 Solicited Injection Site Erythema (≥ 5 cm) | 0 Participants |
Other Pre-specified
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.
Time frame: Days 0 through 7 post-vaccination
Population: Safety parameters were assessed in all enrolled and vaccinated subjects, intend-to-treat population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluzone Intradermal Vaccine | Number of Participants Reporting Solicited Systemic Reactions After Vaccine Injection | Grade 3 Solicited Fever (> 102.2 °F) | 0 Participants |
| Fluzone Intradermal Vaccine | Number of Participants Reporting Solicited Systemic Reactions After Vaccine Injection | Gr 3 Solicited Malaise (Prevents daily activities) | 4 Participants |
| Fluzone Intradermal Vaccine | Number of Participants Reporting Solicited Systemic Reactions After Vaccine Injection | Gr 3 Solicited Headache -Prevents daily activities | 3 Participants |
| Fluzone Intradermal Vaccine | Number of Participants Reporting Solicited Systemic Reactions After Vaccine Injection | Any Solicited Fever | 6 Participants |
| Fluzone Intradermal Vaccine | Number of Participants Reporting Solicited Systemic Reactions After Vaccine Injection | Any Solicited Headache | 25 Participants |
| Fluzone Intradermal Vaccine | Number of Participants Reporting Solicited Systemic Reactions After Vaccine Injection | Any Solicited Myalgia | 31 Participants |
| Fluzone Intradermal Vaccine | Number of Participants Reporting Solicited Systemic Reactions After Vaccine Injection | Any Solicited Malaise | 18 Participants |
| Fluzone Intradermal Vaccine | Number of Participants Reporting Solicited Systemic Reactions After Vaccine Injection | Gr 3 Solicited Myalgia (Prevents daily activities) | 3 Participants |
| Fluzone Intramuscular Vaccine | Number of Participants Reporting Solicited Systemic Reactions After Vaccine Injection | Any Solicited Malaise | 21 Participants |
| Fluzone Intramuscular Vaccine | Number of Participants Reporting Solicited Systemic Reactions After Vaccine Injection | Grade 3 Solicited Fever (> 102.2 °F) | 0 Participants |
| Fluzone Intramuscular Vaccine | Number of Participants Reporting Solicited Systemic Reactions After Vaccine Injection | Any Solicited Headache | 25 Participants |
| Fluzone Intramuscular Vaccine | Number of Participants Reporting Solicited Systemic Reactions After Vaccine Injection | Gr 3 Solicited Headache -Prevents daily activities | 1 Participants |
| Fluzone Intramuscular Vaccine | Number of Participants Reporting Solicited Systemic Reactions After Vaccine Injection | Any Solicited Fever | 3 Participants |
| Fluzone Intramuscular Vaccine | Number of Participants Reporting Solicited Systemic Reactions After Vaccine Injection | Gr 3 Solicited Myalgia (Prevents daily activities) | 1 Participants |
| Fluzone Intramuscular Vaccine | Number of Participants Reporting Solicited Systemic Reactions After Vaccine Injection | Gr 3 Solicited Malaise (Prevents daily activities) | 4 Participants |
| Fluzone Intramuscular Vaccine | Number of Participants Reporting Solicited Systemic Reactions After Vaccine Injection | Any Solicited Myalgia | 26 Participants |