Trial Outcomes & Findings for Study to Determine a Preference for Fluzone Vaccine Given Intradermally (ID) and Intramuscularly (IM) in Healthy Adults (NCT NCT00623181)
NCT ID: NCT00623181
Last Updated: 2016-04-14
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
110 participants
Primary outcome timeframe
Day 0 and up to 7 days post-vaccination
Results posted on
2016-04-14
Participant Flow
Participants were enrolled and treated from 25 January 2008 to 11 March 2008 in 1 medical center in the US.
A total of 110 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
56
|
54
|
|
Overall Study
COMPLETED
|
56
|
54
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Determine a Preference for Fluzone Vaccine Given Intradermally (ID) and Intramuscularly (IM) in Healthy Adults
Baseline characteristics by cohort
| Measure |
Fluzone Intradermal First, Then Fluzone Intramuscular
n=56 Participants
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
|
Fluzone Intramuscular First, Then Fluzone Intradermal
n=54 Participants
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
|
Total
n=110 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
56 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
31.2 Years
STANDARD_DEVIATION 11.44 • n=5 Participants
|
31.3 Years
STANDARD_DEVIATION 10.58 • n=7 Participants
|
31.27 Years
STANDARD_DEVIATION 10.98 • n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
56 participants
n=5 Participants
|
54 participants
n=7 Participants
|
110 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0 and up to 7 days post-vaccinationPopulation: Pain or other discomfort was assessed in the Per-Protocol Population. Data were combined for responses following a similar type of vaccination route.
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.
Outcome measures
| Measure |
Fluzone Intradermal Vaccine
n=101 Participants
Responses of participants following the receipt of a dose of Fluzone Intradermal (ID) in the right deltoid region or the left deltoid region on Day 0
|
Fluzone Intramuscular Vaccine
n=101 Participants
Responses of participants following the receipt of a dose of Fluzone Intramuscular (IM) in the right deltoid region or the left deltoid region on Day 0
|
|---|---|---|
|
Categorical Summary of Pain or Other Discomfort Immediately After Vaccination and on Days 3 and 7 Post-vaccination
Any - Day 0
|
85 Participants
|
75 Participants
|
|
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
|
2 Participants
|
|
Categorical Summary of Pain or Other Discomfort Immediately After Vaccination and on Days 3 and 7 Post-vaccination
Any - Day 3
|
44 Participants
|
35 Participants
|
|
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
|
0 Participants
|
|
Categorical Summary of Pain or Other Discomfort Immediately After Vaccination and on Days 3 and 7 Post-vaccination
Any - Day 7
|
5 Participants
|
4 Participants
|
|
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
|
0 Participants
|
PRIMARY outcome
Timeframe: Days 0, 3, and 7 after vaccinationNumerical 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.
Outcome measures
| Measure |
Fluzone Intradermal Vaccine
n=101 Participants
Responses of participants following the receipt of a dose of Fluzone Intradermal (ID) in the right deltoid region or the left deltoid region on Day 0
|
Fluzone Intramuscular Vaccine
n=101 Participants
Responses of participants following the receipt of a dose of Fluzone Intramuscular (IM) in the right deltoid region or the left deltoid region on Day 0
|
|---|---|---|
|
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
|
2.02 Scores on a scale
Standard Deviation 1.90
|
|
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
|
0.68 Scores on a scale
Standard Deviation 1.20
|
|
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
|
0.05 Scores on a scale
Standard Deviation 0.26
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 0 through 7 post-vaccinationPopulation: Safety parameters were assessed in all enrolled and vaccinated participants, intend-to-treat population.
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.
Outcome measures
| Measure |
Fluzone Intradermal Vaccine
n=110 Participants
Responses of participants following the receipt of a dose of Fluzone Intradermal (ID) in the right deltoid region or the left deltoid region on Day 0
|
Fluzone Intramuscular Vaccine
n=110 Participants
Responses of participants following the receipt of a dose of Fluzone Intramuscular (IM) in the right deltoid region or the left deltoid region on Day 0
|
|---|---|---|
|
Number of Participants Reporting Any Solicited Injection Site Reactions After Vaccine Injection
Any Solicited Injection Site Pain
|
70 Participants
|
75 Participants
|
|
Number of Participants Reporting Any Solicited Injection Site Reactions After Vaccine Injection
Gr 3 Solicited Injection Site -Pain Incapacitating
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Any Solicited Injection Site Reactions After Vaccine Injection
Any Solicited Injection Site Pruritus
|
39 Participants
|
12 Participants
|
|
Number of Participants Reporting Any Solicited Injection Site Reactions After Vaccine Injection
Gr 3 Solicited Inj. Siite Pruritus -Incapacitating
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Any Solicited Injection Site Reactions After Vaccine Injection
Any Solicited Injection Site Erythema
|
92 Participants
|
15 Participants
|
|
Number of Participants Reporting Any Solicited Injection Site Reactions After Vaccine Injection
Grade 3 Solicited Injection Site Erythema (≥ 5 cm)
|
11 Participants
|
0 Participants
|
|
Number of Participants Reporting Any Solicited Injection Site Reactions After Vaccine Injection
Any Solicited Injection Site Swelling
|
68 Participants
|
12 Participants
|
|
Number of Participants Reporting Any Solicited Injection Site Reactions After Vaccine Injection
Grade 3 Solicited Injection Site Swelling (≥ 5 cm)
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Any Solicited Injection Site Reactions After Vaccine Injection
Any Solicited Injection Site Induration
|
74 Participants
|
19 Participants
|
|
Number of Participants Reporting Any Solicited Injection Site Reactions After Vaccine Injection
Gr 3 Solicited Injection Site Induration (≥ 5 cm)
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Any Solicited Injection Site Reactions After Vaccine Injection
Any Solicited Injection Site Ecchymosis
|
14 Participants
|
7 Participants
|
|
Number of Participants Reporting Any Solicited Injection Site Reactions After Vaccine Injection
Gr 3 Solicited Injection Site Ecchymosis (≥ 5 cm)
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 0 through 7 post-vaccinationPopulation: Safety parameters were assessed in all enrolled and vaccinated subjects, intend-to-treat population.
Solicited systemic reactions: Fever (temperature); Headache; Malaise; and Myalgia. Data for this outcome were based on the first vaccination type, intradermal or intramuscular.
Outcome measures
| Measure |
Fluzone Intradermal Vaccine
n=56 Participants
Responses of participants following the receipt of a dose of Fluzone Intradermal (ID) in the right deltoid region or the left deltoid region on Day 0
|
Fluzone Intramuscular Vaccine
n=54 Participants
Responses of participants following the receipt of a dose of Fluzone Intramuscular (IM) in the right deltoid region or the left deltoid region on Day 0
|
|---|---|---|
|
Number of Participants Reporting Solicited Systemic Reactions After Vaccine Injection
Gr 3 Solicited Myalgia (Prevents daily activities)
|
3 Participants
|
1 Participants
|
|
Number of Participants Reporting Solicited Systemic Reactions After Vaccine Injection
Any Solicited Fever
|
6 Participants
|
3 Participants
|
|
Number of Participants Reporting Solicited Systemic Reactions After Vaccine Injection
Grade 3 Solicited Fever (> 102.2 °F)
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Systemic Reactions After Vaccine Injection
Any Solicited Headache
|
25 Participants
|
25 Participants
|
|
Number of Participants Reporting Solicited Systemic Reactions After Vaccine Injection
Gr 3 Solicited Headache -Prevents daily activities
|
3 Participants
|
1 Participants
|
|
Number of Participants Reporting Solicited Systemic Reactions After Vaccine Injection
Any Solicited Malaise
|
18 Participants
|
21 Participants
|
|
Number of Participants Reporting Solicited Systemic Reactions After Vaccine Injection
Gr 3 Solicited Malaise (Prevents daily activities)
|
4 Participants
|
4 Participants
|
|
Number of Participants Reporting Solicited Systemic Reactions After Vaccine Injection
Any Solicited Myalgia
|
31 Participants
|
26 Participants
|
Adverse Events
Fluzone Intradermal First, Then Fluzone Intramuscular
Serious events: 0 serious events
Other events: 92 other events
Deaths: 0 deaths
Fluzone Intramuscular First, Then Fluzone Intradermal
Serious events: 0 serious events
Other events: 75 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Fluzone Intradermal First, Then Fluzone Intramuscular
n=110 participants at risk；n=56 participants at risk
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
|
Fluzone Intramuscular First, Then Fluzone Intradermal
n=110 participants at risk；n=54 participants at risk
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
|
|---|---|---|
|
General disorders
Injection Site Pain
|
63.6%
70/110 • Number of events 70 • Adverse event data were collected from the day of vaccination for up to 28 days post-vaccination.
|
68.2%
75/110 • Number of events 75 • Adverse event data were collected from the day of vaccination for up to 28 days post-vaccination.
|
|
General disorders
Injection Site Pruritus
|
35.5%
39/110 • Number of events 39 • Adverse event data were collected from the day of vaccination for up to 28 days post-vaccination.
|
10.9%
12/110 • Number of events 12 • Adverse event data were collected from the day of vaccination for up to 28 days post-vaccination.
|
|
General disorders
Injection Site Erythema
|
83.6%
92/110 • Number of events 92 • Adverse event data were collected from the day of vaccination for up to 28 days post-vaccination.
|
13.6%
15/110 • Number of events 15 • Adverse event data were collected from the day of vaccination for up to 28 days post-vaccination.
|
|
General disorders
Injection Site Swelling
|
61.8%
68/110 • Number of events 68 • Adverse event data were collected from the day of vaccination for up to 28 days post-vaccination.
|
10.9%
12/110 • Number of events 12 • Adverse event data were collected from the day of vaccination for up to 28 days post-vaccination.
|
|
General disorders
Injection Site Induration
|
67.3%
74/110 • Number of events 74 • Adverse event data were collected from the day of vaccination for up to 28 days post-vaccination.
|
17.3%
19/110 • Number of events 19 • Adverse event data were collected from the day of vaccination for up to 28 days post-vaccination.
|
|
General disorders
Injection Site Ecchymosis
|
12.7%
14/110 • Number of events 14 • Adverse event data were collected from the day of vaccination for up to 28 days post-vaccination.
|
6.4%
7/110 • Number of events 7 • Adverse event data were collected from the day of vaccination for up to 28 days post-vaccination.
|
|
General disorders
Fever
|
10.7%
6/56 • Number of events 6 • Adverse event data were collected from the day of vaccination for up to 28 days post-vaccination.
|
5.6%
3/54 • Number of events 3 • Adverse event data were collected from the day of vaccination for up to 28 days post-vaccination.
|
|
General disorders
Malaise
|
32.1%
18/56 • Number of events 18 • Adverse event data were collected from the day of vaccination for up to 28 days post-vaccination.
|
38.9%
21/54 • Number of events 21 • Adverse event data were collected from the day of vaccination for up to 28 days post-vaccination.
|
|
Nervous system disorders
Headache
|
44.6%
25/56 • Number of events 25 • Adverse event data were collected from the day of vaccination for up to 28 days post-vaccination.
|
46.3%
25/54 • Number of events 25 • Adverse event data were collected from the day of vaccination for up to 28 days post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
55.4%
31/56 • Number of events 31 • Adverse event data were collected from the day of vaccination for up to 28 days post-vaccination.
|
48.1%
26/54 • Number of events 26 • Adverse event data were collected from the day of vaccination for up to 28 days post-vaccination.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
- Publication restrictions are in place
Restriction type: OTHER