Trial Outcomes & Findings for Trial to Describe the Safety and Immunogenicity of Fluzone® (NCT NCT00524940)
NCT ID: NCT00524940
Last Updated: 2016-04-14
Results Overview
Information concerning the safety of Fluzone® vaccine 2007-2008 formulation.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
124 participants
Primary outcome timeframe
0-3 days post-vaccination and entire study duration
Results posted on
2016-04-14
Participant Flow
Participants were recruited from 15 August to 24 September 2007 at one US clinic site.
A total of 124 participants that met the inclusion and exclusion criteria were enrolled and vaccinated.
Participant milestones
| Measure |
Study Group
All participants enrolled and received Fluzone® Vaccine
|
|---|---|
|
Overall Study
STARTED
|
124
|
|
Overall Study
COMPLETED
|
124
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial to Describe the Safety and Immunogenicity of Fluzone®
Baseline characteristics by cohort
| Measure |
Study Group
n=124 Participants
All participants enrolled and received Fluzone® Vaccine
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
68 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
56 Participants
n=5 Participants
|
|
Age, Continuous
|
59.40 years
STANDARD_DEVIATION 19.50 • n=5 Participants
|
|
Sex: Female, Male
Female
|
80 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
124 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0-3 days post-vaccination and entire study durationPopulation: Safety analysis was on all enrolled and vaccinated participants, intend-to-treat Population.
Information concerning the safety of Fluzone® vaccine 2007-2008 formulation.
Outcome measures
| Measure |
Study Group
n=124 Participants
All participants enrolled and received Fluzone® Vaccine
|
|---|---|
|
Solicited Injection Site and Solicited Systemic Reactions Post-vaccination.
Grade 3 Shivering (Prevented daily activities)
|
0 Participants
|
|
Solicited Injection Site and Solicited Systemic Reactions Post-vaccination.
Any Solicited Injection Site Reaction
|
62 Participants
|
|
Solicited Injection Site and Solicited Systemic Reactions Post-vaccination.
Any Pain
|
57 Participants
|
|
Solicited Injection Site and Solicited Systemic Reactions Post-vaccination.
Grade 3 Pain (Incapacitating)
|
0 Participants
|
|
Solicited Injection Site and Solicited Systemic Reactions Post-vaccination.
Any Redness
|
9 Participants
|
|
Solicited Injection Site and Solicited Systemic Reactions Post-vaccination.
Grade 3 Redness (≥5.0 cm)
|
0 Participants
|
|
Solicited Injection Site and Solicited Systemic Reactions Post-vaccination.
Any Swelling
|
7 Participants
|
|
Solicited Injection Site and Solicited Systemic Reactions Post-vaccination.
Grade 3 Swelling (≥ 5.0 cm)
|
1 Participants
|
|
Solicited Injection Site and Solicited Systemic Reactions Post-vaccination.
Any Induration
|
8 Participants
|
|
Solicited Injection Site and Solicited Systemic Reactions Post-vaccination.
Grade 3 Induration (≥ 5.0 cm)
|
0 Participants
|
|
Solicited Injection Site and Solicited Systemic Reactions Post-vaccination.
Any Ecchymosis
|
5 Participants
|
|
Solicited Injection Site and Solicited Systemic Reactions Post-vaccination.
Grade 3 Ecchymosis (≥ 5.0 cm)
|
0 Participants
|
|
Solicited Injection Site and Solicited Systemic Reactions Post-vaccination.
Any Solicited Systemic Reaction
|
40 Participants
|
|
Solicited Injection Site and Solicited Systemic Reactions Post-vaccination.
Any Fever
|
3 Participants
|
|
Solicited Injection Site and Solicited Systemic Reactions Post-vaccination.
Grade 3 Fever (> 102.2°F)
|
0 Participants
|
|
Solicited Injection Site and Solicited Systemic Reactions Post-vaccination.
Any Headache
|
26 Participants
|
|
Solicited Injection Site and Solicited Systemic Reactions Post-vaccination.
Grade 3 Headache (Prevented daily activities)
|
1 Participants
|
|
Solicited Injection Site and Solicited Systemic Reactions Post-vaccination.
Any Malaise
|
15 Participants
|
|
Solicited Injection Site and Solicited Systemic Reactions Post-vaccination.
Grade 3 Malaise (Prevented daily activities)
|
0 Participants
|
|
Solicited Injection Site and Solicited Systemic Reactions Post-vaccination.
Any Myalgia
|
27 Participants
|
|
Solicited Injection Site and Solicited Systemic Reactions Post-vaccination.
Grade 3 Myalgia (Prevented daily activities)
|
0 Participants
|
|
Solicited Injection Site and Solicited Systemic Reactions Post-vaccination.
Any Shivering
|
1 Participants
|
PRIMARY outcome
Timeframe: 21 days post-vaccinationPopulation: The GMT were evaluated in the per-protocol Population
GMTs and their 95% Confidence Interval are presented for each of the 3 antigens in the Fluzone® Vaccine 2007-2008 formulation.
Outcome measures
| Measure |
Study Group
n=112 Participants
All participants enrolled and received Fluzone® Vaccine
|
|---|---|
|
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Pre-vaccination and Post-vaccination.
H1N1 A/Solomon Islands/3/2006 - PRE
|
30.7 Titer
Interval 23.4 to 40.2
|
|
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Pre-vaccination and Post-vaccination.
H1N1 A/Solomon Islands/3/2006 - POST
|
234.1 Titer
Interval 180.6 to 303.5
|
|
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Pre-vaccination and Post-vaccination.
H3N2 A/Wisconsin/67/2005 - PRE
|
88.1 Titer
Interval 66.7 to 116.2
|
|
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Pre-vaccination and Post-vaccination.
H3N2 A/Wisconsin/67/2005 - POST
|
347.9 Titer
Interval 281.0 to 430.7
|
|
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Pre-vaccination and Post-vaccination.
B/Malaysia/2506/2004 - PRE
|
13.0 Titer
Interval 11.0 to 15.4
|
|
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Pre-vaccination and Post-vaccination.
B/Malaysia/2506/2004 - POST
|
35.9 Titer
Interval 29.4 to 43.8
|
Adverse Events
Study Group
Serious events: 0 serious events
Other events: 57 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Study Group
n=124 participants at risk
All participants enrolled and received Fluzone® Vaccine
|
|---|---|
|
General disorders
Injection site pain
|
46.0%
57/124 • Adverse events data were collected from the day of vaccination to 21 days post-vaccination.
|
|
General disorders
Injection site redness
|
7.3%
9/124 • Adverse events data were collected from the day of vaccination to 21 days post-vaccination.
|
|
General disorders
Injection site swelling
|
5.6%
7/124 • Adverse events data were collected from the day of vaccination to 21 days post-vaccination.
|
|
General disorders
Injection site induration
|
6.5%
8/124 • Adverse events data were collected from the day of vaccination to 21 days post-vaccination.
|
|
Nervous system disorders
Headache
|
21.0%
26/124 • Adverse events data were collected from the day of vaccination to 21 days post-vaccination.
|
|
General disorders
Malaise
|
12.1%
15/124 • Adverse events data were collected from the day of vaccination to 21 days post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
21.8%
27/124 • Adverse events data were collected from the day of vaccination to 21 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