Trial Outcomes & Findings for Phase IV Trial to Determine the Safety and Immunogenicity of the WHO Formulation of the 2006-2007 Fluzone® Vaccine (NCT NCT00389532)
NCT ID: NCT00389532
Last Updated: 2016-04-14
Results Overview
Percentage of Participants with Solicited Injection Site or Systemic Reaction(s) within 0-3 days after vaccination with Fluzone® (2006-2007 formulation)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
116 participants
Primary outcome timeframe
0-3 days post-vaccination
Results posted on
2016-04-14
Participant Flow
Study participants were enrolled from October through December 2006 in 1 medical clinic in the US
A total of 116 participants that met the inclusion and exclusion criteria were enrolled and vaccinated.
Participant milestones
| Measure |
Aged 18 to 59 Years
Participants aged 18 to 59 years at enrollment
|
Aged ≥ 60 Years
Participants aged 60 years and older at enrollment
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
56
|
|
Overall Study
COMPLETED
|
60
|
56
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase IV Trial to Determine the Safety and Immunogenicity of the WHO Formulation of the 2006-2007 Fluzone® Vaccine
Baseline characteristics by cohort
| Measure |
Aged 18 to 59 Years
n=60 Participants
Participants aged 18 to 59 years at enrollment
|
Aged ≥ 60 Years
n=56 Participants
Participants aged 60 years and older at enrollment
|
Total
n=116 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
|
60 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Age, Continuous
|
39.5 years
STANDARD_DEVIATION 12.25 • n=5 Participants
|
76.4 years
STANDARD_DEVIATION 8.55 • n=7 Participants
|
57.3 years
STANDARD_DEVIATION 21.33 • n=5 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
60 participants
n=5 Participants
|
56 participants
n=7 Participants
|
116 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0-3 days post-vaccinationPopulation: Analysis was on all enrolled and vaccinated participants, Intend-to-treat population.
Percentage of Participants with Solicited Injection Site or Systemic Reaction(s) within 0-3 days after vaccination with Fluzone® (2006-2007 formulation)
Outcome measures
| Measure |
Aged 18 to 59 Years
n=60 Participants
Participants aged 18 to 59 years at enrollment
|
Aged ≥ 60 Years
n=56 Participants
Participants aged 60 years and older at enrollment
|
|---|---|---|
|
Percentage of Participants With Solicited Injection Site or Systemic Reaction(s) After Fluzone® Vaccination
Any Solicited Injection Site Reaction
|
78 Percentage of Participants
|
38 Percentage of Participants
|
|
Percentage of Participants With Solicited Injection Site or Systemic Reaction(s) After Fluzone® Vaccination
Any Pain
|
78 Percentage of Participants
|
30 Percentage of Participants
|
|
Percentage of Participants With Solicited Injection Site or Systemic Reaction(s) After Fluzone® Vaccination
Grade 3 Pain (Incapacitating)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Solicited Injection Site or Systemic Reaction(s) After Fluzone® Vaccination
Any Redness
|
7 Percentage of Participants
|
9 Percentage of Participants
|
|
Percentage of Participants With Solicited Injection Site or Systemic Reaction(s) After Fluzone® Vaccination
Grade 3 Redness (≥ 5.0 cm)
|
0 Percentage of Participants
|
4 Percentage of Participants
|
|
Percentage of Participants With Solicited Injection Site or Systemic Reaction(s) After Fluzone® Vaccination
Any Swelling
|
3 Percentage of Participants
|
6 Percentage of Participants
|
|
Percentage of Participants With Solicited Injection Site or Systemic Reaction(s) After Fluzone® Vaccination
Grade 3 Swelling (≥ 5.0 cm)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Solicited Injection Site or Systemic Reaction(s) After Fluzone® Vaccination
Any Solicited Systemic Reaction
|
49 Percentage of Participants
|
29 Percentage of Participants
|
|
Percentage of Participants With Solicited Injection Site or Systemic Reaction(s) After Fluzone® Vaccination
Any Fever
|
3 Percentage of Participants
|
2 Percentage of Participants
|
|
Percentage of Participants With Solicited Injection Site or Systemic Reaction(s) After Fluzone® Vaccination
Grade 3 Fever (> 102.2°F)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Solicited Injection Site or Systemic Reaction(s) After Fluzone® Vaccination
Any Headache
|
39 Percentage of Participants
|
11 Percentage of Participants
|
|
Percentage of Participants With Solicited Injection Site or Systemic Reaction(s) After Fluzone® Vaccination
Grade 3 Headache (Prevented daily activities)
|
2 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Solicited Injection Site or Systemic Reaction(s) After Fluzone® Vaccination
Any Malaise
|
25 Percentage of Participants
|
9 Percentage of Participants
|
|
Percentage of Participants With Solicited Injection Site or Systemic Reaction(s) After Fluzone® Vaccination
Grade 3 Malaise (Prevented daily activities)
|
2 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Solicited Injection Site or Systemic Reaction(s) After Fluzone® Vaccination
Any Myalgia
|
27 Percentage of Participants
|
21 Percentage of Participants
|
|
Percentage of Participants With Solicited Injection Site or Systemic Reaction(s) After Fluzone® Vaccination
Grade 3 Myalgia (Prevented daily activities)
|
2 Percentage of Participants
|
0 Percentage of Participants
|
PRIMARY outcome
Timeframe: 21 days post-vaccinationPopulation: Geometric Mean Titers were evaluated in the per-protocol immunogenicity Population
GMTs and their 95% confidence intervals for each of the 3 antigens in the Fluzone® vaccine (2006-2007 formulation) pre-vaccination and 21 days post-vaccination.
Outcome measures
| Measure |
Aged 18 to 59 Years
n=55 Participants
Participants aged 18 to 59 years at enrollment
|
Aged ≥ 60 Years
n=55 Participants
Participants aged 60 years and older at enrollment
|
|---|---|---|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition Antibodies Pre-vaccination and Post-vaccination
H1N1 FLU A/NEW CALEDONIA/20/99 - PRE
|
66.2 Titer
Interval 41.6 to 105.0
|
36.9 Titer
Interval 28.5 to 47.7
|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition Antibodies Pre-vaccination and Post-vaccination
H1N1 FLU A/NEW CALEDONIA/20/99 - POST
|
214 Titer
Interval 151.0 to 304.0
|
77.0 Titer
Interval 57.9 to 102.0
|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition Antibodies Pre-vaccination and Post-vaccination
H3N2 FLU A/WISCONSIN/67/2005 - PRE
|
67.9 Titer
Interval 44.4 to 104.0
|
110 Titer
Interval 70.8 to 170.0
|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition Antibodies Pre-vaccination and Post-vaccination
H3N2 FLU A/WISCONSIN/67/2005 - POST
|
453 Titer
Interval 334.0 to 613.0
|
513 Titer
Interval 363.0 to 726.0
|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition Antibodies Pre-vaccination and Post-vaccination
B FLU B/MALAYSIA SPLIT/2506/2004 - PRE
|
117 Titer
Interval 83.5 to 165.0
|
195 Titer
Interval 157.0 to 241.0
|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition Antibodies Pre-vaccination and Post-vaccination
B FLU B/MALAYSIA SPLIT/2506/2004 - POST
|
788 Titer
Interval 589.0 to 1054.0
|
597 Titer
Interval 477.0 to 748.0
|
Adverse Events
Aged 18 to 59 Years
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Aged ≥ 60 Years
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Aged 18 to 59 Years
n=60 participants at risk
Participants aged 18 to 59 years at enrollment
|
Aged ≥ 60 Years
n=56 participants at risk
Participants aged 60 years and older at enrollment
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
5.0%
3/60 • Number of events 4 • Up to 28 days post-vaccination
|
1.8%
1/56 • Number of events 1 • Up to 28 days post-vaccination
|
|
Nervous system disorders
Headache
|
11.7%
7/60 • Number of events 9 • Up to 28 days post-vaccination
|
0.00%
0/56 • Up to 28 days post-vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.0%
3/60 • Number of events 3 • Up to 28 days post-vaccination
|
1.8%
1/56 • Number of events 1 • Up to 28 days post-vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
5.0%
3/60 • Number of events 3 • Up to 28 days post-vaccination
|
1.8%
1/56 • Number of events 1 • Up to 28 days post-vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
5.0%
3/60 • Number of events 3 • Up to 28 days post-vaccination
|
1.8%
1/56 • Number of events 1 • Up to 28 days post-vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
6.7%
4/60 • Number of events 4 • Up to 28 days post-vaccination
|
0.00%
0/56 • 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