Trial Outcomes & Findings for Safety and Immunogenicity of the World Health Organization (WHO) Formulation of the 2004-2005 Fluzone® Vaccine (NCT NCT00831987)
NCT ID: NCT00831987
Last Updated: 2016-04-14
Results Overview
Solicited local reactions: Erythema (redness), Induration, Bruising, and Pain at the injection site. Solicited systemic events: Fever (temperature), Chills, Rash, Headache, Cough, Runny nose, Nausea, Vomiting, Diarrhea, Malaise, Myalgia, and Arthralgia
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
120 participants
Primary outcome timeframe
0 to 3 days post-vaccination
Results posted on
2016-04-14
Participant Flow
The study participants were enrolled from 06 through 16 August 2004 in 1 US site.
A total of 120 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
Participant milestones
| Measure |
Fluzone® Vaccine Group - Age 18-59 Years
Participants received 1 dose of Fluzone® vaccine on Day 0.
|
Fluzone® Vaccine Group - Age ≥ 60 Years
Participants received 1 dose of Fluzone® vaccine on Day 0.
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
60
|
|
Overall Study
COMPLETED
|
60
|
60
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Immunogenicity of the World Health Organization (WHO) Formulation of the 2004-2005 Fluzone® Vaccine
Baseline characteristics by cohort
| Measure |
Fluzone® Vaccine Group - Age 18-59 Years
n=60 Participants
Participants received 1 dose of Fluzone® vaccine on Day 0.
|
Fluzone® Vaccine Group - Age ≥ 60 Years
n=60 Participants
Participants received 1 dose of Fluzone® vaccine on Day 0.
|
Total
n=120 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
|
4 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Age, Continuous
|
41.3 Years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
74 Years
STANDARD_DEVIATION 5.9 • n=7 Participants
|
57.7 Years
STANDARD_DEVIATION 18.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
60 participants
n=5 Participants
|
60 participants
n=7 Participants
|
120 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0 to 3 days post-vaccinationSolicited local reactions: Erythema (redness), Induration, Bruising, and Pain at the injection site. Solicited systemic events: Fever (temperature), Chills, Rash, Headache, Cough, Runny nose, Nausea, Vomiting, Diarrhea, Malaise, Myalgia, and Arthralgia
Outcome measures
| Measure |
Fluzone® Vaccine Group - Age 18-59 Years
n=60 Participants
Participants received 1 dose of Fluzone® vaccine on Day 0.
|
Fluzone® Vaccine Group - Age ≥ 60 Years
n=60 Participants
Participants received 1 dose of Fluzone® vaccine on Day 0.
|
|---|---|---|
|
Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination
Any Solicited Local (Injection Site) Reaction
|
60 Percentage of Participants
|
23 Percentage of Participants
|
|
Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination
Any Erythema (> 0.5 cm)
|
8 Percentage of Participants
|
5 Percentage of Participants
|
|
Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination
Grade 3 Erythema (≥ 5.0 cm)
|
0 Percentage of Participants
|
2 Percentage of Participants
|
|
Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination
Any Induration (> 0.5 cm)
|
7 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination
Grade 3 Induration (≥ 5.0 cm)
|
2 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination
Any Bruising (> 0.5 cm)
|
2 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination
Grade 3 Bruising (≥ 5.0 cm)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination
Any Pain
|
60 Percentage of Participants
|
20 Percentage of Participants
|
|
Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination
Grade 3 Pain (unable to perform usual activities)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination
Any Solicited Systemic Reaction
|
42 Percentage of Participants
|
23 Percentage of Participants
|
|
Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination
Any Fever (≥ 100.4 º F)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination
Grade 3 Fever (≥ 104.0 º F)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination
Any Headache
|
23 Percentage of Participants
|
8 Percentage of Participants
|
|
Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination
Grade 3 Headache (prevents daily activity)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination
Any Chills
|
2 Percentage of Participants
|
2 Percentage of Participants
|
|
Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination
Grade 3 Chills (prevents daily activity)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination
Any Cough
|
7 Percentage of Participants
|
3 Percentage of Participants
|
|
Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination
Grade 3 Cough (prevents daily activity)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination
Any Runny Nose
|
8 Percentage of Participants
|
3 Percentage of Participants
|
|
Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination
Grade 3 Runny Nose (prevents daily activity)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination
Any Rash
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination
Grade 3 Rash (prevents daily activity)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination
Any Malaise
|
7 Percentage of Participants
|
2 Percentage of Participants
|
|
Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination
Grade 3 Malaise (prevents daily activity)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination
Any Myalgia
|
13 Percentage of Participants
|
8 Percentage of Participants
|
|
Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination
Grade 3 Myalgia (prevents daily activity)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination
Any Arthralgia
|
7 Percentage of Participants
|
2 Percentage of Participants
|
|
Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination
Grade 3 Arthralgia (prevents daily activity)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination
Any Nausea
|
8 Percentage of Participants
|
2 Percentage of Participants
|
|
Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination
Grade 3 Nausea (prevents daily activity)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination
Any Vomiting
|
2 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination
Grade 3 Vomiting (≥ 3 per day)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination
Any Diarrhea
|
3 Percentage of Participants
|
5 Percentage of Participants
|
|
Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination
Grade 3 Diarrhea (≥ 5 episodes per day)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
PRIMARY outcome
Timeframe: Day 0 and Day 21 Post-VaccinationPopulation: Geometric Mean Titers were assessed in the per-protocol population
GMTs and their 95% Confidence Intervals for each of the 3 antigens pre- and post-vaccination with Fluzone® 2004-2005 formulation.
Outcome measures
| Measure |
Fluzone® Vaccine Group - Age 18-59 Years
n=60 Participants
Participants received 1 dose of Fluzone® vaccine on Day 0.
|
Fluzone® Vaccine Group - Age ≥ 60 Years
n=60 Participants
Participants received 1 dose of Fluzone® vaccine on Day 0.
|
|---|---|---|
|
Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-Vaccination With Fluzone® Vaccine
A/NEW CALEDONIA/20/99 (H1N1) Pre-vaccination
|
21.3 Titers
Interval 15.7 to 28.9
|
15.6 Titers
Interval 13.1 to 18.6
|
|
Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-Vaccination With Fluzone® Vaccine
A/New CALEDONIA/20/99 (H1N1) Post-vaccination
|
39.3 Titers
Interval 29.0 to 53.3
|
19.8 Titers
Interval 16.0 to 24.3
|
|
Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-Vaccination With Fluzone® Vaccine
A/WYOMING/03/2003 (H3N2) Pre-vaccination
|
34.2 Titers
Interval 24.1 to 48.7
|
25.6 Titers
Interval 20.1 to 32.6
|
|
Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-Vaccination With Fluzone® Vaccine
A/WYOMING/03/2003 (H3N2) Post-vaccination
|
85.7 Titers
Interval 64.8 to 113.4
|
64.2 Titers
Interval 46.2 to 89.1
|
|
Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-Vaccination With Fluzone® Vaccine
B/JIANGSU/10/2003 Pre-vaccination
|
23.5 Titers
Interval 18.3 to 30.2
|
21.5 Titers
Interval 16.3 to 28.5
|
PRIMARY outcome
Timeframe: 21 Days post-vaccinationOutcome measures
| Measure |
Fluzone® Vaccine Group - Age 18-59 Years
n=60 Participants
Participants received 1 dose of Fluzone® vaccine on Day 0.
|
Fluzone® Vaccine Group - Age ≥ 60 Years
n=60 Participants
Participants received 1 dose of Fluzone® vaccine on Day 0.
|
|---|---|---|
|
Percentage of Participants With at Least 40 Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination
A/NEW CALEDONIA/20/99 (H1N1)
|
60 Percentage of Participants
|
23 Percentage of Participants
|
|
Percentage of Participants With at Least 40 Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination
A/WYOMING/55/2004 (H3N2)
|
87 Percentage of Participants
|
78 Percentage of Participants
|
|
Percentage of Participants With at Least 40 Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination
B/JIANGSU/10/2003
|
45 Percentage of Participants
|
33 Percentage of Participants
|
PRIMARY outcome
Timeframe: Day 21 post-vaccinationOutcome measures
| Measure |
Fluzone® Vaccine Group - Age 18-59 Years
n=60 Participants
Participants received 1 dose of Fluzone® vaccine on Day 0.
|
Fluzone® Vaccine Group - Age ≥ 60 Years
n=60 Participants
Participants received 1 dose of Fluzone® vaccine on Day 0.
|
|---|---|---|
|
Percentage of Participants With at Least a 4-Fold Increase in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination
A/NEW CALEDONIA/20/99 (H1N1)
|
18 Percentage of Participants
|
5 Percentage of Participants
|
|
Percentage of Participants With at Least a 4-Fold Increase in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination
A/WYOMING/55/2004 (H3N2)
|
35 Percentage of Participants
|
33 Percentage of Participants
|
|
Percentage of Participants With at Least a 4-Fold Increase in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination
B/JIANGSU/10/2003
|
47 Percentage of Participants
|
23 Percentage of Participants
|
Adverse Events
Fluzone® Vaccine Group - Age 18-59 Years
Serious events: 0 serious events
Other events: 60 other events
Deaths: 0 deaths
Fluzone® Vaccine Group - Age ≥ 60 Years
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fluzone® Vaccine Group - Age 18-59 Years
n=60 participants at risk
Participants received 1 dose of Fluzone® vaccine on Day 0.
|
Fluzone® Vaccine Group - Age ≥ 60 Years
n=60 participants at risk
Participants received 1 dose of Fluzone® vaccine on Day 0.
|
|---|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/60 • Adverse events data were collected from the day of vaccination for 21 days post-vaccination.
|
1.7%
1/60 • Number of events 1 • Adverse events data were collected from the day of vaccination for 21 days post-vaccination.
|
Other adverse events
| Measure |
Fluzone® Vaccine Group - Age 18-59 Years
n=60 participants at risk
Participants received 1 dose of Fluzone® vaccine on Day 0.
|
Fluzone® Vaccine Group - Age ≥ 60 Years
n=60 participants at risk
Participants received 1 dose of Fluzone® vaccine on Day 0.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
5.0%
3/60 • Adverse events data were collected from the day of vaccination for 21 days post-vaccination.
|
8.3%
5/60 • Adverse events data were collected from the day of vaccination for 21 days post-vaccination.
|
|
General disorders
Injection site erythema
|
13.3%
8/60 • Adverse events data were collected from the day of vaccination for 21 days post-vaccination.
|
8.3%
5/60 • Adverse events data were collected from the day of vaccination for 21 days post-vaccination.
|
|
General disorders
Injection site induration
|
11.7%
7/60 • Adverse events data were collected from the day of vaccination for 21 days post-vaccination.
|
0.00%
0/60 • Adverse events data were collected from the day of vaccination for 21 days post-vaccination.
|
|
General disorders
Injection site pain
|
100.0%
60/60 • Adverse events data were collected from the day of vaccination for 21 days post-vaccination.
|
33.3%
20/60 • Adverse events data were collected from the day of vaccination for 21 days post-vaccination.
|
|
General disorders
Malaise
|
11.7%
7/60 • Adverse events data were collected from the day of vaccination for 21 days post-vaccination.
|
3.3%
2/60 • Adverse events data were collected from the day of vaccination for 21 days post-vaccination.
|
|
Gastrointestinal disorders
Diarrhoea NOS
|
1.7%
1/60 • Adverse events data were collected from the day of vaccination for 21 days post-vaccination.
|
5.0%
3/60 • Adverse events data were collected from the day of vaccination for 21 days post-vaccination.
|
|
Gastrointestinal disorders
Nausea
|
13.3%
8/60 • Adverse events data were collected from the day of vaccination for 21 days post-vaccination.
|
3.3%
2/60 • Adverse events data were collected from the day of vaccination for 21 days post-vaccination.
|
|
Nervous system disorders
Headache
|
16.7%
10/60 • Adverse events data were collected from the day of vaccination for 21 days post-vaccination.
|
5.0%
3/60 • Adverse events data were collected from the day of vaccination for 21 days post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
21.7%
13/60 • Adverse events data were collected from the day of vaccination for 21 days post-vaccination.
|
13.3%
8/60 • Adverse events data were collected from the day of vaccination for 21 days post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.7%
7/60 • Adverse events data were collected from the day of vaccination for 21 days post-vaccination.
|
3.3%
2/60 • Adverse events data were collected from the day of vaccination for 21 days post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.7%
7/60 • Adverse events data were collected from the day of vaccination for 21 days post-vaccination.
|
5.0%
3/60 • Adverse events data were collected from the day of vaccination for 21 days post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea (Runny nose)
|
13.3%
8/60 • Adverse events data were collected from the day of vaccination for 21 days post-vaccination.
|
5.0%
3/60 • Adverse events data were collected from the day of vaccination for 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