Trial Outcomes & Findings for Study of Fluzone® Influenza Virus Vaccine 2011-2012 Formulation (Intramuscular Route) Among Adults (NCT NCT01430819)
NCT ID: NCT01430819
Last Updated: 2013-05-27
Results Overview
Solicited injection site reactions: Pain, Erythema and Swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia. Grade 3 solicited reactions were defined as: Fever ≥ 39.0°C; Pain, Headache, Malaise and Myalgia, significant, prevents daily activities; Erythema and Swelling \> 100 mm.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
300 participants
Primary outcome timeframe
Day 0 to up to Day 28 post-vaccination
Results posted on
2013-05-27
Participant Flow
Study participants were enrolled from 07 September through 24 October 2011 in 6 clinic sites in the US.
A total of 300 participants who met the inclusion, but no exclusion criteria were enrolled and vaccinated.
Participant milestones
| Measure |
Fluzone® Vaccine Group
Participants received the Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation
|
Fluzone® High-Dose Vaccine Group
Participants received the Influenza Virus Vaccine, Fluzone® High-Dose 2011-2012 Formulation.
|
|---|---|---|
|
Overall Study
STARTED
|
150
|
150
|
|
Overall Study
COMPLETED
|
150
|
150
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Fluzone® Influenza Virus Vaccine 2011-2012 Formulation (Intramuscular Route) Among Adults
Baseline characteristics by cohort
| Measure |
Fluzone® Vaccine Group
n=150 Participants
Participants received the Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation.
|
Fluzone® High-Dose Vaccine Group
n=150 Participants
Participants received the Influenza Virus Vaccine: Fluzone® High-Dose 2011-2012 Formulation.
|
Total
n=300 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
150 Participants
n=99 Participants
|
150 Participants
n=107 Participants
|
300 Participants
n=206 Participants
|
|
Age Continuous
|
72.6 Months
STANDARD_DEVIATION 5.8 • n=99 Participants
|
71.6 Months
STANDARD_DEVIATION 4.8 • n=107 Participants
|
72.1 Months
STANDARD_DEVIATION 5.3 • n=206 Participants
|
|
Sex: Female, Male
Female
|
91 Participants
n=99 Participants
|
92 Participants
n=107 Participants
|
183 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=99 Participants
|
58 Participants
n=107 Participants
|
117 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
150 Participants
n=99 Participants
|
150 Participants
n=107 Participants
|
300 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 0 to up to Day 28 post-vaccinationPopulation: Solicited injection site and systemic reactions were assessed in all enrolled and vaccinated participants, Intent-to-treat population (Safety Analysis Set).
Solicited injection site reactions: Pain, Erythema and Swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia. Grade 3 solicited reactions were defined as: Fever ≥ 39.0°C; Pain, Headache, Malaise and Myalgia, significant, prevents daily activities; Erythema and Swelling \> 100 mm.
Outcome measures
| Measure |
Fluzone® Vaccine Group
n=150 Participants
Participants received the Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation.
|
Fluzone® High-Dose Vaccine Group
n=150 Participants
Participants received the Influenza Virus Vaccine: Fluzone® High-Dose 2011-2012 Formulation.
|
|---|---|---|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Fluzone® or Fluzone® High-Dose Vaccine
Any injection site Pain
|
36 Participants
|
79 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Fluzone® or Fluzone® High-Dose Vaccine
Grade 3 injection site Pain
|
1 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Fluzone® or Fluzone® High-Dose Vaccine
Any injection site Erythema
|
7 Participants
|
13 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Fluzone® or Fluzone® High-Dose Vaccine
Any injection site Swelling
|
4 Participants
|
10 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Fluzone® or Fluzone® High-Dose Vaccine
Grade 3 injection site Swelling
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Fluzone® or Fluzone® High-Dose Vaccine
Any Fever
|
2 Participants
|
1 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Fluzone® or Fluzone® High-Dose Vaccine
Grade 3 Fever
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Fluzone® or Fluzone® High-Dose Vaccine
Any Headache
|
26 Participants
|
25 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Fluzone® or Fluzone® High-Dose Vaccine
Grade 3 Headache
|
2 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Fluzone® or Fluzone® High-Dose Vaccine
Any Malaise
|
21 Participants
|
24 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Fluzone® or Fluzone® High-Dose Vaccine
Grade 3 Malaise
|
5 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Fluzone® or Fluzone® High-Dose Vaccine
Any Myalgia
|
25 Participants
|
44 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Fluzone® or Fluzone® High-Dose Vaccine
Grade 3 Myalgia
|
3 Participants
|
1 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Fluzone® or Fluzone® High-Dose Vaccine
Grade 3 injection site Erythema
|
0 Participants
|
2 Participants
Interval 0.0 to 0.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 21 post-vaccinationPopulation: GMTs of antibodies against Influenza vaccine antigens were determined in all enrolled and vaccinated participants, per-protocol population
Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay.
Outcome measures
| Measure |
Fluzone® Vaccine Group
n=147 Participants
Participants received the Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation.
|
Fluzone® High-Dose Vaccine Group
n=145 Participants
Participants received the Influenza Virus Vaccine: Fluzone® High-Dose 2011-2012 Formulation.
|
|---|---|---|
|
Geometric Mean Titers of Antibodies to Vaccine Antigens Before and Following Vaccination With Either Fluzone® or Fluzone® High-Dose Vaccine.
A/H1N1 (Pre-vaccination; N = 147, 145)
|
63.9 Titers
Interval 50.1 to 81.5
|
57.5 Titers
Interval 44.6 to 74.1
|
|
Geometric Mean Titers of Antibodies to Vaccine Antigens Before and Following Vaccination With Either Fluzone® or Fluzone® High-Dose Vaccine.
A/H1N1 (Post-vaccination; N = 147, 144)
|
228 Titers
Interval 187.0 to 279.0
|
442 Titers
Interval 362.0 to 540.0
|
|
Geometric Mean Titers of Antibodies to Vaccine Antigens Before and Following Vaccination With Either Fluzone® or Fluzone® High-Dose Vaccine.
A/H3N2 (Pre-vaccination; N = 147, 145)
|
104 Titers
Interval 80.2 to 134.0
|
102 Titers
Interval 78.1 to 133.0
|
|
Geometric Mean Titers of Antibodies to Vaccine Antigens Before and Following Vaccination With Either Fluzone® or Fluzone® High-Dose Vaccine.
A/H3N2 (Post-vaccination; N = 147, 145)
|
384 Titers
Interval 317.0 to 465.0
|
880 Titers
Interval 721.0 to 1072.0
|
|
Geometric Mean Titers of Antibodies to Vaccine Antigens Before and Following Vaccination With Either Fluzone® or Fluzone® High-Dose Vaccine.
B (Pre-vaccination; N = 147, 145)
|
32.4 Titers
Interval 27.2 to 38.5
|
31.1 Titers
Interval 25.8 to 37.5
|
|
Geometric Mean Titers of Antibodies to Vaccine Antigens Before and Following Vaccination With Either Fluzone® or Fluzone® High-Dose Vaccine.
B (Post-vaccination; N = 147, 145)
|
73.0 Titers
Interval 63.4 to 84.0
|
106 Titers
Interval 90.2 to 125.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 21 post-vaccinationPopulation: Seroconversion to Influenza vaccine antigens were determined in all enrolled and vaccinated participants, per-protocol population
Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay. Seroconversion was defined as either a pre-vaccination HAI titer \< 1:10 and a post-vaccination titer ≥ 1:40; or a pre-vaccination titer ≥ 1:10 and a four-fold increase in post-vaccination titer.
Outcome measures
| Measure |
Fluzone® Vaccine Group
n=147 Participants
Participants received the Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation.
|
Fluzone® High-Dose Vaccine Group
n=145 Participants
Participants received the Influenza Virus Vaccine: Fluzone® High-Dose 2011-2012 Formulation.
|
|---|---|---|
|
Number of Participants With Seroconversion Following Vaccination With Either Fluzone® or Fluzone® High-Dose Vaccine
A/H1N1 (N = 147, 144)
|
53 Participants
|
88 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Seroconversion Following Vaccination With Either Fluzone® or Fluzone® High-Dose Vaccine
A/H3N2 (N = 147, 145)
|
60 Participants
|
100 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Seroconversion Following Vaccination With Either Fluzone® or Fluzone® High-Dose Vaccine
B (N = 147, 145)
|
32 Participants
|
60 Participants
Interval 0.0 to 0.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 21 post-vaccinationPopulation: Geometric mean of titer ratios of antibodies against Influenza vaccine antigens were determined in all enrolled and vaccinated participants, per-protocol population
Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay. Geometric mean of titer ratio is the geometric mean of the individual post-vaccination/pre-vaccination titer ratios.
Outcome measures
| Measure |
Fluzone® Vaccine Group
n=147 Participants
Participants received the Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation.
|
Fluzone® High-Dose Vaccine Group
n=145 Participants
Participants received the Influenza Virus Vaccine: Fluzone® High-Dose 2011-2012 Formulation.
|
|---|---|---|
|
Geometric Mean of Titer Ratios (GMTR) of Antibodies to Vaccine Antigens Before and Following Vaccination With Either Fluzone® or Fluzone® High-Dose Vaccine.
A/H1N1 (N = 147, 144)
|
3.28 Titers
Interval 2.69 to 4.01
|
7.14 Titers
Interval 5.61 to 9.11
|
|
Geometric Mean of Titer Ratios (GMTR) of Antibodies to Vaccine Antigens Before and Following Vaccination With Either Fluzone® or Fluzone® High-Dose Vaccine.
B (N = 147, 145)
|
2.13 Titers
Interval 1.9 to 2.38
|
3.14 Titers
Interval 2.69 to 3.67
|
|
Geometric Mean of Titer Ratios (GMTR) of Antibodies to Vaccine Antigens Before and Following Vaccination With Either Fluzone® or Fluzone® High-Dose Vaccine.
A/H3N2 (N = 147, 145)
|
3.5 Titers
Interval 2.88 to 4.24
|
8.23 Titers
Interval 6.45 to 10.5
|
Adverse Events
Fluzone® Vaccine Group
Serious events: 1 serious events
Other events: 36 other events
Deaths: 0 deaths
Fluzone® High-Dose Vaccine Group
Serious events: 0 serious events
Other events: 79 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fluzone® Vaccine Group
n=150 participants at risk
Participants received the Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation.
|
Fluzone® High-Dose Vaccine Group
n=150 participants at risk
Participants received the Influenza Virus Vaccine: Fluzone® High-Dose 2011-2012 Formulation.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Joint injury
|
0.67%
1/150 • Number of events 1 • Adverse events were recorded following vaccination (Day 0) for up to 28 days post-vaccination
|
0.00%
0/150 • Adverse events were recorded following vaccination (Day 0) for up to 28 days post-vaccination
|
Other adverse events
| Measure |
Fluzone® Vaccine Group
n=150 participants at risk
Participants received the Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation.
|
Fluzone® High-Dose Vaccine Group
n=150 participants at risk
Participants received the Influenza Virus Vaccine: Fluzone® High-Dose 2011-2012 Formulation.
|
|---|---|---|
|
General disorders
Injection site Pain
|
24.0%
36/150 • Number of events 36 • Adverse events were recorded following vaccination (Day 0) for up to 28 days post-vaccination
|
52.7%
79/150 • Number of events 79 • Adverse events were recorded following vaccination (Day 0) for up to 28 days post-vaccination
|
|
General disorders
Injection site Erythema
|
4.7%
7/150 • Number of events 7 • Adverse events were recorded following vaccination (Day 0) for up to 28 days post-vaccination
|
8.7%
13/150 • Number of events 13 • Adverse events were recorded following vaccination (Day 0) for up to 28 days post-vaccination
|
|
General disorders
Injection site Swelling
|
2.7%
4/150 • Number of events 4 • Adverse events were recorded following vaccination (Day 0) for up to 28 days post-vaccination
|
6.7%
10/150 • Number of events 10 • Adverse events were recorded following vaccination (Day 0) for up to 28 days post-vaccination
|
|
General disorders
Malaise
|
14.0%
21/150 • Number of events 21 • Adverse events were recorded following vaccination (Day 0) for up to 28 days post-vaccination
|
16.0%
24/150 • Number of events 24 • Adverse events were recorded following vaccination (Day 0) for up to 28 days post-vaccination
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.7%
25/150 • Number of events 25 • Adverse events were recorded following vaccination (Day 0) for up to 28 days post-vaccination
|
29.3%
44/150 • Number of events 44 • Adverse events were recorded following vaccination (Day 0) for up to 28 days post-vaccination
|
|
Nervous system disorders
Headache
|
17.3%
26/150 • Number of events 26 • Adverse events were recorded following vaccination (Day 0) for up to 28 days post-vaccination
|
16.7%
25/150 • Number of events 25 • Adverse events were recorded following vaccination (Day 0) 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