Trial Outcomes & Findings for Safety and Immunogenicity of Fluzone® Vaccine in Children Who Received 2 Doses of the 2005-2006 Fluzone Formulation. (NCT NCT00390884)
NCT ID: NCT00390884
Last Updated: 2016-04-14
Results Overview
Seroprotection was defined as a Post-vaccination Hemagglutination Inhibition titer of greater than or equal to 1:40.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
173 participants
Primary outcome timeframe
Day 28 Post-vaccination
Results posted on
2016-04-14
Participant Flow
Participants were enrolled into this study from 03 October 2006 to 04 January 2007 at 5 US clinical centers.
A total of 173 participants were enrolled, vaccinated, and analyzed.
Participant milestones
| Measure |
Fluzone®-Primed Group
Participants had received two doses of the 2005-2006 formulation of Fluzone® vaccine in the fall of 2005 (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
|
Fluzone®-Naive Group
Participants had never received influenza vaccine and had received two doses of placebo (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
|
|---|---|---|
|
Overall Study
STARTED
|
116
|
57
|
|
Overall Study
COMPLETED
|
114
|
55
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Fluzone®-Primed Group
Participants had received two doses of the 2005-2006 formulation of Fluzone® vaccine in the fall of 2005 (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
|
Fluzone®-Naive Group
Participants had never received influenza vaccine and had received two doses of placebo (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
Baseline Characteristics
Safety and Immunogenicity of Fluzone® Vaccine in Children Who Received 2 Doses of the 2005-2006 Fluzone Formulation.
Baseline characteristics by cohort
| Measure |
Fluzone®-Primed Group
n=116 Participants
Participants had received two doses of the 2005-2006 formulation of Fluzone® vaccine in the fall of 2005 (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
|
Fluzone®-Naive Group
n=57 Participants
Participants had never received influenza vaccine and had received two doses of placebo (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
|
Total
n=173 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
116 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
173 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
13.8 Months
STANDARD_DEVIATION 1.01 • n=5 Participants
|
13.9 Months
STANDARD_DEVIATION 1.13 • n=7 Participants
|
13.8 Months
STANDARD_DEVIATION 1.07 • n=5 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
68 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
116 participants
n=5 Participants
|
57 participants
n=7 Participants
|
173 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 28 Post-vaccinationPopulation: Hemagglutination inhibition titers to the Fluzone® vaccine antigens were assessed in the per-protocol immunogenicity population.
Seroprotection was defined as a Post-vaccination Hemagglutination Inhibition titer of greater than or equal to 1:40.
Outcome measures
| Measure |
Fluzone®-Primed Group
n=94 Participants
Participants had received two doses of the 2005-2006 formulation of Fluzone® vaccine in the fall of 2005 (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
|
Fluzone®-Naive Group
n=50 Participants
Participants had never received influenza vaccine and had received two doses of placebo (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
|
|---|---|---|
|
Percentage of Seroprotected Participants Post-vaccination With Fluzone®
Flu A/Wisconsin/67/2005 (H3N2) Post -Dose 2
|
79 Percentage of Participants
|
94 Percentage of Participants
|
|
Percentage of Seroprotected Participants Post-vaccination With Fluzone®
Flu B/Malaysia/2506/2004 Post-Dose 2
|
50 Percentage of Participants
|
65 Percentage of Participants
|
|
Percentage of Seroprotected Participants Post-vaccination With Fluzone®
Flu A/New Caledonia/20/99 (H1N1) Post-Dose 1
|
59 Percentage of Participants
|
34 Percentage of Participants
|
|
Percentage of Seroprotected Participants Post-vaccination With Fluzone®
Flu A/Wisconsin/67/2005 (H3N2) Post -Dose 1
|
95 Percentage of Participants
|
80 Percentage of Participants
|
|
Percentage of Seroprotected Participants Post-vaccination With Fluzone®
Flu B/Malaysia/2506/2004 Post-Dose 1
|
10 Percentage of Participants
|
6 Percentage of Participants
|
|
Percentage of Seroprotected Participants Post-vaccination With Fluzone®
Flu A/New Caledonia/20/99 (H1N1) Post-Dose 2
|
62 Percentage of Participants
|
82 Percentage of Participants
|
SECONDARY outcome
Timeframe: Day 28 Post-vaccinationPopulation: The Geometric Mean Titers were analyzed in the per-protocol immunogenicity population
Antibodies against Influenza virus in Fluzone® Vaccine determined by the Hemagglutination inhibition (HAI) assay method.
Outcome measures
| Measure |
Fluzone®-Primed Group
n=94 Participants
Participants had received two doses of the 2005-2006 formulation of Fluzone® vaccine in the fall of 2005 (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
|
Fluzone®-Naive Group
n=50 Participants
Participants had never received influenza vaccine and had received two doses of placebo (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
|
|---|---|---|
|
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Post-vaccination With Fluzone®
Flu A/New Caledonia/20/99 (H1N1) Post-Dose 1
|
41.3 Titers
Interval 32.9 to 52.0
|
22.7 Titers
Interval 17.9 to 28.7
|
|
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Post-vaccination With Fluzone®
Flu A/Wisconsin/67/2005 (H3N2) Post-Dose 1
|
144 Titers
Interval 116.0 to 179.0
|
89.4 Titers
Interval 55.4 to 144.0
|
|
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Post-vaccination With Fluzone®
Flu B/Malaysia/2506/2004 Post-Dose 1
|
11.1 Titers
Interval 8.45 to 14.6
|
9.27 Titers
Interval 6.31 to 13.6
|
|
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Post-vaccination With Fluzone®
Flu A/New Caledonia/20/99 (H1N1) Post-Dose 2
|
42.1 Titers
Interval 27.3 to 64.8
|
78.4 Titers
Interval 47.1 to 131.0
|
|
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Post-vaccination With Fluzone®
Flu A/Wisconsin/67/2005 (H3N2) Post-Dose 2
|
103 Titers
Interval 68.9 to 155.0
|
217 Titers
Interval 122.0 to 388.0
|
|
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Post-vaccination With Fluzone®
Flu B/Malaysia/2506/2004 Post-Dose 2
|
39.2 Titers
Interval 25.5 to 60.3
|
63.9 Titers
Interval 34.9 to 117.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 0-7 Post-vaccinationPopulation: The safety analysis was on all enrolled and vaccinated participants, intent-to-treat population.
Solicited injection site: tenderness, erythema, and swelling; Solicited systemic reactions: fever, vomiting, abnormal crying, drowsiness, appetite loss, and irritability, after each vaccination
Outcome measures
| Measure |
Fluzone®-Primed Group
n=116 Participants
Participants had received two doses of the 2005-2006 formulation of Fluzone® vaccine in the fall of 2005 (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
|
Fluzone®-Naive Group
n=57 Participants
Participants had never received influenza vaccine and had received two doses of placebo (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
|
|---|---|---|
|
Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone®
Any Injection Site Reaction Post-Dose 2
|
57 Percentage of Participants
|
51 Percentage of Participants
|
|
Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone®
Grade 3 Swelling (≥ 5.0 cm)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone®
Any Injection Site Reaction - Any Dose
|
68 Percentage of Participants
|
69 Percentage of Participants
|
|
Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone®
Any Tenderness
|
56 Percentage of Participants
|
49 Percentage of Participants
|
|
Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone®
Grade 3 Tenderness (Crying when limb is moved)
|
1 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone®
Any Fever
|
16 Percentage of Participants
|
24 Percentage of Participants
|
|
Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone®
Grade 3 Fever (≥ 103.2 ºF)
|
2 Percentage of Participants
|
2 Percentage of Participants
|
|
Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone®
Any Vomiting
|
13 Percentage of Participants
|
16 Percentage of Participants
|
|
Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone®
Grade 3 Vomiting (≥ 6 episodes per 24 hours)
|
2 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone®
Any Abnormal Crying
|
55 Percentage of Participants
|
53 Percentage of Participants
|
|
Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone®
Any Drowsiness
|
32 Percentage of Participants
|
33 Percentage of Participants
|
|
Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone®
Any Loss of Appetite
|
53 Percentage of Participants
|
33 Percentage of Participants
|
|
Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone®
Grade 3 Loss of Appetite (Refuses ≥ 3 feeds)
|
2 Percentage of Participants
|
2 Percentage of Participants
|
|
Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone®
Any Irritability
|
74 Percentage of Participants
|
78 Percentage of Participants
|
|
Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone®
Grade 3 Irritability (Inconsolable)
|
5 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone®
Grade 3 Abnormal Crying (> 3 hours)
|
3 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone®
Grade 3 Drowsiness (Slept most of time)
|
1 Percentage of Participants
|
2 Percentage of Participants
|
|
Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone®
Any Systemic Reaction - Any Dose
|
88 Percentage of Participants
|
89 Percentage of Participants
|
|
Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone®
Any Injection Site Reaction Post-Dose 1
|
51 Percentage of Participants
|
55 Percentage of Participants
|
|
Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone®
Any Redness (> 0.5 cm)
|
13 Percentage of Participants
|
11 Percentage of Participants
|
|
Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone®
Grade 3 Redness (≥ 5.0 cm)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone®
Any Swelling (> 0.5 cm)
|
6 Percentage of Participants
|
7 Percentage of Participants
|
|
Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone®
Any Systemic Reaction Post-Dose 1
|
75 Percentage of Participants
|
76 Percentage of Participants
|
|
Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone®
Any Systemic Reaction Post-Dose 2
|
72 Percentage of Participants
|
71 Percentage of Participants
|
Adverse Events
Fluzone®-Primed Group
Serious events: 1 serious events
Other events: 87 other events
Deaths: 0 deaths
Fluzone®-Naive Group
Serious events: 0 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fluzone®-Primed Group
n=116 participants at risk
Participants had received two doses of the 2005-2006 formulation of Fluzone® vaccine in the fall of 2005 (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
|
Fluzone®-Naive Group
n=57 participants at risk
Participants had never received influenza vaccine and had received two doses of placebo (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
|
|---|---|---|
|
Infections and infestations
Gastroenteritis
|
0.86%
1/116 • Number of events 1 • Adverse event data were collected for 2 months post-vaccination.
|
0.00%
0/57 • Adverse event data were collected for 2 months post-vaccination.
|
Other adverse events
| Measure |
Fluzone®-Primed Group
n=116 participants at risk
Participants had received two doses of the 2005-2006 formulation of Fluzone® vaccine in the fall of 2005 (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
|
Fluzone®-Naive Group
n=57 participants at risk
Participants had never received influenza vaccine and had received two doses of placebo (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
19.8%
23/116 • Number of events 27 • Adverse event data were collected for 2 months post-vaccination.
|
22.8%
13/57 • Number of events 14 • Adverse event data were collected for 2 months post-vaccination.
|
|
Gastrointestinal disorders
Teething
|
17.2%
20/116 • Number of events 30 • Adverse event data were collected for 2 months post-vaccination.
|
8.8%
5/57 • Number of events 6 • Adverse event data were collected for 2 months post-vaccination.
|
|
Gastrointestinal disorders
Vomiting
|
14.7%
17/116 • Number of events 17 • Adverse event data were collected for 2 months post-vaccination.
|
8.8%
5/57 • Number of events 5 • Adverse event data were collected for 2 months post-vaccination.
|
|
General disorders
Pyrexia
|
16.4%
19/116 • Number of events 20 • Adverse event data were collected for 2 months post-vaccination.
|
19.3%
11/57 • Number of events 12 • Adverse event data were collected for 2 months post-vaccination.
|
|
Infections and infestations
Croup infectious
|
6.0%
7/116 • Number of events 7 • Adverse event data were collected for 2 months post-vaccination.
|
1.8%
1/57 • Number of events 1 • Adverse event data were collected for 2 months post-vaccination.
|
|
Infections and infestations
Nasopharyngitis
|
11.2%
13/116 • Number of events 15 • Adverse event data were collected for 2 months post-vaccination.
|
10.5%
6/57 • Number of events 6 • Adverse event data were collected for 2 months post-vaccination.
|
|
Infections and infestations
Otitis media
|
22.4%
26/116 • Number of events 28 • Adverse event data were collected for 2 months post-vaccination.
|
15.8%
9/57 • Number of events 10 • Adverse event data were collected for 2 months post-vaccination.
|
|
Infections and infestations
Upper respiratory tract infection
|
20.7%
24/116 • Number of events 31 • Adverse event data were collected for 2 months post-vaccination.
|
15.8%
9/57 • Number of events 9 • Adverse event data were collected for 2 months post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
19.0%
22/116 • Number of events 25 • Adverse event data were collected for 2 months post-vaccination.
|
26.3%
15/57 • Number of events 17 • Adverse event data were collected for 2 months post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.0%
7/116 • Number of events 7 • Adverse event data were collected for 2 months post-vaccination.
|
8.8%
5/57 • Number of events 5 • Adverse event data were collected for 2 months post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
18.1%
21/116 • Number of events 25 • Adverse event data were collected for 2 months post-vaccination.
|
10.5%
6/57 • Number of events 7 • Adverse event data were collected for 2 months post-vaccination.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.6%
3/116 • Number of events 3 • Adverse event data were collected for 2 months post-vaccination.
|
5.3%
3/57 • Number of events 3 • Adverse event data were collected for 2 months 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