Trial Outcomes & Findings for Phase IV Trial to Collect Safety Data and Sera in Healthy Children Given Fluzone Vaccine (NCT NCT00258817)

Last Updated: 2016-04-14

Results Overview

GMTs and their 95% Confidence interval are presented for each of the 3 antigens in the Fluzone® vaccine 2005-2006 Pediatric formulation. Post-dose 1 (Influenza vaccine Primed group); post-dose 2 (Influenza vaccine Naive group)

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

30 participants

Primary outcome timeframe

Day 14 post-vaccination

Results posted on

2016-04-14

Participant Flow

Subjects were enrolled from October to December 2005

A total of 30 subjects that met the inclusion and exclusion criteria were enrolled and vaccinated

Participant milestones

Participant milestones
Measure	Influenza Vaccine-naive Group Participants have never received Influenza virus vaccine. They received 0.25 mL of Fluzone® vaccine on Day 0 and Day 28, respectively.	Influenza Vaccine-primed Group Participants have received Influenza virus vaccine in the past. They received 0.25 mL of Fluzone® vaccine on Day 0.
Overall Study STARTED	15	15
Overall Study COMPLETED	15	15
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase IV Trial to Collect Safety Data and Sera in Healthy Children Given Fluzone Vaccine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Influenza Vaccine-naive Group n=15 Participants Participants have never received Influenza virus vaccine. They received 0.25 mL of Fluzone® vaccine on Day 0 and Day 28, respectively.	Influenza Vaccine-primed Group n=15 Participants Participants have received Influenza virus vaccine in the past. They received 0.25 mL of Fluzone® vaccine on Day 0.	Total n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	15 Participants n=5 Participants	15 Participants n=7 Participants	30 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	11.92 Months STANDARD_DEVIATION 6.36 • n=5 Participants	26.43 Months STANDARD_DEVIATION 8.00 • n=7 Participants	19.18 Months STANDARD_DEVIATION 10.24 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	7 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	8 Participants n=7 Participants	13 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants	15 participants n=7 Participants	30 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 14 post-vaccination

Population: Geometric Mean Titers were assessed on the per-protocol population.

Outcome measures

Outcome measures
Measure	Influenza Vaccine-naive Group n=13 Participants Participants have never received Influenza virus vaccine. They received 0.25 mL of Fluzone® vaccine on Day 0 and Day 28, respectively.	Influenza Vaccine-primed Group n=14 Participants Participants have received Influenza virus vaccine in the past. They received 0.25 mL of Fluzone® vaccine on Day 0.
Geometric Mean Titer (GMT) of Hemagglutination Inhibition Antibodies Pre-vaccination and 14 Days Post-vaccination Flu A/New Caledonia/20/99 (H1N1) - Pre	5.0 Titer Interval 5.0 to 5.0	8.2 Titer Interval 4.3 to 15.6
Geometric Mean Titer (GMT) of Hemagglutination Inhibition Antibodies Pre-vaccination and 14 Days Post-vaccination Flu A/New Caledonia/20/99 (H1N1) - Post	187.8 Titer Interval 105.4 to 334.5	95.1 Titer Interval 44.0 to 205.9
Geometric Mean Titer (GMT) of Hemagglutination Inhibition Antibodies Pre-vaccination and 14 Days Post-vaccination Flu A/New York/55/2004 (H3N2) - Pre	8.5 Titer Interval 4.9 to 14.7	32.8 Titer Interval 10.9 to 98.4
Geometric Mean Titer (GMT) of Hemagglutination Inhibition Antibodies Pre-vaccination and 14 Days Post-vaccination Flu A/New York/55/2004 (H3N2) - Post	328.6 Titer Interval 181.2 to 596.0	249.8 Titer Interval 88.1 to 708.6
Geometric Mean Titer (GMT) of Hemagglutination Inhibition Antibodies Pre-vaccination and 14 Days Post-vaccination Flu B/Jiangsu/10/2003 - Pre	9.2 Titer Interval 4.6 to 18.7	5.3 Titer Interval 4.7 to 5.8
Geometric Mean Titer (GMT) of Hemagglutination Inhibition Antibodies Pre-vaccination and 14 Days Post-vaccination Flu B/Jiangsu/10/2003 - Post	59.7 Titer Interval 22.7 to 156.9	39.0 Titer Interval 17.2 to 88.7

OTHER_PRE_SPECIFIED outcome

Timeframe: 0 to 3 days post-vaccination 1

Population: Safety analysis post-vaccination 1 was on all enrolled and vaccinated subjects, Intend-to-treat population.

Solicited local reactions: injection site erythema, injection site swelling, injection site tenderness; Solicited systemic reactions: fever (temperature), irritability, abnormal crying, drowsiness, lost appetite, and vomiting.

Outcome measures

Outcome measures
Measure	Influenza Vaccine-naive Group n=15 Participants Participants have never received Influenza virus vaccine. They received 0.25 mL of Fluzone® vaccine on Day 0 and Day 28, respectively.	Influenza Vaccine-primed Group n=15 Participants Participants have received Influenza virus vaccine in the past. They received 0.25 mL of Fluzone® vaccine on Day 0.
Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 1 Any Solicited Injection Site Reaction post-dose 1	3 Participants	2 Participants
Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 1 Any injection site Tenderness	2 Participants	1 Participants
Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 1 Grade 3 injection site Tenderness-reduced movement	0 Participants	0 Participants
Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 1 Any injection site Erythema	1 Participants	1 Participants
Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 1 Grade 3 injection site Erythema (≥ 5.0 cm)	0 Participants	1 Participants
Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 1 Any injection site Swelling	1 Participants	1 Participants
Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 1 Grade 3 injection site Swelling (≥ 5.0 cm)	0 Participants	0 Participants
Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 1 Any Solicited Systemic Reactions post-dose 1	10 Participants	5 Participants
Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 1 Any Fever (≥ 100.4°F)	1 Participants	2 Participants
Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 1 Grade 3 Fever (> 103.2°F)	0 Participants	0 Participants
Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 1 Any Crying abnormal	4 Participants	1 Participants
Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 1 Grade 3 Crying abnormal (> 3 hours)	0 Participants	0 Participants
Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 1 Any Irritability	6 Participants	1 Participants
Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 1 Grade 3 Irritability (Inconsolable)	0 Participants	0 Participants
Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 1 Any Vomiting (per 24 hours)	1 Participants	0 Participants
Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 1 Grade 3 Vomiting (≥ 6 episodes)	0 Participants	0 Participants
Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 1 Any Drowsiness	6 Participants	3 Participants
Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 1 Grade 3 Drowsiness (Sleeps most time)	0 Participants	0 Participants
Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 1 Any Appetite lost	4 Participants	1 Participants
Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 1 Grade 3 Appetite lost (Refuse most feeds)	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 0 to 3 days post-vaccination 2

Population: Safety analysis post vaccination 2 was on all enrolled and vaccinated subjects, Intend-to-treat population.

Outcome measures

Outcome measures
Measure	Influenza Vaccine-naive Group n=15 Participants Participants have never received Influenza virus vaccine. They received 0.25 mL of Fluzone® vaccine on Day 0 and Day 28, respectively.	Influenza Vaccine-primed Group Participants have received Influenza virus vaccine in the past. They received 0.25 mL of Fluzone® vaccine on Day 0.
Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 2 Any solicited injection site reaction post-dose 2	2 Participants	—
Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 2 Any injection site Tenderness	1 Participants	—
Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 2 Grade 3 injection site Tenderness-reduced movement	0 Participants	—
Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 2 Any injection site Erythema	0 Participants	—
Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 2 Grade 3 injection site Erythema (≥ 5.0 cm)	0 Participants	—
Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 2 Any injection site Swelling	1 Participants	—
Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 2 Grade 3 injection site Swelling (≥ 5.0 cm)	0 Participants	—
Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 2 Any solicited systemic reactions post-dose 2	8 Participants	—
Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 2 Any Fever (≥ 100.4 ºF)	5 Participants	—
Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 2 Grade 3 Fever (> 103.2 ºF)	0 Participants	—
Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 2 Any Crying abnormal	3 Participants	—
Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 2 Grade 3 Crying abnormal (> 3 hours)	1 Participants	—
Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 2 Any Irritability	5 Participants	—
Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 2 Grade 3 Irritability (inconsolable)	0 Participants	—
Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 2 Any Vomiting (per 24 hours)	0 Participants	—
Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 2 Grade 3 Vomiting (≥ 6 episodes)	0 Participants	—
Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 2 Any Drowsiness	2 Participants	—
Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 2 Grade 3 Drowsiness (sleeping most time)	0 Participants	—
Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 2 Any Appetite lost	3 Participants	—
Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 2 Grade 3 Appetite lost (refuses most feeds)	0 Participants	—

Adverse Events

Influenza Vaccine-naive Group

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Influenza Vaccine-primed Group

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Influenza Vaccine-naive Group n=15 participants at risk Participants have never received Influenza virus vaccine. They received 0.25 mL of Fluzone® vaccine on Day 0 and Day 28, respectively.	Influenza Vaccine-primed Group n=15 participants at risk Participants have received Influenza virus vaccine in the past. They received 0.25 mL of Fluzone® vaccine on Day 0.
General disorders Injection site tenderness	20.0% 3/15 • Adverse events data were collected from day of vaccination for 2 weeks (Influenza vaccine-Primed) and 6 weeks (Influenza vaccine naive) participants.	6.7% 1/15 • Adverse events data were collected from day of vaccination for 2 weeks (Influenza vaccine-Primed) and 6 weeks (Influenza vaccine naive) participants.
General disorders Injection site erythema	6.7% 1/15 • Adverse events data were collected from day of vaccination for 2 weeks (Influenza vaccine-Primed) and 6 weeks (Influenza vaccine naive) participants.	6.7% 1/15 • Adverse events data were collected from day of vaccination for 2 weeks (Influenza vaccine-Primed) and 6 weeks (Influenza vaccine naive) participants.
General disorders Injection site swelling	6.7% 1/15 • Adverse events data were collected from day of vaccination for 2 weeks (Influenza vaccine-Primed) and 6 weeks (Influenza vaccine naive) participants.	6.7% 1/15 • Adverse events data were collected from day of vaccination for 2 weeks (Influenza vaccine-Primed) and 6 weeks (Influenza vaccine naive) participants.
General disorders Pyrexia	20.0% 3/15 • Adverse events data were collected from day of vaccination for 2 weeks (Influenza vaccine-Primed) and 6 weeks (Influenza vaccine naive) participants.	0.00% 0/15 • Adverse events data were collected from day of vaccination for 2 weeks (Influenza vaccine-Primed) and 6 weeks (Influenza vaccine naive) participants.
Psychiatric disorders Crying	33.3% 5/15 • Adverse events data were collected from day of vaccination for 2 weeks (Influenza vaccine-Primed) and 6 weeks (Influenza vaccine naive) participants.	6.7% 1/15 • Adverse events data were collected from day of vaccination for 2 weeks (Influenza vaccine-Primed) and 6 weeks (Influenza vaccine naive) participants.
Psychiatric disorders Irritability	53.3% 8/15 • Adverse events data were collected from day of vaccination for 2 weeks (Influenza vaccine-Primed) and 6 weeks (Influenza vaccine naive) participants.	6.7% 1/15 • Adverse events data were collected from day of vaccination for 2 weeks (Influenza vaccine-Primed) and 6 weeks (Influenza vaccine naive) participants.
Gastrointestinal disorders Vomiting NOS	6.7% 1/15 • Adverse events data were collected from day of vaccination for 2 weeks (Influenza vaccine-Primed) and 6 weeks (Influenza vaccine naive) participants.	0.00% 0/15 • Adverse events data were collected from day of vaccination for 2 weeks (Influenza vaccine-Primed) and 6 weeks (Influenza vaccine naive) participants.
Nervous system disorders Somnolence	40.0% 6/15 • Adverse events data were collected from day of vaccination for 2 weeks (Influenza vaccine-Primed) and 6 weeks (Influenza vaccine naive) participants.	20.0% 3/15 • Adverse events data were collected from day of vaccination for 2 weeks (Influenza vaccine-Primed) and 6 weeks (Influenza vaccine naive) participants.
Metabolism and nutrition disorders Anorexia	40.0% 6/15 • Adverse events data were collected from day of vaccination for 2 weeks (Influenza vaccine-Primed) and 6 weeks (Influenza vaccine naive) participants.	6.7% 1/15 • Adverse events data were collected from day of vaccination for 2 weeks (Influenza vaccine-Primed) and 6 weeks (Influenza vaccine naive) participants.
Gastrointestinal disorders Diarrhoea	6.7% 1/15 • Adverse events data were collected from day of vaccination for 2 weeks (Influenza vaccine-Primed) and 6 weeks (Influenza vaccine naive) participants.	0.00% 0/15 • Adverse events data were collected from day of vaccination for 2 weeks (Influenza vaccine-Primed) and 6 weeks (Influenza vaccine naive) participants.
Infections and infestations Otitis media	6.7% 1/15 • Adverse events data were collected from day of vaccination for 2 weeks (Influenza vaccine-Primed) and 6 weeks (Influenza vaccine naive) participants.	0.00% 0/15 • Adverse events data were collected from day of vaccination for 2 weeks (Influenza vaccine-Primed) and 6 weeks (Influenza vaccine naive) participants.
Infections and infestations Upper respiratory tract infection	20.0% 3/15 • Adverse events data were collected from day of vaccination for 2 weeks (Influenza vaccine-Primed) and 6 weeks (Influenza vaccine naive) participants.	0.00% 0/15 • Adverse events data were collected from day of vaccination for 2 weeks (Influenza vaccine-Primed) and 6 weeks (Influenza vaccine naive) participants.
Infections and infestations Viral infection	6.7% 1/15 • Adverse events data were collected from day of vaccination for 2 weeks (Influenza vaccine-Primed) and 6 weeks (Influenza vaccine naive) participants.	0.00% 0/15 • Adverse events data were collected from day of vaccination for 2 weeks (Influenza vaccine-Primed) and 6 weeks (Influenza vaccine naive) participants.

Additional Information

Medical Director

Sanofi Pasteur Inc.

Email: [email protected]

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.
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