Trial Outcomes & Findings for Study to Collect Sera for Immunogenicity Testing in Children Vaccinated With Fluzone® (NCT NCT00836953)

Last Updated: 2016-04-14

Results Overview

Solicited local reactions: Erythema (redness), induration, bruising and pain at the injection site. Solicited systemic reactions: Fever (temperature), irritability, crying, lethargy, appetite decreased, diarrhea, vomiting and rash.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

33 participants

Primary outcome timeframe

Day 0 to 3 post-vaccination

Results posted on

2016-04-14

Participant Flow

The study participants were enrolled from 11 through 25 September 2003 in 1 US site.

A total of 33 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.

Participant milestones

Participant milestones
Measure	Study Group Participants received study vaccine on Days 0 and 30.
Overall Study STARTED	33
Overall Study COMPLETED	31
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Study Group Participants received study vaccine on Days 0 and 30.
Overall Study Withdrawal by Subject	1
Overall Study Lost to Follow-up	1

Baseline Characteristics

Study to Collect Sera for Immunogenicity Testing in Children Vaccinated With Fluzone®

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Study Group n=33 Participants Participants received study vaccine on Days 0 and 30.
Age, Categorical <=18 years	33 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous Age Continuous	19.08 Months STANDARD_DEVIATION 9.69 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Region of Enrollment United States	33 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 0 to 3 post-vaccination

Population: Safety analysis was on all enrolled and vaccinated subjects with available reaction data, intent-to-treat population

Outcome measures

Outcome measures
Measure	Study Group n=33 Participants Participants received study vaccine on Days 0 and 30.
Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination Any Redness (> 5 mm)	8 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination Grade 3 Redness (> 50 mm)	0 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination Grade 3 Bruising (> 50 mm)	0 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination Any Pain	10 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination Grade 3 Pain (Cries when leg or arm is moved)	0 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination Fever (Rectal Temp)	2 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination Grade 3 Fever (> 103.1 ºF)	2 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination Any Irritability	15 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination Grade 3 Irritability (> 3 hours)	2 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination Any Crying	11 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination Grade 3 Crying (inconsolable for > 3 hours)	1 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination Grade 3 Diarrhea (> 5 diarrhea stools/day)	0 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination Any Solicited Local Reaction Post-Dose 1	9 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination Any Induration (> 5 mm)	5 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination Grade 3 Induration (> 50 mm)	0 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination Any Bruising (> 5 mm)	5 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination Any Solicited Local Reaction Post-Dose 2	12 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination Any Solicited Local Reaction Post-Any Dose	14 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination Any Solicited Systemic Reaction Post-Dose 1	19 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination Any Lethargy	11 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination Grade 3 Lethargy (Uninterested in usual activity)	0 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination Any Appetite Decreased	14 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination Grade 3 Appetite Decreased (Refuses ≥ 3 feeds)	1 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination Any Vomiting	4 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination Grade 3 Vomiting ( ≥ 3 episodes)	0 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination Any Diarrhea	7 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination Grade 3 Diarrhea ( > 5 diarrhea stools/day)	0 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination Rash - Presence of Welts	1 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination Any Solicited Systemic Reaction Post-Dose 2	14 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination Any Solicited Systemic Reaction Post-Any Dose	22 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination Any Fever	7 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination Grade 3 Vomiting (≥ 3 episodes)	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0 and Day 14 after Dose 2

Population: Immunogenicity analysis was on all enrolled and vaccinated subjects with adequate sera for testing, per-protocol population.

Seroprotection defined as percentage of participants with reciprocal hemagglutination inhibition titers ≥40 pre- and post-vaccination.

Outcome measures

Outcome measures
Measure	Study Group n=31 Participants Participants received study vaccine on Days 0 and 30.
Percentage of Participants With Pre- and Post-Vaccination Reciprocal Hemagglutination Inhibition Titers ≥ 40 (Seroprotection) A/Panama (H3N2) Pre-vaccination	10 Percentage of Participants
Percentage of Participants With Pre- and Post-Vaccination Reciprocal Hemagglutination Inhibition Titers ≥ 40 (Seroprotection) A/Panama (H3N2) Post-dose 2	77 Percentage of Participants
Percentage of Participants With Pre- and Post-Vaccination Reciprocal Hemagglutination Inhibition Titers ≥ 40 (Seroprotection) A/New Caledonia (H1N1) Pre-vaccination	10 Percentage of Participants
Percentage of Participants With Pre- and Post-Vaccination Reciprocal Hemagglutination Inhibition Titers ≥ 40 (Seroprotection) A/New Caledonia (H1N1) Post-dose 2	81 Percentage of Participants
Percentage of Participants With Pre- and Post-Vaccination Reciprocal Hemagglutination Inhibition Titers ≥ 40 (Seroprotection) B/Hong Kong Pre-vaccination	0 Percentage of Participants
Percentage of Participants With Pre- and Post-Vaccination Reciprocal Hemagglutination Inhibition Titers ≥ 40 (Seroprotection) B/Hong Kong Post-dose 2	48 Percentage of Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0 and Day 14 Post-dose 2

Population: Immunogenicity analysis was on all enrolled and vaccinated subjects with adequate sera for testing, per-protocol population.

Seroconversion defined as the percentage of participants with ≥ 4-fold increases in reciprocal hemagglutination inhibition titer from pre- to post-vaccination.

Outcome measures

Outcome measures
Measure	Study Group n=31 Participants Participants received study vaccine on Days 0 and 30.
Percentage of Participants With at Least a 4-fold Rise in Reciprocal Hemagglutination Inhibition Titers (Seroconversion) A/Panama (H3N2)	84 Percentage of Participants
Percentage of Participants With at Least a 4-fold Rise in Reciprocal Hemagglutination Inhibition Titers (Seroconversion) A/New Caledonia (H1N1)	94 Percentage of Participants
Percentage of Participants With at Least a 4-fold Rise in Reciprocal Hemagglutination Inhibition Titers (Seroconversion) B/Hong Kong	81 Percentage of Participants

Adverse Events

Study Group

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Study Group n=33 participants at risk Participants received study vaccine on Days 0 and 30.
Gastrointestinal disorders Constipation	6.1% 2/33 • Number of events 2 • Adverse events were collected for the entire study period, from the day of vaccination to Day 44 post-vaccination.
Gastrointestinal disorders Teething	6.1% 2/33 • Number of events 2 • Adverse events were collected for the entire study period, from the day of vaccination to Day 44 post-vaccination.
Gastrointestinal disorders Vomiting NOS	12.1% 4/33 • Number of events 4 • Adverse events were collected for the entire study period, from the day of vaccination to Day 44 post-vaccination.
General disorders Pyrexia	15.2% 5/33 • Number of events 5 • Adverse events were collected for the entire study period, from the day of vaccination to Day 44 post-vaccination.
Infections and infestations Nasopharyngitis	27.3% 9/33 • Number of events 9 • Adverse events were collected for the entire study period, from the day of vaccination to Day 44 post-vaccination.
Respiratory, thoracic and mediastinal disorders Cough	9.1% 3/33 • Number of events 3 • Adverse events were collected for the entire study period, from the day of vaccination to Day 44 post-vaccination.
Respiratory, thoracic and mediastinal disorders Nasal congestion	9.1% 3/33 • Number of events 3 • Adverse events were collected for the entire study period, from the day of vaccination to Day 44 post-vaccination.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	21.2% 7/33 • Number of events 7 • Adverse events were collected for the entire study period, from the day of vaccination to Day 44 post-vaccination.

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
Publication restrictions are in place

Restriction type: OTHER