Trial Outcomes & Findings for Trial to Collect Safety Data and Sera for Immunogenicity Testing (NCT NCT00389857)

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 2006-2007 Pediatric formulation. Post-dose 1 (Influenza vaccine-primed group); Post-dose 2 (Influenza vaccine-naive group)

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

31 participants

Primary outcome timeframe

14 days post-vaccination

Results posted on

2016-04-14

Participant Flow

Subjects were recruited from 13 October to 13 December 2006, at a single site in the US.

A total of 31 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 in the past. They received a single dose 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 a single dose of Fluzone® vaccine on Day 0.
Overall Study STARTED	14	17
Overall Study COMPLETED	14	17
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Trial to Collect Safety Data and Sera for Immunogenicity Testing

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Influenza Vaccine-Naive Group n=14 Participants Participants have never received Influenza virus vaccine in the past. They received a single dose of Fluzone® vaccine on Day 0 and Day 28, respectively.	Influenza Vaccine-Primed Group n=17 Participants Participants have received Influenza virus vaccine in the past. They received a single dose of Fluzone® vaccine on Day 0.	Total n=31 Participants Total of all reporting groups
Age, Categorical <=18 years	14 Participants n=93 Participants	17 Participants n=4 Participants	31 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	15.4 Months STANDARD_DEVIATION 7.40 • n=93 Participants	29.3 Months STANDARD_DEVIATION 6.55 • n=4 Participants	23.0 Months STANDARD_DEVIATION 9.82 • n=27 Participants
Sex: Female, Male Female	8 Participants n=93 Participants	10 Participants n=4 Participants	18 Participants n=27 Participants
Sex: Female, Male Male	6 Participants n=93 Participants	7 Participants n=4 Participants	13 Participants n=27 Participants
Region of Enrollment United States	14 participants n=93 Participants	17 participants n=4 Participants	31 participants n=27 Participants

PRIMARY outcome

Timeframe: 14 days post-vaccination

Population: Geometric mean titers were evaluated in the per-protocol population.

Outcome measures

Outcome measures
Measure	Influenza Vaccine-Naive Group n=13 Participants Subjects have never received Influenza virus vaccine	Influenza Vaccine-Primed Group n=12 Participants Subjects have received Influenza virus vaccine in the past
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibodies Before and After Fluzone® Vaccination H1N1 Flu A/New Caledonia/20/99 - Pre	5.36 Titer Interval 4.83 to 5.95	15.1 Titer Interval 6.51 to 34.8
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibodies Before and After Fluzone® Vaccination H1N1 Flu A/New Caledonia/20/99 - Post	169 Titer Interval 77.5 to 367.0	135 Titer Interval 61.9 to 293.0
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibodies Before and After Fluzone® Vaccination H3N2 Flu A/Wisconsin/67/2005 - Pre	13.7 Titer Interval 2.97 to 62.8	22.0 Titer Interval 8.27 to 58.4
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibodies Before and After Fluzone® Vaccination H3N2 Flu A/Wisconsin/67/2005 - Post	806 Titer Interval 316.0 to 2056.0	698 Titer Interval 400.0 to 1218.0
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibodies Before and After Fluzone® Vaccination Flu B/Malaysia Split/2506/2004 - Pre	5.55 Titer Interval 4.92 to 6.25	6.23 Titer Interval 4.71 to 8.25
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibodies Before and After Fluzone® Vaccination Flu B/Malaysia Split/2506/2004 - Post	234 Titer Interval 107.0 to 511.0	54.8 Titer Interval 20.9 to 144.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 0 to 3 days post-vaccination 1

Population: Safety analysis was on all enrolled and vaccinated participants, intent-to-treat population

Solicited injection site reactions: Erythema, swelling, tenderness for infants/toddlers, and pain for children Solicited systemic reactions: For infants/toddler: fever (temperature), irritability, abnormal crying, drowsiness, lost appetite, vomiting; For children: fever (temperature), headache, malaise, myalgia).

Outcome measures

Outcome measures
Measure	Influenza Vaccine-Naive Group n=14 Participants Subjects have never received Influenza virus vaccine	Influenza Vaccine-Primed Group n=17 Participants Subjects have received Influenza virus vaccine in the past
Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. Any Solicited Injection Site Reaction Post-dose 1	3 Participants	6 Participants
Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. Any injection site Tenderness	3 Participants	2 Participants
Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. Grade 3 injection site Tenderness-reduced movement	0 Participants	0 Participants
Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. Any injection site Pain	0 Participants	4 Participants
Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. Grade 3 injection site Pain (Incapacitating)	0 Participants	0 Participants
Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. Any injection site Redness	2 Participants	1 Participants
Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. Grade 3 injection site Redness (≥ 5.0 cm)	0 Participants	0 Participants
Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. Any injection site Swelling	1 Participants	0 Participants
Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. Grade 3 injection site Swelling (≥ 5.0 cm)	0 Participants	0 Participants
Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. Any Solicited Systemic Reaction Post-dose 1	7 Participants	7 Participants
Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. Any Fever	0 Participants	1 Participants
Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. Grade 3 Fever (>103.1°F)	0 Participants	0 Participants
Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. Any Vomiting (Per 24 hours)	2 Participants	0 Participants
Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. Grade 3 Vomiting (≥ 6 episodes)	0 Participants	0 Participants
Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. Any Abnormal Crying	3 Participants	2 Participants
Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. Grade 3 Abnormal Crying (> 3 hours)	0 Participants	0 Participants
Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. Any Drowsiness	1 Participants	1 Participants
Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. Grade 3 Drowsiness (Sleeping most time)	0 Participants	0 Participants
Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. Any Loss of Appetite	1 Participants	2 Participants
Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. Grade 3 Loss of Appetite (Refuses ≥ 3 feeds)	0 Participants	0 Participants
Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. Any Irritability	5 Participants	2 Participants
Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. Grade 3 Irritability (Inconsolable)	0 Participants	0 Participants
Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. Any Headache	0 Participants	3 Participants
Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. Grade 3 Headache (Prevented daily activities)	0 Participants	0 Participants
Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. Any Myalgia	1 Participants	1 Participants
Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. Grade 3 Myalgia (Prevented daily activities)	0 Participants	0 Participants
Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. Any Malaise	2 Participants	3 Participants
Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. Grade 3 Malaise (Prevented daily activities)	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 0 to 3 days post-vaccination 2

Population: Safety analysis was on all enrolled and vaccinated participants, intend to treat population. Influenza vaccine-primed group did not received vaccination 2

Outcome measures

Outcome measures
Measure	Influenza Vaccine-Naive Group n=14 Participants Subjects have never received Influenza virus vaccine	Influenza Vaccine-Primed Group Subjects have received Influenza virus vaccine in the past
Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 2. Any solicited injection site reaction Post-dose 2	4 Participants	—
Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 2. Any injection site Tenderness	4 Participants	—
Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 2. Grade 3 injection site Tenderness-reduced movement	0 Participants	—
Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 2. Any injection site Pain	0 Participants	—
Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 2. Grade 3 injection site Pain (incapacitating)	0 Participants	—
Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 2. Any injection site Redness	3 Participants	—
Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 2. Grade 3 injection site Redness (≥ 5.0 cm)	0 Participants	—
Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 2. Any injection site Swelling	1 Participants	—
Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 2. Grade 3 injection site Swelling (≥ 5.0 cm)	0 Participants	—
Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 2. Any solicited systemic reaction Post-dose 2	6 Participants	—
Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 2. Any Fever	1 Participants	—
Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 2. Grade 3 Fever (> 103.1ºF)	0 Participants	—
Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 2. Any Vomiting (per 24 hours)	2 Participants	—
Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 2. Grade 3 Vomiting (≥ 6 episodes)	0 Participants	—
Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 2. Any abnormal Crying	4 Participants	—
Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 2. Grade 3 abnormal Crying (> 3 hours)	0 Participants	—
Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 2. Any Drowsiness	3 Participants	—
Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 2. Grade 3 Drowsiness (sleeping most time)	0 Participants	—
Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 2. Any Loss of appetite	5 Participants	—
Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 2. Grade 3 Loss of appetitie (refuses 3 feeds)	0 Participants	—
Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 2. Any Irritability	5 Participants	—
Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 2. Grade 3 Irritability (inconsolable)	0 Participants	—
Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 2. Any Headache	0 Participants	—
Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 2. Grade 3 Headache (prevents daily activities)	0 Participants	—
Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 2. Any Myalgia	0 Participants	—
Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 2. Grade 3 Myalgia (prevents daily activities)	0 Participants	—
Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 2. Any Malaise	0 Participants	—
Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 2. Grade 3 Malaise (prevents daily activities)	0 Participants	—

Adverse Events

Influenza Vaccine-Naive Group

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Influenza Vaccine-Primed Group

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

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

Measure	Influenza Vaccine-Naive Group n=14 participants at risk Participants have never received Influenza virus vaccine in the past. They received a single dose of Fluzone® vaccine on Day 0 and Day 28, respectively.	Influenza Vaccine-Primed Group n=17 participants at risk Participants have received Influenza virus vaccine in the past. They received a single dose of Fluzone® vaccine on Day 0.
General disorders Injection site tenderness	28.6% 4/14 • Adverse events data were collected from the day of vaccination for 14 days post-vaccination (Influenza vaccine-primed) and for 42 days post-vaccination (Influenza vaccine-naive) participants.	11.8% 2/17 • Adverse events data were collected from the day of vaccination for 14 days post-vaccination (Influenza vaccine-primed) and for 42 days post-vaccination (Influenza vaccine-naive) participants.
General disorders Injection site pain	0.00% 0/14 • Adverse events data were collected from the day of vaccination for 14 days post-vaccination (Influenza vaccine-primed) and for 42 days post-vaccination (Influenza vaccine-naive) participants.	23.5% 4/17 • Adverse events data were collected from the day of vaccination for 14 days post-vaccination (Influenza vaccine-primed) and for 42 days post-vaccination (Influenza vaccine-naive) participants.
General disorders Injection site redness	21.4% 3/14 • Adverse events data were collected from the day of vaccination for 14 days post-vaccination (Influenza vaccine-primed) and for 42 days post-vaccination (Influenza vaccine-naive) participants.	5.9% 1/17 • Adverse events data were collected from the day of vaccination for 14 days post-vaccination (Influenza vaccine-primed) and for 42 days post-vaccination (Influenza vaccine-naive) participants.
General disorders Injection site swelling	7.1% 1/14 • Adverse events data were collected from the day of vaccination for 14 days post-vaccination (Influenza vaccine-primed) and for 42 days post-vaccination (Influenza vaccine-naive) participants.	0.00% 0/17 • Adverse events data were collected from the day of vaccination for 14 days post-vaccination (Influenza vaccine-primed) and for 42 days post-vaccination (Influenza vaccine-naive) participants.
General disorders Pyrexia	7.1% 1/14 • Adverse events data were collected from the day of vaccination for 14 days post-vaccination (Influenza vaccine-primed) and for 42 days post-vaccination (Influenza vaccine-naive) participants.	5.9% 1/17 • Adverse events data were collected from the day of vaccination for 14 days post-vaccination (Influenza vaccine-primed) and for 42 days post-vaccination (Influenza vaccine-naive) participants.
Gastrointestinal disorders Vomiting NOS	14.3% 2/14 • Adverse events data were collected from the day of vaccination for 14 days post-vaccination (Influenza vaccine-primed) and for 42 days post-vaccination (Influenza vaccine-naive) participants.	0.00% 0/17 • Adverse events data were collected from the day of vaccination for 14 days post-vaccination (Influenza vaccine-primed) and for 42 days post-vaccination (Influenza vaccine-naive) participants.
Psychiatric disorders Crying	28.6% 4/14 • Adverse events data were collected from the day of vaccination for 14 days post-vaccination (Influenza vaccine-primed) and for 42 days post-vaccination (Influenza vaccine-naive) participants.	11.8% 2/17 • Adverse events data were collected from the day of vaccination for 14 days post-vaccination (Influenza vaccine-primed) and for 42 days post-vaccination (Influenza vaccine-naive) participants.
Nervous system disorders Somnolence	21.4% 3/14 • Adverse events data were collected from the day of vaccination for 14 days post-vaccination (Influenza vaccine-primed) and for 42 days post-vaccination (Influenza vaccine-naive) participants.	5.9% 1/17 • Adverse events data were collected from the day of vaccination for 14 days post-vaccination (Influenza vaccine-primed) and for 42 days post-vaccination (Influenza vaccine-naive) participants.
Metabolism and nutrition disorders Anorexia	35.7% 5/14 • Adverse events data were collected from the day of vaccination for 14 days post-vaccination (Influenza vaccine-primed) and for 42 days post-vaccination (Influenza vaccine-naive) participants.	11.8% 2/17 • Adverse events data were collected from the day of vaccination for 14 days post-vaccination (Influenza vaccine-primed) and for 42 days post-vaccination (Influenza vaccine-naive) participants.
Psychiatric disorders Irritability	42.9% 6/14 • Adverse events data were collected from the day of vaccination for 14 days post-vaccination (Influenza vaccine-primed) and for 42 days post-vaccination (Influenza vaccine-naive) participants.	11.8% 2/17 • Adverse events data were collected from the day of vaccination for 14 days post-vaccination (Influenza vaccine-primed) and for 42 days post-vaccination (Influenza vaccine-naive) participants.
Nervous system disorders Headache	0.00% 0/14 • Adverse events data were collected from the day of vaccination for 14 days post-vaccination (Influenza vaccine-primed) and for 42 days post-vaccination (Influenza vaccine-naive) participants.	17.6% 3/17 • Adverse events data were collected from the day of vaccination for 14 days post-vaccination (Influenza vaccine-primed) and for 42 days post-vaccination (Influenza vaccine-naive) participants.
Musculoskeletal and connective tissue disorders Myalgia	7.1% 1/14 • Adverse events data were collected from the day of vaccination for 14 days post-vaccination (Influenza vaccine-primed) and for 42 days post-vaccination (Influenza vaccine-naive) participants.	5.9% 1/17 • Adverse events data were collected from the day of vaccination for 14 days post-vaccination (Influenza vaccine-primed) and for 42 days post-vaccination (Influenza vaccine-naive) participants.
General disorders Malaise	14.3% 2/14 • Adverse events data were collected from the day of vaccination for 14 days post-vaccination (Influenza vaccine-primed) and for 42 days post-vaccination (Influenza vaccine-naive) participants.	17.6% 3/17 • Adverse events data were collected from the day of vaccination for 14 days post-vaccination (Influenza vaccine-primed) and for 42 days post-vaccination (Influenza vaccine-naive) participants.
Gastrointestinal disorders Diarrhoea	7.1% 1/14 • Adverse events data were collected from the day of vaccination for 14 days post-vaccination (Influenza vaccine-primed) and for 42 days post-vaccination (Influenza vaccine-naive) participants.	5.9% 1/17 • Adverse events data were collected from the day of vaccination for 14 days post-vaccination (Influenza vaccine-primed) and for 42 days post-vaccination (Influenza vaccine-naive) participants.
Gastrointestinal disorders Haematochezia	0.00% 0/14 • Adverse events data were collected from the day of vaccination for 14 days post-vaccination (Influenza vaccine-primed) and for 42 days post-vaccination (Influenza vaccine-naive) participants.	5.9% 1/17 • Adverse events data were collected from the day of vaccination for 14 days post-vaccination (Influenza vaccine-primed) and for 42 days post-vaccination (Influenza vaccine-naive) participants.
Gastrointestinal disorders Teething	7.1% 1/14 • Adverse events data were collected from the day of vaccination for 14 days post-vaccination (Influenza vaccine-primed) and for 42 days post-vaccination (Influenza vaccine-naive) participants.	5.9% 1/17 • Adverse events data were collected from the day of vaccination for 14 days post-vaccination (Influenza vaccine-primed) and for 42 days post-vaccination (Influenza vaccine-naive) participants.
Gastrointestinal disorders Vomiting	7.1% 1/14 • Adverse events data were collected from the day of vaccination for 14 days post-vaccination (Influenza vaccine-primed) and for 42 days post-vaccination (Influenza vaccine-naive) participants.	0.00% 0/17 • Adverse events data were collected from the day of vaccination for 14 days post-vaccination (Influenza vaccine-primed) and for 42 days post-vaccination (Influenza vaccine-naive) participants.
Infections and infestations Nasopharyngitis	0.00% 0/14 • Adverse events data were collected from the day of vaccination for 14 days post-vaccination (Influenza vaccine-primed) and for 42 days post-vaccination (Influenza vaccine-naive) participants.	5.9% 1/17 • Adverse events data were collected from the day of vaccination for 14 days post-vaccination (Influenza vaccine-primed) and for 42 days post-vaccination (Influenza vaccine-naive) participants.
Infections and infestations Otitis media	7.1% 1/14 • Adverse events data were collected from the day of vaccination for 14 days post-vaccination (Influenza vaccine-primed) and for 42 days post-vaccination (Influenza vaccine-naive) participants.	0.00% 0/17 • Adverse events data were collected from the day of vaccination for 14 days post-vaccination (Influenza vaccine-primed) and for 42 days post-vaccination (Influenza vaccine-naive) participants.
Infections and infestations Upper respiratory tract infection	14.3% 2/14 • Adverse events data were collected from the day of vaccination for 14 days post-vaccination (Influenza vaccine-primed) and for 42 days post-vaccination (Influenza vaccine-naive) participants.	0.00% 0/17 • Adverse events data were collected from the day of vaccination for 14 days post-vaccination (Influenza vaccine-primed) and for 42 days post-vaccination (Influenza vaccine-naive) participants.
General disorders Irritability	7.1% 1/14 • Adverse events data were collected from the day of vaccination for 14 days post-vaccination (Influenza vaccine-primed) and for 42 days post-vaccination (Influenza vaccine-naive) participants.	5.9% 1/17 • Adverse events data were collected from the day of vaccination for 14 days post-vaccination (Influenza vaccine-primed) and for 42 days post-vaccination (Influenza vaccine-naive) participants.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/14 • Adverse events data were collected from the day of vaccination for 14 days post-vaccination (Influenza vaccine-primed) and for 42 days post-vaccination (Influenza vaccine-naive) participants.	5.9% 1/17 • Adverse events data were collected from the day of vaccination for 14 days post-vaccination (Influenza vaccine-primed) and for 42 days post-vaccination (Influenza vaccine-naive) participants.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/14 • Adverse events data were collected from the day of vaccination for 14 days post-vaccination (Influenza vaccine-primed) and for 42 days post-vaccination (Influenza vaccine-naive) participants.	5.9% 1/17 • Adverse events data were collected from the day of vaccination for 14 days post-vaccination (Influenza vaccine-primed) and for 42 days post-vaccination (Influenza vaccine-naive) participants.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/14 • Adverse events data were collected from the day of vaccination for 14 days post-vaccination (Influenza vaccine-primed) and for 42 days post-vaccination (Influenza vaccine-naive) participants.	5.9% 1/17 • Adverse events data were collected from the day of vaccination for 14 days post-vaccination (Influenza vaccine-primed) and for 42 days post-vaccination (Influenza vaccine-naive) participants.