Trial Outcomes & Findings for Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Quadrivalent, Influenza Vaccine (NCT NCT02222870)

Last Updated: 2015-10-19

Results Overview

Solicited Injection-site: 6 to \< 36 months - Tenderness, Erythema, and Swelling; 3 to \< 9 years - Pain, Erythema, and Swelling. Solicited systemic reactions: 6 to \< 36 months - Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability; 3 to \< 9 years - Fever, Headache, Malaise, and Myalgia. Grade 3: Fever, \> 39.5˚C (6 to \< 36 months), ≥ 39.0˚C (3 to \< 9 years); Vomiting, ≥ 6 episodes/24 hours or requires parenteral hydration; Crying abnormal, \> 3 hours; Drowsiness, Sleeping often/difficult to wake; Appetite lost, Refuses ≥ 3 or most meals; Irritability, Inconsolable; Headache, Malaise, and Myalgia, Significant, prevents daily activity.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

60 participants

Primary outcome timeframe

Day 0 up to Day 7 post-any injection

Results posted on

2015-10-19

Participant Flow

Study participants were enrolled from 19 August 2014 to 06 November 2014 at 2 clinical sites in the United States.

A total of 60 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and vaccinated in the study.

Participant milestones

Participant milestones
Measure	6 to < 36 Months of Age Participants 6 to \< 36 months of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.	3 to < 9 Years of Age Participants 3 to \< 9 years of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
Overall Study STARTED	30	30
Overall Study COMPLETED	30	30
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Quadrivalent, Influenza Vaccine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	6 to < 36 Months of Age n=30 Participants Participants 6 to \< 36 months of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.	3 to < 9 Years of Age n=30 Participants Participants 3 to \< 9 years of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	30 Participants n=5 Participants	30 Participants n=7 Participants	60 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 Age Continuous	25.0 Months STANDARD_DEVIATION 8.3 • n=5 Participants	66.9 Months STANDARD_DEVIATION 21.8 • n=7 Participants	45.9 Months STANDARD_DEVIATION 26.7 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	17 Participants n=7 Participants	32 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	13 Participants n=7 Participants	28 Participants n=5 Participants
Region of Enrollment United States	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 0 up to Day 7 post-any injection

Population: Solicited injection-site and systemic reactions were assessed in the Safety Analysis Set.

Outcome measures

Outcome measures
Measure	6 to < 36 Months of Age n=30 Participants Participants 6 to \< 36 months of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.	3 to < 9 Years of Age n=30 Participants Participants 3 to \< 9 years of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine Malaise (N=0, 30)	NA Percentage of participants Event was not assessed in this group	13.3 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine Grade 3 Malaise (N=0, 30)	NA Percentage of participants Event was not assessed in this group	0.0 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine Injection-site Tenderness (N=30, 0)	70.0 Percentage of participants	NA Percentage of participants Event was not assessed in this group
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine Grade 3 Injection-site Tenderness (N=30, 0)	3.3 Percentage of participants	NA Percentage of participants Event was not assessed in this group
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine Injection site Pain (N=0, 30)	NA Percentage of participants Event was not assessed in this group	73.3 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine Grade 3 Injection site Pain (N=0, 30)	NA Percentage of participants Event was not assessed in this group	10.0 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine Myalgia (N=0, 30)	NA Percentage of participants Event was not assessed in this group	13.3 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine Grade 3 Myalgia (N=0, 30)	NA Percentage of participants Event was not assessed in this group	0.0 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine Injection-site Erythema	50.0 Percentage of participants	66.7 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine Grade 3 Injection-site Erythema	0.0 Percentage of participants	0.0 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine Injection-site Swelling	23.3 Percentage of participants	43.3 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine Grade 3 Injection site Swelling (6 to <36 months)	0.0 Percentage of participants	0.0 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine Fever	20.7 Percentage of participants	3.3 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine Grade 3 Fever	0.0 Percentage of participants	0.0 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine Vomiting (N=30, 0)	16.7 Percentage of participants	NA Percentage of participants Event was not assessed in this group
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine Grade 3 Vomiting (N=30, 0)	0.0 Percentage of participants	NA Percentage of participants Event was not assessed in this group
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine Crying abnormal (N=30, 0)	33.3 Percentage of participants	NA Percentage of participants Event was not assessed in this group
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine Grade 3 Crying abnormal (N=30, 0)	0.0 Percentage of participants	NA Percentage of participants Event was not assessed in this group
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine Drowsiness (N=30, 0)	30.0 Percentage of participants	NA Percentage of participants Event was not assessed in this group
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine Grade 3 Drowsiness (N=30, 0)	0.0 Percentage of participants	NA Percentage of participants Event was not assessed in this group
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine Appetite lost (N=30, 0)	26.7 Percentage of participants	NA Percentage of participants Event was not assessed in this group
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine Grade 3 Appetite lost	0.0 Percentage of participants	NA Percentage of participants Event was not assessed in this group
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine Irritability (N=30, 0)	53.3 Percentage of participants	NA Percentage of participants Event was not assessed in this group
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine Grade 3 Irritability (N=30, 0)	0.0 Percentage of participants	NA Percentage of participants Event was not assessed in this group
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine Headache (N=0, 30)	NA Percentage of participants Event was not assessed in this group	10.0 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine Grade 3 Headache (N=0, 30)	NA Percentage of participants Event was not assessed in this group	0.0 Percentage of participants

SECONDARY outcome

Timeframe: Day 0 (pre-vaccination) and Day 28 post-final vaccination

Population: Geometric mean titers were assessed in the Per-Protocol Analysis Set.

Geometric titers of influenza antibodies were assessed using the hemagglutination inhibition (HAI) assay.

Outcome measures

Outcome measures
Measure	6 to < 36 Months of Age n=29 Participants Participants 6 to \< 36 months of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.	3 to < 9 Years of Age n=29 Participants Participants 3 to \< 9 years of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
Geometric Mean Titers (GMTs) of Influenza Antibodies Before and Post Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine A/H1N1; Pre-vaccination	32.6 Titers (1/dilutions) Interval 16.4 to 64.9	361 Titers (1/dilutions) Interval 179.0 to 727.0
Geometric Mean Titers (GMTs) of Influenza Antibodies Before and Post Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine A/H1N1; Post-vaccination	447 Titers (1/dilutions) Interval 254.0 to 787.0	1235 Titers (1/dilutions) Interval 793.0 to 1924.0
Geometric Mean Titers (GMTs) of Influenza Antibodies Before and Post Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine A/H3N2; Pre-vaccination	55.9 Titers (1/dilutions) Interval 25.7 to 121.0	277 Titers (1/dilutions) Interval 162.0 to 473.0
Geometric Mean Titers (GMTs) of Influenza Antibodies Before and Post Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine A/H3N2; Post-vaccination	696 Titers (1/dilutions) Interval 416.0 to 1165.0	1250 Titers (1/dilutions) Interval 861.0 to 1814.0
Geometric Mean Titers (GMTs) of Influenza Antibodies Before and Post Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine B (Yamagata); Pre-vaccination	56.6 Titers (1/dilutions) Interval 30.3 to 106.0	281 Titers (1/dilutions) Interval 158.0 to 497.0
Geometric Mean Titers (GMTs) of Influenza Antibodies Before and Post Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine B (Yamagata); Post-vaccination	617 Titers (1/dilutions) Interval 342.0 to 1115.0	1425 Titers (1/dilutions) Interval 972.0 to 2090.0
Geometric Mean Titers (GMTs) of Influenza Antibodies Before and Post Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine B (Victoria); Pre-vaccination	12.5 Titers (1/dilutions) Interval 6.88 to 22.9	156 Titers (1/dilutions) Interval 85.9 to 284.0
Geometric Mean Titers (GMTs) of Influenza Antibodies Before and Post Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine B (Victoria); Post-vaccination	352 Titers (1/dilutions) Interval 203.0 to 612.0	1136 Titers (1/dilutions) Interval 706.0 to 1828.0

SECONDARY outcome

Timeframe: Day 0 (pre-vaccination) and Day 28 post-final vaccination

Population: Seroprotection was assessed in the Per-Protocol Analysis Set.

Influenza antibodies were assessed using the hemagglutination inhibition (HAI) assay. Seroprotection was defined as a titer ≥ 40 (l/dil) at pre-vaccination and at 28 days after the final vaccination.

Outcome measures

Outcome measures
Measure	6 to < 36 Months of Age n=29 Participants Participants 6 to \< 36 months of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.	3 to < 9 Years of Age n=29 Participants Participants 3 to \< 9 years of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
Number of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine A/H1N1; Pre-vaccination	44.8 Percentage of participants	86.2 Percentage of participants
Number of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine A/H1N1; Post-vaccination	93.1 Percentage of participants	96.6 Percentage of participants
Number of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine A/H3N2; Pre-vaccination	62.1 Percentage of participants	93.1 Percentage of participants
Number of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine A/H3N2; Post-vaccination	96.6 Percentage of participants	100.0 Percentage of participants
Number of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine B (Yamagata); Pre-vaccination	55.2 Percentage of participants	89.7 Percentage of participants
Number of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine B (Yamagata); Post-vaccination	100.0 Percentage of participants	100.0 Percentage of participants
Number of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine B (Victoria); Pre-vaccination	17.2 Percentage of participants	82.8 Percentage of participants
Number of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine B (Victoria); Post-vaccination	100.0 Percentage of participants	100.0 Percentage of participants

SECONDARY outcome

Timeframe: Day 28 post-final vaccination

Population: Seroconversion was assessed in the Per-Protocol Analysis Set.

Influenza antibodies were assessed using the hemagglutination inhibition (HAI) assay. Seroconversion is 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 ≥ 4-fold increase in post-vaccination titer.

Outcome measures

Outcome measures
Measure	6 to < 36 Months of Age n=29 Participants Participants 6 to \< 36 months of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.	3 to < 9 Years of Age n=29 Participants Participants 3 to \< 9 years of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
Percentage of Participants With Seroconversion Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine A/H1N1	86.2 Percentage of participants	34.5 Percentage of participants
Percentage of Participants With Seroconversion Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine A/H3N2	89.7 Percentage of participants	58.6 Percentage of participants
Percentage of Participants With Seroconversion Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine B (Yamagata)	86.2 Percentage of participants	58.6 Percentage of participants
Percentage of Participants With Seroconversion Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine B (Victoria)	89.7 Percentage of participants	69.0 Percentage of participants

SECONDARY outcome

Timeframe: Day 28 post-final vaccination

Population: Geometric mean titer ratios were assessed in the Per-Protocol Analysis Set.

Geometric titer ratios of influenza antibodies were assessed using the hemagglutination inhibition (HAI) assay.

Outcome measures

Outcome measures
Measure	6 to < 36 Months of Age n=29 Participants Participants 6 to \< 36 months of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.	3 to < 9 Years of Age n=29 Participants Participants 3 to \< 9 years of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine B (Victoria)	18.9 Titer ratio Interval 11.6 to 30.8	7.10 Titer ratio Interval 4.71 to 10.7
Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine A/H1N1	10.9 Titer ratio Interval 6.61 to 18.0	3.30 Titer ratio Interval 2.14 to 5.11
Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine A/H3N2	10.4 Titer ratio Interval 6.59 to 16.4	4.51 Titer ratio Interval 3.09 to 6.58
Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine B (Yamagata)	10.0 Titer ratio Interval 6.35 to 15.9	5.02 Titer ratio Interval 3.43 to 7.34

Adverse Events

6 to < 36 Months of Age

Serious events: 1 serious events

Other events: 21 other events

Deaths: 0 deaths

3 to < 9 Years of Age

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	6 to < 36 Months of Age n=30 participants at risk Participants 6 to \< 36 months of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.	3 to < 9 Years of Age n=30 participants at risk Participants 3 to \< 9 years of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
Infections and infestations Abscess neck	3.3% 1/30 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 7 post-any vaccination.	0.00% 0/30 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 7 post-any vaccination.

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	6 to < 36 Months of Age n=30 participants at risk Participants 6 to \< 36 months of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.	3 to < 9 Years of Age n=30 participants at risk Participants 3 to \< 9 years of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
Eye disorders Conjunctivitis	6.7% 2/30 • Number of events 2 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 7 post-any vaccination.	0.00% 0/30 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 7 post-any vaccination.
General disorders Pyrexia	10.0% 3/30 • Number of events 3 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 7 post-any vaccination.	3.3% 1/30 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 7 post-any vaccination.
Infections and infestations Otitis media acute	10.0% 3/30 • Number of events 3 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 7 post-any vaccination.	6.7% 2/30 • Number of events 2 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 7 post-any vaccination.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/30 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 7 post-any vaccination.	6.7% 2/30 • Number of events 2 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 7 post-any vaccination.
Respiratory, thoracic and mediastinal disorders Cough	6.7% 2/30 • Number of events 3 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 7 post-any vaccination.	16.7% 5/30 • Number of events 5 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 7 post-any vaccination.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	10.0% 3/30 • Number of events 3 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 7 post-any vaccination.	0.00% 0/30 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 7 post-any vaccination.
General disorders Injection site Tenderness	70.0% 21/30 • Number of events 21 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 7 post-any vaccination.	0.00% 0/30 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 7 post-any vaccination.
General disorders Injection site Erythema	50.0% 15/30 • Number of events 15 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 7 post-any vaccination.	66.7% 20/30 • Number of events 20 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 7 post-any vaccination.
General disorders Injection site Swelling	23.3% 7/30 • Number of events 7 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 7 post-any vaccination.	43.3% 13/30 • Number of events 13 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 7 post-any vaccination.
General disorders Fever	20.7% 6/29 • Number of events 6 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 7 post-any vaccination.	3.3% 1/30 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 7 post-any vaccination.
Gastrointestinal disorders Vomiting	16.7% 5/30 • Number of events 5 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 7 post-any vaccination.	0.00% 0/30 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 7 post-any vaccination.
Psychiatric disorders Crying abnormal	33.3% 10/30 • Number of events 10 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 7 post-any vaccination.	0.00% 0/30 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 7 post-any vaccination.
Nervous system disorders Drowsiness	30.0% 9/30 • Number of events 9 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 7 post-any vaccination.	0.00% 0/30 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 7 post-any vaccination.
Metabolism and nutrition disorders Appetite lost	26.7% 8/30 • Number of events 8 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 7 post-any vaccination.	0.00% 0/30 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 7 post-any vaccination.
Psychiatric disorders Irritability	53.3% 16/30 • Number of events 16 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 7 post-any vaccination.	0.00% 0/30 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 7 post-any vaccination.
General disorders Injection site Pain	0.00% 0/30 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 7 post-any vaccination.	73.3% 22/30 • Number of events 22 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 7 post-any vaccination.
Nervous system disorders Headache	0.00% 0/30 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 7 post-any vaccination.	10.0% 3/30 • Number of events 3 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 7 post-any vaccination.
General disorders Malaise	0.00% 0/30 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 7 post-any vaccination.	13.3% 4/30 • Number of events 4 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 7 post-any vaccination.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/30 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 7 post-any vaccination.	13.3% 4/30 • Number of events 4 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 7 post-any vaccination.