Trial Outcomes & Findings for Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Influenza Virus Vaccine (2012-2013 Formulation) (NCT NCT01691326)

Last Updated: 2014-04-16

Results Overview

Solicited injection site reactions (Age 6 to \< 24 Months): Tenderness, Erythema and Swelling. Solicited systemic reactions: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of appetite, and Irritability. Grade 3: Tenderness, Cries when injected limb is moved; Erythema and Swelling, ≥ 50 mm; Fever, \>103.1°F; Vomiting, ≥6 episodes/24 hours; Abnormal crying, \>3 hours; Drowsiness, Sleeping most of the time; Loss of appetite, Refuses ≥3 feeds/meals or most feeds/meals; Irritability, Inconsolable. Solicited injection site reactions (Age 24 Months to \< 9 Years): Pain, Erythema, and Swelling. Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3: Pain, Incapacitating, unable to perform usual activities; Redness and Swelling, ≥ 50 mm; Fever: ≥102.1°F; 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-vaccination

Results posted on

2014-04-16

Participant Flow

The study participants were enrolled from 19 September 2012 to 12 December 2012 at 2 clinic centers in the United States.

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

Participant milestones

Participant milestones
Measure	Age 6 to < 36 Months Group Participants 6 months to \< 36 months of age that received one or two doses of 0.25 mL of Fluzone vaccine	Age 3 to < 9 Years Group Participants 3 years to \< 9 years of age that received one or two doses 0.5 mL of Fluzone 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® Influenza Virus Vaccine (2012-2013 Formulation)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Age 6 to < 36 Months Group n=30 Participants Participants 6 months to \< 36 months of age that received one or two doses of 0.25 mL of Fluzone vaccine	Age 3 to < 9 Years Group n=30 Participants Participants 3 years to \< 9 years of age that received one or two doses of 0.5 mL of Fluzone 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	1.8 Years STANDARD_DEVIATION 0.6 • n=5 Participants	5.2 Years STANDARD_DEVIATION 1.6 • n=7 Participants	3.5 Years STANDARD_DEVIATION 1.2 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	13 Participants n=7 Participants	27 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	17 Participants n=7 Participants	33 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-vaccination

Population: Solicited injection site reactions and systemic reactions were assessed using the Safety Analysis Set, which includes all persons who received at least one dose of study vaccine.

Outcome measures

Outcome measures
Measure	Age 6 to < 36 Months Group n=30 Participants Participants 6 months to \< 36 months of age that received one or two doses of 0.25 mL of Fluzone vaccine	Age 3 to < 9 Years Group n=30 Participants Participants 3 years to \< 9 years of age that received one or two doses of 0.5 mL of Fluzone vaccine
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation) Grade 3 Irritability (N = 15, 0)	1 Participants	NA Participants Interval 0.0 to 0.0 Irritability was not solicited in this group
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation) Injection site Tenderness (N = 15, 0)	8 Participants	NA Participants Interval 0.0 to 0.0 Injection site Tenderness was not solicited in this group
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation) Grade 3 Injection site Tenderness (N =15, 0)	1 Participants	NA Participants Interval 0.0 to 0.0 Injection site Tenderness was not solicited in this group
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation) Injection site Pain (N =15, 30)	8 Participants	13 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation) Grade 3 Injection site Pain (N = 15, 30)	0 Participants	0 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation) Injection site Erythema (N = 30, 30)	8 Participants	9 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation) Grade 3 Injection site Erythema (N = 30, 30)	0 Participants	0 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation) Injection site Swelling (N = 30, 30)	5 Participants	7 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation) Grade 3 Injection site Swelling (N = 30, 30)	0 Participants	0 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation) Fever (N = 30, 28)	2 Participants	0 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation) Grade 3 Fever (N = 30, 28)	0 Participants	0 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation) Headache (N = 15, 30)	1 Participants	5 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation) Grade 3 Headache (N = 15, 30)	0 Participants	0 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation) Malaise (N = 15, 30)	4 Participants	4 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation) Grade 3 Malaise (N = 15, 30)	0 Participants	0 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation) Myalgia (N = 15, 30)	3 Participants	2 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation) Grade 3 Myalgia (N = 15, 30)	0 Participants	0 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation) Vomiting (N = 15, 0)	1 Participants	NA Participants Interval 0.0 to 0.0 Vomiting was not solicited in this group
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation) Grade 3 Vomiting (N = 15, 0)	0 Participants	NA Participants Interval 0.0 to 0.0 Vomiting was not solicited in this group
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation) Abnormal crying (N = 15, 0)	6 Participants	NA Participants Interval 0.0 to 0.0 Abnormal crying was not solicited in this group
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation) Grade 3 Abnormal crying (N = 15, 0)	0 Participants	NA Participants Interval 0.0 to 0.0 Abnormal crying was not solicited in this group
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation) Drowsiness (N = 15, 0)	5 Participants	NA Participants Interval 0.0 to 0.0 Drowsiness was not solicited in this group
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation) Grade 3 Drowsiness (N = 15, 0)	0 Participants	NA Participants Interval 0.0 to 0.0 Drowsiness was not solicited in this group
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation) Loss of Appetite (N = 15, 0)	4 Participants	NA Participants Interval 0.0 to 0.0 Loss of Appetite was not solicited in this group
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation) Grade 3 Loss of Appetite (N = 15, 0)	0 Participants	NA Participants Interval 0.0 to 0.0 Loss of Appetite was not solicited in this group
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation) Irritability (N = 15, 0)	9 Participants	NA Participants Interval 0.0 to 0.0 Irritability was not solicited in this group

OTHER_PRE_SPECIFIED outcome

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

Population: Geometric mean titers of antibodies against the influenza virus antigens were assessed in the Per-protocol Analysis Set.

The influenza virus antibodies were measured using a hemagglutination inhibition (HAI) assay.

Outcome measures

Outcome measures
Measure	Age 6 to < 36 Months Group n=25 Participants Participants 6 months to \< 36 months of age that received one or two doses of 0.25 mL of Fluzone vaccine	Age 3 to < 9 Years Group n=30 Participants Participants 3 years to \< 9 years of age that received one or two doses of 0.5 mL of Fluzone vaccine
Geometric Mean Titers of Antibodies to Influenza Antigens Before and Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation). A/H1N1 (pre-vaccination)	20.6 Titers Interval 9.93 to 42.6	68.8 Titers Interval 30.5 to 155.0
Geometric Mean Titers of Antibodies to Influenza Antigens Before and Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation). A/H1N1 (post-vaccination)	334 Titers Interval 189.0 to 589.0	864 Titers Interval 559.0 to 1337.0
Geometric Mean Titers of Antibodies to Influenza Antigens Before and Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation). A/H3N2 (pre-vaccination)	23.3 Titers Interval 11.4 to 47.5	84.8 Titers Interval 49.5 to 145.0
Geometric Mean Titers of Antibodies to Influenza Antigens Before and Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation). A/H3N2 (post-vaccination)	506 Titers Interval 296.0 to 865.0	895 Titers Interval 585.0 to 1369.0
Geometric Mean Titers of Antibodies to Influenza Antigens Before and Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation). B (pre-vaccination)	5.82 Titers Interval 4.76 to 7.13	9.66 Titers Interval 7.42 to 12.6
Geometric Mean Titers of Antibodies to Influenza Antigens Before and Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation). B (post-vaccination)	16.7 Titers Interval 11.2 to 24.8	69.6 Titers Interval 46.4 to 105.0

OTHER_PRE_SPECIFIED outcome

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

Population: Seroprotection against the influenza virus antigens were assessed in the Per-protocol Analysis Set.

Influenza virus antibodies were measured using a HAI assay. Seroprotection was defined as a titer ≥40 (1/dilution).

Outcome measures

Outcome measures
Measure	Age 6 to < 36 Months Group n=25 Participants Participants 6 months to \< 36 months of age that received one or two doses of 0.25 mL of Fluzone vaccine	Age 3 to < 9 Years Group n=30 Participants Participants 3 years to \< 9 years of age that received one or two doses of 0.5 mL of Fluzone vaccine
Number of Participants With Seroprotection Before and Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation) A/H1N1 (pre-vaccination)	10 Participants	18 Participants Interval 0.0 to 0.0
Number of Participants With Seroprotection Before and Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation) A/H1N1 (post-vaccination)	24 Participants	30 Participants Interval 0.0 to 0.0
Number of Participants With Seroprotection Before and Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation) A/H3N2 (pre-vaccination)	11 Participants	20 Participants Interval 0.0 to 0.0
Number of Participants With Seroprotection Before and Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation) A/H3N2 (post-vaccination)	25 Participants	30 Participants Interval 0.0 to 0.0
Number of Participants With Seroprotection Before and Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation) B (pre-vaccination)	1 Participants	2 Participants Interval 0.0 to 0.0
Number of Participants With Seroprotection Before and Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation) B (post-vaccination)	6 Participants	21 Participants Interval 0.0 to 0.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 28 after final vaccination

Population: Seroconversion against the influenza virus antigens were assessed in the Per-protocol Analysis Set.

Influenza virus antibodies were measured using a HAI assay. Seroconversion was defined as a pre-vaccination titer \<10 (1/dilution) and a post-vaccination titer ≥40 (1/dilution), or a pre-vaccination titer ≥10 (1/dilution) and ≥4-fold increase in titer 28 days after final vaccination.

Outcome measures

Outcome measures
Measure	Age 6 to < 36 Months Group n=25 Participants Participants 6 months to \< 36 months of age that received one or two doses of 0.25 mL of Fluzone vaccine	Age 3 to < 9 Years Group n=30 Participants Participants 3 years to \< 9 years of age that received one or two doses of 0.5 mL of Fluzone vaccine
Number of Participants With Seroconversion Against Influenza Virus Antigens Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation) A/H1N1	22 Participants	22 Participants Interval 0.0 to 0.0
Number of Participants With Seroconversion Against Influenza Virus Antigens Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation) A/H3N2	23 Participants	25 Participants Interval 0.0 to 0.0
Number of Participants With Seroconversion Against Influenza Virus Antigens Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation) B	5 Participants	20 Participants Interval 0.0 to 0.0

OTHER_PRE_SPECIFIED outcome

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

Population: Geometric mean titer ratios against the influenza virus antigens were assessed in the Per-protocol Analysis Set.

Influenza virus antibodies were measured using a HAI assay. Geometric mean titer ratio is the geometric mean of the individual post-vaccination / pre-vaccination titer of antibodies to the influenza virus antigens

Outcome measures

Outcome measures
Measure	Age 6 to < 36 Months Group n=25 Participants Participants 6 months to \< 36 months of age that received one or two doses of 0.25 mL of Fluzone vaccine	Age 3 to < 9 Years Group n=30 Participants Participants 3 years to \< 9 years of age that received one or two doses of 0.5 mL of Fluzone vaccine
Geometric Mean Titer Ratios (GMTRs) of Antibodies to Influenza Virus Antigens Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation). A/H1N1	11.6 Ratio Interval 7.24 to 18.7	10.7 Ratio Interval 5.56 to 20.5
Geometric Mean Titer Ratios (GMTRs) of Antibodies to Influenza Virus Antigens Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation). A/H3N2	16.2 Ratio Interval 9.45 to 27.9	10.3 Ratio Interval 5.88 to 18.1
Geometric Mean Titer Ratios (GMTRs) of Antibodies to Influenza Virus Antigens Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation). B	1.82 Ratio Interval 1.29 to 2.55	5.34 Ratio Interval 3.75 to 7.6

Adverse Events

6 to < 36 Months Age Group

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

3 to < 9 Years Age Group

Serious events: 0 serious events

Other events: 13 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	6 to < 36 Months Age Group n=30 participants at risk Participants 6 months to \< 36 months of age that received one or two doses of 0.25 mL of Fluzone vaccine	3 to < 9 Years Age Group n=30 participants at risk Participants 3 years to \< 9 years of age that received one or two doses of 0.5 mL of Fluzone vaccine
Gastrointestinal disorders Diarrhoea	13.3% 4/30 • Number of events 4 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 after final vaccination.	0.00% 0/30 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 after final vaccination.
General disorders Pyrexia	3.3% 1/30 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 after final vaccination.	6.7% 2/30 • Number of events 2 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 after final vaccination.
Infections and infestations Upper respiratory tract infection	13.3% 4/30 • Number of events 5 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 after final vaccination.	0.00% 0/30 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 after final 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 28 after final vaccination.	6.7% 2/30 • Number of events 2 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 after final vaccination.
General disorders Injection site Tenderness	53.3% 8/15 • Number of events 8 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 after final vaccination.	— 0/0 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 after final vaccination.
General disorders Injection site Pain	53.3% 8/15 • Number of events 8 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 after final vaccination.	43.3% 13/30 • Number of events 13 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 after final vaccination.
General disorders Injection site Erythema	26.7% 8/30 • Number of events 8 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 after final vaccination.	30.0% 9/30 • Number of events 9 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 after final vaccination.
General disorders Injection site Swelling	16.7% 5/30 • Number of events 5 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 after final vaccination.	23.3% 7/30 • Number of events 7 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 after final vaccination.
General disorders Fever	6.7% 2/30 • Number of events 2 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 after final vaccination.	0.00% 0/28 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 after final vaccination.
Psychiatric disorders Abnormal crying	40.0% 6/15 • Number of events 6 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 after final vaccination.	— 0/0 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 after final vaccination.
Nervous system disorders Drowsiness	33.3% 5/15 • Number of events 5 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 after final vaccination.	— 0/0 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 after final vaccination.
Metabolism and nutrition disorders Loss of Appetite	26.7% 4/15 • Number of events 4 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 after final vaccination.	— 0/0 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 after final vaccination.
Psychiatric disorders Irritability	60.0% 9/15 • Number of events 9 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 after final vaccination.	— 0/0 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 after final vaccination.
Nervous system disorders Headache	6.7% 1/15 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 after final vaccination.	16.7% 5/30 • Number of events 5 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 after final vaccination.
General disorders Malaise	26.7% 4/15 • Number of events 4 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 after final vaccination.	13.3% 4/30 • Number of events 4 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 after final vaccination.
Musculoskeletal and connective tissue disorders Myalgia	20.0% 3/15 • Number of events 3 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 after final vaccination.	6.7% 2/30 • Number of events 2 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 after final vaccination.
Gastrointestinal disorders Vomiting	6.7% 1/15 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 after final vaccination.	— 0/0 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 after final vaccination.