Trial Outcomes & Findings for A Study of Different Formulations of an A/H1N1 Pandemic Vaccine in Healthy Children Aged 6 Months to 9 Years (NCT NCT00952419)

NCT ID: NCT00952419

Last Updated: 2016-04-14

Results Overview

Pre- and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

474 participants

Primary outcome timeframe

Pre-vaccination (Day 0) and 21 days post-vaccination

Results posted on

2016-04-14

Participant Flow

Participants were enrolled from 06 August 2009 to 13 August 2009 at 19 US clinical centers.

A total of 474 participants who met the inclusion and exclusion criteria were enrolled, vaccinated, and included in data analysis.

Participant milestones

Participant milestones
Measure	A/H1N1 Vaccine Group 1 Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.	A/H1N1 Vaccine Group 2 Participants who received a dose of 15 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.	Placebo Group Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
Overall Study STARTED	215	208	51
Overall Study COMPLETED	209	198	51
Overall Study NOT COMPLETED	6	10	0

Reasons for withdrawal

Reasons for withdrawal
Measure	A/H1N1 Vaccine Group 1 Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.	A/H1N1 Vaccine Group 2 Participants who received a dose of 15 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
Overall Study Adverse Event	2	0
Overall Study Protocol Violation	3	7
Overall Study Withdrawal by Subject	1	3

Baseline Characteristics

A Study of Different Formulations of an A/H1N1 Pandemic Vaccine in Healthy Children Aged 6 Months to 9 Years

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	A/H1N1 Vaccine Group 1 n=215 Participants Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.	A/H1N1 Vaccine Group 2 n=208 Participants Participants who received a dose of 15 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.	Placebo Group n=51 Participants Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.	Total n=474 Participants Total of all reporting groups
Age, Categorical <=18 years	215 Participants n=5 Participants	208 Participants n=7 Participants	51 Participants n=5 Participants	474 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	4.1 Years STANDARD_DEVIATION 2.8 • n=5 Participants	4.3 Years STANDARD_DEVIATION 2.8 • n=7 Participants	3.7 Years STANDARD_DEVIATION 2.7 • n=5 Participants	4.2 Years STANDARD_DEVIATION 2.8 • n=4 Participants
Sex: Female, Male Female	111 Participants n=5 Participants	99 Participants n=7 Participants	24 Participants n=5 Participants	234 Participants n=4 Participants
Sex: Female, Male Male	104 Participants n=5 Participants	109 Participants n=7 Participants	27 Participants n=5 Participants	240 Participants n=4 Participants
Region of Enrollment United States	215 participants n=5 Participants	208 participants n=7 Participants	51 participants n=5 Participants	474 participants n=4 Participants

PRIMARY outcome

Timeframe: Pre-vaccination (Day 0) and 21 days post-vaccination

Population: Pre- and post-vaccination antibody titers were assessed in the per-protocol population

Pre- and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.

Outcome measures

Outcome measures
Measure	A/H1N1 Vaccine Group 1 n=92 Participants Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.	A/H1N1 Vaccine Group 2 n=87 Participants Participants who received a dose of 15 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.	Placebo Group n=23 Participants Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months Pre-Vaccination 1 (Day 0) Titers at ≥ 10 1/dil	5 Participants	2 Participants	0 Participants
Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months Post-Vaccination 1 (Day 21) Titers at ≥ 10 1/dil	72 Participants	79 Participants	0 Participants
Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months Post-Vaccination 2 (Day 42) Titers at ≥ 10 1/dil	90 Participants	87 Participants	1 Participants

PRIMARY outcome

Timeframe: Pre-vaccination (Day 0) and Day 21 post-vaccination

Population: Antibody titers were assessed in the per-protocol population.

Seroprotection: Antibody titer of ≥ 40 1/dil. Antibody titers were determined by the hemagglutination inhibition (HAI) test.

Outcome measures

Outcome measures
Measure	A/H1N1 Vaccine Group 1 n=92 Participants Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.	A/H1N1 Vaccine Group 2 n=87 Participants Participants who received a dose of 15 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.	Placebo Group n=23 Participants Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months Pre-Vaccination 1 (Day 0) Titers at ≥ 40 1/dil	5 Participants	2 Participants	0 Participants
Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months Post-Vaccination 1 (Day 21) Titers at ≥ 40 1/dil	43 Participants	42 Participants	0 Participants
Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months Post-Vaccination 2 (Day 42) Titers at ≥ 40 1/dil	84 Participants	86 Participants	1 Participants

PRIMARY outcome

Timeframe: Pre-vaccination (Day 0) and 21 days post-vaccination

Population: Antibody titers were assessed in the per-protocol population.

Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.

Outcome measures

Outcome measures
Measure	A/H1N1 Vaccine Group 1 n=92 Participants Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.	A/H1N1 Vaccine Group 2 n=87 Participants Participants who received a dose of 15 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.	Placebo Group n=23 Participants Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months Pre-Vaccination 1 (Day 0) GMT	5.99 Titers Interval 5.1 to 7.04	5.48 Titers Interval 4.84 to 6.2	5.00 Titers Interval 5.0 to 5.0
Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months Post-Vaccination 1 (Day 21) GMT	33.3 Titers Interval 23.8 to 46.5	45.1 Titers Interval 32.8 to 62.0	5.08 Titers Interval 4.92 to 5.24
Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months Post-Vaccination 2 (Day 42) GMT	368 Titers Interval 271.0 to 500.0	586 Titers Interval 451.0 to 763.0	5.64 Titers Interval 4.39 to 7.24

PRIMARY outcome

Timeframe: Pre-vaccination (Day 0) and 21 days post-vaccination

Population: Pre- and post-vaccination antibody titers were assessed in the per-protocol population

Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.

Outcome measures

Outcome measures
Measure	A/H1N1 Vaccine Group 1 n=98 Participants Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.	A/H1N1 Vaccine Group 2 n=91 Participants Participants who received a dose of 15 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.	Placebo Group n=24 Participants Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years Pre-Vaccination 1(Day 0) Titers at ≥ 10 1/dil	7 Participants	4 Participants	7 Participants
Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years Post-Vaccination 1 (Day 21) Titers at ≥ 10 1/dil	91 Participants	88 Participants	8 Participants
Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years Post-Vaccination 2 (Day 42) Titers at ≥ 10 1/dil	98 Participants	91 Participants	8 Participants

PRIMARY outcome

Timeframe: Pre-vaccination (Day 0) and Day 21 post-vaccination

Population: Pre- and post-vaccination antibody titers were assessed in the per-protocol population

Seroprotection: Antibody titer ≥ 40 1/dil. Antibody titers were determined by the hemagglutination inhibition (HAI) test.

Outcome measures

Outcome measures
Measure	A/H1N1 Vaccine Group 1 n=98 Participants Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.	A/H1N1 Vaccine Group 2 n=91 Participants Participants who received a dose of 15 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.	Placebo Group n=24 Participants Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years Pre-Vaccination 1 (Day 0) Titers at ≥ 40 1/dil	5 Participants	3 Participants	5 Participants
Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years Post-Vaccination 1 (Day 21) Titers at ≥ 40 1/dil	64 Participants	68 Participants	5 Participants
Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years Post-Vaccination 2 (Day 42) Titers at ≥ 40 1/dil	95 Participants	90 Participants	6 Participants

PRIMARY outcome

Timeframe: Pre-vaccination (Day 0) and Day 21 post-vaccination

Population: Antibody titers were assessed in the per-protocol population.

Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.

Outcome measures

Outcome measures
Measure	A/H1N1 Vaccine Group 1 n=98 Participants Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.	A/H1N1 Vaccine Group 2 n=91 Participants Participants who received a dose of 15 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.	Placebo Group n=24 Participants Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years Pre-Vaccination 1 (Day 0) GMT	6.01 Titers Interval 5.2 to 6.94	5.54 Titers Interval 5.03 to 6.1	11.9 Titers Interval 6.17 to 22.9
Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years Post-Vaccination 1 (Day 21) GMT	74.8 Titers Interval 53.5 to 105.0	104 Titers Interval 77.1 to 140.0	12.1 Titers Interval 6.53 to 22.3
Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years Post-Vaccination 2 (Day 42) GMT	459 Titers Interval 348.0 to 605.0	586 Titers Interval 454.0 to 756.0	14.3 Titers Interval 7.02 to 29.3

PRIMARY outcome

Timeframe: Days 0 to 7 post-vaccination

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

Solicited Injection Site Reactions: Tenderness, erythema (redness), swelling, induration (hardening), ecchymosis (bruising). Solicited systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, irritability.

Outcome measures

Outcome measures
Measure	A/H1N1 Vaccine Group 1 n=61 Participants Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.	A/H1N1 Vaccine Group 2 n=56 Participants Participants who received a dose of 15 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.	Placebo Group n=18 Participants Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months Any Ecchymosis - Any Dose	4 Participants	4 Participants	0 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months Any Solicited Systemic Reaction - Any Dose	31 Participants	32 Participants	11 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months Any Grade 3 Solicited Systemic Reaction - Any Dose	3 Participants	4 Participants	0 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months Any Induration - Post Dose 1	6 Participants	3 Participants	1 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months Any Induration - Post Dose 2	4 Participants	3 Participants	0 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months Any Induration - Any Dose	6 Participants	5 Participants	1 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months Grade 3 Induration (≥ 5 cm) Any Dose	0 Participants	0 Participants	0 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months Any Ecchymosis - Post Dose 1	3 Participants	3 Participants	0 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months Any Ecchymosis - Post Dose 2	2 Participants	2 Participants	0 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months Grade 3 Ecchymosis (≥ 5 cm) Any Dose	1 Participants	0 Participants	0 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months Any Fever - Post Dose 1	6 Participants	2 Participants	0 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months Any Fever - Post Dose 2	0 Participants	5 Participants	1 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months Any Fever - Any Dose	6 Participants	6 Participants	1 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months Grade 3 Fever ( ≥102.1 ºF or ≥39.0 ºC) - Any Dose	0 Participants	1 Participants	0 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months Any Vomiting - Post Dose 1	1 Participants	4 Participants	0 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months Any Vomiting - Post Dose 2	2 Participants	3 Participants	0 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months Any Vomiting - Any Dose	3 Participants	6 Participants	0 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months Grade 3 Vomiting (> 6 episodes/24 hr) Any Dose	0 Participants	3 Participants	0 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months Any Crying Abnormal - Post Dose 1	17 Participants	12 Participants	5 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months Any Crying Abnormal - Post Dose 2	8 Participants	9 Participants	4 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months Any Crying Abnormal - Any Dose	20 Participants	14 Participants	7 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months Grade 3 Crying Abnormal (>3 hr) Any Dose	3 Participants	2 Participants	0 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months Any Drowsiness - Post Dose 1	8 Participants	11 Participants	3 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months Any Drowsiness - Post Dose 2	8 Participants	7 Participants	2 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months Any Drowsiness - Any Dose	11 Participants	11 Participants	3 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months Grade 3 Drowsiness (Sleeps most of time) Any Dose	0 Participants	1 Participants	0 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months Any Appetite Lost - Post Dose 1	8 Participants	12 Participants	3 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months Any Appetite Lost - Post Dose 2	5 Participants	9 Participants	3 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months Any Appetite Lost - Any Dose	10 Participants	14 Participants	4 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months Grd 3 Appetite Lost (Refused 3 meals) Any Dose	0 Participants	1 Participants	0 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months Any Irritability - Post Dose 1	23 Participants	22 Participants	7 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months Any Irritability - Post Dose 2	14 Participants	17 Participants	6 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months Any Irritability - Any Dose	26 Participants	25 Participants	9 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months Grade 3 Irritability (Inconsolable) Any Dose	0 Participants	2 Participants	0 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months Any Solicited Injection Site Reaction - Any Dose	33 Participants	23 Participants	11 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months Grade (Grd) 3 Injection Site Reaction - Any Dose	1 Participants	1 Participants	0 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months Any Tenderness - Post Dose 1	24 Participants	14 Participants	5 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months Any Tenderness - Post Dose 2	19 Participants	11 Participants	7 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months Any Tenderness - Any Dose	28 Participants	20 Participants	10 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months Grd 3 Tenderness-Crying or movement less, Any Dose	0 Participants	1 Participants	0 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months Any Erythema - Post Dose 1	13 Participants	4 Participants	1 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months Any Erythema - Post Dose 2	12 Participants	5 Participants	2 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months Any Erythema - Any Dose	19 Participants	7 Participants	3 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months Grade 3 Erythema (≥ 5 cm) Any Dose	0 Participants	0 Participants	0 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months Any Swelling - Post Dose 1	4 Participants	5 Participants	0 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months Any Swelling - Post Dose 2	3 Participants	3 Participants	1 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months Any Swelling - Any Dose	6 Participants	6 Participants	1 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months Grade 3 Swelling (≥ 5 cm) Any Dose	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Days 0 to 7 post-vaccination

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

Solicited Injection Site Reactions: Pain, erythema (redness), swelling, induration (hardening), ecchymosis (bruising). Solicited systemic reactions: Fever (temperature), headache, malaise (feeling unwell), myalgia (muscle aches and pains), shivering.

Outcome measures

Outcome measures
Measure	A/H1N1 Vaccine Group 1 n=44 Participants Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.	A/H1N1 Vaccine Group 2 n=42 Participants Participants who received a dose of 15 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.	Placebo Group n=8 Participants Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months Grade 3 Erythema (≥ 5 cm) Any Dose	0 Participants	0 Participants	0 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months Any Fever - Post Dose 2	3 Participants	1 Participants	0 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months Any Solicited Injection Site Reaction - Any Dose	19 Participants	20 Participants	5 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months Grade (Grd) 3 Injection Site Reaction - Any Dose	0 Participants	2 Participants	0 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months Any Pain - Post Dose 1	12 Participants	12 Participants	3 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months Any Pain - Post Dose 2	10 Participants	16 Participants	2 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months Any Pain - Any Dose	17 Participants	19 Participants	3 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months Grade 3 Pain (Incapacitating) - Any Dose	0 Participants	2 Participants	0 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months Any Erythema - Post Dose 1	5 Participants	7 Participants	3 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months Any Erythema - Post Dose 2	3 Participants	9 Participants	1 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months Any Erythema - Any Dose	6 Participants	12 Participants	3 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months Any Swelling - Post Dose 1	1 Participants	3 Participants	0 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months Any Swelling - Post Dose 2	0 Participants	3 Participants	0 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months Any Swelling - Any Dose	1 Participants	4 Participants	0 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months Grade 3 Swelling (≥ 5 cm) Any Dose	0 Participants	0 Participants	0 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months Any Induration - Post Dose 1	2 Participants	4 Participants	1 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months Any Induration - Post Dose 2	1 Participants	3 Participants	1 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months Any Induration - Any Dose	2 Participants	6 Participants	1 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months Grade 3 Induration (≥ 5 cm) Any Dose	0 Participants	0 Participants	0 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months Any Ecchymosis - Post Dose 1	1 Participants	3 Participants	2 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months Any Ecchymosis - Post Dose 2	2 Participants	3 Participants	0 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months Any Ecchymosis - Any Dose	3 Participants	6 Participants	2 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months Grade 3 Ecchymosis (≥ 5 cm) Any Dose	0 Participants	0 Participants	0 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months Any Solicited Systemic Reaction - Any Dose	14 Participants	13 Participants	3 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months Any Grade 3 Solicited Systemic Reaction - Any Dose	1 Participants	2 Participants	1 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months Any Fever - Post Dose 1	1 Participants	1 Participants	1 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months Any Fever - Any Dose	4 Participants	2 Participants	1 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months Grade 3 Fever (≥ 102.1 ºF or ≥ 39.0 ºC) -Any Dose	1 Participants	1 Participants	1 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months Any Headache - Post Dose 1	1 Participants	1 Participants	1 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months Any Headache - Post Dose 2	0 Participants	1 Participants	1 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months Any Headache - Any Dose	1 Participants	2 Participants	1 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months Grd 3 Headache (Prevents daily activity) Any Dose	0 Participants	0 Participants	0 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months Any Malaise - Post Dose 1	7 Participants	6 Participants	3 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months Any Malaise - Post Dose 2	5 Participants	6 Participants	2 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months Any Malaise - Any Dose	10 Participants	9 Participants	3 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months Grd 3 Malaise (Prevents daily activity) Any Dose	1 Participants	1 Participants	0 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months Any Myalgia - Post Dose 1	4 Participants	3 Participants	2 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months Any Myalgia - Post Dose 2	0 Participants	2 Participants	2 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months Any Myalgia - Any Dose	4 Participants	5 Participants	2 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months Grd 3 Myalgia (Prevents Daily Activity) Any Dose	0 Participants	0 Participants	0 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months Any Shivering - Post Dose 1	1 Participants	1 Participants	0 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months Any Shivering - Post Dose 2	0 Participants	0 Participants	0 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months Any Shivering - Any Dose	1 Participants	1 Participants	0 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months Grade 3 Shivering (Prevents activity) - Any Dose	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Days 0 to 7 post vaccination

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

Outcome measures

Outcome measures
Measure	A/H1N1 Vaccine Group 1 n=114 Participants Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.	A/H1N1 Vaccine Group 2 n=106 Participants Participants who received a dose of 15 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.	Placebo Group n=25 Participants Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years Any Headache - Post Dose 1	15 Participants	11 Participants	5 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years Any Headache - Post Dose 2	13 Participants	10 Participants	3 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years Any Headache - Any Dose	23 Participants	19 Participants	7 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years Gr 3 Headache (Prevents daily activity) Any Dose	0 Participants	4 Participants	0 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years Any Malaise - Post Dose 1	18 Participants	12 Participants	7 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years Any Malaise - Post Dose 2	16 Participants	14 Participants	5 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years Any Solicited Injection Site Reaction - Any Dose	70 Participants	59 Participants	16 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years Grade 3 Injection Site Reaction - Any Dose	3 Participants	3 Participants	0 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years Any Pain - Post Dose 1	48 Participants	42 Participants	12 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years Any Pain - Post Dose 2	34 Participants	31 Participants	8 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years Any Pain - Any Dose	63 Participants	54 Participants	16 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years Grade 3 Pain (Incapacitating) - Any Dose	2 Participants	0 Participants	0 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years Any Erythema - Post Dose 1	14 Participants	14 Participants	2 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years Any Erythema - Post Dose 2	10 Participants	5 Participants	2 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years Any Erythema - Any Dose	19 Participants	15 Participants	2 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years Grade 3 Erythema (≥ 5 cm) Any Dose	1 Participants	1 Participants	0 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years Any Swelling - Post Dose 1	5 Participants	10 Participants	1 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years Any Swelling - Post Dose 2	5 Participants	3 Participants	0 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years Any Swelling - Any Dose	8 Participants	11 Participants	1 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years Grade 3 Swelling (≥ 5 cm) Any Dose	1 Participants	3 Participants	0 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years Any Induration - Post Dose 1	7 Participants	8 Participants	4 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years Any Induration - Post Dose 2	7 Participants	2 Participants	0 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years Any Induration - Any Dose	11 Participants	8 Participants	4 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years Grade 3 Induration (≥ 5 cm) Any Dose	1 Participants	0 Participants	0 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years Any Ecchymosis - Post Dose 1	9 Participants	9 Participants	1 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years Any Ecchymosis - Post Dose 2	6 Participants	4 Participants	1 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years Any Ecchymosis - Any Dose	13 Participants	11 Participants	2 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years Grade 3 Ecchymosis (≥ 5 cm) Any Dose	0 Participants	0 Participants	0 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years Any Solicited Systemic Reaction - Any Dose	51 Participants	38 Participants	12 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years Any Grade 3 Solicited Systemic Reaction - Any Dose	5 Participants	7 Participants	2 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years Any Fever - Post Dose 1	2 Participants	1 Participants	1 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years Any Fever - Post Dose 2	4 Participants	5 Participants	1 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years Any Fever - Any Dose	6 Participants	6 Participants	2 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years Grade 3 Fever (≥ 102.1 ºF or ≥ 39.0 ºC) - Any Dose	1 Participants	3 Participants	1 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years Any Malaise - Any Dose	29 Participants	24 Participants	10 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years Gr 3 Malaise (Prevents daily activity) Any Dose	2 Participants	0 Participants	0 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years Any Myalgia - Post Dose 1	19 Participants	9 Participants	1 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years Any Myalgia - Post Dose 2	14 Participants	11 Participants	3 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years Any Myalgia - Any Dose	32 Participants	18 Participants	3 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years Any Shivering - Post Dose 1	1 Participants	3 Participants	1 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years Any Shivering - Post Dose 2	0 Participants	5 Participants	1 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years Any Shivering - Any Dose	1 Participants	8 Participants	2 Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years Grade 3 Shivering (Prevents activity) - Any Dose	1 Participants	2 Participants	0 Participants

Adverse Events

A/H1N1 Vaccine Group 1

Serious events: 1 serious events

Other events: 110 other events

Deaths: 0 deaths

A/H1N1 Vaccine Group 2

Serious events: 0 serious events

Other events: 104 other events

Deaths: 0 deaths

Placebo Group

Serious events: 1 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	A/H1N1 Vaccine Group 1 n=219 participants at risk Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.	A/H1N1 Vaccine Group 2 n=204 participants at risk Participants who received a dose of 15 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.	Placebo Group n=51 participants at risk Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
Infections and infestations Furuncle	0.46% 1/219 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination.	0.00% 0/204 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination.	0.00% 0/51 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/219 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination.	0.00% 0/204 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination.	2.0% 1/51 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months post-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	A/H1N1 Vaccine Group 1 n=219 participants at risk Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.	A/H1N1 Vaccine Group 2 n=204 participants at risk Participants who received a dose of 15 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.	Placebo Group n=51 participants at risk Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
General disorders Pyrexia	4.6% 10/219 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination.	5.9% 12/204 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination.	2.0% 1/51 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination.
Infections and infestations Upper respiratory tract infection	3.7% 8/219 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination.	4.4% 9/204 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination.	11.8% 6/51 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination.
Respiratory, thoracic and mediastinal disorders Cough	15.5% 34/219 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination.	10.8% 22/204 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination.	5.9% 3/51 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	13.2% 29/219 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination.	10.8% 22/204 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination.	7.8% 4/51 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination.
General disorders Injection site pain	51.3% 80/156 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination.	50.3% 73/145 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination.	57.6% 19/33 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination.
General disorders Injectiuon site tenderness	45.9% 28/61 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination.	36.4% 20/55 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination.	55.6% 10/18 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination.
General disorders Injection site erythema	20.3% 44/217 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination.	16.9% 34/201 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination.	15.7% 8/51 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination.
General disorders Injection site swelling	6.9% 15/217 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination.	10.4% 21/201 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination.	3.9% 2/51 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination.
General disorders Injection site induration	8.8% 19/217 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination.	9.5% 19/201 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination.	11.8% 6/51 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination.
General disorders Injection site ecchymosis	9.2% 20/217 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination.	10.4% 21/201 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination.	7.8% 4/51 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination.
General disorders Pyrexia (Fever)	7.4% 16/217 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination.	7.0% 14/200 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination.	7.8% 4/51 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination.
Nervous system disorders Headache	15.4% 24/156 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination.	14.5% 21/145 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination.	24.2% 8/33 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination.
General disorders Malaise	25.0% 39/156 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination.	22.8% 33/145 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination.	39.4% 13/33 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination.
Musculoskeletal and connective tissue disorders Myalgia	23.1% 36/156 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination.	15.9% 23/145 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination.	15.2% 5/33 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination.
General disorders Shivering	1.3% 2/156 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination.	6.2% 9/145 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination.	6.1% 2/33 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination.
Gastrointestinal disorders Vomiting	4.9% 3/61 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination.	10.9% 6/55 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination.	0.00% 0/18 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination.
Psychiatric disorders Crying abnormal	32.8% 20/61 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination.	25.5% 14/55 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination.	38.9% 7/18 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination.
Nervous system disorders Drowsiness	18.0% 11/61 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination.	20.0% 11/55 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination.	16.7% 3/18 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination.
Metabolism and nutrition disorders Appetite lost	16.4% 10/61 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination.	25.5% 14/55 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination.	22.2% 4/18 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination.
Psychiatric disorders Irritability	42.6% 26/61 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination.	45.5% 25/55 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination.	50.0% 9/18 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination.