Trial Outcomes & Findings for Safety and Immunogenicity of Fluzone® Quadrivalent, Flublok® Quadrivalent, and Fluzone® High-Dose, Influenza Vaccines, 2018-2019 Formulations (NCT NCT03617523)
NCT ID: NCT03617523
Last Updated: 2022-03-29
Results Overview
A solicited reaction was an adverse event (AE) that was pre-listed in the electronic case report form (eCRF) and considered to be related to vaccination. Solicited injection (Inj.) site reactions: tenderness, erythema and swelling. Solicited systemic reactions: fever, vomiting, crying abnormal, drowsiness, appetite lost and irritability.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
240 participants
Primary outcome timeframe
Within 7 days post any vaccination
Results posted on
2022-03-29
Participant Flow
Participants were enrolled from 10 September 2018 to 22 October 2018 at 3 centers in the United States.
A total of 240 participants were enrolled in the study.
Participant milestones
| Measure |
Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months
Participants (aged 6 to less than \[\<\] 36 months) received a 0.25-milliliter (mL) dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
|
Fluzone Quadrivalent Vaccine Group 2: 3 to <9 Years
Participants (aged 3 to \<9 years) received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
|
Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years
Participants (aged 18 to \<65 years) received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0.
|
Flublok Quadrivalent Vaccine Group 4: 18 to <65 Years
Participants (aged 18 to \<65 years) received a 0.5-mL dose of Flublok Quadrivalent vaccine, intramuscularly, at Day 0.
|
Fluzone High-Dose Vaccine Group 5: >=65 Years
Participants (aged greater than or equal to \[\>=\] 65 years) received a 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
61
|
59
|
60
|
|
Overall Study
COMPLETED
|
30
|
30
|
61
|
59
|
60
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Immunogenicity of Fluzone® Quadrivalent, Flublok® Quadrivalent, and Fluzone® High-Dose, Influenza Vaccines, 2018-2019 Formulations
Baseline characteristics by cohort
| Measure |
Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months
n=30 Participants
Participants (aged 6 to \<36 months) received a 0.25-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
|
Fluzone Quadrivalent Vaccine Group 2: 3 to <9 Years
n=30 Participants
Participants (aged 3 to \<9 years) received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
|
Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years
n=61 Participants
Participants (aged 18 to \<65 years) received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0.
|
Flublok Quadrivalent Vaccine Group 4: 18 to <65 Years
n=59 Participants
Participants (aged 18 to \<65 years) received a 0.5-mL dose of Flublok Quadrivalent vaccine, intramuscularly, at Day 0.
|
Fluzone High-Dose Vaccine Group 5: >=65 Years
n=60 Participants
Participants (aged \>=65 years) received a 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0.
|
Total
n=240 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
1.7 years
STANDARD_DEVIATION 0.44 • n=5 Participants
|
5.9 years
STANDARD_DEVIATION 1.76 • n=7 Participants
|
46.7 years
STANDARD_DEVIATION 13.48 • n=5 Participants
|
46.2 years
STANDARD_DEVIATION 13.44 • n=4 Participants
|
73.6 years
STANDARD_DEVIATION 6.42 • n=21 Participants
|
42.6 years
STANDARD_DEVIATION 26.97 • n=10 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
152 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
88 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
54 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
56 Participants
n=21 Participants
|
180 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Within 7 days post any vaccinationPopulation: Analysis was performed on safety analysis set. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
A solicited reaction was an adverse event (AE) that was pre-listed in the electronic case report form (eCRF) and considered to be related to vaccination. Solicited injection (Inj.) site reactions: tenderness, erythema and swelling. Solicited systemic reactions: fever, vomiting, crying abnormal, drowsiness, appetite lost and irritability.
Outcome measures
| Measure |
Fluzone Quadrivalent Vaccine Group 2: 3 to <9 Years
n=29 Participants
Participants (aged 3 to \<9 years) received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
|
Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years
Participants (aged 18 to \<65 years) received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0.
|
Flublok Quadrivalent Vaccine Group 4: 18 to <65 Years
Participants (aged 18 to \<65 years) received a 0.5-mL dose of Flublok Quadrivalent vaccine, intramuscularly, at Day 0.
|
Fluzone High-Dose Vaccine Group 5: >=65 Years
Participants (aged \>=65 years) received a 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0.
|
|---|---|---|---|---|
|
Number of Participants (Group 1: Aged 6 to <36 Months) Reporting Solicited Injection Site Reactions and Systemic Reactions
Injection site tenderness
|
15 Participants
|
—
|
—
|
—
|
|
Number of Participants (Group 1: Aged 6 to <36 Months) Reporting Solicited Injection Site Reactions and Systemic Reactions
Injection site erythema
|
3 Participants
|
—
|
—
|
—
|
|
Number of Participants (Group 1: Aged 6 to <36 Months) Reporting Solicited Injection Site Reactions and Systemic Reactions
Injection site swelling
|
4 Participants
|
—
|
—
|
—
|
|
Number of Participants (Group 1: Aged 6 to <36 Months) Reporting Solicited Injection Site Reactions and Systemic Reactions
Fever
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants (Group 1: Aged 6 to <36 Months) Reporting Solicited Injection Site Reactions and Systemic Reactions
Vomiting
|
3 Participants
|
—
|
—
|
—
|
|
Number of Participants (Group 1: Aged 6 to <36 Months) Reporting Solicited Injection Site Reactions and Systemic Reactions
Crying abnormal
|
4 Participants
|
—
|
—
|
—
|
|
Number of Participants (Group 1: Aged 6 to <36 Months) Reporting Solicited Injection Site Reactions and Systemic Reactions
Drowsiness
|
9 Participants
|
—
|
—
|
—
|
|
Number of Participants (Group 1: Aged 6 to <36 Months) Reporting Solicited Injection Site Reactions and Systemic Reactions
Appetite lost
|
10 Participants
|
—
|
—
|
—
|
|
Number of Participants (Group 1: Aged 6 to <36 Months) Reporting Solicited Injection Site Reactions and Systemic Reactions
Irritability
|
12 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post any vaccinationPopulation: Analysis was performed on safety analysis set.
A solicited reaction was an AE that was pre-listed in the eCRF and considered to be related to vaccination. Solicited injection site reactions: pain, erythema and swelling. Solicited systemic reactions: fever, headache, malaise, and myalgia.
Outcome measures
| Measure |
Fluzone Quadrivalent Vaccine Group 2: 3 to <9 Years
n=30 Participants
Participants (aged 3 to \<9 years) received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
|
Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years
n=61 Participants
Participants (aged 18 to \<65 years) received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0.
|
Flublok Quadrivalent Vaccine Group 4: 18 to <65 Years
n=59 Participants
Participants (aged 18 to \<65 years) received a 0.5-mL dose of Flublok Quadrivalent vaccine, intramuscularly, at Day 0.
|
Fluzone High-Dose Vaccine Group 5: >=65 Years
n=60 Participants
Participants (aged \>=65 years) received a 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0.
|
|---|---|---|---|---|
|
Number of Participants (Groups 2, 3, 4 and 5: Children Aged 3 to <9 Years and Adults 18 to >=65 Years) Reporting Solicited Injection Site Reactions or Systemic Reactions
Injection site pain
|
9 Participants
|
27 Participants
|
22 Participants
|
24 Participants
|
|
Number of Participants (Groups 2, 3, 4 and 5: Children Aged 3 to <9 Years and Adults 18 to >=65 Years) Reporting Solicited Injection Site Reactions or Systemic Reactions
Injection site erythema
|
5 Participants
|
1 Participants
|
0 Participants
|
5 Participants
|
|
Number of Participants (Groups 2, 3, 4 and 5: Children Aged 3 to <9 Years and Adults 18 to >=65 Years) Reporting Solicited Injection Site Reactions or Systemic Reactions
Injection site swelling
|
6 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants (Groups 2, 3, 4 and 5: Children Aged 3 to <9 Years and Adults 18 to >=65 Years) Reporting Solicited Injection Site Reactions or Systemic Reactions
Fever
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants (Groups 2, 3, 4 and 5: Children Aged 3 to <9 Years and Adults 18 to >=65 Years) Reporting Solicited Injection Site Reactions or Systemic Reactions
Headache
|
5 Participants
|
12 Participants
|
13 Participants
|
11 Participants
|
|
Number of Participants (Groups 2, 3, 4 and 5: Children Aged 3 to <9 Years and Adults 18 to >=65 Years) Reporting Solicited Injection Site Reactions or Systemic Reactions
Malaise
|
6 Participants
|
11 Participants
|
6 Participants
|
9 Participants
|
|
Number of Participants (Groups 2, 3, 4 and 5: Children Aged 3 to <9 Years and Adults 18 to >=65 Years) Reporting Solicited Injection Site Reactions or Systemic Reactions
Myalgia
|
6 Participants
|
14 Participants
|
11 Participants
|
15 Participants
|
PRIMARY outcome
Timeframe: 28 days post-final vaccinationPopulation: Analysis was performed on per-protocol analysis set which included participants who received at least 1 dose of the study vaccine and had a valid post-vaccination blood sample result for at least 1 strain without any protocol deviations.
GMT of anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage.
Outcome measures
| Measure |
Fluzone Quadrivalent Vaccine Group 2: 3 to <9 Years
n=26 Participants
Participants (aged 3 to \<9 years) received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
|
Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years
n=29 Participants
Participants (aged 18 to \<65 years) received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0.
|
Flublok Quadrivalent Vaccine Group 4: 18 to <65 Years
Participants (aged 18 to \<65 years) received a 0.5-mL dose of Flublok Quadrivalent vaccine, intramuscularly, at Day 0.
|
Fluzone High-Dose Vaccine Group 5: >=65 Years
Participants (aged \>=65 years) received a 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0.
|
|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Antibodies in Children 6 Months to <9 Years of Age (Groups 1 and 2) Receiving Fluzone Quadrivalent Vaccine
A/H1N1
|
229 titers (1/dilution)
Interval 108.0 to 487.0
|
1008 titers (1/dilution)
Interval 605.0 to 1680.0
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Antibodies in Children 6 Months to <9 Years of Age (Groups 1 and 2) Receiving Fluzone Quadrivalent Vaccine
A/H3N2
|
239 titers (1/dilution)
Interval 94.0 to 606.0
|
1109 titers (1/dilution)
Interval 671.0 to 1833.0
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Antibodies in Children 6 Months to <9 Years of Age (Groups 1 and 2) Receiving Fluzone Quadrivalent Vaccine
B Victoria
|
160 titers (1/dilution)
Interval 79.3 to 323.0
|
688 titers (1/dilution)
Interval 390.0 to 1211.0
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Antibodies in Children 6 Months to <9 Years of Age (Groups 1 and 2) Receiving Fluzone Quadrivalent Vaccine
B Yamagata
|
295 titers (1/dilution)
Interval 167.0 to 524.0
|
1343 titers (1/dilution)
Interval 811.0 to 2223.0
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 21 (post-vaccination)Population: Analysis was performed on per-protocol analysis set.
GMTs of anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage in Groups 3 and 4, and using HAI assay for 3 strains: A/H1N1, A/H3N2 and B Victoria lineage in Group 5.
Outcome measures
| Measure |
Fluzone Quadrivalent Vaccine Group 2: 3 to <9 Years
n=61 Participants
Participants (aged 3 to \<9 years) received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
|
Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years
n=58 Participants
Participants (aged 18 to \<65 years) received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0.
|
Flublok Quadrivalent Vaccine Group 4: 18 to <65 Years
n=60 Participants
Participants (aged 18 to \<65 years) received a 0.5-mL dose of Flublok Quadrivalent vaccine, intramuscularly, at Day 0.
|
Fluzone High-Dose Vaccine Group 5: >=65 Years
Participants (aged \>=65 years) received a 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0.
|
|---|---|---|---|---|
|
Geometric Mean Titers of Antibodies in Adults (Groups 3, 4 and 5) Receiving Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine, or Fluzone High-Dose Vaccine
A/H1N1
|
525 titers (1/dilutions)
Interval 386.0 to 712.0
|
708 titers (1/dilutions)
Interval 498.0 to 1007.0
|
266 titers (1/dilutions)
Interval 195.0 to 363.0
|
—
|
|
Geometric Mean Titers of Antibodies in Adults (Groups 3, 4 and 5) Receiving Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine, or Fluzone High-Dose Vaccine
A/H3N2
|
379 titers (1/dilutions)
Interval 276.0 to 523.0
|
644 titers (1/dilutions)
Interval 456.0 to 909.0
|
359 titers (1/dilutions)
Interval 255.0 to 507.0
|
—
|
|
Geometric Mean Titers of Antibodies in Adults (Groups 3, 4 and 5) Receiving Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine, or Fluzone High-Dose Vaccine
B Victoria
|
588 titers (1/dilutions)
Interval 447.0 to 773.0
|
525 titers (1/dilutions)
Interval 388.0 to 711.0
|
453 titers (1/dilutions)
Interval 337.0 to 608.0
|
—
|
|
Geometric Mean Titers of Antibodies in Adults (Groups 3, 4 and 5) Receiving Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine, or Fluzone High-Dose Vaccine
B Yamagata
|
759 titers (1/dilutions)
Interval 571.0 to 1009.0
|
1102 titers (1/dilutions)
Interval 829.0 to 1465.0
|
NA titers (1/dilutions)
Data not reported since the immune response to the B Yamagata lineage strain was not assessed in Group 5 participants.
|
—
|
PRIMARY outcome
Timeframe: Day 0 (pre-vaccination), 28 days post-final vaccinationPopulation: Analysis was performed on per-protocol analysis set. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
GMT of anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage. GMTRs were calculated as the ratio of GMTs post-final vaccination and pre-vaccination.
Outcome measures
| Measure |
Fluzone Quadrivalent Vaccine Group 2: 3 to <9 Years
n=25 Participants
Participants (aged 3 to \<9 years) received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
|
Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years
n=28 Participants
Participants (aged 18 to \<65 years) received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0.
|
Flublok Quadrivalent Vaccine Group 4: 18 to <65 Years
Participants (aged 18 to \<65 years) received a 0.5-mL dose of Flublok Quadrivalent vaccine, intramuscularly, at Day 0.
|
Fluzone High-Dose Vaccine Group 5: >=65 Years
Participants (aged \>=65 years) received a 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0.
|
|---|---|---|---|---|
|
Geometric Mean Titer Ratios (GMTRs) of Antibodies in Children 6 Months to <9 Years of Age (Groups 1 and 2) Receiving Fluzone Quadrivalent Vaccine
B Yamagata(post-final vaccination/pre-vaccination)
|
11.8 ratio
Interval 7.24 to 19.2
|
8.41 ratio
Interval 4.98 to 14.2
|
—
|
—
|
|
Geometric Mean Titer Ratios (GMTRs) of Antibodies in Children 6 Months to <9 Years of Age (Groups 1 and 2) Receiving Fluzone Quadrivalent Vaccine
A/H1N1(post-final vaccination/pre-vaccination)
|
9.06 ratio
Interval 5.38 to 15.3
|
4.47 ratio
Interval 2.39 to 8.35
|
—
|
—
|
|
Geometric Mean Titer Ratios (GMTRs) of Antibodies in Children 6 Months to <9 Years of Age (Groups 1 and 2) Receiving Fluzone Quadrivalent Vaccine
A/H3N2(post-final vaccination/pre-vaccination)
|
3.94 ratio
Interval 1.92 to 8.12
|
6.40 ratio
Interval 3.95 to 10.4
|
—
|
—
|
|
Geometric Mean Titer Ratios (GMTRs) of Antibodies in Children 6 Months to <9 Years of Age (Groups 1 and 2) Receiving Fluzone Quadrivalent Vaccine
B Victoria(post-final vaccination/pre-vaccination)
|
8.11 ratio
Interval 4.84 to 13.6
|
13.3 ratio
Interval 8.61 to 20.5
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 0 (pre-vaccination), Day 21 (post-vaccination)Population: Analysis was performed on per-protocol analysis set.
GMTs of anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage in Groups 3 and 4, and using HAI assay for 3 strains: A/H1N1, A/H3N2 and B Victoria lineage in Group 5. GMTRs were calculated as the ratio of GMTs post vaccination and pre-vaccination.
Outcome measures
| Measure |
Fluzone Quadrivalent Vaccine Group 2: 3 to <9 Years
n=61 Participants
Participants (aged 3 to \<9 years) received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
|
Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years
n=58 Participants
Participants (aged 18 to \<65 years) received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0.
|
Flublok Quadrivalent Vaccine Group 4: 18 to <65 Years
n=60 Participants
Participants (aged 18 to \<65 years) received a 0.5-mL dose of Flublok Quadrivalent vaccine, intramuscularly, at Day 0.
|
Fluzone High-Dose Vaccine Group 5: >=65 Years
Participants (aged \>=65 years) received a 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0.
|
|---|---|---|---|---|
|
Geometric Mean Titer Ratios of Antibodies in Adults (Groups 3, 4 and 5) Receiving Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine, or Fluzone High-Dose Vaccine
A/H1N1 (post-vaccination/pre-vaccination)
|
2.93 ratio
Interval 2.02 to 4.23
|
6.34 ratio
Interval 4.17 to 9.63
|
3.07 ratio
Interval 2.34 to 4.02
|
—
|
|
Geometric Mean Titer Ratios of Antibodies in Adults (Groups 3, 4 and 5) Receiving Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine, or Fluzone High-Dose Vaccine
A/H3N2 (post-vaccination/pre-vaccination)
|
3.55 ratio
Interval 2.6 to 4.85
|
8.19 ratio
Interval 5.56 to 12.1
|
3.69 ratio
Interval 2.68 to 5.08
|
—
|
|
Geometric Mean Titer Ratios of Antibodies in Adults (Groups 3, 4 and 5) Receiving Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine, or Fluzone High-Dose Vaccine
B Victoria (post-vaccination/pre-vaccination)
|
3.39 ratio
Interval 2.43 to 4.73
|
4.40 ratio
Interval 3.13 to 6.19
|
3.65 ratio
Interval 2.79 to 4.76
|
—
|
|
Geometric Mean Titer Ratios of Antibodies in Adults (Groups 3, 4 and 5) Receiving Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine, or Fluzone High-Dose Vaccine
B Yamagata (post-vaccination/pre-vaccination)
|
2.84 ratio
Interval 2.1 to 3.85
|
5.20 ratio
Interval 3.76 to 7.21
|
NA ratio
Data not reported since the immune response to the B Yamagata lineage strain was not assessed in Group 5 participants.
|
—
|
PRIMARY outcome
Timeframe: 28 days post-final vaccinationPopulation: Analysis was performed on per-protocol analysis set.
Anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage. Seroprotection was defined as antibody titer \>=40 (1/ dilution) at pre-vaccination and at post-final vaccination.
Outcome measures
| Measure |
Fluzone Quadrivalent Vaccine Group 2: 3 to <9 Years
n=26 Participants
Participants (aged 3 to \<9 years) received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
|
Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years
n=29 Participants
Participants (aged 18 to \<65 years) received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0.
|
Flublok Quadrivalent Vaccine Group 4: 18 to <65 Years
Participants (aged 18 to \<65 years) received a 0.5-mL dose of Flublok Quadrivalent vaccine, intramuscularly, at Day 0.
|
Fluzone High-Dose Vaccine Group 5: >=65 Years
Participants (aged \>=65 years) received a 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0.
|
|---|---|---|---|---|
|
Percentage of Participants With Seroprotection to Influenza Vaccine Antigens After Vaccination With Fluzone Quadrivalent Vaccine: Groups 1 and 2
A/H1N1
|
84.6 percentage of participants
Interval 65.1 to 95.6
|
96.6 percentage of participants
Interval 82.2 to 99.9
|
—
|
—
|
|
Percentage of Participants With Seroprotection to Influenza Vaccine Antigens After Vaccination With Fluzone Quadrivalent Vaccine: Groups 1 and 2
A/H3N2
|
80.8 percentage of participants
Interval 60.6 to 93.4
|
96.6 percentage of participants
Interval 82.2 to 99.9
|
—
|
—
|
|
Percentage of Participants With Seroprotection to Influenza Vaccine Antigens After Vaccination With Fluzone Quadrivalent Vaccine: Groups 1 and 2
B Victoria
|
80.8 percentage of participants
Interval 60.6 to 93.4
|
100 percentage of participants
Interval 88.1 to 100.0
|
—
|
—
|
|
Percentage of Participants With Seroprotection to Influenza Vaccine Antigens After Vaccination With Fluzone Quadrivalent Vaccine: Groups 1 and 2
B Yamagata
|
92.3 percentage of participants
Interval 74.9 to 99.1
|
96.6 percentage of participants
Interval 82.2 to 99.9
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 21 (post-vaccination)Population: Analysis was performed on per-protocol analysis set.
Anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage in Groups 3 and 4, and using HAI assay for 3 strains: A/H1N1, A/H3N2 and B Victoria lineage in Group 5. Seroprotection was defined as antibody titer \>=40 (1/dilution) at pre-vaccination and at post-final vaccination.
Outcome measures
| Measure |
Fluzone Quadrivalent Vaccine Group 2: 3 to <9 Years
n=61 Participants
Participants (aged 3 to \<9 years) received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
|
Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years
n=58 Participants
Participants (aged 18 to \<65 years) received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0.
|
Flublok Quadrivalent Vaccine Group 4: 18 to <65 Years
n=60 Participants
Participants (aged 18 to \<65 years) received a 0.5-mL dose of Flublok Quadrivalent vaccine, intramuscularly, at Day 0.
|
Fluzone High-Dose Vaccine Group 5: >=65 Years
Participants (aged \>=65 years) received a 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0.
|
|---|---|---|---|---|
|
Percentage of Participants With Seroprotection to Influenza Vaccine Antigens After Vaccination With Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine or Fluzone High Dose Vaccine: Group 3, 4 and 5
A/H1N1
|
100 percentage of participants
Interval 94.1 to 100.0
|
100 percentage of participants
Interval 93.8 to 100.0
|
93.3 percentage of participants
Interval 83.8 to 98.2
|
—
|
|
Percentage of Participants With Seroprotection to Influenza Vaccine Antigens After Vaccination With Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine or Fluzone High Dose Vaccine: Group 3, 4 and 5
A/H3N2
|
98.4 percentage of participants
Interval 91.2 to 100.0
|
100 percentage of participants
Interval 93.8 to 100.0
|
98.3 percentage of participants
Interval 91.1 to 100.0
|
—
|
|
Percentage of Participants With Seroprotection to Influenza Vaccine Antigens After Vaccination With Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine or Fluzone High Dose Vaccine: Group 3, 4 and 5
B Victoria
|
100 percentage of participants
Interval 94.1 to 100.0
|
98.3 percentage of participants
Interval 90.8 to 100.0
|
98.3 percentage of participants
Interval 91.1 to 100.0
|
—
|
|
Percentage of Participants With Seroprotection to Influenza Vaccine Antigens After Vaccination With Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine or Fluzone High Dose Vaccine: Group 3, 4 and 5
B Yamagata
|
100 percentage of participants
Interval 94.1 to 100.0
|
100 percentage of participants
Interval 93.8 to 100.0
|
NA percentage of participants
Data not reported since the immune response to the B Yamagata lineage strain was not assessed in Group 5 participants.
|
—
|
PRIMARY outcome
Timeframe: 28 days post-final vaccinationPopulation: Analysis was performed on per-protocol analysis set. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage. Seroconversion was defined as either a pre-vaccination titer \<10 (1/dilution) and a post-final vaccination titer \>= 40 (1/dilution) or a pre-vaccination titer \>= 10 (1/dilution) and \>=4-fold increase in post-final vaccination titer.
Outcome measures
| Measure |
Fluzone Quadrivalent Vaccine Group 2: 3 to <9 Years
n=25 Participants
Participants (aged 3 to \<9 years) received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
|
Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years
n=28 Participants
Participants (aged 18 to \<65 years) received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0.
|
Flublok Quadrivalent Vaccine Group 4: 18 to <65 Years
Participants (aged 18 to \<65 years) received a 0.5-mL dose of Flublok Quadrivalent vaccine, intramuscularly, at Day 0.
|
Fluzone High-Dose Vaccine Group 5: >=65 Years
Participants (aged \>=65 years) received a 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0.
|
|---|---|---|---|---|
|
Percentage of Participants With Seroconversion to Influenza Vaccine Antigens After Vaccination With Fluzone Quadrivalent Vaccine: Group 1 and 2
A/H1N1
|
80.0 percentage of participants
Interval 59.3 to 93.2
|
42.9 percentage of participants
Interval 24.5 to 62.8
|
—
|
—
|
|
Percentage of Participants With Seroconversion to Influenza Vaccine Antigens After Vaccination With Fluzone Quadrivalent Vaccine: Group 1 and 2
A/H3N2
|
56.0 percentage of participants
Interval 34.9 to 75.6
|
64.3 percentage of participants
Interval 44.1 to 81.4
|
—
|
—
|
|
Percentage of Participants With Seroconversion to Influenza Vaccine Antigens After Vaccination With Fluzone Quadrivalent Vaccine: Group 1 and 2
B Victoria
|
80.0 percentage of participants
Interval 59.3 to 93.2
|
92.9 percentage of participants
Interval 76.5 to 99.1
|
—
|
—
|
|
Percentage of Participants With Seroconversion to Influenza Vaccine Antigens After Vaccination With Fluzone Quadrivalent Vaccine: Group 1 and 2
B Yamagata
|
88.0 percentage of participants
Interval 68.8 to 97.5
|
78.6 percentage of participants
Interval 59.0 to 91.7
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 21 (post-vaccination)Population: Analysis was performed on per-protocol analysis set.
Anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage in Group 3 and 4, and using an HAI assay for 3 strains: A/H1N1, A/H3N2, and B Victoria lineage in Group 5. Seroconversion was defined as either 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 post-vaccination titer.
Outcome measures
| Measure |
Fluzone Quadrivalent Vaccine Group 2: 3 to <9 Years
n=61 Participants
Participants (aged 3 to \<9 years) received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
|
Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years
n=58 Participants
Participants (aged 18 to \<65 years) received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0.
|
Flublok Quadrivalent Vaccine Group 4: 18 to <65 Years
n=60 Participants
Participants (aged 18 to \<65 years) received a 0.5-mL dose of Flublok Quadrivalent vaccine, intramuscularly, at Day 0.
|
Fluzone High-Dose Vaccine Group 5: >=65 Years
Participants (aged \>=65 years) received a 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0.
|
|---|---|---|---|---|
|
Percentage of Participants With Seroconversion to Influenza Vaccine Antigens After Vaccination With Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine or Fluzone High Dose Vaccine: Group 3, 4 and 5
A/H1N1
|
32.8 percentage of participants
Interval 21.3 to 46.0
|
51.7 percentage of participants
Interval 38.2 to 65.0
|
46.7 percentage of participants
Interval 33.7 to 60.0
|
—
|
|
Percentage of Participants With Seroconversion to Influenza Vaccine Antigens After Vaccination With Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine or Fluzone High Dose Vaccine: Group 3, 4 and 5
A/H3N2
|
44.3 percentage of participants
Interval 31.5 to 57.6
|
70.7 percentage of participants
Interval 57.3 to 81.9
|
50.0 percentage of participants
Interval 36.8 to 63.2
|
—
|
|
Percentage of Participants With Seroconversion to Influenza Vaccine Antigens After Vaccination With Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine or Fluzone High Dose Vaccine: Group 3, 4 and 5
B Victoria
|
32.8 percentage of participants
Interval 21.3 to 46.0
|
46.6 percentage of participants
Interval 33.3 to 60.1
|
46.7 percentage of participants
Interval 33.7 to 60.0
|
—
|
|
Percentage of Participants With Seroconversion to Influenza Vaccine Antigens After Vaccination With Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine or Fluzone High Dose Vaccine: Group 3, 4 and 5
B Yamagata
|
27.9 percentage of participants
Interval 17.1 to 40.8
|
55.2 percentage of participants
Interval 41.5 to 68.3
|
NA percentage of participants
Data not reported since the immune response to the B Yamagata lineage strain was not assessed in Group 5 participants.
|
—
|
Adverse Events
Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Fluzone Quadrivalent Vaccine Group 2: 3 to <9 Years
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years
Serious events: 0 serious events
Other events: 33 other events
Deaths: 0 deaths
Flublok Quadrivalent Vaccine Group 4: 18 to <65 Years
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Fluzone High-Dose Vaccine Group 5: >=65 Years
Serious events: 0 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months
n=30 participants at risk
Participants (aged 6 to \<36 months) received a 0.25 mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
|
Fluzone Quadrivalent Vaccine Group 2: 3 to <9 Years
n=30 participants at risk
Participants (aged 3 to \<9 years) received a 0.5 mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
|
Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years
n=61 participants at risk
Participants (aged 18 to \<65 years) received a 0.5 mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0.
|
Flublok Quadrivalent Vaccine Group 4: 18 to <65 Years
n=59 participants at risk
Participants (aged 18 to \<65 years) received a 0.5 mL dose of Flublok Quadrivalent vaccine, intramuscularly, at Day 0.
|
Fluzone High-Dose Vaccine Group 5: >=65 Years
n=60 participants at risk
Participants (aged \>=65 years) received a 0.5 mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
13.3%
4/30 • Number of events 4 • Adverse events were collected from Day 0 (post-vaccination) up to study end ( i.e., up to Day 21 for adult participants or Day 28 for child participants who received 1 dose; up to Day 56 for participants who received 2 doses).
Solicited reaction (SR) is an AE prelisted in eCRF and considered related to vaccination. A SR is, therefore, an adverse drug reaction observed and reported under conditions prelisted (solicited) in eCRF. An Unsolicited AE is an observed AE that does not fulfill conditions prelisted in eCRF in terms of symptom and/or time to onset post-vaccination. Non-serious adverse events (non-SAE) included SR (within 7 days after vaccination) and unsolicited non-SAE (within 28 days after final vaccination)
|
0.00%
0/30 • Adverse events were collected from Day 0 (post-vaccination) up to study end ( i.e., up to Day 21 for adult participants or Day 28 for child participants who received 1 dose; up to Day 56 for participants who received 2 doses).
Solicited reaction (SR) is an AE prelisted in eCRF and considered related to vaccination. A SR is, therefore, an adverse drug reaction observed and reported under conditions prelisted (solicited) in eCRF. An Unsolicited AE is an observed AE that does not fulfill conditions prelisted in eCRF in terms of symptom and/or time to onset post-vaccination. Non-serious adverse events (non-SAE) included SR (within 7 days after vaccination) and unsolicited non-SAE (within 28 days after final vaccination)
|
0.00%
0/61 • Adverse events were collected from Day 0 (post-vaccination) up to study end ( i.e., up to Day 21 for adult participants or Day 28 for child participants who received 1 dose; up to Day 56 for participants who received 2 doses).
Solicited reaction (SR) is an AE prelisted in eCRF and considered related to vaccination. A SR is, therefore, an adverse drug reaction observed and reported under conditions prelisted (solicited) in eCRF. An Unsolicited AE is an observed AE that does not fulfill conditions prelisted in eCRF in terms of symptom and/or time to onset post-vaccination. Non-serious adverse events (non-SAE) included SR (within 7 days after vaccination) and unsolicited non-SAE (within 28 days after final vaccination)
|
0.00%
0/59 • Adverse events were collected from Day 0 (post-vaccination) up to study end ( i.e., up to Day 21 for adult participants or Day 28 for child participants who received 1 dose; up to Day 56 for participants who received 2 doses).
Solicited reaction (SR) is an AE prelisted in eCRF and considered related to vaccination. A SR is, therefore, an adverse drug reaction observed and reported under conditions prelisted (solicited) in eCRF. An Unsolicited AE is an observed AE that does not fulfill conditions prelisted in eCRF in terms of symptom and/or time to onset post-vaccination. Non-serious adverse events (non-SAE) included SR (within 7 days after vaccination) and unsolicited non-SAE (within 28 days after final vaccination)
|
0.00%
0/60 • Adverse events were collected from Day 0 (post-vaccination) up to study end ( i.e., up to Day 21 for adult participants or Day 28 for child participants who received 1 dose; up to Day 56 for participants who received 2 doses).
Solicited reaction (SR) is an AE prelisted in eCRF and considered related to vaccination. A SR is, therefore, an adverse drug reaction observed and reported under conditions prelisted (solicited) in eCRF. An Unsolicited AE is an observed AE that does not fulfill conditions prelisted in eCRF in terms of symptom and/or time to onset post-vaccination. Non-serious adverse events (non-SAE) included SR (within 7 days after vaccination) and unsolicited non-SAE (within 28 days after final vaccination)
|
|
General disorders
Crying
|
13.3%
4/30 • Number of events 5 • Adverse events were collected from Day 0 (post-vaccination) up to study end ( i.e., up to Day 21 for adult participants or Day 28 for child participants who received 1 dose; up to Day 56 for participants who received 2 doses).
Solicited reaction (SR) is an AE prelisted in eCRF and considered related to vaccination. A SR is, therefore, an adverse drug reaction observed and reported under conditions prelisted (solicited) in eCRF. An Unsolicited AE is an observed AE that does not fulfill conditions prelisted in eCRF in terms of symptom and/or time to onset post-vaccination. Non-serious adverse events (non-SAE) included SR (within 7 days after vaccination) and unsolicited non-SAE (within 28 days after final vaccination)
|
0.00%
0/30 • Adverse events were collected from Day 0 (post-vaccination) up to study end ( i.e., up to Day 21 for adult participants or Day 28 for child participants who received 1 dose; up to Day 56 for participants who received 2 doses).
Solicited reaction (SR) is an AE prelisted in eCRF and considered related to vaccination. A SR is, therefore, an adverse drug reaction observed and reported under conditions prelisted (solicited) in eCRF. An Unsolicited AE is an observed AE that does not fulfill conditions prelisted in eCRF in terms of symptom and/or time to onset post-vaccination. Non-serious adverse events (non-SAE) included SR (within 7 days after vaccination) and unsolicited non-SAE (within 28 days after final vaccination)
|
0.00%
0/61 • Adverse events were collected from Day 0 (post-vaccination) up to study end ( i.e., up to Day 21 for adult participants or Day 28 for child participants who received 1 dose; up to Day 56 for participants who received 2 doses).
Solicited reaction (SR) is an AE prelisted in eCRF and considered related to vaccination. A SR is, therefore, an adverse drug reaction observed and reported under conditions prelisted (solicited) in eCRF. An Unsolicited AE is an observed AE that does not fulfill conditions prelisted in eCRF in terms of symptom and/or time to onset post-vaccination. Non-serious adverse events (non-SAE) included SR (within 7 days after vaccination) and unsolicited non-SAE (within 28 days after final vaccination)
|
0.00%
0/59 • Adverse events were collected from Day 0 (post-vaccination) up to study end ( i.e., up to Day 21 for adult participants or Day 28 for child participants who received 1 dose; up to Day 56 for participants who received 2 doses).
Solicited reaction (SR) is an AE prelisted in eCRF and considered related to vaccination. A SR is, therefore, an adverse drug reaction observed and reported under conditions prelisted (solicited) in eCRF. An Unsolicited AE is an observed AE that does not fulfill conditions prelisted in eCRF in terms of symptom and/or time to onset post-vaccination. Non-serious adverse events (non-SAE) included SR (within 7 days after vaccination) and unsolicited non-SAE (within 28 days after final vaccination)
|
0.00%
0/60 • Adverse events were collected from Day 0 (post-vaccination) up to study end ( i.e., up to Day 21 for adult participants or Day 28 for child participants who received 1 dose; up to Day 56 for participants who received 2 doses).
Solicited reaction (SR) is an AE prelisted in eCRF and considered related to vaccination. A SR is, therefore, an adverse drug reaction observed and reported under conditions prelisted (solicited) in eCRF. An Unsolicited AE is an observed AE that does not fulfill conditions prelisted in eCRF in terms of symptom and/or time to onset post-vaccination. Non-serious adverse events (non-SAE) included SR (within 7 days after vaccination) and unsolicited non-SAE (within 28 days after final vaccination)
|
|
General disorders
Injection Site Erythema
|
10.0%
3/30 • Number of events 3 • Adverse events were collected from Day 0 (post-vaccination) up to study end ( i.e., up to Day 21 for adult participants or Day 28 for child participants who received 1 dose; up to Day 56 for participants who received 2 doses).
Solicited reaction (SR) is an AE prelisted in eCRF and considered related to vaccination. A SR is, therefore, an adverse drug reaction observed and reported under conditions prelisted (solicited) in eCRF. An Unsolicited AE is an observed AE that does not fulfill conditions prelisted in eCRF in terms of symptom and/or time to onset post-vaccination. Non-serious adverse events (non-SAE) included SR (within 7 days after vaccination) and unsolicited non-SAE (within 28 days after final vaccination)
|
16.7%
5/30 • Number of events 5 • Adverse events were collected from Day 0 (post-vaccination) up to study end ( i.e., up to Day 21 for adult participants or Day 28 for child participants who received 1 dose; up to Day 56 for participants who received 2 doses).
Solicited reaction (SR) is an AE prelisted in eCRF and considered related to vaccination. A SR is, therefore, an adverse drug reaction observed and reported under conditions prelisted (solicited) in eCRF. An Unsolicited AE is an observed AE that does not fulfill conditions prelisted in eCRF in terms of symptom and/or time to onset post-vaccination. Non-serious adverse events (non-SAE) included SR (within 7 days after vaccination) and unsolicited non-SAE (within 28 days after final vaccination)
|
1.6%
1/61 • Number of events 1 • Adverse events were collected from Day 0 (post-vaccination) up to study end ( i.e., up to Day 21 for adult participants or Day 28 for child participants who received 1 dose; up to Day 56 for participants who received 2 doses).
Solicited reaction (SR) is an AE prelisted in eCRF and considered related to vaccination. A SR is, therefore, an adverse drug reaction observed and reported under conditions prelisted (solicited) in eCRF. An Unsolicited AE is an observed AE that does not fulfill conditions prelisted in eCRF in terms of symptom and/or time to onset post-vaccination. Non-serious adverse events (non-SAE) included SR (within 7 days after vaccination) and unsolicited non-SAE (within 28 days after final vaccination)
|
0.00%
0/59 • Adverse events were collected from Day 0 (post-vaccination) up to study end ( i.e., up to Day 21 for adult participants or Day 28 for child participants who received 1 dose; up to Day 56 for participants who received 2 doses).
Solicited reaction (SR) is an AE prelisted in eCRF and considered related to vaccination. A SR is, therefore, an adverse drug reaction observed and reported under conditions prelisted (solicited) in eCRF. An Unsolicited AE is an observed AE that does not fulfill conditions prelisted in eCRF in terms of symptom and/or time to onset post-vaccination. Non-serious adverse events (non-SAE) included SR (within 7 days after vaccination) and unsolicited non-SAE (within 28 days after final vaccination)
|
8.3%
5/60 • Number of events 5 • Adverse events were collected from Day 0 (post-vaccination) up to study end ( i.e., up to Day 21 for adult participants or Day 28 for child participants who received 1 dose; up to Day 56 for participants who received 2 doses).
Solicited reaction (SR) is an AE prelisted in eCRF and considered related to vaccination. A SR is, therefore, an adverse drug reaction observed and reported under conditions prelisted (solicited) in eCRF. An Unsolicited AE is an observed AE that does not fulfill conditions prelisted in eCRF in terms of symptom and/or time to onset post-vaccination. Non-serious adverse events (non-SAE) included SR (within 7 days after vaccination) and unsolicited non-SAE (within 28 days after final vaccination)
|
|
General disorders
Injection Site Pain
|
50.0%
15/30 • Number of events 16 • Adverse events were collected from Day 0 (post-vaccination) up to study end ( i.e., up to Day 21 for adult participants or Day 28 for child participants who received 1 dose; up to Day 56 for participants who received 2 doses).
Solicited reaction (SR) is an AE prelisted in eCRF and considered related to vaccination. A SR is, therefore, an adverse drug reaction observed and reported under conditions prelisted (solicited) in eCRF. An Unsolicited AE is an observed AE that does not fulfill conditions prelisted in eCRF in terms of symptom and/or time to onset post-vaccination. Non-serious adverse events (non-SAE) included SR (within 7 days after vaccination) and unsolicited non-SAE (within 28 days after final vaccination)
|
30.0%
9/30 • Number of events 9 • Adverse events were collected from Day 0 (post-vaccination) up to study end ( i.e., up to Day 21 for adult participants or Day 28 for child participants who received 1 dose; up to Day 56 for participants who received 2 doses).
Solicited reaction (SR) is an AE prelisted in eCRF and considered related to vaccination. A SR is, therefore, an adverse drug reaction observed and reported under conditions prelisted (solicited) in eCRF. An Unsolicited AE is an observed AE that does not fulfill conditions prelisted in eCRF in terms of symptom and/or time to onset post-vaccination. Non-serious adverse events (non-SAE) included SR (within 7 days after vaccination) and unsolicited non-SAE (within 28 days after final vaccination)
|
44.3%
27/61 • Number of events 27 • Adverse events were collected from Day 0 (post-vaccination) up to study end ( i.e., up to Day 21 for adult participants or Day 28 for child participants who received 1 dose; up to Day 56 for participants who received 2 doses).
Solicited reaction (SR) is an AE prelisted in eCRF and considered related to vaccination. A SR is, therefore, an adverse drug reaction observed and reported under conditions prelisted (solicited) in eCRF. An Unsolicited AE is an observed AE that does not fulfill conditions prelisted in eCRF in terms of symptom and/or time to onset post-vaccination. Non-serious adverse events (non-SAE) included SR (within 7 days after vaccination) and unsolicited non-SAE (within 28 days after final vaccination)
|
37.3%
22/59 • Number of events 22 • Adverse events were collected from Day 0 (post-vaccination) up to study end ( i.e., up to Day 21 for adult participants or Day 28 for child participants who received 1 dose; up to Day 56 for participants who received 2 doses).
Solicited reaction (SR) is an AE prelisted in eCRF and considered related to vaccination. A SR is, therefore, an adverse drug reaction observed and reported under conditions prelisted (solicited) in eCRF. An Unsolicited AE is an observed AE that does not fulfill conditions prelisted in eCRF in terms of symptom and/or time to onset post-vaccination. Non-serious adverse events (non-SAE) included SR (within 7 days after vaccination) and unsolicited non-SAE (within 28 days after final vaccination)
|
40.0%
24/60 • Number of events 24 • Adverse events were collected from Day 0 (post-vaccination) up to study end ( i.e., up to Day 21 for adult participants or Day 28 for child participants who received 1 dose; up to Day 56 for participants who received 2 doses).
Solicited reaction (SR) is an AE prelisted in eCRF and considered related to vaccination. A SR is, therefore, an adverse drug reaction observed and reported under conditions prelisted (solicited) in eCRF. An Unsolicited AE is an observed AE that does not fulfill conditions prelisted in eCRF in terms of symptom and/or time to onset post-vaccination. Non-serious adverse events (non-SAE) included SR (within 7 days after vaccination) and unsolicited non-SAE (within 28 days after final vaccination)
|
|
General disorders
Injection Site Swelling
|
13.3%
4/30 • Number of events 5 • Adverse events were collected from Day 0 (post-vaccination) up to study end ( i.e., up to Day 21 for adult participants or Day 28 for child participants who received 1 dose; up to Day 56 for participants who received 2 doses).
Solicited reaction (SR) is an AE prelisted in eCRF and considered related to vaccination. A SR is, therefore, an adverse drug reaction observed and reported under conditions prelisted (solicited) in eCRF. An Unsolicited AE is an observed AE that does not fulfill conditions prelisted in eCRF in terms of symptom and/or time to onset post-vaccination. Non-serious adverse events (non-SAE) included SR (within 7 days after vaccination) and unsolicited non-SAE (within 28 days after final vaccination)
|
20.0%
6/30 • Number of events 6 • Adverse events were collected from Day 0 (post-vaccination) up to study end ( i.e., up to Day 21 for adult participants or Day 28 for child participants who received 1 dose; up to Day 56 for participants who received 2 doses).
Solicited reaction (SR) is an AE prelisted in eCRF and considered related to vaccination. A SR is, therefore, an adverse drug reaction observed and reported under conditions prelisted (solicited) in eCRF. An Unsolicited AE is an observed AE that does not fulfill conditions prelisted in eCRF in terms of symptom and/or time to onset post-vaccination. Non-serious adverse events (non-SAE) included SR (within 7 days after vaccination) and unsolicited non-SAE (within 28 days after final vaccination)
|
3.3%
2/61 • Number of events 2 • Adverse events were collected from Day 0 (post-vaccination) up to study end ( i.e., up to Day 21 for adult participants or Day 28 for child participants who received 1 dose; up to Day 56 for participants who received 2 doses).
Solicited reaction (SR) is an AE prelisted in eCRF and considered related to vaccination. A SR is, therefore, an adverse drug reaction observed and reported under conditions prelisted (solicited) in eCRF. An Unsolicited AE is an observed AE that does not fulfill conditions prelisted in eCRF in terms of symptom and/or time to onset post-vaccination. Non-serious adverse events (non-SAE) included SR (within 7 days after vaccination) and unsolicited non-SAE (within 28 days after final vaccination)
|
0.00%
0/59 • Adverse events were collected from Day 0 (post-vaccination) up to study end ( i.e., up to Day 21 for adult participants or Day 28 for child participants who received 1 dose; up to Day 56 for participants who received 2 doses).
Solicited reaction (SR) is an AE prelisted in eCRF and considered related to vaccination. A SR is, therefore, an adverse drug reaction observed and reported under conditions prelisted (solicited) in eCRF. An Unsolicited AE is an observed AE that does not fulfill conditions prelisted in eCRF in terms of symptom and/or time to onset post-vaccination. Non-serious adverse events (non-SAE) included SR (within 7 days after vaccination) and unsolicited non-SAE (within 28 days after final vaccination)
|
5.0%
3/60 • Number of events 3 • Adverse events were collected from Day 0 (post-vaccination) up to study end ( i.e., up to Day 21 for adult participants or Day 28 for child participants who received 1 dose; up to Day 56 for participants who received 2 doses).
Solicited reaction (SR) is an AE prelisted in eCRF and considered related to vaccination. A SR is, therefore, an adverse drug reaction observed and reported under conditions prelisted (solicited) in eCRF. An Unsolicited AE is an observed AE that does not fulfill conditions prelisted in eCRF in terms of symptom and/or time to onset post-vaccination. Non-serious adverse events (non-SAE) included SR (within 7 days after vaccination) and unsolicited non-SAE (within 28 days after final vaccination)
|
|
General disorders
Malaise
|
0.00%
0/30 • Adverse events were collected from Day 0 (post-vaccination) up to study end ( i.e., up to Day 21 for adult participants or Day 28 for child participants who received 1 dose; up to Day 56 for participants who received 2 doses).
Solicited reaction (SR) is an AE prelisted in eCRF and considered related to vaccination. A SR is, therefore, an adverse drug reaction observed and reported under conditions prelisted (solicited) in eCRF. An Unsolicited AE is an observed AE that does not fulfill conditions prelisted in eCRF in terms of symptom and/or time to onset post-vaccination. Non-serious adverse events (non-SAE) included SR (within 7 days after vaccination) and unsolicited non-SAE (within 28 days after final vaccination)
|
20.0%
6/30 • Number of events 6 • Adverse events were collected from Day 0 (post-vaccination) up to study end ( i.e., up to Day 21 for adult participants or Day 28 for child participants who received 1 dose; up to Day 56 for participants who received 2 doses).
Solicited reaction (SR) is an AE prelisted in eCRF and considered related to vaccination. A SR is, therefore, an adverse drug reaction observed and reported under conditions prelisted (solicited) in eCRF. An Unsolicited AE is an observed AE that does not fulfill conditions prelisted in eCRF in terms of symptom and/or time to onset post-vaccination. Non-serious adverse events (non-SAE) included SR (within 7 days after vaccination) and unsolicited non-SAE (within 28 days after final vaccination)
|
18.0%
11/61 • Number of events 11 • Adverse events were collected from Day 0 (post-vaccination) up to study end ( i.e., up to Day 21 for adult participants or Day 28 for child participants who received 1 dose; up to Day 56 for participants who received 2 doses).
Solicited reaction (SR) is an AE prelisted in eCRF and considered related to vaccination. A SR is, therefore, an adverse drug reaction observed and reported under conditions prelisted (solicited) in eCRF. An Unsolicited AE is an observed AE that does not fulfill conditions prelisted in eCRF in terms of symptom and/or time to onset post-vaccination. Non-serious adverse events (non-SAE) included SR (within 7 days after vaccination) and unsolicited non-SAE (within 28 days after final vaccination)
|
10.2%
6/59 • Number of events 6 • Adverse events were collected from Day 0 (post-vaccination) up to study end ( i.e., up to Day 21 for adult participants or Day 28 for child participants who received 1 dose; up to Day 56 for participants who received 2 doses).
Solicited reaction (SR) is an AE prelisted in eCRF and considered related to vaccination. A SR is, therefore, an adverse drug reaction observed and reported under conditions prelisted (solicited) in eCRF. An Unsolicited AE is an observed AE that does not fulfill conditions prelisted in eCRF in terms of symptom and/or time to onset post-vaccination. Non-serious adverse events (non-SAE) included SR (within 7 days after vaccination) and unsolicited non-SAE (within 28 days after final vaccination)
|
15.0%
9/60 • Number of events 9 • Adverse events were collected from Day 0 (post-vaccination) up to study end ( i.e., up to Day 21 for adult participants or Day 28 for child participants who received 1 dose; up to Day 56 for participants who received 2 doses).
Solicited reaction (SR) is an AE prelisted in eCRF and considered related to vaccination. A SR is, therefore, an adverse drug reaction observed and reported under conditions prelisted (solicited) in eCRF. An Unsolicited AE is an observed AE that does not fulfill conditions prelisted in eCRF in terms of symptom and/or time to onset post-vaccination. Non-serious adverse events (non-SAE) included SR (within 7 days after vaccination) and unsolicited non-SAE (within 28 days after final vaccination)
|
|
General disorders
Pyrexia
|
10.0%
3/30 • Number of events 3 • Adverse events were collected from Day 0 (post-vaccination) up to study end ( i.e., up to Day 21 for adult participants or Day 28 for child participants who received 1 dose; up to Day 56 for participants who received 2 doses).
Solicited reaction (SR) is an AE prelisted in eCRF and considered related to vaccination. A SR is, therefore, an adverse drug reaction observed and reported under conditions prelisted (solicited) in eCRF. An Unsolicited AE is an observed AE that does not fulfill conditions prelisted in eCRF in terms of symptom and/or time to onset post-vaccination. Non-serious adverse events (non-SAE) included SR (within 7 days after vaccination) and unsolicited non-SAE (within 28 days after final vaccination)
|
6.7%
2/30 • Number of events 2 • Adverse events were collected from Day 0 (post-vaccination) up to study end ( i.e., up to Day 21 for adult participants or Day 28 for child participants who received 1 dose; up to Day 56 for participants who received 2 doses).
Solicited reaction (SR) is an AE prelisted in eCRF and considered related to vaccination. A SR is, therefore, an adverse drug reaction observed and reported under conditions prelisted (solicited) in eCRF. An Unsolicited AE is an observed AE that does not fulfill conditions prelisted in eCRF in terms of symptom and/or time to onset post-vaccination. Non-serious adverse events (non-SAE) included SR (within 7 days after vaccination) and unsolicited non-SAE (within 28 days after final vaccination)
|
0.00%
0/61 • Adverse events were collected from Day 0 (post-vaccination) up to study end ( i.e., up to Day 21 for adult participants or Day 28 for child participants who received 1 dose; up to Day 56 for participants who received 2 doses).
Solicited reaction (SR) is an AE prelisted in eCRF and considered related to vaccination. A SR is, therefore, an adverse drug reaction observed and reported under conditions prelisted (solicited) in eCRF. An Unsolicited AE is an observed AE that does not fulfill conditions prelisted in eCRF in terms of symptom and/or time to onset post-vaccination. Non-serious adverse events (non-SAE) included SR (within 7 days after vaccination) and unsolicited non-SAE (within 28 days after final vaccination)
|
0.00%
0/59 • Adverse events were collected from Day 0 (post-vaccination) up to study end ( i.e., up to Day 21 for adult participants or Day 28 for child participants who received 1 dose; up to Day 56 for participants who received 2 doses).
Solicited reaction (SR) is an AE prelisted in eCRF and considered related to vaccination. A SR is, therefore, an adverse drug reaction observed and reported under conditions prelisted (solicited) in eCRF. An Unsolicited AE is an observed AE that does not fulfill conditions prelisted in eCRF in terms of symptom and/or time to onset post-vaccination. Non-serious adverse events (non-SAE) included SR (within 7 days after vaccination) and unsolicited non-SAE (within 28 days after final vaccination)
|
3.3%
2/60 • Number of events 2 • Adverse events were collected from Day 0 (post-vaccination) up to study end ( i.e., up to Day 21 for adult participants or Day 28 for child participants who received 1 dose; up to Day 56 for participants who received 2 doses).
Solicited reaction (SR) is an AE prelisted in eCRF and considered related to vaccination. A SR is, therefore, an adverse drug reaction observed and reported under conditions prelisted (solicited) in eCRF. An Unsolicited AE is an observed AE that does not fulfill conditions prelisted in eCRF in terms of symptom and/or time to onset post-vaccination. Non-serious adverse events (non-SAE) included SR (within 7 days after vaccination) and unsolicited non-SAE (within 28 days after final vaccination)
|
|
Infections and infestations
Gastroenteritis Viral
|
0.00%
0/30 • Adverse events were collected from Day 0 (post-vaccination) up to study end ( i.e., up to Day 21 for adult participants or Day 28 for child participants who received 1 dose; up to Day 56 for participants who received 2 doses).
Solicited reaction (SR) is an AE prelisted in eCRF and considered related to vaccination. A SR is, therefore, an adverse drug reaction observed and reported under conditions prelisted (solicited) in eCRF. An Unsolicited AE is an observed AE that does not fulfill conditions prelisted in eCRF in terms of symptom and/or time to onset post-vaccination. Non-serious adverse events (non-SAE) included SR (within 7 days after vaccination) and unsolicited non-SAE (within 28 days after final vaccination)
|
10.0%
3/30 • Number of events 3 • Adverse events were collected from Day 0 (post-vaccination) up to study end ( i.e., up to Day 21 for adult participants or Day 28 for child participants who received 1 dose; up to Day 56 for participants who received 2 doses).
Solicited reaction (SR) is an AE prelisted in eCRF and considered related to vaccination. A SR is, therefore, an adverse drug reaction observed and reported under conditions prelisted (solicited) in eCRF. An Unsolicited AE is an observed AE that does not fulfill conditions prelisted in eCRF in terms of symptom and/or time to onset post-vaccination. Non-serious adverse events (non-SAE) included SR (within 7 days after vaccination) and unsolicited non-SAE (within 28 days after final vaccination)
|
0.00%
0/61 • Adverse events were collected from Day 0 (post-vaccination) up to study end ( i.e., up to Day 21 for adult participants or Day 28 for child participants who received 1 dose; up to Day 56 for participants who received 2 doses).
Solicited reaction (SR) is an AE prelisted in eCRF and considered related to vaccination. A SR is, therefore, an adverse drug reaction observed and reported under conditions prelisted (solicited) in eCRF. An Unsolicited AE is an observed AE that does not fulfill conditions prelisted in eCRF in terms of symptom and/or time to onset post-vaccination. Non-serious adverse events (non-SAE) included SR (within 7 days after vaccination) and unsolicited non-SAE (within 28 days after final vaccination)
|
0.00%
0/59 • Adverse events were collected from Day 0 (post-vaccination) up to study end ( i.e., up to Day 21 for adult participants or Day 28 for child participants who received 1 dose; up to Day 56 for participants who received 2 doses).
Solicited reaction (SR) is an AE prelisted in eCRF and considered related to vaccination. A SR is, therefore, an adverse drug reaction observed and reported under conditions prelisted (solicited) in eCRF. An Unsolicited AE is an observed AE that does not fulfill conditions prelisted in eCRF in terms of symptom and/or time to onset post-vaccination. Non-serious adverse events (non-SAE) included SR (within 7 days after vaccination) and unsolicited non-SAE (within 28 days after final vaccination)
|
0.00%
0/60 • Adverse events were collected from Day 0 (post-vaccination) up to study end ( i.e., up to Day 21 for adult participants or Day 28 for child participants who received 1 dose; up to Day 56 for participants who received 2 doses).
Solicited reaction (SR) is an AE prelisted in eCRF and considered related to vaccination. A SR is, therefore, an adverse drug reaction observed and reported under conditions prelisted (solicited) in eCRF. An Unsolicited AE is an observed AE that does not fulfill conditions prelisted in eCRF in terms of symptom and/or time to onset post-vaccination. Non-serious adverse events (non-SAE) included SR (within 7 days after vaccination) and unsolicited non-SAE (within 28 days after final vaccination)
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
33.3%
10/30 • Number of events 12 • Adverse events were collected from Day 0 (post-vaccination) up to study end ( i.e., up to Day 21 for adult participants or Day 28 for child participants who received 1 dose; up to Day 56 for participants who received 2 doses).
Solicited reaction (SR) is an AE prelisted in eCRF and considered related to vaccination. A SR is, therefore, an adverse drug reaction observed and reported under conditions prelisted (solicited) in eCRF. An Unsolicited AE is an observed AE that does not fulfill conditions prelisted in eCRF in terms of symptom and/or time to onset post-vaccination. Non-serious adverse events (non-SAE) included SR (within 7 days after vaccination) and unsolicited non-SAE (within 28 days after final vaccination)
|
0.00%
0/30 • Adverse events were collected from Day 0 (post-vaccination) up to study end ( i.e., up to Day 21 for adult participants or Day 28 for child participants who received 1 dose; up to Day 56 for participants who received 2 doses).
Solicited reaction (SR) is an AE prelisted in eCRF and considered related to vaccination. A SR is, therefore, an adverse drug reaction observed and reported under conditions prelisted (solicited) in eCRF. An Unsolicited AE is an observed AE that does not fulfill conditions prelisted in eCRF in terms of symptom and/or time to onset post-vaccination. Non-serious adverse events (non-SAE) included SR (within 7 days after vaccination) and unsolicited non-SAE (within 28 days after final vaccination)
|
0.00%
0/61 • Adverse events were collected from Day 0 (post-vaccination) up to study end ( i.e., up to Day 21 for adult participants or Day 28 for child participants who received 1 dose; up to Day 56 for participants who received 2 doses).
Solicited reaction (SR) is an AE prelisted in eCRF and considered related to vaccination. A SR is, therefore, an adverse drug reaction observed and reported under conditions prelisted (solicited) in eCRF. An Unsolicited AE is an observed AE that does not fulfill conditions prelisted in eCRF in terms of symptom and/or time to onset post-vaccination. Non-serious adverse events (non-SAE) included SR (within 7 days after vaccination) and unsolicited non-SAE (within 28 days after final vaccination)
|
0.00%
0/59 • Adverse events were collected from Day 0 (post-vaccination) up to study end ( i.e., up to Day 21 for adult participants or Day 28 for child participants who received 1 dose; up to Day 56 for participants who received 2 doses).
Solicited reaction (SR) is an AE prelisted in eCRF and considered related to vaccination. A SR is, therefore, an adverse drug reaction observed and reported under conditions prelisted (solicited) in eCRF. An Unsolicited AE is an observed AE that does not fulfill conditions prelisted in eCRF in terms of symptom and/or time to onset post-vaccination. Non-serious adverse events (non-SAE) included SR (within 7 days after vaccination) and unsolicited non-SAE (within 28 days after final vaccination)
|
0.00%
0/60 • Adverse events were collected from Day 0 (post-vaccination) up to study end ( i.e., up to Day 21 for adult participants or Day 28 for child participants who received 1 dose; up to Day 56 for participants who received 2 doses).
Solicited reaction (SR) is an AE prelisted in eCRF and considered related to vaccination. A SR is, therefore, an adverse drug reaction observed and reported under conditions prelisted (solicited) in eCRF. An Unsolicited AE is an observed AE that does not fulfill conditions prelisted in eCRF in terms of symptom and/or time to onset post-vaccination. Non-serious adverse events (non-SAE) included SR (within 7 days after vaccination) and unsolicited non-SAE (within 28 days after final vaccination)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/30 • Adverse events were collected from Day 0 (post-vaccination) up to study end ( i.e., up to Day 21 for adult participants or Day 28 for child participants who received 1 dose; up to Day 56 for participants who received 2 doses).
Solicited reaction (SR) is an AE prelisted in eCRF and considered related to vaccination. A SR is, therefore, an adverse drug reaction observed and reported under conditions prelisted (solicited) in eCRF. An Unsolicited AE is an observed AE that does not fulfill conditions prelisted in eCRF in terms of symptom and/or time to onset post-vaccination. Non-serious adverse events (non-SAE) included SR (within 7 days after vaccination) and unsolicited non-SAE (within 28 days after final vaccination)
|
20.0%
6/30 • Number of events 6 • Adverse events were collected from Day 0 (post-vaccination) up to study end ( i.e., up to Day 21 for adult participants or Day 28 for child participants who received 1 dose; up to Day 56 for participants who received 2 doses).
Solicited reaction (SR) is an AE prelisted in eCRF and considered related to vaccination. A SR is, therefore, an adverse drug reaction observed and reported under conditions prelisted (solicited) in eCRF. An Unsolicited AE is an observed AE that does not fulfill conditions prelisted in eCRF in terms of symptom and/or time to onset post-vaccination. Non-serious adverse events (non-SAE) included SR (within 7 days after vaccination) and unsolicited non-SAE (within 28 days after final vaccination)
|
24.6%
15/61 • Number of events 15 • Adverse events were collected from Day 0 (post-vaccination) up to study end ( i.e., up to Day 21 for adult participants or Day 28 for child participants who received 1 dose; up to Day 56 for participants who received 2 doses).
Solicited reaction (SR) is an AE prelisted in eCRF and considered related to vaccination. A SR is, therefore, an adverse drug reaction observed and reported under conditions prelisted (solicited) in eCRF. An Unsolicited AE is an observed AE that does not fulfill conditions prelisted in eCRF in terms of symptom and/or time to onset post-vaccination. Non-serious adverse events (non-SAE) included SR (within 7 days after vaccination) and unsolicited non-SAE (within 28 days after final vaccination)
|
18.6%
11/59 • Number of events 11 • Adverse events were collected from Day 0 (post-vaccination) up to study end ( i.e., up to Day 21 for adult participants or Day 28 for child participants who received 1 dose; up to Day 56 for participants who received 2 doses).
Solicited reaction (SR) is an AE prelisted in eCRF and considered related to vaccination. A SR is, therefore, an adverse drug reaction observed and reported under conditions prelisted (solicited) in eCRF. An Unsolicited AE is an observed AE that does not fulfill conditions prelisted in eCRF in terms of symptom and/or time to onset post-vaccination. Non-serious adverse events (non-SAE) included SR (within 7 days after vaccination) and unsolicited non-SAE (within 28 days after final vaccination)
|
25.0%
15/60 • Number of events 15 • Adverse events were collected from Day 0 (post-vaccination) up to study end ( i.e., up to Day 21 for adult participants or Day 28 for child participants who received 1 dose; up to Day 56 for participants who received 2 doses).
Solicited reaction (SR) is an AE prelisted in eCRF and considered related to vaccination. A SR is, therefore, an adverse drug reaction observed and reported under conditions prelisted (solicited) in eCRF. An Unsolicited AE is an observed AE that does not fulfill conditions prelisted in eCRF in terms of symptom and/or time to onset post-vaccination. Non-serious adverse events (non-SAE) included SR (within 7 days after vaccination) and unsolicited non-SAE (within 28 days after final vaccination)
|
|
Nervous system disorders
Headache
|
0.00%
0/30 • Adverse events were collected from Day 0 (post-vaccination) up to study end ( i.e., up to Day 21 for adult participants or Day 28 for child participants who received 1 dose; up to Day 56 for participants who received 2 doses).
Solicited reaction (SR) is an AE prelisted in eCRF and considered related to vaccination. A SR is, therefore, an adverse drug reaction observed and reported under conditions prelisted (solicited) in eCRF. An Unsolicited AE is an observed AE that does not fulfill conditions prelisted in eCRF in terms of symptom and/or time to onset post-vaccination. Non-serious adverse events (non-SAE) included SR (within 7 days after vaccination) and unsolicited non-SAE (within 28 days after final vaccination)
|
16.7%
5/30 • Number of events 5 • Adverse events were collected from Day 0 (post-vaccination) up to study end ( i.e., up to Day 21 for adult participants or Day 28 for child participants who received 1 dose; up to Day 56 for participants who received 2 doses).
Solicited reaction (SR) is an AE prelisted in eCRF and considered related to vaccination. A SR is, therefore, an adverse drug reaction observed and reported under conditions prelisted (solicited) in eCRF. An Unsolicited AE is an observed AE that does not fulfill conditions prelisted in eCRF in terms of symptom and/or time to onset post-vaccination. Non-serious adverse events (non-SAE) included SR (within 7 days after vaccination) and unsolicited non-SAE (within 28 days after final vaccination)
|
19.7%
12/61 • Number of events 12 • Adverse events were collected from Day 0 (post-vaccination) up to study end ( i.e., up to Day 21 for adult participants or Day 28 for child participants who received 1 dose; up to Day 56 for participants who received 2 doses).
Solicited reaction (SR) is an AE prelisted in eCRF and considered related to vaccination. A SR is, therefore, an adverse drug reaction observed and reported under conditions prelisted (solicited) in eCRF. An Unsolicited AE is an observed AE that does not fulfill conditions prelisted in eCRF in terms of symptom and/or time to onset post-vaccination. Non-serious adverse events (non-SAE) included SR (within 7 days after vaccination) and unsolicited non-SAE (within 28 days after final vaccination)
|
23.7%
14/59 • Number of events 15 • Adverse events were collected from Day 0 (post-vaccination) up to study end ( i.e., up to Day 21 for adult participants or Day 28 for child participants who received 1 dose; up to Day 56 for participants who received 2 doses).
Solicited reaction (SR) is an AE prelisted in eCRF and considered related to vaccination. A SR is, therefore, an adverse drug reaction observed and reported under conditions prelisted (solicited) in eCRF. An Unsolicited AE is an observed AE that does not fulfill conditions prelisted in eCRF in terms of symptom and/or time to onset post-vaccination. Non-serious adverse events (non-SAE) included SR (within 7 days after vaccination) and unsolicited non-SAE (within 28 days after final vaccination)
|
18.3%
11/60 • Number of events 11 • Adverse events were collected from Day 0 (post-vaccination) up to study end ( i.e., up to Day 21 for adult participants or Day 28 for child participants who received 1 dose; up to Day 56 for participants who received 2 doses).
Solicited reaction (SR) is an AE prelisted in eCRF and considered related to vaccination. A SR is, therefore, an adverse drug reaction observed and reported under conditions prelisted (solicited) in eCRF. An Unsolicited AE is an observed AE that does not fulfill conditions prelisted in eCRF in terms of symptom and/or time to onset post-vaccination. Non-serious adverse events (non-SAE) included SR (within 7 days after vaccination) and unsolicited non-SAE (within 28 days after final vaccination)
|
|
Nervous system disorders
Somnolence
|
30.0%
9/30 • Number of events 10 • Adverse events were collected from Day 0 (post-vaccination) up to study end ( i.e., up to Day 21 for adult participants or Day 28 for child participants who received 1 dose; up to Day 56 for participants who received 2 doses).
Solicited reaction (SR) is an AE prelisted in eCRF and considered related to vaccination. A SR is, therefore, an adverse drug reaction observed and reported under conditions prelisted (solicited) in eCRF. An Unsolicited AE is an observed AE that does not fulfill conditions prelisted in eCRF in terms of symptom and/or time to onset post-vaccination. Non-serious adverse events (non-SAE) included SR (within 7 days after vaccination) and unsolicited non-SAE (within 28 days after final vaccination)
|
0.00%
0/30 • Adverse events were collected from Day 0 (post-vaccination) up to study end ( i.e., up to Day 21 for adult participants or Day 28 for child participants who received 1 dose; up to Day 56 for participants who received 2 doses).
Solicited reaction (SR) is an AE prelisted in eCRF and considered related to vaccination. A SR is, therefore, an adverse drug reaction observed and reported under conditions prelisted (solicited) in eCRF. An Unsolicited AE is an observed AE that does not fulfill conditions prelisted in eCRF in terms of symptom and/or time to onset post-vaccination. Non-serious adverse events (non-SAE) included SR (within 7 days after vaccination) and unsolicited non-SAE (within 28 days after final vaccination)
|
0.00%
0/61 • Adverse events were collected from Day 0 (post-vaccination) up to study end ( i.e., up to Day 21 for adult participants or Day 28 for child participants who received 1 dose; up to Day 56 for participants who received 2 doses).
Solicited reaction (SR) is an AE prelisted in eCRF and considered related to vaccination. A SR is, therefore, an adverse drug reaction observed and reported under conditions prelisted (solicited) in eCRF. An Unsolicited AE is an observed AE that does not fulfill conditions prelisted in eCRF in terms of symptom and/or time to onset post-vaccination. Non-serious adverse events (non-SAE) included SR (within 7 days after vaccination) and unsolicited non-SAE (within 28 days after final vaccination)
|
0.00%
0/59 • Adverse events were collected from Day 0 (post-vaccination) up to study end ( i.e., up to Day 21 for adult participants or Day 28 for child participants who received 1 dose; up to Day 56 for participants who received 2 doses).
Solicited reaction (SR) is an AE prelisted in eCRF and considered related to vaccination. A SR is, therefore, an adverse drug reaction observed and reported under conditions prelisted (solicited) in eCRF. An Unsolicited AE is an observed AE that does not fulfill conditions prelisted in eCRF in terms of symptom and/or time to onset post-vaccination. Non-serious adverse events (non-SAE) included SR (within 7 days after vaccination) and unsolicited non-SAE (within 28 days after final vaccination)
|
0.00%
0/60 • Adverse events were collected from Day 0 (post-vaccination) up to study end ( i.e., up to Day 21 for adult participants or Day 28 for child participants who received 1 dose; up to Day 56 for participants who received 2 doses).
Solicited reaction (SR) is an AE prelisted in eCRF and considered related to vaccination. A SR is, therefore, an adverse drug reaction observed and reported under conditions prelisted (solicited) in eCRF. An Unsolicited AE is an observed AE that does not fulfill conditions prelisted in eCRF in terms of symptom and/or time to onset post-vaccination. Non-serious adverse events (non-SAE) included SR (within 7 days after vaccination) and unsolicited non-SAE (within 28 days after final vaccination)
|
|
Psychiatric disorders
Irritability
|
40.0%
12/30 • Number of events 14 • Adverse events were collected from Day 0 (post-vaccination) up to study end ( i.e., up to Day 21 for adult participants or Day 28 for child participants who received 1 dose; up to Day 56 for participants who received 2 doses).
Solicited reaction (SR) is an AE prelisted in eCRF and considered related to vaccination. A SR is, therefore, an adverse drug reaction observed and reported under conditions prelisted (solicited) in eCRF. An Unsolicited AE is an observed AE that does not fulfill conditions prelisted in eCRF in terms of symptom and/or time to onset post-vaccination. Non-serious adverse events (non-SAE) included SR (within 7 days after vaccination) and unsolicited non-SAE (within 28 days after final vaccination)
|
0.00%
0/30 • Adverse events were collected from Day 0 (post-vaccination) up to study end ( i.e., up to Day 21 for adult participants or Day 28 for child participants who received 1 dose; up to Day 56 for participants who received 2 doses).
Solicited reaction (SR) is an AE prelisted in eCRF and considered related to vaccination. A SR is, therefore, an adverse drug reaction observed and reported under conditions prelisted (solicited) in eCRF. An Unsolicited AE is an observed AE that does not fulfill conditions prelisted in eCRF in terms of symptom and/or time to onset post-vaccination. Non-serious adverse events (non-SAE) included SR (within 7 days after vaccination) and unsolicited non-SAE (within 28 days after final vaccination)
|
0.00%
0/61 • Adverse events were collected from Day 0 (post-vaccination) up to study end ( i.e., up to Day 21 for adult participants or Day 28 for child participants who received 1 dose; up to Day 56 for participants who received 2 doses).
Solicited reaction (SR) is an AE prelisted in eCRF and considered related to vaccination. A SR is, therefore, an adverse drug reaction observed and reported under conditions prelisted (solicited) in eCRF. An Unsolicited AE is an observed AE that does not fulfill conditions prelisted in eCRF in terms of symptom and/or time to onset post-vaccination. Non-serious adverse events (non-SAE) included SR (within 7 days after vaccination) and unsolicited non-SAE (within 28 days after final vaccination)
|
0.00%
0/59 • Adverse events were collected from Day 0 (post-vaccination) up to study end ( i.e., up to Day 21 for adult participants or Day 28 for child participants who received 1 dose; up to Day 56 for participants who received 2 doses).
Solicited reaction (SR) is an AE prelisted in eCRF and considered related to vaccination. A SR is, therefore, an adverse drug reaction observed and reported under conditions prelisted (solicited) in eCRF. An Unsolicited AE is an observed AE that does not fulfill conditions prelisted in eCRF in terms of symptom and/or time to onset post-vaccination. Non-serious adverse events (non-SAE) included SR (within 7 days after vaccination) and unsolicited non-SAE (within 28 days after final vaccination)
|
0.00%
0/60 • Adverse events were collected from Day 0 (post-vaccination) up to study end ( i.e., up to Day 21 for adult participants or Day 28 for child participants who received 1 dose; up to Day 56 for participants who received 2 doses).
Solicited reaction (SR) is an AE prelisted in eCRF and considered related to vaccination. A SR is, therefore, an adverse drug reaction observed and reported under conditions prelisted (solicited) in eCRF. An Unsolicited AE is an observed AE that does not fulfill conditions prelisted in eCRF in terms of symptom and/or time to onset post-vaccination. Non-serious adverse events (non-SAE) included SR (within 7 days after vaccination) and unsolicited non-SAE (within 28 days after final vaccination)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
5/30 • Number of events 5 • Adverse events were collected from Day 0 (post-vaccination) up to study end ( i.e., up to Day 21 for adult participants or Day 28 for child participants who received 1 dose; up to Day 56 for participants who received 2 doses).
Solicited reaction (SR) is an AE prelisted in eCRF and considered related to vaccination. A SR is, therefore, an adverse drug reaction observed and reported under conditions prelisted (solicited) in eCRF. An Unsolicited AE is an observed AE that does not fulfill conditions prelisted in eCRF in terms of symptom and/or time to onset post-vaccination. Non-serious adverse events (non-SAE) included SR (within 7 days after vaccination) and unsolicited non-SAE (within 28 days after final vaccination)
|
0.00%
0/30 • Adverse events were collected from Day 0 (post-vaccination) up to study end ( i.e., up to Day 21 for adult participants or Day 28 for child participants who received 1 dose; up to Day 56 for participants who received 2 doses).
Solicited reaction (SR) is an AE prelisted in eCRF and considered related to vaccination. A SR is, therefore, an adverse drug reaction observed and reported under conditions prelisted (solicited) in eCRF. An Unsolicited AE is an observed AE that does not fulfill conditions prelisted in eCRF in terms of symptom and/or time to onset post-vaccination. Non-serious adverse events (non-SAE) included SR (within 7 days after vaccination) and unsolicited non-SAE (within 28 days after final vaccination)
|
0.00%
0/61 • Adverse events were collected from Day 0 (post-vaccination) up to study end ( i.e., up to Day 21 for adult participants or Day 28 for child participants who received 1 dose; up to Day 56 for participants who received 2 doses).
Solicited reaction (SR) is an AE prelisted in eCRF and considered related to vaccination. A SR is, therefore, an adverse drug reaction observed and reported under conditions prelisted (solicited) in eCRF. An Unsolicited AE is an observed AE that does not fulfill conditions prelisted in eCRF in terms of symptom and/or time to onset post-vaccination. Non-serious adverse events (non-SAE) included SR (within 7 days after vaccination) and unsolicited non-SAE (within 28 days after final vaccination)
|
0.00%
0/59 • Adverse events were collected from Day 0 (post-vaccination) up to study end ( i.e., up to Day 21 for adult participants or Day 28 for child participants who received 1 dose; up to Day 56 for participants who received 2 doses).
Solicited reaction (SR) is an AE prelisted in eCRF and considered related to vaccination. A SR is, therefore, an adverse drug reaction observed and reported under conditions prelisted (solicited) in eCRF. An Unsolicited AE is an observed AE that does not fulfill conditions prelisted in eCRF in terms of symptom and/or time to onset post-vaccination. Non-serious adverse events (non-SAE) included SR (within 7 days after vaccination) and unsolicited non-SAE (within 28 days after final vaccination)
|
0.00%
0/60 • Adverse events were collected from Day 0 (post-vaccination) up to study end ( i.e., up to Day 21 for adult participants or Day 28 for child participants who received 1 dose; up to Day 56 for participants who received 2 doses).
Solicited reaction (SR) is an AE prelisted in eCRF and considered related to vaccination. A SR is, therefore, an adverse drug reaction observed and reported under conditions prelisted (solicited) in eCRF. An Unsolicited AE is an observed AE that does not fulfill conditions prelisted in eCRF in terms of symptom and/or time to onset post-vaccination. Non-serious adverse events (non-SAE) included SR (within 7 days after vaccination) and unsolicited non-SAE (within 28 days after final vaccination)
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/30 • Adverse events were collected from Day 0 (post-vaccination) up to study end ( i.e., up to Day 21 for adult participants or Day 28 for child participants who received 1 dose; up to Day 56 for participants who received 2 doses).
Solicited reaction (SR) is an AE prelisted in eCRF and considered related to vaccination. A SR is, therefore, an adverse drug reaction observed and reported under conditions prelisted (solicited) in eCRF. An Unsolicited AE is an observed AE that does not fulfill conditions prelisted in eCRF in terms of symptom and/or time to onset post-vaccination. Non-serious adverse events (non-SAE) included SR (within 7 days after vaccination) and unsolicited non-SAE (within 28 days after final vaccination)
|
6.7%
2/30 • Number of events 2 • Adverse events were collected from Day 0 (post-vaccination) up to study end ( i.e., up to Day 21 for adult participants or Day 28 for child participants who received 1 dose; up to Day 56 for participants who received 2 doses).
Solicited reaction (SR) is an AE prelisted in eCRF and considered related to vaccination. A SR is, therefore, an adverse drug reaction observed and reported under conditions prelisted (solicited) in eCRF. An Unsolicited AE is an observed AE that does not fulfill conditions prelisted in eCRF in terms of symptom and/or time to onset post-vaccination. Non-serious adverse events (non-SAE) included SR (within 7 days after vaccination) and unsolicited non-SAE (within 28 days after final vaccination)
|
0.00%
0/61 • Adverse events were collected from Day 0 (post-vaccination) up to study end ( i.e., up to Day 21 for adult participants or Day 28 for child participants who received 1 dose; up to Day 56 for participants who received 2 doses).
Solicited reaction (SR) is an AE prelisted in eCRF and considered related to vaccination. A SR is, therefore, an adverse drug reaction observed and reported under conditions prelisted (solicited) in eCRF. An Unsolicited AE is an observed AE that does not fulfill conditions prelisted in eCRF in terms of symptom and/or time to onset post-vaccination. Non-serious adverse events (non-SAE) included SR (within 7 days after vaccination) and unsolicited non-SAE (within 28 days after final vaccination)
|
0.00%
0/59 • Adverse events were collected from Day 0 (post-vaccination) up to study end ( i.e., up to Day 21 for adult participants or Day 28 for child participants who received 1 dose; up to Day 56 for participants who received 2 doses).
Solicited reaction (SR) is an AE prelisted in eCRF and considered related to vaccination. A SR is, therefore, an adverse drug reaction observed and reported under conditions prelisted (solicited) in eCRF. An Unsolicited AE is an observed AE that does not fulfill conditions prelisted in eCRF in terms of symptom and/or time to onset post-vaccination. Non-serious adverse events (non-SAE) included SR (within 7 days after vaccination) and unsolicited non-SAE (within 28 days after final vaccination)
|
0.00%
0/60 • Adverse events were collected from Day 0 (post-vaccination) up to study end ( i.e., up to Day 21 for adult participants or Day 28 for child participants who received 1 dose; up to Day 56 for participants who received 2 doses).
Solicited reaction (SR) is an AE prelisted in eCRF and considered related to vaccination. A SR is, therefore, an adverse drug reaction observed and reported under conditions prelisted (solicited) in eCRF. An Unsolicited AE is an observed AE that does not fulfill conditions prelisted in eCRF in terms of symptom and/or time to onset post-vaccination. Non-serious adverse events (non-SAE) included SR (within 7 days after vaccination) and unsolicited non-SAE (within 28 days after final vaccination)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The 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