Trial Outcomes & Findings for A Study to Learn About the Safety and Immune Activity of RSVpreF in Children 2 to <18 Years of Age (NCT NCT05900154)
NCT ID: NCT05900154
Last Updated: 2025-03-06
Results Overview
Local reactions were collected in the electronic diary (e-diary) from Day 1 through Day 7 after vaccination. Local reactions included pain at injection site, redness, and swelling. For participants greater than or equal to (\>=) 2 years to \<12 years of age, redness and swelling were graded as mild: 0.5 to 2.0 centimeter (cm), moderate: \>2.0 to 7.0 cm, and severe: \> 7 cm; for participants \>=12 years of age, mild: \> 2.0 to 5.0 cm, moderate: \>5.0 to 10.0 cm, and severe: \>10 cm. Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
128 participants
Primary outcome timeframe
Day 1 through Day 7 after Vaccination
Results posted on
2025-03-06
Participant Flow
A total of 128 participants were enrolled, however 1 participant was assigned to a vaccine group but did not receive vaccination. Consequently, a total of 127 participants were vaccinated.
Participants were divided into 2 age groups: 5 to less than (\<) 18 years and 2 to \< 5 years. Participants in 5 to \<18 years age group were further stratified as healthy and with high-risk chronic medical conditions.
Participant milestones
| Measure |
RSVpreF 120 Micrograms (mcg): 5 to <18 Years [Healthy Participants]
Healthy participants of age 5 to \<18 years received a single dose of respiratory syncytial virus stabilized prefusion F subunit vaccine (RSVpreF) 120 mcg intramuscularly on Day 1.
|
RSVpreF 120 mcg: 5 to <18 Years [High Risk Participants]
Participants who had high risk chronic medical conditions of age 5 to \<18 years received a single dose of RSVpreF 120 mcg intramuscularly on Day 1.
|
RSVpreF 120 mcg: 2 to < 5 Years
Participants of age 2 to \<5 years received a single dose of RSVpreF 120 mcg intramuscularly on Day 1.
|
RSVpreF 60 mcg: 5 to <18 Years [Healthy Participants]
Healthy participants of age 5 to \<18 years received a single dose of RSVpreF 60 mcg intramuscularly on Day 1.
|
RSVpreF 60 mcg: 5 to <18 Years [High Risk Participants]
Participants who had high risk chronic medical conditions of age 5 to \<18 years received a single dose of RSVpreF 60 mcg intramuscularly on Day 1.
|
RSVpreF 60 mcg: 2 to < 5 Years
Participants of age 2 to \<5 years received a single dose of RSVpreF 60 mcg intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|
|
Vaccination Period
STARTED
|
25
|
23
|
24
|
17
|
18
|
20
|
|
Vaccination Period
COMPLETED
|
25
|
23
|
24
|
17
|
18
|
20
|
|
Vaccination Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Follow-Up Period
STARTED
|
25
|
23
|
24
|
17
|
18
|
20
|
|
Follow-Up Period
COMPLETED
|
24
|
21
|
23
|
17
|
17
|
19
|
|
Follow-Up Period
NOT COMPLETED
|
1
|
2
|
1
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
RSVpreF 120 Micrograms (mcg): 5 to <18 Years [Healthy Participants]
Healthy participants of age 5 to \<18 years received a single dose of respiratory syncytial virus stabilized prefusion F subunit vaccine (RSVpreF) 120 mcg intramuscularly on Day 1.
|
RSVpreF 120 mcg: 5 to <18 Years [High Risk Participants]
Participants who had high risk chronic medical conditions of age 5 to \<18 years received a single dose of RSVpreF 120 mcg intramuscularly on Day 1.
|
RSVpreF 120 mcg: 2 to < 5 Years
Participants of age 2 to \<5 years received a single dose of RSVpreF 120 mcg intramuscularly on Day 1.
|
RSVpreF 60 mcg: 5 to <18 Years [Healthy Participants]
Healthy participants of age 5 to \<18 years received a single dose of RSVpreF 60 mcg intramuscularly on Day 1.
|
RSVpreF 60 mcg: 5 to <18 Years [High Risk Participants]
Participants who had high risk chronic medical conditions of age 5 to \<18 years received a single dose of RSVpreF 60 mcg intramuscularly on Day 1.
|
RSVpreF 60 mcg: 2 to < 5 Years
Participants of age 2 to \<5 years received a single dose of RSVpreF 60 mcg intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|
|
Follow-Up Period
Lost to Follow-up
|
1
|
2
|
1
|
0
|
1
|
1
|
Baseline Characteristics
A Study to Learn About the Safety and Immune Activity of RSVpreF in Children 2 to <18 Years of Age
Baseline characteristics by cohort
| Measure |
RSVpreF 120 mcg: 5 to <18 Years [Healthy Participants]
n=25 Participants
Healthy participants of age 5 to \<18 years received a single dose of RSVpreF 120 mcg intramuscularly on Day 1.
|
RSVpreF 120 mcg: 5 to <18 Years [High Risk Participants]
n=23 Participants
Participants who had high risk chronic medical conditions of age 5 to \<18 years received a single dose of RSVpreF 120 mcg intramuscularly on Day 1.
|
RSVpreF 120 mcg: 2 to < 5 Years
n=24 Participants
Participants of age 2 to \<5 years received a single dose of RSVpreF 120 mcg intramuscularly on Day 1.
|
RSVpreF 60 mcg: 5 to <18 Years [Healthy Participants]
n=17 Participants
Healthy participants of age 5 to \<18 years received a single dose of RSVpreF 60 mcg intramuscularly on Day 1.
|
RSVpreF 60 mcg: 5 to <18 Years [High Risk Participants]
n=18 Participants
Participants who had high risk chronic medical conditions of age 5 to \<18 years received a single dose of RSVpreF 60 mcg intramuscularly on Day 1.
|
RSVpreF 60 mcg: 2 to < 5 Years
n=20 Participants
Participants of age 2 to \<5 years received a single dose of RSVpreF 60 mcg intramuscularly on Day 1.
|
Total
n=127 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Customized
Children (2-11 years)
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
20 Participants
n=8 Participants
|
88 Participants
n=8 Participants
|
|
Age, Customized
Adolescents (12-17 years)
|
16 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
39 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
58 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
13 Participants
n=8 Participants
|
69 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
18 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
15 Participants
n=8 Participants
|
107 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
2 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=8 Participants
|
2 Participants
n=8 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=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
28 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
15 Participants
n=8 Participants
|
87 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
9 Participants
n=8 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=8 Participants
|
0 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 7 after VaccinationPopulation: Safety population included all enrolled participants who received study intervention.
Local reactions were collected in the electronic diary (e-diary) from Day 1 through Day 7 after vaccination. Local reactions included pain at injection site, redness, and swelling. For participants greater than or equal to (\>=) 2 years to \<12 years of age, redness and swelling were graded as mild: 0.5 to 2.0 centimeter (cm), moderate: \>2.0 to 7.0 cm, and severe: \> 7 cm; for participants \>=12 years of age, mild: \> 2.0 to 5.0 cm, moderate: \>5.0 to 10.0 cm, and severe: \>10 cm. Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity).
Outcome measures
| Measure |
RSVpreF 120 mcg: 5 to <18 Years [Healthy Participants]
n=25 Participants
Healthy participants of age 5 to \<18 years received a single dose of RSVpreF 120 mcg intramuscularly on Day 1.
|
RSVpreF 120 mcg: 5 to <18 Years [High Risk Participants]
n=23 Participants
Participants who had high risk chronic medical conditions of age 5 to \<18 years received a single dose of RSVpreF 120 mcg intramuscularly on Day 1.
|
RSVpreF 120 mcg: 2 to <5 Years
n=24 Participants
Participants of age 2 to \<5 years received a single dose of RSVpreF 120 mcg intramuscularly on Day 1.
|
RSVpreF 60 mcg: 5 to <18 Years [Healthy Participants]
n=17 Participants
Healthy participants of age 5 to \<18 years received a single dose of RSVpreF 60 mcg intramuscularly on Day 1.
|
RSVpreF 60 mcg: 5 to <18 Years [High Risk Participants]
n=18 Participants
Participants who had high risk chronic medical conditions of age 5 to \<18 years received a single dose of RSVpreF 60 mcg intramuscularly on Day 1.
|
RSVpreF 60 mcg: 2 to <5 Years
n=20 Participants
Participants of age 2 to \<5 years received a single dose of RSVpreF 60 mcg intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Pain at injection site: Severe
|
4.0 Percentage of participants
Interval 0.1 to 20.4
|
0 Percentage of participants
Interval 0.0 to 14.8
|
0 Percentage of participants
Interval 0.0 to 14.2
|
0 Percentage of participants
Interval 0.0 to 19.5
|
0 Percentage of participants
Interval 0.0 to 18.5
|
0 Percentage of participants
Interval 0.0 to 16.8
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Redness: Mild
|
12.0 Percentage of participants
Interval 2.5 to 31.2
|
4.3 Percentage of participants
Interval 0.1 to 21.9
|
12.5 Percentage of participants
Interval 2.7 to 32.4
|
0 Percentage of participants
Interval 0.0 to 19.5
|
11.1 Percentage of participants
Interval 1.4 to 34.7
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Swelling: Mild
|
4.0 Percentage of participants
Interval 0.1 to 20.4
|
0 Percentage of participants
Interval 0.0 to 14.8
|
4.2 Percentage of participants
Interval 0.1 to 21.1
|
0 Percentage of participants
Interval 0.0 to 19.5
|
11.1 Percentage of participants
Interval 1.4 to 34.7
|
0 Percentage of participants
Interval 0.0 to 16.8
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Swelling: Moderate
|
8.0 Percentage of participants
Interval 1.0 to 26.0
|
8.7 Percentage of participants
Interval 1.1 to 28.0
|
0 Percentage of participants
Interval 0.0 to 14.2
|
5.9 Percentage of participants
Interval 0.1 to 28.7
|
11.1 Percentage of participants
Interval 1.4 to 34.7
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Pain at injection site: Mild
|
36.0 Percentage of participants
Interval 18.0 to 57.5
|
39.1 Percentage of participants
Interval 19.7 to 61.5
|
8.3 Percentage of participants
Interval 1.0 to 27.0
|
35.3 Percentage of participants
Interval 14.2 to 61.7
|
33.3 Percentage of participants
Interval 13.3 to 59.0
|
15.0 Percentage of participants
Interval 3.2 to 37.9
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Pain at injection site: Moderate
|
8.0 Percentage of participants
Interval 1.0 to 26.0
|
8.7 Percentage of participants
Interval 1.1 to 28.0
|
0 Percentage of participants
Interval 0.0 to 14.2
|
5.9 Percentage of participants
Interval 0.1 to 28.7
|
22.2 Percentage of participants
Interval 6.4 to 47.6
|
0 Percentage of participants
Interval 0.0 to 16.8
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Redness: Moderate
|
12.0 Percentage of participants
Interval 2.5 to 31.2
|
4.3 Percentage of participants
Interval 0.1 to 21.9
|
0 Percentage of participants
Interval 0.0 to 14.2
|
5.9 Percentage of participants
Interval 0.1 to 28.7
|
0 Percentage of participants
Interval 0.0 to 18.5
|
0 Percentage of participants
Interval 0.0 to 16.8
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Redness: Severe
|
0 Percentage of participants
Interval 0.0 to 13.7
|
0 Percentage of participants
Interval 0.0 to 14.8
|
0 Percentage of participants
Interval 0.0 to 14.2
|
0 Percentage of participants
Interval 0.0 to 19.5
|
0 Percentage of participants
Interval 0.0 to 18.5
|
0 Percentage of participants
Interval 0.0 to 16.8
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Swelling: Severe
|
0 Percentage of participants
Interval 0.0 to 13.7
|
0 Percentage of participants
Interval 0.0 to 14.8
|
0 Percentage of participants
Interval 0.0 to 14.2
|
0 Percentage of participants
Interval 0.0 to 19.5
|
0 Percentage of participants
Interval 0.0 to 18.5
|
0 Percentage of participants
Interval 0.0 to 16.8
|
PRIMARY outcome
Timeframe: Day 1 through Day 7 after VaccinationPopulation: Safety population included all enrolled participants who received study intervention.
Systemic events included fever, fatigue, headache, vomiting, diarrhea, muscle pain and joint pain and were recorded by participants using e-diary. Fever: oral temperature \>= 38.0 degree Celsius (deg C) and categorized as \>=38.0 to 38.4 deg C (mild), \>38.4 to 38.9 deg C (moderate), and \>38.9 to 40.0 deg C (severe). Fatigue, headache, muscle pain and joint pain were graded as mild (did not interfere with activity), moderate (some interference with activity), and severe (prevented daily routine activity). Vomiting was graded mild: 1-2 times in 24 hours (h), moderate: \>2 times in 24h, and severe: required intravenous hydration. Diarrhea was graded mild: 2-3 loose stools in 24h, moderate: 4-5 loose stools in 24h and severe: 6 or more loose stools in 24h.
Outcome measures
| Measure |
RSVpreF 120 mcg: 5 to <18 Years [Healthy Participants]
n=25 Participants
Healthy participants of age 5 to \<18 years received a single dose of RSVpreF 120 mcg intramuscularly on Day 1.
|
RSVpreF 120 mcg: 5 to <18 Years [High Risk Participants]
n=23 Participants
Participants who had high risk chronic medical conditions of age 5 to \<18 years received a single dose of RSVpreF 120 mcg intramuscularly on Day 1.
|
RSVpreF 120 mcg: 2 to <5 Years
n=24 Participants
Participants of age 2 to \<5 years received a single dose of RSVpreF 120 mcg intramuscularly on Day 1.
|
RSVpreF 60 mcg: 5 to <18 Years [Healthy Participants]
n=17 Participants
Healthy participants of age 5 to \<18 years received a single dose of RSVpreF 60 mcg intramuscularly on Day 1.
|
RSVpreF 60 mcg: 5 to <18 Years [High Risk Participants]
n=18 Participants
Participants who had high risk chronic medical conditions of age 5 to \<18 years received a single dose of RSVpreF 60 mcg intramuscularly on Day 1.
|
RSVpreF 60 mcg: 2 to <5 Years
n=20 Participants
Participants of age 2 to \<5 years received a single dose of RSVpreF 60 mcg intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Fatigue: Severe
|
0 Percentage of participants
Interval 0.0 to 13.7
|
0 Percentage of participants
Interval 0.0 to 14.8
|
0 Percentage of participants
Interval 0.0 to 14.2
|
0 Percentage of participants
Interval 0.0 to 19.5
|
0 Percentage of participants
Interval 0.0 to 18.5
|
0 Percentage of participants
Interval 0.0 to 16.8
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Headache: Mild
|
16.0 Percentage of participants
Interval 4.5 to 36.1
|
26.1 Percentage of participants
Interval 10.2 to 48.4
|
0 Percentage of participants
Interval 0.0 to 14.2
|
29.4 Percentage of participants
Interval 10.3 to 56.0
|
16.7 Percentage of participants
Interval 3.6 to 41.4
|
0 Percentage of participants
Interval 0.0 to 16.8
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Headache: Moderate
|
12.0 Percentage of participants
Interval 2.5 to 31.2
|
8.7 Percentage of participants
Interval 1.1 to 28.0
|
4.2 Percentage of participants
Interval 0.1 to 21.1
|
11.8 Percentage of participants
Interval 1.5 to 36.4
|
16.7 Percentage of participants
Interval 3.6 to 41.4
|
0 Percentage of participants
Interval 0.0 to 16.8
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Headache: Severe
|
0 Percentage of participants
Interval 0.0 to 13.7
|
0 Percentage of participants
Interval 0.0 to 14.8
|
0 Percentage of participants
Interval 0.0 to 14.2
|
0 Percentage of participants
Interval 0.0 to 19.5
|
0 Percentage of participants
Interval 0.0 to 18.5
|
0 Percentage of participants
Interval 0.0 to 16.8
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Muscle pain: Mild
|
16.0 Percentage of participants
Interval 4.5 to 36.1
|
21.7 Percentage of participants
Interval 7.5 to 43.7
|
0 Percentage of participants
Interval 0.0 to 14.2
|
23.5 Percentage of participants
Interval 6.8 to 49.9
|
33.3 Percentage of participants
Interval 13.3 to 59.0
|
0 Percentage of participants
Interval 0.0 to 16.8
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Fever: Mild
|
0 Percentage of participants
Interval 0.0 to 13.7
|
4.3 Percentage of participants
Interval 0.1 to 21.9
|
4.2 Percentage of participants
Interval 0.1 to 21.1
|
0 Percentage of participants
Interval 0.0 to 19.5
|
0 Percentage of participants
Interval 0.0 to 18.5
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Fever: Moderate
|
0 Percentage of participants
Interval 0.0 to 13.7
|
0 Percentage of participants
Interval 0.0 to 14.8
|
0 Percentage of participants
Interval 0.0 to 14.2
|
0 Percentage of participants
Interval 0.0 to 19.5
|
5.6 Percentage of participants
Interval 0.1 to 27.3
|
0 Percentage of participants
Interval 0.0 to 16.8
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Fever: Severe
|
0 Percentage of participants
Interval 0.0 to 13.7
|
0 Percentage of participants
Interval 0.0 to 14.8
|
0 Percentage of participants
Interval 0.0 to 14.2
|
5.9 Percentage of participants
Interval 0.1 to 28.7
|
5.6 Percentage of participants
Interval 0.1 to 27.3
|
0 Percentage of participants
Interval 0.0 to 16.8
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Fatigue: Mild
|
20.0 Percentage of participants
Interval 6.8 to 40.7
|
21.7 Percentage of participants
Interval 7.5 to 43.7
|
20.8 Percentage of participants
Interval 7.1 to 42.2
|
41.2 Percentage of participants
Interval 18.4 to 67.1
|
16.7 Percentage of participants
Interval 3.6 to 41.4
|
30.0 Percentage of participants
Interval 11.9 to 54.3
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Fatigue: Moderate
|
12.0 Percentage of participants
Interval 2.5 to 31.2
|
21.7 Percentage of participants
Interval 7.5 to 43.7
|
8.3 Percentage of participants
Interval 1.0 to 27.0
|
5.9 Percentage of participants
Interval 0.1 to 28.7
|
33.3 Percentage of participants
Interval 13.3 to 59.0
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Muscle pain: Moderate
|
4.0 Percentage of participants
Interval 0.1 to 20.4
|
17.4 Percentage of participants
Interval 5.0 to 38.8
|
0 Percentage of participants
Interval 0.0 to 14.2
|
0 Percentage of participants
Interval 0.0 to 19.5
|
5.6 Percentage of participants
Interval 0.1 to 27.3
|
0 Percentage of participants
Interval 0.0 to 16.8
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Muscle pain: Severe
|
0 Percentage of participants
Interval 0.0 to 13.7
|
0 Percentage of participants
Interval 0.0 to 14.8
|
0 Percentage of participants
Interval 0.0 to 14.2
|
0 Percentage of participants
Interval 0.0 to 19.5
|
0 Percentage of participants
Interval 0.0 to 18.5
|
0 Percentage of participants
Interval 0.0 to 16.8
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Joint pain: Mild
|
4.0 Percentage of participants
Interval 0.1 to 20.4
|
4.3 Percentage of participants
Interval 0.1 to 21.9
|
0 Percentage of participants
Interval 0.0 to 14.2
|
0 Percentage of participants
Interval 0.0 to 19.5
|
11.1 Percentage of participants
Interval 1.4 to 34.7
|
0 Percentage of participants
Interval 0.0 to 16.8
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Joint pain: Moderate
|
4.0 Percentage of participants
Interval 0.1 to 20.4
|
0 Percentage of participants
Interval 0.0 to 14.8
|
0 Percentage of participants
Interval 0.0 to 14.2
|
0 Percentage of participants
Interval 0.0 to 19.5
|
0 Percentage of participants
Interval 0.0 to 18.5
|
0 Percentage of participants
Interval 0.0 to 16.8
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Joint pain: Severe
|
0 Percentage of participants
Interval 0.0 to 13.7
|
0 Percentage of participants
Interval 0.0 to 14.8
|
0 Percentage of participants
Interval 0.0 to 14.2
|
0 Percentage of participants
Interval 0.0 to 19.5
|
0 Percentage of participants
Interval 0.0 to 18.5
|
0 Percentage of participants
Interval 0.0 to 16.8
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Vomiting: Mild
|
0 Percentage of participants
Interval 0.0 to 13.7
|
0 Percentage of participants
Interval 0.0 to 14.8
|
0 Percentage of participants
Interval 0.0 to 14.2
|
5.9 Percentage of participants
Interval 0.1 to 28.7
|
5.6 Percentage of participants
Interval 0.1 to 27.3
|
10.0 Percentage of participants
Interval 1.2 to 31.7
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Vomiting: Moderate
|
0 Percentage of participants
Interval 0.0 to 13.7
|
0 Percentage of participants
Interval 0.0 to 14.8
|
0 Percentage of participants
Interval 0.0 to 14.2
|
0 Percentage of participants
Interval 0.0 to 19.5
|
0 Percentage of participants
Interval 0.0 to 18.5
|
0 Percentage of participants
Interval 0.0 to 16.8
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Vomiting: Severe
|
0 Percentage of participants
Interval 0.0 to 13.7
|
0 Percentage of participants
Interval 0.0 to 14.8
|
0 Percentage of participants
Interval 0.0 to 14.2
|
0 Percentage of participants
Interval 0.0 to 19.5
|
0 Percentage of participants
Interval 0.0 to 18.5
|
0 Percentage of participants
Interval 0.0 to 16.8
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Diarrhea: Mild
|
4.0 Percentage of participants
Interval 0.1 to 20.4
|
8.7 Percentage of participants
Interval 1.1 to 28.0
|
4.2 Percentage of participants
Interval 0.1 to 21.1
|
0 Percentage of participants
Interval 0.0 to 19.5
|
5.6 Percentage of participants
Interval 0.1 to 27.3
|
0 Percentage of participants
Interval 0.0 to 16.8
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Diarrhea: Moderate
|
0 Percentage of participants
Interval 0.0 to 13.7
|
0 Percentage of participants
Interval 0.0 to 14.8
|
8.3 Percentage of participants
Interval 1.0 to 27.0
|
0 Percentage of participants
Interval 0.0 to 19.5
|
0 Percentage of participants
Interval 0.0 to 18.5
|
0 Percentage of participants
Interval 0.0 to 16.8
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Diarrhea: Severe
|
0 Percentage of participants
Interval 0.0 to 13.7
|
0 Percentage of participants
Interval 0.0 to 14.8
|
0 Percentage of participants
Interval 0.0 to 14.2
|
0 Percentage of participants
Interval 0.0 to 19.5
|
0 Percentage of participants
Interval 0.0 to 18.5
|
0 Percentage of participants
Interval 0.0 to 16.8
|
PRIMARY outcome
Timeframe: Within 1 month post VaccinationPopulation: Safety population included all enrolled participants who received study intervention.
AE was defined as any untoward medical occurrence in clinical study participant, temporally associated with use of study intervention, whether or not considered related to study intervention. AEs included serious and all non-serious AE. SAEs were defined as AE that, at any dose: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity; was congenital anomaly or birth defect; was suspected transmission via Pfizer product of infectious agent, pathogenic or nonpathogenic or was considered to be an important medical event. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were included.
Outcome measures
| Measure |
RSVpreF 120 mcg: 5 to <18 Years [Healthy Participants]
n=25 Participants
Healthy participants of age 5 to \<18 years received a single dose of RSVpreF 120 mcg intramuscularly on Day 1.
|
RSVpreF 120 mcg: 5 to <18 Years [High Risk Participants]
n=23 Participants
Participants who had high risk chronic medical conditions of age 5 to \<18 years received a single dose of RSVpreF 120 mcg intramuscularly on Day 1.
|
RSVpreF 120 mcg: 2 to <5 Years
n=24 Participants
Participants of age 2 to \<5 years received a single dose of RSVpreF 120 mcg intramuscularly on Day 1.
|
RSVpreF 60 mcg: 5 to <18 Years [Healthy Participants]
n=17 Participants
Healthy participants of age 5 to \<18 years received a single dose of RSVpreF 60 mcg intramuscularly on Day 1.
|
RSVpreF 60 mcg: 5 to <18 Years [High Risk Participants]
n=18 Participants
Participants who had high risk chronic medical conditions of age 5 to \<18 years received a single dose of RSVpreF 60 mcg intramuscularly on Day 1.
|
RSVpreF 60 mcg: 2 to <5 Years
n=20 Participants
Participants of age 2 to \<5 years received a single dose of RSVpreF 60 mcg intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination
|
0 Percentage of participants
Interval 0.0 to 13.7
|
17.4 Percentage of participants
Interval 5.0 to 38.8
|
12.5 Percentage of participants
Interval 2.7 to 32.4
|
0 Percentage of participants
Interval 0.0 to 19.5
|
27.8 Percentage of participants
Interval 9.7 to 53.5
|
15.0 Percentage of participants
Interval 3.2 to 37.9
|
PRIMARY outcome
Timeframe: Within 6 months post VaccinationPopulation: Safety population included all enrolled participants who received study intervention.
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. SAEs were defined as an AE that, at any dose: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability or incapacity; was a congenital anomaly or birth defect; was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or nonpathogenic or that was considered to be an important medical event.
Outcome measures
| Measure |
RSVpreF 120 mcg: 5 to <18 Years [Healthy Participants]
n=25 Participants
Healthy participants of age 5 to \<18 years received a single dose of RSVpreF 120 mcg intramuscularly on Day 1.
|
RSVpreF 120 mcg: 5 to <18 Years [High Risk Participants]
n=23 Participants
Participants who had high risk chronic medical conditions of age 5 to \<18 years received a single dose of RSVpreF 120 mcg intramuscularly on Day 1.
|
RSVpreF 120 mcg: 2 to <5 Years
n=24 Participants
Participants of age 2 to \<5 years received a single dose of RSVpreF 120 mcg intramuscularly on Day 1.
|
RSVpreF 60 mcg: 5 to <18 Years [Healthy Participants]
n=17 Participants
Healthy participants of age 5 to \<18 years received a single dose of RSVpreF 60 mcg intramuscularly on Day 1.
|
RSVpreF 60 mcg: 5 to <18 Years [High Risk Participants]
n=18 Participants
Participants who had high risk chronic medical conditions of age 5 to \<18 years received a single dose of RSVpreF 60 mcg intramuscularly on Day 1.
|
RSVpreF 60 mcg: 2 to <5 Years
n=20 Participants
Participants of age 2 to \<5 years received a single dose of RSVpreF 60 mcg intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Serious Adverse Events (SAEs) Throughout the Study
|
0 Percentage of participants
Interval 0.0 to 13.7
|
4.3 Percentage of participants
Interval 0.1 to 21.9
|
0 Percentage of participants
Interval 0.0 to 14.2
|
0 Percentage of participants
Interval 0.0 to 19.5
|
5.6 Percentage of participants
Interval 0.1 to 27.3
|
0 Percentage of participants
Interval 0.0 to 16.8
|
PRIMARY outcome
Timeframe: Within 6 months post VaccinationPopulation: Safety population included all enrolled participants who received study intervention.
An NDCMC was defined as a disease or medical condition, which was not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Outcome measures
| Measure |
RSVpreF 120 mcg: 5 to <18 Years [Healthy Participants]
n=25 Participants
Healthy participants of age 5 to \<18 years received a single dose of RSVpreF 120 mcg intramuscularly on Day 1.
|
RSVpreF 120 mcg: 5 to <18 Years [High Risk Participants]
n=23 Participants
Participants who had high risk chronic medical conditions of age 5 to \<18 years received a single dose of RSVpreF 120 mcg intramuscularly on Day 1.
|
RSVpreF 120 mcg: 2 to <5 Years
n=24 Participants
Participants of age 2 to \<5 years received a single dose of RSVpreF 120 mcg intramuscularly on Day 1.
|
RSVpreF 60 mcg: 5 to <18 Years [Healthy Participants]
n=17 Participants
Healthy participants of age 5 to \<18 years received a single dose of RSVpreF 60 mcg intramuscularly on Day 1.
|
RSVpreF 60 mcg: 5 to <18 Years [High Risk Participants]
n=18 Participants
Participants who had high risk chronic medical conditions of age 5 to \<18 years received a single dose of RSVpreF 60 mcg intramuscularly on Day 1.
|
RSVpreF 60 mcg: 2 to <5 Years
n=20 Participants
Participants of age 2 to \<5 years received a single dose of RSVpreF 60 mcg intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Reporting Newly Diagnosed Chronic Medical Condition (NDCMCs) Throughout the Study
|
0 Percentage of participants
Interval 0.0 to 13.7
|
0 Percentage of participants
Interval 0.0 to 14.8
|
0 Percentage of participants
Interval 0.0 to 14.2
|
0 Percentage of participants
Interval 0.0 to 19.5
|
0 Percentage of participants
Interval 0.0 to 18.5
|
0 Percentage of participants
Interval 0.0 to 16.8
|
SECONDARY outcome
Timeframe: Before vaccination and 1 month after vaccinationPopulation: Evaluable immunogenicity population (EIP) included all eligible participants who received the study intervention; had 1-month postvaccination blood collection 27 through 42 days after vaccination; had at least 1 valid and determinate assay result 1 month after vaccination; had no major protocol violations from vaccination through the 1-month postvaccination blood draw. Here, "Number Analyzed" signifies participants evaluable for the specified rows.
Geometric mean titer (GMT) of neutralizing titers (NTs) of respiratory syncytial virus subgroup A and respiratory syncytial virus subgroup B (RSV A and RSV B) before vaccination and 1 month after vaccination were reported in this outcome measure. Assay results below the lower limit of quantification (LLOQ) were set to 0.5\*LLOQ. GMTs and corresponding 2-sided CIs were calculated by exponentiating mean logarithm of titers and corresponding CIs (based on Student's t distribution).
Outcome measures
| Measure |
RSVpreF 120 mcg: 5 to <18 Years [Healthy Participants]
n=24 Participants
Healthy participants of age 5 to \<18 years received a single dose of RSVpreF 120 mcg intramuscularly on Day 1.
|
RSVpreF 120 mcg: 5 to <18 Years [High Risk Participants]
n=21 Participants
Participants who had high risk chronic medical conditions of age 5 to \<18 years received a single dose of RSVpreF 120 mcg intramuscularly on Day 1.
|
RSVpreF 120 mcg: 2 to <5 Years
n=24 Participants
Participants of age 2 to \<5 years received a single dose of RSVpreF 120 mcg intramuscularly on Day 1.
|
RSVpreF 60 mcg: 5 to <18 Years [Healthy Participants]
n=15 Participants
Healthy participants of age 5 to \<18 years received a single dose of RSVpreF 60 mcg intramuscularly on Day 1.
|
RSVpreF 60 mcg: 5 to <18 Years [High Risk Participants]
n=18 Participants
Participants who had high risk chronic medical conditions of age 5 to \<18 years received a single dose of RSVpreF 60 mcg intramuscularly on Day 1.
|
RSVpreF 60 mcg: 2 to <5 Years
n=20 Participants
Participants of age 2 to \<5 years received a single dose of RSVpreF 60 mcg intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Titer of the Neutralizing Titers for RSV A and RSV B Before Vaccination and 1 Month After Vaccination
RSV A: Before vaccination
|
1168 Titer
Interval 706.0 to 1932.0
|
2003 Titer
Interval 1421.0 to 2823.0
|
529 Titer
Interval 335.0 to 835.0
|
916 Titer
Interval 653.0 to 1285.0
|
1667 Titer
Interval 1035.0 to 2684.0
|
561 Titer
Interval 309.0 to 1016.0
|
|
Geometric Mean Titer of the Neutralizing Titers for RSV A and RSV B Before Vaccination and 1 Month After Vaccination
RSV A:1 Month after vaccination
|
27862 Titer
Interval 21493.0 to 36119.0
|
35503 Titer
Interval 26876.0 to 46900.0
|
26146 Titer
Interval 13301.0 to 51396.0
|
25341 Titer
Interval 15394.0 to 41715.0
|
24053 Titer
Interval 17440.0 to 33173.0
|
11004 Titer
Interval 4287.0 to 28245.0
|
|
Geometric Mean Titer of the Neutralizing Titers for RSV A and RSV B Before Vaccination and 1 Month After Vaccination
RSV B: Before vaccination
|
1206 Titer
Interval 717.0 to 2027.0
|
1905 Titer
Interval 1238.0 to 2930.0
|
391 Titer
Interval 231.0 to 661.0
|
965 Titer
Interval 668.0 to 1393.0
|
1760 Titer
Interval 947.0 to 3272.0
|
499 Titer
Interval 258.0 to 967.0
|
|
Geometric Mean Titer of the Neutralizing Titers for RSV A and RSV B Before Vaccination and 1 Month After Vaccination
RSV B:1 Month after vaccination
|
30251 Titer
Interval 21607.0 to 42355.0
|
29019 Titer
Interval 18786.0 to 44827.0
|
16504 Titer
Interval 8267.0 to 32948.0
|
33351 Titer
Interval 23565.0 to 47202.0
|
31174 Titer
Interval 21756.0 to 44668.0
|
10659 Titer
Interval 3526.0 to 32228.0
|
SECONDARY outcome
Timeframe: From before vaccination to 1 month after vaccinationPopulation: EIP included all eligible participants who received the study intervention; had 1-month postvaccination blood collection 27 through 42 days after vaccination; had at least 1 valid and determinate assay result 1 month after vaccination; had no major protocol violations from vaccination through the 1-month postvaccination blood draw. Here, ''Number of Participants Analyzed'' signifies participants evaluable of this outcome measure.
GMFR of neutralizing titers of RSV A and RSV B from before vaccination to 1 month after vaccination were reported in this outcome measure. GMFR and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises and the corresponding CIs (based on the Student's t distribution).
Outcome measures
| Measure |
RSVpreF 120 mcg: 5 to <18 Years [Healthy Participants]
n=24 Participants
Healthy participants of age 5 to \<18 years received a single dose of RSVpreF 120 mcg intramuscularly on Day 1.
|
RSVpreF 120 mcg: 5 to <18 Years [High Risk Participants]
n=20 Participants
Participants who had high risk chronic medical conditions of age 5 to \<18 years received a single dose of RSVpreF 120 mcg intramuscularly on Day 1.
|
RSVpreF 120 mcg: 2 to <5 Years
n=24 Participants
Participants of age 2 to \<5 years received a single dose of RSVpreF 120 mcg intramuscularly on Day 1.
|
RSVpreF 60 mcg: 5 to <18 Years [Healthy Participants]
n=15 Participants
Healthy participants of age 5 to \<18 years received a single dose of RSVpreF 60 mcg intramuscularly on Day 1.
|
RSVpreF 60 mcg: 5 to <18 Years [High Risk Participants]
n=18 Participants
Participants who had high risk chronic medical conditions of age 5 to \<18 years received a single dose of RSVpreF 60 mcg intramuscularly on Day 1.
|
RSVpreF 60 mcg: 2 to <5 Years
n=20 Participants
Participants of age 2 to \<5 years received a single dose of RSVpreF 60 mcg intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Fold Rise (GMFR) of the NTs for RSV A and RSV B From Before Vaccination to 1 Month After Vaccination
RSV A
|
21.9 Fold rise
Interval 14.46 to 33.08
|
18.6 Fold rise
Interval 13.03 to 26.55
|
42.8 Fold rise
Interval 23.41 to 78.16
|
27.7 Fold rise
Interval 17.81 to 42.93
|
13.9 Fold rise
Interval 8.75 to 22.03
|
17.7 Fold rise
Interval 9.02 to 34.67
|
|
Geometric Mean Fold Rise (GMFR) of the NTs for RSV A and RSV B From Before Vaccination to 1 Month After Vaccination
RSV B
|
24.4 Fold rise
Interval 15.53 to 38.26
|
16.3 Fold rise
Interval 9.91 to 26.83
|
39.8 Fold rise
Interval 22.96 to 69.08
|
34.6 Fold rise
Interval 21.63 to 55.23
|
17.0 Fold rise
Interval 9.25 to 31.4
|
20.6 Fold rise
Interval 10.0 to 42.5
|
SECONDARY outcome
Timeframe: Before vaccination and 1 Month after vaccinationPopulation: EIP included all eligible participants who received the study intervention; had 1-month postvaccination blood collection 27 through 42 days after vaccination; had at least 1 valid and determinate assay result 1 month after vaccination; had no major protocol violations from vaccination through the 1-month postvaccination blood draw. Here, "Number of Participants Analyzed" = participants evaluable for this outcome measure and "Number Analyzed" = participants evaluable for specified rows.
Median frequencies of RSV F antigen-specific CD4+ T cells expressing IFN gamma and IL-4 before vaccination and 1 month after vaccination were reported in this outcome measure. RSV F enzyme-linked immune absorbent spot assay (ELISpot) limit of detection (LOD) values were IFN gamma = 20 spot forming cell (SFC) per million peripheral blood mononuclear cell (PBMCs) and IL-4 = 4 SFC/million PBMCs. Assay results below LOD=0.5\*LOD for analysis. Frequencies were defined as the count of the RSV F antigen-specific CD4+ T cells and median frequencies were defined as the median of the counts.
Outcome measures
| Measure |
RSVpreF 120 mcg: 5 to <18 Years [Healthy Participants]
n=23 Participants
Healthy participants of age 5 to \<18 years received a single dose of RSVpreF 120 mcg intramuscularly on Day 1.
|
RSVpreF 120 mcg: 5 to <18 Years [High Risk Participants]
n=21 Participants
Participants who had high risk chronic medical conditions of age 5 to \<18 years received a single dose of RSVpreF 120 mcg intramuscularly on Day 1.
|
RSVpreF 120 mcg: 2 to <5 Years
n=22 Participants
Participants of age 2 to \<5 years received a single dose of RSVpreF 120 mcg intramuscularly on Day 1.
|
RSVpreF 60 mcg: 5 to <18 Years [Healthy Participants]
n=15 Participants
Healthy participants of age 5 to \<18 years received a single dose of RSVpreF 60 mcg intramuscularly on Day 1.
|
RSVpreF 60 mcg: 5 to <18 Years [High Risk Participants]
n=18 Participants
Participants who had high risk chronic medical conditions of age 5 to \<18 years received a single dose of RSVpreF 60 mcg intramuscularly on Day 1.
|
RSVpreF 60 mcg: 2 to <5 Years
n=17 Participants
Participants of age 2 to \<5 years received a single dose of RSVpreF 60 mcg intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|
|
Median Frequencies of RSV F Antigen-Specific Cluster of Differentiation 4 (CD4+) Thymus-Derived Lymphocytes (T) Cells Expressing Interferon (IFN) Gamma and Interleukin-4 (IL-4) Before Vaccination and 1 Month After Vaccination
INF gamma before vaccination
|
47 SFC/million PBMCs
Interval 10.0 to 241.0
|
60 SFC/million PBMCs
Interval 10.0 to 193.0
|
10 SFC/million PBMCs
Interval 10.0 to 67.0
|
53 SFC/million PBMCs
Interval 10.0 to 277.0
|
41 SFC/million PBMCs
Interval 10.0 to 336.0
|
10 SFC/million PBMCs
Interval 10.0 to 79.0
|
|
Median Frequencies of RSV F Antigen-Specific Cluster of Differentiation 4 (CD4+) Thymus-Derived Lymphocytes (T) Cells Expressing Interferon (IFN) Gamma and Interleukin-4 (IL-4) Before Vaccination and 1 Month After Vaccination
INF gamma 1 month after vaccination
|
255 SFC/million PBMCs
Interval 10.0 to 829.0
|
293 SFC/million PBMCs
Interval 10.0 to 1339.0
|
61 SFC/million PBMCs
Interval 10.0 to 257.0
|
244 SFC/million PBMCs
Interval 23.0 to 1027.0
|
187 SFC/million PBMCs
Interval 10.0 to 780.0
|
45 SFC/million PBMCs
Interval 10.0 to 184.0
|
|
Median Frequencies of RSV F Antigen-Specific Cluster of Differentiation 4 (CD4+) Thymus-Derived Lymphocytes (T) Cells Expressing Interferon (IFN) Gamma and Interleukin-4 (IL-4) Before Vaccination and 1 Month After Vaccination
IL-4 before vaccination
|
2 SFC/million PBMCs
Interval 2.0 to 2.0
|
2 SFC/million PBMCs
Interval 2.0 to 11.0
|
2 SFC/million PBMCs
Interval 2.0 to 2.0
|
2 SFC/million PBMCs
Interval 2.0 to 4.0
|
2 SFC/million PBMCs
Interval 2.0 to 5.0
|
2 SFC/million PBMCs
Interval 2.0 to 4.0
|
|
Median Frequencies of RSV F Antigen-Specific Cluster of Differentiation 4 (CD4+) Thymus-Derived Lymphocytes (T) Cells Expressing Interferon (IFN) Gamma and Interleukin-4 (IL-4) Before Vaccination and 1 Month After Vaccination
IL-4 1 month after vaccination
|
2 SFC/million PBMCs
Interval 2.0 to 16.0
|
4 SFC/million PBMCs
Interval 2.0 to 28.0
|
2 SFC/million PBMCs
Interval 2.0 to 7.0
|
2 SFC/million PBMCs
Interval 2.0 to 24.0
|
2 SFC/million PBMCs
Interval 2.0 to 15.0
|
2 SFC/million PBMCs
Interval 2.0 to 13.0
|
Adverse Events
Healthy RSVpreF 120 Micrograms (mcg)
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
High Risk RSVpreF 120 mcg
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
2 to < 5 Years RSVpreF 120 mcg
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Healthy RSVpreF 60 mcg
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
High Risk RSVpreF 60 mcg
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
2 to < 5 Years RSVpreF 60 mcg
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Healthy RSVpreF 120 Micrograms (mcg)
n=25 participants at risk
Healthy participants with 5 to \< 18 years of age received a single dose of 120 mcg RSVpreF as standard dose level intramuscularly into the deltoid muscle (Vaccination 1) on Day 1.
|
High Risk RSVpreF 120 mcg
n=23 participants at risk
High risk participants with 5 to \< 18 years of age received a single dose of 120 mcg RSVpreF as standard dose level intramuscularly into the deltoid muscle (Vaccination 1) on Day 1.
|
2 to < 5 Years RSVpreF 120 mcg
n=24 participants at risk
Participants with 2 to \< 5 years of age received a single dose of 120 mcg RSVpreF as standard dose level intramuscularly into the deltoid muscle (Vaccination 1) on Day 1.
|
Healthy RSVpreF 60 mcg
n=17 participants at risk
Healthy participants with 5 to \< 18 years of age received a single dose of 60 mcg RSVpreF as standard dose level intramuscularly into the deltoid muscle (Vaccination 1) on Day 1.
|
High Risk RSVpreF 60 mcg
n=18 participants at risk
High risk participants with 5 to \< 18 years of age received a single dose of 60 mcg RSVpreF as standard dose level intramuscularly into the deltoid muscle (Vaccination 1) on Day 1.
|
2 to < 5 Years RSVpreF 60 mcg
n=20 participants at risk
Participants with 2 to \< 5 years of age received a single dose of 60 mcg RSVpreF as standard dose level intramuscularly into the deltoid muscle (Vaccination 1) on Day 1.
|
|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/25 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
0.00%
0/23 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
0.00%
0/24 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
0.00%
0/17 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
5.6%
1/18 • Number of events 1 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
0.00%
0/20 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
|
Immune system disorders
Food allergy
|
0.00%
0/25 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
4.3%
1/23 • Number of events 1 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
0.00%
0/24 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
0.00%
0/17 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
0.00%
0/18 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
0.00%
0/20 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
Other adverse events
| Measure |
Healthy RSVpreF 120 Micrograms (mcg)
n=25 participants at risk
Healthy participants with 5 to \< 18 years of age received a single dose of 120 mcg RSVpreF as standard dose level intramuscularly into the deltoid muscle (Vaccination 1) on Day 1.
|
High Risk RSVpreF 120 mcg
n=23 participants at risk
High risk participants with 5 to \< 18 years of age received a single dose of 120 mcg RSVpreF as standard dose level intramuscularly into the deltoid muscle (Vaccination 1) on Day 1.
|
2 to < 5 Years RSVpreF 120 mcg
n=24 participants at risk
Participants with 2 to \< 5 years of age received a single dose of 120 mcg RSVpreF as standard dose level intramuscularly into the deltoid muscle (Vaccination 1) on Day 1.
|
Healthy RSVpreF 60 mcg
n=17 participants at risk
Healthy participants with 5 to \< 18 years of age received a single dose of 60 mcg RSVpreF as standard dose level intramuscularly into the deltoid muscle (Vaccination 1) on Day 1.
|
High Risk RSVpreF 60 mcg
n=18 participants at risk
High risk participants with 5 to \< 18 years of age received a single dose of 60 mcg RSVpreF as standard dose level intramuscularly into the deltoid muscle (Vaccination 1) on Day 1.
|
2 to < 5 Years RSVpreF 60 mcg
n=20 participants at risk
Participants with 2 to \< 5 years of age received a single dose of 60 mcg RSVpreF as standard dose level intramuscularly into the deltoid muscle (Vaccination 1) on Day 1.
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Headache (HEADACHE)
|
28.0%
7/25 • Number of events 7 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
34.8%
8/23 • Number of events 8 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
4.2%
1/24 • Number of events 1 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
41.2%
7/17 • Number of events 7 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
33.3%
6/18 • Number of events 6 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
0.00%
0/20 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
|
Nervous system disorders
Syncope
|
0.00%
0/25 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
0.00%
0/23 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
0.00%
0/24 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
0.00%
0/17 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
5.6%
1/18 • Number of events 1 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
0.00%
0/20 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/25 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
0.00%
0/23 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
0.00%
0/24 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
0.00%
0/17 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
5.6%
1/18 • Number of events 1 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
0.00%
0/20 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
|
Gastrointestinal disorders
Diarrhoea (DIARRHEA)
|
4.0%
1/25 • Number of events 1 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
8.7%
2/23 • Number of events 2 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
12.5%
3/24 • Number of events 3 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
0.00%
0/17 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
5.6%
1/18 • Number of events 1 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
0.00%
0/20 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
|
Gastrointestinal disorders
Vomiting (VOMITING)
|
0.00%
0/25 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
0.00%
0/23 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
0.00%
0/24 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
5.9%
1/17 • Number of events 1 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
5.6%
1/18 • Number of events 1 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
10.0%
2/20 • Number of events 2 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
|
Skin and subcutaneous tissue disorders
Erythema (REDNESS)
|
24.0%
6/25 • Number of events 6 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
8.7%
2/23 • Number of events 2 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
12.5%
3/24 • Number of events 3 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
5.9%
1/17 • Number of events 1 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
11.1%
2/18 • Number of events 2 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
5.0%
1/20 • Number of events 1 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia (JOINT PAIN)
|
8.0%
2/25 • Number of events 2 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
4.3%
1/23 • Number of events 1 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
0.00%
0/24 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
0.00%
0/17 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
11.1%
2/18 • Number of events 2 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
0.00%
0/20 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/25 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
0.00%
0/23 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
0.00%
0/24 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
5.9%
1/17 • Number of events 1 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
0.00%
0/18 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
0.00%
0/20 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
|
Musculoskeletal and connective tissue disorders
Myalgia (MUSCLE PAIN)
|
20.0%
5/25 • Number of events 5 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
39.1%
9/23 • Number of events 9 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
0.00%
0/24 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
23.5%
4/17 • Number of events 4 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
38.9%
7/18 • Number of events 7 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
0.00%
0/20 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
|
Infections and infestations
COVID-19
|
0.00%
0/25 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
0.00%
0/23 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
0.00%
0/24 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
0.00%
0/17 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
5.6%
1/18 • Number of events 1 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
0.00%
0/20 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/25 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
0.00%
0/23 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
0.00%
0/24 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
0.00%
0/17 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
5.6%
1/18 • Number of events 1 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
0.00%
0/20 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
|
Infections and infestations
Viral infection
|
0.00%
0/25 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
0.00%
0/23 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
4.2%
1/24 • Number of events 1 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
0.00%
0/17 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
5.6%
1/18 • Number of events 1 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
5.0%
1/20 • Number of events 1 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/25 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
0.00%
0/23 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
0.00%
0/24 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
0.00%
0/17 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
5.6%
1/18 • Number of events 1 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
0.00%
0/20 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
|
General disorders
Axillary pain
|
0.00%
0/25 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
0.00%
0/23 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
0.00%
0/24 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
0.00%
0/17 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
5.6%
1/18 • Number of events 1 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
0.00%
0/20 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
|
General disorders
Fatigue
|
0.00%
0/25 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
8.7%
2/23 • Number of events 2 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
0.00%
0/24 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
0.00%
0/17 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
5.6%
1/18 • Number of events 1 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
0.00%
0/20 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
|
General disorders
Fatigue (FATIGUE)
|
32.0%
8/25 • Number of events 8 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
43.5%
10/23 • Number of events 10 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
29.2%
7/24 • Number of events 7 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
47.1%
8/17 • Number of events 8 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
50.0%
9/18 • Number of events 9 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
35.0%
7/20 • Number of events 7 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
|
General disorders
Injection site erythema
|
0.00%
0/25 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
8.7%
2/23 • Number of events 2 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
0.00%
0/24 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
0.00%
0/17 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
0.00%
0/18 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
0.00%
0/20 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
|
General disorders
Injection site pain
|
8.0%
2/25 • Number of events 2 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
13.0%
3/23 • Number of events 3 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
0.00%
0/24 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
5.9%
1/17 • Number of events 1 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
5.6%
1/18 • Number of events 1 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
0.00%
0/20 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
|
General disorders
Injection site pain (PAIN AT INJECTION SITE)
|
48.0%
12/25 • Number of events 12 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
47.8%
11/23 • Number of events 11 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
8.3%
2/24 • Number of events 2 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
41.2%
7/17 • Number of events 7 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
55.6%
10/18 • Number of events 10 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
15.0%
3/20 • Number of events 3 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
|
General disorders
Injection site swelling
|
0.00%
0/25 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
0.00%
0/23 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
0.00%
0/24 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
0.00%
0/17 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
5.6%
1/18 • Number of events 1 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
0.00%
0/20 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
|
General disorders
Pyrexia
|
0.00%
0/25 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
0.00%
0/23 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
8.3%
2/24 • Number of events 2 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
0.00%
0/17 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
0.00%
0/18 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
5.0%
1/20 • Number of events 1 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
|
General disorders
Pyrexia (FEVER)
|
0.00%
0/25 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
4.3%
1/23 • Number of events 1 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
4.2%
1/24 • Number of events 1 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
5.9%
1/17 • Number of events 1 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
11.1%
2/18 • Number of events 2 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
5.0%
1/20 • Number of events 1 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
|
General disorders
Swelling (SWELLING)
|
12.0%
3/25 • Number of events 3 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
8.7%
2/23 • Number of events 2 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
4.2%
1/24 • Number of events 1 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
5.9%
1/17 • Number of events 1 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
22.2%
4/18 • Number of events 4 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
5.0%
1/20 • Number of events 1 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
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Immune system disorders
Food allergy
|
0.00%
0/25 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
0.00%
0/23 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
0.00%
0/24 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
0.00%
0/17 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
5.6%
1/18 • Number of events 1 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
|
0.00%
0/20 • Local reactions and systemic events: Within 7 days after vaccination. SAEs: Within 6 months post Vaccination and other AEs: Within 1 month post Vaccination
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER