Trial Outcomes & Findings for Study to Assess the Immune Response, the Safety and the Reactogenicity of Respiratory Syncytial Virus (RSV) Prefusion Protein 3 Older Adult (OA) (RSVPreF3 OA) Investigational Vaccine When co Administered With PCV20 in Older Adults (NCT NCT05879107)
NCT ID: NCT05879107
Last Updated: 2025-05-18
Results Overview
The OP titers were measured with multiplexed opsonophagocytosis assay and the results were expressed as GMT for each of the pneumococcal vaccine serotype.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1113 participants
Primary outcome timeframe
At Day 31
Results posted on
2025-05-18
Participant Flow
This study was conducted in adult participants aged 60 years and older, in 38 study sites.
Out of 1113 participants, a total of 1110 were eligible and were randomized in a 1:1 ratio to either co-administration group or control group at Day 1.
Participant milestones
| Measure |
Co-administration Group
Participants received both respiratory syncytial virus prefusion protein 3 older adult (RSVPreF3 OA) vaccine and 20-valent pneumococcal conjugate vaccine (PCV20) on Day 1.
|
Control Group
Participants received PCV20 vaccine on Day 1 and RSVPreF3 OA vaccine on Day 31.
|
|---|---|---|
|
Overall Study
STARTED
|
553
|
557
|
|
Overall Study
COMPLETED
|
539
|
531
|
|
Overall Study
NOT COMPLETED
|
14
|
26
|
Reasons for withdrawal
| Measure |
Co-administration Group
Participants received both respiratory syncytial virus prefusion protein 3 older adult (RSVPreF3 OA) vaccine and 20-valent pneumococcal conjugate vaccine (PCV20) on Day 1.
|
Control Group
Participants received PCV20 vaccine on Day 1 and RSVPreF3 OA vaccine on Day 31.
|
|---|---|---|
|
Overall Study
Withdrawal by participant, not due to an adverse event
|
5
|
7
|
|
Overall Study
Migrated / moved from the study area
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
8
|
13
|
|
Overall Study
Death
|
0
|
2
|
|
Overall Study
Other
|
0
|
3
|
Baseline Characteristics
Study to Assess the Immune Response, the Safety and the Reactogenicity of Respiratory Syncytial Virus (RSV) Prefusion Protein 3 Older Adult (OA) (RSVPreF3 OA) Investigational Vaccine When co Administered With PCV20 in Older Adults
Baseline characteristics by cohort
| Measure |
Co-administration Group
n=553 Participants
Participants received both RSVPreF3 OA vaccine and PCV20 on Day 1.
|
Control Group
n=557 Participants
Participants received PCV20 vaccine on Day 1 and RSVPreF3 OA vaccine on Day 31.
|
Total
n=1110 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.6 years
STANDARD_DEVIATION 7.28 • n=93 Participants
|
69.6 years
STANDARD_DEVIATION 7.41 • n=4 Participants
|
69.6 years
STANDARD_DEVIATION 7.35 • n=27 Participants
|
|
Sex: Female, Male
Female
|
316 Participants
n=93 Participants
|
315 Participants
n=4 Participants
|
631 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
237 Participants
n=93 Participants
|
242 Participants
n=4 Participants
|
479 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
64 Participants
n=93 Participants
|
54 Participants
n=4 Participants
|
118 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
All Other Races
|
7 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White
|
476 Participants
n=93 Participants
|
488 Participants
n=4 Participants
|
964 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
2 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: At Day 31Population: Per protocol set (PPS) for PCV20 included all eligible participants in the exposed set who: received the PVC20 vaccine, had immunogenicity results for OP titers, complied with blood draw interval, without intercurrent medical conditions and without prohibited concomitant medication/vaccination and who did not meet any of the criteria for elimination up to blood sample collection. Only participants with data available at the specified timepoint were included in the analysis.
The OP titers were measured with multiplexed opsonophagocytosis assay and the results were expressed as GMT for each of the pneumococcal vaccine serotype.
Outcome measures
| Measure |
Co-administration Group
n=514 Participants
Participants received both RSVPreF3 OA vaccine and PCV20 on Day 1.
|
Control Group
n=497 Participants
Participants received PCV20 vaccine on Day 1 and RSVPreF3 OA vaccine on Day 31.
|
|---|---|---|
|
Adjusted Geometric Mean Titers (GMT) of Opsonophagocytic (OP) Titers at 1 Month After the PCV20 Vaccination
Strep pneumoniae - serotype 1
|
74.7 Titers
Interval 64.1 to 87.1
|
110.8 Titers
Interval 94.8 to 129.5
|
|
Adjusted Geometric Mean Titers (GMT) of Opsonophagocytic (OP) Titers at 1 Month After the PCV20 Vaccination
Strep pneumoniae - serotype 3
|
88.5 Titers
Interval 78.3 to 99.9
|
116.2 Titers
Interval 102.7 to 131.5
|
|
Adjusted Geometric Mean Titers (GMT) of Opsonophagocytic (OP) Titers at 1 Month After the PCV20 Vaccination
Strep pneumoniae - serotype 4
|
1220.9 Titers
Interval 1072.9 to 1389.3
|
1634.1 Titers
Interval 1433.4 to 1862.8
|
|
Adjusted Geometric Mean Titers (GMT) of Opsonophagocytic (OP) Titers at 1 Month After the PCV20 Vaccination
Strep pneumoniae - serotype 5
|
191.0 Titers
Interval 159.9 to 228.1
|
260.3 Titers
Interval 217.3 to 311.8
|
|
Adjusted Geometric Mean Titers (GMT) of Opsonophagocytic (OP) Titers at 1 Month After the PCV20 Vaccination
Strep pneumoniae - serotype 6A
|
1790.0 Titers
Interval 1527.8 to 2097.2
|
2458.3 Titers
Interval 2091.8 to 2889.1
|
|
Adjusted Geometric Mean Titers (GMT) of Opsonophagocytic (OP) Titers at 1 Month After the PCV20 Vaccination
Strep pneumoniae - serotype 6B
|
2121.6 Titers
Interval 1839.0 to 2447.6
|
2996.9 Titers
Interval 2590.3 to 3467.2
|
|
Adjusted Geometric Mean Titers (GMT) of Opsonophagocytic (OP) Titers at 1 Month After the PCV20 Vaccination
Strep pneumoniae - serotype 7F
|
2411.3 Titers
Interval 2154.1 to 2699.2
|
3225.1 Titers
Interval 2876.2 to 3616.4
|
|
Adjusted Geometric Mean Titers (GMT) of Opsonophagocytic (OP) Titers at 1 Month After the PCV20 Vaccination
Strep pneumoniae - serotype 8
|
522.9 Titers
Interval 458.5 to 596.4
|
723.0 Titers
Interval 632.5 to 826.5
|
|
Adjusted Geometric Mean Titers (GMT) of Opsonophagocytic (OP) Titers at 1 Month After the PCV20 Vaccination
Strep pneumoniae - serotype 9V
|
937.0 Titers
Interval 822.3 to 1067.8
|
1161.0 Titers
Interval 1016.7 to 1325.8
|
|
Adjusted Geometric Mean Titers (GMT) of Opsonophagocytic (OP) Titers at 1 Month After the PCV20 Vaccination
Strep pneumoniae - serotype 10A
|
6033.4 Titers
Interval 5299.5 to 6868.9
|
7349.4 Titers
Interval 6437.8 to 8389.9
|
|
Adjusted Geometric Mean Titers (GMT) of Opsonophagocytic (OP) Titers at 1 Month After the PCV20 Vaccination
Strep pneumoniae - serotype 11A
|
798.0 Titers
Interval 691.5 to 921.0
|
944.2 Titers
Interval 816.9 to 1091.5
|
|
Adjusted Geometric Mean Titers (GMT) of Opsonophagocytic (OP) Titers at 1 Month After the PCV20 Vaccination
Strep pneumoniae - serotype 12F
|
1608.4 Titers
Interval 1382.9 to 1870.8
|
1932.4 Titers
Interval 1656.5 to 2254.3
|
|
Adjusted Geometric Mean Titers (GMT) of Opsonophagocytic (OP) Titers at 1 Month After the PCV20 Vaccination
Strep pneumoniae - serotype 14
|
2322.3 Titers
Interval 2050.5 to 2630.1
|
3301.4 Titers
Interval 2909.1 to 3746.7
|
|
Adjusted Geometric Mean Titers (GMT) of Opsonophagocytic (OP) Titers at 1 Month After the PCV20 Vaccination
Strep pneumoniae - serotype 15B
|
4336.4 Titers
Interval 3765.8 to 4993.5
|
6350.2 Titers
Interval 5500.4 to 7331.3
|
|
Adjusted Geometric Mean Titers (GMT) of Opsonophagocytic (OP) Titers at 1 Month After the PCV20 Vaccination
Strep pneumoniae - serotype 18C
|
1148.6 Titers
Interval 997.6 to 1322.5
|
1480.0 Titers
Interval 1282.4 to 1708.0
|
|
Adjusted Geometric Mean Titers (GMT) of Opsonophagocytic (OP) Titers at 1 Month After the PCV20 Vaccination
Strep pneumoniae - serotype 19A
|
1392.3 Titers
Interval 1244.3 to 1557.8
|
1933.8 Titers
Interval 1725.2 to 2167.7
|
|
Adjusted Geometric Mean Titers (GMT) of Opsonophagocytic (OP) Titers at 1 Month After the PCV20 Vaccination
Strep pneumoniae - serotype 19F
|
525.6 Titers
Interval 461.6 to 598.5
|
696.7 Titers
Interval 610.6 to 794.9
|
|
Adjusted Geometric Mean Titers (GMT) of Opsonophagocytic (OP) Titers at 1 Month After the PCV20 Vaccination
Strep pneumoniae - serotype 22F
|
5492.3 Titers
Interval 4788.1 to 6300.1
|
7351.5 Titers
Interval 6397.0 to 8448.5
|
|
Adjusted Geometric Mean Titers (GMT) of Opsonophagocytic (OP) Titers at 1 Month After the PCV20 Vaccination
Strep pneumoniae - serotype 23F
|
729.7 Titers
Interval 613.0 to 868.6
|
995.0 Titers
Interval 832.8 to 1188.7
|
|
Adjusted Geometric Mean Titers (GMT) of Opsonophagocytic (OP) Titers at 1 Month After the PCV20 Vaccination
Strep pneumoniae - serotype 33F
|
14902.8 Titers
Interval 13220.7 to 16798.8
|
20920.9 Titers
Interval 18526.9 to 23624.3
|
PRIMARY outcome
Timeframe: At Day 31 for Co-administration Group and at Day 61 for Control GroupPopulation: PPS for RSVPreF3 OA included all eligible participants in the exposed set who: received the RSVPreF3 OA vaccine, had immunogenicity results for RSV neutralizing titers, complied with blood draw interval, without intercurrent medical conditions and without prohibited concomitant medication/vaccination and who did not meet any of the criteria for elimination up to blood sample collection. Only the participants with RSV-A data at the specified timepoints were included in the analysis.
Neutralizing titers were measured with neutralization assay and the results were expressed in ED60.
Outcome measures
| Measure |
Co-administration Group
n=512 Participants
Participants received both RSVPreF3 OA vaccine and PCV20 on Day 1.
|
Control Group
n=382 Participants
Participants received PCV20 vaccine on Day 1 and RSVPreF3 OA vaccine on Day 31.
|
|---|---|---|
|
Adjusted GMTs of Respiratory Syncytial Virus-A (RSV-A) Neutralizing Titers [Estimated Dilution 60 (ED60)] at 1 Month After the RSVPreF3 OA Vaccination
|
8338.2 Titers
Interval 7639.0 to 9101.4
|
8872.7 Titers
Interval 8038.2 to 9793.9
|
PRIMARY outcome
Timeframe: At Day 31 for Co-administration Group and at Day 61 for Control GroupPopulation: PPS for RSVPreF3 OA. Only the participants with RSV-B data at the specified timepoints were included in the analysis.
Neutralizing titers were measured with neutralization assay and the results were expressed in ED60.
Outcome measures
| Measure |
Co-administration Group
n=511 Participants
Participants received both RSVPreF3 OA vaccine and PCV20 on Day 1.
|
Control Group
n=382 Participants
Participants received PCV20 vaccine on Day 1 and RSVPreF3 OA vaccine on Day 31.
|
|---|---|---|
|
Adjusted GMTs of RSV-B Neutralizing Titers (ED60) at 1 Month After the RSVPreF3 OA Vaccination
|
9477.5 Titers
Interval 8695.4 to 10329.9
|
9497.6 Titers
Interval 8620.5 to 10463.9
|
SECONDARY outcome
Timeframe: At 1 month after the RSVPreF3 OA vaccine dose (Day 31 for Co-administration Group and Day 61 for Control Group) compared to Pre-vaccination (Day 1 for Co-administration Group and Day 31 for Control Group)Population: PPS for RSVPreF3 OA. Only the participants with RSV-A data at the specified timepoints were included in the analysis.
The MGI was defined as the geometric mean increase of the within participant ratios of the post-vaccination titer over the pre-vaccination titer. Neutralizing titers were measured with neutralization assay.
Outcome measures
| Measure |
Co-administration Group
n=512 Participants
Participants received both RSVPreF3 OA vaccine and PCV20 on Day 1.
|
Control Group
n=382 Participants
Participants received PCV20 vaccine on Day 1 and RSVPreF3 OA vaccine on Day 31.
|
|---|---|---|
|
Mean Geometric Increase (MGI) of RSV-A Neutralizing Titers at 1 Month After the RSVPreF3 OA Vaccination
|
8.3 Ratio
Interval 7.6 to 9.1
|
9.3 Ratio
Interval 8.3 to 10.3
|
SECONDARY outcome
Timeframe: At 1 month after the RSVPreF3 OA vaccine dose (Day 31 for Co-administration Group and Day 61 for Control Group) compared to Pre-vaccination (Day 1 for Co-administration Group and Day 31 for Control Group)Population: PPS for RSVPreF3 OA. Only the participants with RSV-B data at the specified timepoints were included in the analysis.
The MGI was defined as the geometric mean increase of the within participant ratios of the post-vaccination titer over the pre-vaccination titer. Neutralizing titers were measured with neutralization assay.
Outcome measures
| Measure |
Co-administration Group
n=511 Participants
Participants received both RSVPreF3 OA vaccine and PCV20 on Day 1.
|
Control Group
n=382 Participants
Participants received PCV20 vaccine on Day 1 and RSVPreF3 OA vaccine on Day 31.
|
|---|---|---|
|
MGI of RSV-B Neutralizing Titers at 1 Month After the RSVPreF3 OA Vaccination
|
9.4 Ratio
Interval 8.6 to 10.2
|
9.1 Ratio
Interval 8.2 to 10.1
|
SECONDARY outcome
Timeframe: Within 7 days (the day of vaccination and 6 subsequent days) after each vaccine administration (vaccines administered at Day 1 for Co-Administration Group and at Days 1 and 31 for Control group)Population: Exposed set included all participants in the Enrolled set who received at least 1 study intervention. Only those participants with solicited administration site AEs were included in this analysis.
The solicited administration site events after vaccination include pain, erythema/redness, and swelling.
Outcome measures
| Measure |
Co-administration Group
n=537 Participants
Participants received both RSVPreF3 OA vaccine and PCV20 on Day 1.
|
Control Group
n=546 Participants
Participants received PCV20 vaccine on Day 1 and RSVPreF3 OA vaccine on Day 31.
|
|---|---|---|
|
Number of Participants With Solicited Administration Site Adverse Events (AEs) After Each Vaccine Dose Administration
Pain at injection site, PCV20 dose, given at Day 1
|
283 Participants
|
208 Participants
|
|
Number of Participants With Solicited Administration Site Adverse Events (AEs) After Each Vaccine Dose Administration
Pain at injection site, RSV dose, given at Day 1
|
290 Participants
|
—
|
|
Number of Participants With Solicited Administration Site Adverse Events (AEs) After Each Vaccine Dose Administration
Pain at injection site, RSV dose, given at Day 31
|
—
|
225 Participants
|
|
Number of Participants With Solicited Administration Site Adverse Events (AEs) After Each Vaccine Dose Administration
Erythema at injection site, PCV20 dose, given at Day 1
|
24 Participants
|
21 Participants
|
|
Number of Participants With Solicited Administration Site Adverse Events (AEs) After Each Vaccine Dose Administration
Erythema at injection site, RSV dose, given at Day 1
|
54 Participants
|
—
|
|
Number of Participants With Solicited Administration Site Adverse Events (AEs) After Each Vaccine Dose Administration
Erythema at injection site, RSV dose, given at Day 31
|
—
|
33 Participants
|
|
Number of Participants With Solicited Administration Site Adverse Events (AEs) After Each Vaccine Dose Administration
Swelling at injection site, PCV20 dose, given at Day 1
|
17 Participants
|
17 Participants
|
|
Number of Participants With Solicited Administration Site Adverse Events (AEs) After Each Vaccine Dose Administration
Swelling at injection site, RSV dose, given at Day 1
|
26 Participants
|
—
|
|
Number of Participants With Solicited Administration Site Adverse Events (AEs) After Each Vaccine Dose Administration
Swelling at injection site, RSV dose, given at Day 31
|
—
|
21 Participants
|
SECONDARY outcome
Timeframe: Within 7 days (the day of vaccination and 6 subsequent days) after each vaccine administration (vaccines administered at Day 1 for Co-Administration Group and at Days 1 and 31 for Control group)Population: Exposed set. Only those participants with solicited systemic AEs were included in this analysis.
The solicited systemic events after vaccination include fever (pyrexia), headache, fatigue, myalgia and arthralgia. Fever is defined as body temperature \>=38 degree Celsius; preferred location for measuring the temperature is oral.
Outcome measures
| Measure |
Co-administration Group
n=538 Participants
Participants received both RSVPreF3 OA vaccine and PCV20 on Day 1.
|
Control Group
n=546 Participants
Participants received PCV20 vaccine on Day 1 and RSVPreF3 OA vaccine on Day 31.
|
|---|---|---|
|
Number of Participants With Solicited Systemic AEs After Each Vaccine Dose Administration
Fever, Dosing at Day 1
|
16 Participants
|
4 Participants
|
|
Number of Participants With Solicited Systemic AEs After Each Vaccine Dose Administration
Fever, Dosing at Day 31
|
—
|
8 Participants
|
|
Number of Participants With Solicited Systemic AEs After Each Vaccine Dose Administration
Headache, Dosing at Day 1
|
144 Participants
|
83 Participants
|
|
Number of Participants With Solicited Systemic AEs After Each Vaccine Dose Administration
Headache, Dosing at Day 31
|
—
|
97 Participants
|
|
Number of Participants With Solicited Systemic AEs After Each Vaccine Dose Administration
Fatigue, Dosing at Day 1
|
198 Participants
|
152 Participants
|
|
Number of Participants With Solicited Systemic AEs After Each Vaccine Dose Administration
Fatigue, Dosing at Day 31
|
—
|
144 Participants
|
|
Number of Participants With Solicited Systemic AEs After Each Vaccine Dose Administration
Myalgia, Dosing at Day 1
|
176 Participants
|
89 Participants
|
|
Number of Participants With Solicited Systemic AEs After Each Vaccine Dose Administration
Myalgia, Dosing at Day 31
|
—
|
108 Participants
|
|
Number of Participants With Solicited Systemic AEs After Each Vaccine Dose Administration
Arthralgia, Dosing at Day 1
|
80 Participants
|
41 Participants
|
|
Number of Participants With Solicited Systemic AEs After Each Vaccine Dose Administration
Arthralgia, Dosing at Day 31
|
—
|
67 Participants
|
SECONDARY outcome
Timeframe: Within 30 days (the day of vaccination and 29 subsequent days) after each vaccine administration (vaccines administered at Day 1 for Co-Administration Group and at Days 1 and 31 for Control group)Population: Exposed set.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the administration of a study vaccine, which does not necessarily have a causal relationship with study vaccine. An unsolicited AE is an AE that is either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events. Unsolicited AEs are communicated by participant/participant's caregiver(s) who have signed the informed consent. Unsolicited AEs include both serious adverse events (SAEs) and non-serious AEs.
Outcome measures
| Measure |
Co-administration Group
n=553 Participants
Participants received both RSVPreF3 OA vaccine and PCV20 on Day 1.
|
Control Group
n=557 Participants
Participants received PCV20 vaccine on Day 1 and RSVPreF3 OA vaccine on Day 31.
|
|---|---|---|
|
Number of Participants With Unsolicited AEs
|
60 Participants
|
98 Participants
|
SECONDARY outcome
Timeframe: Throughout the study period (from Day 1 up to 6 months after the last dose administration [last dose given at Day 1 for Co-administration Group and Day 31 for Control Group])Population: Exposed set.
An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.
Outcome measures
| Measure |
Co-administration Group
n=553 Participants
Participants received both RSVPreF3 OA vaccine and PCV20 on Day 1.
|
Control Group
n=557 Participants
Participants received PCV20 vaccine on Day 1 and RSVPreF3 OA vaccine on Day 31.
|
|---|---|---|
|
Number of Participants With SAEs
|
9 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Throughout the study period (from Day 1 up to 6 months after the last dose administration [last dose given at Day 1 for Co-administration Group and Day 31 for Control Group])Population: Exposed set.
The pIMD is a subset of AEs of special interest that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.
Outcome measures
| Measure |
Co-administration Group
n=553 Participants
Participants received both RSVPreF3 OA vaccine and PCV20 on Day 1.
|
Control Group
n=557 Participants
Participants received PCV20 vaccine on Day 1 and RSVPreF3 OA vaccine on Day 31.
|
|---|---|---|
|
Number of Participants With Potential Immune-mediated Diseases (pIMDs)
|
2 Participants
|
1 Participants
|
Adverse Events
Co-administration Group
Serious events: 9 serious events
Other events: 410 other events
Deaths: 0 deaths
Control Group
Serious events: 14 serious events
Other events: 423 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Co-administration Group
n=553 participants at risk
Participants received both RSVPreF3 OA vaccine and PCV20 on Day 1.
|
Control Group
n=557 participants at risk
Participants received PCV20 vaccine on Day 1 and RSVPreF3 OA vaccine on Day 31.
|
|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/553 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.18%
1/557 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.18%
1/553 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/557 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/553 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.18%
1/557 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.18%
1/553 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/557 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
General disorders
Death
|
0.00%
0/553 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.36%
2/557 • Number of events 2 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Pneumonia bacterial
|
0.18%
1/553 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/557 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Device related infection
|
0.00%
0/553 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.18%
1/557 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Influenza
|
0.00%
0/553 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.18%
1/557 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/553 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.36%
2/557 • Number of events 2 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Necrotising fasciitis
|
0.00%
0/553 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.18%
1/557 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/553 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.18%
1/557 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/553 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.18%
1/557 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Injury, poisoning and procedural complications
Fracture displacement
|
0.18%
1/553 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/557 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Injury, poisoning and procedural complications
Fall
|
0.18%
1/553 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/557 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/553 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.18%
1/557 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.18%
1/553 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/557 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer recurrent
|
0.00%
0/553 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.18%
1/557 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer stage I
|
0.18%
1/553 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/557 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/553 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.18%
1/557 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/553 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.18%
1/557 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour rupture
|
0.00%
0/553 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.18%
1/557 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Nervous system disorders
Dizziness
|
0.18%
1/553 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/557 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/553 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.18%
1/557 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/553 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.18%
1/557 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/553 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.18%
1/557 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.18%
1/553 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/557 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
Other adverse events
| Measure |
Co-administration Group
n=553 participants at risk
Participants received both RSVPreF3 OA vaccine and PCV20 on Day 1.
|
Control Group
n=557 participants at risk
Participants received PCV20 vaccine on Day 1 and RSVPreF3 OA vaccine on Day 31.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/553 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.18%
1/557 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/553 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.18%
1/557 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Cardiac disorders
Atrial fibrillation
|
0.18%
1/553 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/557 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Cardiac disorders
Cardiovascular disorder
|
0.00%
0/553 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.18%
1/557 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Cardiac disorders
Tachycardia
|
0.18%
1/553 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/557 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Ear and labyrinth disorders
Ear congestion
|
0.00%
0/553 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.18%
1/557 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Endocrine disorders
Graves' disease
|
0.00%
0/553 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.18%
1/557 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Endocrine disorders
Hyperthyroidism
|
0.18%
1/553 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/557 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/553 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.18%
1/557 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Eye disorders
Orbital haematoma
|
0.18%
1/553 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/557 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Eye disorders
Swelling of eyelid
|
0.00%
0/553 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.18%
1/557 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.18%
1/553 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.54%
3/557 • Number of events 3 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/553 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.18%
1/557 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Gastrointestinal disorders
Gastritis
|
0.18%
1/553 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.18%
1/557 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/553 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.18%
1/557 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Gastrointestinal disorders
Nausea
|
0.18%
1/553 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/557 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Gastrointestinal disorders
Periodontal inflammation
|
0.00%
0/553 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.18%
1/557 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/553 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.18%
1/557 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/553 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.18%
1/557 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
General disorders
Asthenia
|
0.18%
1/553 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/557 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
General disorders
Axillary pain
|
0.00%
0/553 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.18%
1/557 • Number of events 2 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
General disorders
Chills
|
0.36%
2/553 • Number of events 3 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.18%
1/557 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
General disorders
Fatigue
|
35.8%
198/553 • Number of events 245 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
39.0%
217/557 • Number of events 262 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
General disorders
Influenza like illness
|
0.18%
1/553 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.18%
1/557 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
General disorders
Injection site erythema
|
11.6%
64/553 • Number of events 85 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
8.6%
48/557 • Number of events 61 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
General disorders
Injection site pain
|
60.9%
337/553 • Number of events 404 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
56.0%
312/557 • Number of events 365 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
General disorders
Injection site pruritus
|
1.1%
6/553 • Number of events 6 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.36%
2/557 • Number of events 2 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
General disorders
Injection site swelling
|
6.9%
38/553 • Number of events 49 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
6.8%
38/557 • Number of events 46 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
General disorders
Malaise
|
0.00%
0/553 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.18%
1/557 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
General disorders
Pyrexia
|
3.3%
18/553 • Number of events 20 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
2.3%
13/557 • Number of events 14 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
General disorders
Swelling
|
0.00%
0/553 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.18%
1/557 • Number of events 2 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.18%
1/553 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/557 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/553 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.18%
1/557 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Arthritis infective
|
0.00%
0/553 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.18%
1/557 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Bronchitis
|
0.36%
2/553 • Number of events 2 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.54%
3/557 • Number of events 3 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/553 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.18%
1/557 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Coronavirus infection
|
0.00%
0/553 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.18%
1/557 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
COVID-19
|
0.18%
1/553 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
2.0%
11/557 • Number of events 11 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/553 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.72%
4/557 • Number of events 4 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Infective tenosynovitis
|
0.18%
1/553 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/557 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Influenza
|
0.18%
1/553 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.18%
1/557 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Nasopharyngitis
|
0.90%
5/553 • Number of events 5 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.72%
4/557 • Number of events 4 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Oral herpes
|
0.18%
1/553 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.72%
4/557 • Number of events 4 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/553 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.18%
1/557 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Pharyngitis
|
0.18%
1/553 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/557 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.18%
1/553 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/557 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/553 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.18%
1/557 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Sinusitis
|
0.72%
4/553 • Number of events 4 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/557 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/553 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.18%
1/557 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.18%
1/553 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
1.3%
7/557 • Number of events 7 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/553 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.90%
5/557 • Number of events 5 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Varicella zoster virus infection
|
0.18%
1/553 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/557 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Wound infection
|
0.18%
1/553 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/557 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/553 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.36%
2/557 • Number of events 2 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/553 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.54%
3/557 • Number of events 3 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/553 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.18%
1/557 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/553 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.18%
1/557 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/553 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.36%
2/557 • Number of events 2 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/553 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.36%
2/557 • Number of events 2 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/553 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.18%
1/557 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.18%
1/553 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.18%
1/557 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.18%
1/553 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/557 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.18%
1/553 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/557 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.18%
1/553 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/557 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/553 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.18%
1/557 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/553 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.18%
1/557 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/553 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.18%
1/557 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.00%
0/553 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.18%
1/557 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.18%
1/553 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/557 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Injury, poisoning and procedural complications
Tooth dislocation
|
0.18%
1/553 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/557 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Injury, poisoning and procedural complications
Wound
|
0.18%
1/553 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/557 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Investigations
Fibrin D dimer increased
|
0.18%
1/553 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/557 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Investigations
SARS-CoV-2 test positive
|
0.18%
1/553 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/557 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.18%
1/553 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/557 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/553 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.36%
2/557 • Number of events 2 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/553 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.18%
1/557 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.18%
1/553 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.18%
1/557 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.5%
80/553 • Number of events 100 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
16.9%
94/557 • Number of events 115 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.36%
2/553 • Number of events 2 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.72%
4/557 • Number of events 4 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/553 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.18%
1/557 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.18%
1/553 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/557 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
31.8%
176/553 • Number of events 205 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
28.2%
157/557 • Number of events 185 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/553 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.36%
2/557 • Number of events 2 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.18%
1/553 • Number of events 2 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/557 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.18%
1/553 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/557 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/553 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.18%
1/557 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.18%
1/553 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/557 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/553 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.54%
3/557 • Number of events 3 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Nervous system disorders
Dysgeusia
|
0.36%
2/553 • Number of events 2 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/557 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Nervous system disorders
Headache
|
26.0%
144/553 • Number of events 168 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
25.5%
142/557 • Number of events 175 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Nervous system disorders
Paraesthesia
|
0.18%
1/553 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/557 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Nervous system disorders
Sinus headache
|
0.18%
1/553 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/557 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Nervous system disorders
Syncope
|
0.00%
0/553 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.18%
1/557 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Psychiatric disorders
Depression
|
0.18%
1/553 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/557 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Psychiatric disorders
Insomnia
|
0.54%
3/553 • Number of events 3 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/557 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Renal and urinary disorders
Hypertonic bladder
|
0.00%
0/553 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.18%
1/557 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/553 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.36%
2/557 • Number of events 2 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/553 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.18%
1/557 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/553 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.18%
1/557 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/553 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.18%
1/557 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/553 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.18%
1/557 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.36%
2/553 • Number of events 2 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/557 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.18%
1/553 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/557 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/553 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.72%
4/557 • Number of events 4 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.36%
2/553 • Number of events 2 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.18%
1/557 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/553 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.18%
1/557 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.18%
1/553 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/557 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.18%
1/553 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.54%
3/557 • Number of events 3 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/553 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.18%
1/557 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.36%
2/553 • Number of events 2 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.36%
2/557 • Number of events 2 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.18%
1/553 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/557 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Vascular disorders
Hypertension
|
0.36%
2/553 • Number of events 2 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
0.18%
1/557 • Number of events 1 • Solicited AEs were collected up to Day 7 post each vaccination. Unsolicited AEs were collected up to Day 30 post each vaccination. SAEs and pIMDs were collected throughout the study period from Day 1 up to 6 months post last vaccination.
Solicited and unsolicited events were reported per participant for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the full clinical trial.
- Publication restrictions are in place
Restriction type: OTHER