Trial Outcomes & Findings for Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Toddlers (NCT NCT03205358)
NCT ID: NCT03205358
Last Updated: 2022-04-04
Results Overview
A solicited reaction was defined as an adverse reaction (AR) observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the case report form (CRF) and considered as related to vaccination. Solicited injection site reactions: Tenderness, Erythema, and Swelling. Solicited systemic reactions: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3 solicited injection site reactions: Tenderness: cries when injected limb was moved or the movement of the injected limb was reduced; Erythema and Swelling: greater than or equal to (≥) 50 millimeter (mm). Grade 3 solicited systemic reactions: Fever: greater than \[\>\] 39.5 degree Celsius (°C); Vomiting: ≥6 episodes per 24 hours or requiring parenteral hydration; crying abnormal: \>3 hours; Drowsiness: sleeping most of the time or difficult to wake up; Appetite lost: refuses ≥3 feeds or refuses most feeds; Irritability: inconsolable.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
188 participants
Primary outcome timeframe
Day 0 up to Day 7 post-vaccination
Results posted on
2022-04-04
Participant Flow
Study participants were enrolled from 31 March 2015 to 17 July 2015 at 8 clinic centers in Finland.
A total of 188 participants who met all inclusion and none of the exclusion criteria were randomized and vaccinated in the study.
Participant milestones
| Measure |
Group 1: MenACYW Conjugate Vaccine
Healthy, meningococcal-vaccine naive toddlers aged 12 to 23 months received a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid (MenACYW) Conjugate vaccine.
|
Group 2: NIMENRIX®
Healthy, meningococcal-vaccine naive toddlers aged 12 to 23 months received a single dose of NIMENRIX® vaccine.
|
|---|---|---|
|
Overall Study
STARTED
|
94
|
94
|
|
Overall Study
COMPLETED
|
94
|
94
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Toddlers
Baseline characteristics by cohort
| Measure |
Group 1: MenACYW Conjugate Vaccine
n=94 Participants
Healthy, meningococcal-vaccine naive toddlers aged 12 to 23 months received a single dose of MenACYW Conjugate vaccine.
|
Group 2: NIMENRIX®
n=94 Participants
Healthy, meningococcal-vaccine naive toddlers aged 12 to 23 months received a single dose of NIMENRIX® vaccine.
|
Total
n=188 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
1.44 years
STANDARD_DEVIATION 0.302 • n=5 Participants
|
1.47 years
STANDARD_DEVIATION 0.314 • n=7 Participants
|
1.45 years
STANDARD_DEVIATION 0.308 • n=5 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
57 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0 up to Day 7 post-vaccinationPopulation: Analysis was performed on safety analysis set.
A solicited reaction was defined as an adverse reaction (AR) observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the case report form (CRF) and considered as related to vaccination. Solicited injection site reactions: Tenderness, Erythema, and Swelling. Solicited systemic reactions: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3 solicited injection site reactions: Tenderness: cries when injected limb was moved or the movement of the injected limb was reduced; Erythema and Swelling: greater than or equal to (≥) 50 millimeter (mm). Grade 3 solicited systemic reactions: Fever: greater than \[\>\] 39.5 degree Celsius (°C); Vomiting: ≥6 episodes per 24 hours or requiring parenteral hydration; crying abnormal: \>3 hours; Drowsiness: sleeping most of the time or difficult to wake up; Appetite lost: refuses ≥3 feeds or refuses most feeds; Irritability: inconsolable.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine
n=94 Participants
Healthy, meningococcal-vaccine naive toddlers aged 12 to 23 months received a single dose of MenACYW Conjugate vaccine.
|
Group 2: NIMENRIX®
n=94 Participants
Healthy, meningococcal-vaccine naive toddlers aged 12 to 23 months received a single dose of NIMENRIX® vaccine.
|
|---|---|---|
|
Number of Participants Reporting Solicited Injection-Site and Systemic Reaction Following Vaccination With Either MenACYW Conjugate Vaccine or NIMENRIX®
Any Fever
|
7 Participants
|
4 Participants
|
|
Number of Participants Reporting Solicited Injection-Site and Systemic Reaction Following Vaccination With Either MenACYW Conjugate Vaccine or NIMENRIX®
Grade 3 Fever
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection-Site and Systemic Reaction Following Vaccination With Either MenACYW Conjugate Vaccine or NIMENRIX®
Any Injection site tenderness
|
28 Participants
|
31 Participants
|
|
Number of Participants Reporting Solicited Injection-Site and Systemic Reaction Following Vaccination With Either MenACYW Conjugate Vaccine or NIMENRIX®
Grade 3 Injection site tenderness
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Solicited Injection-Site and Systemic Reaction Following Vaccination With Either MenACYW Conjugate Vaccine or NIMENRIX®
Any Injection site erythema
|
29 Participants
|
33 Participants
|
|
Number of Participants Reporting Solicited Injection-Site and Systemic Reaction Following Vaccination With Either MenACYW Conjugate Vaccine or NIMENRIX®
Grade 3 Injection site erythema
|
2 Participants
|
1 Participants
|
|
Number of Participants Reporting Solicited Injection-Site and Systemic Reaction Following Vaccination With Either MenACYW Conjugate Vaccine or NIMENRIX®
Any Injection site swelling
|
14 Participants
|
17 Participants
|
|
Number of Participants Reporting Solicited Injection-Site and Systemic Reaction Following Vaccination With Either MenACYW Conjugate Vaccine or NIMENRIX®
Grade 3 Injection site swelling
|
1 Participants
|
3 Participants
|
|
Number of Participants Reporting Solicited Injection-Site and Systemic Reaction Following Vaccination With Either MenACYW Conjugate Vaccine or NIMENRIX®
Any Vomiting
|
4 Participants
|
5 Participants
|
|
Number of Participants Reporting Solicited Injection-Site and Systemic Reaction Following Vaccination With Either MenACYW Conjugate Vaccine or NIMENRIX®
Grade 3 Vomiting
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection-Site and Systemic Reaction Following Vaccination With Either MenACYW Conjugate Vaccine or NIMENRIX®
Any Abnormal crying
|
31 Participants
|
37 Participants
|
|
Number of Participants Reporting Solicited Injection-Site and Systemic Reaction Following Vaccination With Either MenACYW Conjugate Vaccine or NIMENRIX®
Grade 3 Abnormal crying
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection-Site and Systemic Reaction Following Vaccination With Either MenACYW Conjugate Vaccine or NIMENRIX®
Any Drowsiness
|
32 Participants
|
26 Participants
|
|
Number of Participants Reporting Solicited Injection-Site and Systemic Reaction Following Vaccination With Either MenACYW Conjugate Vaccine or NIMENRIX®
Grade 3 Drowsiness
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection-Site and Systemic Reaction Following Vaccination With Either MenACYW Conjugate Vaccine or NIMENRIX®
Any Loss of appetite
|
22 Participants
|
34 Participants
|
|
Number of Participants Reporting Solicited Injection-Site and Systemic Reaction Following Vaccination With Either MenACYW Conjugate Vaccine or NIMENRIX®
Grade 3 Loss of appetite
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting Solicited Injection-Site and Systemic Reaction Following Vaccination With Either MenACYW Conjugate Vaccine or NIMENRIX®
Any Irritability
|
49 Participants
|
53 Participants
|
|
Number of Participants Reporting Solicited Injection-Site and Systemic Reaction Following Vaccination With Either MenACYW Conjugate Vaccine or NIMENRIX®
Grade 3 Irritability
|
0 Participants
|
2 Participants
|
Adverse Events
Group 1: MenACYW Conjugate Vaccine
Serious events: 1 serious events
Other events: 49 other events
Deaths: 0 deaths
Group 2: NIMENRIX®
Serious events: 0 serious events
Other events: 53 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1: MenACYW Conjugate Vaccine
n=94 participants at risk
Healthy, meningococcal-vaccine naive toddlers aged 12 to 23 months received a single dose of MenACYW Conjugate vaccine.
|
Group 2: NIMENRIX®
n=94 participants at risk
Healthy, meningococcal-vaccine naive toddlers aged 12 to 23 months received a single dose of NIMENRIX® vaccine.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Ligament injury
|
1.1%
1/94 • Number of events 1 • Unsolicited adverse events (AEs) data were collected from Day 0 up to Day 30 post-vaccination. The solicited reactions (SRs) were collected up to Day 7 after vaccination. Serious AEs were collected throughout the trial (up to 30 days after vaccination).
SR was an AR observed and reported under the conditions (symptom and onset) pre-listed in the case report form (CRF). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the CRF in terms of diagnosis and/or onset post-vaccination. Analysis was performed on safety analysis set population.
|
0.00%
0/94 • Unsolicited adverse events (AEs) data were collected from Day 0 up to Day 30 post-vaccination. The solicited reactions (SRs) were collected up to Day 7 after vaccination. Serious AEs were collected throughout the trial (up to 30 days after vaccination).
SR was an AR observed and reported under the conditions (symptom and onset) pre-listed in the case report form (CRF). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the CRF in terms of diagnosis and/or onset post-vaccination. Analysis was performed on safety analysis set population.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
1.1%
1/94 • Number of events 1 • Unsolicited adverse events (AEs) data were collected from Day 0 up to Day 30 post-vaccination. The solicited reactions (SRs) were collected up to Day 7 after vaccination. Serious AEs were collected throughout the trial (up to 30 days after vaccination).
SR was an AR observed and reported under the conditions (symptom and onset) pre-listed in the case report form (CRF). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the CRF in terms of diagnosis and/or onset post-vaccination. Analysis was performed on safety analysis set population.
|
0.00%
0/94 • Unsolicited adverse events (AEs) data were collected from Day 0 up to Day 30 post-vaccination. The solicited reactions (SRs) were collected up to Day 7 after vaccination. Serious AEs were collected throughout the trial (up to 30 days after vaccination).
SR was an AR observed and reported under the conditions (symptom and onset) pre-listed in the case report form (CRF). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the CRF in terms of diagnosis and/or onset post-vaccination. Analysis was performed on safety analysis set population.
|
Other adverse events
| Measure |
Group 1: MenACYW Conjugate Vaccine
n=94 participants at risk
Healthy, meningococcal-vaccine naive toddlers aged 12 to 23 months received a single dose of MenACYW Conjugate vaccine.
|
Group 2: NIMENRIX®
n=94 participants at risk
Healthy, meningococcal-vaccine naive toddlers aged 12 to 23 months received a single dose of NIMENRIX® vaccine.
|
|---|---|---|
|
Nervous system disorders
Drowsiness
|
34.0%
32/94 • Number of events 32 • Unsolicited adverse events (AEs) data were collected from Day 0 up to Day 30 post-vaccination. The solicited reactions (SRs) were collected up to Day 7 after vaccination. Serious AEs were collected throughout the trial (up to 30 days after vaccination).
SR was an AR observed and reported under the conditions (symptom and onset) pre-listed in the case report form (CRF). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the CRF in terms of diagnosis and/or onset post-vaccination. Analysis was performed on safety analysis set population.
|
27.7%
26/94 • Number of events 26 • Unsolicited adverse events (AEs) data were collected from Day 0 up to Day 30 post-vaccination. The solicited reactions (SRs) were collected up to Day 7 after vaccination. Serious AEs were collected throughout the trial (up to 30 days after vaccination).
SR was an AR observed and reported under the conditions (symptom and onset) pre-listed in the case report form (CRF). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the CRF in terms of diagnosis and/or onset post-vaccination. Analysis was performed on safety analysis set population.
|
|
General disorders
Pyrexia
|
2.1%
2/94 • Number of events 2 • Unsolicited adverse events (AEs) data were collected from Day 0 up to Day 30 post-vaccination. The solicited reactions (SRs) were collected up to Day 7 after vaccination. Serious AEs were collected throughout the trial (up to 30 days after vaccination).
SR was an AR observed and reported under the conditions (symptom and onset) pre-listed in the case report form (CRF). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the CRF in terms of diagnosis and/or onset post-vaccination. Analysis was performed on safety analysis set population.
|
6.4%
6/94 • Number of events 7 • Unsolicited adverse events (AEs) data were collected from Day 0 up to Day 30 post-vaccination. The solicited reactions (SRs) were collected up to Day 7 after vaccination. Serious AEs were collected throughout the trial (up to 30 days after vaccination).
SR was an AR observed and reported under the conditions (symptom and onset) pre-listed in the case report form (CRF). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the CRF in terms of diagnosis and/or onset post-vaccination. Analysis was performed on safety analysis set population.
|
|
General disorders
Injection site Tenderness
|
29.8%
28/94 • Number of events 28 • Unsolicited adverse events (AEs) data were collected from Day 0 up to Day 30 post-vaccination. The solicited reactions (SRs) were collected up to Day 7 after vaccination. Serious AEs were collected throughout the trial (up to 30 days after vaccination).
SR was an AR observed and reported under the conditions (symptom and onset) pre-listed in the case report form (CRF). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the CRF in terms of diagnosis and/or onset post-vaccination. Analysis was performed on safety analysis set population.
|
33.0%
31/94 • Number of events 31 • Unsolicited adverse events (AEs) data were collected from Day 0 up to Day 30 post-vaccination. The solicited reactions (SRs) were collected up to Day 7 after vaccination. Serious AEs were collected throughout the trial (up to 30 days after vaccination).
SR was an AR observed and reported under the conditions (symptom and onset) pre-listed in the case report form (CRF). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the CRF in terms of diagnosis and/or onset post-vaccination. Analysis was performed on safety analysis set population.
|
|
General disorders
Injection site Erythema
|
30.9%
29/94 • Number of events 29 • Unsolicited adverse events (AEs) data were collected from Day 0 up to Day 30 post-vaccination. The solicited reactions (SRs) were collected up to Day 7 after vaccination. Serious AEs were collected throughout the trial (up to 30 days after vaccination).
SR was an AR observed and reported under the conditions (symptom and onset) pre-listed in the case report form (CRF). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the CRF in terms of diagnosis and/or onset post-vaccination. Analysis was performed on safety analysis set population.
|
35.1%
33/94 • Number of events 33 • Unsolicited adverse events (AEs) data were collected from Day 0 up to Day 30 post-vaccination. The solicited reactions (SRs) were collected up to Day 7 after vaccination. Serious AEs were collected throughout the trial (up to 30 days after vaccination).
SR was an AR observed and reported under the conditions (symptom and onset) pre-listed in the case report form (CRF). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the CRF in terms of diagnosis and/or onset post-vaccination. Analysis was performed on safety analysis set population.
|
|
General disorders
Injection site Swelling
|
14.9%
14/94 • Number of events 14 • Unsolicited adverse events (AEs) data were collected from Day 0 up to Day 30 post-vaccination. The solicited reactions (SRs) were collected up to Day 7 after vaccination. Serious AEs were collected throughout the trial (up to 30 days after vaccination).
SR was an AR observed and reported under the conditions (symptom and onset) pre-listed in the case report form (CRF). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the CRF in terms of diagnosis and/or onset post-vaccination. Analysis was performed on safety analysis set population.
|
18.1%
17/94 • Number of events 17 • Unsolicited adverse events (AEs) data were collected from Day 0 up to Day 30 post-vaccination. The solicited reactions (SRs) were collected up to Day 7 after vaccination. Serious AEs were collected throughout the trial (up to 30 days after vaccination).
SR was an AR observed and reported under the conditions (symptom and onset) pre-listed in the case report form (CRF). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the CRF in terms of diagnosis and/or onset post-vaccination. Analysis was performed on safety analysis set population.
|
|
General disorders
Fever
|
7.4%
7/94 • Number of events 7 • Unsolicited adverse events (AEs) data were collected from Day 0 up to Day 30 post-vaccination. The solicited reactions (SRs) were collected up to Day 7 after vaccination. Serious AEs were collected throughout the trial (up to 30 days after vaccination).
SR was an AR observed and reported under the conditions (symptom and onset) pre-listed in the case report form (CRF). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the CRF in terms of diagnosis and/or onset post-vaccination. Analysis was performed on safety analysis set population.
|
4.3%
4/94 • Number of events 4 • Unsolicited adverse events (AEs) data were collected from Day 0 up to Day 30 post-vaccination. The solicited reactions (SRs) were collected up to Day 7 after vaccination. Serious AEs were collected throughout the trial (up to 30 days after vaccination).
SR was an AR observed and reported under the conditions (symptom and onset) pre-listed in the case report form (CRF). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the CRF in terms of diagnosis and/or onset post-vaccination. Analysis was performed on safety analysis set population.
|
|
Psychiatric disorders
Abnormal crying
|
33.0%
31/94 • Number of events 31 • Unsolicited adverse events (AEs) data were collected from Day 0 up to Day 30 post-vaccination. The solicited reactions (SRs) were collected up to Day 7 after vaccination. Serious AEs were collected throughout the trial (up to 30 days after vaccination).
SR was an AR observed and reported under the conditions (symptom and onset) pre-listed in the case report form (CRF). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the CRF in terms of diagnosis and/or onset post-vaccination. Analysis was performed on safety analysis set population.
|
39.4%
37/94 • Number of events 37 • Unsolicited adverse events (AEs) data were collected from Day 0 up to Day 30 post-vaccination. The solicited reactions (SRs) were collected up to Day 7 after vaccination. Serious AEs were collected throughout the trial (up to 30 days after vaccination).
SR was an AR observed and reported under the conditions (symptom and onset) pre-listed in the case report form (CRF). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the CRF in terms of diagnosis and/or onset post-vaccination. Analysis was performed on safety analysis set population.
|
|
Psychiatric disorders
Irritability
|
52.1%
49/94 • Number of events 49 • Unsolicited adverse events (AEs) data were collected from Day 0 up to Day 30 post-vaccination. The solicited reactions (SRs) were collected up to Day 7 after vaccination. Serious AEs were collected throughout the trial (up to 30 days after vaccination).
SR was an AR observed and reported under the conditions (symptom and onset) pre-listed in the case report form (CRF). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the CRF in terms of diagnosis and/or onset post-vaccination. Analysis was performed on safety analysis set population.
|
56.4%
53/94 • Number of events 53 • Unsolicited adverse events (AEs) data were collected from Day 0 up to Day 30 post-vaccination. The solicited reactions (SRs) were collected up to Day 7 after vaccination. Serious AEs were collected throughout the trial (up to 30 days after vaccination).
SR was an AR observed and reported under the conditions (symptom and onset) pre-listed in the case report form (CRF). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the CRF in terms of diagnosis and/or onset post-vaccination. Analysis was performed on safety analysis set population.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.5%
8/94 • Number of events 8 • Unsolicited adverse events (AEs) data were collected from Day 0 up to Day 30 post-vaccination. The solicited reactions (SRs) were collected up to Day 7 after vaccination. Serious AEs were collected throughout the trial (up to 30 days after vaccination).
SR was an AR observed and reported under the conditions (symptom and onset) pre-listed in the case report form (CRF). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the CRF in terms of diagnosis and/or onset post-vaccination. Analysis was performed on safety analysis set population.
|
4.3%
4/94 • Number of events 4 • Unsolicited adverse events (AEs) data were collected from Day 0 up to Day 30 post-vaccination. The solicited reactions (SRs) were collected up to Day 7 after vaccination. Serious AEs were collected throughout the trial (up to 30 days after vaccination).
SR was an AR observed and reported under the conditions (symptom and onset) pre-listed in the case report form (CRF). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the CRF in terms of diagnosis and/or onset post-vaccination. Analysis was performed on safety analysis set population.
|
|
Gastrointestinal disorders
Vomiting
|
4.3%
4/94 • Number of events 4 • Unsolicited adverse events (AEs) data were collected from Day 0 up to Day 30 post-vaccination. The solicited reactions (SRs) were collected up to Day 7 after vaccination. Serious AEs were collected throughout the trial (up to 30 days after vaccination).
SR was an AR observed and reported under the conditions (symptom and onset) pre-listed in the case report form (CRF). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the CRF in terms of diagnosis and/or onset post-vaccination. Analysis was performed on safety analysis set population.
|
5.3%
5/94 • Number of events 5 • Unsolicited adverse events (AEs) data were collected from Day 0 up to Day 30 post-vaccination. The solicited reactions (SRs) were collected up to Day 7 after vaccination. Serious AEs were collected throughout the trial (up to 30 days after vaccination).
SR was an AR observed and reported under the conditions (symptom and onset) pre-listed in the case report form (CRF). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the CRF in terms of diagnosis and/or onset post-vaccination. Analysis was performed on safety analysis set population.
|
|
Metabolism and nutrition disorders
Loss of appetite
|
23.4%
22/94 • Number of events 22 • Unsolicited adverse events (AEs) data were collected from Day 0 up to Day 30 post-vaccination. The solicited reactions (SRs) were collected up to Day 7 after vaccination. Serious AEs were collected throughout the trial (up to 30 days after vaccination).
SR was an AR observed and reported under the conditions (symptom and onset) pre-listed in the case report form (CRF). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the CRF in terms of diagnosis and/or onset post-vaccination. Analysis was performed on safety analysis set population.
|
36.2%
34/94 • Number of events 34 • Unsolicited adverse events (AEs) data were collected from Day 0 up to Day 30 post-vaccination. The solicited reactions (SRs) were collected up to Day 7 after vaccination. Serious AEs were collected throughout the trial (up to 30 days after vaccination).
SR was an AR observed and reported under the conditions (symptom and onset) pre-listed in the case report form (CRF). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the CRF in terms of diagnosis and/or onset post-vaccination. Analysis was performed on safety analysis set population.
|
|
Infections and infestations
Gastroenteritis
|
2.1%
2/94 • Number of events 2 • Unsolicited adverse events (AEs) data were collected from Day 0 up to Day 30 post-vaccination. The solicited reactions (SRs) were collected up to Day 7 after vaccination. Serious AEs were collected throughout the trial (up to 30 days after vaccination).
SR was an AR observed and reported under the conditions (symptom and onset) pre-listed in the case report form (CRF). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the CRF in terms of diagnosis and/or onset post-vaccination. Analysis was performed on safety analysis set population.
|
7.4%
7/94 • Number of events 7 • Unsolicited adverse events (AEs) data were collected from Day 0 up to Day 30 post-vaccination. The solicited reactions (SRs) were collected up to Day 7 after vaccination. Serious AEs were collected throughout the trial (up to 30 days after vaccination).
SR was an AR observed and reported under the conditions (symptom and onset) pre-listed in the case report form (CRF). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the CRF in terms of diagnosis and/or onset post-vaccination. Analysis was performed on safety analysis set population.
|
|
Infections and infestations
Nasopharyngitis
|
9.6%
9/94 • Number of events 9 • Unsolicited adverse events (AEs) data were collected from Day 0 up to Day 30 post-vaccination. The solicited reactions (SRs) were collected up to Day 7 after vaccination. Serious AEs were collected throughout the trial (up to 30 days after vaccination).
SR was an AR observed and reported under the conditions (symptom and onset) pre-listed in the case report form (CRF). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the CRF in terms of diagnosis and/or onset post-vaccination. Analysis was performed on safety analysis set population.
|
5.3%
5/94 • Number of events 5 • Unsolicited adverse events (AEs) data were collected from Day 0 up to Day 30 post-vaccination. The solicited reactions (SRs) were collected up to Day 7 after vaccination. Serious AEs were collected throughout the trial (up to 30 days after vaccination).
SR was an AR observed and reported under the conditions (symptom and onset) pre-listed in the case report form (CRF). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the CRF in terms of diagnosis and/or onset post-vaccination. Analysis was performed on safety analysis set population.
|
|
Infections and infestations
Otitis media
|
4.3%
4/94 • Number of events 4 • Unsolicited adverse events (AEs) data were collected from Day 0 up to Day 30 post-vaccination. The solicited reactions (SRs) were collected up to Day 7 after vaccination. Serious AEs were collected throughout the trial (up to 30 days after vaccination).
SR was an AR observed and reported under the conditions (symptom and onset) pre-listed in the case report form (CRF). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the CRF in terms of diagnosis and/or onset post-vaccination. Analysis was performed on safety analysis set population.
|
6.4%
6/94 • Number of events 6 • Unsolicited adverse events (AEs) data were collected from Day 0 up to Day 30 post-vaccination. The solicited reactions (SRs) were collected up to Day 7 after vaccination. Serious AEs were collected throughout the trial (up to 30 days after vaccination).
SR was an AR observed and reported under the conditions (symptom and onset) pre-listed in the case report form (CRF). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the CRF in terms of diagnosis and/or onset post-vaccination. Analysis was performed on safety analysis set population.
|
|
Infections and infestations
Respiratory tract infection
|
5.3%
5/94 • Number of events 7 • Unsolicited adverse events (AEs) data were collected from Day 0 up to Day 30 post-vaccination. The solicited reactions (SRs) were collected up to Day 7 after vaccination. Serious AEs were collected throughout the trial (up to 30 days after vaccination).
SR was an AR observed and reported under the conditions (symptom and onset) pre-listed in the case report form (CRF). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the CRF in terms of diagnosis and/or onset post-vaccination. Analysis was performed on safety analysis set population.
|
1.1%
1/94 • Number of events 1 • Unsolicited adverse events (AEs) data were collected from Day 0 up to Day 30 post-vaccination. The solicited reactions (SRs) were collected up to Day 7 after vaccination. Serious AEs were collected throughout the trial (up to 30 days after vaccination).
SR was an AR observed and reported under the conditions (symptom and onset) pre-listed in the case report form (CRF). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the CRF in terms of diagnosis and/or onset post-vaccination. Analysis was performed on safety analysis set population.
|
|
Infections and infestations
Rhinitis
|
7.4%
7/94 • Number of events 7 • Unsolicited adverse events (AEs) data were collected from Day 0 up to Day 30 post-vaccination. The solicited reactions (SRs) were collected up to Day 7 after vaccination. Serious AEs were collected throughout the trial (up to 30 days after vaccination).
SR was an AR observed and reported under the conditions (symptom and onset) pre-listed in the case report form (CRF). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the CRF in terms of diagnosis and/or onset post-vaccination. Analysis was performed on safety analysis set population.
|
5.3%
5/94 • Number of events 5 • Unsolicited adverse events (AEs) data were collected from Day 0 up to Day 30 post-vaccination. The solicited reactions (SRs) were collected up to Day 7 after vaccination. Serious AEs were collected throughout the trial (up to 30 days after vaccination).
SR was an AR observed and reported under the conditions (symptom and onset) pre-listed in the case report form (CRF). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the CRF in terms of diagnosis and/or onset post-vaccination. Analysis was performed on safety analysis set population.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.5%
8/94 • Number of events 8 • Unsolicited adverse events (AEs) data were collected from Day 0 up to Day 30 post-vaccination. The solicited reactions (SRs) were collected up to Day 7 after vaccination. Serious AEs were collected throughout the trial (up to 30 days after vaccination).
SR was an AR observed and reported under the conditions (symptom and onset) pre-listed in the case report form (CRF). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the CRF in terms of diagnosis and/or onset post-vaccination. Analysis was performed on safety analysis set population.
|
17.0%
16/94 • Number of events 16 • Unsolicited adverse events (AEs) data were collected from Day 0 up to Day 30 post-vaccination. The solicited reactions (SRs) were collected up to Day 7 after vaccination. Serious AEs were collected throughout the trial (up to 30 days after vaccination).
SR was an AR observed and reported under the conditions (symptom and onset) pre-listed in the case report form (CRF). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the CRF in terms of diagnosis and/or onset post-vaccination. Analysis was performed on safety analysis set population.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable participant matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
- Publication restrictions are in place
Restriction type: OTHER