Trial Outcomes & Findings for Study of Sanofi Pasteur and Lanzhou Institute's Meningococcal (Group A and C) Polysaccharide Vaccine in Children (NCT NCT01430611)
NCT ID: NCT01430611
Last Updated: 2014-05-08
Results Overview
Seroconversion status was defined as antibody titers against meningococcal serogroups A and C, 30 days after vaccine administration ≥ 4-fold increase from pre-vaccination level measured by 2,3,5 triphenyltetrazolium chloride (TTC) serum bactericidal assay using baby rabbit complement (SBA-BR).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
666 participants
Primary outcome timeframe
Day 30 post-vaccination
Results posted on
2014-05-08
Participant Flow
The study participants were enrolled from 23 August 2011 to 12 October 2011 at a single center in China.
A total of 665 of the 666 participants who met all of the inclusion and none of the exclusion criteria that were randomized were vaccinated in this study.
Participant milestones
| Measure |
Meningo A+C® (Group 1)
Children aged 2 to 6 years received a single dose of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine
|
Meng Ling Kang® (Group 2)
Children aged 2 to 6 years received a single dose of Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
|
|---|---|---|
|
Overall Study
STARTED
|
332
|
333
|
|
Overall Study
COMPLETED
|
315
|
318
|
|
Overall Study
NOT COMPLETED
|
17
|
15
|
Reasons for withdrawal
| Measure |
Meningo A+C® (Group 1)
Children aged 2 to 6 years received a single dose of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine
|
Meng Ling Kang® (Group 2)
Children aged 2 to 6 years received a single dose of Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
15
|
14
|
Baseline Characteristics
Study of Sanofi Pasteur and Lanzhou Institute's Meningococcal (Group A and C) Polysaccharide Vaccine in Children
Baseline characteristics by cohort
| Measure |
Meningo A+C® (Group 1)
n=332 Participants
Children aged 2 to 6 years received a single dose of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine
|
Meng Ling Kang® (Group 2)
n=333 Participants
Children aged 2 to 6 years received a single dose of Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
|
Total
n=665 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
332 Participants
n=99 Participants
|
333 Participants
n=107 Participants
|
665 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
3.2 Years
STANDARD_DEVIATION 1.1 • n=99 Participants
|
3.1 Years
STANDARD_DEVIATION 1.0 • n=107 Participants
|
3.2 Years
STANDARD_DEVIATION 1.1 • n=206 Participants
|
|
Sex: Female, Male
Female
|
144 Participants
n=99 Participants
|
133 Participants
n=107 Participants
|
277 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
188 Participants
n=99 Participants
|
200 Participants
n=107 Participants
|
388 Participants
n=206 Participants
|
|
Region of Enrollment
China
|
332 Participants
n=99 Participants
|
333 Participants
n=107 Participants
|
665 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 30 post-vaccinationPopulation: Seroconversion was assessed in the Per-protocol Analysis Set.
Seroconversion status was defined as antibody titers against meningococcal serogroups A and C, 30 days after vaccine administration ≥ 4-fold increase from pre-vaccination level measured by 2,3,5 triphenyltetrazolium chloride (TTC) serum bactericidal assay using baby rabbit complement (SBA-BR).
Outcome measures
| Measure |
Meningo A+C® (Group 1)
n=304 Participants
Children aged 2 to 6 years received a single dose of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine
|
Meng Ling Kang® (Group 2)
n=308 Participants
Children aged 2 to 6 years received a single dose of Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
|
|---|---|---|
|
Number of Participants With Seroconversion Following Vaccination With Either Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
Serogroup A (N = 304, 308)
|
295 Participants
|
301 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Seroconversion Following Vaccination With Either Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
Serogroup C (N = 304, 308)
|
288 Participants
|
292 Participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Day 0 (pre-vaccination) and Day 30 post-vaccinationPopulation: Immunogenicity was assessed in the Per Protocol Analysis Set.
Meningococcal Group A antibodies were measured by 2,3,5 triphenyltetrazolium chloride (TTC) serum bactericidal assay using baby rabbit complement (SBA-BR)..
Outcome measures
| Measure |
Meningo A+C® (Group 1)
n=304 Participants
Children aged 2 to 6 years received a single dose of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine
|
Meng Ling Kang® (Group 2)
n=308 Participants
Children aged 2 to 6 years received a single dose of Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
|
|---|---|---|
|
Percentage of Participants With Post-vaccination Titer ≥1:8 for Serogroup A Before and Following Vaccination of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
Serogroup A (pre-vaccination)
|
12.5 Percentage of participants
|
8.8 Percentage of participants
Interval 0.0 to 0.0
|
|
Percentage of Participants With Post-vaccination Titer ≥1:8 for Serogroup A Before and Following Vaccination of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
Serogroup A (post-vaccination)
|
98.0 Percentage of participants
|
99.0 Percentage of participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Day 0 (pre-vaccination) and Day 30 post-vaccinationPopulation: Immunogenicity was assessed in the Per Protocol Analysis Set.
Meningococcal Group C antibodies were measured by 2,3,5 triphenyltetrazolium chloride (TTC) serum bactericidal assay using baby rabbit complement (SBA-BR)..
Outcome measures
| Measure |
Meningo A+C® (Group 1)
n=304 Participants
Children aged 2 to 6 years received a single dose of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine
|
Meng Ling Kang® (Group 2)
n=308 Participants
Children aged 2 to 6 years received a single dose of Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
|
|---|---|---|
|
Percentage of Participants With Post-vaccination Titer ≥1:8 for Serogroup C Before and Following Vaccination of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
Serogroup C (pre-vaccination)
|
25.0 Percentage of participants
|
26.0 Percentage of participants
Interval 0.0 to 0.0
|
|
Percentage of Participants With Post-vaccination Titer ≥1:8 for Serogroup C Before and Following Vaccination of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
Serogroup C (post-vaccination)
|
97.0 Percentage of participants
|
96.8 Percentage of participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Day 0 (pre-vaccination) and Day 30 post-vaccinationPopulation: Geometric mean titers were assessed in the Full Analysis Set.
Meningococcal Group A and C antibodies were measured by 2,3,5 triphenyltetrazolium chloride (TTC) serum bactericidal assay using baby rabbit complement (SBA-BR).
Outcome measures
| Measure |
Meningo A+C® (Group 1)
n=332 Participants
Children aged 2 to 6 years received a single dose of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine
|
Meng Ling Kang® (Group 2)
n=333 Participants
Children aged 2 to 6 years received a single dose of Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
|
|---|---|---|
|
Geometric Mean Titers of Serogroup A and C Antibodies Following Vaccination With Either Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
Serogroup C (post-vaccination; N = 315, 318)
|
181 Titers
Interval 158.0 to 208.0
|
192 Titers
Interval 168.0 to 220.0
|
|
Geometric Mean Titers of Serogroup A and C Antibodies Following Vaccination With Either Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
Serogroup A (pre-vaccination; N = 332, 333)
|
1.75 Titers
Interval 1.52 to 2.0
|
1.45 Titers
Interval 1.29 to 1.63
|
|
Geometric Mean Titers of Serogroup A and C Antibodies Following Vaccination With Either Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
Serogroup A (post-vaccination; N = 315, 318)
|
207 Titers
Interval 182.0 to 236.0
|
223 Titers
Interval 201.0 to 248.0
|
|
Geometric Mean Titers of Serogroup A and C Antibodies Following Vaccination With Either Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
Serogroup C (pre-vaccination; N = 332, 333)
|
3.57 Titers
Interval 3.2 to 3.97
|
3.65 Titers
Interval 3.28 to 4.07
|
SECONDARY outcome
Timeframe: Day 0 (pre-vaccination) and Day 30 post-vaccinationPopulation: Geometric mean titers were assessed in the Per-protocol Analysis Set.
Meningococcal Group A antibodies were measured by 2,3,5 triphenyltetrazolium chloride (TTC) serum bactericidal assay using baby rabbit complement (SBA-BR).
Outcome measures
| Measure |
Meningo A+C® (Group 1)
n=304 Participants
Children aged 2 to 6 years received a single dose of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine
|
Meng Ling Kang® (Group 2)
n=308 Participants
Children aged 2 to 6 years received a single dose of Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
|
|---|---|---|
|
Geometric Mean Titers of Serogroup A Antibodies Following Vaccination With Either Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
Serogroup A (post-vaccination)
|
203 Titers
Interval 178.0 to 233.0
|
225 Titers
Interval 202.0 to 250.0
|
|
Geometric Mean Titers of Serogroup A Antibodies Following Vaccination With Either Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
Serogroup A (pre-vaccination)
|
1.71 Titers
Interval 1.49 to 1.97
|
1.44 Titers
Interval 1.27 to 1.63
|
SECONDARY outcome
Timeframe: Day 0 (pre-vaccination) and Day 30 post-vaccinationPopulation: Geometric mean titers were assessed in the Per-protocol Analysis Set.
Meningococcal Group C antibodies were measured by 2,3,5 triphenyltetrazolium chloride (TTC) serum bactericidal assay using baby rabbit complement (SBA-BR).
Outcome measures
| Measure |
Meningo A+C® (Group 1)
n=304 Participants
Children aged 2 to 6 years received a single dose of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine
|
Meng Ling Kang® (Group 2)
n=308 Participants
Children aged 2 to 6 years received a single dose of Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
|
|---|---|---|
|
Geometric Mean Titers of Serogroup C Antibodies Following Vaccination With Either Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
Serogroup C (pre-vaccination)
|
3.66 Titers
Interval 3.27 to 4.1
|
3.64 Titers
Interval 3.25 to 4.07
|
|
Geometric Mean Titers of Serogroup C Antibodies Following Vaccination With Either Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
Serogroup C (post-vaccination)
|
179 Titers
Interval 155.0 to 206.0
|
191 Titers
Interval 167.0 to 220.0
|
SECONDARY outcome
Timeframe: Day 0 up to Day 7 post-vaccinationPopulation: Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set (SafAS). A Group 2 subject received the wrong vaccine and was included in Full Analysis Set for Group 2 (where classification was per vaccine randomized to) and also Group 1 SafAS (where classification was according to vaccine actually received).
Solicited injection site: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3 injection site: Pain, Incapacitating, unable to perform usual activities; Erythema and Swelling, ≥30 mm. Grade 3 systemic reactions: Fever, temperature \>39˚C; Headache, Malaise, and Myalgia, Significant, preventing daily activity.
Outcome measures
| Measure |
Meningo A+C® (Group 1)
n=333 Participants
Children aged 2 to 6 years received a single dose of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine
|
Meng Ling Kang® (Group 2)
n=332 Participants
Children aged 2 to 6 years received a single dose of Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
|
|---|---|---|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Vaccination of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
Injection site Pain (N = 331, 331)
|
82 Participants
|
71 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Vaccination of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
Grade 3 Injection site Pain (N = 331, 331)
|
1 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Vaccination of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
Injection site Erythema (N = 331, 331)
|
44 Participants
|
32 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Vaccination of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
Grade 3 Injection site Erythema (N = 331, 331)
|
1 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Vaccination of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
Injection site Swelling (N = 331, 331)
|
20 Participants
|
17 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Vaccination of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
Grade 3 Injection site Swelling (N = 331, 331)
|
0 Participants
|
1 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Vaccination of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
Fever (N = 330, 330)
|
46 Participants
|
39 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Vaccination of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
Grade 3 Fever (N = 330, 330)
|
1 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Vaccination of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
Headache (N = 331, 331)
|
27 Participants
|
20 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Vaccination of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
Grade 3 Headache (N = 331, 331)
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Vaccination of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
Malaise (N = 331, 331)
|
32 Participants
|
33 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Vaccination of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
Grade 3 Malaise (N = 331, 331)
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Vaccination of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
Myalgia (N = 331, 331)
|
29 Participants
|
42 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Vaccination of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
Grade 3 Myalgia (N = 331, 331)
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
Adverse Events
Meningo A+C® (Group 1)
Serious events: 2 serious events
Other events: 82 other events
Deaths: 0 deaths
Meng Ling Kang® (Group 2)
Serious events: 1 serious events
Other events: 71 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Meningo A+C® (Group 1)
n=333 participants at risk
Children aged 2 to 6 years received a single dose of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine
|
Meng Ling Kang® (Group 2)
n=332 participants at risk
Children aged 2 to 6 years received a single dose of Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.30%
1/333 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
A Group 2 subject received the wrong vaccine and was included in Full Analysis Set for Group 2 (classification per vaccine randomized to) and also Group 1 Safety Analysis Set (SafAS, classification according to vaccine actually received). For the solicited injection site and systemic reactions, the total (N) is the number with available data.
|
0.00%
0/332 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
A Group 2 subject received the wrong vaccine and was included in Full Analysis Set for Group 2 (classification per vaccine randomized to) and also Group 1 Safety Analysis Set (SafAS, classification according to vaccine actually received). For the solicited injection site and systemic reactions, the total (N) is the number with available data.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/333 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
A Group 2 subject received the wrong vaccine and was included in Full Analysis Set for Group 2 (classification per vaccine randomized to) and also Group 1 Safety Analysis Set (SafAS, classification according to vaccine actually received). For the solicited injection site and systemic reactions, the total (N) is the number with available data.
|
0.30%
1/332 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
A Group 2 subject received the wrong vaccine and was included in Full Analysis Set for Group 2 (classification per vaccine randomized to) and also Group 1 Safety Analysis Set (SafAS, classification according to vaccine actually received). For the solicited injection site and systemic reactions, the total (N) is the number with available data.
|
|
Infections and infestations
Bronchopneumonia
|
0.30%
1/333 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
A Group 2 subject received the wrong vaccine and was included in Full Analysis Set for Group 2 (classification per vaccine randomized to) and also Group 1 Safety Analysis Set (SafAS, classification according to vaccine actually received). For the solicited injection site and systemic reactions, the total (N) is the number with available data.
|
0.00%
0/332 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
A Group 2 subject received the wrong vaccine and was included in Full Analysis Set for Group 2 (classification per vaccine randomized to) and also Group 1 Safety Analysis Set (SafAS, classification according to vaccine actually received). For the solicited injection site and systemic reactions, the total (N) is the number with available data.
|
Other adverse events
| Measure |
Meningo A+C® (Group 1)
n=333 participants at risk
Children aged 2 to 6 years received a single dose of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine
|
Meng Ling Kang® (Group 2)
n=332 participants at risk
Children aged 2 to 6 years received a single dose of Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
16.8%
56/333 • Number of events 60 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
A Group 2 subject received the wrong vaccine and was included in Full Analysis Set for Group 2 (classification per vaccine randomized to) and also Group 1 Safety Analysis Set (SafAS, classification according to vaccine actually received). For the solicited injection site and systemic reactions, the total (N) is the number with available data.
|
13.9%
46/332 • Number of events 48 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
A Group 2 subject received the wrong vaccine and was included in Full Analysis Set for Group 2 (classification per vaccine randomized to) and also Group 1 Safety Analysis Set (SafAS, classification according to vaccine actually received). For the solicited injection site and systemic reactions, the total (N) is the number with available data.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.1%
17/333 • Number of events 17 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
A Group 2 subject received the wrong vaccine and was included in Full Analysis Set for Group 2 (classification per vaccine randomized to) and also Group 1 Safety Analysis Set (SafAS, classification according to vaccine actually received). For the solicited injection site and systemic reactions, the total (N) is the number with available data.
|
8.7%
29/332 • Number of events 32 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
A Group 2 subject received the wrong vaccine and was included in Full Analysis Set for Group 2 (classification per vaccine randomized to) and also Group 1 Safety Analysis Set (SafAS, classification according to vaccine actually received). For the solicited injection site and systemic reactions, the total (N) is the number with available data.
|
|
General disorders
Injection site Pain
|
24.8%
82/331 • Number of events 82 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
A Group 2 subject received the wrong vaccine and was included in Full Analysis Set for Group 2 (classification per vaccine randomized to) and also Group 1 Safety Analysis Set (SafAS, classification according to vaccine actually received). For the solicited injection site and systemic reactions, the total (N) is the number with available data.
|
21.5%
71/331 • Number of events 71 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
A Group 2 subject received the wrong vaccine and was included in Full Analysis Set for Group 2 (classification per vaccine randomized to) and also Group 1 Safety Analysis Set (SafAS, classification according to vaccine actually received). For the solicited injection site and systemic reactions, the total (N) is the number with available data.
|
|
General disorders
Injection site Erythema
|
13.3%
44/331 • Number of events 44 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
A Group 2 subject received the wrong vaccine and was included in Full Analysis Set for Group 2 (classification per vaccine randomized to) and also Group 1 Safety Analysis Set (SafAS, classification according to vaccine actually received). For the solicited injection site and systemic reactions, the total (N) is the number with available data.
|
9.7%
32/331 • Number of events 32 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
A Group 2 subject received the wrong vaccine and was included in Full Analysis Set for Group 2 (classification per vaccine randomized to) and also Group 1 Safety Analysis Set (SafAS, classification according to vaccine actually received). For the solicited injection site and systemic reactions, the total (N) is the number with available data.
|
|
General disorders
Injection site Swelling
|
6.0%
20/331 • Number of events 20 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
A Group 2 subject received the wrong vaccine and was included in Full Analysis Set for Group 2 (classification per vaccine randomized to) and also Group 1 Safety Analysis Set (SafAS, classification according to vaccine actually received). For the solicited injection site and systemic reactions, the total (N) is the number with available data.
|
5.1%
17/331 • Number of events 17 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
A Group 2 subject received the wrong vaccine and was included in Full Analysis Set for Group 2 (classification per vaccine randomized to) and also Group 1 Safety Analysis Set (SafAS, classification according to vaccine actually received). For the solicited injection site and systemic reactions, the total (N) is the number with available data.
|
|
General disorders
Fever
|
13.9%
46/330 • Number of events 46 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
A Group 2 subject received the wrong vaccine and was included in Full Analysis Set for Group 2 (classification per vaccine randomized to) and also Group 1 Safety Analysis Set (SafAS, classification according to vaccine actually received). For the solicited injection site and systemic reactions, the total (N) is the number with available data.
|
11.8%
39/330 • Number of events 39 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
A Group 2 subject received the wrong vaccine and was included in Full Analysis Set for Group 2 (classification per vaccine randomized to) and also Group 1 Safety Analysis Set (SafAS, classification according to vaccine actually received). For the solicited injection site and systemic reactions, the total (N) is the number with available data.
|
|
Nervous system disorders
Headache
|
8.2%
27/331 • Number of events 27 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
A Group 2 subject received the wrong vaccine and was included in Full Analysis Set for Group 2 (classification per vaccine randomized to) and also Group 1 Safety Analysis Set (SafAS, classification according to vaccine actually received). For the solicited injection site and systemic reactions, the total (N) is the number with available data.
|
6.0%
20/331 • Number of events 20 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
A Group 2 subject received the wrong vaccine and was included in Full Analysis Set for Group 2 (classification per vaccine randomized to) and also Group 1 Safety Analysis Set (SafAS, classification according to vaccine actually received). For the solicited injection site and systemic reactions, the total (N) is the number with available data.
|
|
General disorders
Malaise
|
9.7%
32/331 • Number of events 32 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
A Group 2 subject received the wrong vaccine and was included in Full Analysis Set for Group 2 (classification per vaccine randomized to) and also Group 1 Safety Analysis Set (SafAS, classification according to vaccine actually received). For the solicited injection site and systemic reactions, the total (N) is the number with available data.
|
10.0%
33/331 • Number of events 33 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
A Group 2 subject received the wrong vaccine and was included in Full Analysis Set for Group 2 (classification per vaccine randomized to) and also Group 1 Safety Analysis Set (SafAS, classification according to vaccine actually received). For the solicited injection site and systemic reactions, the total (N) is the number with available data.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.8%
29/331 • Number of events 29 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
A Group 2 subject received the wrong vaccine and was included in Full Analysis Set for Group 2 (classification per vaccine randomized to) and also Group 1 Safety Analysis Set (SafAS, classification according to vaccine actually received). For the solicited injection site and systemic reactions, the total (N) is the number with available data.
|
12.7%
42/331 • Number of events 42 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
A Group 2 subject received the wrong vaccine and was included in Full Analysis Set for Group 2 (classification per vaccine randomized to) and also Group 1 Safety Analysis Set (SafAS, classification according to vaccine actually received). For the solicited injection site and systemic reactions, the total (N) is the number with available data.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
- Publication restrictions are in place
Restriction type: OTHER