Trial Outcomes & Findings for Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Adolescents (NCT NCT02199691)
NCT ID: NCT02199691
Last Updated: 2022-04-04
Results Overview
Antibody titers against meningococcal serogroups A, C, Y, and W measured by hSBA. The hSBA vaccine seroresponse for serogroups A, C, Y, and W was defined as post-vaccination hSBA titers greater than or equal to (\>=) 1:8 for participants with pre-vaccination hSBA titers less than (\<) 1:8 or at least a 4-fold increase in hSBA titers from pre- to post vaccination for participants with pre-vaccination hSBA titers \>= 1:8. Data for this outcome measure was not planned to be collected and analyzed for Group 4:Tdap+HPV.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
1715 participants
Primary outcome timeframe
Day 30 (post-vaccination)
Results posted on
2022-04-04
Participant Flow
Study participants were enrolled in 40 centers in the Unites States (US) from 22 July 2014 to 25 February 2015.
A total of 1715 participants were enrolled and randomized in the study.
Participant milestones
| Measure |
Group 1: MenACYW Conjugate Vaccine
Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine on Day 0.
|
Group 2: MENVEO® Vaccine
Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of MENVEO® vaccine on Day 0.
|
Group 3: MenACYW Conjugate Vaccine+Tdap+HPV
Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of MenACYW Conjugate vaccine, Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap), and Dose 1 of Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant (HPV) on Day 0. HPV Vaccine Dose 2 and Dose 3 were given at 2 and 6 months, respectively, after Dose 1 given on Day 0.
|
Group 4: Tdap+HPV
Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of Tdap and Dose 1 of HPV on Day 0. HPV Vaccine Dose 2 and Dose 3 were given at 2 and 6 months, respectively, after Dose 1 given on Day 0.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
505
|
507
|
403
|
300
|
|
Overall Study
Safety Analysis Set (SafAS)
|
503
|
501
|
392
|
296
|
|
Overall Study
COMPLETED
|
495
|
500
|
376
|
270
|
|
Overall Study
NOT COMPLETED
|
10
|
7
|
27
|
30
|
Reasons for withdrawal
| Measure |
Group 1: MenACYW Conjugate Vaccine
Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine on Day 0.
|
Group 2: MENVEO® Vaccine
Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of MENVEO® vaccine on Day 0.
|
Group 3: MenACYW Conjugate Vaccine+Tdap+HPV
Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of MenACYW Conjugate vaccine, Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap), and Dose 1 of Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant (HPV) on Day 0. HPV Vaccine Dose 2 and Dose 3 were given at 2 and 6 months, respectively, after Dose 1 given on Day 0.
|
Group 4: Tdap+HPV
Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of Tdap and Dose 1 of HPV on Day 0. HPV Vaccine Dose 2 and Dose 3 were given at 2 and 6 months, respectively, after Dose 1 given on Day 0.
|
|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
3
|
3
|
6
|
7
|
|
Overall Study
Withdrawal by Subject
|
5
|
3
|
12
|
13
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
9
|
10
|
Baseline Characteristics
Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Adolescents
Baseline characteristics by cohort
| Measure |
Group 1: MenACYW Conjugate Vaccine
n=505 Participants
Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of MenACYW Conjugate vaccine on Day 0.
|
Group 2: MENVEO® Vaccine
n=507 Participants
Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of MENVEO® vaccine on Day 0.
|
Group 3: MenACYW Conjugate Vaccine+Tdap+HPV
n=403 Participants
Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of MenACYW Conjugate vaccine, Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap), and Dose 1 of HPV Vaccine on Day 0. HPV Vaccine Dose 2 and Dose 3 were given at 2 and 6 months, respectively, after Dose 1 given on Day 0.
|
Group 4: Tdap+HPV
n=300 Participants
Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of Tdap and Dose 1 of HPV Vaccine on Day 0. HPV Vaccine Dose 2 and Dose 3 were given at 2 and 6 months, respectively, after Dose 1 given on Day 0.
|
Total
n=1715 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
11.4 years
STANDARD_DEVIATION 1.39 • n=5 Participants
|
11.4 years
STANDARD_DEVIATION 1.39 • n=7 Participants
|
11.3 years
STANDARD_DEVIATION 1.06 • n=5 Participants
|
11.4 years
STANDARD_DEVIATION 1.41 • n=4 Participants
|
11.4 years
STANDARD_DEVIATION 1.32 • n=21 Participants
|
|
Sex: Female, Male
Female
|
259 Participants
n=5 Participants
|
232 Participants
n=7 Participants
|
197 Participants
n=5 Participants
|
144 Participants
n=4 Participants
|
832 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
246 Participants
n=5 Participants
|
275 Participants
n=7 Participants
|
206 Participants
n=5 Participants
|
156 Participants
n=4 Participants
|
883 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
30 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
85 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
442 Participants
n=5 Participants
|
456 Participants
n=7 Participants
|
361 Participants
n=5 Participants
|
261 Participants
n=4 Participants
|
1520 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
26 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
82 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
505 Participants
n=5 Participants
|
507 Participants
n=7 Participants
|
403 Participants
n=5 Participants
|
300 Participants
n=4 Participants
|
1715 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day 30 (post-vaccination)Population: Analysis was performed on Per-Protocol Analysis Set-1(PPAS-1) defined for accessing the ACYW \& Tdap immune response data for all participants after they had received vaccination(s) at Visit 1(Day 0) \& completed blood sampling (BL) at Visit 2(Day 30). Here 'Number analyzed' signifies number of participants with available data for specified category.
Antibody titers against meningococcal serogroups A, C, Y, and W measured by hSBA. The hSBA vaccine seroresponse for serogroups A, C, Y, and W was defined as post-vaccination hSBA titers greater than or equal to (\>=) 1:8 for participants with pre-vaccination hSBA titers less than (\<) 1:8 or at least a 4-fold increase in hSBA titers from pre- to post vaccination for participants with pre-vaccination hSBA titers \>= 1:8. Data for this outcome measure was not planned to be collected and analyzed for Group 4:Tdap+HPV.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine
n=463 Participants
Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of MenACYW Conjugate vaccine on Day 0.
|
Group 2: MENVEO® Vaccine
n=464 Participants
Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of MENVEO® vaccine on Day 0.
|
|---|---|---|
|
Percentage of Participants Achieving Vaccine Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine
Serogroup A
|
75.6 percentage of participants
Interval 71.4 to 79.4
|
66.4 percentage of participants
Interval 61.9 to 70.7
|
|
Percentage of Participants Achieving Vaccine Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine
Serogroup C
|
97.2 percentage of participants
Interval 95.2 to 98.5
|
72.6 percentage of participants
Interval 68.3 to 76.6
|
|
Percentage of Participants Achieving Vaccine Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine
Serogroup Y
|
97.0 percentage of participants
Interval 95.0 to 98.3
|
80.8 percentage of participants
Interval 76.9 to 84.3
|
|
Percentage of Participants Achieving Vaccine Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine
Serogroup W
|
86.2 percentage of participants
Interval 82.7 to 89.2
|
66.6 percentage of participants
Interval 62.1 to 70.9
|
SECONDARY outcome
Timeframe: Day 30 (post-vaccination on Day 0)Population: Analysis was performed on PPAS-1. Here 'Number analyzed' signifies number of participants with available data for specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 4: Tdap+HPV.
Antibody titers against meningococcal serogroups A, C, Y, and W measured by hSBA. The hSBA vaccine seroresponse for serogroups A, C, Y, and W was defined as post-vaccination hSBA titers \>= 1:8 for participants with pre-vaccination hSBA titers \< 1:8 or at least a 4-fold increase in hSBA titers from pre- to post vaccination for participants with pre-vaccination hSBA titers \>= 1:8.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine
n=463 Participants
Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of MenACYW Conjugate vaccine on Day 0.
|
Group 2: MENVEO® Vaccine
n=360 Participants
Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of MENVEO® vaccine on Day 0.
|
|---|---|---|
|
Percentage of Participants Achieving hSBA Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MenACYW Conjugate Vaccine Given With Tdap and HPV Vaccines
Serogroup A
|
75.6 percentage of participants
|
80.6 percentage of participants
|
|
Percentage of Participants Achieving hSBA Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MenACYW Conjugate Vaccine Given With Tdap and HPV Vaccines
Serogroup C
|
97.2 percentage of participants
|
97.2 percentage of participants
|
|
Percentage of Participants Achieving hSBA Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MenACYW Conjugate Vaccine Given With Tdap and HPV Vaccines
Serogroup Y
|
97.0 percentage of participants
|
95.6 percentage of participants
|
|
Percentage of Participants Achieving hSBA Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MenACYW Conjugate Vaccine Given With Tdap and HPV Vaccines
Serogroup W
|
86.2 percentage of participants
|
83.9 percentage of participants
|
SECONDARY outcome
Timeframe: Day 30 (post-vaccination on Day 0)Population: Analysis was performed on PPAS-1. Here 'Number analyzed' signifies number of participants with available data for specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 1: MenACYW Conjugate vaccine and Group 2: MENVEO® vaccine.
Anti-Pertussis toxoid (PT), Filamentous hemagglutinin (FHA), Pertactin (PRN), and Fimbriae types 2 and 3 (FIM) antibodies were measured by enzyme-linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine
n=360 Participants
Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of MenACYW Conjugate vaccine on Day 0.
|
Group 2: MENVEO® Vaccine
n=263 Participants
Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of MENVEO® vaccine on Day 0.
|
|---|---|---|
|
Geometric Mean Concentrations (GMCs) of PT, FHA, PRN, and FIM Antibodies Following Vaccination With Either MenACYW Conjugate Vaccine Given With Tdap and HPV Vaccines or Tdap and HPV Vaccines
Anti-Pertussis toxoid (PT)
|
37.5 ELISA units (EU)/mL
Interval 33.8 to 41.7
|
44.4 ELISA units (EU)/mL
Interval 39.5 to 49.9
|
|
Geometric Mean Concentrations (GMCs) of PT, FHA, PRN, and FIM Antibodies Following Vaccination With Either MenACYW Conjugate Vaccine Given With Tdap and HPV Vaccines or Tdap and HPV Vaccines
Filamentous hemagglutinin (FHA)
|
180 ELISA units (EU)/mL
Interval 168.0 to 194.0
|
242 ELISA units (EU)/mL
Interval 218.0 to 268.0
|
|
Geometric Mean Concentrations (GMCs) of PT, FHA, PRN, and FIM Antibodies Following Vaccination With Either MenACYW Conjugate Vaccine Given With Tdap and HPV Vaccines or Tdap and HPV Vaccines
Pertactin (PRN)
|
200 ELISA units (EU)/mL
Interval 177.0 to 225.0
|
265 ELISA units (EU)/mL
Interval 231.0 to 304.0
|
|
Geometric Mean Concentrations (GMCs) of PT, FHA, PRN, and FIM Antibodies Following Vaccination With Either MenACYW Conjugate Vaccine Given With Tdap and HPV Vaccines or Tdap and HPV Vaccines
Fimbriae types 2 and 3 (FIM)
|
339 ELISA units (EU)/mL
Interval 285.0 to 403.0
|
499 ELISA units (EU)/mL
Interval 414.0 to 601.0
|
SECONDARY outcome
Timeframe: Day 30 (post-vaccination on Day 0)Population: Analysis was performed on PPAS-1. Here "Number analyzed' signifies number of participants with available data for specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 1: MenACYW Conjugate vaccine and Group 2: MENVEO® vaccine.
Anti-Diphtheria antibodies were measured by a toxin neutralization test. Anti-Tetanus antibodies were measured by ELISA.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine
n=360 Participants
Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of MenACYW Conjugate vaccine on Day 0.
|
Group 2: MENVEO® Vaccine
n=263 Participants
Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of MENVEO® vaccine on Day 0.
|
|---|---|---|
|
Percentage of Participants Achieving Anti-Tetanus and Anti-Diphtheria Concentrations >= 1.0 International Unit (IU)/mL Following Vaccination With Either MenACYW Conjugate Vaccine Given With Tdap and HPV Vaccines or Tdap and HPV Vaccines
Diphtheria
|
97.8 percentage of participants
Interval 95.7 to 99.0
|
98.9 percentage of participants
Interval 96.7 to 99.8
|
|
Percentage of Participants Achieving Anti-Tetanus and Anti-Diphtheria Concentrations >= 1.0 International Unit (IU)/mL Following Vaccination With Either MenACYW Conjugate Vaccine Given With Tdap and HPV Vaccines or Tdap and HPV Vaccines
Tetanus
|
99.7 percentage of participants
Interval 98.5 to 100.0
|
99.6 percentage of participants
Interval 97.9 to 100.0
|
SECONDARY outcome
Timeframe: Day 210 (post-vaccination on Day 0)Population: Per-Protocol Analysis Set-2(PPAS-2)defined for accessing HPV immune response data for participants in Group 3 \& 4 after they received third HPV vaccination at Visit 4(Day 180)\& completed blood sample at Visit 5(BL3 \[Day 210\]).Data for this outcome measure was not planned to be collected and analyzed for Groups 1 and 2.
Anti-HPV 6, 11, 16, and 18 antibodies were measured using a competitive Luminex immunoassay. Seroconversion was defined as changing serostatus from seronegative to seropositive. Cutoff values for HPV seropositivity were \>= 20 milli-Merck units per milliliter (mMU/mL) for types 6 and 16, \>= 16 mMU/mL for type 11, and \>= 24mMU/mL for type 18.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine
n=242 Participants
Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of MenACYW Conjugate vaccine on Day 0.
|
Group 2: MENVEO® Vaccine
n=164 Participants
Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of MENVEO® vaccine on Day 0.
|
|---|---|---|
|
Percentage of Participants Achieving Seroconversion for Anti-HPV6, HPV11, HPV16, and HPV18 Antibodies Following Vaccination With Either MenACYW Conjugate Vaccine Given With Tdap and HPV Vaccines or Tdap and HPV Vaccines
HPV Type 6
|
97.5 percentage of participants
Interval 94.7 to 99.1
|
95.7 percentage of participants
Interval 91.4 to 98.3
|
|
Percentage of Participants Achieving Seroconversion for Anti-HPV6, HPV11, HPV16, and HPV18 Antibodies Following Vaccination With Either MenACYW Conjugate Vaccine Given With Tdap and HPV Vaccines or Tdap and HPV Vaccines
HPV Type 11
|
99.6 percentage of participants
Interval 97.7 to 100.0
|
98.8 percentage of participants
Interval 95.7 to 99.9
|
|
Percentage of Participants Achieving Seroconversion for Anti-HPV6, HPV11, HPV16, and HPV18 Antibodies Following Vaccination With Either MenACYW Conjugate Vaccine Given With Tdap and HPV Vaccines or Tdap and HPV Vaccines
HPV Type 16
|
99.2 percentage of participants
Interval 97.0 to 99.9
|
98.8 percentage of participants
Interval 95.7 to 99.9
|
|
Percentage of Participants Achieving Seroconversion for Anti-HPV6, HPV11, HPV16, and HPV18 Antibodies Following Vaccination With Either MenACYW Conjugate Vaccine Given With Tdap and HPV Vaccines or Tdap and HPV Vaccines
HPV Type 18
|
99.2 percentage of participants
Interval 97.0 to 99.9
|
98.8 percentage of participants
Interval 95.7 to 99.9
|
SECONDARY outcome
Timeframe: Within 7 days after vaccines injections at Day 0Population: Analysis was performed on Safety Analysis Set (SafAS) defined as participants who received at least one dose of the study vaccine(s) and had any safety data available. All participants had their safety data analyzed according to vaccine(s) they actually received. Here, 'Number analyzed'=participants with available data for each specified category.
A Solicited Reaction (SR) was an Adverse Event (AE) that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). Solicited injection site reactions included: Pain, Erythema, and Swelling.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine
n=503 Participants
Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of MenACYW Conjugate vaccine on Day 0.
|
Group 2: MENVEO® Vaccine
n=501 Participants
Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of MENVEO® vaccine on Day 0.
|
|---|---|---|
|
Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Vaccination With MenACYW Conjugate Vaccine or MENVEO® Vaccine at Day 0: Group 1 and Group 2
Pain
|
224 Participants
|
209 Participants
|
|
Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Vaccination With MenACYW Conjugate Vaccine or MENVEO® Vaccine at Day 0: Group 1 and Group 2
Erythema
|
25 Participants
|
37 Participants
|
|
Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Vaccination With MenACYW Conjugate Vaccine or MENVEO® Vaccine at Day 0: Group 1 and Group 2
Swelling
|
27 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: Within 7 days after vaccines injections at Day 0Population: Analysis was performed on SafAS. Here "Overall number of participants analyzed" = participants evaluable for this outcome measure.
A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). Solicited injection site reactions included: Pain, Erythema, and Swelling.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine
n=388 Participants
Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of MenACYW Conjugate vaccine on Day 0.
|
Group 2: MENVEO® Vaccine
Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of MENVEO® vaccine on Day 0.
|
|---|---|---|
|
Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Vaccination With MenACYW Conjugate Vaccine Given With Tdap and HPV Vaccines at Day 0: Group 3
MenACYW site: Pain
|
183 Participants
|
—
|
|
Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Vaccination With MenACYW Conjugate Vaccine Given With Tdap and HPV Vaccines at Day 0: Group 3
MenACYW site: Erythema
|
15 Participants
|
—
|
|
Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Vaccination With MenACYW Conjugate Vaccine Given With Tdap and HPV Vaccines at Day 0: Group 3
MenACYW site: Swelling
|
17 Participants
|
—
|
|
Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Vaccination With MenACYW Conjugate Vaccine Given With Tdap and HPV Vaccines at Day 0: Group 3
Tdap site: Pain
|
286 Participants
|
—
|
|
Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Vaccination With MenACYW Conjugate Vaccine Given With Tdap and HPV Vaccines at Day 0: Group 3
Tdap site: Erythema
|
28 Participants
|
—
|
|
Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Vaccination With MenACYW Conjugate Vaccine Given With Tdap and HPV Vaccines at Day 0: Group 3
Tdap site: Swelling
|
24 Participants
|
—
|
|
Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Vaccination With MenACYW Conjugate Vaccine Given With Tdap and HPV Vaccines at Day 0: Group 3
HPV site: Pain
|
288 Participants
|
—
|
|
Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Vaccination With MenACYW Conjugate Vaccine Given With Tdap and HPV Vaccines at Day 0: Group 3
HPV site: Erythema
|
31 Participants
|
—
|
|
Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Vaccination With MenACYW Conjugate Vaccine Given With Tdap and HPV Vaccines at Day 0: Group 3
HPV site: Swelling
|
26 Participants
|
—
|
SECONDARY outcome
Timeframe: Within 7 days after vaccines injections at Day 0Population: Analysis was performed on SafAS. Here "Overall number of participants analyzed" = participants evaluable for this outcome measure.
A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). Solicited injection site reactions included: Pain, Erythema, and Swelling.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine
n=289 Participants
Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of MenACYW Conjugate vaccine on Day 0.
|
Group 2: MENVEO® Vaccine
Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of MENVEO® vaccine on Day 0.
|
|---|---|---|
|
Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Vaccination With Tdap and HPV Vaccines at Day 0: Group 4
HPV site: Pain
|
201 Participants
|
—
|
|
Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Vaccination With Tdap and HPV Vaccines at Day 0: Group 4
Tdap site: Pain
|
211 Participants
|
—
|
|
Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Vaccination With Tdap and HPV Vaccines at Day 0: Group 4
Tdap site: Erythema
|
14 Participants
|
—
|
|
Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Vaccination With Tdap and HPV Vaccines at Day 0: Group 4
Tdap site: Swelling
|
20 Participants
|
—
|
|
Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Vaccination With Tdap and HPV Vaccines at Day 0: Group 4
HPV site: Erythema
|
16 Participants
|
—
|
|
Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Vaccination With Tdap and HPV Vaccines at Day 0: Group 4
HPV site: Swelling
|
23 Participants
|
—
|
Adverse Events
Group 1: MenACYW Conjugate Vaccine
Serious events: 4 serious events
Other events: 331 other events
Deaths: 0 deaths
Group 2: MENVEO® Vaccine
Serious events: 4 serious events
Other events: 337 other events
Deaths: 0 deaths
Group 3: MenACYW Conjugate Vaccine+Tdap+HPV
Serious events: 4 serious events
Other events: 348 other events
Deaths: 0 deaths
Group 4: Tdap+HPV
Serious events: 4 serious events
Other events: 263 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1: MenACYW Conjugate Vaccine
n=503 participants at risk
Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of MenACYW Conjugate vaccine on Day 0.
|
Group 2: MENVEO® Vaccine
n=501 participants at risk
Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of MENVEO® vaccine on Day 0.
|
Group 3: MenACYW Conjugate Vaccine+Tdap+HPV
n=392 participants at risk
Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of MenACYW Conjugate vaccine, Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap), and Dose 1 of HPV Vaccine on Day 0. HPV Vaccine Dose 2 and Dose 3 were given at 2 and 6 months, respectively, after Dose 1 given on Day 0.
|
Group 4: Tdap+HPV
n=296 participants at risk
Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of Tdap and Dose 1 of HPV Vaccine on Day 0. HPV Vaccine Dose 2 and Dose 3 were given at 2 and 6 months, respectively, after Dose 1 given on Day 0.
|
|---|---|---|---|---|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/503 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/501 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.26%
1/392 • Number of events 1 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/296 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Faecaloma
|
0.20%
1/503 • Number of events 1 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/501 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/392 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/296 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
General disorders
Mucosal Inflammation
|
0.20%
1/503 • Number of events 1 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/501 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/392 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/296 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/503 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.20%
1/501 • Number of events 1 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/392 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.68%
2/296 • Number of events 2 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Staphylococcal Scalded Skin Syndrome
|
0.00%
0/503 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/501 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/392 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.34%
1/296 • Number of events 1 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Metabolism and nutrition disorders
Type 1 Diabetes Mellitus
|
0.20%
1/503 • Number of events 1 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/501 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/392 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/296 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Convulsion
|
0.20%
1/503 • Number of events 1 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/501 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.26%
1/392 • Number of events 1 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/296 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Psychiatric disorders
Abnormal Behaviour
|
0.00%
0/503 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.20%
1/501 • Number of events 1 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/392 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/296 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Psychiatric disorders
Major Depression
|
0.00%
0/503 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.20%
1/501 • Number of events 1 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/392 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/296 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Psychiatric disorders
Suicidal Ideation
|
0.00%
0/503 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/501 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.26%
1/392 • Number of events 1 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.34%
1/296 • Number of events 2 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/503 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/501 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.26%
1/392 • Number of events 1 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/296 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Skin and subcutaneous tissue disorders
Erythema Multiforme
|
0.00%
0/503 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.20%
1/501 • Number of events 1 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/392 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/296 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
Other adverse events
| Measure |
Group 1: MenACYW Conjugate Vaccine
n=503 participants at risk
Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of MenACYW Conjugate vaccine on Day 0.
|
Group 2: MENVEO® Vaccine
n=501 participants at risk
Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of MENVEO® vaccine on Day 0.
|
Group 3: MenACYW Conjugate Vaccine+Tdap+HPV
n=392 participants at risk
Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of MenACYW Conjugate vaccine, Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap), and Dose 1 of HPV Vaccine on Day 0. HPV Vaccine Dose 2 and Dose 3 were given at 2 and 6 months, respectively, after Dose 1 given on Day 0.
|
Group 4: Tdap+HPV
n=296 participants at risk
Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of Tdap and Dose 1 of HPV Vaccine on Day 0. HPV Vaccine Dose 2 and Dose 3 were given at 2 and 6 months, respectively, after Dose 1 given on Day 0.
|
|---|---|---|---|---|
|
General disorders
Injection Site Erythema
|
5.0%
25/503 • Number of events 25 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
7.4%
37/501 • Number of events 37 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
11.2%
44/392 • Number of events 74 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
8.1%
24/296 • Number of events 30 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
General disorders
Injection Site Pain
|
44.5%
224/503 • Number of events 224 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
41.7%
209/501 • Number of events 209 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
83.4%
327/392 • Number of events 759 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
79.1%
234/296 • Number of events 412 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
General disorders
Injection Site Swelling
|
5.4%
27/503 • Number of events 27 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
6.4%
32/501 • Number of events 32 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
10.7%
42/392 • Number of events 67 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
10.8%
32/296 • Number of events 43 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
General disorders
Malaise
|
25.8%
130/503 • Number of events 130 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
26.1%
131/501 • Number of events 131 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
28.8%
113/392 • Number of events 113 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
27.4%
81/296 • Number of events 81 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Pharyngitis
|
3.0%
15/503 • Number of events 15 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
6.4%
32/501 • Number of events 34 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
5.6%
22/392 • Number of events 22 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
4.7%
14/296 • Number of events 16 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
4.8%
24/503 • Number of events 27 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
6.0%
30/501 • Number of events 33 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
6.9%
27/392 • Number of events 31 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
4.1%
12/296 • Number of events 13 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
34.8%
175/503 • Number of events 175 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
34.5%
173/501 • Number of events 173 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
61.0%
239/392 • Number of events 239 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
54.4%
161/296 • Number of events 161 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Headache
|
30.8%
155/503 • Number of events 165 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
31.7%
159/501 • Number of events 168 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
34.9%
137/392 • Number of events 145 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
29.4%
87/296 • Number of events 89 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
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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