Trial Outcomes & Findings for Study to Evaluate the Safety and Immunogenicity of Combined Hepatitis A/B Vaccine With MenACWY-CRM Conjugate Vaccine (NCT NCT01453348)
NCT ID: NCT01453348
Last Updated: 2017-06-08
Results Overview
Assessment was made to demonstrate the non-inferiority of hepatitis A/B vaccine with MenACWY-CRM as compared to hepatitis A/B vaccine without MenACWY-CRM, as measured by geometric mean concentrations on day 57 in previously unvaccinated subjects or on day 29 after a booster dose in previously vaccinated subjects.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
252 participants
Primary outcome timeframe
Day 57 (previously unprimed subjects) day 29 (previously primed subjects) postvaccination.
Results posted on
2017-06-08
Participant Flow
Subjects were enrolled at four centers in Germany.
All enrolled subjects were included in the trial.
Participant milestones
| Measure |
HepA/B
Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine.
|
HepA/B+MenACWY-CRM
Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine; all the subjects concomitantly received one dose of MenACWY-CRM conjugate vaccine.
|
MenACWY-CRM
Subjects ≥ 18 to ≤ 64 years of age who received one dose of MenACWY-CRM conjugate vaccine.
|
|---|---|---|---|
|
Overall Study
STARTED
|
84
|
84
|
84
|
|
Overall Study
COMPLETED
|
83
|
83
|
83
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
1
|
Reasons for withdrawal
| Measure |
HepA/B
Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine.
|
HepA/B+MenACWY-CRM
Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine; all the subjects concomitantly received one dose of MenACWY-CRM conjugate vaccine.
|
MenACWY-CRM
Subjects ≥ 18 to ≤ 64 years of age who received one dose of MenACWY-CRM conjugate vaccine.
|
|---|---|---|---|
|
Overall Study
Death
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
Baseline Characteristics
Study to Evaluate the Safety and Immunogenicity of Combined Hepatitis A/B Vaccine With MenACWY-CRM Conjugate Vaccine
Baseline characteristics by cohort
| Measure |
HepA/B
n=84 Participants
Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine.
|
HepA/B+MenACWY-CRM
n=84 Participants
Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine; all the subjects concomitantly received one dose of MenACWY-CRM conjugate vaccine.
|
MenACWY-CRM
n=84 Participants
Subjects ≥ 18 to ≤ 64 years of age who received one dose of MenACWY-CRM conjugate vaccine.
|
Total
n=252 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
39.0 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
39.9 years
STANDARD_DEVIATION 12.6 • n=7 Participants
|
39.7 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
39.5 years
STANDARD_DEVIATION 11.9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
135 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
117 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 57 (previously unprimed subjects) day 29 (previously primed subjects) postvaccination.Population: Analysis was done on Per Protocol (PP) population who provided evaluable serum samples and whose assay results were available at the relevant time points, and had no major protocol deviations
Assessment was made to demonstrate the non-inferiority of hepatitis A/B vaccine with MenACWY-CRM as compared to hepatitis A/B vaccine without MenACWY-CRM, as measured by geometric mean concentrations on day 57 in previously unvaccinated subjects or on day 29 after a booster dose in previously vaccinated subjects.
Outcome measures
| Measure |
HepA/B+MenACWY-CRM
n=78 Participants
Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine ; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine; all the subjects concomitantly received one dose of MenACWY-CRM conjugate vaccine.
|
HepA/B
n=78 Participants
Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine.
|
MenACWY-CRM
Subjects ≥ 18 to ≤ 64 years of age who received one dose of MenACWY-CRM conjugate vaccine.
|
|---|---|---|---|
|
Geometric Mean antiHAV and antiHBV Concentrations (GMCs), 28 Days After Primary and Booster Vaccination
Prevaccination AntiHAV
|
48 Concentrations (mIU/mL)
Interval 27.0 to 85.0
|
30 Concentrations (mIU/mL)
Interval 17.0 to 54.0
|
—
|
|
Geometric Mean antiHAV and antiHBV Concentrations (GMCs), 28 Days After Primary and Booster Vaccination
28 days after primary or booster AntiHAV
|
786 Concentrations (mIU/mL)
Interval 591.0 to 1046.0
|
884 Concentrations (mIU/mL)
Interval 664.0 to 1176.0
|
—
|
|
Geometric Mean antiHAV and antiHBV Concentrations (GMCs), 28 Days After Primary and Booster Vaccination
Prevaccination AntiHBV (N=78, 76)
|
22 Concentrations (mIU/mL)
Interval 12.0 to 39.0
|
31 Concentrations (mIU/mL)
Interval 17.0 to 57.0
|
—
|
|
Geometric Mean antiHAV and antiHBV Concentrations (GMCs), 28 Days After Primary and Booster Vaccination
28 days after primary or booster AntiHBV (N=78,76)
|
844 Concentrations (mIU/mL)
Interval 513.0 to 1387.0
|
711 Concentrations (mIU/mL)
Interval 429.0 to 1179.0
|
—
|
SECONDARY outcome
Timeframe: 28 days post primary or booster vaccination.Population: Analysis was done on modified intention-to-treat (MITT) population- subjects who provided evaluable serum samples whose assay results are available for at least one antigen on visit day 1 and a post baseline visit.
Immunogenicity was assessed as the percentages of subjects with anti-HAV concentration ≥20 mIU/mL and anti- HBsAg antibody concentration ≥10 mIU/mL, 28 days after primary or booster vaccination.
Outcome measures
| Measure |
HepA/B+MenACWY-CRM
n=83 Participants
Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine ; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine; all the subjects concomitantly received one dose of MenACWY-CRM conjugate vaccine.
|
HepA/B
n=82 Participants
Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine.
|
MenACWY-CRM
Subjects ≥ 18 to ≤ 64 years of age who received one dose of MenACWY-CRM conjugate vaccine.
|
|---|---|---|---|
|
Percentages of Subjects With antiHAV and antiHBsAg Antibodies Concentrations Above Seroprotection Level 28 Days After Primary or Booster Vaccination
AntiHAV antibody concentration ≥20mIU/mL (Day 1)
|
42 percentage of subjects
Interval 31.0 to 54.0
|
33 percentage of subjects
Interval 23.0 to 44.0
|
—
|
|
Percentages of Subjects With antiHAV and antiHBsAg Antibodies Concentrations Above Seroprotection Level 28 Days After Primary or Booster Vaccination
28 days after primary/booster AntiHAV
|
96 percentage of subjects
Interval 90.0 to 99.0
|
99 percentage of subjects
Interval 93.0 to 100.0
|
—
|
|
Percentages of Subjects With antiHAV and antiHBsAg Antibodies Concentrations Above Seroprotection Level 28 Days After Primary or Booster Vaccination
AntiHBsAg antibody concentration ≥10mIU/mL (Day 1)
|
47 percentage of subjects
Interval 36.0 to 58.0
|
44 percentage of subjects
Interval 33.0 to 55.0
|
—
|
|
Percentages of Subjects With antiHAV and antiHBsAg Antibodies Concentrations Above Seroprotection Level 28 Days After Primary or Booster Vaccination
28 days after primary/booster AntiHBV
|
75 percentage of subjects
Interval 64.0 to 84.0
|
80 percentage of subjects
Interval 70.0 to 88.0
|
—
|
SECONDARY outcome
Timeframe: 28 days postvaccination (day 29).Population: Analysis was done on modified intention-to-treat (MITT) population- subjects who provided evaluable serum samples whose assay results are available for at least one antigen on visit day 1 and a post baseline visit.
Immunogenicity was assessed as the seroresponse rates for meningococcal serogroups A, C, W and Y elicited by MenACWY-CRM on day 29 when given concomitantly with combined hepatitis A/B vaccine or given alone. For a subject with a baseline hSBA titer \< 1:4, seroresponse is defined as a postvaccination hSBA titer ≥1:8; for a subject with a baseline hSBA titer ≥ 1:4, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.
Outcome measures
| Measure |
HepA/B+MenACWY-CRM
n=83 Participants
Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine ; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine; all the subjects concomitantly received one dose of MenACWY-CRM conjugate vaccine.
|
HepA/B
n=83 Participants
Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine.
|
MenACWY-CRM
Subjects ≥ 18 to ≤ 64 years of age who received one dose of MenACWY-CRM conjugate vaccine.
|
|---|---|---|---|
|
Percentages of Subjects With Seroresponse Against N Meningitidis A, C, W and Y Serogroups at Day 29
MenA-hSBA Overall Seroresponse (N=83, 82)
|
71 percentage of subjects
Interval 60.0 to 81.0
|
65 percentage of subjects
Interval 53.0 to 75.0
|
—
|
|
Percentages of Subjects With Seroresponse Against N Meningitidis A, C, W and Y Serogroups at Day 29
MenC-hSBA Overall Seroresponse
|
66 percentage of subjects
Interval 55.0 to 76.0
|
59 percentage of subjects
Interval 48.0 to 70.0
|
—
|
|
Percentages of Subjects With Seroresponse Against N Meningitidis A, C, W and Y Serogroups at Day 29
MenW-hSBA Overall Seroresponse (N=83, 82)
|
40 percentage of subjects
Interval 29.0 to 51.0
|
34 percentage of subjects
Interval 24.0 to 45.0
|
—
|
|
Percentages of Subjects With Seroresponse Against N Meningitidis A, C, W and Y Serogroups at Day 29
MenY-hSBA Overall Seroresponse
|
70 percentage of subjects
Interval 59.0 to 79.0
|
64 percentage of subjects
Interval 53.0 to 74.0
|
—
|
SECONDARY outcome
Timeframe: 28 days post vaccination (day 29).Population: Analysis was done on modified intention-to-treat (MITT) population- subjects who provided evaluable serum samples whose assay results are available for at least one antigen on visit day 1 and a post baseline visit.
Immunogenicity was assessed in terms of geometric mean titers (GMTs) of antibodies to meningococcal serogroups A, C, W and Y on day 29 when given concomitantly with combined hepatitis A/B vaccine or given alone.
Outcome measures
| Measure |
HepA/B+MenACWY-CRM
n=84 Participants
Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine ; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine; all the subjects concomitantly received one dose of MenACWY-CRM conjugate vaccine.
|
HepA/B
n=84 Participants
Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine.
|
MenACWY-CRM
Subjects ≥ 18 to ≤ 64 years of age who received one dose of MenACWY-CRM conjugate vaccine.
|
|---|---|---|---|
|
hSBA GMTs Assay Titers Against N Meningitidis A, C, W and Y Serogroups at Day 29
Men A Human Complement SBA; Day 1 (N= 84, 84)
|
2.68 Titers
Interval 2.27 to 3.17
|
2.71 Titers
Interval 2.29 to 3.2
|
—
|
|
hSBA GMTs Assay Titers Against N Meningitidis A, C, W and Y Serogroups at Day 29
Men A Human Complement SBA; Day 29 (N=83, 82)
|
43 Titers
Interval 27.0 to 67.0
|
36 Titers
Interval 23.0 to 58.0
|
—
|
|
hSBA GMTs Assay Titers Against N Meningitidis A, C, W and Y Serogroups at Day 29
Men C Human Complement SBA; Day 1 (N= 84, 84)
|
7.39 Titers
Interval 5.49 to 9.94
|
6.35 Titers
Interval 4.71 to 8.57
|
—
|
|
hSBA GMTs Assay Titers Against N Meningitidis A, C, W and Y Serogroups at Day 29
Men C Human Complement SBA; Day 29 (N=83, 83)
|
75 Titers
Interval 50.0 to 112.0
|
56 Titers
Interval 37.0 to 83.0
|
—
|
|
hSBA GMTs Assay Titers Against N Meningitidis A, C, W and Y Serogroups at Day 29
Men W Human Complement SBA; Day 1 (N=84, 83)
|
30 Titers
Interval 21.0 to 42.0
|
31 Titers
Interval 22.0 to 45.0
|
—
|
|
hSBA GMTs Assay Titers Against N Meningitidis A, C, W and Y Serogroups at Day 29
Men W Human Complement SBA; Day 29 (N=83, 83)
|
110 Titers
Interval 84.0 to 145.0
|
109 Titers
Interval 82.0 to 144.0
|
—
|
|
hSBA GMTs Assay Titers Against N Meningitidis A, C, W and Y Serogroups at Day 29
Men Y Human Complement SBA; Day 1 (N= 84, 84)
|
6.63 Titers
Interval 5.06 to 8.68
|
5.56 Titers
Interval 4.23 to 7.3
|
—
|
|
hSBA GMTs Assay Titers Against N Meningitidis A, C, W and Y Serogroups at Day 29
Men Y Human Complement SBA; Day 29 (N=83, 83)
|
78 Titers
Interval 55.0 to 111.0
|
62 Titers
Interval 44.0 to 89.0
|
—
|
SECONDARY outcome
Timeframe: Day 1 to day 57.Population: Analysis was done on safety set- subjects who provided any post-baseline safety data.
Safety was assessed in terms of percentage of all spontaneously reported AEs collected from the time the subject signed the informed consent form (day 1), until the subject stopped study participation (day 57).
Outcome measures
| Measure |
HepA/B+MenACWY-CRM
n=84 Participants
Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine ; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine; all the subjects concomitantly received one dose of MenACWY-CRM conjugate vaccine.
|
HepA/B
n=85 Participants
Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine.
|
MenACWY-CRM
n=83 Participants
Subjects ≥ 18 to ≤ 64 years of age who received one dose of MenACWY-CRM conjugate vaccine.
|
|---|---|---|---|
|
Percentages of Subjects With Unsolicited Adverse Events (AEs)
AE leading to withdrawal
|
0 percentage of subjects
|
1 percentage of subjects
|
1 percentage of subjects
|
|
Percentages of Subjects With Unsolicited Adverse Events (AEs)
Any AE
|
43 percentage of subjects
|
39 percentage of subjects
|
36 percentage of subjects
|
|
Percentages of Subjects With Unsolicited Adverse Events (AEs)
Atleast possibly related AE
|
23 percentage of subjects
|
27 percentage of subjects
|
17 percentage of subjects
|
|
Percentages of Subjects With Unsolicited Adverse Events (AEs)
Any SAE
|
1 percentage of subjects
|
0 percentage of subjects
|
1 percentage of subjects
|
|
Percentages of Subjects With Unsolicited Adverse Events (AEs)
Death
|
0 percentage of subjects
|
0 percentage of subjects
|
1 percentage of subjects
|
Adverse Events
HepA/B
Serious events: 1 serious events
Other events: 25 other events
Deaths: 0 deaths
HepA/B+ACWY
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
ACWY
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
HepA/B
n=84 participants at risk
Subject ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine.
|
HepA/B+ACWY
n=85 participants at risk
Subject ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine; all the subjects concomitantly received one dose of MenACWY-CRM conjugate vaccine.
|
ACWY
n=83 participants at risk
Subject ≥ 18 to ≤ 64 years of age who received one dose of MenACWY-CRM conjugate vaccine.
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RENAL CANCER
|
1.2%
1/84 • Day 1 to day 57.
Safety was assessed in terms of percentages of all Serious AEs collected from the time the subject signed the informed consent form until he/she stopped study participation.One subject randomized to receive MenACWY-CRM, received HepA/B+MenACWY-CRM vaccine, instead. The safety set included 85 subjects for HepA/B+MenACWY group and 83 for MenACWY.
|
0.00%
0/85 • Day 1 to day 57.
Safety was assessed in terms of percentages of all Serious AEs collected from the time the subject signed the informed consent form until he/she stopped study participation.One subject randomized to receive MenACWY-CRM, received HepA/B+MenACWY-CRM vaccine, instead. The safety set included 85 subjects for HepA/B+MenACWY group and 83 for MenACWY.
|
0.00%
0/83 • Day 1 to day 57.
Safety was assessed in terms of percentages of all Serious AEs collected from the time the subject signed the informed consent form until he/she stopped study participation.One subject randomized to receive MenACWY-CRM, received HepA/B+MenACWY-CRM vaccine, instead. The safety set included 85 subjects for HepA/B+MenACWY group and 83 for MenACWY.
|
|
Psychiatric disorders
COMPLETED SUICIDE
|
0.00%
0/84 • Day 1 to day 57.
Safety was assessed in terms of percentages of all Serious AEs collected from the time the subject signed the informed consent form until he/she stopped study participation.One subject randomized to receive MenACWY-CRM, received HepA/B+MenACWY-CRM vaccine, instead. The safety set included 85 subjects for HepA/B+MenACWY group and 83 for MenACWY.
|
0.00%
0/85 • Day 1 to day 57.
Safety was assessed in terms of percentages of all Serious AEs collected from the time the subject signed the informed consent form until he/she stopped study participation.One subject randomized to receive MenACWY-CRM, received HepA/B+MenACWY-CRM vaccine, instead. The safety set included 85 subjects for HepA/B+MenACWY group and 83 for MenACWY.
|
1.2%
1/83 • Day 1 to day 57.
Safety was assessed in terms of percentages of all Serious AEs collected from the time the subject signed the informed consent form until he/she stopped study participation.One subject randomized to receive MenACWY-CRM, received HepA/B+MenACWY-CRM vaccine, instead. The safety set included 85 subjects for HepA/B+MenACWY group and 83 for MenACWY.
|
Other adverse events
| Measure |
HepA/B
n=84 participants at risk
Subject ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine.
|
HepA/B+ACWY
n=85 participants at risk
Subject ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine; all the subjects concomitantly received one dose of MenACWY-CRM conjugate vaccine.
|
ACWY
n=83 participants at risk
Subject ≥ 18 to ≤ 64 years of age who received one dose of MenACWY-CRM conjugate vaccine.
|
|---|---|---|---|
|
General disorders
FATIGUE
|
2.4%
2/84 • Day 1 to day 57.
Safety was assessed in terms of percentages of all Serious AEs collected from the time the subject signed the informed consent form until he/she stopped study participation.One subject randomized to receive MenACWY-CRM, received HepA/B+MenACWY-CRM vaccine, instead. The safety set included 85 subjects for HepA/B+MenACWY group and 83 for MenACWY.
|
7.1%
6/85 • Day 1 to day 57.
Safety was assessed in terms of percentages of all Serious AEs collected from the time the subject signed the informed consent form until he/she stopped study participation.One subject randomized to receive MenACWY-CRM, received HepA/B+MenACWY-CRM vaccine, instead. The safety set included 85 subjects for HepA/B+MenACWY group and 83 for MenACWY.
|
0.00%
0/83 • Day 1 to day 57.
Safety was assessed in terms of percentages of all Serious AEs collected from the time the subject signed the informed consent form until he/she stopped study participation.One subject randomized to receive MenACWY-CRM, received HepA/B+MenACWY-CRM vaccine, instead. The safety set included 85 subjects for HepA/B+MenACWY group and 83 for MenACWY.
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
2.4%
2/84 • Day 1 to day 57.
Safety was assessed in terms of percentages of all Serious AEs collected from the time the subject signed the informed consent form until he/she stopped study participation.One subject randomized to receive MenACWY-CRM, received HepA/B+MenACWY-CRM vaccine, instead. The safety set included 85 subjects for HepA/B+MenACWY group and 83 for MenACWY.
|
1.2%
1/85 • Day 1 to day 57.
Safety was assessed in terms of percentages of all Serious AEs collected from the time the subject signed the informed consent form until he/she stopped study participation.One subject randomized to receive MenACWY-CRM, received HepA/B+MenACWY-CRM vaccine, instead. The safety set included 85 subjects for HepA/B+MenACWY group and 83 for MenACWY.
|
6.0%
5/83 • Day 1 to day 57.
Safety was assessed in terms of percentages of all Serious AEs collected from the time the subject signed the informed consent form until he/she stopped study participation.One subject randomized to receive MenACWY-CRM, received HepA/B+MenACWY-CRM vaccine, instead. The safety set included 85 subjects for HepA/B+MenACWY group and 83 for MenACWY.
|
|
General disorders
INJECTION SITE PAIN
|
4.8%
4/84 • Day 1 to day 57.
Safety was assessed in terms of percentages of all Serious AEs collected from the time the subject signed the informed consent form until he/she stopped study participation.One subject randomized to receive MenACWY-CRM, received HepA/B+MenACWY-CRM vaccine, instead. The safety set included 85 subjects for HepA/B+MenACWY group and 83 for MenACWY.
|
5.9%
5/85 • Day 1 to day 57.
Safety was assessed in terms of percentages of all Serious AEs collected from the time the subject signed the informed consent form until he/she stopped study participation.One subject randomized to receive MenACWY-CRM, received HepA/B+MenACWY-CRM vaccine, instead. The safety set included 85 subjects for HepA/B+MenACWY group and 83 for MenACWY.
|
1.2%
1/83 • Day 1 to day 57.
Safety was assessed in terms of percentages of all Serious AEs collected from the time the subject signed the informed consent form until he/she stopped study participation.One subject randomized to receive MenACWY-CRM, received HepA/B+MenACWY-CRM vaccine, instead. The safety set included 85 subjects for HepA/B+MenACWY group and 83 for MenACWY.
|
|
Infections and infestations
NASOPHARYNGITIS
|
7.1%
6/84 • Day 1 to day 57.
Safety was assessed in terms of percentages of all Serious AEs collected from the time the subject signed the informed consent form until he/she stopped study participation.One subject randomized to receive MenACWY-CRM, received HepA/B+MenACWY-CRM vaccine, instead. The safety set included 85 subjects for HepA/B+MenACWY group and 83 for MenACWY.
|
10.6%
9/85 • Day 1 to day 57.
Safety was assessed in terms of percentages of all Serious AEs collected from the time the subject signed the informed consent form until he/she stopped study participation.One subject randomized to receive MenACWY-CRM, received HepA/B+MenACWY-CRM vaccine, instead. The safety set included 85 subjects for HepA/B+MenACWY group and 83 for MenACWY.
|
6.0%
5/83 • Day 1 to day 57.
Safety was assessed in terms of percentages of all Serious AEs collected from the time the subject signed the informed consent form until he/she stopped study participation.One subject randomized to receive MenACWY-CRM, received HepA/B+MenACWY-CRM vaccine, instead. The safety set included 85 subjects for HepA/B+MenACWY group and 83 for MenACWY.
|
|
Nervous system disorders
HEADACHE
|
17.9%
15/84 • Day 1 to day 57.
Safety was assessed in terms of percentages of all Serious AEs collected from the time the subject signed the informed consent form until he/she stopped study participation.One subject randomized to receive MenACWY-CRM, received HepA/B+MenACWY-CRM vaccine, instead. The safety set included 85 subjects for HepA/B+MenACWY group and 83 for MenACWY.
|
7.1%
6/85 • Day 1 to day 57.
Safety was assessed in terms of percentages of all Serious AEs collected from the time the subject signed the informed consent form until he/she stopped study participation.One subject randomized to receive MenACWY-CRM, received HepA/B+MenACWY-CRM vaccine, instead. The safety set included 85 subjects for HepA/B+MenACWY group and 83 for MenACWY.
|
2.4%
2/83 • Day 1 to day 57.
Safety was assessed in terms of percentages of all Serious AEs collected from the time the subject signed the informed consent form until he/she stopped study participation.One subject randomized to receive MenACWY-CRM, received HepA/B+MenACWY-CRM vaccine, instead. The safety set included 85 subjects for HepA/B+MenACWY group and 83 for MenACWY.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place