Trial Outcomes & Findings for A Phase 3b, Randomized, Open-Label Study to Evaluate the Safety and Immunogenicity of Select Travel Vaccines When Administered Concomitantly With MenACWY in Adults (NCT NCT01466387)
NCT ID: NCT01466387
Last Updated: 2014-03-11
Results Overview
Assessment was made to demonstrate the non-inferiority of the geometric mean anti-typhoid Vi antibody concentrations, 28 days after the vaccination of typhoid Vi polysaccharide (TF) and yellow fever (YF) vaccines given concomitantly with MenACWY-CRM197 to typhoid Vi polysaccharide and yellow fever vaccines given alone in healthy adults aged ≥18 years to ≤60 years.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
552 participants
Primary outcome timeframe
Baseline and 1 month postvaccination (day 29).
Results posted on
2014-03-11
Participant Flow
Subjects were enrolled at 5 sites (Berhard Nocht Institut, Germany, Berliner Centrum fuer Reise, Germany, Universitat Rostock, Germany, University of Munich, Germany, Vacc and Travel Med. Center, Czech Republic)
All enrolled subjects were included in the trial.
Participant milestones
| Measure |
TF+YF
Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide and yellow fever vaccine.
|
TF+YF+MenACWY-CRM197
Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide, yellow fever and meningococcal ACWY conjugate vaccine.
|
JE+Rabies
Subjects ≥18 years to ≤60 years of age who received two doses of Japanese encephalitis and three doses of Rabies vaccine.
|
JE+Rabies+MenACWY-CRM197
Subjects ≥18 years to ≤60 years of age who received two doses of Japanese encephalitis and three doses of Rabies and one dose of meningococcal ACWY conjugate vaccine.
|
Rabies
Subjects ≥18 years to ≤60 years of age who received three doses of Rabies vaccine.
|
MenACWY-CRM197 (Combined)
Subjects ≥18 years to ≤60 years of age who received one dose of meningococcal ACWY conjugate vaccine.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
101
|
100
|
99
|
101
|
51
|
100
|
|
Overall Study
COMPLETED
|
100
|
100
|
98
|
99
|
51
|
99
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
2
|
0
|
1
|
Reasons for withdrawal
| Measure |
TF+YF
Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide and yellow fever vaccine.
|
TF+YF+MenACWY-CRM197
Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide, yellow fever and meningococcal ACWY conjugate vaccine.
|
JE+Rabies
Subjects ≥18 years to ≤60 years of age who received two doses of Japanese encephalitis and three doses of Rabies vaccine.
|
JE+Rabies+MenACWY-CRM197
Subjects ≥18 years to ≤60 years of age who received two doses of Japanese encephalitis and three doses of Rabies and one dose of meningococcal ACWY conjugate vaccine.
|
Rabies
Subjects ≥18 years to ≤60 years of age who received three doses of Rabies vaccine.
|
MenACWY-CRM197 (Combined)
Subjects ≥18 years to ≤60 years of age who received one dose of meningococcal ACWY conjugate vaccine.
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Phase 3b, Randomized, Open-Label Study to Evaluate the Safety and Immunogenicity of Select Travel Vaccines When Administered Concomitantly With MenACWY in Adults
Baseline characteristics by cohort
| Measure |
TF+YF
n=101 Participants
Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide and yellow fever vaccine.
|
TF+YF+MenACWY-CRM197
n=100 Participants
Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide, yellow fever and meningococcal ACWY conjugate vaccine.
|
JE+Rabies
n=99 Participants
Subjects ≥18 years to ≤60 years of age who received two doses of Japanese encephalitis and three doses of Rabies vaccine.
|
JE+Rabies+MenACWY-CRM197
n=101 Participants
Subjects ≥18 years to ≤60 years of age who received two doses of Japanese encephalitis and three doses of Rabies and one dose of meningococcal ACWY conjugate vaccine.
|
Rabies
n=51 Participants
Subjects ≥18 years to ≤60 years of age who received three doses of Rabies vaccine.
|
MenACWY-CRM197 (Combined)
n=100 Participants
Subjects ≥18 years to ≤60 years of age who received one dose of meningococcal ACWY conjugate vaccine.
|
Total
n=552 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
36.5 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
35.1 years
STANDARD_DEVIATION 11.0 • n=7 Participants
|
35.0 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
35.0 years
STANDARD_DEVIATION 11.1 • n=4 Participants
|
35.8 years
STANDARD_DEVIATION 11.6 • n=21 Participants
|
36.9 years
STANDARD_DEVIATION 11.2 • n=8 Participants
|
35.7 years
STANDARD_DEVIATION 11.2 • n=8 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
50 Participants
n=8 Participants
|
267 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
50 Participants
n=8 Participants
|
285 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline and 1 month postvaccination (day 29).Population: Analysis was done on the per-protocol (PP) set, ie, the subjects who received the vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violations as defined prior to analysis.
Assessment was made to demonstrate the non-inferiority of the geometric mean anti-typhoid Vi antibody concentrations, 28 days after the vaccination of typhoid Vi polysaccharide (TF) and yellow fever (YF) vaccines given concomitantly with MenACWY-CRM197 to typhoid Vi polysaccharide and yellow fever vaccines given alone in healthy adults aged ≥18 years to ≤60 years.
Outcome measures
| Measure |
TF+YF
n=100 Participants
Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide and yellow fever vaccine.
|
TF+YF+MenACWY-CRM197
n=99 Participants
Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide, yellow fever and meningococcal ACWY conjugate vaccine.
|
Rabies
Subjects ≥18 years to ≤60 years of age who received three doses of Rabies vaccine
|
|---|---|---|---|
|
Geometric Mean Anti-typhoid Vi Antibody Concentrations
Day 1 (Typhoid Fever)
|
6.37 El.U/mL
Interval 5.3 to 7.65
|
5.6 El.U/mL
Interval 4.66 to 6.73
|
—
|
|
Geometric Mean Anti-typhoid Vi Antibody Concentrations
Day 29 (Typhoid Fever)
|
134 El.U/mL
Interval 104.0 to 174.0
|
153 El.U/mL
Interval 118.0 to 197.0
|
—
|
PRIMARY outcome
Timeframe: Baseline and 1 month postvaccination (day 29).Population: Analysis was done on the per-protocol (PP) set, ie, the subjects who received the vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violations as defined prior to analysis.
Assessment was made to demonstrate the non-inferiority of the geometric mean anti-yellow fever antibody titers, 28 days after the vaccination of typhoid Vi polysaccharide (TF) and yellow fever (YF) vaccines given concomitantly with MenACWY-CRM197 to typhoid Vi polysaccharide and yellow fever vaccines given alone in healthy adults aged ≥18 years to ≤60 years.
Outcome measures
| Measure |
TF+YF
n=100 Participants
Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide and yellow fever vaccine.
|
TF+YF+MenACWY-CRM197
n=99 Participants
Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide, yellow fever and meningococcal ACWY conjugate vaccine.
|
Rabies
Subjects ≥18 years to ≤60 years of age who received three doses of Rabies vaccine
|
|---|---|---|---|
|
Geometric Mean Anti-Yellow Fever Antibody Titer
Day 1 (Yellow Fever)
|
9.05 Titers
Interval 6.82 to 12.0
|
12 Titers
Interval 8.68 to 15.0
|
—
|
|
Geometric Mean Anti-Yellow Fever Antibody Titer
Day 29 (Yellow Fever)
|
5244 Titers
Interval 3929.0 to 7000.0
|
5022 Titers
Interval 3754.0 to 6717.0
|
—
|
PRIMARY outcome
Timeframe: Baseline and 1 month post last vaccination (day 57).Population: Analysis was done on the PP set, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violations as defined prior to analysis.
Assessment was made to demonstrate the non-inferiority of the geometric mean anti-Japanese encephalitis neutralizing antibody titers, 28 days after the vaccination of the second dose of Japanese Encephalitis vaccine and third dose of the rabies virus vaccine given concomitantly with MenACWY-CRM197 or alone in healthy adults aged ≥18 years to ≤60 years.
Outcome measures
| Measure |
TF+YF
n=96 Participants
Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide and yellow fever vaccine.
|
TF+YF+MenACWY-CRM197
n=97 Participants
Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide, yellow fever and meningococcal ACWY conjugate vaccine.
|
Rabies
Subjects ≥18 years to ≤60 years of age who received three doses of Rabies vaccine
|
|---|---|---|---|
|
Geometric Mean Anti-Japanese Encephalitis Neutralizing Antibody Titers
Day 1 (Japanese Encephalitis)
|
5.61 Titers
Interval 5.11 to 6.15
|
5.58 Titers
Interval 5.09 to 6.12
|
—
|
|
Geometric Mean Anti-Japanese Encephalitis Neutralizing Antibody Titers
Day 57 (Japanese Encephalitis)
|
183 Titers
Interval 151.0 to 221.0
|
165 Titers
Interval 136.0 to 199.0
|
—
|
PRIMARY outcome
Timeframe: Baseline and 1 month post last vaccination (day 57).Population: Analysis was done on the per-protocol (PP) set, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violations as defined prior to analysis.
Assessment was made to demonstrate the non-inferiority of the geometric mean anti-rabies virus neutralizing antibody concentrations, 28 days after the vaccination of the second dose of Japanese encephalitis vaccine and third dose of rabies virus vaccine given concomitantly with MenACWY-CRM197 or alone in healthy adults aged ≥18 years to ≤60 years.
Outcome measures
| Measure |
TF+YF
n=96 Participants
Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide and yellow fever vaccine.
|
TF+YF+MenACWY-CRM197
n=97 Participants
Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide, yellow fever and meningococcal ACWY conjugate vaccine.
|
Rabies
Subjects ≥18 years to ≤60 years of age who received three doses of Rabies vaccine
|
|---|---|---|---|
|
Geometric Mean Anti-Rabies Virus Neutralizing Antibody Concentration
Day 1 (Rabies)
|
0.056 IU/mL
Interval 0.05 to 0.062
|
0.049 IU/mL
Interval 0.044 to 0.054
|
—
|
|
Geometric Mean Anti-Rabies Virus Neutralizing Antibody Concentration
Day 57 (Rabies)
|
12 IU/mL
Interval 9.68 to 14.0
|
11 IU/mL
Interval 8.84 to 13.0
|
—
|
SECONDARY outcome
Timeframe: Baseline and 1 month postvaccination (day 29).Population: Analysis was done on the Modified-Intention to Treat (MITT) set, i.e. the subjects who provided evaluable serum samples whose assay results are available for at least one antigen on baseline and on at least one post-baseline visit.
Immunogenicity was assessed as the percentages of subjects who achieved seroprotection as measured by neutralization test for anti-YF neutralizing antibody titers after the vaccination of typhoid Vi polysaccharide and yellow fever, given alone or concomitantly with MenACWY-CRM197 on day 29. Seroprotection is defined as percentages of subjects who achieved anti-YF neutralizing antibody titers ≥ 1/10 on day 29.
Outcome measures
| Measure |
TF+YF
n=100 Participants
Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide and yellow fever vaccine.
|
TF+YF+MenACWY-CRM197
n=100 Participants
Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide, yellow fever and meningococcal ACWY conjugate vaccine.
|
Rabies
Subjects ≥18 years to ≤60 years of age who received three doses of Rabies vaccine
|
|---|---|---|---|
|
Percentages Of Subjects With Anti-YF Neutralizing Antibody Titers ≥ 1/10, 28 Days After The Vaccination Of Typhoid Vi Polysaccharide And Yellow Fever, Concomitantly With MenACWY-CRM197 Or Given Alone
Day 1 (Yellow Fever)
|
34 Percentages of subjects
Interval 25.0 to 44.0
|
36 Percentages of subjects
Interval 27.0 to 46.0
|
—
|
|
Percentages Of Subjects With Anti-YF Neutralizing Antibody Titers ≥ 1/10, 28 Days After The Vaccination Of Typhoid Vi Polysaccharide And Yellow Fever, Concomitantly With MenACWY-CRM197 Or Given Alone
Day 29 (Yellow Fever)
|
100 Percentages of subjects
Interval 96.0 to 100.0
|
97 Percentages of subjects
Interval 91.0 to 99.0
|
—
|
SECONDARY outcome
Timeframe: Baseline and 1 month post last vaccination (day 57).Population: The analysis was done on the MITT data set.
Immunogenicity was measured as the percentages of subjects who achieved seroprotection as measured by neutralization test for anti-Japanese encephalitis neutralizing antibody titers, 28 days after administration of the second dose of Japanese encephalitis virus vaccine and 28 days after the vaccination of third dose of rabies virus vaccine, given alone or concomitantly with MenACWY-CRM197. Seroprotection is defined as percentages of subjects who achieved anti-JE neutralizing titers ≥ 1/10 on Day 57.
Outcome measures
| Measure |
TF+YF
n=98 Participants
Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide and yellow fever vaccine.
|
TF+YF+MenACWY-CRM197
n=99 Participants
Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide, yellow fever and meningococcal ACWY conjugate vaccine.
|
Rabies
Subjects ≥18 years to ≤60 years of age who received three doses of Rabies vaccine
|
|---|---|---|---|
|
Percentages Of Subjects With Anti-JE Neutralizing Antibody Titers ≥ 1/10, 28 Days After The Vaccination Of The Last Doses Of Japanese Encephalitis And Rabies, Given Concomitantly With MenACWY-CRM197 Or Alone
Day 1 (Japanese Encephalitis)
|
3 Percentages of subects
Interval 1.0 to 9.0
|
4 Percentages of subects
Interval 1.0 to 10.0
|
—
|
|
Percentages Of Subjects With Anti-JE Neutralizing Antibody Titers ≥ 1/10, 28 Days After The Vaccination Of The Last Doses Of Japanese Encephalitis And Rabies, Given Concomitantly With MenACWY-CRM197 Or Alone
Day 57 (Japanese Encephalitis)
|
99 Percentages of subects
Interval 94.0 to 100.0
|
98 Percentages of subects
Interval 93.0 to 100.0
|
—
|
SECONDARY outcome
Timeframe: Baseline and 1 month post last vaccination (day 57).Population: Analysis was done on the MITT data set.
Immunogenicity was assessed as the percentages of subjects who achieved seroprotection as measured by neutralization test for anti-rabies neutralizing antibody titers, 28 days after administration of the second dose of Japanese encephalitis virus vaccine and 28 days after the vaccination of third dose of rabies virus vaccine, given alone or concomitantly with MenACWY-CRM197. Seroprotection is defined as a subject with a baseline hSBA titer \< 1:4, seroresponse was defined as a post-vaccination hSBA titer ≥ 1:8; for a subject with a baseline hSBA titer ≥ 1:4, seroresponse was defined as a post-vaccination hSBA titer of at least 4 times the baseline.
Outcome measures
| Measure |
TF+YF
n=98 Participants
Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide and yellow fever vaccine.
|
TF+YF+MenACWY-CRM197
n=99 Participants
Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide, yellow fever and meningococcal ACWY conjugate vaccine.
|
Rabies
Subjects ≥18 years to ≤60 years of age who received three doses of Rabies vaccine
|
|---|---|---|---|
|
Percentages Of Subjects With Anti-Rabies Virus Antibody Concentrations ≥ 0.5 IU/mL 28 Days After the Vaccination Of The Last Doses Of Japanese Encephalitis And Rabies Virus, Given Concomitantly With MenACWY-CRM197 Or Alone
Day 1 (Rabies)
|
3 Percentages of subjects
Interval 1.0 to 9.0
|
1 Percentages of subjects
Interval 0.026 to 5.0
|
—
|
|
Percentages Of Subjects With Anti-Rabies Virus Antibody Concentrations ≥ 0.5 IU/mL 28 Days After the Vaccination Of The Last Doses Of Japanese Encephalitis And Rabies Virus, Given Concomitantly With MenACWY-CRM197 Or Alone
Day 57 (Rabies)
|
100 Percentages of subjects
Interval 96.0 to 100.0
|
100 Percentages of subjects
Interval 96.0 to 100.0
|
—
|
SECONDARY outcome
Timeframe: Baseline and 1 month postvaccination (day 29).Population: Analysis was done on the MITT data set.
Immunogenicity was assessed by Serum Bactericidal Assay using human complement (hSBA) geometric mean titers (GMTs) for meningococcal serogroups A,C,W,Y 28 days after administration of MenACWY-CRM197 given concomitantly with typhoid Vi polysaccharide and yellow fever vaccines or alone.
Outcome measures
| Measure |
TF+YF
n=99 Participants
Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide and yellow fever vaccine.
|
TF+YF+MenACWY-CRM197
n=100 Participants
Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide, yellow fever and meningococcal ACWY conjugate vaccine.
|
Rabies
Subjects ≥18 years to ≤60 years of age who received three doses of Rabies vaccine
|
|---|---|---|---|
|
Geometric Mean hSBA Titers For Meningococcal Serogroups A,C,W,Y 28 Days After The Vaccination Of MenACWY-CRM197 Given Concomitantly With Typhoid Vi Polysaccharide And Yellow Fever Vaccines Alone
Serogroup A (Day 1)
|
2.94 titers
Interval 2.43 to 3.56
|
2.78 titers
Interval 2.3 to 3.36
|
—
|
|
Geometric Mean hSBA Titers For Meningococcal Serogroups A,C,W,Y 28 Days After The Vaccination Of MenACWY-CRM197 Given Concomitantly With Typhoid Vi Polysaccharide And Yellow Fever Vaccines Alone
Serogroup A (Day 29)
|
65 titers
Interval 44.0 to 95.0
|
62 titers
Interval 42.0 to 90.0
|
—
|
|
Geometric Mean hSBA Titers For Meningococcal Serogroups A,C,W,Y 28 Days After The Vaccination Of MenACWY-CRM197 Given Concomitantly With Typhoid Vi Polysaccharide And Yellow Fever Vaccines Alone
Serogroup C (Day 1)
|
7.94 titers
Interval 5.94 to 11.0
|
7.03 titers
Interval 5.27 to 9.38
|
—
|
|
Geometric Mean hSBA Titers For Meningococcal Serogroups A,C,W,Y 28 Days After The Vaccination Of MenACWY-CRM197 Given Concomitantly With Typhoid Vi Polysaccharide And Yellow Fever Vaccines Alone
Serogroup C (Day 29)
|
49 titers
Interval 35.0 to 70.0
|
54 titers
Interval 38.0 to 76.0
|
—
|
|
Geometric Mean hSBA Titers For Meningococcal Serogroups A,C,W,Y 28 Days After The Vaccination Of MenACWY-CRM197 Given Concomitantly With Typhoid Vi Polysaccharide And Yellow Fever Vaccines Alone
Serogroup W (Day 1)
|
50 titers
Interval 35.0 to 71.0
|
32 titers
Interval 22.0 to 45.0
|
—
|
|
Geometric Mean hSBA Titers For Meningococcal Serogroups A,C,W,Y 28 Days After The Vaccination Of MenACWY-CRM197 Given Concomitantly With Typhoid Vi Polysaccharide And Yellow Fever Vaccines Alone
Serogroup W (Day 29)
|
129 titers
Interval 94.0 to 177.0
|
211 titers
Interval 154.0 to 290.0
|
—
|
|
Geometric Mean hSBA Titers For Meningococcal Serogroups A,C,W,Y 28 Days After The Vaccination Of MenACWY-CRM197 Given Concomitantly With Typhoid Vi Polysaccharide And Yellow Fever Vaccines Alone
Serogroup Y (Day 1)
|
7.61 titers
Interval 5.71 to 10.0
|
7.76 titers
Interval 5.83 to 10.0
|
—
|
|
Geometric Mean hSBA Titers For Meningococcal Serogroups A,C,W,Y 28 Days After The Vaccination Of MenACWY-CRM197 Given Concomitantly With Typhoid Vi Polysaccharide And Yellow Fever Vaccines Alone
Serogroup Y (Day 29)
|
89 titers
Interval 62.0 to 129.0
|
78 titers
Interval 54.0 to 113.0
|
—
|
SECONDARY outcome
Timeframe: 1 month postvaccination (day 29)Population: The analysis was done on the MITT data set.
Immunogenicity was assessed by seroresponse rates as measured by human serum bactericidal activity (hSBA) titers for meningococcal serogroups A,C,W,Y 28 days after administration of MenACWY-CRM197 given concomitantly with typhoid Vi polysaccharide and yellow fever vaccines or alone. 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 four times the baseline.
Outcome measures
| Measure |
TF+YF
n=100 Participants
Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide and yellow fever vaccine.
|
TF+YF+MenACWY-CRM197
n=99 Participants
Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide, yellow fever and meningococcal ACWY conjugate vaccine.
|
Rabies
Subjects ≥18 years to ≤60 years of age who received three doses of Rabies vaccine
|
|---|---|---|---|
|
Seroresponse Rate For Meningococcal Serogroups A,C,W,Y 28 Days After Vaccination of MenACWY-CRM197 Given Concomitantly With Typhoid Vi Polysaccharide and Yellow Fever Vaccines or Alone
Serogroup A (Overall Seroresponse)
|
72 Percentages of subjects
Interval 62.0 to 81.0
|
71 Percentages of subjects
Interval 61.0 to 79.0
|
—
|
|
Seroresponse Rate For Meningococcal Serogroups A,C,W,Y 28 Days After Vaccination of MenACWY-CRM197 Given Concomitantly With Typhoid Vi Polysaccharide and Yellow Fever Vaccines or Alone
Serogroup C (Overall Seroresponse)
|
48 Percentages of subjects
Interval 38.0 to 58.0
|
47 Percentages of subjects
Interval 37.0 to 58.0
|
—
|
|
Seroresponse Rate For Meningococcal Serogroups A,C,W,Y 28 Days After Vaccination of MenACWY-CRM197 Given Concomitantly With Typhoid Vi Polysaccharide and Yellow Fever Vaccines or Alone
Serogroup W (Overall Seroresponse)
|
51 Percentages of subjects
Interval 40.0 to 61.0
|
30 Percentages of subjects
Interval 21.0 to 40.0
|
—
|
|
Seroresponse Rate For Meningococcal Serogroups A,C,W,Y 28 Days After Vaccination of MenACWY-CRM197 Given Concomitantly With Typhoid Vi Polysaccharide and Yellow Fever Vaccines or Alone
Serogroup Y (Overall Seroresponse)
|
63 Percentages of subjects
Interval 53.0 to 72.0
|
66 Percentages of subjects
Interval 55.0 to 75.0
|
—
|
SECONDARY outcome
Timeframe: Baseline and 1 month post last vaccination (day 29 or day 57).Population: The analysis was done on the MITT data set.
Immunogenicity was measured by human serum bactericidal activity (hSBA) geometric mean titers (GMTs) for meningococcal serogroups A,C,W,Y 28 days after administration of MenACWY-CRM197 given concomitantly with Japanese encephalitis and rabies virus vaccines or alone.
Outcome measures
| Measure |
TF+YF
n=99 Participants
Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide and yellow fever vaccine.
|
TF+YF+MenACWY-CRM197
n=99 Participants
Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide, yellow fever and meningococcal ACWY conjugate vaccine.
|
Rabies
Subjects ≥18 years to ≤60 years of age who received three doses of Rabies vaccine
|
|---|---|---|---|
|
Geometric Mean hSBA Titers for Meningococcal Serogroups A,C,W,Y 28 Days After the Vaccination of MenACWY-CRM197 Given Concomitantly With Japanese Encephalitis and Rabies Virus Vaccines or Alone
Serogroup A (Day 1)
|
3.21 titers
Interval 2.65 to 3.88
|
2.94 titers
Interval 2.43 to 3.56
|
—
|
|
Geometric Mean hSBA Titers for Meningococcal Serogroups A,C,W,Y 28 Days After the Vaccination of MenACWY-CRM197 Given Concomitantly With Japanese Encephalitis and Rabies Virus Vaccines or Alone
Serogroup A (Day 29 or Day 57)
|
32 titers
Interval 22.0 to 47.0
|
65 titers
Interval 44.0 to 95.0
|
—
|
|
Geometric Mean hSBA Titers for Meningococcal Serogroups A,C,W,Y 28 Days After the Vaccination of MenACWY-CRM197 Given Concomitantly With Japanese Encephalitis and Rabies Virus Vaccines or Alone
Serogroup C (Day 1)
|
8.81 titers
Interval 6.59 to 12.0
|
7.94 titers
Interval 5.94 to 11.0
|
—
|
|
Geometric Mean hSBA Titers for Meningococcal Serogroups A,C,W,Y 28 Days After the Vaccination of MenACWY-CRM197 Given Concomitantly With Japanese Encephalitis and Rabies Virus Vaccines or Alone
Serogroup C (Day 29 or Day 57)
|
44 titers
Interval 31.0 to 62.0
|
49 titers
Interval 35.0 to 70.0
|
—
|
|
Geometric Mean hSBA Titers for Meningococcal Serogroups A,C,W,Y 28 Days After the Vaccination of MenACWY-CRM197 Given Concomitantly With Japanese Encephalitis and Rabies Virus Vaccines or Alone
Serogroup W (Day 1)
|
54 titers
Interval 38.0 to 77.0
|
50 titers
Interval 35.0 to 71.0
|
—
|
|
Geometric Mean hSBA Titers for Meningococcal Serogroups A,C,W,Y 28 Days After the Vaccination of MenACWY-CRM197 Given Concomitantly With Japanese Encephalitis and Rabies Virus Vaccines or Alone
Serogroup W (Day 29 or Day 57)
|
119 titers
Interval 87.0 to 164.0
|
129 titers
Interval 94.0 to 177.0
|
—
|
|
Geometric Mean hSBA Titers for Meningococcal Serogroups A,C,W,Y 28 Days After the Vaccination of MenACWY-CRM197 Given Concomitantly With Japanese Encephalitis and Rabies Virus Vaccines or Alone
Serogroup Y (Day 1)
|
8.11 titers
Interval 6.08 to 11.0
|
7.61 titers
Interval 5.71 to 10.0
|
—
|
|
Geometric Mean hSBA Titers for Meningococcal Serogroups A,C,W,Y 28 Days After the Vaccination of MenACWY-CRM197 Given Concomitantly With Japanese Encephalitis and Rabies Virus Vaccines or Alone
Serogroup Y (Day 29 or Day 57)
|
55 titers
Interval 38.0 to 80.0
|
89 titers
Interval 62.0 to 129.0
|
—
|
SECONDARY outcome
Timeframe: 1 month post last vaccination (day 29 or day 57)Population: The analysis was done on the MITT data set.
Immunogenicity was assessed by seroresponse rates as measured by human serum bactericidal activity (hSBA) titers for meningococcal serogroups A,C,W,Y 28 days after administration of MenACWY-CRM197 given concomitantly with Japanese encephalitis and rabies virus vaccines or alone. Seroresponse is defined as a subject with a baseline hSBA titer \< 1:4, seroresponse was defined as a post-vaccination hSBA titer ≥ 1:8; for a subject with a baseline hSBA titer ≥ 1:4, seroresponse was defined as a postvaccination hSBA titer of at least 4 times the baseline.
Outcome measures
| Measure |
TF+YF
n=99 Participants
Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide and yellow fever vaccine.
|
TF+YF+MenACWY-CRM197
n=99 Participants
Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide, yellow fever and meningococcal ACWY conjugate vaccine.
|
Rabies
Subjects ≥18 years to ≤60 years of age who received three doses of Rabies vaccine
|
|---|---|---|---|
|
Seroresponse Rate for Meningococcal Serogroups A,C,W,Y 28 Days After Vaccination of MenACWY-CRM197 Given Concomitantly With Japanese Encephalitis and Rabies Virus Vaccines or Alone
Serogroup A (Overall Seroresponse)
|
60 Percentages of subjects
Interval 49.0 to 69.0
|
71 Percentages of subjects
Interval 61.0 to 79.0
|
—
|
|
Seroresponse Rate for Meningococcal Serogroups A,C,W,Y 28 Days After Vaccination of MenACWY-CRM197 Given Concomitantly With Japanese Encephalitis and Rabies Virus Vaccines or Alone
Serogroup C (Overall Seroresponse)
|
43 Percentages of subjects
Interval 33.0 to 54.0
|
47 Percentages of subjects
Interval 37.0 to 58.0
|
—
|
|
Seroresponse Rate for Meningococcal Serogroups A,C,W,Y 28 Days After Vaccination of MenACWY-CRM197 Given Concomitantly With Japanese Encephalitis and Rabies Virus Vaccines or Alone
Serogroup W (Overall Seroresponse)
|
32 Percentages of subjects
Interval 23.0 to 42.0
|
30 Percentages of subjects
Interval 21.0 to 40.0
|
—
|
|
Seroresponse Rate for Meningococcal Serogroups A,C,W,Y 28 Days After Vaccination of MenACWY-CRM197 Given Concomitantly With Japanese Encephalitis and Rabies Virus Vaccines or Alone
Serogroup Y (Overall Seroresponse)
|
56 Percentages of subjects
Interval 45.0 to 66.0
|
66 Percentages of subjects
Interval 55.0 to 75.0
|
—
|
SECONDARY outcome
Timeframe: Baseline and 1 month post last vaccination (day 57).Population: The analysis was done on the MITT data set.
The immunogenicity was assessed in rabies virus vaccine as measured by geometric mean rabies virus neutralizing antibody concentration, 28 days after vaccination of the third dose, when administered alone or concomitantly either with Japanese encephalitis vaccine or with Japanese Encephalitis and MenACWY-CRM197 vaccines.
Outcome measures
| Measure |
TF+YF
n=99 Participants
Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide and yellow fever vaccine.
|
TF+YF+MenACWY-CRM197
n=98 Participants
Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide, yellow fever and meningococcal ACWY conjugate vaccine.
|
Rabies
n=51 Participants
Subjects ≥18 years to ≤60 years of age who received three doses of Rabies vaccine
|
|---|---|---|---|
|
Geometric Mean Rabies Virus Neutralizing Antibody Concentration 28 Days After the Last Vaccination Of Rabies Virus Vaccine Concomitantly Either With Japanese Encephalitis or With Japanese Encephalitis And MenACWY-CRM197
Day 1 (Rabies)
|
0.051 IU/mL
Interval 0.044 to 0.059
|
0.057 IU/mL
Interval 0.049 to 0.065
|
0.068 IU/mL
Interval 0.056 to 0.082
|
|
Geometric Mean Rabies Virus Neutralizing Antibody Concentration 28 Days After the Last Vaccination Of Rabies Virus Vaccine Concomitantly Either With Japanese Encephalitis or With Japanese Encephalitis And MenACWY-CRM197
Day 57 (Rabies)
|
11 IU/mL
Interval 8.84 to 13.0
|
11 IU/mL
Interval 9.49 to 14.0
|
8.97 IU/mL
Interval 6.98 to 12.0
|
SECONDARY outcome
Timeframe: Baseline and 1 month post last vaccination (day 57).Population: The analysis was done on the MITT data set.
Immunogenicity was measured as the percentages of subjects who achieved seroprotection of anti-rabies virus antibody concentrations 28 days after vaccination of the third dose of rabies virus vaccine, when administered alone or concomitantly either with Japanese encephalitis or with Japanese encephalitis and MenACWY-CRM197 vaccines. Seroprotection is defined as percentages of subjects who achieved anti-rabies virus antibody concentrations ≥ 0.5 IU/mL on day 57.
Outcome measures
| Measure |
TF+YF
n=99 Participants
Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide and yellow fever vaccine.
|
TF+YF+MenACWY-CRM197
n=98 Participants
Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide, yellow fever and meningococcal ACWY conjugate vaccine.
|
Rabies
n=51 Participants
Subjects ≥18 years to ≤60 years of age who received three doses of Rabies vaccine
|
|---|---|---|---|
|
Percentages of Subjects With Anti-rabies Virus Concentrations ≥ 0.5 IU/mL, 28 Days After the Last Vaccination of Rabies Virus Vaccine Concomitantly Either With Japanese Encephalitis or With Japanese Encephalitis and MenACWY-CRM197
Day 1 (Rabies)
|
1 Percentages of subjects
Interval 0.026 to 5.0
|
3 Percentages of subjects
Interval 1.0 to 9.0
|
8 Percentages of subjects
Interval 2.0 to 19.0
|
|
Percentages of Subjects With Anti-rabies Virus Concentrations ≥ 0.5 IU/mL, 28 Days After the Last Vaccination of Rabies Virus Vaccine Concomitantly Either With Japanese Encephalitis or With Japanese Encephalitis and MenACWY-CRM197
Day 57 (Rabies)
|
100 Percentages of subjects
Interval 96.0 to 100.0
|
100 Percentages of subjects
Interval 96.0 to 100.0
|
100 Percentages of subjects
Interval 93.0 to 100.0
|
SECONDARY outcome
Timeframe: day 1 to day 57 post last vaccinationPopulation: Analysis was done on the safety data set, i.e. the subjects in the exposed population who provided postvaccination safety data.
In addition to the AEs and SAEs. Additional AESI were collected from day 1 to day 57 postvaccination in subjects after the vaccination of Japanese encephalitis and rabies virus vaccines given concomitantly with MenACWY-CRM197 or alone.
Outcome measures
| Measure |
TF+YF
n=101 Participants
Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide and yellow fever vaccine.
|
TF+YF+MenACWY-CRM197
n=99 Participants
Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide, yellow fever and meningococcal ACWY conjugate vaccine.
|
Rabies
Subjects ≥18 years to ≤60 years of age who received three doses of Rabies vaccine
|
|---|---|---|---|
|
Number of Subjects With Adverse Events of Special Interest After Any Vaccination of Japanese Encephalitis and Rabies Virus Vaccines Given Concomitantly With MenACWY-CRM197 or Alone
Injection site erythema
|
0 subjects
|
1 subjects
|
—
|
|
Number of Subjects With Adverse Events of Special Interest After Any Vaccination of Japanese Encephalitis and Rabies Virus Vaccines Given Concomitantly With MenACWY-CRM197 or Alone
Hypersensitivity
|
1 subjects
|
0 subjects
|
—
|
|
Number of Subjects With Adverse Events of Special Interest After Any Vaccination of Japanese Encephalitis and Rabies Virus Vaccines Given Concomitantly With MenACWY-CRM197 or Alone
Paresthesia
|
0 subjects
|
1 subjects
|
—
|
|
Number of Subjects With Adverse Events of Special Interest After Any Vaccination of Japanese Encephalitis and Rabies Virus Vaccines Given Concomitantly With MenACWY-CRM197 or Alone
Erythema
|
1 subjects
|
0 subjects
|
—
|
|
Number of Subjects With Adverse Events of Special Interest After Any Vaccination of Japanese Encephalitis and Rabies Virus Vaccines Given Concomitantly With MenACWY-CRM197 or Alone
Pruritus
|
1 subjects
|
1 subjects
|
—
|
|
Number of Subjects With Adverse Events of Special Interest After Any Vaccination of Japanese Encephalitis and Rabies Virus Vaccines Given Concomitantly With MenACWY-CRM197 or Alone
Hot flush
|
1 subjects
|
0 subjects
|
—
|
Adverse Events
TF+YF
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
TF+YF+MenACWY-CRM197
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
JE+Rabies
Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths
JE+Rabies+MenACWY-CRM197
Serious events: 1 serious events
Other events: 22 other events
Deaths: 0 deaths
Rabies
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
MenACWY-CRM197 (Combined)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TF+YF
n=101 participants at risk
Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide and yellow fever vaccine.
|
TF+YF+MenACWY-CRM197
n=100 participants at risk
Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide, yellow fever and meningococcal ACWY conjugate vaccine.
|
JE+Rabies
n=99 participants at risk
Subjects ≥18 years to ≤60 years of age who received two doses of Japanese encephalitis and three doses of Rabies vaccine.
|
JE+Rabies+MenACWY-CRM197
n=101 participants at risk
Subjects ≥18 years to ≤60 years of age who received two doses of Japanese encephalitis and three doses of Rabies and one dose of meningococcal ACWY conjugate vaccine.
|
Rabies
n=51 participants at risk
Subjects ≥18 years to ≤60 years of age who received three doses of Rabies vaccine.
|
MenACWY-CRM197 (Combined)
n=100 participants at risk
Subjects ≥18 years to ≤60 years of age who received one dose of meningococcal ACWY conjugate vaccine.
|
|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/101 • day 1 to day 29 (one month postvaccination); day 1 to day 57 (one month post last vaccination)
AEs and SAEs were collected from day 1-29 for subjects vaccinated with typhoid Vi polysaccharide+YF +MenACWY-CRM197 or alone, from day 1-57 vaccinated with JE+rabies virus+MenACWY-CRM197 or alone and who received rabies vaccine alone.
|
0.00%
0/100 • day 1 to day 29 (one month postvaccination); day 1 to day 57 (one month post last vaccination)
AEs and SAEs were collected from day 1-29 for subjects vaccinated with typhoid Vi polysaccharide+YF +MenACWY-CRM197 or alone, from day 1-57 vaccinated with JE+rabies virus+MenACWY-CRM197 or alone and who received rabies vaccine alone.
|
1.0%
1/99 • day 1 to day 29 (one month postvaccination); day 1 to day 57 (one month post last vaccination)
AEs and SAEs were collected from day 1-29 for subjects vaccinated with typhoid Vi polysaccharide+YF +MenACWY-CRM197 or alone, from day 1-57 vaccinated with JE+rabies virus+MenACWY-CRM197 or alone and who received rabies vaccine alone.
|
0.00%
0/101 • day 1 to day 29 (one month postvaccination); day 1 to day 57 (one month post last vaccination)
AEs and SAEs were collected from day 1-29 for subjects vaccinated with typhoid Vi polysaccharide+YF +MenACWY-CRM197 or alone, from day 1-57 vaccinated with JE+rabies virus+MenACWY-CRM197 or alone and who received rabies vaccine alone.
|
0.00%
0/51 • day 1 to day 29 (one month postvaccination); day 1 to day 57 (one month post last vaccination)
AEs and SAEs were collected from day 1-29 for subjects vaccinated with typhoid Vi polysaccharide+YF +MenACWY-CRM197 or alone, from day 1-57 vaccinated with JE+rabies virus+MenACWY-CRM197 or alone and who received rabies vaccine alone.
|
0.00%
0/100 • day 1 to day 29 (one month postvaccination); day 1 to day 57 (one month post last vaccination)
AEs and SAEs were collected from day 1-29 for subjects vaccinated with typhoid Vi polysaccharide+YF +MenACWY-CRM197 or alone, from day 1-57 vaccinated with JE+rabies virus+MenACWY-CRM197 or alone and who received rabies vaccine alone.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/101 • day 1 to day 29 (one month postvaccination); day 1 to day 57 (one month post last vaccination)
AEs and SAEs were collected from day 1-29 for subjects vaccinated with typhoid Vi polysaccharide+YF +MenACWY-CRM197 or alone, from day 1-57 vaccinated with JE+rabies virus+MenACWY-CRM197 or alone and who received rabies vaccine alone.
|
0.00%
0/100 • day 1 to day 29 (one month postvaccination); day 1 to day 57 (one month post last vaccination)
AEs and SAEs were collected from day 1-29 for subjects vaccinated with typhoid Vi polysaccharide+YF +MenACWY-CRM197 or alone, from day 1-57 vaccinated with JE+rabies virus+MenACWY-CRM197 or alone and who received rabies vaccine alone.
|
0.00%
0/99 • day 1 to day 29 (one month postvaccination); day 1 to day 57 (one month post last vaccination)
AEs and SAEs were collected from day 1-29 for subjects vaccinated with typhoid Vi polysaccharide+YF +MenACWY-CRM197 or alone, from day 1-57 vaccinated with JE+rabies virus+MenACWY-CRM197 or alone and who received rabies vaccine alone.
|
0.99%
1/101 • day 1 to day 29 (one month postvaccination); day 1 to day 57 (one month post last vaccination)
AEs and SAEs were collected from day 1-29 for subjects vaccinated with typhoid Vi polysaccharide+YF +MenACWY-CRM197 or alone, from day 1-57 vaccinated with JE+rabies virus+MenACWY-CRM197 or alone and who received rabies vaccine alone.
|
0.00%
0/51 • day 1 to day 29 (one month postvaccination); day 1 to day 57 (one month post last vaccination)
AEs and SAEs were collected from day 1-29 for subjects vaccinated with typhoid Vi polysaccharide+YF +MenACWY-CRM197 or alone, from day 1-57 vaccinated with JE+rabies virus+MenACWY-CRM197 or alone and who received rabies vaccine alone.
|
0.00%
0/100 • day 1 to day 29 (one month postvaccination); day 1 to day 57 (one month post last vaccination)
AEs and SAEs were collected from day 1-29 for subjects vaccinated with typhoid Vi polysaccharide+YF +MenACWY-CRM197 or alone, from day 1-57 vaccinated with JE+rabies virus+MenACWY-CRM197 or alone and who received rabies vaccine alone.
|
Other adverse events
| Measure |
TF+YF
n=101 participants at risk
Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide and yellow fever vaccine.
|
TF+YF+MenACWY-CRM197
n=100 participants at risk
Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide, yellow fever and meningococcal ACWY conjugate vaccine.
|
JE+Rabies
n=99 participants at risk
Subjects ≥18 years to ≤60 years of age who received two doses of Japanese encephalitis and three doses of Rabies vaccine.
|
JE+Rabies+MenACWY-CRM197
n=101 participants at risk
Subjects ≥18 years to ≤60 years of age who received two doses of Japanese encephalitis and three doses of Rabies and one dose of meningococcal ACWY conjugate vaccine.
|
Rabies
n=51 participants at risk
Subjects ≥18 years to ≤60 years of age who received three doses of Rabies vaccine.
|
MenACWY-CRM197 (Combined)
n=100 participants at risk
Subjects ≥18 years to ≤60 years of age who received one dose of meningococcal ACWY conjugate vaccine.
|
|---|---|---|---|---|---|---|
|
General disorders
Injection site pain
|
11.9%
12/101 • day 1 to day 29 (one month postvaccination); day 1 to day 57 (one month post last vaccination)
AEs and SAEs were collected from day 1-29 for subjects vaccinated with typhoid Vi polysaccharide+YF +MenACWY-CRM197 or alone, from day 1-57 vaccinated with JE+rabies virus+MenACWY-CRM197 or alone and who received rabies vaccine alone.
|
8.0%
8/100 • day 1 to day 29 (one month postvaccination); day 1 to day 57 (one month post last vaccination)
AEs and SAEs were collected from day 1-29 for subjects vaccinated with typhoid Vi polysaccharide+YF +MenACWY-CRM197 or alone, from day 1-57 vaccinated with JE+rabies virus+MenACWY-CRM197 or alone and who received rabies vaccine alone.
|
6.1%
6/99 • day 1 to day 29 (one month postvaccination); day 1 to day 57 (one month post last vaccination)
AEs and SAEs were collected from day 1-29 for subjects vaccinated with typhoid Vi polysaccharide+YF +MenACWY-CRM197 or alone, from day 1-57 vaccinated with JE+rabies virus+MenACWY-CRM197 or alone and who received rabies vaccine alone.
|
4.0%
4/101 • day 1 to day 29 (one month postvaccination); day 1 to day 57 (one month post last vaccination)
AEs and SAEs were collected from day 1-29 for subjects vaccinated with typhoid Vi polysaccharide+YF +MenACWY-CRM197 or alone, from day 1-57 vaccinated with JE+rabies virus+MenACWY-CRM197 or alone and who received rabies vaccine alone.
|
3.9%
2/51 • day 1 to day 29 (one month postvaccination); day 1 to day 57 (one month post last vaccination)
AEs and SAEs were collected from day 1-29 for subjects vaccinated with typhoid Vi polysaccharide+YF +MenACWY-CRM197 or alone, from day 1-57 vaccinated with JE+rabies virus+MenACWY-CRM197 or alone and who received rabies vaccine alone.
|
2.0%
2/100 • day 1 to day 29 (one month postvaccination); day 1 to day 57 (one month post last vaccination)
AEs and SAEs were collected from day 1-29 for subjects vaccinated with typhoid Vi polysaccharide+YF +MenACWY-CRM197 or alone, from day 1-57 vaccinated with JE+rabies virus+MenACWY-CRM197 or alone and who received rabies vaccine alone.
|
|
General disorders
Headache
|
6.9%
7/101 • day 1 to day 29 (one month postvaccination); day 1 to day 57 (one month post last vaccination)
AEs and SAEs were collected from day 1-29 for subjects vaccinated with typhoid Vi polysaccharide+YF +MenACWY-CRM197 or alone, from day 1-57 vaccinated with JE+rabies virus+MenACWY-CRM197 or alone and who received rabies vaccine alone.
|
10.0%
10/100 • day 1 to day 29 (one month postvaccination); day 1 to day 57 (one month post last vaccination)
AEs and SAEs were collected from day 1-29 for subjects vaccinated with typhoid Vi polysaccharide+YF +MenACWY-CRM197 or alone, from day 1-57 vaccinated with JE+rabies virus+MenACWY-CRM197 or alone and who received rabies vaccine alone.
|
9.1%
9/99 • day 1 to day 29 (one month postvaccination); day 1 to day 57 (one month post last vaccination)
AEs and SAEs were collected from day 1-29 for subjects vaccinated with typhoid Vi polysaccharide+YF +MenACWY-CRM197 or alone, from day 1-57 vaccinated with JE+rabies virus+MenACWY-CRM197 or alone and who received rabies vaccine alone.
|
5.0%
5/101 • day 1 to day 29 (one month postvaccination); day 1 to day 57 (one month post last vaccination)
AEs and SAEs were collected from day 1-29 for subjects vaccinated with typhoid Vi polysaccharide+YF +MenACWY-CRM197 or alone, from day 1-57 vaccinated with JE+rabies virus+MenACWY-CRM197 or alone and who received rabies vaccine alone.
|
9.8%
5/51 • day 1 to day 29 (one month postvaccination); day 1 to day 57 (one month post last vaccination)
AEs and SAEs were collected from day 1-29 for subjects vaccinated with typhoid Vi polysaccharide+YF +MenACWY-CRM197 or alone, from day 1-57 vaccinated with JE+rabies virus+MenACWY-CRM197 or alone and who received rabies vaccine alone.
|
4.0%
4/100 • day 1 to day 29 (one month postvaccination); day 1 to day 57 (one month post last vaccination)
AEs and SAEs were collected from day 1-29 for subjects vaccinated with typhoid Vi polysaccharide+YF +MenACWY-CRM197 or alone, from day 1-57 vaccinated with JE+rabies virus+MenACWY-CRM197 or alone and who received rabies vaccine alone.
|
|
General disorders
Influenza like illness
|
5.0%
5/101 • day 1 to day 29 (one month postvaccination); day 1 to day 57 (one month post last vaccination)
AEs and SAEs were collected from day 1-29 for subjects vaccinated with typhoid Vi polysaccharide+YF +MenACWY-CRM197 or alone, from day 1-57 vaccinated with JE+rabies virus+MenACWY-CRM197 or alone and who received rabies vaccine alone.
|
9.0%
9/100 • day 1 to day 29 (one month postvaccination); day 1 to day 57 (one month post last vaccination)
AEs and SAEs were collected from day 1-29 for subjects vaccinated with typhoid Vi polysaccharide+YF +MenACWY-CRM197 or alone, from day 1-57 vaccinated with JE+rabies virus+MenACWY-CRM197 or alone and who received rabies vaccine alone.
|
5.1%
5/99 • day 1 to day 29 (one month postvaccination); day 1 to day 57 (one month post last vaccination)
AEs and SAEs were collected from day 1-29 for subjects vaccinated with typhoid Vi polysaccharide+YF +MenACWY-CRM197 or alone, from day 1-57 vaccinated with JE+rabies virus+MenACWY-CRM197 or alone and who received rabies vaccine alone.
|
5.9%
6/101 • day 1 to day 29 (one month postvaccination); day 1 to day 57 (one month post last vaccination)
AEs and SAEs were collected from day 1-29 for subjects vaccinated with typhoid Vi polysaccharide+YF +MenACWY-CRM197 or alone, from day 1-57 vaccinated with JE+rabies virus+MenACWY-CRM197 or alone and who received rabies vaccine alone.
|
0.00%
0/51 • day 1 to day 29 (one month postvaccination); day 1 to day 57 (one month post last vaccination)
AEs and SAEs were collected from day 1-29 for subjects vaccinated with typhoid Vi polysaccharide+YF +MenACWY-CRM197 or alone, from day 1-57 vaccinated with JE+rabies virus+MenACWY-CRM197 or alone and who received rabies vaccine alone.
|
2.0%
2/100 • day 1 to day 29 (one month postvaccination); day 1 to day 57 (one month post last vaccination)
AEs and SAEs were collected from day 1-29 for subjects vaccinated with typhoid Vi polysaccharide+YF +MenACWY-CRM197 or alone, from day 1-57 vaccinated with JE+rabies virus+MenACWY-CRM197 or alone and who received rabies vaccine alone.
|
|
Infections and infestations
Nasopharyngitis
|
3.0%
3/101 • day 1 to day 29 (one month postvaccination); day 1 to day 57 (one month post last vaccination)
AEs and SAEs were collected from day 1-29 for subjects vaccinated with typhoid Vi polysaccharide+YF +MenACWY-CRM197 or alone, from day 1-57 vaccinated with JE+rabies virus+MenACWY-CRM197 or alone and who received rabies vaccine alone.
|
3.0%
3/100 • day 1 to day 29 (one month postvaccination); day 1 to day 57 (one month post last vaccination)
AEs and SAEs were collected from day 1-29 for subjects vaccinated with typhoid Vi polysaccharide+YF +MenACWY-CRM197 or alone, from day 1-57 vaccinated with JE+rabies virus+MenACWY-CRM197 or alone and who received rabies vaccine alone.
|
3.0%
3/99 • day 1 to day 29 (one month postvaccination); day 1 to day 57 (one month post last vaccination)
AEs and SAEs were collected from day 1-29 for subjects vaccinated with typhoid Vi polysaccharide+YF +MenACWY-CRM197 or alone, from day 1-57 vaccinated with JE+rabies virus+MenACWY-CRM197 or alone and who received rabies vaccine alone.
|
6.9%
7/101 • day 1 to day 29 (one month postvaccination); day 1 to day 57 (one month post last vaccination)
AEs and SAEs were collected from day 1-29 for subjects vaccinated with typhoid Vi polysaccharide+YF +MenACWY-CRM197 or alone, from day 1-57 vaccinated with JE+rabies virus+MenACWY-CRM197 or alone and who received rabies vaccine alone.
|
3.9%
2/51 • day 1 to day 29 (one month postvaccination); day 1 to day 57 (one month post last vaccination)
AEs and SAEs were collected from day 1-29 for subjects vaccinated with typhoid Vi polysaccharide+YF +MenACWY-CRM197 or alone, from day 1-57 vaccinated with JE+rabies virus+MenACWY-CRM197 or alone and who received rabies vaccine alone.
|
1.0%
1/100 • day 1 to day 29 (one month postvaccination); day 1 to day 57 (one month post last vaccination)
AEs and SAEs were collected from day 1-29 for subjects vaccinated with typhoid Vi polysaccharide+YF +MenACWY-CRM197 or alone, from day 1-57 vaccinated with JE+rabies virus+MenACWY-CRM197 or alone and who received rabies vaccine alone.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place