Meningococcal Disease, Meningococcal Meningitis, Typhoid, Yellow Fever, Rabies, Japanese Encephalitis
Conditions
Keywords
Adults, international travel vaccination, Meningococcal disease, meningococcal meningitis, typhoid, yellow fever, rabies, Japanese encephalitis
Brief summary
This study compares the safety and immunogenicity profile of several travel vaccines given alone or concomitantly with MenACWY-CRM to healthy adults.
Interventions
BIOLOGICALTyphoid Vi Polysaccharide Vaccine
One dose of typhoid Vi polysaccharide vaccine.
BIOLOGICALYellow Fever Vaccine
One dose of yellow fever vaccine.
BIOLOGICALJapanese Encephalitis Vaccine
Two doses of Japanese Encephalitis Vaccine.
BIOLOGICALRabies Vaccine
Three doses of Rabies vaccine.
BIOLOGICALMenACWY-CRM Vaccine
One dose of MenACWY-CRM vaccine.
Sponsors
Novartis Vaccines
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
Female and male subjects who must be healthy and must be: 1. Between 18 and 60 years of age inclusive and who have given their written informed consent; 2. Available for all visits and telephone calls scheduled for the study; 3. In good health as determined by medical history, physical examination and clinical judgment of the investigator; 4. For female subjects, having a negative urine pregnancy test.
Exclusion criteria
Individuals not eligible to be enrolled in the study are those: 1. who are breastfeeding; 2. who have a personal history of Neisseria meningitidis infection, typhoid fever, rabies, or any flavivirus infection (e.g., Japanese encephalitis, tick-borne encephalitis, yellow fever, dengue fever, West Nile virus infection); 3. who have been immunized with any of the study vaccines within the last five years as determined by medical history and/or vaccination card; 4. who have received investigational agents or vaccines within 30 days prior to enrollment or who expect to receive an investigational agent or vaccine prior to completion of the study; 5. who have received live licensed vaccines within 30 days and inactive vaccine within 15 days prior to enrollment or for whom receipt of a licensed vaccine is anticipated during the study period. (Exception: Influenza vaccine may be administered up to 15 days prior to each study immunization and no less than 15 days after each study immunization); 6. who have received an anti-malaria drug, up to 2 months prior to the study; 7. who have experienced, within the 7 days prior to enrollment, significant acute infection (for example requiring systemic antibiotic treatment or antiviral therapy) or have experienced fever (defined as body temperature ≥ 38°C) within 3 days prior to enrollment; 8. who have any serious acute, chronic or progressive disease such as: * history of cancer * complicated diabetes mellitus * advanced arteriosclerotic disease * autoimmune disease * HIV infection or AIDS * blood dyscrasias * congestive heart failure * renal failure * severe malnutrition (Note: Subjects with mild asthma are eligible for enrollment. Subjects with moderate or severe asthma requiring routine use of inhaled or systemic corticosteroids are not eligible for enrollment); 9. who have epilepsy, any progressive neurological disease or history of Guillain-Barre syndrome; 10. who have a history of anaphylaxis, serious vaccine reactions, or allergy to any vaccine component, including but not limited to latex allergy, egg allergy, antibiotic allergy, chicken proteins or gelatin allergy; 11. who have a known or suspected impairment/alteration of immune function, either congenital or acquired or resulting from (for example): * receipt of immunosuppressive therapy within 30 days prior to enrollment (systemic corticosteroids administered for more than 5 days, or in a daily dose \> 1 mg/kg/day prednisone or equivalent during any of 30 days prior to enrollment, or cancer chemotherapy); * receipt of immunostimulants; * receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within 90 days prior to enrollment and for the full length of the study; 12. who are known to have a bleeding diathesis, or any condition that may be associated with a prolonged bleeding time; 13. who have myasthenia gravis; thyroid or thymic disorders, 14. who have any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives; 15. who are part of the study personnel or close family members of those conducting this study. 16. for whom a long-term stay (≥ 1 month) was planned in Africa, Latin America, or Asia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Anti-typhoid Vi Antibody Concentrations | Baseline and 1 month postvaccination (day 29). | 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. |
| Geometric Mean Anti-Yellow Fever Antibody Titer | Baseline and 1 month postvaccination (day 29). | 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. |
| Geometric Mean Anti-Japanese Encephalitis Neutralizing Antibody Titers | Baseline and 1 month post last vaccination (day 57). | 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. |
| Geometric Mean Anti-Rabies Virus Neutralizing Antibody Concentration | Baseline and 1 month post last vaccination (day 57). | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 1 month postvaccination (day 29) | 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. |
| 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 | Baseline and 1 month post last vaccination (day 29 or day 57). | 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. |
| 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 | 1 month post last vaccination (day 29 or day 57) | 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. |
| 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 | Baseline and 1 month postvaccination (day 29). | 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. |
| 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 | Baseline and 1 month post last vaccination (day 57). | 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. |
| 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 | day 1 to day 57 post last vaccination | 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. |
| 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 | Baseline and 1 month post last vaccination (day 57). | 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. |
| 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 | Baseline and 1 month post last vaccination (day 57). | 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. |
| 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 | Baseline and 1 month post last vaccination (day 57). | 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. |
| 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 | Baseline and 1 month postvaccination (day 29). | 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. |
Countries
Czechia, Germany
Participant flow
Recruitment details
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)
Pre-assignment details
All enrolled subjects were included in the trial.
Participants by arm
| Arm | Count |
|---|---|
| TF+YF Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide and yellow fever vaccine. | 101 |
| 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. | 100 |
| JE+Rabies Subjects ≥18 years to ≤60 years of age who received two doses of Japanese encephalitis and three doses of Rabies vaccine. | 99 |
| 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. | 101 |
| Rabies Subjects ≥18 years to ≤60 years of age who received three doses of Rabies vaccine. | 51 |
| MenACWY-CRM197 (Combined) Subjects ≥18 years to ≤60 years of age who received one dose of meningococcal ACWY conjugate vaccine. | 100 |
| Total | 552 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| 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
| Characteristic | TF+YF | TF+YF+MenACWY-CRM197 | JE+Rabies | JE+Rabies+MenACWY-CRM197 | Rabies | MenACWY-CRM197 (Combined) | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 36.5 years STANDARD_DEVIATION 10.8 | 35.1 years STANDARD_DEVIATION 11 | 35.0 years STANDARD_DEVIATION 11.5 | 35.0 years STANDARD_DEVIATION 11.1 | 35.8 years STANDARD_DEVIATION 11.6 | 36.9 years STANDARD_DEVIATION 11.2 | 35.7 years STANDARD_DEVIATION 11.2 |
| Sex: Female, Male Female | 49 Participants | 44 Participants | 53 Participants | 50 Participants | 21 Participants | 50 Participants | 267 Participants |
| Sex: Female, Male Male | 52 Participants | 56 Participants | 46 Participants | 51 Participants | 30 Participants | 50 Participants | 285 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 27 / 101 | 30 / 100 | 23 / 99 | 22 / 101 | 9 / 51 | 9 / 100 |
| serious Total, serious adverse events | 0 / 101 | 0 / 100 | 1 / 99 | 1 / 101 | 0 / 51 | 0 / 100 |
Outcome results
Primary
Geometric Mean Anti-Japanese Encephalitis Neutralizing Antibody Titers
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.
Time frame: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| TF+YF | Geometric Mean Anti-Japanese Encephalitis Neutralizing Antibody Titers | Day 1 (Japanese Encephalitis) | 5.61 Titers |
| TF+YF | Geometric Mean Anti-Japanese Encephalitis Neutralizing Antibody Titers | Day 57 (Japanese Encephalitis) | 183 Titers |
| TF+YF+MenACWY-CRM197 | Geometric Mean Anti-Japanese Encephalitis Neutralizing Antibody Titers | Day 1 (Japanese Encephalitis) | 5.58 Titers |
| TF+YF+MenACWY-CRM197 | Geometric Mean Anti-Japanese Encephalitis Neutralizing Antibody Titers | Day 57 (Japanese Encephalitis) | 165 Titers |
Comparison: The primary criterion for immunogenicity (postvaccination, day 57) was that the lower limit of the two sided 95% CI around the observed ratio of geometric mean titers between the second dose of Japanese Encephalitis and third dose of rabies virus vaccines given concomitantly with MenACWY-CRM197 to Japanese Encephalitis and rabies virus vaccines given alone was greater than 0.5.95% CI: [0.7, 1.16]ANCOVA
Primary
Geometric Mean Anti-Rabies Virus Neutralizing Antibody Concentration
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.
Time frame: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| TF+YF | Geometric Mean Anti-Rabies Virus Neutralizing Antibody Concentration | Day 1 (Rabies) | 0.056 IU/mL |
| TF+YF | Geometric Mean Anti-Rabies Virus Neutralizing Antibody Concentration | Day 57 (Rabies) | 12 IU/mL |
| TF+YF+MenACWY-CRM197 | Geometric Mean Anti-Rabies Virus Neutralizing Antibody Concentration | Day 1 (Rabies) | 0.049 IU/mL |
| TF+YF+MenACWY-CRM197 | Geometric Mean Anti-Rabies Virus Neutralizing Antibody Concentration | Day 57 (Rabies) | 11 IU/mL |
Comparison: The primary criterion for immunogenicity (postvaccination, day 57) was that the lower limit of the two sided 95% CI around the observed ratio of geometric mean concentrations between the second dose of Japanese encephalitis and third dose of rabies virus vaccines given concomitantly with MenACWY-CRM197 to Japanese encephalitis and rabies virus vaccines given alone was greater than 0.5.95% CI: [0.71, 1.17]ANCOVA
Primary
Geometric Mean Anti-typhoid Vi Antibody Concentrations
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.
Time frame: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| TF+YF | Geometric Mean Anti-typhoid Vi Antibody Concentrations | Day 29 (Typhoid Fever) | 134 El.U/mL |
| TF+YF | Geometric Mean Anti-typhoid Vi Antibody Concentrations | Day 1 (Typhoid Fever) | 6.37 El.U/mL |
| TF+YF+MenACWY-CRM197 | Geometric Mean Anti-typhoid Vi Antibody Concentrations | Day 1 (Typhoid Fever) | 5.6 El.U/mL |
| TF+YF+MenACWY-CRM197 | Geometric Mean Anti-typhoid Vi Antibody Concentrations | Day 29 (Typhoid Fever) | 153 El.U/mL |
Comparison: The primary criterion for immunogenicity (postvaccination, day 29) was that the lower limit of the two-sided 95% confidence interval around the observed ratio of geometric mean concentrations between one dose of typhoid Vi polysaccharide and yellow fever vaccines given concomitantly with MenACWY-CRM197 to typhoid Vi polysaccharide and yellow fever vaccines given alone was greater than 0.5.95% CI: [0.81, 1.6]ANCOVA
Primary
Geometric Mean Anti-Yellow Fever Antibody Titer
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.
Time frame: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| TF+YF | Geometric Mean Anti-Yellow Fever Antibody Titer | Day 1 (Yellow Fever) | 9.05 Titers |
| TF+YF | Geometric Mean Anti-Yellow Fever Antibody Titer | Day 29 (Yellow Fever) | 5244 Titers |
| TF+YF+MenACWY-CRM197 | Geometric Mean Anti-Yellow Fever Antibody Titer | Day 1 (Yellow Fever) | 12 Titers |
| TF+YF+MenACWY-CRM197 | Geometric Mean Anti-Yellow Fever Antibody Titer | Day 29 (Yellow Fever) | 5022 Titers |
Comparison: The primary criterion for immunogenicity (postvaccination, day 29) was that the lower limit of the two sided 95% CI around the observed ratio of geometric mean titers between one dose of typhoid Vi polysaccharide and yellow fever vaccines given concomitantly with MenACWY-CRM197 to typhoid Vi polysaccharide and yellow fever vaccines given alone was greater than 0.5.95% CI: [0.65, 1.41]ANCOVA
Secondary
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
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.
Time frame: Baseline and 1 month post last vaccination (day 29 or day 57).
Population: The analysis was done on the MITT data set.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| TF+YF | 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 |
| TF+YF | 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 |
| TF+YF | 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 |
| TF+YF | 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 |
| TF+YF | 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 |
| TF+YF | 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 |
| TF+YF | 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 |
| TF+YF | 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 |
| TF+YF+MenACWY-CRM197 | 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) | 50 titers |
| TF+YF+MenACWY-CRM197 | 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) | 2.94 titers |
| TF+YF+MenACWY-CRM197 | 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) | 89 titers |
| TF+YF+MenACWY-CRM197 | 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) | 65 titers |
| TF+YF+MenACWY-CRM197 | 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) | 129 titers |
| TF+YF+MenACWY-CRM197 | 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) | 7.94 titers |
| TF+YF+MenACWY-CRM197 | 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) | 49 titers |
| TF+YF+MenACWY-CRM197 | 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) | 7.61 titers |
Secondary
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
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.
Time frame: Baseline and 1 month postvaccination (day 29).
Population: Analysis was done on the MITT data set.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| TF+YF | 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 |
| TF+YF | 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 |
| TF+YF | 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 |
| TF+YF | 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 |
| TF+YF | 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 |
| TF+YF | 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 |
| TF+YF | 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 |
| TF+YF | 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 |
| TF+YF+MenACWY-CRM197 | 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) | 32 titers |
| TF+YF+MenACWY-CRM197 | 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) | 2.78 titers |
| TF+YF+MenACWY-CRM197 | 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) | 62 titers |
| TF+YF+MenACWY-CRM197 | 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) | 7.03 titers |
| TF+YF+MenACWY-CRM197 | 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) | 7.76 titers |
| TF+YF+MenACWY-CRM197 | 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) | 54 titers |
| TF+YF+MenACWY-CRM197 | 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) | 211 titers |
| TF+YF+MenACWY-CRM197 | 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) | 78 titers |
Secondary
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
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.
Time frame: Baseline and 1 month post last vaccination (day 57).
Population: The analysis was done on the MITT data set.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| TF+YF | 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 |
| TF+YF | 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 |
| TF+YF+MenACWY-CRM197 | 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) | 0.057 IU/mL |
| TF+YF+MenACWY-CRM197 | 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 |
| Rabies | 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) | 0.068 IU/mL |
| Rabies | 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) | 8.97 IU/mL |
Secondary
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
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.
Time frame: day 1 to day 57 post last vaccination
Population: Analysis was done on the safety data set, i.e. the subjects in the exposed population who provided postvaccination safety data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TF+YF | 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 |
| TF+YF | 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 |
| TF+YF | 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 |
| TF+YF | 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 |
| TF+YF | 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 |
| TF+YF | 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 |
| TF+YF+MenACWY-CRM197 | 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 | 1 subjects |
| TF+YF+MenACWY-CRM197 | 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 | 1 subjects |
| TF+YF+MenACWY-CRM197 | 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 | 0 subjects |
| TF+YF+MenACWY-CRM197 | 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 |
| TF+YF+MenACWY-CRM197 | 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 | 0 subjects |
| TF+YF+MenACWY-CRM197 | 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 | 0 subjects |
Secondary
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
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.
Time frame: Baseline and 1 month post last vaccination (day 57).
Population: The analysis was done on the MITT data set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TF+YF | 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 |
| TF+YF | 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 |
| TF+YF+MenACWY-CRM197 | 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) | 4 Percentages of subects |
| TF+YF+MenACWY-CRM197 | 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) | 98 Percentages of subects |
Secondary
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
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.
Time frame: Baseline and 1 month post last vaccination (day 57).
Population: Analysis was done on the MITT data set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TF+YF | 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 |
| TF+YF | 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 |
| TF+YF+MenACWY-CRM197 | 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) | 1 Percentages of subjects |
| TF+YF+MenACWY-CRM197 | 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 |
Secondary
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
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.
Time frame: Baseline and 1 month post last vaccination (day 57).
Population: The analysis was done on the MITT data set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TF+YF | 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 |
| TF+YF | 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 |
| TF+YF+MenACWY-CRM197 | 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 |
| TF+YF+MenACWY-CRM197 | 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) | 3 Percentages of subjects |
| Rabies | 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 |
| Rabies | 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) | 8 Percentages of subjects |
Secondary
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
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TF+YF | 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 |
| TF+YF | 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 |
| TF+YF+MenACWY-CRM197 | 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) | 36 Percentages of subjects |
| TF+YF+MenACWY-CRM197 | 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) | 97 Percentages of subjects |
Secondary
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
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.
Time frame: 1 month post last vaccination (day 29 or day 57)
Population: The analysis was done on the MITT data set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TF+YF | 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 |
| TF+YF | 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 |
| TF+YF | 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 |
| TF+YF | 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 |
| TF+YF+MenACWY-CRM197 | 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) | 30 Percentages of subjects |
| TF+YF+MenACWY-CRM197 | 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) | 71 Percentages of subjects |
| TF+YF+MenACWY-CRM197 | 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) | 66 Percentages of subjects |
| TF+YF+MenACWY-CRM197 | 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) | 47 Percentages of subjects |
Secondary
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
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.
Time frame: 1 month postvaccination (day 29)
Population: The analysis was done on the MITT data set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TF+YF | 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 |
| TF+YF | 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 |
| TF+YF | 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 |
| TF+YF | 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 |
| TF+YF+MenACWY-CRM197 | 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) | 30 Percentages of subjects |
| TF+YF+MenACWY-CRM197 | 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) | 71 Percentages of subjects |
| TF+YF+MenACWY-CRM197 | 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) | 66 Percentages of subjects |
| TF+YF+MenACWY-CRM197 | 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) | 47 Percentages of subjects |