A Phase 3b, Randomized, Open-Label Study to Evaluate the... | NCT01466387

NCT01466387

ID	Type	Description	Link
2011-000475-14	EudraCT Number

Status Module

Name	Class
Novartis Vaccines	INDUSTRY

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TF+YF	Active Comparator	Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide and yellow fever vaccine.	Biological: Typhoid Vi Polysaccharide Vaccine Biological: Yellow Fever Vaccine
TF + YF + MenACWY-CRM197	Active Comparator	Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide, yellow fever and meningococcal ACWY conjugate vaccine.	Biological: Typhoid Vi Polysaccharide Vaccine Biological: Yellow Fever Vaccine Biological: MenACWY-CRM Vaccine
JE + Rabies	Active Comparator	Subjects ≥18 years to ≤60 years of age who received two doses of Japanese encephalitis and three doses of Rabies vaccine.	Biological: Japanese Encephalitis Vaccine Biological: Rabies Vaccine
JE + Rab + MenACWY-CRM197	Active Comparator	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.	Biological: Japanese Encephalitis Vaccine Biological: Rabies Vaccine Biological: MenACWY-CRM Vaccine
Rabies	Active Comparator

Name	Type	Description	Arm Group Labels	Other Names
Typhoid Vi Polysaccharide Vaccine	Biological	One dose of typhoid Vi polysaccharide vaccine.	TF + YF + MenACWY-CRM197 TF+YF

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	Baseline and 1 month postvaccination (day 29).
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.	Baseline and 1 month postvaccination (day 29).
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.	Baseline and 1 month post last vaccination (day 57).
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.	Baseline and 1 month post last vaccination (day 57).

Secondary Outcomes

Measure	Description	Time Frame
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.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female and male subjects who must be healthy and must be:

Between 18 and 60 years of age inclusive and who have given their written informed consent;
Available for all visits and telephone calls scheduled for the study;
In good health as determined by medical history, physical examination and clinical judgment of the investigator;
For female subjects, having a negative urine pregnancy test.

Exclusion Criteria:

Individuals not eligible to be enrolled in the study are those:

who are breastfeeding;
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);
who have been immunized with any of the study vaccines within the last five years as determined by medical history and/or vaccination card;
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;
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);
who have received an anti-malaria drug, up to 2 months prior to the study;
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;
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);
who have epilepsy, any progressive neurological disease or history of Guillain-Barre syndrome;
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;
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;
who are known to have a bleeding diathesis, or any condition that may be associated with a prolonged bleeding time;
who have myasthenia gravis; thyroid or thymic disorders,
who have any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives;
who are part of the study personnel or close family members of those conducting this study.
for whom a long-term stay (≥ 1 month) was planned in Africa, Latin America, or Asia.

Facility	Status	City	State	ZIP	Country	Contacts
Centrum ockovani a cestovni mediciny (Vaccination and Travel Medicine Centre) Poliklinika II		Bratri Stefanu 895	Hradec Kralove	500 03	Czechia

PubMed Identifier	Type	Citation	Retractions
25308927	Derived	Alberer M, Burchard G, Jelinek T, Reisinger E, Beran J, Hlavata LC, Forleo-Neto E, Dagnew AF, Arora AK. Safety and immunogenicity of typhoid fever and yellow fever vaccines when administered concomitantly with quadrivalent meningococcal ACWY glycoconjugate vaccine in healthy adults. J Travel Med. 2015 Jan-Feb;22(1):48-56. doi: 10.1111/jtm.12164. Epub 2014 Oct 13.
24873986

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	TF+YF	Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide and yellow fever vaccine.
FG001	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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	TF+YF	Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide and yellow fever vaccine.
BG001	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.
BG002	JE+Rabies	Subjects ≥18 years to ≤60 years of age who received two doses of Japanese encephalitis and three doses of Rabies vaccine.
BG003	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.
BG004	Rabies	Subjects ≥18 years to ≤60 years of age who received three doses of Rabies vaccine.
BG005	MenACWY-CRM197 (Combined)	Subjects ≥18 years to ≤60 years of age who received one dose of meningococcal ACWY conjugate vaccine.
BG006	Total	Total of all reporting groups

Units	Counts
Participants	BG000101 BG001100 BG00299 BG003101 BG00451 BG005100 BG006552

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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.

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.

Posted

Geometric Mean

95% Confidence Interval

El.U/mL

Baseline and 1 month postvaccination (day 29).

ID	Title	Description
OG000	TF+YF	Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide and yellow fever vaccine.
OG001	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.

Units	Counts
Participants	OG000100 OG00199

Title

Denominators

Categories

Day 1 (Typhoid Fever)

Title	Measurements
	OG0006.37(5.3 to 7.65) OG0015.6(4.66 to 6.73)

Day 29 (Typhoid Fever)

Title	Measurements
	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	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.	ANCOVA	The ANCOVA model included vaccine group and center as factors, age as covariate and was adjusted for baseline.		The testing was done by assessing the confidence interval of the ratio.	Ratio of GMC	1.14			2-Sided	95	0.81	1.6				Yes

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.

Posted

Geometric Mean

95% Confidence Interval

Titers

Baseline and 1 month postvaccination (day 29).

ID	Title	Description
OG000	TF+YF	Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide and yellow fever vaccine.
OG001	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.

Units	Counts
Participants

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.

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.

Posted

Geometric Mean

95% Confidence Interval

Titers

Baseline and 1 month post last vaccination (day 57).

ID	Title	Description
OG000	JE+Rabies	Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of Rabies vaccine.
OG001	JE+Rab+MenACWY-CRM197	Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of Rabies vaccine and one dose of Meningococcal conjugate vaccine.

Units	Counts

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.

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.

Posted

Geometric Mean

95% Confidence Interval

IU/mL

Baseline and 1 month post last vaccination (day 57).

ID	Title	Description
OG000	JE+Rabies	Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of Rabies vaccine.
OG001	JE+Rab+MenACWY-CRM197	Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of Rabies vaccine and one dose of Meningococcal conjugate vaccine.

Units	Counts

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.

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.

Posted

Number

95% Confidence Interval

Percentages of subjects

Baseline and 1 month postvaccination (day 29).

ID	Title	Description
OG000	TF+YF	Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide and yellow fever vaccine.
OG001	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.

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.

The analysis was done on the MITT data set.

Posted

Number

95% Confidence Interval

Percentages of subects

Baseline and 1 month post last vaccination (day 57).

ID	Title	Description
OG000	JE+Rabies	Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of Rabies vaccine.
OG001	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.

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.

Analysis was done on the MITT data set.

Posted

Number

95% Confidence Interval

Percentages of subjects

Baseline and 1 month post last vaccination (day 57).

ID	Title	Description
OG000	JE+Rabies	Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of Rabies vaccine.
OG001	JE+Rabies+MenACWY-CRM197	Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of Rabies vaccine and one dose of Meningococcal conjugate vaccine.

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.

Analysis was done on the MITT data set.

Posted

Geometric Mean

95% Confidence Interval

titers

Baseline and 1 month postvaccination (day 29).

ID	Title	Description
OG000	MenACWY-CRM197 (Combined)	Subjects ≥18 years to ≤60 years of age who received one dose of meningococcal ACWY conjugate vaccine.
OG001	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.

Units	Counts
Participants

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.

The analysis was done on the MITT data set.

Posted

Number

95% Confidence Interval

Percentages of subjects

1 month postvaccination (day 29)

ID	Title	Description
OG000	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.
OG001	MenACWY-CRM197 (Combined)	Subjects ≥18 years to ≤60 years of age who received one dose of meningococcal ACWY conjugate vaccine.

Units	Counts

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.

The analysis was done on the MITT data set.

Posted

Geometric Mean

95% Confidence Interval

titers

Baseline and 1 month post last vaccination (day 29 or day 57).

ID	Title	Description
OG000	JE + Rab + 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.
OG001	MenACWY-CRM197 (Combined)	Subjects ≥18 years to ≤60 years of age who received one dose of meningococcal ACWY conjugate vaccine.

Units	Counts
Participants

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.

The analysis was done on the MITT data set.

Posted

Number

95% Confidence Interval

Percentages of subjects

1 month post last vaccination (day 29 or day 57)

ID	Title	Description
OG000	JE + Rab + 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.
OG001	MenACWY-CRM197 (Combined)	Subjects ≥18 years to ≤60 years of age who received one dose of meningococcal ACWY conjugate vaccine.

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.

The analysis was done on the MITT data set.

Posted

Geometric Mean

95% Confidence Interval

IU/mL

Baseline and 1 month post last vaccination (day 57).

ID	Title	Description
OG000	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.
OG001	JE + Rabies	Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of rabies vaccine.
OG002	Rabies	Subjects ≥18 years to ≤60 years of age who received three doses of Rabies vaccine

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.

The analysis was done on the MITT data set.

Posted

Number

95% Confidence Interval

Percentages of subjects

Baseline and 1 month post last vaccination (day 57).

ID	Title	Description
OG000	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.
OG001	JE + Rabies	Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of Rabies vaccine.
OG002	Rabies

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.

Analysis was done on the safety data set, i.e. the subjects in the exposed population who provided postvaccination safety data.

Posted

Number

subjects

day 1 to day 57 post last vaccination

ID	Title	Description
OG000	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.
OG001	JE + Rabies	Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of Rabies vaccine.

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	TF+YF	Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide and yellow fever vaccine.	0	101	27	101
EG001	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.	0	100	30	100
EG002	JE+Rabies	Subjects ≥18 years to ≤60 years of age who received two doses of Japanese encephalitis and three doses of Rabies vaccine.	1	99	23	99
EG003	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.	1	101	22	101
EG004	Rabies	Subjects ≥18 years to ≤60 years of age who received three doses of Rabies vaccine.	0	51	9	51
EG005	MenACWY-CRM197 (Combined)	Subjects ≥18 years to ≤60 years of age who received one dose of meningococcal ACWY conjugate vaccine.	0	100	9	100

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Injury	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment		EG0000 affected101 at risk EG0010 affected100 at risk EG0021 affected99 at risk EG0030 affected101 at risk EG0040 affected51 at risk EG0050 affected100 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment		EG0000 affected101 at risk EG0010 affected100 at risk EG0020 affected99 at risk EG003

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Injection site pain	General disorders	MedDRA	Non-systematic Assessment	EG00012 affected101 at risk EG0018 affected100 at risk EG0026 affected99 at risk EG0034 affected101 at risk EG0042 affected51 at risk EG0052 affected100 at risk
Headache	General disorders	MedDRA	Non-systematic Assessment	EG0007 affected101 at risk EG00110 affected100 at risk EG0029 affected99 at risk EG003
Influenza like illness	General disorders	MedDRA	Non-systematic Assessment	EG0005 affected101 at risk EG0019 affected100 at risk EG0025 affected99 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0003 affected101 at risk EG0013 affected100 at risk EG0023 affected99 at risk EG003

ID	Term
D008589	Meningococcal Infections
D008585	Meningitis, Meningococcal
D014435	Typhoid Fever
D015004	Yellow Fever
D011818	Rabies
D004672	Encephalitis, Japanese

ID	Term
D016870	Neisseriaceae Infections
D016905	Gram-Negative Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections
D016920	Meningitis, Bacterial
D020806	Central Nervous System Bacterial Infections
D002494	Central Nervous System Infections
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D008581	Meningitis
D000090862	Neuroinflammatory Diseases
D012480	Salmonella Infections
D004756	Enterobacteriaceae Infections
D000096724	Mosquito-Borne Diseases
D000079426	Vector Borne Diseases
D001102	Arbovirus Infections
D014777	Virus Diseases
D018177	Flavivirus Infections
D018178	Flaviviridae Infections
D012327	RNA Virus Infections
D006482	Hemorrhagic Fevers, Viral
D018353	Rhabdoviridae Infections
D018701	Mononegavirales Infections
D004671	Encephalitis, Arbovirus
D018792	Encephalitis, Viral
D020805	Central Nervous System Viral Diseases
D000069544	Infectious Encephalitis
D004660	Encephalitis
D001927	Brain Diseases

ID	Term
C057664	Vi polysaccharide vaccine, typhoid
D022341	Yellow Fever Vaccine
D022321	Japanese Encephalitis Vaccines
D011819	Rabies Vaccines
C556088	MenACWY-CRM vaccine

ID	Term
D014765	Viral Vaccines
D014612	Vaccines
D001688	Biological Products
D045424	Complex Mixtures