Meningococcal DiseasePhase 3NCT01466387

A Phase 3b, Randomized, Open-Label Study to Evaluate the Safety and Immunogenicity of Select Travel Vaccines When Administered Concomitantly With MenACWY in Adults

A Phase 3 study testing Typhoid Vi Polysaccharide Vaccine, Yellow Fever Vaccine and Japanese Encephalitis Vaccine in people with Meningococcal Disease and Meningococcal Meningitis, run by Novartis at 5 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study compares the safety and immunogenicity profile of several travel vaccines given alone or concomitantly with MenACWY-CRM to healthy adults. Read more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Meningococcal Disease, Meningococcal Meningitis, Typhoid
What is being tested?: Typhoid Vi Polysaccharide Vaccine, Yellow Fever Vaccine and Japanese Encephalitis Vaccine
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 552 participants
Where: 5 sitesin 2 countries
Study dates: Nov 2011to Apr 2012
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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.

Show all 30Show fewer

(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.

Trial locations and contacts

5 sites in 2 countries.

Country

City, postcode or hospital

5 sites in 2 countries

Germany4 sites

Study site
Bernhard Nocht Strasse 74, Free and Hanseatic City of Hamburg, 20359
Berliner Centrum Fur Reise und Tropenmedizin
Jaegerstrasse 67-69, State of Berlin, 10117
University of Munich Georgenstr.5
München, 80799
Universitat Rostock, Ernst Heydemann Str 6
Rostock, 18057

Other trials in Germany

Czechia1 site

Centrum ockovani a cestovni mediciny (Vaccination and Travel Medicine Centre) Poliklinika II
Bratri Stefanu 895, Hradec Kralove, 500 03

Other trials in Czechia

About this study

Official title: A Phase 3b, Randomized, Open-Label Study to Evaluate the Safety and Immunogenicity of Select Travel Vaccines When Administered Concomitantly With Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Adults

This study compares the safety and immunogenicity profile of several travel vaccines given alone or concomitantly with MenACWY-CRM to healthy adults.

Conditions: Meningococcal Disease, Meningococcal Meningitis, Typhoid, Yellow Fever, Rabies, Japanese Encephalitis
Being tested: Typhoid Vi Polysaccharide Vaccine, Yellow Fever Vaccine, Japanese Encephalitis Vaccine, Rabies Vaccine, MenACWY-CRM Vaccine
Keywords: Adults, international travel vaccination, Meningococcal disease, meningococcal meningitis, typhoid, yellow fever, rabies, Japanese encephalitis
Medical subject headings: Meningococcal Infections, Meningitis, Meningococcal, Typhoid Fever, Yellow Fever, Rabies, Encephalitis, Japanese

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Typhoid Vi Polysaccharide VaccineBiological
One dose of typhoid Vi polysaccharide vaccine.
Yellow Fever VaccineBiological
One dose of yellow fever vaccine.
Japanese Encephalitis VaccineBiological
Two doses of Japanese Encephalitis Vaccine.
Rabies VaccineBiological
Three doses of Rabies vaccine.
MenACWY-CRM VaccineBiological
One dose of MenACWY-CRM vaccine.

Study groups in NCT01466387
Study group	Role	What they receive
TF+YF	Active comparator	Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide and yellow fever vaccine. Receives: 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. Receives: 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. Receives: 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. Receives: Biological: Japanese Encephalitis Vaccine; Biological: Rabies Vaccine; Biological: MenACWY-CRM Vaccine
Rabies	Active comparator	Subjects ≥18 years to ≤60 years of age who received three doses of Rabies vaccine. Receives: Biological: Rabies Vaccine
MenACWY-CRM197 (Combined)	Active comparator	Subjects ≥18 years to ≤60 years of age who received one dose of meningococcal ACWY conjugate vaccine. Receives: Biological: MenACWY-CRM Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (10)

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.
Measured: Baseline and 1 month postvaccination (day 29).
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.
Measured: Baseline and 1 month post last vaccination (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
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.
Measured: Baseline and 1 month post last vaccination (day 57).
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.
Measured: Baseline and 1 month postvaccination (day 29).
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.
Measured: 1 month postvaccination (day 29)
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.
Measured: Baseline and 1 month post last vaccination (day 29 or day 57).
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.
Measured: 1 month post last vaccination (day 29 or day 57)
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.
Measured: Baseline and 1 month post last vaccination (day 57).
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.
Measured: Baseline and 1 month post last vaccination (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
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.
Measured: day 1 to day 57 post last vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2011Apr 2012

First posted8 Nov 2011 (estimated)
Study startNov 2011
Primary completionApr 2012
Study completionApr 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Meningococcal DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 552 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01466387
Sponsor's protocol ID: V59_38
Other IDs: 2011-000475-14
Status last verified: Feb 2014
First submitted: 3 Nov 2011
Last updated: 11 Mar 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 25308927
Alberer M, Burchard G, Jelinek T, Reisinger E, Beran J, Meyer S, Forleo-Neto E, Gniel D, Dagnew AF, Arora AK. Co-administration of a meningococcal glycoconjugate ACWY vaccine with travel vaccines: a randomized, open-label, multi-center study. Travel Med Infect Dis. 2014 Sep-Oct;12(5):485-93. doi: 10.1016/j.tmaid.2014.04.011. Epub 2014 May 9.
PubMed 24873986

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Meningococcal Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3b, Randomized, Open-Label Study to Evaluate the Safety and Immunogenicity of Select Travel Vaccines When Administered Concomitantly With Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Adults
ClinicalTrials.gov ID: NCT01466387
Acronym / sponsor ID: V59_38
Conditions: Meningococcal Disease, Meningococcal Meningitis, Typhoid, Yellow Fever, Rabies, Japanese Encephalitis
Keywords: Adults, international travel vaccination, Meningococcal disease, meningococcal meningitis, typhoid, yellow fever, rabies, Japanese encephalitis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 552 participants (actual)
Lead sponsor: NovartisIndustry (pharma, biotech, devices)
Collaborators: Novartis Vaccines
Study start: Nov 2011
Primary completion: Apr 2012 (actual)
Study completion: Apr 2012 (actual)
First posted: 8 Nov 2011 (estimated)
Results: Posted 11 Mar 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study compares the safety and immunogenicity profile of several travel vaccines given alone or concomitantly with MenACWY-CRM to healthy adults.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
TF+YF	Active comparator	Biological: Typhoid Vi Polysaccharide Vaccine, Biological: Yellow Fever VaccineSubjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide and yellow fever vaccine.
TF + YF + MenACWY-CRM197	Active comparator	Biological: Typhoid Vi Polysaccharide Vaccine, Biological: Yellow Fever Vaccine, Biological: MenACWY-CRM VaccineSubjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide, yellow fever and meningococcal ACWY conjugate vaccine.
JE + Rabies	Active comparator	Biological: Japanese Encephalitis Vaccine, Biological: Rabies VaccineSubjects ≥18 years to ≤60 years of age who received two doses of Japanese encephalitis and three doses of Rabies vaccine.
JE + Rab + MenACWY-CRM197	Active comparator	Biological: Japanese Encephalitis Vaccine, Biological: Rabies Vaccine, Biological: MenACWY-CRM VaccineSubjects ≥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	Active comparator	Biological: Rabies VaccineSubjects ≥18 years to ≤60 years of age who received three doses of Rabies vaccine.
MenACWY-CRM197 (Combined)	Active comparator	Biological: MenACWY-CRM VaccineSubjects ≥18 years to ≤60 years of age who received one dose of meningococcal ACWY conjugate vaccine.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (30 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Typhoid Vi Polysaccharide VaccineOne dose of typhoid Vi polysaccharide vaccine.	Biological	TF + YF + MenACWY-CRM197, TF+YF
Yellow Fever VaccineOne dose of yellow fever vaccine.	Biological	TF + YF + MenACWY-CRM197, TF+YF
Japanese Encephalitis VaccineTwo doses of Japanese Encephalitis Vaccine.	Biological	JE + Rab + MenACWY-CRM197, JE + Rabies
Rabies VaccineThree doses of Rabies vaccine.	Biological	JE + Rab + MenACWY-CRM197, JE + Rabies, Rabies
MenACWY-CRM VaccineOne dose of MenACWY-CRM vaccine.	Biological	JE + Rab + MenACWY-CRM197, MenACWY-CRM197 (Combined), TF + YF + MenACWY-CRM197

Primary outcome

Geometric Mean Anti-typhoid Vi Antibody Concentrations
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.

10 secondary outcomes

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
Time frame: Baseline and 1 month postvaccination (day 29).
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
Time frame: Baseline and 1 month post last vaccination (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
Time frame: Baseline and 1 month post last vaccination (day 57).
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
Time frame: Baseline and 1 month postvaccination (day 29).
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
Time frame: 1 month postvaccination (day 29)
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
Time frame: Baseline and 1 month post last vaccination (day 29 or day 57).
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
Time frame: 1 month post last vaccination (day 29 or day 57)
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
Time frame: Baseline and 1 month post last vaccination (day 57).
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
Time frame: Baseline and 1 month post last vaccination (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
Time frame: day 1 to day 57 post last vaccination

Results and safety

Results posted to the registry on 11 Mar 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TF+YF	101	100
TF+YF+MenACWY-CRM197	100	100
JE+Rabies	99	98
JE+Rabies+MenACWY-CRM197	101	99
Rabies	51	51
MenACWY-CRM197 (Combined)	100	99

Primary outcome: Geometric Mean Anti-typhoid Vi Antibody Concentrations

Time frame: Baseline and 1 month postvaccination (day 29).. Geometric mean (95% Confidence Interval). Unit: El.U/mL

Measure	TF+YF n = 100	TF+YF+MenACWY-CRM197 n = 99
Day 1 (Typhoid Fever)	6.37 (5.3 to 7.65)	5.6 (4.66 to 6.73)
Day 29 (Typhoid Fever)	134 (104 to 174)	153 (118 to 197)

TF+YF vs TF+YF+MenACWY-CRM197: Ratio of GMC: 1.14 (95% CI 0.81 to 1.6), ANCOVA

Population analysed: 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.

Primary outcome: Geometric Mean Anti-Yellow Fever Antibody Titer

Time frame: Baseline and 1 month postvaccination (day 29).. Geometric mean (95% Confidence Interval). Unit: Titers

Measure	TF+YF n = 100	TF+YF+MenACWY-CRM197 n = 99
Day 1 (Yellow Fever)	9.05 (6.82 to 12)	12 (8.68 to 15)
Day 29 (Yellow Fever)	5244 (3929 to 7000)	5022 (3754 to 6717)

TF+YF vs TF+YF+MenACWY-CRM197: Ratio of GMT.: 0.96 (95% CI 0.65 to 1.41), ANCOVA

Primary outcome: Geometric Mean Anti-Japanese Encephalitis Neutralizing Antibody Titers

Time frame: Baseline and 1 month post last vaccination (day 57).. Geometric mean (95% Confidence Interval). Unit: Titers

Measure	JE+Rabies n = 96	JE+Rab+MenACWY-CRM197 n = 97
Day 1 (Japanese Encephalitis)	5.61 (5.11 to 6.15)	5.58 (5.09 to 6.12)
Day 57 (Japanese Encephalitis)	183 (151 to 221)	165 (136 to 199)

JE+Rabies vs JE+Rab+MenACWY-CRM197: Ratio of GMT: 0.9 (95% CI 0.7 to 1.16), ANCOVA

Population analysed: 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.

Primary outcome: Geometric Mean Anti-Rabies Virus Neutralizing Antibody Concentration

Time frame: Baseline and 1 month post last vaccination (day 57).. Geometric mean (95% Confidence Interval). Unit: IU/mL

Measure	JE+Rabies n = 96	JE+Rab+MenACWY-CRM197 n = 97
Day 1 (Rabies)	0.056 (0.05 to 0.062)	0.049 (0.044 to 0.054)
Day 57 (Rabies)	12 (9.68 to 14)	11 (8.84 to 13)

JE+Rabies vs JE+Rab+MenACWY-CRM197: Ratio of GMC: 0.91 (95% CI 0.71 to 1.17), ANCOVA

Population analysed: 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.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: day 1 to day 29 (one month postvaccination); day 1 to day 57 (one month post last vaccination). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TF+YF	0 of 101 (0%)	27 of 101 (26.7%)	Not reported
TF+YF+MenACWY-CRM197	0 of 100 (0%)	30 of 100 (30%)	Not reported
JE+Rabies	1 of 99 (1%)	23 of 99 (23.2%)	Not reported
JE+Rabies+MenACWY-CRM197	1 of 101 (1%)	22 of 101 (21.8%)	Not reported
Rabies	0 of 51 (0%)	9 of 51 (17.6%)	Not reported
MenACWY-CRM197 (Combined)	0 of 100 (0%)	9 of 100 (9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25308927Alberer 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.
Derived from this study: PubMed 24873986Alberer M, Burchard G, Jelinek T, Reisinger E, Beran J, Meyer S, Forleo-Neto E, Gniel D, Dagnew AF, Arora AK. Co-administration of a meningococcal glycoconjugate ACWY vaccine with travel vaccines: a randomized, open-label, multi-center study. Travel Med Infect Dis. 2014 Sep-Oct;12(5):485-93. doi: 10.1016/j.tmaid.2014.04.011. Epub 2014 May 9.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

5 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Germany, Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Geometric Mean Anti-typhoid Vi Antibody Concentrations (time frame: Baseline and 1 month postvaccination (day 29).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01466387, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2014.