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

NCT01466387 | Completed Phase 3 Results DMC

• 2 other identifiers: V59_382011-000475-14
• Study Type: interventional
• Target: 552
• Locations: 2 countries
• Sites: 5

Brief Summary

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

Keywords

Adults; international travel vaccination; Meningococcal disease; meningococcal meningitis; typhoid; yellow fever; rabies; Japanese encephalitis

Outcome Measures

Primary Outcomes (4)

• 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 (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

  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

  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

  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

  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

  1 month postvaccination (day 29)

Study Arms (6)

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

Subjects ≥18 years to ≤60 years of age who received three doses of Rabies vaccine.

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.

Biological: MenACWY-CRM Vaccine

Interventions

Typhoid Vi Polysaccharide Vaccine BIOLOGICAL

One dose of typhoid Vi polysaccharide vaccine.

TF + YF + MenACWY-CRM197; TF+YF

Yellow Fever Vaccine BIOLOGICAL

One dose of yellow fever vaccine.

TF + YF + MenACWY-CRM197; TF+YF

Japanese Encephalitis Vaccine BIOLOGICAL

Two doses of Japanese Encephalitis Vaccine.

JE + Rab + MenACWY-CRM197; JE + Rabies

Rabies Vaccine BIOLOGICAL

Three doses of Rabies vaccine.

JE + Rab + MenACWY-CRM197; JE + Rabies; Rabies

MenACWY-CRM Vaccine BIOLOGICAL

One dose of MenACWY-CRM vaccine.

JE + Rab + MenACWY-CRM197; MenACWY-CRM197 (Combined); TF + YF + MenACWY-CRM197

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis: lead
• Novartis Vaccines: collaborator

Study Sites (5)

Centrum ockovani a cestovni mediciny (Vaccination and Travel Medicine Centre) Poliklinika II

Bratri Stefanu 895, Hradec Kralove, 500 03, Czechia

Location

Unknown Facility

Bernhard Nocht Strasse 74, Hamburg, 20359, Germany

Location

Berliner Centrum Fur Reise und Tropenmedizin

Jaegerstrasse 67-69, State of Berlin, 10117, Germany

Location

University of Munich Georgenstr.5

München, 80799, Germany

Location

Universitat Rostock, Ernst Heydemann Str 6

Rostock, 18057, Germany

Location

Related Publications (2)

• 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.

  PMID: 25308927 DERIVED

• 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.

  PMID: 24873986 DERIVED

MeSH Terms

Conditions

Meningococcal Infections; Meningitis, Meningococcal; Typhoid Fever; Yellow Fever; Rabies; Encephalitis, Japanese

Interventions

Vi polysaccharide vaccine, typhoid; Yellow Fever Vaccine; Japanese Encephalitis Vaccines; Rabies Vaccines; MenACWY-CRM vaccine

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Meningitis, Bacterial; Central Nervous System Bacterial Infections; Central Nervous System Infections; Central Nervous System Diseases; Nervous System Diseases; Meningitis; Neuroinflammatory Diseases; Salmonella Infections; Enterobacteriaceae Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral; Rhabdoviridae Infections; Mononegavirales Infections; Encephalitis, Arbovirus; Encephalitis, Viral; Central Nervous System Viral Diseases; Infectious Encephalitis; Encephalitis; Brain Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Posting Director
• Organization: Novartis Vaccines and Diagnostics

RegistryContactVaccinesUS@novartis.com

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2011
• First Posted: November 8, 2011
• Study Start: November 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: March 11, 2014
• Results First Posted: March 11, 2014

Record last verified: 2014-02

Locations

DE (4); CZ (1)