Study to Evaluate the Safety and Immunogenicity of Travel Vaccines when Administered Concomitantly with Meningococcal ACWY Conjugate Vaccine in Healthy Adults

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-000475-14-DE

Enrollment

550

Registered

2011-06-08

Start date

2011-10-25

Completion date

Unknown

Last updated

2013-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Study to Evaluate the Safety and Immunogenicity of Select Travel Vaccines when Administered Concomitantly with Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Adults MedDRA version: 14.0 Level: PT Classification code 10027202 Term: Meningitis bacterial System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: Menveo Product Name: Novartis MenACWY Conjugate Vaccine Pharmaceutical Form: Powder and solution for solution for injection INN or Proposed INN: NA CAS Number: NA Current Sponsor code: NA

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion Criteria: Female and male subjects eligible to be enrolled in this study must be: ? available for all study visits, ? able to give written informed consent, ? between 18 and 60 years of age, and ? generally in good health. Subjects with previous vaccination with one or more antigens related to any of the study vaccines, determined by history (interview of the subject) and/or by review of his or her vaccination card, will be eligible to participate in the study if more than 5 years have elapsed since vaccination. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 550 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Exclusion criteria: Serious, acute, or chronic illnesses are reasons for exclusion. Women will be required to have a negative urine pregnancy test before being enrolled in the study. The full list of inclusion and exclusion criteria is included in protocol section 4.0. 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) is considered exclusion criteria.

Design outcomes

Primary

Measure	Time frame
Main Objective: Primary Africa/Latam Traveler Scheme ? To establish the non-inferiority of typhoid Vi polysaccharide and yellow fever vaccines given concomitantly with MenACWY-CRM to typhoid Vi polysaccharide and yellow fever vaccines given alone, as measured by geometric mean titers/concentrations (GMTs/GMCs) to typhoid and yellow fever, 28 days after vaccine administration (Group 2 vs.1). Asia Traveler Scheme ? To establish the non-inferiority of Japanese encephalitis and rabies virus vaccines given concomitantly with MenACWY-CRM to Japanese encephalitis and rabies virus vaccines given alone, as measured by GMTs to Japanese encephalitis 28 days after administration of the 2nd dose of Japanese encephalitis vaccine and by GMCs to rabies 28 days after administration of the 3rd dose of rabies virus vaccine (Group 5 vs. 4).;Secondary Objective: To assess seroprotection rates elicited by typhoid Vi polysaccharide and yellow fever vaccines 28 days after vaccine administration, given alone or concomitantly with MenACWY-CRM. To assess seroprotection rates elicited by Japanese encephalitis and rabies virus vaccines, 28 days after administration of the 2nd dose of Japanese encephalitis virus vaccine and 28 days after the administration of 3rd dose of rabies virus vaccine, given alone or concomitantly with MenACWY-CRM. To assess the immune response of MenACWY-CRM as measured by GMTs, 28 days after vaccination, when administered concomitantly with typhoid Vi polysaccharide and yellow fever vaccines or given alone. To assess seroresponse rates elicited by MenACWY-CRM, 28 days after vaccination when administered concomitantly with typhoid Vi polysaccharide and yellow fever vaccines or given alone. Please refer to protocol for further information on additional secondary immunogenicity and safety objectives.;Primary end point(s): Primary Endpoints Africa/Latam Traveler Scheme ? GMTs/GMCs of antibodies to typhoid Vi polysaccharide and yellow fever virus on Day 29. Asia Traveler Sch	—

Measure

Time frame

Main Objective: Primary Africa/Latam Traveler Scheme ? To establish the non-inferiority of typhoid Vi polysaccharide and yellow fever vaccines given concomitantly with MenACWY-CRM to typhoid Vi polysaccharide and yellow fever vaccines given alone, as measured by geometric mean titers/concentrations (GMTs/GMCs) to typhoid and yellow fever, 28 days after vaccine administration (Group 2 vs.1). Asia Traveler Scheme ? To establish the non-inferiority of Japanese encephalitis and rabies virus vaccines given concomitantly with MenACWY-CRM to Japanese encephalitis and rabies virus vaccines given alone, as measured by GMTs to Japanese encephalitis 28 days after administration of the 2nd dose of Japanese encephalitis vaccine and by GMCs to rabies 28 days after administration of the 3rd dose of rabies virus vaccine (Group 5 vs. 4).;Secondary Objective: To assess seroprotection rates elicited by typhoid Vi polysaccharide and yellow fever vaccines 28 days after vaccine administration, given alone or concomitantly with MenACWY-CRM. To assess seroprotection rates elicited by Japanese encephalitis and rabies virus vaccines, 28 days after administration of the 2nd dose of Japanese encephalitis virus vaccine and 28 days after the administration of 3rd dose of rabies virus vaccine, given alone or concomitantly with MenACWY-CRM. To assess the immune response of MenACWY-CRM as measured by GMTs, 28 days after vaccination, when administered concomitantly with typhoid Vi polysaccharide and yellow fever vaccines or given alone. To assess seroresponse rates elicited by MenACWY-CRM, 28 days after vaccination when administered concomitantly with typhoid Vi polysaccharide and yellow fever vaccines or given alone. Please refer to protocol for further information on additional secondary immunogenicity and safety objectives.;Primary end point(s): Primary Endpoints Africa/Latam Traveler Scheme ? GMTs/GMCs of antibodies to typhoid Vi polysaccharide and yellow fever virus on Day 29. Asia Traveler Sch

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Secondary

Measure	Time frame
Secondary end point(s): Secondary Endpoints Africa/Latam Traveler Scheme ? Percentage of subjects with anti-typhoid Vi antibodies = 150 El.U/mL on Day 29. ? Percentage of subjects with anti-YF neutralizing antibody titers = 1/10 on Day 29. Asia Traveler Scheme ? Percentage of subjects with anti-JE neutralizing antibody titers = 1/10 on Day 57. ? Percentage of subjects with anti-rabies virus antibody concentrations = 0.5 IU/mL on Day 57. Africa/Latam & Asia Traveler Schemes ? GMTs of antibodies to meningococcal serogroups A, C, W and Y on Day 29. ? Seroresponse rates for meningococcal serogroups A, C, W and Y on Day 29. For a subject with a baseline hSBA titer < 1:4, 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 post-vaccination hSBA titer of at least 4 times the baseline. Safety Endpoints Safety will be assessed for all subjects in terms of the frequency and percentage of spontaneously reported adverse events (AEs) and serious adverse events (SAEs). AEs and SAEs will be collected from the time the subject signs the ICF until he or she stops study participation. For subjects in Groups 4 and 5, in addition to the above referenced AEs and SAEs, additional AESI will be collected and assessed.;Timepoint(s) of evaluation of this end point: 1 to 2 Months	—

Measure

Time frame

Secondary end point(s): Secondary Endpoints Africa/Latam Traveler Scheme ? Percentage of subjects with anti-typhoid Vi antibodies = 150 El.U/mL on Day 29. ? Percentage of subjects with anti-YF neutralizing antibody titers = 1/10 on Day 29. Asia Traveler Scheme ? Percentage of subjects with anti-JE neutralizing antibody titers = 1/10 on Day 57. ? Percentage of subjects with anti-rabies virus antibody concentrations = 0.5 IU/mL on Day 57. Africa/Latam & Asia Traveler Schemes ? GMTs of antibodies to meningococcal serogroups A, C, W and Y on Day 29. ? Seroresponse rates for meningococcal serogroups A, C, W and Y on Day 29. For a subject with a baseline hSBA titer < 1:4, 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 post-vaccination hSBA titer of at least 4 times the baseline. Safety Endpoints Safety will be assessed for all subjects in terms of the frequency and percentage of spontaneously reported adverse events (AEs) and serious adverse events (SAEs). AEs and SAEs will be collected from the time the subject signs the ICF until he or she stops study participation. For subjects in Groups 4 and 5, in addition to the above referenced AEs and SAEs, additional AESI will be collected and assessed.;Timepoint(s) of evaluation of this end point: 1 to 2 Months

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Countries

Czech Republic, Germany

Contacts

Public ContactRegulatory Affairs Manager

Novartis Vaccines and Diagnostics S.r.l.

dario.de_angelis@novartis.com+390577245421

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026