CompletedPhase 3

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

Czechia, Germany552 participantsStarted 2011-11

Plain-language summary

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

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Geometric Mean Anti-typhoid Vi Antibody Concentrations

Timeframe: Baseline and 1 month postvaccination (day 29).

Geometric Mean Anti-Yellow Fever Antibody Titer

Timeframe: Baseline and 1 month postvaccination (day 29).

Geometric Mean Anti-Japanese Encephalitis Neutralizing Antibody Titers

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

Geometric Mean Anti-Rabies Virus Neutralizing Antibody Concentration

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

Trial details

NCT IDNCT01466387

SponsorNovartis

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-04

Results submitted2013-08-21

View on ClinicalTrials.gov More Meningococcal Disease trials

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

. 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.

What they're measuring

Geometric Mean Anti-typhoid Vi Antibody Concentrations

Timeframe: Baseline and 1 month postvaccination (day 29).

Geometric Mean Anti-Yellow Fever Antibody Titer

Timeframe: Baseline and 1 month postvaccination (day 29).

Geometric Mean Anti-Japanese Encephalitis Neutralizing Antibody Titers

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

Geometric Mean Anti-Rabies Virus Neutralizing Antibody Concentration

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