A Phase 3b, Randomized, Open-Label Study to Evaluate the Safety and Immunogenicity of Select Trav… (NCT01466387) | Clinical Trial Compass
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 range18 Years – 60 Years
SexALL
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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.
✕. 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;
What they're measuring
1
Geometric Mean Anti-typhoid Vi Antibody Concentrations
Timeframe: Baseline and 1 month postvaccination (day 29).
2
Geometric Mean Anti-Yellow Fever Antibody Titer
Timeframe: Baseline and 1 month postvaccination (day 29).
3
Geometric Mean Anti-Japanese Encephalitis Neutralizing Antibody Titers
Timeframe: Baseline and 1 month post last vaccination (day 57).
4
Geometric Mean Anti-Rabies Virus Neutralizing Antibody Concentration
Timeframe: Baseline and 1 month post last vaccination (day 57).