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

Novartis

Status and phase

Completed

Phase 3

Conditions

Typhoid

Japanese Encephalitis

Yellow Fever

Meningococcal Meningitis

Meningococcal Disease

Rabies

Treatments

Biological: Yellow Fever Vaccine

Biological: Japanese Encephalitis Vaccine

Biological: Rabies Vaccine

Biological: Typhoid Vi Polysaccharide Vaccine

Biological: MenACWY-CRM Vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT01466387

V59_38

2011-000475-14 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment

552 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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
- 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 design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

552 participants in 6 patient groups

TF+YF

Active Comparator group

Description:

Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide and yellow fever vaccine.

Treatment:

Biological: Typhoid Vi Polysaccharide Vaccine

Biological: Yellow Fever Vaccine

TF + YF + MenACWY-CRM197

Active Comparator group

Description:

Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide, yellow fever and meningococcal ACWY conjugate vaccine.

Treatment:

Biological: MenACWY-CRM Vaccine

Biological: Typhoid Vi Polysaccharide Vaccine

Biological: Yellow Fever Vaccine

JE + Rabies

Active Comparator group

Description:

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

Treatment:

Biological: Japanese Encephalitis Vaccine

Biological: Rabies Vaccine

JE + Rab + MenACWY-CRM197

Active Comparator group

Description:

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.

Treatment:

Biological: MenACWY-CRM Vaccine

Biological: Japanese Encephalitis Vaccine

Biological: Rabies Vaccine

Rabies

Active Comparator group

Description:

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

Treatment:

Biological: Rabies Vaccine

MenACWY-CRM197 (Combined)

Active Comparator group