Safety and Immunogenicity of 2 Different Vaccination Schedules of Rabies and Japanese Encephalitis Vaccines in Healthy Adult Subjects

Novartis

Status and phase: Completed; Phase 3

Conditions: Japanese Encephalitis; Rabies

Treatments: Other: Placebo; Biological: Japanese Encephalitis; Biological: Rabies

Study type: Interventional

Funder types: Industry

Identifiers

NCT01662440

2011-005173-23 (EudraCT Number)

V49_23

Details and patient eligibility

About

Establish non-inferiority of the immune response and evaluate the safety and tolerability of Rabies and Japanese Encephalitis (JE) vaccines given concomitantly or alone and according to either of 2 schedules for preexposure prophylaxis.

Enrollment: 661 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Males and females between 18 and 65 years of age (inclusive).
2. Subjects who have given written consent.
3. Individuals in good health as per investigator judgement.

Exclusion criteria

1. If female, pregnancy or unwillingness to practice acceptable contraception.
2. If female, pregnant or breast-feeding or any positive/indeterminate pregnancy test.
3. Contraindication or precaution against Rabies and Japanese Encephalitis vaccination.
4. Unable to comprehend and to follow all required study procedures for the whole period of the study.
5. Participating in any other clinical trial 30 days prior to first study visit.
6. History of previous rabies/rabies immunoglobulin and/or Japanese Encephalitis immunization.
7. Receiving or planning to receive anti-malarial medications (e.g. Mefloquine) 14 days prior to Day 1 vaccination through Day 43.
8. Received any other vaccines within 2 weeks prior to enrollment in this study or plan to receive any vaccine within 4 weeks from the study vaccines.
9. Ever received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 12 weeks.
10. Individuals who are part of study personnel or close family members conducting this study.
11. Body temperature ≥38 degrees Celsius (≥ 100.4° F) within 3 days of intended study vaccination.
12. Plans to travel within the next year to areas where Rabies and/or Japanese Encephalitis vaccine may be considered or offered. This includes but is not limited to India, Asia, Pacific-Rim, African countries.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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661 participants in 4 patient groups

R/JE - Conv

Active Comparator group

Description:

Subjects received Rabies and Japanese Encephalitis (JE) vaccines following the conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg; and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.

Treatment:

Biological: Japanese Encephalitis

Biological: Rabies

Other: Placebo

R/JE - Acc

Experimental group

Description:

Subjects received Rabies and JE vaccines following the accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg; and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.

Treatment:

Biological: Japanese Encephalitis

Biological: Rabies

Other: Placebo

R - Conv

Active Comparator group

Description:

Subjects received Rabies vaccine following the conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg; and placebo on days 1, 8 and 29 in the left arm.

Treatment:

Biological: Rabies

Other: Placebo

JE - Conv

Active Comparator group

Description:

Subjects received JE vaccine following the conventional schedule, ie, placebo on days 1, 4, 8 and 29 in the right arm or leg; and JE vaccination on days 1 and 29 and placebo injection on day 8 in the left arm.

Treatment:

Biological: Japanese Encephalitis

Other: Placebo