Safety and Immunogenicity of Two Intradermal Rabies Vaccine Regimens Administered With and Without Human Rabies Immunoglobulin in Subjects = 1 Years of Age

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02177032
• Date of registration: 24/06/2014
• Prospective Registration: No
• Primary sponsor: Novartis
• Public title: Safety and Immunogenicity of Two Intradermal Rabies Vaccine Regimens Administered With and Without Human Rabies Immunoglobulin in Subjects = 1 Years of Age
• Scientific title: Phase 3, Randomized, Stratified, Open Label, Multicenter, Controlled Clinical Study to Evaluate Safety and Immunogenicity of a Rabies Vaccine Administered, With and Without Human Rabies Immunoglobulin, Using the New "4-sites, 1-week" Intradermal Regimen for Postexposure Prophylaxis Compared to the Currently Recommended "2-sites, TRC" Intradermal Regimen in Children and Adults Subjects.
• Date of first enrolment: June 2014
• Target sample size: 885
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02177032
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Philippines, Thailand

Contacts

• Name: Novartis Vaccines
• Affiliation: Novartis Vaccines

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Healthy males and females = 1 years of age

2. Individuals/ individual's parents or legal guardians who have given written consent

3. Individuals in good health

4. Individuals who can comply with study procedures

Exclusion Criteria:

1. Behavioral or cognitive impairment or psychiatric disease.

2. Unable to comprehend and to follow all required study procedures for the whole period
of the study.

3. History of illness or with an ongoing illness that may pose additional risk to the
individual if he/she participates in the study.

4. Individuals = 1 to = 17 years of age, who have or ever had a malignancy.

5. Individuals = 18 years of age, who have or who within the last 5 years, have had a
malignancy (excluding nonmelanotic skin cancer) or lymphoproliferative disorder.

6. Known or suspected impairment of the immune system (including but not limited to HIV,
autoimmune disorders, immunosuppressive therapy as applicable).

7. Female of childbearing potential who has not used any of the "acceptable contraceptive
methods" for at least 2 months prior to study entry.

8. Female of childbearing potential, refusal to use an "acceptable birth control method"
through day 50.

9. Female of childbearing potential, with a positive pregnancy test prior to enrollment.

10. Received blood, blood products and/or plasma derivatives or any parenteral
immunoglobulin preparation in the previous 12 weeks.

11. Allergic to any of the vaccine components.

12. Allergic to any of the human rabies immunoglobulin components.

13. Contraindication or precaution against rabies vaccination.

14. Contraindication or precaution against man rabies immunoglobulin administration.

15. Planning to receive anti-malaria medications (e.g. Mefloquine) 14 days prior to day 1
vaccination through day 50.

16. Participating in any clinical trial with another investigational product 30 days prior
to first study visit or intent to participate in another clinical study at any time
during the conduct of this study.

17. Received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for
live vaccines) prior to enrollment in this study or who are planning to receive any
vaccine within 28 days from the study vaccines.

18. Body temperature = 38.0°C (= 100.4°F) within 3 days of intended study vaccination.

19. Received rabies vaccines or rabies immunoglobulin or have been exposed to rabies.

20. Part of the study personnel or immediate family members of study personnel conducting
this study.

21. Current or history of drug or alcohol abuse within the past 2 years.



Age minimum: 1 Year
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Rabies Infection

Intervention(s)

Biological: Rabies vaccine

Biological: Rabies vaccines + Rabies immunoglobulins

Primary Outcome(s)

Percentages of Subjects With RVNA Titer >= 0.5 and Vaccine Group Differences ("4-sites, 1-week" to That of "2-sites, TRC" ID PEP Regimen of the PCEC Rabies Vaccine With or Without HRIG Administration) [Time Frame: Study day 50 (D50)]

Secondary Outcome(s)

Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination [Time Frame: From day 1 to day 3; from day 4 to day 7; from day 8 to day 14; from day 29 to day 35(2-sites, TRC PEP, ID regimen)]

Percentages of Subjects With Anti-RVNA Titer =0.5 IU/mL in Children and Adult Subjects, = 1 Years of Age [Time Frame: At Days 8, 15, 50, 91, 181 and 366]

Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration =0.5 IU/mL and Vaccine Group Differences in Adult Subjects, = 18 Years of Age [Time Frame: At Days 8, 15, 50, 91, 181 and 366]

Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration and Vaccine Group Differences in Adult Subjects, = 18 Years of Age [Time Frame: At Days 8, 15, 50, 91, 181 and 366]

Number of Subjects Reporting Unsolicited Adverse Events (AEs) [Time Frame: Day 1 to Day 366]

Percentages of Subjects With Anti-RVNA Titer =0.5 IU/mL at Days 8, 15, 91, 181 and 366 in Children and Adult Subjects and Vaccine Group Differences (2 ID Rabies Vaccine Regimens (4-sites, 1-week and 2-sites, TRC), With or Without HRIG), = 1 Years of Age [Time Frame: At Days 8, 15, 91, 181 and 366]

Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration and Between-group (2 ID Rabies Vaccine Regimens (4-sites, 1-week and 2-sites, TRC) With or Without HRIG) Ratio of GMCs [Time Frame: Study Day 50]

Percentages of Subjects With Anti-RVNA Titer =0.5 IU/mL in Adult Subjects, = 18 Years of Age [Time Frame: At Days 8, 15,50, 91, 181 and 366]

Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration in Children and Adult Subjects, = 1 Years of Age [Time Frame: At Days 8, 15, 50, 91, 181 and 366]

Geometric Mean Rabies Virus Neutralizing Antibody Concentration at Days 8, 15, 91, 181 and 366 & Between-group (2 ID Rabies Vaccine Regimens (4-sites,1-week & 2-sites, TRC) With or Without HRIG) Ratio of GMCs in Children & Adult Subjects,= 1 Years of Age [Time Frame: At Days 8, 15, 91, 181 and 366]

Secondary ID(s)

2013-CT0191

V49_30

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Novartis Vaccines

Results

• Results available: Yes
• Date Posted: 07/04/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02177032