A Randomized, Open-label Study Comparing Two Different Rabies Vaccine Schedules in Chinese Children and Older Adults

NCT01680016 | Completed Phase 3 Results

• 1 other identifier: V49_24
• Study Type: interventional
• Target: 644
• Locations: 1 country
• Sites: 1

Brief Summary

This study was designed to evaluate the safety and immunogenicity of two simulated postexposure rabies vaccination schedules (Zagreb 2-1-1 and Essen 1-1-1-1-1) in Chinese children and older adults.

Conditions

Rabies

Keywords

Rabies virus, postexposure, vaccine schedule, children, older adults

Outcome Measures

Primary Outcomes (6)

• Non-inferiority in Immune Response of the Zagreb Postexposure Schedule of Rabipur to That of the Conventional Essen Postexposure Schedule of Rabipur as Measured by GMC of RVNA Titer 14 Days After First Vaccination in Children Aged ≥6 to ≤17 Years.

  Immunogenicity was measured as the geometric mean concentrations (GMCs) of rabies virus neutralizing antibody (RVNA) titer , evaluated using the rapid fluorescent focus inhibition test, before vaccination and 14 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.

  Before vaccination (day 1) and 14 days after first vaccination (day 15)

• Non-inferiority in Immune Response of the Zagreb Postexposure Schedule of Rabipur to That of the Conventional Essen Postexposure Schedule of Rabipur as Measured by GMC of RVNA Titer 14 Days After the First Vaccination in Older Adults Aged ≥51 Years

  Immunogenicity was measured as the GMCs of Rabies Virus Neutralizing Antibody (RVNA) titer , evaluated using the rapid fluorescent focus inhibition test, before vaccination and 14 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.

  Before vaccination (day 1) and 14 days after first vaccination (day 15).

• Number of Children Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur

  Safety was assessed as the number of children who reported solicited local and systemic adverse events from day 1 up to and including day 7 after any vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.

  Days 1 to 7 postvaccination

• Number of Older Adults Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur

  Safety was assessed as the number of subjects who reported solicited local and systemic adverse events from day 1 up to and including day 7 after any vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.

  Days 1 to 7 postvaccination

• Number of Children Who Reported Unsolicited Adverse Events (AEs)

  The safety of Rabipur was assessed in terms of subjects(Children) exposed to study vaccine who reported all Unsolicited AEs (including serious adverse events \[SAE\]s and AEs leading to subject withdrawal) from V1/day 1 (postvaccination) through V7/study termination day 43.

  From V1/day 1 (postvaccination) through V7/study termination day 43

• Number of Older Adults Who Reported Unsolicited Adverse Events (AEs)

  The safety of Rabipur was assessed in terms of subjects(Older Adults) exposed to study vaccine who reported all Unsolicited AEs (including serious adverse events \[SAE\]s and AEs leading to subject withdrawal) from V1/day 1 (postvaccination) through V7/study termination day 43.

  from V1/day 1 (postvaccination) through V7/study termination day 43

Secondary Outcomes (6)

• Percentages of Children With RVNA Titers ≥0.5 IU/mL 14 Days After First Vaccination of Rabipur

  Before vaccination (day 1) and 14 days after first vaccination (day 15).

• Percentages of Older Adults With RVNA Titers ≥0.5 IU/mL 14 Days After First Vaccination of Rabipur

  Before vaccination (day 1) and 14 days after first vaccination (day 15).

• Percentages of Children With RVNA Titers ≥0.5 IU/mL 42 Days After First Vaccination of Rabipur

  Before vaccination (day 1) and 42 days after first vaccination (day 43).

• Percentages of Older Adults With RVNA Titers ≥0.5 IU/mL 42 Days After First Vaccination of Rabipur

  Before vaccination (day 1) and 42 days after first vaccination (day 43).

• GMCs of RVNA Titer 42 Days After First Vaccination in Children.

  Before vaccination (day 1) and 42 days after first vaccination (day 43)

Study Arms (4)

Zagreb(≥6 to ≤17 Years)

EXPERIMENTAL

Biological: Zagreb

Zagreb(≥51 Years)

EXPERIMENTAL

Biological: Zagreb

Essen(≥6 to ≤17 Years)

ACTIVE COMPARATOR

Biological: Essen

Essen(≥51 Years)

ACTIVE COMPARATOR

Biological: Essen

Interventions

Zagreb BIOLOGICAL

Subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22

Zagreb(≥51 Years); Zagreb(≥6 to ≤17 Years)

Essen BIOLOGICAL

Subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29

Essen(≥51 Years); Essen(≥6 to ≤17 Years)

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals between 6-17 years of age and 51 years of age or older
• Individuals who were in good health
• Provided consent, complied with study procedures and duration of follow-up

You may not qualify if:

• Contraindications to vaccination with rabies vaccine
• Body temperature ≥37.5◦C (axillary) within 3 days of intended study vaccination
• Known hypersensitivity to the components of the vaccine
• Previously received any rabies vaccine or immune globulin
• Previous or planned treatment with antimalarial medications
• History of psychiatric disease, immune disorder, bleeding disorder, drug/alcohol abuse within the past 2 years, malignancy
• Female subjects who were pregnant or unwilling to practice acceptable birth control methods
• Individuals enrolled or plans to enroll in another investigational trial

Sponsors & Collaborators

• Novartis Vaccines: lead

Study Sites (1)

Mengshan Center for Disease Prevention and Control (CDC)

Mengshan, Guangxi, 530028, China

Location

Related Publications (1)

• Li R, Li Y, Wen S, Wen H, Nong Y, Mo Z, Xie F, Pellegrini M. Immunogenicity and safety of purified chick-embryo cell rabies vaccine under Zagreb 2-1-1 or 5-dose Essen regimen in Chinese children 6 to 17 years old and adults over 50 years: a randomized open-label study. Hum Vaccin Immunother. 2015;11(2):435-42. doi: 10.4161/21645515.2014.994460.

  PMID: 25692350 DERIVED

MeSH Terms

Conditions

Rabies

Interventions

hemoglobin A2 Zagreb

Condition Hierarchy (Ancestors)

Rhabdoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Results Point of Contact

• Title: Posting Director
• Organization: Novartis Vaccines and Diagnostics

RegistryContactVaccinesUS@novartis.com

Study Officials

• Novartis Vaccines

  Novartis Vaccines

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2012
• First Posted: September 6, 2012
• Study Start: September 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: May 20, 2014
• Results First Posted: May 20, 2014

Record last verified: 2014-04

Locations

CN (1)