Observation Study an Immunogenicity Modified TRC-ID Regimen With CPRV With or Without Rabies Immunoglobulin in Children

NCT02339896 | Unknown

• 1 other identifier: RC5704
• Study Type: observational
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief Summary

To determine Immunogenicity and Safety Study of Modified TRC-ID Regimen with A New Chromatographically Purified Vero Cell Rabies Vaccine (SPEEDA®) as post exposure rabies intradermal regimen with or without Rabies Immunoglobulin in Children

Conditions

Dog Bite

Keywords

rabies; modified TRC intradermal rabies vaccine; SPEEDA

Outcome Measures

Primary Outcomes (1)

• determine the level of rabies neutralizing antibodies after using SPEEDA® with modified TRC-ID rabies with or without RIG and the safety of using SPEEDA® with modified TRC-ID rabies with or without RIG in children

  1 year 6 month

Study Arms (2)

WHO category 2

Children patient who have experienced WHO category II exposure will receive rabies vaccine (SPEEDA) 0.1 ml intradermal two site for 4 times

Biological: rabies vaccine

WHO category 3

Children patient who have experienced WHO category II exposure will receive rabies vaccine (SPEEDA) 0.1 ml intradermal two site for 4 times with ERIG

Biological: rabies vaccine

Interventions

rabies vaccine BIOLOGICAL

rabies vaccine 0.1 ml intradermal two site for 4 times

WHO category 2; WHO category 3

Eligibility Criteria

• Age: 1 Year - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

recruit the patients from Rabies clinic of Queen Saovabha Memorial Institute, Thammasat Hospital, Charoen Krung Pracha Rak Hospital and HRM Princess Maha Chakri Sirindhorn Medical Center and all had experienced WHO category II or III exposure to suspected rabid animal. In patients with WHO category III have to receive a heterologous biological (ERIG or HRIG)

You may qualify if:

• they are 1-15 years healthy children
• give signed informed consent from their parents
• willing to participate in this study and be able to receive the vaccination and collect blood sample as the study plan.

You may not qualify if:

• they have prior history of rabies vaccination or any equine/human serum administration such as snake antivenom and tetanus antiserum or vaccine allergy
• Persons who have immunosuppressive conditions such as known HIV infection, transplantation, chronic renal failure, receiving of steroid or immunosuppressive drugs
• person received anti-malarial drugs within the previous two months or any blood products within previous three months were excluded
• Urine pregnancy test must be done in all female adolescents to exclude the pregnancy in first visit

Sponsors & Collaborators

• Queen Saovabha Memorial Institute: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Rabies Neutralizing antibody

MeSH Terms

Conditions

Rabies

Interventions

Rabies Vaccines

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Piyada Angsuwatcharakon, MD

  QSMI TRC society

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 365 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 7, 2015
• First Posted: January 16, 2015
• Study Start: February 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: January 1, 2016
• Last Updated: January 16, 2015

Record last verified: 2015-01