Randomized Clinical Trial to evaluate the Immunogenicity and Reactogenicity of the Brazilian Hepatitis B Vaccine (Butang®) in Infants using the Ventrogluteal area as an alternative intramuscular injection site

Not Applicable

Completed

• Conditions: Hepatitis B vaccine; Infections and Infestations; Hepatitis B

• Registration Number: ISRCTN69460769
• Lead Sponsor: Federal University of Goiás (Universidade Federal de Goiás) (Brazil)

Brief Summary

2010 results in: https://www.ncbi.nlm.nih.gov/pubmed/20189173 (added 10/05/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-07-04
• Study Completion: 2008-08-01
• Last Update Posted: 27 May 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 580

Inclusion Criteria

1. Newborn
2. Birth weight of more than or equal to 2.5 kg
3. In good health

Exclusion Criteria

1. Previous hepatitis B vaccination
2. Mother Hepatitis B Virus (HBV) and/or HIV positive
3. History of blood or immunoglobulin transfusion
4. Any condition which, in the opinion of the investigator, may interfere in the evaluation of the objectives of the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Immunogenicity, assessed using blood samples collected 45 days after the third dose.

Secondary Outcome Measures

Name	Time	Method
Reactogenicity, assessed 48-72 hours after each vaccine dose. These will be scored on visual scales (0: no reaction to 5: highest level of reaction).