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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN69460769
Enrollment
560
Registered
2007-07-04
Start date
2007-07-01
Completion date
Unknown
Last updated
2019-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B vaccine Infections and Infestations Hepatitis B

Interventions

All infants will receive hepatitis B vaccine by intramuscular route. First dose Group 1: Hepatitis B vaccine (10 µg) into ventrogluteal area Group 2: H

Sponsors

Federal University of Goiás (Universidade Federal de Goiás) (Brazil)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Immunogenicity, assessed using blood samples collected 45 days after the third dose.—

Secondary

MeasureTime frame
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).—

Countries

Brazil

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026