Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
SAPP 16625
Study information
Scientific title
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
Acronym
RCT IR HBV IVG
Study hypothesis
Hepatitis B vaccine administered into ventrogluteal area induces similar immune response to anterolateral thigh injection in infants.
Ethics approval
Local ethics committee of Maternal/Infant Hospital, Secretary of Health of Goiás (Hospital Materno-Infantil, Secretaria Estadual de Saúde de Goiás, Brazil) approved on 6th October 2006 (ref: CEP-HMI n. 11/06)
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Prevention
Patient information sheet
Condition
Hepatitis B vaccine
Intervention
All infants will receive hepatitis B vaccine by intramuscular route.
First dose
Group 1: Hepatitis B vaccine (10 µg) into ventrogluteal area
Group 2: Hepatitis B vaccination (10 µg) into anterolateral thigh
Second dose (administered 30 days after the first dose)
Group 1: Hepatitis B vaccine (10 µg) into ventrogluteal area
Group 2: Hepatitis B vaccination (10 µg) into anterolateral thigh
Third dose (administered 180 days after the first dose)
Group 1: Hepatitis B vaccine (10 µg) into ventrogluteal area
Group 2: Hepatitis B vaccination (10 µg) into anterolateral thigh
48 to 72 hours after each vaccine dose, infants will be evaluated in order to detect local (pain, redness, swelling) or systemic (fever, urticaria, persistent crying / screaming) adverse events.
Blood samples (5 mL) will be collected 45 days after third hepatitis B vaccine dose in all participants.
Intervention type
Drug
Phase
Not Specified
Drug names
Hepatitis B vaccine
Primary outcome measure
Immunogenicity, assessed using blood samples collected 45 days after the third dose.
Secondary outcome measures
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).
Overall trial start date
01/07/2007
Overall trial end date
01/08/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Newborn
2. Birth weight of more than or equal to 2.5 kg
3. In good health
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
560
Total final enrolment
580
Participant 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
Recruitment start date
01/07/2007
Recruitment end date
01/08/2008
Locations
Countries of recruitment
Brazil
Trial participating centre
Rua 227 Qd 68
Goiânia
74605-080
Brazil
Sponsor information
Organisation
Federal University of Goiás (Universidade Federal de Goiás) (Brazil)
Sponsor details
Câmpus Samambaia (Câmpus II)
Prédio da Reitoria
Caixa Postal 131
Goiânia
Goiás
74001-970
Brazil
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
The National Council for Scientific and Technological Development (Conselho Nacional de Pesquisa) (CNPq) (Brazil)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2010 results in: https://www.ncbi.nlm.nih.gov/pubmed/20189173 (added 10/05/2019)