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
| ISRCTN | ISRCTN69460769 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN69460769 |
| Secondary identifying numbers | SAPP 16625 |
- Submission date
- 30/05/2007
- Registration date
- 04/07/2007
- Last edited
- 10/05/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Sheila Araujo Teles
Scientific
Scientific
Rua 227 Qd 68
S/N - Setor Leste Universitário
Goiânia
74605-080
Brazil
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Prevention |
| 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 |
| Study acronym | RCT IR HBV IVG |
| Study objectives | Hepatitis B vaccine administered into ventrogluteal area induces similar immune response to anterolateral thigh injection in infants. |
| Ethics approval(s) | 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) |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/07/2007 |
| Completion date | 01/08/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 560 |
| Total final enrolment | 580 |
| Key inclusion criteria | 1. Newborn 2. Birth weight of more than or equal to 2.5 kg 3. In good health |
| Key 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 |
| Date of first enrolment | 01/07/2007 |
| Date of final enrolment | 01/08/2008 |
Locations
Countries of recruitment
- Brazil
Study participating centre
Rua 227 Qd 68
Goiânia
74605-080
Brazil
74605-080
Brazil
Sponsor information
Federal University of Goiás (Universidade Federal de Goiás) (Brazil)
University/education
University/education
Câmpus Samambaia (Câmpus II)
Prédio da Reitoria
Caixa Postal 131
Goiânia
Goiás
74001-970
Brazil
| Website | Http://www.ufg.br |
|---|---|
"ROR" |
https://ror.org/0039d5757 |
Funders
Funder type
Government
The National Council for Scientific and Technological Development (Conselho Nacional de Pesquisa) (CNPq) (Brazil)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2010 | 10/05/2019 | Yes | No |
Editorial Notes
10/05/2019: Publication reference and total final enrolment added.
