Condition category
Infections and Infestations
Date applied
30/05/2007
Date assigned
04/07/2007
Last edited
04/07/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Sheila Araujo Teles

ORCID ID

Contact details

Rua 227 Qd 68
S/N - Setor Leste Universitário
Goiânia
74605-080
Brazil

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

SAPP 16625

Study information

Scientific title

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 measures

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

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

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

Http://www.ufg.br

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes