Condition category
Infections and Infestations
Date applied
25/06/2008
Date assigned
30/06/2008
Last edited
30/06/2008
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 Luiz Antônio Bastos Camacho

ORCID ID

Contact details

Rua Leoplodo Bulhões 1480/820
Manguinhos
Rio de Janeiro
21041-210
Brazil
+55 21 2598 2630
luiz.camacho@ensp.fiocruz.br

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ASCLIN/001/2007

Study information

Scientific title

Immunogenicity and safety of Brazilian combined vaccine against diphtheria, tetanus, pertussis, haemophilus influenzae type B and hepatitis B (DTPw/HB/hib)

Acronym

Study hypothesis

The Brazilian combined diphtheria, tetanus, pertussis, haemophilus influenzae type B and hepatitis B (DTPw/HB/hib) vaccine is as immunogenic and safe as the current DTPw/Hib and HB vaccines administered separately.

Ethics approval

Ethics approval received from the Fiocruz Ethics Committee on the 14th January 2007 (ref: 400/07).

Study design

Multicentre, non-inferiority randomised controlled trial, partially blinded.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Diphtheria, tetanus, pertussis, hepatitis B and haemophilus influenzae type B diseases

Intervention

1. Experimental group: vaccine (DTPw/HB/Hib) at 2, 4 and 6 months of age
2. Control group: DTPw/Hib and HB vaccines in concomitant injections at different sites

Both groups will receive HB vaccine at birth.

Intervention type

Drug

Phase

Not Specified

Drug names

Combined diphtheria, tetanus, pertussis, haemophilus influenzae type B and hepatitis B (DTPw/HB/hib) vaccine, DTPw/Hib vaccine, HB vaccine

Primary outcome measures

Antibody titres to diphtheria, tetanus, pertussis, haemophilus influenzae (PRP) and hepatitis B, and seroprotection rate, measured after third dose, shoud be non-inferior to that from the reference vaccines (DTP/Hib and HB vaccines given separately).

Secondary outcome measures

1. Adverse event after each dose shoud be equivalent to reference vaccines
2. Consistency of production evaluated by equivalence in immunogenicity and safety of three lots of the experimental vaccine DTPw/HB/Hib

Overall trial start date

17/03/2008

Overall trial end date

30/09/2009

Reason abandoned

Eligibility

Participant inclusion criteria

Healthy newborns (newborns and infants up to 7 months of age, of both sexes) whose parents/tutors understand the risk and benefits of the trial and agree to participate with written and informed consent.

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

1200 volunteers

Participant exclusion criteria

Newborns or mothers:
1. Hepatitis B surface antigen (HBsAg) positive
2. Human immunodeficiency virus (HIV) seropositive
3. With positive serology for syphilis

Recruitment start date

17/03/2008

Recruitment end date

30/09/2009

Locations

Countries of recruitment

Brazil

Trial participating centre

Rua Leoplodo Bulhões 1480/820
Rio de Janeiro
21041-210
Brazil

Sponsor information

Organisation

Bio-Manguinhos/Fiocruz (Brazil)

Sponsor details

c/o Akira Homma
Director
Avenida Brasil 4365
Manguinhos
Rio de Janeiro
21040-900
Brazil

Sponsor type

Research organisation

Website

http://www.bio.fiocruz.br

Funders

Funder type

Government

Funder name

Brazilian Ministry of Health (Brazil)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Brazilian Ministry of Science and Technology (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