Brazilian pentavalent vaccine

ISRCTN	ISRCTN95974322
DOI	https://doi.org/10.1186/ISRCTN95974322
Protocol serial number	ASCLIN/001/2007
Sponsor	Bio-Manguinhos/Fiocruz (Brazil)
Funders	Brazilian Ministry of Health (Brazil), Brazilian Ministry of Science and Technology (Brazil)

Submission date: 25/06/2008
Registration date: 30/06/2008
Last edited: 30/06/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Luiz Antônio Bastos Camacho
Scientific

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

Phone	+55 21 2598 2630
Email	luiz.camacho@ensp.fiocruz.br

Study information

Primary study design	Interventional
Study design	Multicentre, non-inferiority randomised controlled trial, partially blinded.
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Immunogenicity and safety of Brazilian combined vaccine against diphtheria, tetanus, pertussis, haemophilus influenzae type B and hepatitis B (DTPw/HB/hib)
Study objectives	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(s)	Ethics approval received from the Fiocruz Ethics Committee on the 14th January 2007 (ref: 400/07).
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Combined diphtheria, tetanus, pertussis, haemophilus influenzae type B and hepatitis B (DTPw/HB/hib) vaccine, DTPw/Hib vaccine, HB vaccine
Primary outcome measure(s)	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).
Key secondary outcome measure(s)	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
Completion date	30/09/2009

Eligibility

Participant type(s)	Patient
Age group	Child
Upper age limit	7 Months
Sex	All
Target sample size at registration	1200
Key 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.
Key exclusion criteria	Newborns or mothers: 1. Hepatitis B surface antigen (HBsAg) positive 2. Human immunodeficiency virus (HIV) seropositive 3. With positive serology for syphilis
Date of first enrolment	17/03/2008
Date of final enrolment	30/09/2009

Locations

Countries of recruitment

Brazil

Study participating centre

Rua Leoplodo Bulhões 1480/820

Rio de Janeiro
21041-210
Brazil

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes