Diphtheria, tetanus, pertussis, hepatitis B and haemophilus influenzae type B diseases Infections and Infestations Bacterial infection of unspecified site
Conditions
Interventions
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
Sponsors
Bio-Manguinhos/Fiocruz (Brazil)
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
Exclusion criteria: Newborns or mothers: 1. Hepatitis B surface antigen (HBsAg) positive 2. Human immunodeficiency virus (HIV) seropositive 3. With positive serology for syphilis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Brazil
Outcome results
None listed