Immunogenicity and safety of combined vaccine against diphtheria, tetanus, pertussis and haemophilus influenzae type B: clinical validation of a product totally produced in Brazil

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN67676353

Enrollment

1000

Registered

2006-03-16

Start date

2006-01-03

Completion date

Unknown

Last updated

2019-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diphtheria, tetanus, pertussis, haemophilus influenzae type B Infections and Infestations Bacterial diseases

Interventions

Three doses of Brazilian vaccines versus one dose of GSK vaccine

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Healthy children from two to six months of age

Exclusion criteria

Exclusion criteria: 1. Unhealthy children 2. Previous vaccination 3. Immunodeficiency

Design outcomes

Primary

Measure	Time frame
Polyribosil Ribitol Phosphate (PRP) titres and seroprotection after third dose should be equivalent to GSK vaccine.	—

Secondary

Measure	Time frame
1. Adverse event after each dose should be equivalent to GSK vaccine 2. Titres and seroprotection after second dose should be equivalent to GSK vaccine	—

Countries

Brazil

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026