Immunogenicity and safety of combined vaccine against diphtheria, tetanus, pertussis and haemophilus influenzae type B: clinical validation of a product totally produced in Brazil
| ISRCTN | ISRCTN67676353 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN67676353 |
| Protocol serial number | ANVISA nr. 25351.086984/05-71 |
| Sponsor | Bio-Manguinhos/Fiocruz (Brazil) |
| Funder | Bio-Manguinhos/Fiocruz (Brazil) |
- Submission date
- 16/02/2006
- Registration date
- 16/03/2006
- Last edited
- 04/06/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Reinaldo Menezes Martins
Scientific
Scientific
Av Brasil 4365
Rio de Janeiro
CEP 21040-900
Brazil
| Phone | +55 21 3882 9479 |
|---|---|
| rmenezes@bio.fiocruz.br |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Double blind, randomised, controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Immunogenicity and safety of combined vaccine against diphtheria, tetanus, pertussis and haemophilus influenzae type B: clinical validation of a product totally produced in Brazil |
| Study objectives | The Brazilian vaccine is equivalent to Glaxosmithkline (GSK) vaccine. |
| Ethics approval(s) | Ethics approval received from the National Ethics Committee of the Ministry of Health on the 24th May 2005 (ref: 11.501). |
| Health condition(s) or problem(s) studied | Diphtheria, tetanus, pertussis, haemophilus influenzae type B |
| Intervention | Three doses of Brazilian vaccines versus one dose of GSK vaccine |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Vaccine against diphtheria, tetanus, pertussis and haemophilus influenzae type B |
| Primary outcome measure(s) |
Polyribosil Ribitol Phosphate (PRP) titres and seroprotection after third dose should be equivalent to GSK vaccine. |
| Key secondary outcome measure(s) |
1. Adverse event after each dose should be equivalent to GSK vaccine |
| Completion date | 03/03/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 2 Months |
| Upper age limit | 6 Months |
| Sex | All |
| Target sample size at registration | 1000 |
| Total final enrolment | 1000 |
| Key inclusion criteria | Healthy children from two to six months of age |
| Key exclusion criteria | 1. Unhealthy children 2. Previous vaccination 3. Immunodeficiency |
| Date of first enrolment | 03/01/2006 |
| Date of final enrolment | 03/03/2007 |
Locations
Countries of recruitment
- Brazil
Study participating centre
Av Brasil 4365
Rio de Janeiro
CEP 21040-900
Brazil
CEP 21040-900
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? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2008 | 04/06/2019 | Yes | No |
Editorial Notes
04/06/2019: Total final enrolment and publication reference were added.
