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 |
| Secondary identifying numbers | ANVISA nr. 25351.086984/05-71 |
- 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
| Study design | Double blind, randomised, controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Prevention |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Vaccine against diphtheria, tetanus, pertussis and haemophilus influenzae type B |
| Primary outcome measure | Polyribosil Ribitol Phosphate (PRP) titres and seroprotection after third dose should be equivalent to GSK vaccine. |
| Secondary outcome measures | 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 |
| Overall study start date | 03/01/2006 |
| Completion date | 03/03/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 2 Months |
| Upper age limit | 6 Months |
| Sex | Both |
| Target number of participants | 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
Sponsor information
Bio-Manguinhos/Fiocruz (Brazil)
Industry
Industry
Av. Brasil 4365
Rio de Janeiro
CEP 21040-900
Brazil
| Phone | +55 21 3882 9305 |
|---|---|
| akira@bio.fiocruz.br | |
| Website | http://www.bio.fiocruz.br |
"ROR" |
https://ror.org/05gj5j117 |
Funders
Funder type
Industry
Bio-Manguinhos/Fiocruz (Brazil)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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.
