Brazilian pentavalent vaccine
| ISRCTN | ISRCTN95974322 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95974322 |
| Secondary identifying numbers | ASCLIN/001/2007 |
- 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
Not provided at time of registration
Contact information
Dr Luiz Antônio Bastos Camacho
Scientific
Scientific
Rua Leoplodo Bulhões 1480/820
Manguinhos
Rio de Janeiro
21041-210
Brazil
| Phone | +55 21 2598 2630 |
|---|---|
| luiz.camacho@ensp.fiocruz.br |
Study information
| Study design | Multicentre, non-inferiority randomised controlled trial, partially blinded. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 hypothesis | 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). |
| Condition | 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 |
| Pharmaceutical study type(s) | |
| 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 | 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 outcome measures | 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 |
| Overall study start date | 17/03/2008 |
| Overall study end date | 30/09/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Upper age limit | 7 Months |
| Sex | Both |
| Target number of participants | 1200 volunteers |
| Participant 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. |
| Participant exclusion criteria | Newborns or mothers: 1. Hepatitis B surface antigen (HBsAg) positive 2. Human immunodeficiency virus (HIV) seropositive 3. With positive serology for syphilis |
| Recruitment start date | 17/03/2008 |
| Recruitment end date | 30/09/2009 |
Locations
Countries of recruitment
- Brazil
Study participating centre
Rua Leoplodo Bulhões 1480/820
Rio de Janeiro
21041-210
Brazil
21041-210
Brazil
Sponsor information
Bio-Manguinhos/Fiocruz (Brazil)
Research organisation
Research organisation
c/o Akira Homma
Director
Avenida Brasil 4365
Manguinhos
Rio de Janeiro
21040-900
Brazil
| Website | http://www.bio.fiocruz.br |
|---|---|
"ROR" |
https://ror.org/05gj5j117 |
Funders
Funder type
Government
Brazilian Ministry of Health (Brazil)
No information available
Brazilian Ministry of Science and Technology (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 |
