Yellow fever vaccine dose-response study on children
| ISRCTN | ISRCTN36905484 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN36905484 |
| Secondary identifying numbers | ASCLIN 01-2011 |
- Submission date
- 27/04/2011
- Registration date
- 20/06/2011
- Last edited
- 20/06/2011
- 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 of protocol
Not provided at time of registration
Contact information
Mrs Tatiana Noronha
Scientific
Scientific
Avenida Brasil
4.365. Manguinhos
Rio de Janeiro
21040-360
Brazil
Study information
| Study design | Double-blind randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Yellow fever vaccine dose-response study of 17-DD on children between 9 and 11 months of age: a double-blind randomised controlled trial |
| Study objectives | Yellow fever vaccine at lower doses is effective and safe in children between 9 and 11 months of age |
| Ethics approval(s) | Ethics Committee of Centre for Biological and Health Sciences (Centro de Ciências Biológicas e da Saúde) (CCBS) approved on 30th March 2011 (Protocol: 17/2011) |
| Health condition(s) or problem(s) studied | Yellow Fever |
| Intervention | Vaccination with one dose subcutaneously (sc) of yellow fever vaccine in current use or in five decreasing dilutions, and a placebo (placebo will receive vaccine as soon as possible): Arm 1: Reference vaccine (in current use): approximately 60,000 plaque-forming units (PFU), no protamine sulfate addition [approximately 12,000, 50% mouse lethal dose (MLD50)] Arm 2: approximately 60,000 PFU wtih protamine sulfate addition (approximately 12,000 MLD50) Arm 3: approximately 20,000 PFU, no protamine sulfate addition (approximately 4,000 MLD50) Arm 4: approximately 20,000 PFU with protamine sulfate addition (approximately 4,000 MLD50) Arm 5: approximately 6,000 PFU, no protamine sulfate addition (approximately 1,200 MLD50) Arm 6: approximately 6,000 PFU with protamine sulfate addition (approximately 1,200 MLD50) Volunteers will be followed up for a month after vaccination and 9 to 15 months after vaccination there will be another blood collection, for evaluation of duration of immunity. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Yellow fever vaccine |
| Primary outcome measure | To evaluate the immunogenicity of yellow fever vaccine used in decreasing doses and with addition of a purification step in the process of vaccine producing in children 9-11 months of age in relation to the formulation currently used. It will be measured by blood samples 30 days after vaccination and serum antibodies before and after vaccination |
| Secondary outcome measures | 1. Reactogenicity 2. Frequency of viraemia measured 5 days after vaccination 3. Duration of immunity measured one year later (9 - 15 months is acceptable) after vaccination |
| Overall study start date | 01/06/2011 |
| Completion date | 31/08/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 1800 |
| Key inclusion criteria | 1. Healthy children, aged 9 - 11 months old 2. Guardians agree to participate after reading and understanding free and informed consent form |
| Key exclusion criteria | 1. Prior vaccination against yellow fever 2. Use of immunosuppressor drugs in the last 12 months 3. Personal history of autoimmune diseases 4. Personal history of thymus diseases 5. Personal history of anaphylactic reactions to foods, drugs or vaccines 6. Personal history of allergy to eggs, erythromycin, canamycin or gelatin 7. Persons who received immunoglobulin, blood transfusions or blood derivatives in the last 12 months 8. Persons who received live virus vaccines in the last 30 days or who plan to receive them in the following 30 days after yellow fever vaccination 9. Acute febrile disease with an impaired general condition on time of vaccination 10. Metabolic diseases or metabolism inborn errors 11. Personal history of primary acquired immunodeficiency 12. Personal history of neoplasia (on treatment) |
| Date of first enrolment | 01/06/2011 |
| Date of final enrolment | 31/08/2012 |
Locations
Countries of recruitment
- Brazil
Study participating centre
Avenida Brasil
Rio de Janeiro
21040-360
Brazil
21040-360
Brazil
Sponsor information
Bio-Manguinhos/Fiocruz (Brazil)
Industry
Industry
c/o Carla da Silva Sepulveda
Avenida Brasil
4365. Manguinhos
Rio de Janeiro
21040-360
Brazil
| Phone | +55 (0)21 3882 7062 |
|---|---|
| carla.silva@bio.fiocruz.br | |
"ROR" |
https://ror.org/05gj5j117 |
Funders
Funder type
Government
Foundation for Scientific and Technological Development in Health (Fundação para o Desenvolvimento Científico e Tecnológico em Saúde [FIOTEC])/Oswaldo Cruz Foundation (Fundacio Oswaldo Crux [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 |
