Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
ASCLIN 01-2011
Study information
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
Acronym
Study hypothesis
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)
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
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Overall study end date
31/08/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Healthy children, aged 9 - 11 months old
2. Guardians agree to participate after reading and understanding free and informed consent form
Participant type(s)
Patient
Age group
Neonate
Sex
Both
Target number of participants
1800
Participant 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)
Recruitment start date
01/06/2011
Recruitment end date
31/08/2012
Locations
Countries of recruitment
Brazil
Study participating centre
Avenida Brasil
Rio de Janeiro
21040-360
Brazil
Sponsor information
Organisation
Bio-Manguinhos/Fiocruz (Brazil)
Sponsor details
c/o Carla da Silva Sepulveda
Avenida Brasil
4365. Manguinhos
Rio de Janeiro
21040-360
Brazil
+55 (0)21 3882 7062
carla.silva@bio.fiocruz.br
Sponsor type
Industry
Website
ROR
Funders
Funder type
Government
Funder name
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)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|