Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
479663/2004-1 (CNPq)
Study information
Scientific title
Multicentre, randomised, double-blind trial comparing yellow fever vaccines from 17D and WHO 17DD-213/77 substrains in children
Acronym
Study hypothesis
Yellow fever is a severe mosquito-borne viral hemorrhagic disease, which may cause hepatitis, renal failure and shock. It is endemic in tropical areas of South America and Africa, where epidemics also occur. Vaccination is the only effective means of control. Safe and efficacious vaccines have been available for decades. Seroconversion rates in infants (about 80%) have been reported to be lower than in older children and adults (>95%).
Hypothesis:
That yellow fever vaccines prepared from 17DD and World Health Organization (WHO) 17D-213/77 inducing similar antibody response in individuals below two years of age are similar. Maternal immunity and simultaneous immunisation with other attenuated vaccines affect seroconversion of infants by yellow fever vaccine.
Ethics approval
Approved by the research ethics committee of the Oswaldo Cruz Foundation on 16 February 2005 (number 236A/03)
Study design
Randomised, double-blind trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Prevention
Patient information sheet
Condition
Yellow fever
Intervention
Two groups (allocation ratio 1:1) will be compared:
1. 17DD yellow fever vaccine, which is currently used for routine immunisation of residents and travellers to endemic areas in Brazil
2. A vaccine prepared with the WHO 17D-213/77 substrain especially for the trial, using the same process except for the vaccine virus
Both vaccines are manufactured by Bio-Manguinhos, Fiocruz (Rio de Janeiro, Brazil).
Intervention type
Drug
Phase
Not Specified
Drug names
17D substrain of yellow fever and 17 WHO-213/77 substrain of yellow fever
Primary outcome measure
Seroconversion from non-responder (before vaccination) to patients exhibiting response or a four-fold increase in yellow fever antibody titers after vaccination.
Secondary outcome measures
1. Adverse events within 30 days of immunisation
2. Seroconversion for measles, rubella and mumps
Overall trial start date
01/02/2006
Overall trial end date
31/08/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Children aged between 9 and 23 months, brought by their guardians to public health care units in regions where vaccination against yellow fever is recommended by the Brazilian National Program of Immunisation
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
3500
Participant exclusion criteria
1. Severe malnutrition
2. Transitory or permanent immunodeficiency
3. Treatment with immunoglobulin or blood products
4. Administration of experimental drugs or vaccines in the previous 60 days or next 60 days of yellow fever vaccination
5. Hypersensitivity to chicken egg products or gelatin
6. Chronic or acute conditions constituting temporary contraindications to routine
7. Immunisation
8. Fever above 37.5°C
9. Mothers unwilling or unable to return 30 days after vaccination for blood collection
Recruitment start date
01/02/2006
Recruitment end date
31/08/2006
Locations
Countries of recruitment
Brazil
Trial participating centre
1480 Rua Leopoldo Bulhões
Rio de Janeiro
21041-210
Brazil
Sponsor information
Organisation
Bio-Manguinhos (Brazil)
Sponsor details
4365 Av. Brasil
Pavilhão Rocha Lima
Manguinhos
Rio de Janeiro
21040-900
Brazil
Sponsor type
Industry
Website
Funders
Funder type
Government
Funder name
Brazilian Ministry of Health (Brazil) (Protocol number: 25386.001044/2004-32)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The National Council of Scientific and Technologic Development (CNPq) (Brazil) (Protocol number: 479663/2004-1)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Oswaldo Cruz Foundation (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
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2015 results in http://www.ncbi.nlm.nih.gov/pubmed/26517656