Multicentre, randomised, double-blind trial comparing yellow fever vaccines from 17D and WHO 17DD-213/77 substrains in children

ISRCTN ISRCTN72367932
DOI https://doi.org/10.1186/ISRCTN72367932
Secondary identifying numbers 479663/2004-1 (CNPq)
Submission date
13/01/2006
Registration date
03/02/2006
Last edited
02/11/2015
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 Luiz Antonio Camacho
Scientific

1480 Rua Leopoldo Bulhões
Sala 820
Prédio Ernani Braga
Manguinhos
Rio de Janeiro
21041-210
Brazil

Study information

Study designRandomised, double-blind trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typePrevention
Scientific titleMulticentre, randomised, double-blind trial comparing yellow fever vaccines from 17D and WHO 17DD-213/77 substrains in children
Study objectivesYellow 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(s)Approved by the research ethics committee of the Oswaldo Cruz Foundation on 16 February 2005 (number 236A/03)
Health condition(s) or problem(s) studiedYellow fever
InterventionTwo 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)17D substrain of yellow fever and 17 WHO-213/77 substrain of yellow fever
Primary outcome measureSeroconversion from non-responder (before vaccination) to patients exhibiting response or a four-fold increase in yellow fever antibody titers after vaccination.
Secondary outcome measures1. Adverse events within 30 days of immunisation
2. Seroconversion for measles, rubella and mumps
Overall study start date01/02/2006
Completion date31/08/2006

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit9 Months
Upper age limit23 Months
SexBoth
Target number of participants3500
Key inclusion criteriaChildren 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
Key exclusion criteria1. 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
Date of first enrolment01/02/2006
Date of final enrolment31/08/2006

Locations

Countries of recruitment

  • Brazil

Study participating centre

1480 Rua Leopoldo Bulhões
Rio de Janeiro
21041-210
Brazil

Sponsor information

Bio-Manguinhos (Brazil)
Industry

4365 Av. Brasil
Pavilhão Rocha Lima
Manguinhos
Rio de Janeiro
21040-900
Brazil

Website http://www.bio.fiocruz.br
ROR logo "ROR" https://ror.org/05gj5j117

Funders

Funder type

Government

Brazilian Ministry of Health (Brazil) (Protocol number: 25386.001044/2004-32)

No information available

The National Council of Scientific and Technologic Development (CNPq) (Brazil) (Protocol number: 479663/2004-1)

No information available

Oswaldo Cruz Foundation (Brazil)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/09/2015 Yes No

Editorial Notes

02/11/2015: Publication reference added.