Condition category
Infections and Infestations
Date applied
13/01/2006
Date assigned
03/02/2006
Last edited
02/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Luiz Antonio Camacho

ORCID ID

Contact details

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

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 measures

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

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

http://www.bio.fiocruz.br

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

Results - basic reporting

Publication summary

2015 results in http://www.ncbi.nlm.nih.gov/pubmed/26517656

Publication citations

Additional files

Editorial Notes

02/11/2015: Publication reference added.