Condition category
Infections and Infestations
Date applied
27/04/2011
Date assigned
20/06/2011
Last edited
20/06/2011
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

Mrs Tatiana Noronha

ORCID ID

Contact details

Avenida Brasil
4.365. Manguinhos
Rio de Janeiro
21040-360
Brazil

Additional identifiers

EudraCT 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

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

Trial setting

GP practices

Trial 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

Phase

Not Applicable

Drug names

Yellow fever vaccine

Primary outcome measures

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 trial start date

01/06/2011

Overall trial end date

31/08/2012

Reason abandoned

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

Patient

Age group

Neonate

Gender

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

Trial 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

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes