Yellow fever vaccine dose-response study on children

Yellow fever vaccine dose-response study of 17-DD on children between 9 and 11 months of age: a double-blind randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN36905484

Enrollment

1800

Registered

2011-06-20

Start date

2011-06-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Yellow Fever Infections and Infestations Yellow fever

Interventions

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: Referen

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Healthy children, aged 9 - 11 months old 2. Guardians agree to participate after reading and understanding free and informed consent form

Exclusion criteria

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)

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

Brazil

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026