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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN72367932
Enrollment
3500
Registered
2006-02-03
Start date
2006-02-01
Completion date
Unknown
Last updated
2016-10-17

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

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

Sponsors

Bio-Manguinhos (Brazil)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Seroconversion from non-responder (before vaccination) to patients exhibiting response or a four-fold increase in yellow fever antibody titers after vaccination.

Secondary

MeasureTime frame
1. Adverse events within 30 days of immunisation 2. Seroconversion for measles, rubella and mumps

Countries

Brazil

Outcome results

None listed

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