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 |
| Protocol serial number | 479663/2004-1 (CNPq) |
| Sponsor | Bio-Manguinhos (Brazil) |
| Funders | Brazilian Ministry of Health (Brazil) (Protocol number: 25386.001044/2004-32), The National Council of Scientific and Technologic Development (CNPq) (Brazil) (Protocol number: 479663/2004-1), Oswaldo Cruz Foundation (Brazil) |
- 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
Scientific
1480 Rua Leopoldo Bulhões
Sala 820
Prédio Ernani Braga
Manguinhos
Rio de Janeiro
21041-210
Brazil
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, double-blind trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Multicentre, randomised, double-blind trial comparing yellow fever vaccines from 17D and WHO 17DD-213/77 substrains in children |
| Study objectives | 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(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) studied | 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 / device / biological / vaccine name(s) | 17D substrain of yellow fever and 17 WHO-213/77 substrain of yellow fever |
| Primary outcome measure(s) |
Seroconversion from non-responder (before vaccination) to patients exhibiting response or a four-fold increase in yellow fever antibody titers after vaccination. |
| Key secondary outcome measure(s) |
1. Adverse events within 30 days of immunisation |
| Completion date | 31/08/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 9 Months |
| Upper age limit | 23 Months |
| Sex | All |
| Target sample size at registration | 3500 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/02/2006 |
| Date of final enrolment | 31/08/2006 |
Locations
Countries of recruitment
- Brazil
Study participating centre
1480 Rua Leopoldo Bulhões
Rio de Janeiro
21041-210
Brazil
21041-210
Brazil
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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.
