Yellow FeverNCT05644145
Immunogenicity of Yellow Fever Vaccine in a Pediatric Population Vaccinated at 12-23 Months of Age in Argentina
A study testing Serological study after yellow fever vaccination in people with Yellow Fever, run by Ministry of Public Health, Argentina at 3 sites in Argentina.
Trial summary
Northern Argentina is a risk area for yellow fever (YF). Recent studies have suggested that immunity wanes in children vaccinated between 9 and 23 months of age. In 2015, a collaborative study conducted by the Ministry of Health (MoH) of Argentina, the Pan American Health Organization (PAHO), and the US Centers for… Read more about this study
- Who is it for?
- Ages 4 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Yellow Fever
- What is being tested?
- Serological study after yellow fever vaccination
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 361 participants
- Where
- 3 sitesArgentina
- Study dates
- 6 Dec 2022to 30 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children enrolled in the 2015 study received one dose of YF vaccine and had documented seroconversion regardless of the
- Healthy child, determined by clinical history
- Availability to perform a single blood draw
- Informed consent signed by the parents.
Who cannot join
- Children in the 2015 study received one dose of the Yellow Fever vaccine and had NO documented seroconversion.
- Children enrolled in the 2015 study received a dose of the Yellow Fever vaccine and had documented seroconversion but, for different reasons, received a booster (minimum interval of one month between doses).
- Children enrolled in the 2015 study received one dose of the Yellow Fever vaccine and had documented seroconversion but developed Yellow Fever
- Children enrolled in the 2015 study received one dose of the Yellow Fever vaccine and had documented seroconversion but are participating in another clinical drug trial of a drug, vaccine, or medical device
- Children enrolled in the 2015 study received a dose of the Yellow Fever vaccine and had documented seroconversion but, for various reasons, are immunocompromised:
- Weakened immune function, including HIV infection, primary immunodeficiencies, having received immunosuppressive doses of oral or injectable corticosteroids (or equivalent), having received immunomodulators or chemotherapeutic agents, disease of the thymus, Severe illness/fever (mild illness without fever is not an exclusion criteria)
- ● Any condition that, in the judgment of study personnel, poses a risk to the health of the participant or interferes with the assessment of response to the vaccine
Trial locations and contacts
3 sites in 1 country.
Argentina3 sites
SAMIC Eldorado Hospital
Eldorado, Misiones Province
SAMIC Obera Hospital
Obera, Misiones Province
Favoloro Hospital
Posadas, Misiones Province
About this study
Official title: Estudio Sobre Respuesta de Anticuerpos Neutralizantes Contra la Fiebre Amarilla Cuatro a Siete años después de Vacunar Una población pediátrica Entre Los 12 y 23 Meses de Edad en Argentina
Northern Argentina is a risk area for yellow fever (YF). Recent studies have suggested that immunity wanes in children vaccinated between 9 and 23 months of age. In 2015, a collaborative study conducted by the Ministry of Health (MoH) of Argentina, the Pan American Health Organization (PAHO), and the US Centers for Disease Control and Prevention (CDC) assessed the immunogenicity and safety of co-administration of YF and MMR vaccines in a pediatric population at 12-13 months of age. A total of 741 children presenting for routine immunization at 12-13 months of age enrolled and completed the study. It is now four to seven years since this pediatric group received their YF vaccinations. This cohort is unique because their initial YF vaccination and immune response to the vaccine dose are well characterized. Contact information collected during the earlier study will be used to locate the children. If consent is obtained, a 5ml specimen of blood will be collected and shipped to the CDC's Arboviral Diseases Reference Laboratory (ADRL) in Fort Collins, CO for plaque reduction neutralization testing using a 50% cut-off (PRNT50) to detect YF virus-specific neutralizing antibodies. Children with neutralizing antibody titers that are higher than their baseline titer collected approximately 28 days following YF vaccination will have PRNTs done for cross-reacting flaviviruses.
Read the detailed description
Yellow fever (YF) continues to be a public health problem for 13 countries in the Americas, including northern Argentina. From 1960 to 2019, these countries reported 9,673 confirmed cases and 2,480 deaths. In the same period, Argentina reported 69 confirmed cases with two deaths. Vaccination against YF is recommended for all children living in risk areas in the Americas. In Argentina, the vaccine was administered at the same visit as the measles, mumps, and rubella (MMR) vaccine at 12 months of age.
A study published in 2011 found that simultaneous vaccination with YF and MMR vaccines had a negative impact on YF, mumps, and rubella seroconversion rates in Brazilian children aged 12 to 23 months. In 2013, the Strategic Advisory Group of Experts (SAGE) on immunization reviewed the available data on the co-administration of the YF vaccine with other inactivated and lived attenuated vaccines. In its June 2013 position paper, the WHO states that the YF vaccine can be co-administered with other vaccines but recommends further studies on co-administration with other vaccines, including MMR. In 2013, the Ministry of Health of Argentina changed the indication age for the YF vaccine to be administered to the pediatric population of 18 months, given concerns about a possible interference with MMR and the number of additional vaccines recommended for the pediatric population of 12 months.
In 2015, a collaborative study between the Ministry of Health (MoH) of Argentina, the Pan American Health Organization (PAHO), and the US Centers for Disease Control and Prevention (CDC) was initiated to assess the immunogenicity and the safety of joint administration of the YF and MMR vaccines in the pediatric population vaccinated at 12-13 months of age. 741 children presenting for routine immunization at 12-13 months of age enrolled and completed the study. Three randomized groups received the YF and MMR vaccines simultaneously or 28 days apart. The study found high seroconversion rates against all antigens in the co-administered and sequential groups. However, the magnitude of the antibody response was lower for YF, rubella, and mumps when the vaccines were co-administered.
The WHO currently states that a single dose of the YF vaccine is sufficient to confer lifelong sustained protective immunity against the disease; a booster dose is unnecessary. However, since the booster dose requirement was removed in 2013, new data have been published from pediatric population cohorts in Brazil, Mali, and Ghana, indicating a decrease in the proportion of children seropositive for neutralizing antibodies over time. Seropositivity rates as low as 28% for children in Ghana have been reported two years after vaccination. Given these findings, WHO and PAHO have prioritized obtaining additional longer-term immunogenicity data for the pediatric population vaccinated against YF.
The children who participated in the Argentina YF and MMR vaccination study provide an opportunity to assess whether the Argentine childhood immunization program provides adequate long-term immunity against YF. The last minor enrolled in 2018; It has been four to seven years since this pediatric group received their regular YF vaccinations. This cohort is unique because their initial YF vaccination and immune response to the vaccine dose are well characterized. This program evaluation is necessary to provide Argentina with evidence to inform future changes to its childhood immunization schedule.
Contact information collected during the co-administration study will be used to locate the children who completed the study. If consent is obtained, a 5ml specimen of blood will be collected and shipped to the CDC's Arboviral Diseases Reference Laboratory (ADRL) in Fort Collins, CO for plaque reduction neutralization testing using a 50% cut-off (PRNT50) to detect YF virus-specific neutralizing antibodies. Children with neutralizing antibody titers that are higher than their baseline titer collected approximately 28 days following YF vaccination will have PRNTs done for cross-reacting flaviviruses.
- Conditions
- Yellow Fever
- Being tested
- Serological study after yellow fever vaccination
- Keywords
- Antibodies response, Yellow Fever Vaccine
- Medical subject headings
- Yellow Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serological study after yellow fever vaccinationBiological
Also called Immunogenicity after yellow fever vaccine
It is a serological survey of the cohort of children who participated in the preliminary investigation and seroconverted after vaccination against yellow fever.
| Study group | Role | What they receive |
|---|---|---|
| Yellow fever seropositive vaccinated pediatric population in Argentina | Experimental | Yellow fever seropositive pediatric population in Argentina after receiving the YF vaccine at 12-23 months of age. Receives: Biological: Serological study after yellow fever vaccination |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of the pediatric population seropositive for yellow fever ≥ 4 years after yellow fever vaccination at 12-23 months of age in Argentina.
The proportion of children with detectable neutralizing antibodies 4-7 years following yellow fever vaccination.
Measured: 4-7 years following vaccination
Secondary outcomes (1)
To assess the influence of simultaneous administration versus sequential administration 28 days apart of yellow fever and MMR vaccines on yellow fever seropositivity and neutralizing antibody titers four to seven years later.
In the co-administration study, the target population was randomized into three groups. Group 1 received the yellow fever and MMR vaccines simultaneously, group 2 received the MMR vaccine followed by the yellow fever vaccine 28 days later, and group 3 received the yellow fever vaccine followed by the MMR vaccine 28 days later.
Measured: 4-7 years following vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start6 Dec 2022
- Primary completion7 Sep 2023
- Study completion30 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Yellow FeverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- It is a seroepidemiological study to evaluate the Immunization Program. It is a serological survey of the cohort of children who participated in the preliminary investigation and seroconverted after vaccination against yellow fever.
- Masking
- None (open label)
- Enrolment
- 361 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ministry of Public Health, Argentina
- Sponsor type
- Other government
- Collaborators
- Centers for Disease Control and Prevention, Pan American Health Organization
- Responsible party
- Principal investigator, Andrea Uboldi, Ministry of Public Health, Argentina
- Investigators
- Carla Vizzotti, Study chair, Ministry of Public Health, Argentina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05644145
- Sponsor's protocol ID
- IS003815
- Status last verified
- Dec 2024
- First submitted
- 11 Nov 2022
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified datasets generated in this study, including particular individual data that underlie the results reported in this article after identification, will be available for three years, starting after publication, to researchers who provide a methodologically sound proposal. All variables deemed to be personally identifiable information will be categorized or removed. The study protocol and informed consent forms will be available also.
Publications
Nascimento Silva JR, Camacho LA, Siqueira MM, Freire Mde S, Castro YP, Maia Mde L, Yamamura AM, Martins RM, Leal Mde L; Collaborative Group for the Study of Yellow Fever Vaccines. Mutual interference on the immune response to yellow fever vaccine and a combined vaccine against measles, mumps and rubella. Vaccine. 2011 Aug 26;29(37):6327-34. doi: 10.1016/j.vaccine.2011.05.019. Epub 2011 Jun 2.
PubMed 21640779de Noronha TG, de Lourdes de Sousa Maia M, Geraldo Leite Ribeiro J, Campos Lemos JA, Maria Barbosa de Lima S, Martins-Filho OA, Campi-Azevedo AC, da Silva Freire M, de Menezes Martins R, Bastos Camacho LA; Collaborative Group for Studies of Yellow Fever Vaccine. Duration of post-vaccination humoral immunity against yellow fever in children. Vaccine. 2019 Nov 15;37(48):7147-7154. doi: 10.1016/j.vaccine.2019.09.051. Epub 2019 Oct 4.
PubMed 31590934Campi-Azevedo AC, Reis LR, Peruhype-Magalhaes V, Coelho-Dos-Reis JG, Antonelli LR, Fonseca CT, Costa-Pereira C, Souza-Fagundes EM, da Costa-Rocha IA, Mambrini JVM, Lemos JAC, Ribeiro JGL, Caldas IR, Camacho LAB, Maia MLS, de Noronha TG, de Lima SMB, Simoes M, Freire MDS, Martins RM, Homma A, Tauil PL, Vasconcelos PFC, Romano APM, Domingues CM, Teixeira-Carvalho A, Martins-Filho OA. Short-Lived Immunity After 17DD Yellow Fever Single Dose Indicates That Booster Vaccination May Be Required to Guarantee Protective Immunity in Children. Front Immunol. 2019 Sep 26;10:2192. doi: 10.3389/fimmu.2019.02192. eCollection 2019.
PubMed 31616412Domingo C, Fraissinet J, Ansah PO, Kelly C, Bhat N, Sow SO, Mejia JE. Long-term immunity against yellow fever in children vaccinated during infancy: a longitudinal cohort study. Lancet Infect Dis. 2019 Dec;19(12):1363-1370. doi: 10.1016/S1473-3099(19)30323-8. Epub 2019 Sep 19.
PubMed 31543249Vaccines and vaccination against yellow fever. WHO position paper -- June 2013. Wkly Epidemiol Rec. 2013 Jul 5;88(27):269-83. No abstract available. English, French.
PubMed 23909008Who. Vaccines and vaccination against yellow fever: WHO Position Paper, June 2013--recommendations. Vaccine. 2015 Jan 1;33(1):76-7. doi: 10.1016/j.vaccine.2014.05.040. Epub 2014 May 20.
PubMed 24852721
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estudio Sobre Respuesta de Anticuerpos Neutralizantes Contra la Fiebre Amarilla Cuatro a Siete años después de Vacunar Una población pediátrica Entre Los 12 y 23 Meses de Edad en Argentina
- ClinicalTrials.gov ID
- NCT05644145
- Acronym / sponsor ID
- IS003815
- Conditions
- Yellow Fever
- Keywords
- Antibodies response, Yellow Fever Vaccine
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 361 participants (actual)
- Lead sponsor
- Ministry of Public Health, ArgentinaOther government
- Collaborators
- Centers for Disease Control and Prevention, Pan American Health Organization
- Study start
- 6 Dec 2022 (actual)
- Primary completion
- 7 Sep 2023 (actual)
- Study completion
- 30 Jul 2025 (estimated)
- First posted
- 9 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Northern Argentina is a risk area for yellow fever (YF). Recent studies have suggested that immunity wanes in children vaccinated between 9 and 23 months of age. In 2015, a collaborative study conducted by the Ministry of Health (MoH) of Argentina, the Pan American Health Organization (PAHO), and the US Centers for Disease Control and Prevention (CDC) assessed the immunogenicity and safety of co-administration of YF and MMR vaccines in a pediatric population at 12-13 months of age. A total of 741 children presenting for routine immunization at 12-13 months of age enrolled and completed the study. It is now four to seven years since this pediatric group received their YF vaccinations. This cohort is unique because their initial YF vaccination and immune response to the vaccine dose are well characterized. Contact information collected during the earlier study will be used to locate the children. If consent is obtained, a 5ml specimen of blood will be collected and shipped to the CDC's Arboviral Diseases Reference Laboratory (ADRL) in Fort Collins, CO for plaque reduction neutralization testing using a 50% cut-off (PRNT50) to detect YF virus-specific neutralizing antibodies. Children with neutralizing antibody titers that are higher than their baseline titer collected approximately 28 days following YF vaccination will have PRNTs done for cross-reacting flaviviruses.
Detailed description
Yellow fever (YF) continues to be a public health problem for 13 countries in the Americas, including northern Argentina. From 1960 to 2019, these countries reported 9,673 confirmed cases and 2,480 deaths. In the same period, Argentina reported 69 confirmed cases with two deaths. Vaccination against YF is recommended for all children living in risk areas in the Americas. In Argentina, the vaccine was administered at the same visit as the measles, mumps, and rubella (MMR) vaccine at 12 months of age.
A study published in 2011 found that simultaneous vaccination with YF and MMR vaccines had a negative impact on YF, mumps, and rubella seroconversion rates in Brazilian children aged 12 to 23 months. In 2013, the Strategic Advisory Group of Experts (SAGE) on immunization reviewed the available data on the co-administration of the YF vaccine with other inactivated and lived attenuated vaccines. In its June 2013 position paper, the WHO states that the YF vaccine can be co-administered with other vaccines but recommends further studies on co-administration with other vaccines, including MMR. In 2013, the Ministry of Health of Argentina changed the indication age for the YF vaccine to be administered to the pediatric population of 18 months, given concerns about a possible interference with MMR and the number of additional vaccines recommended for the pediatric population of 12 months.
In 2015, a collaborative study between the Ministry of Health (MoH) of Argentina, the Pan American Health Organization (PAHO), and the US Centers for Disease Control and Prevention (CDC) was initiated to assess the immunogenicity and the safety of joint administration of the YF and MMR vaccines in the pediatric population vaccinated at 12-13 months of age. 741 children presenting for routine immunization at 12-13 months of age enrolled and completed the study. Three randomized groups received the YF and MMR vaccines simultaneously or 28 days apart. The study found high seroconversion rates against all antigens in the co-administered and sequential groups. However, the magnitude of the antibody response was lower for YF, rubella, and mumps when the vaccines were co-administered.
The WHO currently states that a single dose of the YF vaccine is sufficient to confer lifelong sustained protective immunity against the disease; a booster dose is unnecessary. However, since the booster dose requirement was removed in 2013, new data have been published from pediatric population cohorts in Brazil, Mali, and Ghana, indicating a decrease in the proportion of children seropositive for neutralizing antibodies over time. Seropositivity rates as low as 28% for children in Ghana have been reported two years after vaccination. Given these findings, WHO and PAHO have prioritized obtaining additional longer-term immunogenicity data for the pediatric population vaccinated against YF.
The children who participated in the Argentina YF and MMR vaccination study provide an opportunity to assess whether the Argentine childhood immunization program provides adequate long-term immunity against YF. The last minor enrolled in 2018; It has been four to seven years since this pediatric group received their regular YF vaccinations. This cohort is unique because their initial YF vaccination and immune response to the vaccine dose are well characterized. This program evaluation is necessary to provide Argentina with evidence to inform future changes to its childhood immunization schedule.
Contact information collected during the co-administration study will be used to locate the children who completed the study. If consent is obtained, a 5ml specimen of blood will be collected and shipped to the CDC's Arboviral Diseases Reference Laboratory (ADRL) in Fort Collins, CO for plaque reduction neutralization testing using a 50% cut-off (PRNT50) to detect YF virus-specific neutralizing antibodies. Children with neutralizing antibody titers that are higher than their baseline titer collected approximately 28 days following YF vaccination will have PRNTs done for cross-reacting flaviviruses.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- It is a seroepidemiological study to evaluate the Immunization Program. It is a serological survey of the cohort of children who participated in the preliminary investigation and seroconverted after vaccination against yellow fever.
| Arm | Type | Receives |
|---|---|---|
| Yellow fever seropositive vaccinated pediatric population in Argentina | Experimental | Biological: Serological study after yellow fever vaccinationYellow fever seropositive pediatric population in Argentina after receiving the YF vaccine at 12-23 months of age. |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children enrolled in the 2015 study received one dose of YF vaccine and had documented seroconversion regardless of the
- Healthy child, determined by clinical history
- Availability to perform a single blood draw
- Informed consent signed by the parents.
Key exclusion criteria (7 listed)
- Children in the 2015 study received one dose of the Yellow Fever vaccine and had NO documented seroconversion.
- Children enrolled in the 2015 study received a dose of the Yellow Fever vaccine and had documented seroconversion but, for different reasons, received a booster (minimum interval of one month between doses).
- Children enrolled in the 2015 study received one dose of the Yellow Fever vaccine and had documented seroconversion but developed Yellow Fever
- Children enrolled in the 2015 study received one dose of the Yellow Fever vaccine and had documented seroconversion but are participating in another clinical drug trial of a drug, vaccine, or medical device
- Children enrolled in the 2015 study received a dose of the Yellow Fever vaccine and had documented seroconversion but, for various reasons, are immunocompromised:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serological study after yellow fever vaccinationAlso: Immunogenicity after yellow fever vaccineIt is a serological survey of the cohort of children who participated in the preliminary investigation and seroconverted after vaccination against yellow fever. | Biological | Yellow fever seropositive vaccinated pediatric population in Argentina |
Primary outcome
The proportion of the pediatric population seropositive for yellow fever ≥ 4 years after yellow fever vaccination at 12-23 months of age in Argentina.
Time frame: 4-7 years following vaccination
The proportion of children with detectable neutralizing antibodies 4-7 years following yellow fever vaccination.
1 secondary outcome
To assess the influence of simultaneous administration versus sequential administration 28 days apart of yellow fever and MMR vaccines on yellow fever seropositivity and neutralizing antibody titers four to seven years later.
Time frame: 4-7 years following vaccination
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Background: PubMed 21640779Nascimento Silva JR, Camacho LA, Siqueira MM, Freire Mde S, Castro YP, Maia Mde L, Yamamura AM, Martins RM, Leal Mde L; Collaborative Group for the Study of Yellow Fever Vaccines. Mutual interference on the immune response to yellow fever vaccine and a combined vaccine against measles, mumps and rubella. Vaccine. 2011 Aug 26;29(37):6327-34. doi: 10.1016/j.vaccine.2011.05.019. Epub 2011 Jun 2.
- Background: PubMed 31590934de Noronha TG, de Lourdes de Sousa Maia M, Geraldo Leite Ribeiro J, Campos Lemos JA, Maria Barbosa de Lima S, Martins-Filho OA, Campi-Azevedo AC, da Silva Freire M, de Menezes Martins R, Bastos Camacho LA; Collaborative Group for Studies of Yellow Fever Vaccine. Duration of post-vaccination humoral immunity against yellow fever in children. Vaccine. 2019 Nov 15;37(48):7147-7154. doi: 10.1016/j.vaccine.2019.09.051. Epub 2019 Oct 4.
- Background: PubMed 31616412Campi-Azevedo AC, Reis LR, Peruhype-Magalhaes V, Coelho-Dos-Reis JG, Antonelli LR, Fonseca CT, Costa-Pereira C, Souza-Fagundes EM, da Costa-Rocha IA, Mambrini JVM, Lemos JAC, Ribeiro JGL, Caldas IR, Camacho LAB, Maia MLS, de Noronha TG, de Lima SMB, Simoes M, Freire MDS, Martins RM, Homma A, Tauil PL, Vasconcelos PFC, Romano APM, Domingues CM, Teixeira-Carvalho A, Martins-Filho OA. Short-Lived Immunity After 17DD Yellow Fever Single Dose Indicates That Booster Vaccination May Be Required to Guarantee Protective Immunity in Children. Front Immunol. 2019 Sep 26;10:2192. doi: 10.3389/fimmu.2019.02192. eCollection 2019.
- Background: PubMed 31543249Domingo C, Fraissinet J, Ansah PO, Kelly C, Bhat N, Sow SO, Mejia JE. Long-term immunity against yellow fever in children vaccinated during infancy: a longitudinal cohort study. Lancet Infect Dis. 2019 Dec;19(12):1363-1370. doi: 10.1016/S1473-3099(19)30323-8. Epub 2019 Sep 19.
- Background: PubMed 23909008Vaccines and vaccination against yellow fever. WHO position paper -- June 2013. Wkly Epidemiol Rec. 2013 Jul 5;88(27):269-83. No abstract available. English, French.
- Background: PubMed 24852721Who. Vaccines and vaccination against yellow fever: WHO Position Paper, June 2013--recommendations. Vaccine. 2015 Jan 1;33(1):76-7. doi: 10.1016/j.vaccine.2014.05.040. Epub 2014 May 20.
- PAHO-WHO Member States reports to Health Emergency Information \& Risk assessment Unit (HIM) PAHO Health Emergencies Departments, 2022. Data compilation, analysis and report production.Link provided by the sponsor.
- Ropero Alba Maria, 2020. Immunogenicity of Co-administered Yellow Fever and Measles, Mumps, and Rubella (MMR) VaccinesLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Deidentified datasets generated in this study, including particular individual data that underlie the results reported in this article after identification, will be available for three years, starting after publication, to researchers who provide a methodologically sound proposal. All variables deemed to be personally identifiable information will be categorized or removed. The study protocol and informed consent forms will be available also.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carla Vizzotti study chair
Ministry of Public Health, Argentina
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serological study after yellow fever vaccination in people with Yellow Fever, run by Ministry of Public Health, Argentina at 3 sites in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of the pediatric population seropositive for yellow fever ≥ 4 years after yellow fever vaccination at 12-23 months of age in Argentina. (time frame: 4-7 years following vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05644145, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.