Vaccine Response ImpairedPhase 4NCT03368495
Immunogenicity of Co-administered Yellow Fever and Measles, Mumps, and Rubella (MMR) Vaccines
A Phase 4 study testing Co-administration of MMR/YF, MMR followed by YF and YF followed by MMR in people with Vaccine Response Impaired, run by Alba Maria Ropero at 4 sites in Argentina.
Trial summary
This study evaluates seroconversion against measles, mumps, rubella and yellow fever following vaccination. One-third of children will receive both yellow fever and measles, mumps, and rubella (MMR) vaccines on the same day; one- third of children will receive MMR vaccine at enrollment followed by yellow fever vaccine… Read more about this study
- Who is it for?
- Ages 12 to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Vaccine Response Impaired
- What is being tested?
- Co-administration of MMR/YF, MMR followed by YF and YF followed by MMR
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 851 participants
- Where
- 4 sitesArgentina
- Study dates
- 23 Nov 2015to 30 Jun 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 12 to 24 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 12 to 24 months at the time of enrollment
- Healthy child, determined by clinical history
- Availability to do study visits and blood sampling on days 28 + 7 and 56 + 14
- Informed consent signed by parents
Who cannot join
- Previous vaccination against yellow fever, measles, mumps, or rubella
- History of yellow fever, measles, mumps or rubella
- Contraindication for any of the study vaccines: yellow fever vaccine or triple viral vaccine, including:
- Allergy to eggs, gelatin, or neomycin
- Weakened immunological function, including HIV infection, primary immunodeficiencies, having received immunosuppressive doses of oral or injectable corticosteroids (or equivalent), having received immunomodulators or chemotherapeutic agents
- Thymus disease
Show all 13Show fewer
- Serious illness/fever (mild illness without fever is not an exclusion criterion)
- Administration of immunoglobulins or other blood derivative within 6 months of enrollment in the study or during the study
- Exception: children with a history of Kawasaki disease who received gammaglobulin cannot be enrolled if they received it in the previous 11 months.
- Administration of any other attenuated viral vaccine (i.e., for chickenpox) in the month prior to enrollment, or if the administration of any other attenuated viral vaccine is expected during the study (up to 3 months)
- Not being available for the entire study period (up to 3 months), or not able to make the scheduled visits or complete the study procedures
- Participating in another clinical drug trial of a drug, vaccine, or medical device
- Any condition that, in opinion of the study staff, represents a health risk to the participant or interferes with the evaluation of the response to the vaccine (i.e., children in percentile ≤ 3 in the height/weight tables will be considered undernourished and cannot be selected)
Trial locations and contacts
4 sites in 1 country.
Argentina4 sites
SAMIC Eldorado Hospital
Eldorado, Misiones Province
SAMIC Obera Hospital
Obera, Misiones Province
Favoloro Hospital
Posadas, Misiones Province
IPS Hospital
Posadas, Misiones Province
About this study
Official title: Immunogenicity of Co-administered Yellow Fever and Measles, Mumps, and Rubella (MMR) Vaccines in Children Under 2 Years Old in Argentina
This study evaluates seroconversion against measles, mumps, rubella and yellow fever following vaccination. One-third of children will receive both yellow fever and measles, mumps, and rubella (MMR) vaccines on the same day; one- third of children will receive MMR vaccine at enrollment followed by yellow fever vaccine 4 weeks later; one-third of children will receive yellow fever vaccine at enrollment followed by MMR vaccine 4 weeks later.
Read the detailed description
The World Health Organization (WHO) and the Pan American Health Organization recommend that yellow fever and measles, mumps and rubella (MMR) vaccines be administered on the same day or at least 4 weeks apart to prevent interference between live vaccines. In 2011 a Brazilian study demonstrated lower seroconversion against yellow fever, rubella, and mumps when the two vaccines were administered on the same day compared with administering them separately. WHO urged that additional studies be conducted to examine this issue.
This Phase IV study aims to determine if seroconversion against measles, mumps, rubella, and yellow fever after administration of MMR and yellow fever vaccines on the same day is non-inferior to seroconversion after sequential administration 28 days apart in health 12-month old children.
- Conditions
- Vaccine Response Impaired
- Being tested
- Co-administration of MMR/YF, MMR followed by YF, YF followed by MMR
- Keywords
- yellow fever vaccine, MMR vaccine, immunogenicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Co-administration of MMR/YFBiological
Both MMR \& yellow fever vaccines administered on Day 0.
MMR followed by YFBiological
MMR vaccine administered on Day 0 and yellow fever vaccine administered on Day 28.
YF followed by MMRBiological
Yellow fever vaccine administered on Day 0 and MMR vaccine administered on Day 28.
| Study group | Role | What they receive |
|---|---|---|
| Co-administration of MMR/YF | Experimental | Participants randomized to this arm will receive both MMR and yellow fever vaccines on Day 0. Receives: Biological: Co-administration of MMR/YF |
| MMR followed by YF | Active comparator | Participants randomized to this arm will receive MMR vaccine on Day 0 followed by yellow fever vaccine on Day 28. Receives: Biological: MMR followed by YF |
| YF followed by MMR | Active comparator | Participants randomized to this arm will receive YF vaccine on Day 0 followed by MMR vaccine on Day 28. Receives: Biological: YF followed by MMR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroconversion after yellow fever vaccination using the plaque reduction neutralization test (PRNT).
PRNTs will be used to measure antibody titers for yellow fever.
Measured: 28-35 days post-vaccination
Seroconversion after MMR vaccination using the ELISA method.
The ELISA method will be used to measure antibody titers for measles, mumps, and rubella.
Measured: 28-35 days post-vaccination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2017
- Study start23 Nov 2015
- Primary completionJun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vaccine Response ImpairedStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 851 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alba Maria Ropero
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Ministry of Public Health, Argentina
- Responsible party
- Sponsor-investigator, Alba Maria Ropero, Pan American Health Organization
- Investigators
- Cristian Biscayart, MD, Principal investigator, Minsterio de Salud de la Nacion, Argentina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03368495
- Sponsor's protocol ID
- PAHO-2014-07-0011
- Status last verified
- May 2019
- First submitted
- 21 Nov 2017
- Last updated
- 21 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Vizzotti C, Harris JB, Aquino A, Rancano C, Biscayart C, Bonaventura R, Pontoriero A, Baumeister E, Freire MC, Magarinos M, Duarte B, Grant G, Reef S, Laven J, Wannemuehler KA, Alvarez AMR, Staples JE. Immune response to co-administration of measles, mumps, and rubella (MMR), and yellow fever vaccines: a randomized non-inferiority trial among one-year-old children in Argentina. BMC Infect Dis. 2023 Mar 17;23(1):165. doi: 10.1186/s12879-023-08114-1.
PubMed 36932346
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity of Co-administered Yellow Fever and Measles, Mumps, and Rubella (MMR) Vaccines in Children Under 2 Years Old in Argentina
- ClinicalTrials.gov ID
- NCT03368495
- Acronym / sponsor ID
- PAHO-2014-07-0011
- Conditions
- Vaccine Response Impaired
- Keywords
- yellow fever vaccine, MMR vaccine, immunogenicity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 851 participants (actual)
- Lead sponsor
- Alba Maria RoperoUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Ministry of Public Health, Argentina
- Study start
- 23 Nov 2015 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 11 Dec 2017 (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.
This study evaluates seroconversion against measles, mumps, rubella and yellow fever following vaccination. One-third of children will receive both yellow fever and measles, mumps, and rubella (MMR) vaccines on the same day; one- third of children will receive MMR vaccine at enrollment followed by yellow fever vaccine 4 weeks later; one-third of children will receive yellow fever vaccine at enrollment followed by MMR vaccine 4 weeks later.
Detailed description
The World Health Organization (WHO) and the Pan American Health Organization recommend that yellow fever and measles, mumps and rubella (MMR) vaccines be administered on the same day or at least 4 weeks apart to prevent interference between live vaccines. In 2011 a Brazilian study demonstrated lower seroconversion against yellow fever, rubella, and mumps when the two vaccines were administered on the same day compared with administering them separately. WHO urged that additional studies be conducted to examine this issue.
This Phase IV study aims to determine if seroconversion against measles, mumps, rubella, and yellow fever after administration of MMR and yellow fever vaccines on the same day is non-inferior to seroconversion after sequential administration 28 days apart in health 12-month old children.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Co-administration of MMR/YF | Experimental | Biological: Co-administration of MMR/YFParticipants randomized to this arm will receive both MMR and yellow fever vaccines on Day 0. |
| MMR followed by YF | Active comparator | Biological: MMR followed by YFParticipants randomized to this arm will receive MMR vaccine on Day 0 followed by yellow fever vaccine on Day 28. |
| YF followed by MMR | Active comparator | Biological: YF followed by MMRParticipants randomized to this arm will receive YF vaccine on Day 0 followed by MMR vaccine on Day 28. |
Who may qualify
- Ages
- 12 to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age 12 to 24 months at the time of enrollment
- Healthy child, determined by clinical history
- Availability to do study visits and blood sampling on days 28 + 7 and 56 + 14
- Informed consent signed by parents
Key exclusion criteria (13 listed)
- Previous vaccination against yellow fever, measles, mumps, or rubella
- History of yellow fever, measles, mumps or rubella
- Contraindication for any of the study vaccines: yellow fever vaccine or triple viral vaccine, including:
- Administration of immunoglobulins or other blood derivative within 6 months of enrollment in the study or during the study
- Administration of any other attenuated viral vaccine (i.e., for chickenpox) in the month prior to enrollment, or if the administration of any other attenuated viral vaccine is expected during the study (up to 3 months)
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 |
|---|---|---|
| Co-administration of MMR/YFBoth MMR \& yellow fever vaccines administered on Day 0. | Biological | Co-administration of MMR/YF |
| MMR followed by YFMMR vaccine administered on Day 0 and yellow fever vaccine administered on Day 28. | Biological | MMR followed by YF |
| YF followed by MMRYellow fever vaccine administered on Day 0 and MMR vaccine administered on Day 28. | Biological | YF followed by MMR |
Primary outcome
Seroconversion after yellow fever vaccination using the plaque reduction neutralization test (PRNT).
Time frame: 28-35 days post-vaccination
PRNTs will be used to measure antibody titers for yellow fever.
Seroconversion after MMR vaccination using the ELISA method.
Time frame: 28-35 days post-vaccination.
The ELISA method will be used to measure antibody titers for measles, mumps, and rubella.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2019.
- Derived from this study: PubMed 36932346Vizzotti C, Harris JB, Aquino A, Rancano C, Biscayart C, Bonaventura R, Pontoriero A, Baumeister E, Freire MC, Magarinos M, Duarte B, Grant G, Reef S, Laven J, Wannemuehler KA, Alvarez AMR, Staples JE. Immune response to co-administration of measles, mumps, and rubella (MMR), and yellow fever vaccines: a randomized non-inferiority trial among one-year-old children in Argentina. BMC Infect Dis. 2023 Mar 17;23(1):165. doi: 10.1186/s12879-023-08114-1.
- Individual participant dataSharing planned: Undecided
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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.
Cristian Biscayart, MD principal investigator
Minsterio de Salud de la Nacion, Argentina
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Co-administration of MMR/YF, MMR followed by YF and YF followed by MMR in people with Vaccine Response Impaired, run by Alba Maria Ropero at 4 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 13 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: finished, as of the sponsor's last update on 21 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Seroconversion after yellow fever vaccination using the plaque reduction neutralization test (PRNT). (time frame: 28-35 days post-vaccination). The study lists 2 primary outcomes in all. 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 NCT03368495, which also lists 1 linked publication.
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 21 May 2019.