MumpsNCT01874457
Serological Study in Children 12 to 23 Months Vaccinated With MMR (Measles, Mumps and Rubella)
An observational study of Mumps and Rubella, run by The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz) at 1 site in Brazil.
Trial summary
On a previous study conducted in Brazil. The MMR vaccine from 2 different producers had a mumps seroconversion much lower (71%) than the expected 95%, according to the package insert. This could indicate that a substantial proportion of children was not protected after MMR dose. Read more about this study
- Who is it for?
- Ages 12 to 24 monthsHealthy volunteers can take part
- What is being tested?
- MMR (Mumps, Measles and Rubella)
- How many people
- 150 participants
- Where
- 1 siteBrazil
- Study dates
- May 2008to Aug 2009
- Phase
- Observational
- 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
Study population: Children 12-23 months and 29 days old, in the routine of PNI in health units in the city of Rio de Janeiro.
Who may be able to join
- Children of both sexes;
- Age between 12 months to 23 months and 29 days;
- Child in good health, with no significant past medical history;
- Have completed blood sampling before vaccination;
- Have not been vaccinated with MMR.
- Agreement by parents/tutors with the child's participation in the study and signing of the Informed Consent Form (ICF);
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- Parents/Tutors provide name, address, telephone number and other information for the contact if necessary;
- Parents/Tutors able to understand the risks of the experiment, although minimal;
- Parents/Tutors able to understand and sign the informed consent form.
- Availability of return for collecting post-vaccination samples.
Who cannot join
- Children with a history of measles, rubella and / or mumps.
- Having received MMR vaccine previously, as documented in vaccination card.
- Having received a transfusion of blood or blood products, including immunoglobulins, within last 12 months.
- Skin lesions at sites of venipuncture.
- Child subject to abnormal bleeding after injections.
- Use within 6 months of corticosteroids (excluding topical or aerosol) and immunosuppressants.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Serological Study of Measles, Mumps and Rubella in Children 12 to 23 Months Vaccinated With MMR (Measles, Mumps and Rubella) in Health Centers Where a Phase III Study Should be Conducted
On a previous study conducted in Brazil. The MMR vaccine from 2 different producers had a mumps seroconversion much lower (71%) than the expected 95%, according to the package insert. This could indicate that a substantial proportion of children was not protected after MMR dose.
Read the detailed description
Given the above and considering: (1) future clinical study with the MMR vaccine produced entirely in Bio-Manguinhos/Fiocruz from technology transfer from GlaxoSmithKline (GSK), (2) the importance to the National Immunization Program (NIP) to provide the population a MMR vaccine to ensure high protection against mumps, similar to what occurs with measles and rubella components, it was considered essential to conduct a preliminary immunogenicity assessment of the MMR vaccine produced by BioManguinhos.
- Being tested
- MMR (Mumps, Measles and Rubella)
- Medical subject headings
- Mumps, Rubella, Measles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MMR (Mumps, Measles and Rubella)Biological
MMR (Mumps, Measles and Rubella)
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunoresponse after first dose
Assess the immunoresponse for measles, mumps and rubella after vaccination with MMR in children 12-23 months and 29 days old, in the routine of National Immunization Program (NIP) in health units in the city of Rio de Janeiro.
Measured: 42 days
Secondary outcomes (1)
Immunoresponse after revaccination
To evaluate the immunoresponse after revaccination of children who did not seroconvert for any of the three components of the vaccine.
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2013 (estimated)
- Study startMay 2008
- Primary completionMar 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MumpsStudies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Glória Regina da Silva e Sá, Doctorate, Principal investigator, Immunobiological Technology Institute (Bio-Manguinhos)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01874457
- Sponsor's protocol ID
- ASCLIN/002/2008
- Status last verified
- Jun 2013
- First submitted
- 7 Jun 2013
- Last updated
- 17 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Serological Study of Measles, Mumps and Rubella in Children 12 to 23 Months Vaccinated With MMR (Measles, Mumps and Rubella) in Health Centers Where a Phase III Study Should be Conducted
- ClinicalTrials.gov ID
- NCT01874457
- Acronym / sponsor ID
- ASCLIN/002/2008
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)University, hospital or other
- Study start
- May 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 11 Jun 2013 (estimated)
- 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.
On a previous study conducted in Brazil. The MMR vaccine from 2 different producers had a mumps seroconversion much lower (71%) than the expected 95%, according to the package insert. This could indicate that a substantial proportion of children was not protected after MMR dose.
Detailed description
Given the above and considering: (1) future clinical study with the MMR vaccine produced entirely in Bio-Manguinhos/Fiocruz from technology transfer from GlaxoSmithKline (GSK), (2) the importance to the National Immunization Program (NIP) to provide the population a MMR vaccine to ensure high protection against mumps, similar to what occurs with measles and rubella components, it was considered essential to conduct a preliminary immunogenicity assessment of the MMR vaccine produced by BioManguinhos.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children 12-23 months and 29 days old, in the routine of PNI in health units in the city of Rio de Janeiro.
Key inclusion criteria (10 listed)
- Children of both sexes;
- Age between 12 months to 23 months and 29 days;
- Child in good health, with no significant past medical history;
- Have completed blood sampling before vaccination;
- Have not been vaccinated with MMR.
Key exclusion criteria (6 listed)
- Children with a history of measles, rubella and / or mumps.
- Having received MMR vaccine previously, as documented in vaccination card.
- Having received a transfusion of blood or blood products, including immunoglobulins, within last 12 months.
- Skin lesions at sites of venipuncture.
- Child subject to abnormal bleeding after injections.
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 |
|---|---|---|
| MMR (Mumps, Measles and Rubella)MMR (Mumps, Measles and Rubella) | Biological | – |
Primary outcome
Immunoresponse after first dose
Time frame: 42 days
Assess the immunoresponse for measles, mumps and rubella after vaccination with MMR in children 12-23 months and 29 days old, in the routine of National Immunization Program (NIP) in health units in the city of Rio de Janeiro.
1 secondary outcome
Immunoresponse after revaccination
Time frame: 42 days
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 17 Jun 2013.
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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.
Glória Regina da Silva e Sá, Doctorate principal investigator
Immunobiological Technology Institute (Bio-Manguinhos)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mumps and Rubella, run by The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz) at 1 site in Brazil.
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 10 inclusion and 6 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 17 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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?
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?
Immunoresponse after first dose (time frame: 42 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jun 2013.