MeaslesNCT02712203
MMR and MMRV Vaccines: Effect of Age at First Dose on Safety and Immunogenicity of the Measles Component.
An observational study of Measles, run by CHU de Quebec-Universite Laval.
Trial summary
Healthy children who received two doses of GlaxoSmithKline (GSK) Biologicals' live attenuated measles-mumps-rubella vaccine (MMR) or measles-mumps-rubella-varicella vaccine (MMRV) in their second year of life.The purpose of this study is to assess the effect of the age at administration of the first dose on the… Read more about this study
- Who is it for?
- Ages 11 to 22 monthsHealthy volunteers can take part
- Conditions the study is for
- Measles
- What is being tested?
- MMR vaccine / MMRV vaccine
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 5,808 participants
- Where
- No sites listed yet
- Study dates
- Jul 2004to Dec 2016
- 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 11 to 22 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Subjects aged 11 to 22 months selected to participate in clinical trials to assess the safety and immunogenicity of the GSK biological Priorix-Tetra™ in Germany, Austria, Finland, Greece, Poland, Czech Republic, Italy, Lithuania, Norway, Romania, Russian Federation, Slovakia, Sweden, United States and Puerto Rico.
Who may be able to join
- Healthy male or female subject between 11 to 22 months at the time of first vaccination.
- Written informed consent obtained from the parent/guardian of the subject.
Who cannot join
- History of previous measles, mumps, rubella and/or varicella vaccination or disease or known exposure to any of these diseases within 30 days prior to the inclusion in the study.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, included the chronic administration (defined as more than 14 days) of immune-suppressants or other immune-modifying drugs within six months prior to the firs vaccine dose.
- History of any neurologic disorders or seizures.
- History of allergic diseases or reactions likely to be exacerbated by any component of the vaccines.
- Planned administration of a vaccine not foreseen by the study protocol from 30 days prior to each vaccination until 42-56 days after each vaccination
About this study
Official title: Measles-mumps-rubella and Measles-mumps-rubella-varicella Vaccines: Effect of Age at First Dose on Safety and Immunogenicity of the Measles Component.
Healthy children who received two doses of GlaxoSmithKline (GSK) Biologicals' live attenuated measles-mumps-rubella vaccine (MMR) or measles-mumps-rubella-varicella vaccine (MMRV) in their second year of life.The purpose of this study is to assess the effect of the age at administration of the first dose on the reactogenicity and immunogenicity of the measles component of these vaccines.
In addition, this study will evaluate if the effect of the age at first dose is modified by the type of vaccine administered.
- Conditions
- Measles
- Being tested
- MMR vaccine / MMRV vaccine
- Keywords
- Measles vaccine, Priorix, Priorix-Tetra, Age at vaccination
- Medical subject headings
- Measles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MMR vaccine / MMRV vaccineBiological
Also called Priorix®, Priorix-Tetra®
Subcutaneous injection, two doses
| Study group | Role | What they receive |
|---|---|---|
| 12 months | MMR vaccine / MMRV vaccine : administration of the first dose at 12 months of age Receives: Biological: MMR vaccine / MMRV vaccine | |
| 13 months | MMR vaccine / MMRV vaccine : administration of the first dose at 13 months of age Receives: Biological: MMR vaccine / MMRV vaccine | |
| 14 months | MMR vaccine / MMRV vaccine : administration of the first dose at 14 months of age Receives: Biological: MMR vaccine / MMRV vaccine | |
| 15 months or more | MMR vaccine / MMRV vaccine : administration of the first dose at 12 months of age or older Receives: Biological: MMR vaccine / MMRV vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short term seropositivity rates & anti-measles antibody titers after vaccination with MMR or MMRV
Antibody titers are expressed as Geometric Mean Concentrations (GMC) in mIU/mL. The cut-off for seropositivity is anti-measles antibody titer ≥ 150 mIU/mL (performed on seronegative subjects prior to vaccination).
Measured: At day 42 after administration of a dose of MMR or MMRV vaccine
Secondary outcomes (3)
Injection site reaction
Injection site reaction is defined by the presence of pain, redness and swelling
Measured: Days 0-3 after vaccination
Systemic symptoms
Will include fever (defined as rectal temperature ≥38°C), general malaise and measles-like rash
Measured: Days 0 - 42 after administration of a dose of MMR or MMRV vaccine
Long term seropositivity rates and anti-measles antibody titers after vaccination with MMR or MMRV
Antibody titers are expressed as Geometric Mean Concentrations (GMC) in mIU/mL The cut-off for seropositivity is anti-measles antibody titer ≥ 150 mIU/mL
Measured: 2 and 3 years after vaccination with 2 doses of MMR or MMRV vaccines
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2016 (estimated)
- Study startJul 2004
- Primary completionJul 2010
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MeaslesStudies 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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 5,808 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Quebec-Universite Laval
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Principal investigator, Gaston De Serres, CHU de Quebec-Universite Laval
- Investigators
- Gaston De Serres, MD, PhD, Principal investigator, CHU de Quebec-Universite Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02712203
- Sponsor's protocol ID
- 200783
- Status last verified
- Mar 2016
- First submitted
- 14 Mar 2016
- Last updated
- 18 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Czajka H, Schuster V, Zepp F, Esposito S, Douha M, Willems P. A combined measles, mumps, rubella and varicella vaccine (Priorix-Tetra): immunogenicity and safety profile. Vaccine. 2009 Nov 5;27(47):6504-11. doi: 10.1016/j.vaccine.2009.07.076. Epub 2009 Aug 7.
PubMed 19665608Schuster V, Otto W, Maurer L, Tcherepnine P, Pfletschinger U, Kindler K, Soemantri P, Walther U, Macholdt U, Douha M, Pierson P, Willems P. Immunogenicity and safety assessments after one and two doses of a refrigerator-stable tetravalent measles-mumps-rubella-varicella vaccine in healthy children during the second year of life. Pediatr Infect Dis J. 2008 Aug;27(8):724-30. doi: 10.1097/INF.0b013e318170bb22.
PubMed 18600190Knuf M, Habermehl P, Zepp F, Mannhardt W, Kuttnig M, Muttonen P, Prieler A, Maurer H, Bisanz H, Tornieporth N, Descamps D, Willems P. Immunogenicity and safety of two doses of tetravalent measles-mumps-rubella-varicella vaccine in healthy children. Pediatr Infect Dis J. 2006 Jan;25(1):12-8. doi: 10.1097/01.inf.0000195626.35239.58.
PubMed 16395096
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measles-mumps-rubella and Measles-mumps-rubella-varicella Vaccines: Effect of Age at First Dose on Safety and Immunogenicity of the Measles Component.
- ClinicalTrials.gov ID
- NCT02712203
- Acronym / sponsor ID
- 200783
- Conditions
- Measles
- Keywords
- Measles vaccine, Priorix, Priorix-Tetra, Age at vaccination
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,808 participants (actual)
- Lead sponsor
- CHU de Quebec-Universite LavalUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Jul 2004
- Primary completion
- Jul 2010 (actual)
- Study completion
- Dec 2016 (estimated)
- First posted
- 18 Mar 2016 (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.
Healthy children who received two doses of GlaxoSmithKline (GSK) Biologicals' live attenuated measles-mumps-rubella vaccine (MMR) or measles-mumps-rubella-varicella vaccine (MMRV) in their second year of life.The purpose of this study is to assess the effect of the age at administration of the first dose on the reactogenicity and immunogenicity of the measles component of these vaccines.
In addition, this study will evaluate if the effect of the age at first dose is modified by the type of vaccine administered.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 12 months | – | Biological: MMR vaccine / MMRV vaccineMMR vaccine / MMRV vaccine : administration of the first dose at 12 months of age |
| 13 months | – | Biological: MMR vaccine / MMRV vaccineMMR vaccine / MMRV vaccine : administration of the first dose at 13 months of age |
| 14 months | – | Biological: MMR vaccine / MMRV vaccineMMR vaccine / MMRV vaccine : administration of the first dose at 14 months of age |
| 15 months or more | – | Biological: MMR vaccine / MMRV vaccineMMR vaccine / MMRV vaccine : administration of the first dose at 12 months of age or older |
Who may qualify
- Ages
- 11 to 22 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Subjects aged 11 to 22 months selected to participate in clinical trials to assess the safety and immunogenicity of the GSK biological Priorix-Tetra™ in Germany, Austria, Finland, Greece, Poland, Czech Republic, Italy, Lithuania, Norway, Romania, Russian Federation, Slovakia, Sweden, United States and Puerto Rico.
Key inclusion criteria (2 listed)
- Healthy male or female subject between 11 to 22 months at the time of first vaccination.
- Written informed consent obtained from the parent/guardian of the subject.
Key exclusion criteria (5 listed)
- History of previous measles, mumps, rubella and/or varicella vaccination or disease or known exposure to any of these diseases within 30 days prior to the inclusion in the study.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, included the chronic administration (defined as more than 14 days) of immune-suppressants or other immune-modifying drugs within six months prior to the firs vaccine dose.
- History of any neurologic disorders or seizures.
- History of allergic diseases or reactions likely to be exacerbated by any component of the vaccines.
- Planned administration of a vaccine not foreseen by the study protocol from 30 days prior to each vaccination until 42-56 days after each vaccination
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 vaccine / MMRV vaccineAlso: Priorix®, Priorix-Tetra®Subcutaneous injection, two doses | Biological | 12 months, 13 months, 14 months, 15 months or more |
Primary outcome
Short term seropositivity rates & anti-measles antibody titers after vaccination with MMR or MMRV
Time frame: At day 42 after administration of a dose of MMR or MMRV vaccine
Antibody titers are expressed as Geometric Mean Concentrations (GMC) in mIU/mL. The cut-off for seropositivity is anti-measles antibody titer ≥ 150 mIU/mL (performed on seronegative subjects prior to vaccination).
3 secondary outcomes
Injection site reaction
Time frame: Days 0-3 after vaccination
Systemic symptoms
Time frame: Days 0 - 42 after administration of a dose of MMR or MMRV vaccine
Long term seropositivity rates and anti-measles antibody titers after vaccination with MMR or MMRV
Time frame: 2 and 3 years after vaccination with 2 doses of MMR or MMRV vaccines
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2016.
- Background: PubMed 19665608Czajka H, Schuster V, Zepp F, Esposito S, Douha M, Willems P. A combined measles, mumps, rubella and varicella vaccine (Priorix-Tetra): immunogenicity and safety profile. Vaccine. 2009 Nov 5;27(47):6504-11. doi: 10.1016/j.vaccine.2009.07.076. Epub 2009 Aug 7.
- Background: PubMed 18600190Schuster V, Otto W, Maurer L, Tcherepnine P, Pfletschinger U, Kindler K, Soemantri P, Walther U, Macholdt U, Douha M, Pierson P, Willems P. Immunogenicity and safety assessments after one and two doses of a refrigerator-stable tetravalent measles-mumps-rubella-varicella vaccine in healthy children during the second year of life. Pediatr Infect Dis J. 2008 Aug;27(8):724-30. doi: 10.1097/INF.0b013e318170bb22.
- Background: PubMed 16395096Knuf M, Habermehl P, Zepp F, Mannhardt W, Kuttnig M, Muttonen P, Prieler A, Maurer H, Bisanz H, Tornieporth N, Descamps D, Willems P. Immunogenicity and safety of two doses of tetravalent measles-mumps-rubella-varicella vaccine in healthy children. Pediatr Infect Dis J. 2006 Jan;25(1):12-8. doi: 10.1097/01.inf.0000195626.35239.58.
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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.
Gaston De Serres, MD, PhD principal investigator
CHU de Quebec-Universite Laval
Questions about this trial
What is this clinical trial studying?
An observational study of Measles, run by CHU de Quebec-Universite Laval.
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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 18 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Short term seropositivity rates & anti-measles antibody titers after vaccination with MMR or MMRV (time frame: At day 42 after administration of a dose of MMR or MMRV vaccine). 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 NCT02712203, which also lists 3 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 18 Mar 2016.