MumpsNCT01738841
Safety Study of Measles-Mumps-Rubella-Varicella (MMRV) Vaccine, Priorix-Tetra™ in Children Living in the Philippines
An observational study of Mumps and Rubella, run by GlaxoSmithKline.
Trial summary
This study will collect data on the safety of the MMRV vaccine (Priorix-Tetra™) used in routine practice in children aged 12 months to 12 years living in the Philippines. Read more about this study
- Who is it for?
- Ages 12 months to 12 yearsHealthy volunteers can take part
- What is being tested?
- Priorix-Tetra™ and Safety data collection
- Type of treatment
- Injection or infusion
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2013to Mar 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 12 months to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children aged 12 months to 12 years living in Philippines will receive Priorix-Tetra as prescribed by the physician.
Who may be able to join
- Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol.
- Written informed consent obtained from the parent(s)/LAR(s) of the subject.
- Male or female subjects living in the Philippines between, and including, the ages of 12 months and 12 years at the time of the vaccination.
- Female subjects of child bearing potential may be enrolled in the study, if the subject:
- has agreed to be abstinent or practiced adequate contraception for 30 days prior to vaccination, and
- has a negative pregnancy test on the day of vaccination, and
- has agreed to continue adequate contraception during the entire treatment period and for 3 months after completion of the vaccination.
Who cannot join
- Child in care.
- Any contraindications to vaccination as stated in the Prescribing Information.
- Acute, severe febrile illness at the time of enrollment. The presence of a minor infection, such as a cold, will not exclude the subject from the study.
- Previous receipt of a measles, mumps, rubella and/or varicella-virus containing vaccine less than 3 months prior to study entry.
- Previous enrolment in this trial.
- Subjects with impaired immune function, including primary or secondary immunodeficiencies based on medical history.
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- History of hypersensitivity to any component of the vaccine.
- History of hypersensitivity following previous administration of measles, mumps, rubella and/or varicella-virus containing vaccines.
- Receipt of human gamma globulins or a blood transfusion within 3 months prior to study entry.
- Hypersensitivity to latex.
- Pregnant or lactating female.
About this study
Official title: Post-marketing Surveillance Study of GSK Biologicals' Live, Attenuated Measles, Mumps, Rubella and Varicella Vaccine, Priorix-Tetra, Following a Single Vaccine Dose Given According to Local Prescribing Information in the Philippines
This study will collect data on the safety of the MMRV vaccine (Priorix-Tetra™) used in routine practice in children aged 12 months to 12 years living in the Philippines.
Read the detailed description
The participating physicians will enroll only those subjects for whom they would prescribe Priorix-Tetra in the course of their normal clinical practice.
- Being tested
- Priorix-Tetra™, Safety data collection
- Keywords
- Combined measles-mumps-rubella-varicella vaccine, Priorix-Tetra™, MMRV, children, Post-marketing surveillance, Philippines
- Medical subject headings
- Mumps, Rubella, Measles, Chickenpox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Priorix-Tetra™Biological
Single dose, subcutaneous injection
Safety data collectionOther
Recording of adverse events, using diary cards
| Study group | Role | What they receive |
|---|---|---|
| Cohort Group | Children aged 12 months to 12 years will receive Priorix-Tetra as prescribed by the physician. Receives: Biological: Priorix-Tetra™; Other: Safety data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Grade 3 adverse events (AEs) with a causal relationship to vaccination
Measured: Between Day 0 and Day 42
Secondary outcomes (4)
Occurrence of Grade 3 AEs
Measured: Between Day 0 and Day 42
Occurrence of medically-attended AEs
Measured: Between Day 0 and Day 42
Occurrence of Serious Adverse Events (SAEs)
Measured: From the time of vaccination (Week 0) to study end (Week 6)
Occurrence of febrile convulsions
Measured: Between Day 0 and Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2012 (estimated)
- Study startAug 2013
- Primary completionMar 2016 (estimated)
- Study completionMar 2016 (estimated)
Why it stopped: Local authorities no longer require routine PMS studies; GSK does not believe the study would add meaningfully to the safety data already available for MMRV.
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.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01738841
- Sponsor's protocol ID
- 114229
- Status last verified
- Jul 2013
- First submitted
- 28 Nov 2012
- Last updated
- 22 Jul 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-marketing Surveillance Study of GSK Biologicals' Live, Attenuated Measles, Mumps, Rubella and Varicella Vaccine, Priorix-Tetra, Following a Single Vaccine Dose Given According to Local Prescribing Information in the Philippines
- ClinicalTrials.gov ID
- NCT01738841
- Acronym / sponsor ID
- 114229
- Keywords
- Combined measles-mumps-rubella-varicella vaccine, Priorix-Tetra™, MMRV, children, Post-marketing surveillance, Philippines
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Local authorities no longer require routine PMS studies; GSK does not believe the study would add meaningfully to the safety data already available for MMRV.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 30 Nov 2012 (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.
This study will collect data on the safety of the MMRV vaccine (Priorix-Tetra™) used in routine practice in children aged 12 months to 12 years living in the Philippines.
Detailed description
The participating physicians will enroll only those subjects for whom they would prescribe Priorix-Tetra in the course of their normal clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort Group | – | Biological: Priorix-Tetra™, Other: Safety data collectionChildren aged 12 months to 12 years will receive Priorix-Tetra as prescribed by the physician. |
Who may qualify
- Ages
- 12 months to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children aged 12 months to 12 years living in Philippines will receive Priorix-Tetra as prescribed by the physician.
Key inclusion criteria (7 listed)
- Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol.
- Written informed consent obtained from the parent(s)/LAR(s) of the subject.
- Male or female subjects living in the Philippines between, and including, the ages of 12 months and 12 years at the time of the vaccination.
- Female subjects of child bearing potential may be enrolled in the study, if the subject:
Key exclusion criteria (11 listed)
- Child in care.
- Any contraindications to vaccination as stated in the Prescribing Information.
- Acute, severe febrile illness at the time of enrollment. The presence of a minor infection, such as a cold, will not exclude the subject from the study.
- Previous receipt of a measles, mumps, rubella and/or varicella-virus containing vaccine less than 3 months prior to study entry.
- Previous enrolment in this trial.
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 |
|---|---|---|
| Priorix-Tetra™Single dose, subcutaneous injection | Biological | Cohort Group |
| Safety data collectionRecording of adverse events, using diary cards | Other | Cohort Group |
Primary outcome
Occurrence of Grade 3 adverse events (AEs) with a causal relationship to vaccination
Time frame: Between Day 0 and Day 42
4 secondary outcomes
Occurrence of Grade 3 AEs
Time frame: Between Day 0 and Day 42
Occurrence of medically-attended AEs
Time frame: Between Day 0 and Day 42
Occurrence of Serious Adverse Events (SAEs)
Time frame: From the time of vaccination (Week 0) to study end (Week 6)
Occurrence of febrile convulsions
Time frame: Between Day 0 and Day 42
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 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.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
An observational study of Mumps and Rubella, run by GlaxoSmithKline.
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 7 inclusion and 11 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: withdrawn, as of the sponsor's last update on 22 Jul 2013. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Occurrence of Grade 3 adverse events (AEs) with a causal relationship to vaccination (time frame: Between Day 0 and Day 42). 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 22 Jul 2013.