An observational study in Mumps, Rubella and Measles, sponsored by GlaxoSmithKline. Withdrawn. Open to participants aged 12 Months to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-07-22.
Sponsored by GlaxoSmithKline · Observational
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.
The participating physicians will enroll only those subjects for whom they would prescribe Priorix-Tetra in the course of their normal clinical practice.
83 studies on the registry are indexed under Mumps; 8 are open to participants now.
Browse Mumps studies →GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 118 are open to participants now.
Of its 264 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Children aged 12 months to 12 years living in Philippines will receive Priorix-Tetra as prescribed by the physician.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Female subjects of child bearing potential may be enrolled in the study, if the subject:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Children aged 12 months to 12 years will receive Priorix-Tetra as prescribed by the physician.
Biological: Priorix-Tetra™ · Other: Safety data collection
Single dose, subcutaneous injection
Recording of adverse events, using diary cards
Occurrence of Grade 3 adverse events (AEs) with a causal relationship to vaccination
Time frame: Between Day 0 and Day 42
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
No study locations are listed for this record.
The record gives a start of Aug 2013, a primary completion of Mar 2016 and a completion of Mar 2016. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is withdrawn, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.
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