A Phase 4 interventional study of Inactivated Hep A vaccine; Attenuated Measles Mumps Rubella and Attenuated Measles Mumps Rubella; Inactivated Hep A vaccine in Measles, Mumps and Rubella, sponsored by Sanofi Pasteur, a Sanofi Company. Completed at 1 site in Turkey. Open to participants aged 12 Months to 13 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-01-22.
Sponsored by Sanofi Pasteur, a Sanofi Company (part of Sanofi) · Phase 4, Interventional, and Prevention
The present study will explore the immunogenicity of AVAXIM™ 80U-Pediatric in 12-13 months Turkish children and check if the administration of the MMR trivalent vaccine on the same day but at different site will interfere on immunogenicity for the four valences Hepatitis A, Measles, Mumps, and Rubella.
134 studies on the registry are indexed under Measles; 17 are open to participants now.
This study's enrollment of 470 is below the median of 852 across 105 interventional studies indexed under Measles.
Browse Measles studies →Sanofi Pasteur, a Sanofi Company is the lead sponsor of 374 studies on the registry; 4 are open to participants now.
Of its 94 completed or terminated interventional studies of FDA-regulated products, 73 (78%) have results posted.
First submitted after Sanofi Pasteur became part of Sanofi.
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A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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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.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
Biological: Inactivated Hep A vaccine; Attenuated Measles Mumps Rubella
Biological: Attenuated Measles Mumps Rubella; Inactivated Hep A vaccine
Biological: Inactivated Hep A vaccine; Attenuated Measles Mumps Rubella
0.5 mL, intramuscular (IM) (HAV Day 0 and 168); 0.5 mL, IM (MMR Day 28)
Also known as: AVAXIM™, TRIMOVAX™
0.5 mL, IM (MMR, Day 0); 0.5 mL, IM (HAV Day 28 and 168)
Also known as: TRIMOVAX™, AVAXIM™
0.5 mL, IM (HAV Day 0 and 168); 0.5 mL, IM (MMR, Day 0)
Also known as: AVAXIM™, TRIMOVAX™
To provide information concerning the immunogenicity of Hepatitis A Vaccine in subjects receiving Pediatric vaccines.
Time frame: Day 7 - Day 196
This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Measles-Mumps-Rubella Vaccine
Sanofi Pasteur, a Sanofi Company →