Trial · NCT02184572
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects Reporting Fever After MMR (Priorix or M-M-R II/M-M-R VaxPro [Lot 1 or Lot 2]) Vaccination | During Day 5 to Day 12 post-vaccination period | Fever was assessed for temperature equal to/above (≥) 38.0°C and above (\>) 39.0°C. The safety profile for fever was assessed based on the group difference (INV\_MMR minus COM\_MMR) in incidence of fever equal to or below the cut-off value. |
| Secondary | Percentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value | At Day 42 post vaccination | Seroresponse was defined as post-vaccination anti-measles virus antibody concentration greater than or equal to \[≥\] 200 milli International Units per milliliter \[mIU/mL\] (Enzyme-Linked Immunosorbent Assay \[ELISA\], Enzygnost) among subjects who were seronegative (antibody concentration less than \[\<\] 150 mIU/mL) before vaccination. |
| Secondary | Anti-measles Virus Antibody Concentrations | At Day 42 post vaccination | Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. Analyses included initially seronegative subjects only. |
| Secondary | Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value | At Day 42 post vaccination | Seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥ 10 ELISA Unit per milliliter \[EU/mL\] (ELISA, Pharmaceutical Product Development, Inc.\[PPD\]) among subjects who were seronegative (antibody concentration \< 5 EU/mL) before vaccination. |
| Secondary | Anti-mumps Virus Antibody Concentrations | At Day 42 post vaccination | Antibody concentrations were expressed as GMCs in EU/mL. Analyses included initially seronegative subjects only. |
| Secondary | Percentage of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value | At Day 42 post vaccination | Seroresponse was defined as post-vaccination anti-rubella virus antibody concentration ≥ 10 International Unit per milliliter \[IU/mL\] (ELISA, Enzygnost) among subjects who were seronegative (antibody concentration \< 4 IU/mL) before vaccination. |
| Secondary | Anti-rubella Virus Antibody Concentrations | At Day 42 post vaccination | Antibody concentrations were expressed as GMCs in IU/mL. Analyses included initially seronegative subjects only. |
| Secondary | Number of Subjects With Any Solicited Local Adverse Events (AEs) | During the 4-day (Days 0-3) post-vaccination period | Assessed solicited local AEs were injection site pain, redness and swelling. Any = Occurrence of AE regardless of intensity grade or relation to vaccination. |
| Secondary | Number of Subjects With Any Solicited General AEs | During the 15-day (Days 0-14) post-vaccination period | Assessed solicited general AEs were drowsiness, irritability/fussiness and loss of appetite. Any = Occurrence of AE regardless of intensity grade or relation to vaccination. |
| Secondary | Number of Subjects Reporting Any Fever | During the 43-day (Days 0-42) post-vaccination period | Any fever (≥ 38°C) = Occurrence of fever regardless of intensity grade or relation to vaccination. |
| Secondary | Number of Subjects Reporting Any Rash | During the 43-day (Days 0-42) post-vaccination period | Any rash = Occurrence of AE regardless of intensity grade or relation to vaccination. |
| Secondary | Number of Subjects Reporting MMR Specific Solicited General AEs | During the 43-day (Days 0-42) post-vaccination period | Assessed MMR specific solicited general AEs were parotid gland swelling and any suspected signs of meningism including febrile convulsions. Any = Occurrence of AE regardless of intensity grade or relation to vaccination. |
| Secondary | Number of Subjects Reporting Any Unsolicited AEs | During the 43-day (Days 0-42) post-vaccination period | Unsolicited AE included any AE reported in addition to those solicited during the clinical study and any 'solicited' AE with onset outside the specified period of follow-up for solicited AEs. Any = Occurrence of AE regardless of intensity grade or relation to vaccination. |
| Secondary | Number of Subjects Reporting AEs of Specific Interest | Day 0 through the end of the study (Day 180) | AEs of specific interest included new onset chronic disease (NOCD) (e.g., autoimmune disorders, asthma, type I diabetes, vasculitis, celiac disease, conditions associated with sub-acute or chronic thrombocytopenia and allergies) and AEs prompting emergency room (ER) visits. |
| Secondary | Number of Subjects Reporting Any Serious Adverse Events (SAEs) | Day 0 through the end of the study (Day 180) | SAE included any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization or resulted in disability/incapacity. Any = Occurrence of AE regardless of intensity grade or relation to vaccination. |
| Secondary | Number of Subjects Reporting Measles-like Illness | During Day 5 to Day 12 post-vaccination period | Measles-like illness was defined as the occurrence of the following signs/symptoms in the absence of another confirmed diagnosis: maculopapular rash (includes measles/rubella-like rash), fever (≥ 38°C) and at least one of the symptoms: cough, coryza (runny nose), conjunctivitis or diarrhea, with fever or rash. Other event must be one of cough, coryza, conjunctivitis, or diarrhea. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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