Immunogenicity & Safety Study of GSK Biologicals' Combined Measles-mumps-rubella-varicella Vaccine 208136

Browse trials for

• Measles 134
• Chickenpox 180
• Mumps 83
• Rubella 85

Keywords

• second year of life
• one-dose schedule
• varicella
• rubella
• measles
• mumps

Measles

134 studies on the registry are indexed under Measles; 17 are open to participants now.

This study's enrollment of 475 is below the median of 852 across 105 interventional studies indexed under Measles.

Lead sponsor

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.

Study arms

• Experimental
  PRIORIX-TETRA GROUP

  Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix-Tetra® vaccine at Day 0, administered subcutaneously in the deltoid region of the left upper arm.

  Biological: Priorix-Tetra®

• Active comparator
  PRIORIX + VARILRIX GROUP

  Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix™ vaccine together with one dose of Varilrix™ vaccine at Day 0, administered subcutaneously in the deltoid regions of the left or right upper arm, respectively.

  Biological: PriorixTM · Biological: VarilrixTM

Interventions

• BiologicalPriorixTM

  Subcutaneous administration in left upper arm

• BiologicalVarilrixTM

  Subcutaneous administration in right upper arm

• BiologicalPriorix-Tetra®

  Subcutaneous injection in left upper arm

Primary outcomes

1. Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Zoster Virus (VZV) Antibodies Above the Cut-off Values

   Seroconversion was defined as the appearance of antibodies \[i.e. titer greater than or equal to (≥) the cut-off value\] in the sera of subjects seronegative \[i.e. titer below (\<) cut-off value\] before vaccination. Cut-off values were the following: Anti-measles concentration ≥ 150 milli-international units per milliliter (mIU/mL); Anti-mumps concentration ≥ 231 units per milliliter (U/mL); Anti-rubella concentration ≥ 4 international units per milliliter (IU/mL); Anti-VZV titer ≥ 1:4 dilution.

   Time frame: At 42 days post-vaccination

Secondary outcomes

1. Antibody Concentrations Against Measles

   Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).

   Time frame: At 42-days post-vaccination

2. Antibody Concentrations Against Mumps

   Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in units per milliliter (U/mL).

   Time frame: At 42-days post-vaccination

3. Antibody Concentrations Against Rubella

   Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).

   Time frame: At 42-days post-vaccination

4. Antibody Titers Against Varicela Viruses

   Antibody titers were presented as geometric mean titers (GMTs).

   Time frame: At 42-days post-vaccination

5. Number of Subjects With Any and Grade 3 Solicited Local Symptoms

   Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cry when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.

   Time frame: During the 4-day (Days 0-3) post-vaccination period

6. Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

   Solicited general symptoms assessed were fever \[defined as rectal temperature ≥38.0 degrees Celsius (°C)\], rash, meningism and parotid gland swelling. Any= incidence of the specified symptoms regardless of intensity grade or relationship to study vaccine. Grade 3 fever= rectal temperature above (\>) 39.5°C. Grade 3 rash= more than 150 lesions. Grade 3 meningism and parotid gland swelling= meningism/parotid gland swelling symptom which prevented normal everyday activities. Related = general symptom assessed by the investigator as causally related to the vaccination.

   Time frame: During the 43-day (Days 0-42) post-vaccination period

7. Number of Subjects With Any Unsolicited Adverse Events (AEs)

   An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.

   Time frame: Within the 43-day (Days 0-42) post-vaccination period

8. Number of Subjects With Serious Adverse Events (SAEs)

   Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.

   Time frame: During the entire study period (from Day 0 up to Day 43 or Day 57)

Baseline characteristics

Publications

• Cha SH, Shin SH, Lee TJ, Kim CH, Povey M, Kim HM, Nicholson O. Immunogenicity and safety of a tetravalent measles-mumps-rubella-varicella vaccine: an open-labeled, randomized trial in healthy Korean children. Clin Exp Vaccine Res. 2014 Jan;3(1):91-9. doi: 10.7774/cevr.2014.3.1.91. Epub 2013 Dec 18. PubMed 24427766 ↗

Related links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. ↗

Individual participant data

Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.