Comparison of GSK Measles-mumps-rubella-varicella (MMRV) Vaccine Versus PriorixTM

Browse trials for

• Measles 120
• Chickenpox 152
• Herpes Zoster 360
• Rubella 92
• Mumps 46

Keywords

• Mumps
• Immunogenicity
• Vaccines
• Safety
• Rubella
• Combined Vaccine
• Varicella Vaccine
• Children
• Measles
• Humans

Study arms

• Experimental
  Priorix-Tetra Group

  Subjects received 2 doses of Priorix-Tetra® vaccine, 1 at Day 0 and 1 at Month 6, administered subcutaneously in the left anterolateral thigh.

  Biological: GSK Biological's investigational MMRV vaccine 208136

• Experimental
  Priorix/ Priorix-Tetra Group

  Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix-Tetra® vaccine at Month 6, both administered subcutaneously in the left anterolateral thigh.

  Biological: GSK Biological's investigational MMRV vaccine 208136 · Biological: Priorix™

• Active comparator
  Control Group

  Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix™ vaccine co-administered with Varilirix™ vaccine at Month 6, administered subcutaneously in the left and right anterolateral thigh.

  Biological: Priorix™ · Biological: Varilrix™

Interventions

• BiologicalGSK Biological's investigational MMRV vaccine 208136

  Subcutaneous injection

• BiologicalPriorix™

  Subcutaneous injection

• BiologicalVarilrix™

  Subcutaneous injection

Primary outcomes

1. Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies

   Seroconversion was defined as the appearance of antibodies \[i.e. concentration/titre greater than or equal to (≥) the cut-off value\] in the serum of subjects seronegative before vaccination. The cut-off values for seroconversion were 150 milli-international units per milliliter (mIU/mL), 231 units per milliliter (U/mL), 4 international units per milliliter (IU/mL) and for immunoglobulin G (IgG) varicella antibodies 1:4 dilution for measles, mumps, rubella and varicella, respectively.

   Time frame: At 42 - 56 days after the second vaccination dose at week 30

Secondary outcomes

1. Number of Seroconverted Subjects for Measles, Mumps, Rubella and Varicella Antibodies

   Seroconversion was defined as the appearance of antibodies (i.e. concentration/titre ≥ the cut-off value) in the serum of subjects seronegative before vaccination. The cut-off values for seroconversion were 150 mIU/mL, 231 U/mL, 4 IU/mL and for IgG varicella antibodies 1:4 dilution for measles, mumps, rubella and varicella, respectively.

   Time frame: Approximately 42 to 56 days after the first vaccine dose at week 6

2. Antibody Concentrations Against Measles, Mumps, Rubella and Varicella Viruses

   Antibody concentrations were summarized by geometric mean concentrations (GMCs) with their 95% confidence intervals (CIs).

   Time frame: At 42 - 56 days after the first (at Week 6) and second (at Week 30) vaccination dose

3. Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms

   Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried 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 following each dose (Dose 1 and Dose 2)

4. Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms

   Assessed solicited general symptoms were meningism and parotid gland swelling. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 meningism and parotid gland swelling = meningism/parotid gland swelling which prevented normal everyday activities. Related = symptom assessed by the investigator as related to the vaccination.

   Time frame: During the 43-day (Days 0-42) post-vaccination period following each dose (Dose 1 and Dose 2)

5. Number of Subjects Reporting Any, Grade 3 and Related Fever

   Any fever was defined as fever ≥ 38.0°C and grade 3 fever was defined as fever \> 39.5°C after vaccination. Related fever was defined as fever assessed by the investigator as related to the vaccination.

   Time frame: During the 43-day (Days 0-42) post-vaccination period following each dose (Dose 1 and Dose 2)

6. Number of Subjects Reporting Any, Grade 3 and Related Rash

   Any rash was defined as incidence of a rash regardless of intensity grade or relationship to vaccination and grade 3 rash greater than (\>) 150 lesions. Related rash was defined as rash assessed by the investigator as causally related to the vaccination

   Time frame: During the 43-day (Days 0-42) post-vaccination period following each dose (Dose 1 and Dose 2)

7. Number of Subjects Reporting Any Unsolicited Adverse Event

   An unsolicited Adverse Event (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 AE reported in addition to those solicited during the clinical study. Also 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 43-day (Days 0-42) after the first and second vaccination dose

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

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

   Time frame: From the first study dose up to study end (Month 0 to Month 7.5 approximately)

Baseline characteristics

Publications

• Lalwani S, Chatterjee S, Balasubramanian S, Bavdekar A, Mehta S, Datta S, Povey M, Henry O. Immunogenicity and safety of early vaccination with two doses of a combined measles-mumps-rubella-varicella vaccine in healthy Indian children from 9 months of age: a phase III, randomised, non-inferiority trial. BMJ Open. 2015 Sep 11;5(9):e007202. doi: 10.1136/bmjopen-2014-007202. PubMed 26362659 ↗

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.