Back to resultsComparison of GSK Measles-mumps-rubella-varicella (MMRV) Vaccine Versus PriorixTM
Primary Purpose
Varicella, Rubella, Mumps
Status
Completed
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
GSK Biological's investigational MMRV vaccine 208136
Priorix™
Varilrix™
Sponsored by
About this trial
This is an interventional prevention trial for Varicella focused on measuring Mumps, Immunogenicity, Vaccines, Safety, Rubella, Combined Vaccine, Varicella Vaccine, Children, Measles, Humans
Eligibility Criteria
Inclusion Criteria:
- Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
- Male or female subjects between and including 9 and 10 months of age at the time of the first vaccination.
- Written informed consent obtained from the the parent or guardian of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
Exclusion Criteria:
- Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- Planned administration/administration of a vaccine not foreseen by the study protocol starting 30 days prior to administration of any dose of the study vaccine, up to 42 days after the vaccine dose with the exception of hepatitis A vaccine and oral poliovirus vaccine .
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-registered product.
- Previous vaccination against measles, mumps, rubella and varicella.
- History of measles, mumps, rubella and/or varicella diseases.
- Known exposure to measles, mumps, rubella and/or varicella within 30 days prior to the start of the study.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- A family history of congenital or hereditary immunodeficiency.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines including neomycin.
- Major congenital defects or serious chronic illness.
- History of any neurologic disorders or seizures.
- Acute disease at the time of enrolment.
- Axillary temperature > 37.5°C (99.5°F) / Rectal temperature > 38°C (100.4°F).
- Administration of immunoglobulins and/or any blood products during the six months before entering the study or planned administration during the study period.
- Presence of a susceptible high-risk person in the same household during the study period.
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Priorix-Tetra Group
Priorix/ Priorix-Tetra Group
Control Group
Arm Description
Subjects received 2 doses of Priorix-Tetra® vaccine, 1 at Day 0 and 1 at Month 6, administered subcutaneously in the left anterolateral thigh.
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Antibody Concentrations Against Measles, Mumps, Rubella and Varicella Viruses
Antibody concentrations were summarized by geometric mean concentrations (GMCs) with their 95% confidence intervals (CIs).
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.
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.
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.
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
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00969436
Brief Title
Comparison of GSK Measles-mumps-rubella-varicella (MMRV) Vaccine Versus PriorixTM
Official Title
A Phase IIIb, Open, Randomised, Multicentre, Primary Study in Healthy Children, to Establish the Non-inferiority of GlaxoSmithKline (GSK) Biologicals' MeMuRu-OKA Vaccine (Administered at 9 and 15 Months of Age) Versus Priorix™ (9 Months of Age) and Priorix™ Co-administered With Varilrix™ at 15 Months of Age (Comparator) and Also to Evaluate the Non-inferiority of Priorix™ (9 Months of Age) and MeMuRu-OKA Vaccine (15 Months of Age) Versus the Comparator, All Administered Subcutaneously as Two-dose Primary Vaccination Course
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
November 9, 2009 (Actual)
Primary Completion Date
February 21, 2011 (Actual)
Study Completion Date
February 21, 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to assess non-inferiority of two different vaccination regimens using GSK Biological's MMRV vaccine (two doses at 9 and 15 months) or Priorix™ (9 months) and one dose of MMRV vaccine (15 months) to the current standard of care which is Priorix™ administered at 9 months of age followed by concomitant administration of Priorix™ with Varilrix™ at 15 months of age in a measles endemic environment such as India.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicella, Rubella, Mumps, Measles
Keywords
Mumps, Immunogenicity, Vaccines, Safety, Rubella, Combined Vaccine, Varicella Vaccine, Children, Measles, Humans
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
450 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Priorix-Tetra Group
Arm Type
Experimental
Arm Description
Subjects received 2 doses of Priorix-Tetra® vaccine, 1 at Day 0 and 1 at Month 6, administered subcutaneously in the left anterolateral thigh.
Arm Title
Priorix/ Priorix-Tetra Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
GSK Biological's investigational MMRV vaccine 208136
Intervention Description
Subcutaneous injection
Intervention Type
Biological
Intervention Name(s)
Priorix™
Intervention Description
Subcutaneous injection
Intervention Type
Biological
Intervention Name(s)
Varilrix™
Intervention Description
Subcutaneous injection
Primary Outcome Measure Information:
Title
Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies
Description
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 Outcome Measure Information:
Title
Number of Seroconverted Subjects for Measles, Mumps, Rubella and Varicella Antibodies
Description
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
Title
Antibody Concentrations Against Measles, Mumps, Rubella and Varicella Viruses
Description
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
Title
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Description
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)
Title
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Description
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)
Title
Number of Subjects Reporting Any, Grade 3 and Related Fever
Description
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)
Title
Number of Subjects Reporting Any, Grade 3 and Related Rash
Description
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)
Title
Number of Subjects Reporting Any Unsolicited Adverse Event
Description
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
Title
Number of Subjects With Serious Adverse Events (SAEs)
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Months
Maximum Age & Unit of Time
10 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
Male or female subjects between and including 9 and 10 months of age at the time of the first vaccination.
Written informed consent obtained from the the parent or guardian of the subject.
Healthy subjects as established by medical history and clinical examination before entering into the study.
Exclusion Criteria:
Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
Planned administration/administration of a vaccine not foreseen by the study protocol starting 30 days prior to administration of any dose of the study vaccine, up to 42 days after the vaccine dose with the exception of hepatitis A vaccine and oral poliovirus vaccine .
Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-registered product.
Previous vaccination against measles, mumps, rubella and varicella.
History of measles, mumps, rubella and/or varicella diseases.
Known exposure to measles, mumps, rubella and/or varicella within 30 days prior to the start of the study.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
A family history of congenital or hereditary immunodeficiency.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccines including neomycin.
Major congenital defects or serious chronic illness.
History of any neurologic disorders or seizures.
Acute disease at the time of enrolment.
Axillary temperature > 37.5°C (99.5°F) / Rectal temperature > 38°C (100.4°F).
Administration of immunoglobulins and/or any blood products during the six months before entering the study or planned administration during the study period.
Presence of a susceptible high-risk person in the same household during the study period.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Bangalore
ZIP/Postal Code
560034
Country
India
Facility Name
GSK Investigational Site
City
Chennai
Country
India
Facility Name
GSK Investigational Site
City
Goa
ZIP/Postal Code
403202
Country
India
Facility Name
GSK Investigational Site
City
Kolkata
ZIP/Postal Code
700073
Country
India
Facility Name
GSK Investigational Site
City
Pune
ZIP/Postal Code
411 011
Country
India
Facility Name
GSK Investigational Site
City
Pune
Country
India
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Citations:
PubMed Identifier
26362659
Citation
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.
Results Reference
derived
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
109995
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
109995
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
109995
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
109995
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
109995
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
109995
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
109995
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Learn more about this trial
Comparison of GSK Measles-mumps-rubella-varicella (MMRV) Vaccine Versus PriorixTM
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