Back to resultsImmunogenicity & Safety Study of GSK Biologicals' 208136 Vaccine Formulated With New Measles and Rubella Working Seeds
Primary Purpose
Measles, Varicella, Mumps
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Priorix-Tetra (combined measles-mumps-rubella-varicella vaccine)
GSK Biologicals' 208136, new formulation
Sponsored by
About this trial
This is an interventional prevention trial for Measles focused on measuring Working seed virus, Rubella, Mumps, Varicella, Combined measles-mumps-rubella-varicella vaccine, Pediatric immunization, Measles
Eligibility Criteria
Inclusion Criteria:
- Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study.
- A male or female between, and including, 11 and 21 months of age (e.g. from age 11months until the day before age 22 months) at the time of the first vaccination.
- Written informed consent obtained from the parent or guardian of the subject after they have been advised on the risks and benefits of the study in a language they clearly understand, and before performance of any study procedure.
- Free of obvious healthy problems as established by medical history and clinical examination before entering into the study.
Exclusion Criteria:
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- Administration of immunoglobulins and/or any blood products during the six months before entering the study or planned administration during the study period.
- Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days prior to until 42 days after each study vaccine dose with the exception of oral polio vaccine (OPV) which can be given at any time and routine inactivated vaccines such as pneumococcal, meningococcal or Haemophilus influenzae type b conjugate vaccines, inactivated influenza or diphtheria/tetanus containing vaccines which can be administered up to eight days before each study vaccine dose.
- Previous vaccination against measles, mumps, rubella and/or varicella.
- History of measles, mumps, rubella and/or varicella/zoster diseases.
- Known exposure to measles, mumps, rubella and/or varicella within 30 days prior to study start.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- A family history of congenital or hereditary immunodeficiency.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s), including systemic hypersensitivity to neomycin.
- Major congenital defects or serious chronic illness.
- History of any neurologic disorders or seizures.
- Acute disease at the time of enrolment.
- Rectal temperature ≥38°C or axillary temperature >=37.5°C at the time of vaccination.
- Residence in the same household as a high risk person e.g.:
- New-born infants (0-4 weeks of age)
- Pregnant women who have a negative history of chickenpox
- Persons with known immunodeficiency
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 Type
Experimental
Experimental
Arm Label
Priorix-Tetra new WS Group
Priorix-Tetra current WS Group
Arm Description
Subjects received 2 doses of Priorix-Tetra vaccine formulated with new measles and rubella working seeds at Day 0 and Week 12.
Subjects received 2 doses of Priorix-Tetra vaccine manufactured with current working seed virus at Day 0 and Week 12.
Outcomes
Primary Outcome Measures
Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies Greater Than or Equal to (≥) the Cut-off Value.
Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. The cut-off values for seroconversion was 150 milli international units per milliliter (mIU/mL), 231 units per milliliter (U/mL), 4 international units per milliliter (IU/mL) and 1:4 dilution for measles, mumps, rubella and varicella, respectively.
Secondary Outcome Measures
Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies ≥ the Cut-off Value.
Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. The cut-off values for seroconversion was 150 mIU/mL, 231 U/mL, 4 IU/mL and 1:4 dilution for measles, mumps, rubella and varicella, respectively.
Antibody Titers Against Measles, Mumps, Rubella and Varicella Viruses
Antibody titers were summarized by geometric mean titers (GMTs) with their 95% confidence intervals.
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 and Grade 3 Solicited General Symptoms
Assessed solicited general symptoms were meningism and parotid gland swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 meningism and parotid gland swelling = meningism/ parotid gland swelling which prevented normal everyday activities.
Number of Subjects Reporting Any, Grade 3 and Related Fever
Any fever was defined as fever greater than or equal to (≥) 38.0 Celsius degrees (°C) and grade 3 fever greater than (>) 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 (Local or General), Grade 3 and Related Rashes
Rash was defined as: 1) measles/ rubella rashes (macular or maculo-papular rashes): presence of macules, discolored small patches or spots of the skin, neither elevated nor depressed below the skin's surface; 2) varicella rash (maculo-papulo-vesicular): simultaneous presence of macules, papules and vesicles raised above the skin's surface; 3) other types of rash (heat rash, diaper rash etc.). Any rash = occurrence of rash regardless of intensity grade or relationship to vaccination Grade 3 rash ≥ 150 lesions and Related = rash assessed by the investigator as related to the vaccination.
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Event (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. Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. Grade 3 was defined as an event that prevented normal activity and Related was defined as an event assessed by the investigator as causally related to the study vaccination.
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Event (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. Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. Grade 3 was defined as an event that prevented normal activity and Related was defined as an event assessed by the investigator as causally related to the study vaccination.
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/ incapacity or is a congenital anomaly/ birth defect in the offspring of a study subject.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00892775
Brief Title
Immunogenicity & Safety Study of GSK Biologicals' 208136 Vaccine Formulated With New Measles and Rubella Working Seeds
Official Title
Immunogenicity & Safety Study of GSK Biologicals' 208136 Vaccine Formulated With New Measles and Rubella Working Seeds
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
June 3, 2009 (Actual)
Primary Completion Date
September 17, 2010 (Actual)
Study Completion Date
December 13, 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
This study is undertaken to generate clinical data on GSK Biologicals' combined measles-mumps-rubella-varicella vaccine manufactured with measles and rubella obtained from newly established working seed viruses which are one passage further than the current working seed viruses. The measles-mumps-rubella-varicella vaccine manufactured with the current working seed viruses will serve as comparator.
A seed lot system is a system according to which successive batches of a vaccine are derived from the same master seed virus. For routine production, a working seed lot is prepared from the master seed virus.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Measles, Varicella, Mumps, Rubella
Keywords
Working seed virus, Rubella, Mumps, Varicella, Combined measles-mumps-rubella-varicella vaccine, Pediatric immunization, Measles
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
501 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Priorix-Tetra new WS Group
Arm Type
Experimental
Arm Description
Subjects received 2 doses of Priorix-Tetra vaccine formulated with new measles and rubella working seeds at Day 0 and Week 12.
Arm Title
Priorix-Tetra current WS Group
Arm Type
Experimental
Arm Description
Subjects received 2 doses of Priorix-Tetra vaccine manufactured with current working seed virus at Day 0 and Week 12.
Intervention Type
Biological
Intervention Name(s)
Priorix-Tetra (combined measles-mumps-rubella-varicella vaccine)
Intervention Description
Vaccine will be administered subcutaneously in the left upper arm (deltoid region)
Intervention Type
Biological
Intervention Name(s)
GSK Biologicals' 208136, new formulation
Intervention Description
Vaccine will be administered subcutaneously in the left upper arm (deltoid region)
Primary Outcome Measure Information:
Title
Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies Greater Than or Equal to (≥) the Cut-off Value.
Description
Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. The cut-off values for seroconversion was 150 milli international units per milliliter (mIU/mL), 231 units per milliliter (U/mL), 4 international units per milliliter (IU/mL) and 1:4 dilution for measles, mumps, rubella and varicella, respectively.
Time Frame
At 42-56 days after the first dose of study vaccine (Week 6)
Secondary Outcome Measure Information:
Title
Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies ≥ the Cut-off Value.
Description
Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. The cut-off values for seroconversion was 150 mIU/mL, 231 U/mL, 4 IU/mL and 1:4 dilution for measles, mumps, rubella and varicella, respectively.
Time Frame
At 42-56 days after the second dose of study vaccine (Week 18)
Title
Antibody Titers Against Measles, Mumps, Rubella and Varicella Viruses
Description
Antibody titers were summarized by geometric mean titers (GMTs) with their 95% confidence intervals.
Time Frame
At 42-56 days after the first and second dose of study vaccine(s).
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
Within 4 days after each vaccination (Days 0-3)
Title
Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms
Description
Assessed solicited general symptoms were meningism and parotid gland swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 meningism and parotid gland swelling = meningism/ parotid gland swelling which prevented normal everyday activities.
Time Frame
Within 43 days (Days 0-42) after each vaccination
Title
Number of Subjects Reporting Any, Grade 3 and Related Fever
Description
Any fever was defined as fever greater than or equal to (≥) 38.0 Celsius degrees (°C) and grade 3 fever greater than (>) 39.5°C after vaccination. Related fever was defined as fever assessed by the investigator as related to the vaccination.
Time Frame
Within 43 days (Days 0-42) after each vaccination
Title
Number of Subjects Reporting Any (Local or General), Grade 3 and Related Rashes
Description
Rash was defined as: 1) measles/ rubella rashes (macular or maculo-papular rashes): presence of macules, discolored small patches or spots of the skin, neither elevated nor depressed below the skin's surface; 2) varicella rash (maculo-papulo-vesicular): simultaneous presence of macules, papules and vesicles raised above the skin's surface; 3) other types of rash (heat rash, diaper rash etc.). Any rash = occurrence of rash regardless of intensity grade or relationship to vaccination Grade 3 rash ≥ 150 lesions and Related = rash assessed by the investigator as related to the vaccination.
Time Frame
Within 43 days (Days 0-42) after each vaccination
Title
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Event (AEs)
Description
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. Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. Grade 3 was defined as an event that prevented normal activity and Related was defined as an event assessed by the investigator as causally related to the study vaccination.
Time Frame
Within 43 days (Days 0-42) after first vaccination dose
Title
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Event (AEs)
Description
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. Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. Grade 3 was defined as an event that prevented normal activity and Related was defined as an event assessed by the investigator as causally related to the study vaccination.
Time Frame
Within 43 days (Days 86-128) after second vaccination dose
Title
Number of Subjects With Serious Adverse Events (SAEs)
Description
Serious adverse events (SAEs) assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/ incapacity or is a congenital anomaly/ birth defect in the offspring of a study subject.
Time Frame
From first study dose (Day 0) until study end (Week 18)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
11 Months
Maximum Age & Unit of Time
21 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 (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study.
A male or female between, and including, 11 and 21 months of age (e.g. from age 11months until the day before age 22 months) at the time of the first vaccination.
Written informed consent obtained from the parent or guardian of the subject after they have been advised on the risks and benefits of the study in a language they clearly understand, and before performance of any study procedure.
Free of obvious healthy problems as established by medical history and clinical examination before entering into the study.
Exclusion Criteria:
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
Administration of immunoglobulins and/or any blood products during the six months before entering the study or planned administration during the study period.
Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days prior to until 42 days after each study vaccine dose with the exception of oral polio vaccine (OPV) which can be given at any time and routine inactivated vaccines such as pneumococcal, meningococcal or Haemophilus influenzae type b conjugate vaccines, inactivated influenza or diphtheria/tetanus containing vaccines which can be administered up to eight days before each study vaccine dose.
Previous vaccination against measles, mumps, rubella and/or varicella.
History of measles, mumps, rubella and/or varicella/zoster diseases.
Known exposure to measles, mumps, rubella and/or varicella within 30 days prior to study start.
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
A family history of congenital or hereditary immunodeficiency.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s), including systemic hypersensitivity to neomycin.
Major congenital defects or serious chronic illness.
History of any neurologic disorders or seizures.
Acute disease at the time of enrolment.
Rectal temperature ≥38°C or axillary temperature >=37.5°C at the time of vaccination.
Residence in the same household as a high risk person e.g.:
New-born infants (0-4 weeks of age)
Pregnant women who have a negative history of chickenpox
Persons with known immunodeficiency
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
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
GSK Investigational Site
City
Singapore
ZIP/Postal Code
228510
Country
Singapore
Facility Name
GSK Investigational Site
City
Singapore
ZIP/Postal Code
229899
Country
Singapore
Facility Name
GSK Investigational Site
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
GSK Investigational Site
City
Taipei
ZIP/Postal Code
104
Country
Taiwan
Facility Name
GSK Investigational Site
City
Taipei
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD for this study will be made available via the Clinical Study Data Request site.
IPD Sharing Time Frame
IPD is available via the Clinical Study Data Request site (click on the link provided below)
IPD Sharing Access Criteria
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
IPD Sharing URL
http://clinicalstudydatarequest.com
Citations:
PubMed Identifier
23425607
Citation
Huang LM, Lee BW, Chan PC, Povey M, Henry O. Immunogenicity and safety of combined measles-mumps-rubella-varicella vaccine using new measles and rubella working seeds in healthy children in Taiwan and Singapore: a phase II, randomized, double-blind trial. Hum Vaccin Immunother. 2013 Jun;9(6):1308-15. doi: 10.4161/hv.24035. Epub 2013 Feb 20.
Results Reference
background
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
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
108760
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
108760
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
108760
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
108760
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
108760
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
108760
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Learn more about this trial
Immunogenicity & Safety Study of GSK Biologicals' 208136 Vaccine Formulated With New Measles and Rubella Working Seeds
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