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Immunogenicity & Safety Study of GSK Biologicals' 208136 Vaccine Formulated With New Measles and Rubella Working Seeds

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00892775
First received: May 4, 2009
Last updated: May 4, 2017
Last verified: May 2017
  Purpose

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.


Condition Intervention Phase
Measles
Varicella
Mumps
Rubella
Biological: Priorix-Tetra TM (combined measles-mumps-rubella-varicella vaccine)
Biological: GSK Biologicals' 208136, new formulation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Prevention
Official Title: Immunogenicity & Safety Study of GSK Biologicals' 208136 Vaccine Formulated With New Measles and Rubella Working Seeds

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of subjects seroconverted for measles, mumps, rubella and varicella antibodies greater than or equal to (≥) the cut-off value. [ Time Frame: At 42-56 days after the first dose of study vaccine (Week 6) ]
    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. [ Time Frame: At 42-56 days after the second dose of study vaccine (Week 18) ]
    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 [ Time Frame: At 42-56 days after the first and second dose of study vaccine(s). ]
    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 [ Time Frame: Within 4 days after each vaccination (Days 0-3) ]
    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 [ Time Frame: Within 43 days (Days 0-42) after each vaccination ]
    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 [ Time Frame: Within 43 days (Days 0-42) after each vaccination ]
    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 [ Time Frame: Within 43 days (Days 0-42) after each vaccination ]
    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) [ Time Frame: Within 43 days (Days 0-42) after first vaccination dose ]
    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) [ Time Frame: Within 43 days (Days 86-128) after second vaccination dose ]
    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) [ Time Frame: From first study dose (Day 0) until study end (Week 18) ]
    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.


Enrollment: 501
Actual Study Start Date: June 3, 2009
Study Completion Date: December 13, 2010
Primary Completion Date: September 17, 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Priorix-Tetra new WS Group
Subjects received 2 doses of Priorix-Tetra™ vaccine formulated with new measles and rubella working seeds at Day 0 and Week 12.
Biological: GSK Biologicals' 208136, new formulation
Vaccine will be administered subcutaneously in the left upper arm (deltoid region)
Experimental: Priorix-Tetra current WS Group
Subjects received 2 doses of Priorix-Tetra™ vaccine manufactured with current working seed virus or new measles and rubella working seeds at Day 0 and Week 12.
Biological: Priorix-Tetra TM (combined measles-mumps-rubella-varicella vaccine)
Vaccine will be administered subcutaneously in the left upper arm (deltoid region)

  Eligibility

Ages Eligible for Study:   11 Months to 21 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00892775

Locations
Singapore
GSK Investigational Site
Singapore, Singapore, 119074
GSK Investigational Site
Singapore, Singapore, 228510
GSK Investigational Site
Singapore, Singapore, 229899
Taiwan
GSK Investigational Site
Taipei, Taiwan, 100
GSK Investigational Site
Taipei, Taiwan, 104
GSK Investigational Site
Taipei, Taiwan
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Publications:
Study Data/Documents: Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 108760
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 108760
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 108760
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 108760
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 108760
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 108760
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00892775     History of Changes
Other Study ID Numbers: 108760
Study First Received: May 4, 2009
Last Updated: May 4, 2017
Individual Participant Data  
Plan to Share IPD: Yes
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.

Keywords provided by GlaxoSmithKline:
Working seed virus
Rubella
Mumps
Varicella
Combined measles-mumps-rubella-varicella vaccine
Pediatric immunization
Measles

Additional relevant MeSH terms:
Measles
Chickenpox
Herpes Zoster
Rubella
Morbillivirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases
Herpesviridae Infections
DNA Virus Infections
Rubivirus Infections
Togaviridae Infections
Vaccines
Tetracycline
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2017