Trial record 15 of 36 for:    Febrile Seizures

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:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00892775
First received: May 4, 2009
Last updated: June 1, 2011
Last verified: May 2011
  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
Rubella Disease
Mumps Disease
Varicella Disease
Measles Disease
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:
  • Seroconversion rates for measles, mumps, rubella and varicella [ Time Frame: approximately 42-56 days after the first dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measles, mumps, rubella and varicella seroconversion rates [ Time Frame: 42-56 days after the second dose ] [ Designated as safety issue: No ]
  • Measles, mumps, rubella and varicella antibody titres [ Time Frame: 42-56 days after the first and second doses ] [ Designated as safety issue: No ]
  • Occurrence of any and any grade 3 (severe) solicited local symptoms (injection site redness, pain and swelling) [ Time Frame: within four days after each vaccination (Day 0-3) ] [ Designated as safety issue: No ]
  • Occurrence of any and any grade 3 (severe) solicited general in terms of fever, rash, any sign of meningitis including febrile convulsion and parotitis [ Time Frame: symptoms within 43 days after each vaccination (Day 0-42) ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited symptoms [ Time Frame: within 43 days after each vaccination (Day 0-42) ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events [ Time Frame: from the first study vaccine dose up to study end ] [ Designated as safety issue: No ]

Enrollment: 501
Study Start Date: June 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group MMRVnew WS group
This group will consist of 332 subjects who will receive the MMRV vaccine formulated with the new measles and rubella working seed viruses.
Biological: GSK Biologicals' 208136, new formulation
Vaccine will be administered subcutaneously in the left upper arm (deltoid region)
Experimental: Group MMRV group
This group will consist of 166 subjects who will receive the MMRV vaccine formulated with the current measles and rubella working seed viruses.
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
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00892775

Locations
Singapore
GSK Investigational Site
Singapore, Singapore, 229899
GSK Investigational Site
Singapore, Singapore, 228510
GSK Investigational Site
Singapore, Singapore, 119074
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

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00892775     History of Changes
Other Study ID Numbers: 108760
Study First Received: May 4, 2009
Last Updated: June 1, 2011
Health Authority: Singapore: Health Sciences Authority
Taiwan: Department of Health

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

Additional relevant MeSH terms:
Chickenpox
Herpes Zoster
Measles
Mumps
Rubella
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Morbillivirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Rubulavirus Infections
Parotitis
Parotid Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Rubivirus Infections
Togaviridae Infections

ClinicalTrials.gov processed this record on April 23, 2014