Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Combined Measles-mumps-rubella (MMR) Vaccine in Subjects Four to Six Years of Age

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by GlaxoSmithKline
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01621802
First received: June 14, 2012
Last updated: August 14, 2014
Last verified: August 2014
  Purpose

The purpose of this study is to support licensure of GSK Biologicals' MMR vaccine (Priorix®) in the US by generating immunogenicity and safety data in contrast to the US standard of care, Merck's MMR vaccine (M-M-R®II), when given as a second dose to children four to six years of age.


Condition Intervention Phase
Rubella
Mumps
Measles
Biological: Priorix®
Biological: Merck's M-M-R®II, Measles, Mumps, and Rubella Virus Vaccine (also known as M-M-R Vax Pro™)
Biological: Kinrix®
Biological: Varivax®
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety Study of GSK Biologicals' Combined Measles-mumps-rubella Vaccine in Subjects Four to Six Years of Age (209762)

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Immunogenicity with respect to the components of the Inv_MMR vaccine as compared to Com_MMR vaccine when given with VV and DTaP-IPV vaccines in terms of antibody concentration [ Time Frame: 42 days after vaccination (At Day 42) ] [ Designated as safety issue: No ]
  • Immunogenicity with respect to the components of the Inv_MMR vaccine as compared to Com_MMR vaccine when given without VV and DTaP-IPV in terms of antibody concentration [ Time Frame: 42 days after vaccination (At Day 42) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Immunogenicity with respect to VV in terms of antibody concentration [ Time Frame: 42 days after vaccination (At Day 42) ] [ Designated as safety issue: No ]
  • Immunogenicity with respect to the components of DTaP- IPV vaccine in terms of antibody concentration [ Time Frame: 42 days after vaccination (At Day 42) ] [ Designated as safety issue: No ]
  • Occurrence of solicited local symptoms [ Time Frame: Days 0-3 ] [ Designated as safety issue: No ]
  • Occurrence of solicited general symptoms [ Time Frame: Days 0-42 ] [ Designated as safety issue: No ]
  • Occurrence of Adverse events of specific interest [ Time Frame: From Day 0 through the end of study (Day 180) ] [ Designated as safety issue: No ]
  • Occurrence of Unsolicited adverse events [ Time Frame: From Day 0 to Day 42 ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events [ Time Frame: From Day 0 through end of study (Day 180) ] [ Designated as safety issue: No ]

Estimated Enrollment: 4000
Study Start Date: June 2012
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Inv _MMR_co
Subjects will receive 1 dose of the study vaccine (Priorix®) co administered with DTaP-IPV and VV vaccines at Day 0
Biological: Priorix®
Single dose administered subcutaneously (SC) with or without licensed co-administered vaccines, DTaP-IPV and varicella
Biological: Kinrix®
Single dose administered SC with varicella vaccine and with either Priorix® or M-M-R®II
Biological: Varivax®
Single dose administered SC with DTaP-IPV vaccine and with either Priorix® or M-M-R®
Active Comparator: Com_MMR_L1_co
Subjects will receive 1 dose of the licensed vaccine (M-M-R®II or M-M-R Vax Pro™) lot 1 co administered with DTaP-IPV and VV vaccines at Day 0
Biological: Merck's M-M-R®II, Measles, Mumps, and Rubella Virus Vaccine (also known as M-M-R Vax Pro™)
Single dose administered SC with or without DTaP-IPV and varicella vaccines
Biological: Kinrix®
Single dose administered SC with varicella vaccine and with either Priorix® or M-M-R®II
Biological: Varivax®
Single dose administered SC with DTaP-IPV vaccine and with either Priorix® or M-M-R®
Active Comparator: Com_MMR_L2_co
Subjects will receive 1 dose of the licensed vaccine ((M-M-R®II or M-M-R Vax Pro™) lot 2 co administered with DTaP-IPV and VV vaccines at Day 0
Biological: Merck's M-M-R®II, Measles, Mumps, and Rubella Virus Vaccine (also known as M-M-R Vax Pro™)
Single dose administered SC with or without DTaP-IPV and varicella vaccines
Biological: Kinrix®
Single dose administered SC with varicella vaccine and with either Priorix® or M-M-R®II
Biological: Varivax®
Single dose administered SC with DTaP-IPV vaccine and with either Priorix® or M-M-R®
Experimental: Inv_MMR_i
Subjects will receive 1 dose of the study vaccine at Day 0
Biological: Priorix®
Single dose administered subcutaneously (SC) with or without licensed co-administered vaccines, DTaP-IPV and varicella
Active Comparator: Com_MMR_L1_i
Subjects will receive 1 dose of the licensed vaccine lot 1 at Day 0
Biological: Merck's M-M-R®II, Measles, Mumps, and Rubella Virus Vaccine (also known as M-M-R Vax Pro™)
Single dose administered SC with or without DTaP-IPV and varicella vaccines
Active Comparator: Com_MMR_L2_i
Subjects will receive 1 dose of the licensed vaccine lot 2 at Day 0
Biological: Merck's M-M-R®II, Measles, Mumps, and Rubella Virus Vaccine (also known as M-M-R Vax Pro™)
Single dose administered SC with or without DTaP-IPV and varicella vaccines
Experimental: Inv _MMR_s
Subjects will receive 1 dose of the study vaccine at Day 0
Biological: Priorix®
Single dose administered subcutaneously (SC) with or without licensed co-administered vaccines, DTaP-IPV and varicella
Active Comparator: Com_MMR_L1_s
Subjects will receive 1 dose of the licensed vaccine lot 1 at Day 0
Biological: Merck's M-M-R®II, Measles, Mumps, and Rubella Virus Vaccine (also known as M-M-R Vax Pro™)
Single dose administered SC with or without DTaP-IPV and varicella vaccines
Active Comparator: Com_MMR_L2_s
Subjects will receive 1 dose of the licensed vaccine lot 2 at Day 0
Biological: Merck's M-M-R®II, Measles, Mumps, and Rubella Virus Vaccine (also known as M-M-R Vax Pro™)
Single dose administered SC with or without DTaP-IPV and varicella vaccines

Detailed Description:

The GSK Biologicals' MMR vaccine (Priorix®) and Merck's MMR vaccine (M-M-R®II) are referred to as Inv_MMR vaccine and Com_MMR vaccine respectively. 2 lots of the comparator vaccine (Com_MMR_L1 and Com_MMR_L2) will be used, but the 2 lots will be analysed as a pool.

The Inv_MMR vaccine will be administered as a second dose to children who already received a first dose Com_MMR vaccine. Since the second dose of a MMR vaccine in the US is routinely co-administered with DTaP-IPV vaccine (Kinrix®) and varicella vaccine (VV) (ProQuad® or Varivax®), some children will receive one dose of these vaccines along with either of the MMR vaccines.

  Eligibility

Ages Eligible for Study:   4 Years to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who the investigator believes that they and/or their parent(s) or LAR/s can and will comply with the requirements of the protocol.
  • Male or female subjects 4 to 6 years of age at the time of vaccination.
  • Written informed consent is obtained from the parent(s)/LAR(s) of the subject (assent will be obtained from subjects in line with local rules and regulations).
  • Subjects in stable health as determined by investigator's physical examination and assessment of subjects' medical history.
  • Subjects received either a single dose of M-M-R II, M-M-R VaxPro or ProQuad in the second year of life.
  • For subjects enrolled in the sub-cohort receiving co-administered DTaP-IPV and VV:

    • subjects received previous DTaP vaccine doses with INFANRIX® and/or PEDIARIX® for the first three doses and INFANRIX® for the fourth dose of the DTaP-containing vaccine.
    • subjects received a first dose of VV in the second year of life.

Exclusion Criteria:

  • Child in care.
  • Use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before the day of study vaccination/s or planned during the entire study period.
  • Previous vaccination with a second dose of measles, mumps, rubella containing vaccine/s.
  • Chronic administration of immunosuppressants or other immune-modifying drugs during the period starting 180 days prior to Day 0 or any planned administration of immunosuppressive and immune-modifying drugs during the entire study. Inhaled and topical steroids are allowed.
  • Administration of immunoglobulins and/or any blood products during the period starting 180 days before entering the study or planned administration from the date of vaccination through the immunogenicity evaluation at Visit 2.
  • Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting 30 days prior to the study vaccination/s and ending 42 days after the vaccination/s (at Visit 2), with the exception of live intranasal or inactivated influenza (flu) vaccine, which may be given at any time during the study, including the day of study vaccination/s. Inactivated influenza vaccine must be administered at a different location from the study vaccine. Any age appropriate vaccine may be given starting at Visit 2, and anytime thereafter.
  • 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-investigational product.
  • History of measles, mumps, and/or rubella disease.
  • Known exposure to measles, mumps and/or rubella during the period starting 30 days prior to enrollment.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s), including systemic hypersensitivity to neomycin or gelatin.
  • Blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems.
  • Acute disease at the time of enrollment. Acute disease is defined as the presence of a moderate or severe illness with or without fever. Fever is defined as temperature ≥38°C (100.4°F) measured by any age appropriate route. All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection without fever.
  • Active untreated tuberculosis according to the subject's medical history.
  • Any other condition which, in the opinion of the investigator, prevents the subject from participating in the study.

In addition, for subjects enrolled in the sub-cohort receiving co-administered DTaP-IPV+VV:

  • Previous vaccination with a second dose of varicella-containing vaccine.
  • Receipt of any varicella-containing vaccine during the period starting 90 days before the day of study vaccination.
  • History of varicella/zoster disease.
  • Known exposure to varicella/zoster during the period starting 30 days prior to enrollment.
  • History of diphtheria, tetanus, pertussis, and/or poliomyelitis disease.
  • Vaccination against diphtheria, tetanus, pertussis or polio given after the second year of life.
  • Occurrence of transient thrombocytopenia or neurological complications following an earlier immunization against diphtheria and/or tetanus toxoids.
  • Following a previous administration of DTP vaccine: temperature ≥40.6°C (>105°F) during the period starting 48 hours not due to another identifiable cause, collapse or shock-like state during the period starting 48 hours, persistent, inconsolable crying lasting three hours or more within 48 hours, seizures with or without fever occurring during the period starting three days, or encephalopathy of unknown aetiology occurring during the period starting 7 days of a previous administration of DTP vaccine.
  • Hypersensitivity reaction to any component of the DTaP-IPV and/or varicella vaccines.
  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: NCT01621802

Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

  Show 68 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01621802     History of Changes
Other Study ID Numbers: 115158, 2011-004638-32
Study First Received: June 14, 2012
Last Updated: August 14, 2014
Health Authority: Korea: Food and Drug Administration
United States: Food and Drug Administration
Taiwan: Department of Health

Keywords provided by GlaxoSmithKline:
Safety
Measles, mumps and rubella diseases
Immunogenicity

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

ClinicalTrials.gov processed this record on August 28, 2014