Consistency Study of GlaxoSmithKline (GSK) Biologicals' MMR Vaccine (209762) (Priorix®) Comparing Immunogenicity and Safety to Merck & Co., Inc.'s MMR Vaccine (M M R®II), in Children 12 to 15 Months of Age

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by GlaxoSmithKline
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01702428
First received: October 4, 2012
Last updated: August 7, 2014
Last verified: July 2014
  Purpose

The purpose of this study is to evaluate consistency in terms of the immune response to three different lots of GSK Biologicals' trivalent MMR vaccine manufactured to target potencies, and compare its immunogenicity to Merck & Co., Inc.'s MMR vaccine, which is approved for use in the United States (US).


Condition Intervention Phase
Rubella
Measles
Mumps
Biological: GSK Biologicals measles, mumps and rubella vaccine live (GSK 209762).
Biological: Merck & Co., Inc.'s M-M-R®II (also called M-M-R Vax Pro®), combined measles-mumps-rubella virus vaccine.
Biological: Varivax® (Merck & Co., Inc.)
Biological: Havrix®
Biological: Prevnar 13® (Pfizer Inc.)
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: Consistency Study of GSK Biologicals' MMR Vaccine (209762) (Priorix®) Comparing Immunogenicity and Safety to Merck & Co., Inc.'s MMR Vaccine (M M R®II), in Healthy Children 12 to 15 Months of Age

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Immunogenicity of the MMR vaccines in terms of antibody concentration [ Time Frame: At Day 42 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Immunogenicity of the Varivax, Havrix and Prevnar 13 vaccines in a subset of children, in terms of antibody concentrations [ Time Frame: At Day 42 ] [ Designated as safety issue: No ]
  • Complementary read-out for immunogenicity of the MMR vaccines in terms of antibody concentration [ Time Frame: At Day 42 ] [ Designated as safety issue: No ]
    Measles virus antibody concentration equal to or above the cut-off of 150 mIU/mL. Rubella virus antibody concentration equal to or above the cut-off of 4 IU/mL.

  • Occurrence of solicited local symptoms [ Time Frame: Days 0-3 after vaccination ] [ Designated as safety issue: No ]
  • Occurrence of solicited general symptoms [ Time Frame: Days 0-42 after vaccination ] [ Designated as safety issue: No ]
  • Occurrence of Unsolicited adverse events [ Time Frame: Days 0-42 after vaccination ] [ 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 Serious adverse events (SAEs) [ Time Frame: From Day 0 through the end of study (Day 180) ] [ Designated as safety issue: No ]

Estimated Enrollment: 5000
Study Start Date: November 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Inv_MMR_L1 Group
Subjects will receive 1 dose of Inv_MMR lot 1 vaccine (i.e., MMR_MMR_L1) co administered with Varivax and Havrix vaccines at Visit 1 (Day 0). All US subjects will also be given Prevnar 13.
Biological: GSK Biologicals measles, mumps and rubella vaccine live (GSK 209762).
Single dose administered subcutaneously (SC) in the tricep region of the left arm at Visit 1 (Day 0).
Other Name: Priorix®
Biological: Varivax® (Merck & Co., Inc.)
Single dose administered SC in the tricep region of the right arm at Visit 1 (Day 0), with either one of the three Inv_MMR vaccine lots or one of the two active control Com_MMR vaccine lots.
Biological: Havrix®
Single dose administered intramuscularly (IM) in the anterolateral region of the right thigh at Visit 1 (Day 0), with either one of the three Inv_MMR vaccine lots or one of the two active control Com_MMR vaccine lots.
Biological: Prevnar 13® (Pfizer Inc.)
Single dose administered IM in the anterolateral region of the left thigh at Visit 1 (Day 0), with either one of the three Inv_MMR vaccine lots or one of the two active control Com_MMR vaccine lots in the US only.
Experimental: Inv_MMR_L2 Group
Subjects will receive 1 dose of Inv_MMR lot 2 vaccine (i.e., MMR_MMR_L2) co administered with Varivax and Havrix vaccines at Visit 1 (Day 0). All US subjects will also be given Prevnar 13.
Biological: GSK Biologicals measles, mumps and rubella vaccine live (GSK 209762).
Single dose administered subcutaneously (SC) in the tricep region of the left arm at Visit 1 (Day 0).
Other Name: Priorix®
Biological: Varivax® (Merck & Co., Inc.)
Single dose administered SC in the tricep region of the right arm at Visit 1 (Day 0), with either one of the three Inv_MMR vaccine lots or one of the two active control Com_MMR vaccine lots.
Biological: Havrix®
Single dose administered intramuscularly (IM) in the anterolateral region of the right thigh at Visit 1 (Day 0), with either one of the three Inv_MMR vaccine lots or one of the two active control Com_MMR vaccine lots.
Biological: Prevnar 13® (Pfizer Inc.)
Single dose administered IM in the anterolateral region of the left thigh at Visit 1 (Day 0), with either one of the three Inv_MMR vaccine lots or one of the two active control Com_MMR vaccine lots in the US only.
Experimental: Inv_MMR_L3 Group
Subjects will receive 1 dose of Inv_MMR lot 3 vaccine (i.e., MMR_MMR_L3) co administered with Varivax and Havrix vaccines at Visit 1 (Day 0). All US subjects will also be given Prevnar 13.
Biological: GSK Biologicals measles, mumps and rubella vaccine live (GSK 209762).
Single dose administered subcutaneously (SC) in the tricep region of the left arm at Visit 1 (Day 0).
Other Name: Priorix®
Biological: Varivax® (Merck & Co., Inc.)
Single dose administered SC in the tricep region of the right arm at Visit 1 (Day 0), with either one of the three Inv_MMR vaccine lots or one of the two active control Com_MMR vaccine lots.
Biological: Havrix®
Single dose administered intramuscularly (IM) in the anterolateral region of the right thigh at Visit 1 (Day 0), with either one of the three Inv_MMR vaccine lots or one of the two active control Com_MMR vaccine lots.
Biological: Prevnar 13® (Pfizer Inc.)
Single dose administered IM in the anterolateral region of the left thigh at Visit 1 (Day 0), with either one of the three Inv_MMR vaccine lots or one of the two active control Com_MMR vaccine lots in the US only.
Active Comparator: Com_MMR_L1 Group
Subjects will receive 1 dose of Com_MMR lot 1 vaccine (i.e., Com_MMR_L1) co administered with Varivax and Havrix vaccines at Visit 1 (Day 0). All US subjects will also be given Prevnar 13.
Biological: Merck & Co., Inc.'s M-M-R®II (also called M-M-R Vax Pro®), combined measles-mumps-rubella virus vaccine.
Single dose administered SC in the tricep region of the left arm at Visit 1 (Day 0).
Biological: Varivax® (Merck & Co., Inc.)
Single dose administered SC in the tricep region of the right arm at Visit 1 (Day 0), with either one of the three Inv_MMR vaccine lots or one of the two active control Com_MMR vaccine lots.
Biological: Havrix®
Single dose administered intramuscularly (IM) in the anterolateral region of the right thigh at Visit 1 (Day 0), with either one of the three Inv_MMR vaccine lots or one of the two active control Com_MMR vaccine lots.
Biological: Prevnar 13® (Pfizer Inc.)
Single dose administered IM in the anterolateral region of the left thigh at Visit 1 (Day 0), with either one of the three Inv_MMR vaccine lots or one of the two active control Com_MMR vaccine lots in the US only.
Active Comparator: Com_MMR_L2 Group
Subjects will receive 1 dose of Com_MMR lot 2 vaccine (i.e., Com_MMR_L2) co administered with Varivax and Havrix vaccines at Visit 1 (Day 0). All US subjects will also be given Prevnar 13.
Biological: Merck & Co., Inc.'s M-M-R®II (also called M-M-R Vax Pro®), combined measles-mumps-rubella virus vaccine.
Single dose administered SC in the tricep region of the left arm at Visit 1 (Day 0).
Biological: Varivax® (Merck & Co., Inc.)
Single dose administered SC in the tricep region of the right arm at Visit 1 (Day 0), with either one of the three Inv_MMR vaccine lots or one of the two active control Com_MMR vaccine lots.
Biological: Havrix®
Single dose administered intramuscularly (IM) in the anterolateral region of the right thigh at Visit 1 (Day 0), with either one of the three Inv_MMR vaccine lots or one of the two active control Com_MMR vaccine lots.
Biological: Prevnar 13® (Pfizer Inc.)
Single dose administered IM in the anterolateral region of the left thigh at Visit 1 (Day 0), with either one of the three Inv_MMR vaccine lots or one of the two active control Com_MMR vaccine lots in the US only.

Detailed Description:

This study will evaluate the consistency of the immune response to three different lots of GSK Biologicals' trivalent investigational MMR vaccine (referred to as Inv_MMR vaccine, throughout this document) and compare its immunogenicity to the US standard of care comparator vaccine (M M R®II, Merck and Co., Inc., referred to as Com_MMR throughout this document) in children during their second year of life. The Inv_MMR vaccine will be given as one of three consistency lots manufactured to target potencies designated as Inv_MMR_L1, Inv_MMR_L2 and Inv_MMR_L3. The Com_MMR vaccine will be given as one of two lots designated Com_MMR_L1 and Com_MMR_L2 and will be analyzed as pooled lots within the study. The MMR vaccine will be co-administered with Varivax, Havrix and (in the US sub-cohort only) Prevnar 13 which are routinely administered to children of this age in the US.

  Eligibility

Ages Eligible for Study:   12 Months to 15 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female child between 12 and 15 months of age at the time of vaccination.
  • The investigator believes that the parent(s) or Legally Acceptable Representative(s) (LAR(s)) of the child, can, and will comply with the requirements of the protocol.
  • Written informed consent obtained from the parent(s)/LAR(s) of the child.
  • Child is in stable health as determined by investigator's clinical examination and assessment of child's medical history.

For US children only:

• Child that previously received a 3-dose series of Prevnar 13 only (i.e., no doses given as Prevnar/Prevenar), at least 60 days prior to study entry.

Exclusion Criteria:

  • Child in care.
  • Use of any investigational or non-registered product other than the study vaccine(s) during the period starting 30 days before the day of study vaccination (i.e., 30 days prior to Day 0) or planned use during the entire study period.
  • Concurrently participating in another clinical study, in which the child has been or will be exposed to an investigational or a non-investigational product.
  • Chronic administration of immunosuppressants, or other immune-modifying drugs during the period starting 180 days prior to the first vaccine dose or any planned administration of immunosuppressive and immune-modifying drugs during the entire study.

    • For corticosteroids, this will mean prednisone, ≥0.5 mg/kg/day or equivalent.
    • Inhaled and topical steroids are allowed.
  • Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting 30 days prior to study vaccination at Visit 1 and ending at Visit 2. Please Note:

    • Inactivated influenza (Flu) vaccine and Haemophilus influenzae type b conjugate vaccine (Hib) vaccines may be given at any time during the study, including the day of study vaccination (Flu and Hib vaccines must be administered at a different location than the study vaccine/s).
    • Any age appropriate vaccine may be given starting at Visit 2 and anytime thereafter.
  • 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.
  • History of measles, mumps, rubella, varicella/zoster and/or hepatitis A disease.
  • Known exposure to measles, mumps, rubella and/or varicella/zoster during the period starting within 30 days prior to first study vaccination.
  • Previous vaccination against measles, mumps, rubella, hepatitis A and/or varicella virus.
  • 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 hypersensitivity to neomycin, latex 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. All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection without fever.
  • Active untreated tuberculosis based on medical history.
  • Any other condition which, in the opinion of the investigator, prevents the child from participating in the study.

For US children only:

  • Child that previously received a vaccination with heptavalent Prevnar/Prevenar (prior vaccination should be with 3 doses of Prevnar 13 only).
  • Child that previously received a fourth dose of any pneumococcal conjugate vaccine.
  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: NCT01702428

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

  Show 101 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01702428     History of Changes
Other Study ID Numbers: 115648, 2011-004891-12
Study First Received: October 4, 2012
Last Updated: August 7, 2014
Health Authority: Argentina: ANMAT: The National Administration of Drugs, Foodstuffs and Medical Technology
Estonia: State Agency of Medicines
United States: Food and Drug Administration
Finland: Finnish Medicines Agency
Mexico: Ministry of Health, Secretary of Health

Keywords provided by GlaxoSmithKline:
Safety
Consistency study
Measles, mumps and rubella diseases
Healthy children
Immunogenicity

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

ClinicalTrials.gov processed this record on August 20, 2014