Trial record 5 of 12 for:    Open Studies | "Mumps"

Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Combined Measles-mumps-rubella (MMR) Vaccine in Children in Their Second Year of Life

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by GlaxoSmithKline
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01681992
First received: September 6, 2012
Last updated: October 2, 2014
Last verified: September 2014
  Purpose

The purpose of this study is to evaluate end of shelf-life potency in terms of the immunogenicity and safety of GSK Biologicals' trivalent MMR vaccine, by comparing it to Merck & Co., Inc.'s MMR vaccine, which is approved for use in the United States (US).


Condition Intervention Phase
Measles
Mumps
Rubella
Biological: GSK Biologicals measles, mumps and rubella vaccine live (GSK 209762).
Biological: Merck & Co., Inc.'s M-M-R®II, combined measles-mumps-rubella virus vaccine live.
Biological: Varivax® (Merck & Co., Inc.)
Biological: Havrix®
Biological: Prevnar 13® (Pfizer Inc.)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety Study of GSK Biologicals' Priorix® Vaccine (209762) at an End of Shelf-life Potency Compared to Merck & Co., Inc.'s MMR Vaccine When Both Are Given on a 2-dose Schedule to Healthy Children in Their 2nd Year of Life

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Immunogenicity of the MMR vaccines [ Time Frame: At Day 42 ] [ Designated as safety issue: No ]
    Seroresponses for MMR are defined as a post-vacc., anti-virus Ab conc. in children who were seronegative pre-vacc. as follows: For measles virus, a post-vacc. anti-measles virus Ab conc. of ≥200 mIU/mL (ELISA) in children <150 mIU/mL pre-vacc.; For mumps virus, a post-vacc. anti-mumps virus Ab conc. ≥10 EU/mL (ELISA) in children <5 EU/mL pre-vacc.; For mumps virus as measured by PRNT, a post-vacc. anti-mumps virus Ab conc. ≥4 ED50 (PRNT) in children <2.5 ED50 before Dose 1; For rubella virus, a post-vacc. anti-rubella virus Ab conc. ≥10 IU/mL (ELISA) in children <4 IU/mL pre-vacc.


Secondary Outcome Measures:
  • Immunogenicity of the MMR vaccines post-dose 2 (US post-dose 2 sub-cohort) in terms of antibody concentration. [ Time Frame: At Day 84 ] [ 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 Unsolicited adverse events. [ 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 222) ] [ Designated as safety issue: No ]
  • Serious adverse events (SAEs). [ Time Frame: From Day 0 through the end of study (Day 222) ] [ Designated as safety issue: No ]

Estimated Enrollment: 4500
Study Start Date: October 2012
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Inv_MMR_ Min Group
Subjects will receive 1 dose of Inv_MMR vaccine (i.e. Inv_MMR_Min) co administered with Varivax and Havrix vaccines at Visit 1 (Day 0). All US subjects will also be given Prevnar 13. Approximately 6 weeks later (Visit 2), subjects will be administered a separate lot of the Inv_MMR vaccine (Inv_MMR_Release) for the second dose.
Biological: GSK Biologicals measles, mumps and rubella vaccine live (GSK 209762).
Single dose administered subcutaneously (SC) of either Inv_MMR_Min or Inv_MMR_Med depending on group assigned followed by a second SC injection of Inv_MMR_Release about 6 weeks later.
Other Name: Priorix®
Biological: Varivax® (Merck & Co., Inc.)
Single dose SC injection administered at Visit 1 (Day 0) with either one of two Inv_MMR vaccine lots (Inv_MMR_Min or Inv_MMR_Med) or one of two active control Com_MMR vaccine lots (Com_MMR_L1 and Com_MMR_L2).
Biological: Havrix®
Single dose Intramuscular injection (IM) administered at Visit 1 (Day 0) with either one of two Inv_MMR vaccine lots (Inv_MMR_Min or Inv_MMR_Med) or one of two active control Com_MMR vaccine lots (Com_MMR_L1 and Com_MMR_L2).
Biological: Prevnar 13® (Pfizer Inc.)
Single dose Intramuscular injection (IM) administered at Visit 1 (Day 0) in subjects enrolled in US with either one of two Inv_MMR vaccine lots (Inv_MMR_Min or Inv_MMR_Med) or one of two active control Com_MMR vaccine lots (Com_MMR_L1 and Com_MMR_L2).
Experimental: Inv_MMR_Med Group
Subjects will receive 1 dose of Inv_MMR vaccine (i.e. Inv_MMR_Med) co administered with Varivax and Havrix vaccines at Visit 1 (Day 0). All US subjects will also be given Prevnar 13. Approximately 6 weeks later (Visit 2), subjects will be administered a separate lot of the Inv_MMR vaccine (Inv_MMR_Release) for the second dose.
Biological: GSK Biologicals measles, mumps and rubella vaccine live (GSK 209762).
Single dose administered subcutaneously (SC) of either Inv_MMR_Min or Inv_MMR_Med depending on group assigned followed by a second SC injection of Inv_MMR_Release about 6 weeks later.
Other Name: Priorix®
Biological: Varivax® (Merck & Co., Inc.)
Single dose SC injection administered at Visit 1 (Day 0) with either one of two Inv_MMR vaccine lots (Inv_MMR_Min or Inv_MMR_Med) or one of two active control Com_MMR vaccine lots (Com_MMR_L1 and Com_MMR_L2).
Biological: Havrix®
Single dose Intramuscular injection (IM) administered at Visit 1 (Day 0) with either one of two Inv_MMR vaccine lots (Inv_MMR_Min or Inv_MMR_Med) or one of two active control Com_MMR vaccine lots (Com_MMR_L1 and Com_MMR_L2).
Biological: Prevnar 13® (Pfizer Inc.)
Single dose Intramuscular injection (IM) administered at Visit 1 (Day 0) in subjects enrolled in US with either one of two Inv_MMR vaccine lots (Inv_MMR_Min or Inv_MMR_Med) or one of two active control Com_MMR vaccine lots (Com_MMR_L1 and Com_MMR_L2).
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. Approximately 6 weeks later (Visit 2), subjects will be administered Com_MMR_L1 or Com_MMR_L2 for the second dose.
Biological: Merck & Co., Inc.'s M-M-R®II, combined measles-mumps-rubella virus vaccine live.
Single dose administered by SC injection of either Com_MMR_L1 or Com_MMR_L2 depending on group assigned followed by a second dose SC injection of either Com_MMR_L1 or Com_MMR_L2 about 6 weeks later.
Biological: Varivax® (Merck & Co., Inc.)
Single dose SC injection administered at Visit 1 (Day 0) with either one of two Inv_MMR vaccine lots (Inv_MMR_Min or Inv_MMR_Med) or one of two active control Com_MMR vaccine lots (Com_MMR_L1 and Com_MMR_L2).
Biological: Havrix®
Single dose Intramuscular injection (IM) administered at Visit 1 (Day 0) with either one of two Inv_MMR vaccine lots (Inv_MMR_Min or Inv_MMR_Med) or one of two active control Com_MMR vaccine lots (Com_MMR_L1 and Com_MMR_L2).
Biological: Prevnar 13® (Pfizer Inc.)
Single dose Intramuscular injection (IM) administered at Visit 1 (Day 0) in subjects enrolled in US with either one of two Inv_MMR vaccine lots (Inv_MMR_Min or Inv_MMR_Med) or one of two active control Com_MMR vaccine lots (Com_MMR_L1 and Com_MMR_L2).
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. Approximately 6 weeks later (Visit 2), subjects will be administered Com_MMR_L1 or Com_MMR_L2 for the second dose.
Biological: Merck & Co., Inc.'s M-M-R®II, combined measles-mumps-rubella virus vaccine live.
Single dose administered by SC injection of either Com_MMR_L1 or Com_MMR_L2 depending on group assigned followed by a second dose SC injection of either Com_MMR_L1 or Com_MMR_L2 about 6 weeks later.
Biological: Varivax® (Merck & Co., Inc.)
Single dose SC injection administered at Visit 1 (Day 0) with either one of two Inv_MMR vaccine lots (Inv_MMR_Min or Inv_MMR_Med) or one of two active control Com_MMR vaccine lots (Com_MMR_L1 and Com_MMR_L2).
Biological: Havrix®
Single dose Intramuscular injection (IM) administered at Visit 1 (Day 0) with either one of two Inv_MMR vaccine lots (Inv_MMR_Min or Inv_MMR_Med) or one of two active control Com_MMR vaccine lots (Com_MMR_L1 and Com_MMR_L2).
Biological: Prevnar 13® (Pfizer Inc.)
Single dose Intramuscular injection (IM) administered at Visit 1 (Day 0) in subjects enrolled in US with either one of two Inv_MMR vaccine lots (Inv_MMR_Min or Inv_MMR_Med) or one of two active control Com_MMR vaccine lots (Com_MMR_L1 and Com_MMR_L2).

Detailed Description:

This trial is a Phase IIIA, randomized, observer-blind, controlled, multi-center, multi-country study with four parallel groups. This study will evaluate the immunogenicity and safety of GSK Biologicals' trivalent investigational MMR vaccine (referred to as Inv_MMR vaccine, throughout this document) in contrast 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 first dose of this two-dose study is designed to establish the end of shelf-life potency of Inv_MMR vaccine. The Inv_MMR vaccine will be given as one of two lots; one of a minimum potency, designated Inv_MMR_Min; and the other at a mid-range or medium potency designated Inv_MMR_Med to two groups. The second dose for both of these Inv_MMR groups will have a potency within the release range of the marketed vaccine. The Com_MMR vaccine will consist of two lots designated Com_MMR_L1 and Com_MMR_L2 and will be analyzed as pooled lots within the study. The first MMR vaccine dose 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 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 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.

    • 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 (or ending at Visit 3 for the US post-dose 2 sub-cohort). 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 (or starting at Visit 3 for the US post-dose 2 sub-cohort), and anytime thereafter.
  • Administration of immunoglobulins and/or any blood products during the period starting 180 days prior to study vaccination at Visit 1 or planned administration from the date of vaccination through the immunogenicity evaluation at Visit 2, or at Visit 3 for the US post-dose 2 sub-cohort.
  • History of measles, mumps, rubella, varicella/zoster and/or hepatitis A diseases.
  • Known exposure to measles, mumps, rubella and/or varicella/zoster during the period starting 30 days prior to the 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. 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 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 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:

• A 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: NCT01681992

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

  Show 95 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01681992     History of Changes
Other Study ID Numbers: 115649, 2011-004905-26
Study First Received: September 6, 2012
Last Updated: October 2, 2014
Health Authority: Spain: Agencia Espanola de Medicamentos y Productos Sanitarios
Finland: Finnish Medicines Agency
United States: Food and Drug Administration
Malaysia: National Pharmaceutical Control Bureau
Thailand: Ministry of Public Health
Czech Republic: Statni ustav pro kontrolu leciv

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

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

ClinicalTrials.gov processed this record on October 22, 2014