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

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Measles; Mumps; Rubella

Intervention: 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.) (Biological)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

Summary

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).

Clinical Details

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 Measles-mumps-rubella (MMR) Vaccine When Both Are Given on a 2-dose Schedule to Healthy Children in Their 2nd Year of Life

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: Evaluation of immunogenicity of the MMR vaccines in terms of antibody concentration.

Secondary outcome:

Evaluation of immunogenicity of the MMR vaccines post-dose 2 (US sub-cohort) in terms of antibody concentration.

Occurrence of solicited local symptoms.

Occurrence of solicited general symptoms.

Occurrence of Unsolicited adverse events.

Occurrence of Adverse events of specific interest.

Serious adverse events (SAEs).

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

Minimum age: 12 Months. Maximum age: 15 Months. Gender(s): Both.

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 with last dose 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.

Locations and Contacts

GSK Investigational Site, Benesov 256 01, Czech Republic

GSK Investigational Site, Chlumec nad Cidlinou 50351, Czech Republic

GSK Investigational Site, Decin 405 01, Czech Republic

GSK Investigational Site, Jindrichuv Hradec 37701, Czech Republic

GSK Investigational Site, Kladno 272 01, Czech Republic

GSK Investigational Site, Liberec 46015, Czech Republic

GSK Investigational Site, Lipnik nad Becvou 75131, Czech Republic

GSK Investigational Site, Nachod 547 01, Czech Republic

GSK Investigational Site, Odolena voda 25070, Czech Republic

GSK Investigational Site, Ostrava - Poruba 70800, Czech Republic

GSK Investigational Site, Pardubice 532 03, Czech Republic

GSK Investigational Site, Plzen 305 99, Czech Republic

GSK Investigational Site, Praha 6 1600, Czech Republic

GSK Investigational Site, Helsinki 00100, Finland

GSK Investigational Site, Helsinki 00930, Finland

GSK Investigational Site, Jarvenpaa 04400, Finland

GSK Investigational Site, Oulu 90220, Finland

GSK Investigational Site, Tampere 33100, Finland

GSK Investigational Site, Turku 20520, Finland

GSK Investigational Site, Kuala Terengganu 20400, Malaysia

GSK Investigational Site, Kuching 93586, Malaysia

GSK Investigational Site, Sibu 96000, Malaysia

GSK Investigational Site, Barceloneta 00617, Puerto Rico

GSK Investigational Site, Cidra 00739, Puerto Rico

GSK Investigational Site, Guayama 00784, Puerto Rico

GSK Investigational Site, Ponce 00716, Puerto Rico

GSK Investigational Site, San Juan 00936-5067, Puerto Rico

GSK Investigational Site, Santurce 00912, Puerto Rico

GSK Investigational Site, Antequera/Málaga 29200, Spain

GSK Investigational Site, Barcelona 08042, Spain

GSK Investigational Site, Centelles (Barcelona) 08540, Spain

GSK Investigational Site, L'Eliana, Valencia 46183, Spain

GSK Investigational Site, Manlleu 08560, Spain

GSK Investigational Site, Quart de Poblet, Valencia 46930, Spain

GSK Investigational Site, Santiago de Compostela 15706, Spain

GSK Investigational Site, Sevilla 41014, Spain

GSK Investigational Site, Valencia 46020, Spain

GSK Investigational Site, Valencia 46024, Spain

GSK Investigational Site, Valencia 46200, Spain

GSK Investigational Site, Vic 08500, Spain

GSK Investigational Site, Bangkok 10330, Thailand

GSK Investigational Site, Bangkok 10400, Thailand

GSK Investigational Site, Bangkok 10700, Thailand

GSK Investigational Site, Chiang mai 50200, Thailand

GSK Investigational Site, Patumtani 12121, Thailand

GSK Investigational Site, Birmingham, Alabama 35205, United States

GSK Investigational Site, Phoenix, Arizona 85032, United States

GSK Investigational Site, Phoenix, Arizona 85282, United States

GSK Investigational Site, Jonesboro, Arkansas 72401, United States

GSK Investigational Site, Little Rock, Arkansas 72205, United States

GSK Investigational Site, Anaheim, California 92805, United States

GSK Investigational Site, Long Beach, California 90813, United States

GSK Investigational Site, West Covina, California 91790, United States

GSK Investigational Site, Altamonte Springs, Florida 32701, United States

GSK Investigational Site, Miami Lakes, Florida 33014, United States

GSK Investigational Site, Miami, Florida 33184, United States

GSK Investigational Site, Naples, Florida 34102, United States

GSK Investigational Site, Tampa, Florida 33606, United States

GSK Investigational Site, Muncie, Indiana 47304-5547, United States

GSK Investigational Site, New Albany, Indiana 47150, United States

GSK Investigational Site, West Des Moines, Iowa 50265, United States

GSK Investigational Site, Wichita, Kansas 67205, United States

GSK Investigational Site, Louisville, Kentucky 40207, United States

GSK Investigational Site, Nicholasville, Kentucky 40356, United States

GSK Investigational Site, Annapolis, Maryland 21401, United States

GSK Investigational Site, Baltimore, Maryland 21201, United States

GSK Investigational Site, Frederick, Maryland 21702, United States

GSK Investigational Site, Kansas City, Missouri 64108, United States

GSK Investigational Site, Bellevue, Nebraska 68123, United States

GSK Investigational Site, Fremont, Nebraska 68025, United States

GSK Investigational Site, Lincoln, Nebraska 68504, United States

GSK Investigational Site, Lincoln, Nebraska 68506, United States

GSK Investigational Site, Omaha, Nebraska 68131, United States

GSK Investigational Site, Clyde, North Carolina 28721, United States

GSK Investigational Site, Holly Springs, North Carolina 27540, United States

GSK Investigational Site, Cleveland, Ohio 44106, United States

GSK Investigational Site, Cleveland, Ohio 44121, United States

GSK Investigational Site, Dayton, Ohio 45406, United States

GSK Investigational Site, Dayton, Ohio 45414, United States

GSK Investigational Site, Youngstown, Ohio 44514, United States

GSK Investigational Site, Youngstown, Ohio 44505, United States

GSK Investigational Site, Gresham, Oregon 97030, United States

GSK Investigational Site, Indiana, Pennsylvania 15701, United States

GSK Investigational Site, Johnstown, Pennsylvania 15904, United States

GSK Investigational Site, Charleston, South Carolina 29406, United States

GSK Investigational Site, Charleston, South Carolina 29414, United States

GSK Investigational Site, Houston, Texas 77087, United States

GSK Investigational Site, Waco, Texas 76710, United States

GSK Investigational Site, Layton, Utah 84041, United States

GSK Investigational Site, Springville, Utah 84663, United States

GSK Investigational Site, St. George, Utah 84790, United States

GSK Investigational Site, Midlothian, Virginia 23113, United States

GSK Investigational Site, Richmond, Virginia 23223, United States

GSK Investigational Site, Richmond, Virginia 23294, United States

GSK Investigational Site, Ellensburg, Washington 98926, United States

Additional Information

Starting date: October 2012
Last updated: August 13, 2015

Page last updated: August 20, 2015

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