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Immunogenicity of GSKs' MMR Vaccine (209762) vs. M-M-R® II, When Given With Routine Vaccines at 12-15 Months of Age
This study is not yet open for participant recruitment.
Verified by GlaxoSmithKline, April 2009
First Received: March 12, 2009   Last Updated: April 23, 2009   History of Changes
Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00861744
  Purpose

The purpose of this study is to compare two measles, mumps and rubella conjugate vaccines (manufactured by GSK and Merck and Company ) in terms of the immune response elicited and safety with a six month follow-up after first vaccination. Additionally, antibody persistence will be assessed one and two years after administration of MMR vaccine


Condition Intervention Phase
Diseases Caused by Measles, Mumps, Rubella and Varicella Viruses
Biological: M-M-R® II (Merck and Co)
Biological: Varivax®
Biological: GSK Biological's investigational vaccine 209762
Biological: Havrix®
Biological: Prevnar®
Phase II

MedlinePlus related topics: Chickenpox Measles Mumps Rubella Shingles
Drug Information available for: Heptavalent pneumococcal conjugate vaccine Pneumococcal Vaccines Chickenpox Vaccine
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title: Immunogenicity of GlaxoSmithKline Biologicals' MMR Vaccine (209762) vs. M-M-R® II, When co-Administered With Hepatitis A, Varicella and Pneumococcal Conjugate Vaccines to Children 12-15 Months of Age

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Anti-rubella virus antibody concentration (in the serum of subjects below the cut-off before vaccination lot by lot) [ Time Frame: Day 0 and Day 42 ] [ Designated as safety issue: No ]
  • Anti-mumps virus antibody titer (in the serum of subjects below the cut-off before vaccination, lot by lot) [ Time Frame: Day 0 and Day 42 ] [ Designated as safety issue: No ]
  • Anti-measles virus antibody concentration (in the serum of subjects below the cut-off before vaccination, lot by lot) [ Time Frame: Day 0 and Day 42 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Anti-measles virus antibody concentration (in the serum of subjects below the cut-off before vaccination, pooled lots) [ Time Frame: Day 0 and Day 42 ] [ Designated as safety issue: No ]
  • Anti-mumps virus antibody titer (in the serum of subjects below the cut-off before vaccination, pooled lots) [ Time Frame: Day 0 and Day 42 ] [ Designated as safety issue: No ]
  • Anti-rubella virus antibody concentration (in the serum of subjects below the cut-off before vaccination, pooled lots) [ Time Frame: Day 0 and Day 42 ] [ Designated as safety issue: No ]
  • Anti-varicella antibody concentration (in the serum of subjects below the cut-off before vaccination) [ Time Frame: Day 0 and Day 42 ] [ Designated as safety issue: No ]
  • Concentrations/titers of antibody to measles, mumps, rubella and varicella [ Time Frame: Day 0 and Day 42 ] [ Designated as safety issue: No ]
  • Concentrations/titers of antibody to measles, mumps, rubella and varicella [ Time Frame: 1 year post-vaccination ] [ Designated as safety issue: No ]
  • Anti-measles, anti-mumps, and anti-rubella antibody titer/concentration (in the serum of subjects below the cut-off before vaccination) [ Time Frame: 1 year post-vaccination ] [ Designated as safety issue: No ]
  • Concentrations/titers of antibody to measles, mumps, rubella and varicella [ Time Frame: 2 years post-vaccination ] [ Designated as safety issue: No ]
  • Anti-measles, anti-mumps, and anti-rubella antibody titer/concentration (in the serum of subjects below the cut-off before vaccination) [ Time Frame: 2 years post-vaccination ] [ Designated as safety issue: No ]
  • Occurrence of solicited injection site symptoms (local) (pain, redness, swelling) [ Time Frame: 4-days after vaccination. ] [ Designated as safety issue: No ]
  • Occurrence of investigator-confirmed measles/rubella-like rash and varicella-like rash [ Time Frame: Over 43 days after vaccination. ] [ Designated as safety issue: No ]
  • Occurrence of other rash (i.e. rash not confirmed by the investigator to be either measles/rubella-like or varicella-like in nature) [ Time Frame: Over 43 days after vaccination. ] [ Designated as safety issue: No ]
  • Occurrence of investigator-confirmed parotid/salivary gland swelling [ Time Frame: Over 43 days after vaccination. ] [ Designated as safety issue: No ]
  • Occurrence of drowsiness, loss of appetite and irritability [ Time Frame: Over 15 days after vaccination. ] [ Designated as safety issue: No ]
  • Occurrence and timing of febrile convulsions [ Time Frame: Over 43 days after vaccination. ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited symptoms and medically-attended adverse events (excluding rash and parotid/salivary gland swelling) and febrile convulsions [ Time Frame: Over 43 days after vaccination. ] [ Designated as safety issue: No ]
  • Occurrence of new onset chronic illnesses and conditions prompting ER visits [ Time Frame: Approximately 6 months after vaccination ] [ Designated as safety issue: No ]
  • Occurrence of all serious adverse events (SAEs) [ Time Frame: Approximately 6 months after vaccination ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events (SAEs) related to study participation, prompting study withdrawal and/or leading to death [ Time Frame: Between Day 180/Visit 3 and Day 730/Visit 5. ] [ Designated as safety issue: No ]
  • Occurrence of fever [ Time Frame: Over 15 days and over 43 days after vaccination. ] [ Designated as safety issue: No ]

Estimated Enrollment: 1200
Study Start Date: June 2009
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Group 3: Experimental
Subjects in this group will receive GSK 209762 investigational vaccine (Lot 3)
Biological: GSK Biological's investigational vaccine 209762
Subcutaneous injection, one dose
Group 1: Experimental
Subjects in this group will receive GSK 209762 investigational vaccine (Lot 1)
Biological: Varivax®
Subcutaneous injection, one dose
Biological: GSK Biological's investigational vaccine 209762
Subcutaneous injection, one dose
Biological: Havrix®
Intramuscular injection, one dose
Biological: Prevnar®
Intramuscular injection, one dose
Group 2: Experimental
Subjects in this group will receive GSK 209762 investigational vaccine (Lot 2)
Biological: GSK Biological's investigational vaccine 209762
Subcutaneous injection, one dose
Group 4: Active Comparator
Subjects in this group will randomly receive one of three different commercially-available lot of M-M-R II (Merck and Co.)
Biological: M-M-R® II (Merck and Co)
Subcutaneous injection, one dose
Biological: Varivax®
Subcutaneous injection, one dose
Biological: Havrix®
Intramuscular injection, one dose
Biological: Prevnar®
Intramuscular injection, one dose

  Eligibility

Ages Eligible for Study:   12 Months to 16 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects for whom the investigator believes 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.
  • Male or female between 12 and 15 months of age (e.g. from age 12 months until the day before age 16 months) at the time of vaccination.
  • Written informed consent obtained from the parent/guardian of the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Have previously received three doses of 7-valent pneumococcal conjugate vaccine within the first year of life with the third dose administered at least 30 days prior to enrolment and vaccination with study vaccines.

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.
  • 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 (pharmaceutical product or device).
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
  • Planned administration/ administration of a vaccine not foreseen by the study protocol from 30 days prior to vaccination until 42 days after vaccination, except for influenza vaccine and Hib vaccine.
  • Previous vaccination against measles, mumps, rubella and/or varicella.
  • Previous vaccination against hepatitis A or receipt of a fourth dose of pneumococcal conjugate vaccine.
  • History of measles, mumps, rubella, varicella/zoster and hepatitis A diseases.
  • Known exposure to measles, mumps, rubella and/or varicella/zoster within 30 days prior to the start of the study.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required), 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 vaccines.
  • Major congenital defects or serious chronic illness.
  • History of any neurologic disorders or seizures, including febrile seizures.
  • Acute disease at the time of enrolment.
  • Administration of polyclonal immunoglobulins and/or any blood products during the six months before entering the study or planned administration during the study period.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00861744

Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718

  Show 54 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GSK ( Study Director )
Study ID Numbers: 111870
Study First Received: March 12, 2009
Last Updated: April 23, 2009
ClinicalTrials.gov Identifier: NCT00861744     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Measles, Mumps, Rubella, Varicella Vaccine
Vaccines
Combined Vaccine
Children
Humans
Immunogenicity
Safety

Study placed in the following topic categories:
Virus Diseases
Hepatitis
Herpes Zoster
Paramyxoviridae Infections
Measles
Chickenpox
Hepatitis A
DNA Virus Infections
Rubella
Togaviridae Infections
Mumps
Herpesviridae Infections

Additional relevant MeSH terms:
Herpes Zoster
RNA Virus Infections
Morbillivirus Infections
Paramyxoviridae Infections
Measles
Chickenpox
Rubella
Togaviridae Infections
Herpesviridae Infections
Virus Diseases
Rubivirus Infections
DNA Virus Infections
Mononegavirales Infections

ClinicalTrials.gov processed this record on May 07, 2009