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Completed

NCT Number: NCT00861744

Immunogenicity of GSKs' MMR Vaccine (209762) vs. M-M-R® II, When Given With Routine Vaccines at 12-15 Months of Age

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.

The Protocol Posting has been updated following Protocol amendment 1 and 2, Oct 2009.

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Key information

Conditions

Rubella Infections Measles Measles-Mumps-Rubella Vaccine Mononegavirales Infections Morbillivirus Infections Mouth Diseases Mumps Paramyxoviridae Infections Parotid Diseases Parotitis RNA Virus Infections Rubivirus Infections Rubulavirus Infections Salivary Gland Diseases Stomatognathic Diseases Togaviridae Infections Virus Diseases

Age range

12 month–15 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

GSK Investigational Site, Bayamón, Puerto Rico

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.
  • Hypersensitivity to latex
  • 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.

Treatment and study plan

GSK Biological's investigational vaccine 209762

Biological

Subcutaneous injection, one dose

M-M-R® II (Merck and Co)

Biological

Subcutaneous injection, one dose

VARIVAX®

Biological

Subcutaneous injection, one dose

Havrix®

Biological

Intramuscular injection, one dose

Prevnar®

Biological

Intramuscular injection, one dose

Primary outcomes

  1. Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value.

    Time frame: At Day 42 after administration of a dose of Priorix vaccine.

    Anti-measles virus antibody cut-off-value assessed was ≥ 200 milli-International Units per milliliter (mIU/mL). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations <150 mIU/mL prior to vaccination.

  2. Number of Subjects With Anti-mumps Virus Antibody Titer Equal to or Above the Cut-off-value.

    Time frame: At Day 42 after administration of a dose of Priorix vaccine.

    Anti-mumps virus antibody cut-off-value assessed was ≥ 51 Estimated Dose 50 (ED50). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations <24 ED50 prior to vaccination.

  3. Number of Subjects With Anti-rubella Virus Antibody Concentrations Equal to or Above the Cut-off-value.

    Time frame: At Day 42 after administration of a dose of Priorix vaccine.

    Anti-rubella virus antibody cut-off-value assessed was ≥ 10 International Units per milliliter (IU/mL).

Secondary outcomes

  1. Number of Subjects With Anti-varicella Antibody Concentration Equal to or Above the Cut-off-value.

    Time frame: At Day 42 after administration of a dose of Varivax vaccine.

    Anti-varicella virus antibody cut-off-value assessed was ≥ 75 milli-International Units per milliliter (mIU/mL).

  2. Anti-measles Virus Antibody Concentrations

    Time frame: At Day 42 after administration of a dose of Priorix vaccine.

    Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations <150 mIU/mL prior to vaccination.

  3. Anti-mumps Virus Antibody Concentrations

    Time frame: At Day 42 after administration of a dose of Priorix vaccine.

    Antibody concentrations are expressed as Geometric Mean Titer (GMT). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with antibody titer < 24 ED50 prior to vaccination.

  4. Anti-rubella Virus Antibody Concentrations

    Time frame: At Day 42 after administration of a dose of Priorix vaccine.

    Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in IU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations <4 IU/mL prior to vaccination.

  5. Anti-S. Pneumoniae Antibody Concentrations (by Serotype).

    Time frame: At Day 42 after vaccination

    Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in µg/mL.

  6. Anti-varicella Antibody Concentrations.

    Time frame: At Day 42 after administration of a dose of Varivax vaccine.

    Antibody concentrations are expressed as Geometric Mean Titers (GMT). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with antibody concentration < 25 mIU/mL prior to vaccination.

  7. Anti-hepatitis A Virus Antibody Concentrations.

    Time frame: At Day 42 after administration of a dose of Havrix vaccine.

    Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-hepatitis A virus antibody concentrations <15 mIU/mL prior to vaccination.

  8. Number of Subjects With Anti-hepatitis A Antibody Concentrations Equal to or Above the Cut-off-value.

    Time frame: At Day 42 after administration of a dose of Havrix vaccine.

    Anti-hepatitis A antibody cut-off-value assessed was ≥15 milli-International Units per milliliter (mIU/mL).

  9. Anti-S. Pneumoniae Antibody Concentrations (by Serotype).

    Time frame: At Day 0 before vaccination

    Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in µg/mL.

  10. Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value

    Time frame: At 1 year post-vaccination

    Anti-measles virus antibody cut-off-value assessed was ≥ 200 milli-International Units per milliliter (mIU/mL).

  11. Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value

    Time frame: At 2 years post-vaccination

    Anti-measles virus antibody cut-off-value assessed was ≥ 200 milli-International Units per milliliter (mIU/mL).

  12. Anti-measles Virus Antibody Concentrations

    Time frame: At 2 years post-vaccination

    Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations <150 mIU/mL prior to vaccination.

  13. Anti-measles Virus Antibody Concentrations

    Time frame: At 1 year post-vaccination

    Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations <150 mIU/mL prior to vaccination.

  14. Number of Subjects Reporting Investigator-confirmed Measles/Rubella-like Rash and Varicella-like Rash.

    Time frame: During the 43-day (Days 0-42) post-vaccination period

  15. Number of Subjects Reporting Febrile Convulsions

    Time frame: During the 43-day (Days 0-42) post-vaccination period

    Timing of febrile convulsions: events occured on Day 29 in the Priorix 2 Group and Day 0 in the MMR II Group. All cases of febrile convulsions were case of meningism.

  16. Anti-mumps Virus Antibody Titers (Enhanced Plaque Reduction Neutralization (PRN))

    Time frame: At 1 year post-vaccination

    Antibody titers were expressed as Geometric Mean Titer (GMT). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with antibody titer < 24 ED50 prior to vaccination.

  17. Number of Subjects Reporting Other Rash.

    Time frame: During the 43-day (Days 0-42) post-vaccination period

    Other rash = not confirmed by the investigator to be either measles/rubella-like or varicella-like in nature

  18. Number of Subjects With Anti-mumps Virus Antibody Titers Above the Cut-off Value (Enhanced PRN)

    Time frame: At 1 year post-vaccination

    Anti-mumps virus antibody cut-off-value assessed was ≥ 51 ED50.

  19. Number of Subjects With Anti-rubella Virus Antibody Concentrations Equal to or Above the Cut-off-value.

    Time frame: At 1 year post-vaccination

    Anti-rubella virus antibody cut-off-value assessed was ≥ 10 International Units per milliliter (IU/mL). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations <4 IU/mL prior to vaccination.

  20. Number of Subjects With Anti-rubella Virus Antibody Concentrations Equal to or Above the Cut-off-value.

    Time frame: At 2 years post-vaccination

    Anti-rubella virus antibody cut-off-value assessed was ≥ 10 International Units per milliliter (IU/mL).

  21. Anti-rubella Virus Antibody Concentrations

    Time frame: At 1 year post-vaccination

    Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in IU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations <4 IU/mL prior to vaccination.

  22. Anti-rubella Virus Antibody Concentrations

    Time frame: At 2 years post-vaccination

    Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in IU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations <4 IU/mL prior to vaccination.

  23. Number of Subjects Reporting Fever.

    Time frame: During the 15-day (Days 0-14) and 43 days (Days 0-42) post-vaccination period

    fever is assessed for temperature ≥38°C/100.4°F and >39.5°C/103.1°F as measured rectally.

  24. Number of Subjects With Solicited Local Symptoms.

    Time frame: During the 4-day (Days 0-3) post-vaccination period

    Solicited local symptoms assessed were pain, redness and swelling.

  25. Number of Subjects Reporting Medically Attended Visit (MAEs)

    Time frame: During the 43-day (Days 0-42) post-vaccination period

    MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.

  26. Number of Subjects With Unsolicited Adverse Events (AEs).

    Time frame: During the 43-day (Days 0-42) post-vaccination period

    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

  27. Number of Subjects Reporting Investigator-confirmed Parotid/Salivary Gland Swelling.

    Time frame: During the 43-day (Days 0-42) post-vaccination period

    Swelling with accompanying general symptoms

  28. Number of Subjects With Solicited General Symptoms.

    Time frame: During the 15-day (Days 0-14) post-vaccination period

    Assessed solicited general symptoms were drowsiness, irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade.

  29. Number of Subjects Reporting New Onset Chronic Illnesses (NOCIs).

    Time frame: From Day 0 to Day 180 after vaccination

    NOCIs included autoimmune disorders, asthma, type I diabetes, allergies.

  30. Number of Subjects Reporting Serious Adverse Events (SAEs)

    Time frame: From Day 0 to Day 180 after vaccination

    SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.

  31. Number of Subjects Reporting Serious Adverse Events (SAEs).

    Time frame: From Day 180 to Day 730 after vaccination

    SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are congenital anomaly/birth defect in the offspring of a study subject.

  32. Number of Subjects Reporting Conditions Prompting Emergency Room (ER) Visits.

    Time frame: From Day 0 to Day 180 after vaccination

  33. Anti-mumps Virus Antibody Titers (Unenhanced PRN)

    Time frame: At 1 year post-vaccination

    Antibody titers were expressed as Geometric Mean Titer (GMT).

  34. Number of Subjects With Anti-mumps Virus Antibody Titers Above the Cut-off Value (Unenhanced PRN)

    Time frame: At 1 year post-vaccination

    Anti-mumps virus antibody cut-off-value assessed was ≥ 4 Estimated Dose 50 (ED50).

  35. Anti-mumps Virus Antibody Titers (Unenhanced PRN)

    Time frame: At 2 years post-vaccination

    Antibody concentrations are expressed as Geometric Mean Titer (GMT).

  36. Number of Subjects With Anti-mumps Virus Antibody Titers Above the Cut-off Value (Unenhanced PRN)

    Time frame: At 2 years post-vaccination

    Anti-mumps virus antibody cut-off-value assessed was ≥ 4 Estimated Dose 50 (ED50).

  37. Anti-mumps Virus Antibody Concentrations (Pharmaceutical Product Development (PPD) ELISA)

    Time frame: At 1 year post-vaccination

    Antibody concentrations are expressed as Geometric Mean Concentrations (GMC) in ELISA units per milliliter (EU/mL). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations <5 EU/mL prior to vaccination.

  38. Number of Subjects With Anti-mumps Virus Antibody Concentrations Above the Cut-off Value (PPD ELISA)

    Time frame: At 1 year post-vaccination

    Anti-mumps virus antibody cut-off-value assessed was ≥ 10 ELISA units per milliliter (EU/mL)

  39. Anti-mumps Virus Antibody Concentrations (PPD ELISA)

    Time frame: At 2 years post-vaccination

    Antibody concentrations are expressed as Geometric Mean Concentrations (GMC) in ELISA units per milliliter (EU/mL). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations <5 EU/mL prior to vaccination.

  40. Number of Subjects With Anti-mumps Virus Antibody Concentrations Above the Cut-off Value (PPD ELISA)

    Time frame: At 2 years post-vaccination

    Anti-mumps virus antibody cut-off-value assessed was ≥ 10 ELISA units per milliliter (EU/mL)

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Phase II, Randomized, Observer Blind, Controlled, Multicenter Study to Assess Immunogenicity and Antibody Persistence Following Vaccination With GSK's Candidate Combined Measles, Mumps, and Rubella Vaccine (MMR) Versus M-M-R® II as a First Dose, Both Administered Subcutaneously at 12-15 Months of Age, Concomitantly With Hepatitis A Vaccine (HAV), Varicella Vaccine (VV) and Pneumococcal Conjugate Vaccine (PCV) But at Separate Sites.

Important dates

Study start
2009
Primary completion
2010
Study completion
2012
First posted
Mar 13, 2009
Registry last updated
Jan 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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