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Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Combined Measles-mumps-rubella (MMR) Vaccine in Subjects Four to Six Years of Age

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01621802
First Posted: June 18, 2012
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
June 14, 2012
June 18, 2012
October 18, 2016
September 13, 2017
October 12, 2017
June 21, 2012
July 6, 2015   (Final data collection date for primary outcome measure)
  • Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value [ Time Frame: 42 days post vaccination (At Day 42) ]
    Seroresponse was defined as post-vaccination anti-measles virus antibody concentration equal to or above (≥) 200 milli-international Units per milliliter (mIU/mL). Analysis was done in sub-cohorts 1 and 2 only.
  • Number of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value [ Time Frame: 42 days post vaccination (At Day 42) ]
    Seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥ 10 ELISA Units per milliliter (EU/mL). Analysis was done in sub-cohorts 1 and 2 only.
  • Number of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value [ Time Frame: 42 days post vaccination (At Day 42) ]
    Seroresponse was defined as post-vaccination anti-rubella virus antibody concentration ≥ 10 International Units per milliliter (IU/mL). Analysis was done in sub-cohorts 1 and 2 only.
  • Evaluation of Immunogenicity in Terms of Anti-measles Virus Antibody Concentrations [ Time Frame: 42 days after vaccination (At Day 42) ]
    Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. Analysis was done in sub-cohorts 1 and 2 only.
  • Evaluation of Immunogenicity in Terms of Anti-mumps Virus Antibody Concentrations [ Time Frame: 42 days post vaccination (At Day 42) ]
    Antibody concentrations were expressed as GMCs in EU/mL. Analysis was done in sub-cohorts 1 and 2 only.
  • Evaluation of Immunogenicity in Terms of Anti-rubella Virus Antibody Concentrations [ Time Frame: 42 days post vaccination (At Day 42) ]
    Antibody concentrations were expressed as GMCs in IU/mL. Analysis was done in sub-cohorts 1 and 2 only.
  • Immunogenicity with respect to the components of the Inv_MMR vaccine as compared to Com_MMR vaccine when given with VV and DTaP-IPV vaccines in terms of antibody concentration [ Time Frame: 42 days after vaccination (At Day 42) ]
  • Immunogenicity with respect to the components of the Inv_MMR vaccine as compared to Com_MMR vaccine when given without VV and DTaP-IPV in terms of antibody concentration [ Time Frame: 42 days after vaccination (At Day 42) ]
Complete list of historical versions of study NCT01621802 on ClinicalTrials.gov Archive Site
  • Number of Subjects With Anti-varicella Zoster Virus (VZV) Antibody Concentration Equal to or Above the Cut-off-value [ Time Frame: 42 days post vaccination (At Day 42) ]
    Seroresponse was defined as post-vaccination anti-VZV antibody concentration ≥ 75 mIU/mL. Analysis was done in sub-cohort 1 only.
  • Evaluation of Immunogenicity in Terms of Anti-VZV Antibody Concentrations [ Time Frame: 42 days post vaccination (At Day 42) ]
    Antibody concentrations were expressed as GMCs in mIU/mL. Analysis was done in sub-cohort 1 only.
  • Number of Subjects With Antibody Booster Response to Diphtheria Toxin (Anti-D) and Tetanus Toxin (Anti-T) [ Time Frame: 42 days post vaccination (At Day 42) ]

    Booster response was defined as:

    For subjects with pre-vaccination antibody concentration less than (<) 0.1 IU/mL, antibody concentration ≥ 0.4 IU/ml at Day 42.

    For subjects with pre-vaccination antibody concentration ≥ 0.1 IU/mL: antibody concentration at Day 42 ≥ 4 fold the pre-vaccination antibody concentration.

    Analysis was done in sub-cohort 1 only.

  • Number of Subjects With Antibody Booster Response to Pertussis Toxin (PT) [ Time Frame: 42 days post vaccination (At Day 42) ]

    Booster response was defined as:

    For initially seronegative subjects, antibody concentration ≥ 10.772 IU/mL at Day 42.

    For initially seropositive subjects with pre-vaccination antibody concentration < 10.772 IU/mL: antibody concentration at Day 42 ≥ 4 fold the pre-vaccination antibody concentration.

    For initially seropositive subjects with pre-vaccination antibody concentration ≥ 10.772 IU/mL: antibody concentration at Day 42 ≥ 2 fold the pre-vaccination antibody concentration.

    Analysis was done in sub-cohort 1 only.

  • Number of Subjects With Antibody Booster Response to Filamentous Hemagglutinin (FHA) [ Time Frame: 42 days post vaccination (At Day 42) ]

    Booster response was defined as:

    For initially seronegative subjects, antibody concentration ≥ 8.184 IU/ml at Day 42.

    For initially seropositive subjects with pre-vaccination antibody concentration < 8.184 IU/mL: antibody concentration at Day 42 ≥ 4 fold the pre-vaccination antibody concentration.

    For initially seropositive subjects with pre-vaccination antibody concentration ≥ 8.184 IU/mL: antibody concentration at Day 42 ≥ 2 fold the pre-vaccination antibody concentration.

    Analysis was done in sub-cohort 1 only.

  • Number of Subjects With Antibody Booster Response to Pertactin (PRN) [ Time Frame: 42 days post vaccination (At Day 42) ]

    Booster response was defined as:

    For initially seronegative subjects, antibody concentration ≥ 8.748 IU/mL at Day 42.

    For initially seropositive subjects with pre-vaccination antibody concentration < 8.748 IU/mL: antibody concentration at Day 42 ≥ 4 fold the pre-vaccination antibody concentration.

    For initially seropositive subjects with pre-vaccination antibody concentration ≥ 8.748 IU/mL: antibody concentration at Day 42 ≥ 2 fold the pre-vaccination antibody concentration.

    Analysis was done in sub-cohort 1 only.

  • Evaluation of Immunogenicity in Terms of Anti-D and Anti-T Antibody Concentrations [ Time Frame: 42 days post vaccination (At Day 42) ]
    Antibody concentrations were expressed as GMCs in IU/mL. Analysis was done in sub-cohort 1 only.
  • Evaluation of Immunogenicity in Terms of Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations [ Time Frame: 42 days post vaccination (At Day 42) ]
    Antibody concentrations were expressed as GMCs in EU/mL. Analysis was done in sub-cohort 1 only.
  • Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL [ Time Frame: 42 days post vaccination (At Day 42) ]
    Analysis was done in sub-cohort 1 only.
  • Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 1.0 IU/mL [ Time Frame: 42 days post vaccination (At Day 42) ]
    Analysis was done in sub-cohort 1 only.
  • Evaluation of Immunogenicity in Terms of Anti-polio Virus Types 1, 2 and 3 Antibody Titers [ Time Frame: 42 days post vaccination (At Day 42) ]
    Antibody titers were expressed as Geometric Mean Titers (GMTs) in ED50. Analysis was done in sub-cohort 1 only.
  • Number of Subjects With Solicited Local Symptoms [ Time Frame: During the 4-day (Days 0-3) post-vaccination period ]
    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 Pain = Cried when limb was moved/spontaneously painful. Grade 3 redness and swelling = greater than 50 millimeters (m m ) i.e . > 50mm.
  • Number of Subjects With Solicited General Symptoms [ Time Frame: During the 4-day (Days 0-3) post-vaccination period ]

    Assessed solicited general symptoms were drowsiness and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 Drowsiness = Drowsiness that prevented normal activity, Grade 3 Loss of appetite = Not eating at all. Related = symptom assessed by the investigator as causally related to study vaccination.

    Analysis was done for sub-cohort 1 only.

  • Number of Subjects Reporting Fever [ Time Frame: During the 43-day (Days 0-42) post-vaccination period ]
    Any fever = fever ≥ 38°C; Grade 3 fever = fever > 39.5°C; Related = fever assessed by the investigator as causally related to study vaccination.
  • Number of Subjects Reporting MMR Specific Solicited General Symptoms [ Time Frame: During the 43-day (Days 0-42) post-vaccination period ]
    Assessed MMR specific symptoms were parotid gland swelling and any suspected signs of meningism including febrile convulsions. Any = occurrence of any general symptoms regardless of their intensity grade or relationship to vaccination. Grade 3 Parotid/salivary gland swelling = Swelling accompanied with general symptoms. Grade 3 Sign of meningism (any suspected signs including febrile convulsions) = An event which prevented normal, everyday activities. Related = symptom assessed by the investigator as causally related to study vaccination.
  • Number of Subjects Reporting Investigator-confirmed Rash [ Time Frame: During the 43-day (Days 0-42) post-vaccination period ]
    Assessed any rash, varicella-like rash, measles/rubella-like rash, Grade 3, related. Any= occurrence of rash regardless of intensity grade. Grade 3 measles/rubella/varicella-like rash = Rash with more than 150 lesions. Other Grade 3 Rash = Rash that prevented normal, everyday activities. Related= Rash assessed by the investigator as causally related to study vaccination.
  • Number of Subjects With New Onset Chronic Diseases (NOCDs) [ Time Frame: During the entire study period (from Day 0 up to Day 180) ]
    NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.
  • Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits [ Time Frame: During the entire study period (from Day 0 up to Day 180) ]
    The number of subjects reporting adverse events resulting in Emergency Room (ER) visits is reported.
  • 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 was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
  • Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: During the entire study period (from Day 0 up to Day 180) ]
    Serious adverse events (SAEs) assessed included medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Any SAE = occurrence of SAE regardless of intensity grade or relation to vaccination.
  • Immunogenicity with respect to VV in terms of antibody concentration [ Time Frame: 42 days after vaccination (At Day 42) ]
  • Immunogenicity with respect to the components of DTaP- IPV vaccine in terms of antibody concentration [ Time Frame: 42 days after vaccination (At Day 42) ]
  • Occurrence of solicited local symptoms [ Time Frame: Days 0-3 ]
  • Occurrence of solicited general symptoms [ Time Frame: Days 0-42 ]
  • Occurrence of Adverse events of specific interest [ Time Frame: From Day 0 through the end of study (Day 180) ]
  • Occurrence of Unsolicited adverse events [ Time Frame: From Day 0 to Day 42 ]
  • Occurrence of serious adverse events [ Time Frame: From Day 0 through end of study (Day 180) ]
Not Provided
Not Provided
 
Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Combined Measles-mumps-rubella (MMR) Vaccine in Subjects Four to Six Years of Age
Immunogenicity and Safety Study of GSK Biologicals' Combined Measles-mumps-rubella Vaccine in Subjects Four to Six Years of Age (209762)
The purpose of this study is to support licensure of GSK Biologicals' MMR vaccine (Priorix®) in the US by generating immunogenicity and safety data in contrast to the US standard of care, Merck's MMR vaccine (M-M-R®II), when given as a second dose to children four to six years of age.

The GSK Biologicals' MMR vaccine (Priorix®) and Merck's MMR vaccine (M-M-R®II) are referred to as Inv_MMR vaccine and Com_MMR vaccine respectively. 2 lots of the comparator vaccine (Com_MMR_L1 and Com_MMR_L2) will be used, but the 2 lots will be analysed as a pool.

The Inv_MMR vaccine will be administered as a second dose to children who already received a first dose Com_MMR vaccine. Since the second dose of a MMR vaccine in the US is routinely co-administered with DTaP-IPV vaccine (Kinrix®) and varicella vaccine (VV) (ProQuad® or Varivax®), some children will receive one dose of these vaccines along with either of the MMR vaccines.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Rubella
  • Mumps
  • Measles
  • Biological: Priorix
    One dose administered subcutaneously in the triceps region of the right arm.
  • Biological: M-M-R II
    One dose administered subcutaneously in the triceps region of the right arm.
  • Biological: Kinrix
    One dose administered by deep intramuscular injection in the upper left deltoid.
  • Biological: ProQuad
    One dose administered subcutaneously in the triceps region of the left arm.
  • Experimental: Inv _MMR_CO Group
    Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
    Interventions:
    • Biological: Priorix
    • Biological: Kinrix
    • Biological: ProQuad
  • Active Comparator: Com_MMR_CO Group
    Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
    Interventions:
    • Biological: M-M-R II
    • Biological: Kinrix
    • Biological: ProQuad
  • Experimental: Inv_MMR_I Group
    Subjects received one dose of Priorix at Visit 1 (Day 0).
    Intervention: Biological: Priorix
  • Active Comparator: Com_MMR_I Group
    Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
    Intervention: Biological: M-M-R II
  • Experimental: Inv _MMR_S Group
    Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).
    Intervention: Biological: Priorix
  • Active Comparator: Com_MMR_S Group
    Subjects in this safety cohort received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
    Intervention: Biological: M-M-R II
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4011
November 9, 2015
July 6, 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects who the investigator believes that they and/or their parent(s) or LAR/s can and will comply with the requirements of the protocol.
  • Male or female subjects 4 to 6 years of age at the time of vaccination.
  • Written informed consent is obtained from the parent(s)/LAR(s) of the subject (assent will be obtained from subjects in line with local rules and regulations).
  • Subjects in stable health as determined by investigator's physical examination and assessment of subjects' medical history.
  • Subjects received either a single dose of M-M-R II, M-M-R VaxPro or ProQuad in the second year of life.
  • For subjects enrolled in the sub-cohort receiving co-administered DTaP-IPV and VV:

    • subjects received previous DTaP vaccine doses with INFANRIX® and/or PEDIARIX® for the first three doses and INFANRIX® for the fourth dose of the DTaP-containing vaccine.
    • subjects received a first dose of VV in the second year of life.

Exclusion Criteria:

  • Child in care.
  • Use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before the day of study vaccination/s or planned during the entire study period.
  • Previous vaccination with a second dose of measles, mumps, rubella containing vaccine/s.
  • Chronic administration of immunosuppressants or other immune-modifying drugs during the period starting 180 days prior to Day 0 or any planned administration of immunosuppressive and immune-modifying drugs during the entire study. Inhaled and topical steroids are allowed.
  • 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.
  • Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting 30 days prior to the study vaccination/s and ending 42 days after the vaccination/s (at Visit 2), with the exception of live intranasal or inactivated influenza (flu) vaccine, which may be given at any time during the study, including the day of study vaccination/s. Inactivated influenza vaccine must be administered at a different location from the study vaccine. Any age appropriate vaccine may be given starting at Visit 2, and anytime thereafter.
  • 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.
  • History of measles, mumps, and/or rubella disease.
  • Known exposure to measles, mumps and/or rubella during the period starting 30 days prior to enrollment.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s), including systemic hypersensitivity to neomycin 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) measured 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 according to the subject's medical history.
  • Any other condition which, in the opinion of the investigator, prevents the subject from participating in the study.

In addition, for subjects enrolled in the sub-cohort receiving co-administered DTaP-IPV+VV:

  • Previous vaccination with a second dose of varicella-containing vaccine.
  • Receipt of any varicella-containing vaccine during the period starting 90 days before the day of study vaccination.
  • History of varicella/zoster disease.
  • Known exposure to varicella/zoster during the period starting 30 days prior to enrollment.
  • History of diphtheria, tetanus, pertussis, and/or poliomyelitis disease.
  • Vaccination against diphtheria, tetanus, pertussis or polio given after the second year of life.
  • Occurrence of transient thrombocytopenia or neurological complications following an earlier immunization against diphtheria and/or tetanus toxoids.
  • Following a previous administration of DTP vaccine: temperature ≥40.6°C (>105°F) during the period starting 48 hours not due to another identifiable cause, collapse or shock-like state during the period starting 48 hours, persistent, inconsolable crying lasting three hours or more within 48 hours, seizures with or without fever occurring during the period starting three days, or encephalopathy of unknown aetiology occurring during the period starting 7 days of a previous administration of DTP vaccine.
  • Hypersensitivity reaction to any component of the DTaP-IPV and/or varicella vaccines.
Sexes Eligible for Study: All
4 Years to 6 Years   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of,   Puerto Rico,   Taiwan,   United States
 
 
NCT01621802
115158
2011-004638-32 ( EudraCT Number )
Not Provided
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP