Immunogenicity and Safety Study of GSK Biologicals' Combined Measles-mumps-rubella Vaccine in Subjects Four to Six Years of Age (209762)
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Measles-Mumps-Rubella
- Sponsor
- GlaxoSmithKline
- Enrollment
- 4011
- Locations
- 1
- Primary Endpoint
- Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
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
- •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.
Outcomes
Primary Outcomes
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.
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.
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-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.
Secondary Outcomes
- Evaluation of Immunogenicity in Terms of Anti-VZV Antibody Concentrations(42 days post vaccination (At Day 42))
- Number of Subjects With Anti-varicella Zoster Virus (VZV) Antibody Concentration Equal to or Above the Cut-off-value(42 days post vaccination (At Day 42))
- Number of Subjects With Antibody Booster Response to Diphtheria Toxin (Anti-D) and Tetanus Toxin (Anti-T)(42 days post vaccination (At Day 42))
- Number of Subjects With Antibody Booster Response to Pertactin (PRN)(42 days post vaccination (At Day 42))
- Number of Subjects Reporting Fever(During the 43-day (Days 0-42) post-vaccination period)
- Number of Subjects With Antibody Booster Response to Pertussis Toxin (PT)(42 days post vaccination (At Day 42))
- Number of Subjects With Antibody Booster Response to Filamentous Hemagglutinin (FHA)(42 days post vaccination (At Day 42))
- Evaluation of Immunogenicity in Terms of Anti-D and Anti-T Antibody Concentrations(42 days post vaccination (At Day 42))
- Number of Subjects With Solicited General Symptoms(During the 4-day (Days 0-3) post-vaccination period)
- Evaluation of Immunogenicity in Terms of Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations(42 days post vaccination (At Day 42))
- Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 1.0 IU/mL(42 days post vaccination (At Day 42))
- Number of Subjects Reporting MMR Specific Solicited General Symptoms(During the 43-day (Days 0-42) post-vaccination period)
- Number of Subjects Reporting Investigator-confirmed Rash(During the 43-day (Days 0-42) post-vaccination period)
- Number of Subjects With New Onset Chronic Diseases (NOCDs)(During the entire study period (from Day 0 up to Day 180))
- Number of Subjects With Unsolicited Adverse Events (AEs)(During the 43-day (Days 0-42) post-vaccination period)
- Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL(42 days post vaccination (At Day 42))
- Evaluation of Immunogenicity in Terms of Anti-polio Virus Types 1, 2 and 3 Antibody Titers(42 days post vaccination (At Day 42))
- Number of Subjects With Solicited Local Symptoms(During the 4-day (Days 0-3) post-vaccination period)
- Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits(During the entire study period (from Day 0 up to Day 180))
- Number of Subjects With Serious Adverse Events (SAEs)(During the entire study period (from Day 0 up to Day 180))