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Phase 3 N=5,003 Randomized Triple-blind Prevention

Consistency Study of GlaxoSmithKline (GSK) Biologicals' MMR Vaccine (209762) (Priorix) Comparing Immunogenicity and Safety to Merck & Co., Inc.'s MMR Vaccine (M-M-R II), in Children 12 to 15 Months of Age

Rubella · Measles · Mumps

Enrolled (actual)
5,003
Serious AEs
2.1%
Results posted
Jun 2018
Primary outcome: Primary: Percentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value — 98.2; 98.9; 98.1; 98.1 Percentage of subjects

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Priorix (Biological); M-M-R II (Biological); Varivax (Biological); Havrix (Biological); Prevnar 13 (Biological)
Age
Pediatric · 0+ yrs
Sex
All
Sponsor
GlaxoSmithKline
Primary completion
Nov 2014

Outcome Measures

OutcomeResultp-value
PRIMARY
Percentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value
98.2; 98.9; 98.1; 98.1; 98.6; 97.8
PRIMARY
Anti-measles Virus Antibody Concentrations
2970.3; 3023.6; 3058.3
PRIMARY
Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value
99.7; 99.3; 99.2; 98.6; 98.6; 98.0
PRIMARY
Anti-mumps Virus Antibody Concentration
71.7; 76.9; 69.0
PRIMARY
Percentage of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value
99.4; 99.7; 99.4; 97.2; 97.1; 97.7
PRIMARY
Anti-rubella Virus Antibody Concentration
57.2; 53.1; 57.0
PRIMARY
Percentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value in Pooled MMR Groups
98.4; 98.1; 98.2; 98.0
PRIMARY
Anti-measles Virus Antibody Concentrations in Pooled MMR Groups
3017.4; 3074.4
PRIMARY
Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value in Pooled MMR Groups
99.4; 99.3; 98.4; 97.6
PRIMARY
Anti-mumps Virus Antibody Concentration in Pooled MMR Groups
72.4; 69.1
PRIMARY
Percentage of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value in Pooled MMR Groups
99.5; 99.6; 97.3; 98.5
PRIMARY
Anti-rubella Virus Antibody Concentration in Pooled MMR Groups
55.7; 64.0
SECONDARY
Percentage of Subjects With an Anti-Varicella Zoster Virus (VZV) Antibody Concentration Equal to or Above the Cut-off Value in US Sub-cohort of Pooled MMR Groups
99.7; 99.6; 92.2; 90.9
SECONDARY
Anti-VZV Virus Antibody Concentration in US Sub-cohort of Pooled MMR Groups
169.6; 167.2
SECONDARY
Percentage of Subjects With an Anti-HAV Antibody Concentration Equal to or Above the Cut-off Value in US Sub-cohort of Pooled MMR Groups
88.9; 87.4
SECONDARY
Anti-HAV Antibody Concentrations in US Sub-cohort of Pooled MMR Groups
42.0; 42.4
SECONDARY
Anti-S.Pneumoniae Antibody Concentration in US Sub-cohort of Pooled MMR Groups
2.257; 2.425; 0.506; 0.496; 1.618; 1.872
SECONDARY
Number of Subjects With Any Solicited Local Adverse Events (AEs)
331; 315; 273; 919; 349; 296
SECONDARY
Number of Subjects With Any Solicited General AEs
533; 535; 533; 1601; 586; 764
SECONDARY
Number of Subjects Reporting Any Fever
404; 422; 418; 1244; 412
SECONDARY
Number of Subjects Reporting Any Rash
352; 331; 360; 1043; 378; 106
SECONDARY
Number of Subjects Reporting Any MMR Specific Solicited AEs
4; 1; 5; 10; 3; 0
SECONDARY
Number of Subjects Reporting Any Unsolicited AEs
615; 633; 609; 1857; 618
SECONDARY
Number of Subjects Reporting AEs of Specific Interest
40; 39; 49; 128; 48; 123
SECONDARY
Number of Subjects Reporting Any Serious Adverse Events (SAEs)
21; 28; 28; 77; 25

Summary

The purpose of this study is to evaluate consistency in terms of the immune response to three different lots of GSK Biologicals' trivalent MMR vaccine manufactured to target potencies, and compare its immunogenicity to Merck & Co., Inc.'s MMR vaccine, which is approved for use in the United States (US).

Eligibility 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 only (i.e., no doses given as Prevnar/Prevenar), with the 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 (i.e., 30 days prior to Day 0) 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.
  • For corticosteroids, this will mean prednisone, ≥0.5 mg/kg/day or equivalent.
  • 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. Please Note:
  • Inactivated influenza (Flu) vaccine and Haemophilus influenzae type b conjugate vaccine (Hib) vaccines may be given at any time, including the day of study vaccination (Flu and Hib vaccines must be administered at a different location than the study vaccine/s).
  • Any other age appropriate vaccine may be given starting at Visit 2 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.
  • History of measles, mumps, rubella, varicella/zoster and/or hepatitis A disease.
  • Known exposure to measles, mumps, rubella and/or varicella/zoster during the period starting within 30 days prior to 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. 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:

  • Child that previously received a vaccination with heptavalent Prevnar/Prevenar (prior vaccination should be with 3 doses of Prevnar 13 only).
  • Child that previously received a fourth dose of any pneumococcal conjugate vaccine.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01702428). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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