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Phase 3 N=4,007 Randomized Quadruple-blind Prevention

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

Measles-Mumps-Rubella

Enrolled (actual)
4,007
Serious AEs
1.3%
Results posted
Sep 2017
Primary outcome: Primary: Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value — 697; 249; 736; 281 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Priorix (Biological); M-M-R II (Biological); Kinrix (Biological); ProQuad (Biological)
Age
Pediatric · 4+ yrs
Sex
All
Sponsor
GlaxoSmithKline
Primary completion
Jul 2015

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value
697; 249; 736; 281
PRIMARY
Number of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value
698; 250; 736; 283
PRIMARY
Number of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value
696; 249; 736; 283
PRIMARY
Evaluation of Immunogenicity in Terms of Anti-measles Virus Antibody Concentrations
4335.0; 4215.6; 3646.6; 3503.9
PRIMARY
Evaluation of Immunogenicity in Terms of Anti-mumps Virus Antibody Concentrations
170.5; 190.1; 167.2; 176.2
PRIMARY
Evaluation of Immunogenicity in Terms of Anti-rubella Virus Antibody Concentrations
96.4; 96.0; 98.9; 98.7
SECONDARY
Number of Subjects With Anti-varicella Zoster Virus (VZV) Antibody Concentration Equal to or Above the Cut-off-value
693; 247
SECONDARY
Evaluation of Immunogenicity in Terms of Anti-VZV Antibody Concentrations
887.7; 820.4
SECONDARY
Number of Subjects With Antibody Booster Response to Diphtheria Toxin (Anti-D) and Tetanus Toxin (Anti-T)
657; 233; 621; 224
SECONDARY
Number of Subjects With Antibody Booster Response to Pertussis Toxin (PT)
643; 225
SECONDARY
Number of Subjects With Antibody Booster Response to Filamentous Hemagglutinin (FHA)
620; 221
SECONDARY
Number of Subjects With Antibody Booster Response to Pertactin (PRN)
657; 233
SECONDARY
Evaluation of Immunogenicity in Terms of Anti-D and Anti-T Antibody Concentrations
17.2; 17.8; 7.4; 8.4
SECONDARY
Evaluation of Immunogenicity in Terms of Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
76.6; 73.9; 316.2; 319.3; 402.2; 427.3
SECONDARY
Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL
684; 243; 684; 243
SECONDARY
Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 1.0 IU/mL
683; 242; 678; 243
SECONDARY
Evaluation of Immunogenicity in Terms of Anti-polio Virus Types 1, 2 and 3 Antibody Titers
1618.7; 1587.3; 2026.4; 2206.1; 2753.5; 3040.6
SECONDARY
Number of Subjects With Solicited Local Symptoms
295; 109; 152; 64; 278; 123
SECONDARY
Number of Subjects With Solicited General Symptoms
199; 72; 10; 3; 180; 63
SECONDARY
Number of Subjects Reporting Fever
177; 67; 146; 58; 257; 96
SECONDARY
Number of Subjects Reporting MMR Specific Solicited General Symptoms
0; 2; 1; 0; 0; 0
SECONDARY
Number of Subjects Reporting Investigator-confirmed Rash
61; 28; 37; 12; 56; 23
SECONDARY
Number of Subjects With New Onset Chronic Diseases (NOCDs)
8; 4; 6; 0; 11; 3
SECONDARY
Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits
61; 29; 64; 22; 102; 36
SECONDARY
Number of Subjects With Unsolicited Adverse Events (AEs)
276; 90; 314; 112; 508; 186
SECONDARY
Number of Subjects With Serious Adverse Events (SAEs)
4; 0; 14; 1; 25; 9

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.

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 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/z
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01621802). 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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