Phase 3
N=4,007
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
Bottom Line
View on ClinicalTrials.gov: NCT01621802 ↗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
| Outcome | Result | p-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
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.