- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03207750
This Study Will Evaluate the Immunogenicity, Reactogenicity and Safety of the Routine Infant Vaccines Pediarix®, Hiberix® and Prevenar 13® When Co-administered With GlaxoSmithKline (GSK) Biologicals' Liquid Human Rotavirus Vaccine (HRV) as Compared to GSK's Licensed Lyophilized Vaccine
Immunogenicity, Reactogenicity and Safety Study of Pediarix®, Hiberix® and Prevenar 13® Co-administered With Two Different Formulations of GSK Biologicals' HRV Vaccine (444563) in Healthy Infants 6-12 Weeks of Age
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35205
- GSK Investigational Site
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Arkansas
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Fayetteville, Arkansas, United States, 72703
- GSK Investigational Site
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Jonesboro, Arkansas, United States, 72401
- GSK Investigational Site
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California
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Daly City, California, United States, 94015
- GSK Investigational Site
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Oakland, California, United States, 94611
- GSK Investigational Site
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Walnut Creek, California, United States, 94596
- GSK Investigational Site
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West Covina, California, United States, 91790
- GSK Investigational Site
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Colorado
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Colorado Springs, Colorado, United States, 80922
- GSK Investigational Site
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Florida
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Altamonte Springs, Florida, United States, 32701
- GSK Investigational Site
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Boynton Beach, Florida, United States, 33435
- GSK Investigational Site
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Miami, Florida, United States, 33142
- GSK Investigational Site
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Tampa, Florida, United States, 33617
- GSK Investigational Site
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Idaho
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Nampa, Idaho, United States, 83686
- GSK Investigational Site
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Kentucky
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Bardstown, Kentucky, United States, 40004
- GSK Investigational Site
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Louisville, Kentucky, United States, 40202
- GSK Investigational Site
-
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Maryland
-
Frederick, Maryland, United States, 21702
- GSK Investigational Site
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Massachusetts
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Fall River, Massachusetts, United States, 02721
- GSK Investigational Site
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Michigan
-
Bingham Farms, Michigan, United States, 48025
- GSK Investigational Site
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Nebraska
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Lincoln, Nebraska, United States, 68505
- GSK Investigational Site
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Lincoln, Nebraska, United States, 68504
- GSK Investigational Site
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Lincoln, Nebraska, United States, 68522
- GSK Investigational Site
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New York
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Bronx, New York, United States, 10468
- GSK Investigational Site
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Syracuse, New York, United States, 13202
- GSK Investigational Site
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North Carolina
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Boone, North Carolina, United States, 28607
- GSK Investigational Site
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Raleigh, North Carolina, United States, 27609
- GSK Investigational Site
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Ohio
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Cleveland, Ohio, United States, 44121
- GSK Investigational Site
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Dayton, Ohio, United States, 45414
- GSK Investigational Site
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Dayton, Ohio, United States, 45419
- GSK Investigational Site
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Dayton, Ohio, United States, 45406
- GSK Investigational Site
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Grove City, Ohio, United States, 43123
- GSK Investigational Site
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Pennsylvania
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Hermitage, Pennsylvania, United States, 16148
- GSK Investigational Site
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South Carolina
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Charleston, South Carolina, United States, 29407
- GSK Investigational Site
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North Charleston, South Carolina, United States, 29406-9170
- GSK Investigational Site
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Tennessee
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Kingsport, Tennessee, United States, 37660
- GSK Investigational Site
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Texas
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Fort Worth, Texas, United States, 76107
- GSK Investigational Site
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Galveston, Texas, United States, 77555
- GSK Investigational Site
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Tomball, Texas, United States, 77375
- GSK Investigational Site
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Utah
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Kaysville, Utah, United States, 84037
- GSK Investigational Site
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Layton, Utah, United States, 84041
- GSK Investigational Site
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Murray, Utah, United States, 84107
- GSK Investigational Site
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Orem, Utah, United States, 84057
- GSK Investigational Site
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Provo, Utah, United States, 84604
- GSK Investigational Site
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Roy, Utah, United States, 84067
- GSK Investigational Site
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South Jordan, Utah, United States, 84095
- GSK Investigational Site
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Syracuse, Utah, United States, 84075
- GSK Investigational Site
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Virginia
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Charlottesville, Virginia, United States, 22902
- GSK Investigational Site
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Wisconsin
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Marshfield, Wisconsin, United States, 54449
- GSK Investigational Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subjects' parent(s)/[LAR(s)] who, in the opinion of the investigator can and will comply with the requirements of the protocol.
- A male or female between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination.
- Written or witnessed/thumb printed informed consent obtained from the parent(s)/LAR(s) of the subject prior to performing any study specific procedure.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
Exclusion Criteria:
- Child in care.
- Use of any investigational or non-registered product other than the study vaccines during the period starting 30 days before the first dose of study vaccines (Day-29 to Day 1), or planned use during the study period.
- Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone (≥0.5 mg/kg/day, or equivalent). Inhaled and topical steroids are allowed.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- Administration of long-acting immune-modifying drugs at any time during the study period.
- Planned administration/administration of a vaccine not foreseen by the study protocol within the period starting 30 days before the first dose of vaccine administration and ending at Visit 4, with the exception of the inactivated influenza vaccine, which is allowed at any time during the study, if administered at a site which is different from the sites used to administer the co-administered vaccines.
- 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 vaccine/product.
- Uncorrected congenital malformation of the gastrointestinal tract that would predispose for Intussusception (IS).
- History of IS.
- Very prematurely born infants (born ≤28 weeks of gestation).
- Family history of congenital or hereditary immunodeficiency.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- Major congenital defects or serious chronic illness.
- Previous vaccination against Haemophilus type b (Hib), diphtheria, tetanus, pertussis, pneumococcus, RV and/or poliovirus.
- Previous confirmed occurrence of RV GE, Hib, diphtheria, tetanus, pertussis, pneumococcus, hepatitis B and/or polio disease.
- Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
- GE within 7 days preceding the study vaccine administration.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
- Hypersensitivity to latex.
- History of any neurological disorders or seizures.
- History of Severe combined immunodeficiency (SCID).
Acute disease and/or fever at the time of enrolment.
- Fever is defined as temperature ≥38.0°C/100.4°F. The preferred location for measuring temperature in this study will be the oral cavity, the axilla and the rectum.
- Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: HRV PCV-free Liq Group
Healthy female or male subjects, between and including 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in PCV-free liquid formulation, according to a 0, 2-month schedule, co-administered with one dose of each Pediarix, Hiberix and Prevnar-13 at three timepoints (day 1, month 2 and month 4).
PCV-free implies no detection of PCV-1 and PCV-2 according to the limit of detection of the tests used.
|
Two doses administered orally according to a 0, 2 month schedule as per the immunization schedule for HRV vaccine administration in the US.
Other Names:
Three doses administered intramuscularly according to a 0, 2, 4 month schedule.
Other Names:
Three doses administered intramuscularly according to a 0, 2, 4 month schedule.
Other Names:
Three doses administered intramuscularly according to a 0, 2, 4 month schedule.
Other Names:
|
ACTIVE_COMPARATOR: HRV Lyo Group
Healthy female or male subjects, between and including 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in lyophilized formulation, according to a 0, 2-month schedule, co-administered with one dose of each Pediarix, Hiberix and Prevnar-13 at three timepoints (day 1, month 2 and month 4).
|
Two doses administered orally according to a 0, 2 month schedule as per the immunization schedule for HRV vaccine administration in the US.
Other Names:
Three doses administered intramuscularly according to a 0, 2, 4 month schedule.
Other Names:
Three doses administered intramuscularly according to a 0, 2, 4 month schedule.
Other Names:
Three doses administered intramuscularly according to a 0, 2, 4 month schedule.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Seroprotected Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations Above or Equal to Cut-off Value.
Time Frame: At Month 5 (One month after Dose 3 of co-administered vaccines)
|
Immunogenicity was assessed using Enzyme Linked Immunosorbent Assay (ELISA) in terms of seroprotection rates against diphtheria toxoid.
A seroprotected subject is a subject whose antibody concentration is greater than or equal to (≥) the level defining clinical protection.
The following seroprotection thresholds were applicable:anti-D antibody concentrations ≥ 0.1 International Units/milliliter (IU/mL), anti-T antibody concentrations ≥ 0.1 IU/mL.
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At Month 5 (One month after Dose 3 of co-administered vaccines)
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Number of Seroprotected Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations Above or Equal to Cut-off Value.
Time Frame: At Month 5 (One month after Dose 3 of co-administered vaccines)
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Immunogenicity was assessed using ChemiLuminescence ImmunoAssay (CLIA) in terms of seroprotection rates against Hepatitis B. A seroprotected subject is a subject whose antibody concentration is ≥ the level defining clinical protection.
The following seroprotection thresholds were applicable:anti-HB antibody concentrations ≥ 10 milli International Units/milliliter (mIU/mL).
|
At Month 5 (One month after Dose 3 of co-administered vaccines)
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Number of Seroprotected Subjects With Anti-polio Virus Types 1, 2 and 3 Antibody Titers Above or Equal to Cut-off Value.
Time Frame: At Month 5 (One month after Dose 3 of co-administered vaccines)
|
Immunogenicity was assessed using virus micro-neutralization test in terms of seroprotection rates against polio virus types 1, 2 and 3. A seroprotected subject is a subject whose antibody concentration is ≥ the level defining clinical protection.
The following seroprotection thresholds were applicable:anti-polio virus types 1, 2 and 3 types antibody titers ≥ 8 Estimated Dose 50% (ED50).
|
At Month 5 (One month after Dose 3 of co-administered vaccines)
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Immunogenicity in Terms of Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations.
Time Frame: At Month 5 (One month after Dose 3 of co-administered vaccines)
|
Antibody concentrations against PT, FHA and PRN were determined and expressed as Geometric Mean Concentrations (GMCs).The GMC calculations were performed by taking the anti-log of the mean of the log concentration transformations.
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At Month 5 (One month after Dose 3 of co-administered vaccines)
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Immunogenicity in Terms of Anti-pneumococcal Serotypes (Anti-PnPS) Antibody Concentrations.
Time Frame: At Month 5 (One month after Dose 3 of co-administered vaccines)
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Antibody concentrations against pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) were determined and expressed as GMCs in micrograms per milliliter (µg/mL).The GMC calculations were performed by taking the anti-log of the mean of the log concentration transformations.
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At Month 5 (One month after Dose 3 of co-administered vaccines)
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Number of Seroprotected Subjects With Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibody Concentrations Above or Equal to Cut-off Value of 0.15 µg/mL.
Time Frame: At Month 5 (One month after Dose 3 of co-administered vaccines)
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Immunogenicity was assessed in terms of seroprotection rates against PRP antibodies.
A seroprotected subject is a subject whose antibody concentration is ≥ the level defining clinical protection.
The following seroprotection thresholds were applicable:anti-PRP antibody concentrations ≥ 0.15 µg/mL.
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At Month 5 (One month after Dose 3 of co-administered vaccines)
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Number of Seroprotected Subjects With Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibody Concentrations Above or Equal to Cut-off Value of 1.0 µg/mL.
Time Frame: At Month 5 (One month after Dose 3 of co-administered vaccines)
|
Immunogenicity was assessed in terms of seroprotection rates against PRP antibodies.
A seroprotected subject is a subject whose antibody concentration is ≥ the level defining clinical protection.
The following seroprotection thresholds were applicable:anti-PRP antibody concentrations ≥ 1.0 µg/mL.
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At Month 5 (One month after Dose 3 of co-administered vaccines)
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Number of Subjects With Seroresponse to Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies.
Time Frame: At Month 5 (One month after Dose 3 of co-administered vaccines)
|
Seroresponse is defined as the percentage of subjects showing an antibody concentration above a threshold that leads to 95% seroresponse in the HRV lyophilized Group.
The cut-offs used were as follows: anti-PT (18.566
IU/mL), anti-FHA (35.711
IU/mL) and anti-PRN (11.034
IU/mL).
|
At Month 5 (One month after Dose 3 of co-administered vaccines)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Seropositive Subjects With Anti-Rota Virus Immunoglobulin A (Anti-RV IgA) Antibody Concentrations Above or Equal to Cut-off Value of 20 Units/Milliliter (U/mL).
Time Frame: At Month 5 (Three months after Dose 2 of HRV vaccine)
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Immunogenicity was assessed in terms of seropositivity against Rota virus IgA antibodies.
The cut off used was ≥ 20 U/mL.
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At Month 5 (Three months after Dose 2 of HRV vaccine)
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Number of Seropositive Subjects With Anti-RV IgA Antibody Concentrations Above or Equal to Cut-off Value of 90 U/mL.
Time Frame: At Month 5 (Three months after Dose 2 of HRV vaccine)
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Immunogenicity was assessed in terms of seropositivity against Rota virus IgA antibodies.
The cut off used was ≥ 90 U/mL.
|
At Month 5 (Three months after Dose 2 of HRV vaccine)
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Number of Seropositive Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Above or Equal to Cut-off Value.
Time Frame: At Month 5 (One month after Dose 3 of co-administered vaccines)
|
Immunogenicity was assessed using ELISA technique in terms of seropositivity against PT, FHA and PRN antibodies. The cut-offs for antibodies were the Lower Limit Of Quantification (LLOQ) of the assays which were ≥ 2.693 IU/mL (anti-PT), ≥ 2.046 IU/mL (anti-FHA) and ≥ 2.187 IU/mL (anti-PRN). The Limit of Quantification is the lowest analyte concentration that can be quantitatively detected with a stated accuracy and precision, and LLOQ is the lowest standard curve point obtained by extrapolation, that can still be used for quantification. |
At Month 5 (One month after Dose 3 of co-administered vaccines)
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Number of Seropositive Subjects With Anti-PnPS Antibody Concentrations Above or Equal to Cut-off Value.
Time Frame: At Month 5 (One month after Dose 3 of co-administered vaccines)
|
Immunogenicity was assessed using ELISA technique in terms of seropositivity against Pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) antibodies.
The cut-off used was ≥ 0.35 µg/mL.
|
At Month 5 (One month after Dose 3 of co-administered vaccines)
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Immunogenicity in Terms of Anti-D and Anti-T Antibody Concentrations.
Time Frame: At Month 5 (One month after Dose 3 of co-administered vaccines)
|
Antibody concentrations against diphtheria and tetanus were determined and expressed as GMCs.
The GMC calculations were performed by taking the anti-log of the mean of the log concentration transformations.
|
At Month 5 (One month after Dose 3 of co-administered vaccines)
|
Immunogenicity in Terms of Anti-PRP Antibody Concentrations.
Time Frame: At Month 5 (One month after Dose 3 of co-administered vaccines)
|
Antibody concentrations against PRP were determined and expressed as GMCs.
The GMC calculations were performed by taking the anti-log of the mean of the log concentration transformations.
|
At Month 5 (One month after Dose 3 of co-administered vaccines)
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Immunogenicity in Terms of Anti-HBs Antibody Concentrations.
Time Frame: At Month 5 (One month after Dose 3 of co-administered vaccines)
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Antibody concentrations against Hepatitis B were determined and expressed as GMCs.
The GMC calculations were performed by taking the anti-log of the mean of the log concentration transformations.
|
At Month 5 (One month after Dose 3 of co-administered vaccines)
|
Immunogenicity in Terms of Anti-poliovirus Types 1, 2 and 3 Antibody Titers.
Time Frame: At Month 5 (One month after Dose 3 of co-administered vaccines)
|
Antibody concentrations against Poliovirus types 1, 2 and 3 were determined and expressed as Geometric Mean Titers (GMTs).
|
At Month 5 (One month after Dose 3 of co-administered vaccines)
|
Number of Subjects With Any Solicited General Adverse Events (AEs).
Time Frame: During the 8-day (Days 1-8) follow-up period after each HRV vaccination.
|
Assessed solicited general AEs were cough/runny nose; diarrhoea; fever measured by 3 routes which were oral, axillary and rectal, defined as temperature ≥ 38.0 degrees Celsius (°C); irritability; loss of appetite and vomiting.
Any = any solicited general AE irrespective of its intensity grade and relationship to vaccination
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During the 8-day (Days 1-8) follow-up period after each HRV vaccination.
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Number of Subjects With Any Unsolicited AEs.
Time Frame: During the 31-day (Days 1-31) follow-up period after each HRV vaccination.
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Unsolicited AEs assessed include any AE reported in addition to those solicited during the clinical study.
Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms were reported as an unsolicited AE.
Any= Any unsolicited AE irrespective of its intensity grade and relationship to vaccination.
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During the 31-day (Days 1-31) follow-up period after each HRV vaccination.
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Number of Subjects With Any Serious Adverse Events (SAEs).
Time Frame: During the entire study period (Day 1 to Month 10)
|
SAEs assessed include any untoward medical occurrence that resulted in death, were life-threatening, required hospitalization or prolongation of existing hospitalization or resulted in disability/incapacity.
|
During the entire study period (Day 1 to Month 10)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201663
- 2016-003210-27 (EUDRACT_NUMBER)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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