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Trial record 2 of 19 for:    pediarix gsk

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03207750
Recruitment Status : Completed
First Posted : July 5, 2017
Results First Posted : October 31, 2019
Last Update Posted : December 29, 2020
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
The purpose of this study is to assess if there is any immune interference between the Porcine circovirus free (PCV-free) liquid Human rotavirus (HRV) vaccine and routine infant vaccinations currently in use in the US, namely Pediarix®, Hiberix® and Prevenar 13® as compared to the currently licensed lyophilized formulation of the HRV vaccine when co-administered with the same routine vaccinations in healthy infants 6-12 weeks of age

Condition or disease Intervention/treatment Phase
Rotavirus Infection Rotavirus Vaccines Biological: Rotarix Biological: Pediarix Biological: Hiberix Biological: Prevenar 13 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : September 14, 2017
Actual Primary Completion Date : October 9, 2018
Actual Study Completion Date : March 1, 2019

Resource links provided by the National Library of Medicine


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.
Biological: Rotarix
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:
  • GSK Biologicals' PCV-free liquid formulation of oral live attenuated HRV vaccine.
  • GSK Biologicals' lyophilized formulation of oral live attenuated HRV vaccine.

Biological: Pediarix
Three doses administered intramuscularly according to a 0, 2, 4 month schedule.
Other Names:
  • GSK Biologicals' Diphtheria and tetanus toxoids and acellular pertussis adsorbed
  • hepatitis B (recombinant) and inactivated poliovirus vaccine.

Biological: Hiberix
Three doses administered intramuscularly according to a 0, 2, 4 month schedule.
Other Name: GSK Biologicals' Haemophilus b conjugate vaccine (tetanus toxoid conjugate)

Biological: Prevenar 13
Three doses administered intramuscularly according to a 0, 2, 4 month schedule.
Other Name: Pfizer's Pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 Protein)

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).
Biological: Rotarix
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:
  • GSK Biologicals' PCV-free liquid formulation of oral live attenuated HRV vaccine.
  • GSK Biologicals' lyophilized formulation of oral live attenuated HRV vaccine.

Biological: Pediarix
Three doses administered intramuscularly according to a 0, 2, 4 month schedule.
Other Names:
  • GSK Biologicals' Diphtheria and tetanus toxoids and acellular pertussis adsorbed
  • hepatitis B (recombinant) and inactivated poliovirus vaccine.

Biological: Hiberix
Three doses administered intramuscularly according to a 0, 2, 4 month schedule.
Other Name: GSK Biologicals' Haemophilus b conjugate vaccine (tetanus toxoid conjugate)

Biological: Prevenar 13
Three doses administered intramuscularly according to a 0, 2, 4 month schedule.
Other Name: Pfizer's Pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 Protein)




Primary Outcome Measures :
  1. 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.

  2. 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) ]
    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).

  3. 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).

  4. 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.

  5. 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) ]
    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.

  6. 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) ]
    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.

  7. 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.

  8. 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).


Secondary Outcome Measures :
  1. 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) ]
    Immunogenicity was assessed in terms of seropositivity against Rota virus IgA antibodies. The cut off used was ≥ 20 U/mL.

  2. 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) ]
    Immunogenicity was assessed in terms of seropositivity against Rota virus IgA antibodies. The cut off used was ≥ 90 U/mL.

  3. 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.


  4. 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.

  5. 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.

  6. 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.

  7. Immunogenicity in Terms of Anti-HBs Antibody Concentrations. [ Time Frame: At Month 5 (One month after Dose 3 of co-administered vaccines) ]
    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.

  8. 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).

  9. 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

  10. Number of Subjects With Any Unsolicited AEs. [ Time Frame: During the 31-day (Days 1-31) follow-up period after each HRV vaccination. ]
    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.

  11. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Weeks to 12 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03207750


Locations
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United States, Alabama
GSK Investigational Site
Birmingham, Alabama, United States, 35205
United States, Arkansas
GSK Investigational Site
Fayetteville, Arkansas, United States, 72703
GSK Investigational Site
Jonesboro, Arkansas, United States, 72401
United States, California
GSK Investigational Site
Daly City, California, United States, 94015
GSK Investigational Site
Oakland, California, United States, 94611
GSK Investigational Site
Walnut Creek, California, United States, 94596
GSK Investigational Site
West Covina, California, United States, 91790
United States, Colorado
GSK Investigational Site
Colorado Springs, Colorado, United States, 80922
United States, Florida
GSK Investigational Site
Altamonte Springs, Florida, United States, 32701
GSK Investigational Site
Boynton Beach, Florida, United States, 33435
GSK Investigational Site
Miami, Florida, United States, 33142
GSK Investigational Site
Tampa, Florida, United States, 33617
United States, Idaho
GSK Investigational Site
Nampa, Idaho, United States, 83686
United States, Kentucky
GSK Investigational Site
Bardstown, Kentucky, United States, 40004
GSK Investigational Site
Louisville, Kentucky, United States, 40202
United States, Maryland
GSK Investigational Site
Frederick, Maryland, United States, 21702
United States, Massachusetts
GSK Investigational Site
Fall River, Massachusetts, United States, 02721
United States, Michigan
GSK Investigational Site
Bingham Farms, Michigan, United States, 48025
United States, Nebraska
GSK Investigational Site
Lincoln, Nebraska, United States, 68504
GSK Investigational Site
Lincoln, Nebraska, United States, 68505
GSK Investigational Site
Lincoln, Nebraska, United States, 68522
United States, New York
GSK Investigational Site
Bronx, New York, United States, 10468
GSK Investigational Site
Syracuse, New York, United States, 13202
United States, North Carolina
GSK Investigational Site
Boone, North Carolina, United States, 28607
GSK Investigational Site
Raleigh, North Carolina, United States, 27609
United States, Ohio
GSK Investigational Site
Cleveland, Ohio, United States, 44121
GSK Investigational Site
Dayton, Ohio, United States, 45406
GSK Investigational Site
Dayton, Ohio, United States, 45414
GSK Investigational Site
Dayton, Ohio, United States, 45419
GSK Investigational Site
Grove City, Ohio, United States, 43123
United States, Pennsylvania
GSK Investigational Site
Hermitage, Pennsylvania, United States, 16148
United States, South Carolina
GSK Investigational Site
Charleston, South Carolina, United States, 29407
GSK Investigational Site
North Charleston, South Carolina, United States, 29406-9170
United States, Tennessee
GSK Investigational Site
Kingsport, Tennessee, United States, 37660
United States, Texas
GSK Investigational Site
Fort Worth, Texas, United States, 76107
GSK Investigational Site
Galveston, Texas, United States, 77555
GSK Investigational Site
Tomball, Texas, United States, 77375
United States, Utah
GSK Investigational Site
Kaysville, Utah, United States, 84037
GSK Investigational Site
Layton, Utah, United States, 84041
GSK Investigational Site
Murray, Utah, United States, 84107
GSK Investigational Site
Orem, Utah, United States, 84057
GSK Investigational Site
Provo, Utah, United States, 84604
GSK Investigational Site
Roy, Utah, United States, 84067
GSK Investigational Site
South Jordan, Utah, United States, 84095
GSK Investigational Site
Syracuse, Utah, United States, 84075
United States, Virginia
GSK Investigational Site
Charlottesville, Virginia, United States, 22902
United States, Wisconsin
GSK Investigational Site
Marshfield, Wisconsin, United States, 54449
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
  Study Documents (Full-Text)

Documents provided by GlaxoSmithKline:
Study Protocol  [PDF] October 27, 2016
Statistical Analysis Plan  [PDF] August 1, 2017

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03207750    
Other Study ID Numbers: 201663
2016-003210-27 ( EudraCT Number )
First Posted: July 5, 2017    Key Record Dates
Results First Posted: October 31, 2019
Last Update Posted: December 29, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD for this study is available via the Clinical Study Data Request site.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: IPD is available via the Clinical Study Data Request site (copy the URL below to your browser)
Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
URL: https://www.clinicalstudydatarequest.com/Posting.aspx?ID=20750

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GlaxoSmithKline:
Immunogenicity
lyophilized formulation
United States
Reactogenicity
Safety
Porcine circovirus -free
Human rotavirus vaccine
liquid formulation
Healthy infants
Additional relevant MeSH terms:
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Rotavirus Infections
Reoviridae Infections
RNA Virus Infections
Virus Diseases
Infections
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs