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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

NCT ID: NCT03207750

Last Updated: 2020-12-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-14

Study Completion Date

2019-03-01

Brief Summary

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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

Detailed Description

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Conditions

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Rotavirus Infection Rotavirus Vaccines

Keywords

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Immunogenicity lyophilized formulation United States Reactogenicity Safety Porcine circovirus -free Human rotavirus vaccine liquid formulation Healthy infants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Rotarix

Intervention Type BIOLOGICAL

Two doses administered orally according to a 0, 2 month schedule as per the immunization schedule for HRV vaccine administration in the US.

Pediarix

Intervention Type BIOLOGICAL

Three doses administered intramuscularly according to a 0, 2, 4 month schedule.

Hiberix

Intervention Type BIOLOGICAL

Three doses administered intramuscularly according to a 0, 2, 4 month schedule.

Prevenar 13

Intervention Type BIOLOGICAL

Three doses administered intramuscularly according to a 0, 2, 4 month schedule.

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).

Group Type ACTIVE_COMPARATOR

Rotarix

Intervention Type BIOLOGICAL

Two doses administered orally according to a 0, 2 month schedule as per the immunization schedule for HRV vaccine administration in the US.

Pediarix

Intervention Type BIOLOGICAL

Three doses administered intramuscularly according to a 0, 2, 4 month schedule.

Hiberix

Intervention Type BIOLOGICAL

Three doses administered intramuscularly according to a 0, 2, 4 month schedule.

Prevenar 13

Intervention Type BIOLOGICAL

Three doses administered intramuscularly according to a 0, 2, 4 month schedule.

Interventions

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Rotarix

Two doses administered orally according to a 0, 2 month schedule as per the immunization schedule for HRV vaccine administration in the US.

Intervention Type BIOLOGICAL

Pediarix

Three doses administered intramuscularly according to a 0, 2, 4 month schedule.

Intervention Type BIOLOGICAL

Hiberix

Three doses administered intramuscularly according to a 0, 2, 4 month schedule.

Intervention Type BIOLOGICAL

Prevenar 13

Three doses administered intramuscularly according to a 0, 2, 4 month schedule.

Intervention Type BIOLOGICAL

Other Intervention Names

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GSK Biologicals' PCV-free liquid formulation of oral live attenuated HRV vaccine. GSK Biologicals' lyophilized formulation of oral live attenuated HRV vaccine. GSK Biologicals' Diphtheria and tetanus toxoids and acellular pertussis adsorbed hepatitis B (recombinant) and inactivated poliovirus vaccine. GSK Biologicals' Haemophilus b conjugate vaccine (tetanus toxoid conjugate) Pfizer's Pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 Protein)

Eligibility Criteria

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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.
Minimum Eligible Age

6 Weeks

Maximum Eligible Age

12 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Birmingham, Alabama, United States

Site Status

GSK Investigational Site

Fayetteville, Arkansas, United States

Site Status

GSK Investigational Site

Jonesboro, Arkansas, United States

Site Status

GSK Investigational Site

Daly City, California, United States

Site Status

GSK Investigational Site

Oakland, California, United States

Site Status

GSK Investigational Site

Walnut Creek, California, United States

Site Status

GSK Investigational Site

West Covina, California, United States

Site Status

GSK Investigational Site

Colorado Springs, Colorado, United States

Site Status

GSK Investigational Site

Altamonte Springs, Florida, United States

Site Status

GSK Investigational Site

Boynton Beach, Florida, United States

Site Status

GSK Investigational Site

Miami, Florida, United States

Site Status

GSK Investigational Site

Tampa, Florida, United States

Site Status

GSK Investigational Site

Nampa, Idaho, United States

Site Status

GSK Investigational Site

Bardstown, Kentucky, United States

Site Status

GSK Investigational Site

Louisville, Kentucky, United States

Site Status

GSK Investigational Site

Frederick, Maryland, United States

Site Status

GSK Investigational Site

Fall River, Massachusetts, United States

Site Status

GSK Investigational Site

Bingham Farms, Michigan, United States

Site Status

GSK Investigational Site

Lincoln, Nebraska, United States

Site Status

GSK Investigational Site

Lincoln, Nebraska, United States

Site Status

GSK Investigational Site

Lincoln, Nebraska, United States

Site Status

GSK Investigational Site

Syracuse, New York, United States

Site Status

GSK Investigational Site

The Bronx, New York, United States

Site Status

GSK Investigational Site

Boone, North Carolina, United States

Site Status

GSK Investigational Site

Raleigh, North Carolina, United States

Site Status

GSK Investigational Site

Cleveland, Ohio, United States

Site Status

GSK Investigational Site

Dayton, Ohio, United States

Site Status

GSK Investigational Site

Dayton, Ohio, United States

Site Status

GSK Investigational Site

Dayton, Ohio, United States

Site Status

GSK Investigational Site

Grove City, Ohio, United States

Site Status

GSK Investigational Site

Hermitage, Pennsylvania, United States

Site Status

GSK Investigational Site

Charleston, South Carolina, United States

Site Status

GSK Investigational Site

North Charleston, South Carolina, United States

Site Status

GSK Investigational Site

Kingsport, Tennessee, United States

Site Status

GSK Investigational Site

Fort Worth, Texas, United States

Site Status

GSK Investigational Site

Galveston, Texas, United States

Site Status

GSK Investigational Site

Tomball, Texas, United States

Site Status

GSK Investigational Site

Kaysville, Utah, United States

Site Status

GSK Investigational Site

Layton, Utah, United States

Site Status

GSK Investigational Site

Murray, Utah, United States

Site Status

GSK Investigational Site

Orem, Utah, United States

Site Status

GSK Investigational Site

Provo, Utah, United States

Site Status

GSK Investigational Site

Roy, Utah, United States

Site Status

GSK Investigational Site

South Jordan, Utah, United States

Site Status

GSK Investigational Site

Syracuse, Utah, United States

Site Status

GSK Investigational Site

Charlottesville, Virginia, United States

Site Status

GSK Investigational Site

Marshfield, Wisconsin, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2016-003210-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

201663

Identifier Type: -

Identifier Source: org_study_id