Rotavirus InfectionPhase 3NCT03207750

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

A Phase 3 study testing Rotarix, Pediarix and Hiberix in people with Rotavirus Infection and Rotavirus Vaccines, run by GlaxoSmithKline at 47 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 6 to 12 weeksHealthy volunteers can take part
Conditions the study is for: Rotavirus Infection, Rotavirus Vaccines
What is being tested?: Rotarix, Pediarix and Hiberix
Type of treatment: Vaccines, Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,280 participants
Where: 47 sitesUnited States
Study dates: 14 Sep 2017to 1 Mar 2019
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 to 12 weeks
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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.

Who cannot join

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.

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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.

Trial locations and contacts

47 sites in 1 country.

City, postcode or hospital

47 sites in 1 country

United States47 sites

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

Other trials in United States

About this study

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

Conditions: Rotavirus Infection, Rotavirus Vaccines
Being tested: Rotarix, Pediarix, Hiberix, Prevenar 13
Keywords: Immunogenicity, lyophilized formulation, United States, Reactogenicity, Safety, Porcine circovirus -free, Human rotavirus vaccine, liquid formulation, Healthy infants
Medical subject headings: Rotavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RotarixBiological
Also called GSK Biologicals' PCV-free liquid formulation of oral live attenuated HRV vaccine., GSK Biologicals' lyophilized formulation of oral live attenuated HRV vaccine.
Two doses administered orally according to a 0, 2 month schedule as per the immunization schedule for HRV vaccine administration in the US.
PediarixBiological
Also called GSK Biologicals' Diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B (recombinant) and inactivated poliovirus vaccine.
Three doses administered intramuscularly according to a 0, 2, 4 month schedule.
HiberixBiological
Also called GSK Biologicals' Haemophilus b conjugate vaccine (tetanus toxoid conjugate)
Three doses administered intramuscularly according to a 0, 2, 4 month schedule.
Prevenar 13Biological
Also called Pfizer's Pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 Protein)
Three doses administered intramuscularly according to a 0, 2, 4 month schedule.

Study groups in NCT03207750
Study group	Role	What they receive
HRV PCV-free Liq Group	Experimental	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. Receives: Biological: Rotarix; Biological: Pediarix; Biological: Hiberix; Biological: Prevenar 13
HRV Lyo Group	Active comparator	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). Receives: Biological: Rotarix; Biological: Pediarix; Biological: Hiberix; Biological: Prevenar 13

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Seroprotected Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations Above or Equal to Cut-off Value.
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.
Measured: At Month 5 (One month after Dose 3 of co-administered vaccines)
Number of Seroprotected Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations Above or Equal to Cut-off Value.
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).
Measured: At Month 5 (One month after Dose 3 of co-administered vaccines)
Number of Seroprotected Subjects With Anti-polio Virus Types 1, 2 and 3 Antibody Titers Above or Equal to Cut-off Value.
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).
Measured: At Month 5 (One month after Dose 3 of co-administered vaccines)
Immunogenicity in Terms of Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations.
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.
Measured: At Month 5 (One month after Dose 3 of co-administered vaccines)
Immunogenicity in Terms of Anti-pneumococcal Serotypes (Anti-PnPS) Antibody Concentrations.
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.
Measured: At Month 5 (One month after Dose 3 of co-administered vaccines)
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.
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.
Measured: At Month 5 (One month after Dose 3 of co-administered vaccines)
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.
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.
Measured: At Month 5 (One month after Dose 3 of co-administered vaccines)
Number of Subjects With Seroresponse to Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies.
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).
Measured: At Month 5 (One month after Dose 3 of co-administered vaccines)

Secondary outcomes (11)

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).
Immunogenicity was assessed in terms of seropositivity against Rota virus IgA antibodies. The cut off used was ≥ 20 U/mL.
Measured: At Month 5 (Three months after Dose 2 of HRV vaccine)
Number of Seropositive Subjects With Anti-RV IgA Antibody Concentrations Above or Equal to Cut-off Value of 90 U/mL.
Immunogenicity was assessed in terms of seropositivity against Rota virus IgA antibodies. The cut off used was ≥ 90 U/mL.
Measured: At Month 5 (Three months after Dose 2 of HRV vaccine)
Number of Seropositive Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Above or Equal to Cut-off Value.
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.
Measured: At Month 5 (One month after Dose 3 of co-administered vaccines)
Number of Seropositive Subjects With Anti-PnPS Antibody Concentrations Above or Equal to Cut-off Value.
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.
Measured: At Month 5 (One month after Dose 3 of co-administered vaccines)
Immunogenicity in Terms of Anti-D and Anti-T Antibody Concentrations.
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.
Measured: At Month 5 (One month after Dose 3 of co-administered vaccines)
Immunogenicity in Terms of Anti-PRP Antibody Concentrations.
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.
Measured: At Month 5 (One month after Dose 3 of co-administered vaccines)
Immunogenicity in Terms of Anti-HBs Antibody Concentrations.
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.
Measured: 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.
Antibody concentrations against Poliovirus types 1, 2 and 3 were determined and expressed as Geometric Mean Titers (GMTs).
Measured: At Month 5 (One month after Dose 3 of co-administered vaccines)
Number of Subjects With Any Solicited General Adverse Events (AEs).
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
Measured: During the 8-day (Days 1-8) follow-up period after each HRV vaccination.
Number of Subjects With Any Unsolicited AEs.
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.
Measured: During the 31-day (Days 1-31) follow-up period after each HRV vaccination.
Number of Subjects With Any Serious Adverse Events (SAEs).
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.
Measured: During the entire study period (Day 1 to Month 10)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Sep 20171 Mar 2019

First posted5 Jul 2017
Study start14 Sep 2017
Primary completion9 Oct 2018
Study completion1 Mar 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Rotavirus InfectionStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 1,280 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03207750
Sponsor's protocol ID: 201663
Other IDs: 2016-003210-27, 2016
Status last verified: Dec 2020
First submitted: 16 Jun 2017
Last updated: 29 Dec 2020
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: IPD for this study is available via the Clinical Study Data Request site.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Rotavirus Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03207750
Acronym / sponsor ID: 201663
Conditions: Rotavirus Infection, Rotavirus Vaccines
Keywords: Immunogenicity, lyophilized formulation, United States, Reactogenicity, Safety, Porcine circovirus -free, Human rotavirus vaccine, liquid formulation
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,280 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 14 Sep 2017 (actual)
Primary completion: 9 Oct 2018 (actual)
Study completion: 1 Mar 2019 (actual)
First posted: 5 Jul 2017 (actual)
Results: Posted 31 Oct 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
HRV PCV-free Liq Group	Experimental	Biological: Rotarix, Biological: Pediarix, Biological: Hiberix, Biological: Prevenar 13Healthy 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.
HRV Lyo Group	Active comparator	Biological: Rotarix, Biological: Pediarix, Biological: Hiberix, Biological: Prevenar 13Healthy 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).

Who may qualify

Ages: 6 to 12 weeks
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (24 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RotarixAlso: GSK Biologicals' PCV-free liquid formulation of oral live attenuated HRV vaccine., GSK Biologicals' lyophilized formulation of oral live attenuated HRV vaccine.Two doses administered orally according to a 0, 2 month schedule as per the immunization schedule for HRV vaccine administration in the US.	Biological	HRV Lyo Group, HRV PCV-free Liq Group
PediarixAlso: GSK Biologicals' Diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B (recombinant) and inactivated poliovirus vaccine.Three doses administered intramuscularly according to a 0, 2, 4 month schedule.	Biological	HRV Lyo Group, HRV PCV-free Liq Group
HiberixAlso: GSK Biologicals' Haemophilus b conjugate vaccine (tetanus toxoid conjugate)Three doses administered intramuscularly according to a 0, 2, 4 month schedule.	Biological	HRV Lyo Group, HRV PCV-free Liq Group
Prevenar 13Also: Pfizer's Pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 Protein)Three doses administered intramuscularly according to a 0, 2, 4 month schedule.	Biological	HRV Lyo Group, HRV PCV-free Liq Group

Primary outcome

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.
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).
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).
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.
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.
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.
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.
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).

11 secondary outcomes

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)
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)
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)
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 in Terms of Anti-D and Anti-T Antibody Concentrations.
Time frame: 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)
Immunogenicity in Terms of Anti-HBs Antibody Concentrations.
Time frame: 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)
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.
Number of Subjects With Any Unsolicited AEs.
Time frame: During the 31-day (Days 1-31) follow-up period after each HRV vaccination.
Number of Subjects With Any Serious Adverse Events (SAEs).
Time frame: During the entire study period (Day 1 to Month 10)

Results and safety

Results posted to the registry on 31 Oct 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
HRV Porcine Circovirus (PCV)-Free Liquid Group	632	574
HRV Lyophilized Group	640	574

Primary outcome: 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). Count of participants. Unit: Participants

Measure	HRV Porcine Circovirus (PCV)-Free Liquid Group n = 486	HRV Lyophilized Group n = 495
Anti-D	478	486
Anti-T	486	495

HRV Porcine Circovirus (PCV)-Free Liquid Group vs HRV Lyophilized Group: Difference in anti-D concentration: -0.00 (95% CI -0.80 to 0.79)
HRV Porcine Circovirus (PCV)-Free Liquid Group vs HRV Lyophilized Group: Difference in anti-T concentration: -0.00 (95% CI -0.79 to 0.77)

Population analysed: Analysis was performed on the Per protocol set (PPS) for immunogenicity which included all vaccinated subjects for whom immunogenicity data were available, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one routine infant vaccine antigen component.

Primary outcome: 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). Count of participants. Unit: Participants

Measure	HRV Porcine Circovirus (PCV)-Free Liquid Group n = 460	HRV Lyophilized Group n = 471
Value	457	471

HRV Porcine Circovirus (PCV)-Free Liquid Group vs HRV Lyophilized Group: Difference in anti-HB concentration: -0.65 (95% CI -1.90 to 0.16)

Population analysed: Analysis was performed on the PPS for immunogenicity which included all vaccinated subjects for whom immunogenicity data were available, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one routine infant vaccine antigen component.

Primary outcome: 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). Count of participants. Unit: Participants

Measure	HRV Porcine Circovirus (PCV)-Free Liquid Group n = 477	HRV Lyophilized Group n = 487
Anti-Polio 1	477	486
Anti-Polio 2	463	478
Anti-Polio 3	439	454

HRV Porcine Circovirus (PCV)-Free Liquid Group vs HRV Lyophilized Group: Difference in anti-polio 1 concentration: 0.21 (95% CI -0.60 to 1.15)
HRV Porcine Circovirus (PCV)-Free Liquid Group vs HRV Lyophilized Group: Difference in anti-polio 2 concentration: -0.01 (95% CI -1.02 to 0.98)
HRV Porcine Circovirus (PCV)-Free Liquid Group vs HRV Lyophilized Group: Difference in anti-polio 3 concentration: -0.00 (95% CI -0.87 to 0.84)

Primary outcome: 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). Geometric mean (95% Confidence Interval). Unit: IU/mL

Measure	HRV Porcine Circovirus (PCV)-Free Liquid Group n = 486	HRV Lyophilized Group n = 495
Anti-PT	51 (47.8 to 54.5)	54.2 (51.3 to 57.4)
Anti-FHA	107.3 (101.4 to 113.5)	107.7 (101.6 to 114.1)
Anti-PRN	55 (50.1 to 60.4)	56.6 (51.9 to 61.7)

HRV Porcine Circovirus (PCV)-Free Liquid Group vs HRV Lyophilized Group: GMC ratio: 0.94 (95% CI 0.86 to 1.03), ANOVA
HRV Porcine Circovirus (PCV)-Free Liquid Group vs HRV Lyophilized Group: GMC ratio: 1.00 (95% CI 0.92 to 1.08), ANOVA
HRV Porcine Circovirus (PCV)-Free Liquid Group vs HRV Lyophilized Group: GMC ratio: 0.97 (95% CI 0.86 to 1.10), ANOVA

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after each HRV vaccination. SAEs: Throughout the study period (Day 1 to Month 10).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
HRV Porcine Circovirus (PCV)-Free Liquid Group	20 of 632 (3.2%)	571 of 632 (90.3%)	1 of 632
HRV Lyophilized Group	19 of 640 (3%)	589 of 640 (92%)	0 of 640

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. IPD for this study is available via the Clinical Study Data Request site.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

47 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rotarix, Pediarix and Hiberix in people with Rotavirus Infection and Rotavirus Vaccines, run by GlaxoSmithKline at 47 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 47 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03207750.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2020.