Infections, RotavirusPhase 3NCT02914184

Evaluation of Immunogenicity and Safety of Two Formulations of GSK Biologicals' Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 Weeks

A Phase 3 study testing HRV PCV-free liquid vaccine and Rotarix in people with Infections, Rotavirus and Rotavirus Vaccines, run by GlaxoSmithKline at 66 sites in 8 countries.

Completed

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

Official record

Search all trials

Trial summary

Who is it for?: Ages 6 to 12 weeksHealthy volunteers can take part
Conditions the study is for: Infections, Rotavirus, Rotavirus Vaccines
What is being tested?: HRV PCV-free liquid vaccine and Rotarix
Type of treatment: Vaccines, Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,612 participants
Where: 66 sitesin 8 countries
Study dates: 27 Oct 2016to 26 Nov 2018
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.
Written informed consent obtained from the parent(s)/LAR(s) (Legally acceptable representatives) of the subject prior to performing any study specific procedure.
A male or female infant between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination.
Born full-term (i.e., between a gestation period of 37 weeks 0 days and 41 weeks 6 days).
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 0), or planned use during the study period.
Chronic administration 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 in the period starting 30 days before the first dose of vaccine administration and ending at Visit 3, with the exception of the inactivated influenza vaccine, which is allowed at any time during the study and other licensed routine childhood vaccinations.

Show all 20Show fewer

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.
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 RV.
Previous confirmed occurrence of RVGE.
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.
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 (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.

Trial locations and contacts

66 sites in 8 countries.

Country

City, postcode or hospital

66 sites in 8 countries

United States19 sites

GSK Investigational Site
Anaheim, California, 92804
GSK Investigational Site
Birmingham, Alabama, 35235
GSK Investigational Site
Cheraw, South Carolina, 29520
GSK Investigational Site
Cleveland, Ohio, 44121
GSK Investigational Site
Erie, Pennsylvania, 16506
GSK Investigational Site
Kansas City, Missouri, 64108
GSK Investigational Site
Layton, Utah, 84041
GSK Investigational Site
Marshfield, Wisconsin, 54449
GSK Investigational Site
Murray, Utah, 84107
GSK Investigational Site
Nampa, Idaho, 83686
GSK Investigational Site
Newton, Kansas, 67114
GSK Investigational Site
North Charleston, South Carolina, 29456-9170
GSK Investigational Site
Orem, Utah, 84057
GSK Investigational Site
Paramount, California, 90723
GSK Investigational Site
Provo, Utah, 84604
GSK Investigational Site
Sacramento, California, 95815
GSK Investigational Site
San Jose, California, 95119
GSK Investigational Site
Syracuse, Utah, 84075
GSK Investigational Site
Topeka, Kansas, 66604

Other trials in United States

Finland10 sites

GSK Investigational Site
Espoo, 02230
GSK Investigational Site
Helsinki, 00100
GSK Investigational Site
Helsinki, 00930
GSK Investigational Site
Jarvenpaa, 04400
GSK Investigational Site
Kokkola, 67100
GSK Investigational Site
Oulu, 90220
GSK Investigational Site
Pori, 28100
GSK Investigational Site
Seinäjoki, 60100
GSK Investigational Site
Tampere, 33100
GSK Investigational Site
Turku, 20520

Other trials in Finland

Spain10 sites

GSK Investigational Site
Antequera/Málaga, 29200
GSK Investigational Site
Castellon, 12004
GSK Investigational Site
Castellon, 12530
GSK Investigational Site
Madrid, 28050
GSK Investigational Site
Málaga, Andalusia, 29004
GSK Investigational Site
Marbella, 29600
GSK Investigational Site
Seville, 41013
GSK Investigational Site
Valencia, 46020
GSK Investigational Site
Valencia, 46023
GSK Investigational Site
Valencia, 46200

Other trials in Spain

Japan7 sites

GSK Investigational Site
Chiba, 274-0063
GSK Investigational Site
Chiba, 299-4503
GSK Investigational Site
Saitama, 350-0001
GSK Investigational Site
Saitama, 360-0846
GSK Investigational Site
Tokyo, 146-0095
GSK Investigational Site
Tokyo, 167-0052
GSK Investigational Site
Tokyo, 190-0002

Other trials in Japan

Germany6 sites

GSK Investigational Site
Bramsche, 49565
GSK Investigational Site
Frankenthal, Rhineland-Palatinate, 67227
GSK Investigational Site
Goch, North Rhine-Westphalia, 47574
GSK Investigational Site
Mannheim, Baden-Wurttemberg, 68161
GSK Investigational Site
Schönau am Königssee, Bavaria, 83471
GSK Investigational Site
Tauberbischofsheim, Baden-Wurttemberg, 97941

Other trials in Germany

South Korea6 sites

GSK Investigational Site
Gangwon-do, 26426
GSK Investigational Site
Gyeonggido, 442723
GSK Investigational Site
Incheon, 21431
GSK Investigational Site
Seoul, 01450
GSK Investigational Site
Seoul, 02447
GSK Investigational Site
Seoul, 04619

Other trials in South Korea

Taiwan6 sites

GSK Investigational Site
Hsinchu, 300
GSK Investigational Site
Taichung, 404
GSK Investigational Site
Taichung, 407
GSK Investigational Site
Taipei, 100
GSK Investigational Site
Taipei, 104
GSK Investigational Site
Taoyuan, 333

Other trials in Taiwan

Costa Rica2 sites

GSK Investigational Site
San José, Provincia de San José
GSK Investigational Site
San José

Other trials in Costa Rica

About this study

Official title: Immunogenicity and Safety Study of Two Formulations of GlaxoSmithKline (GSK) Biologicals' Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 Weeks

The purpose of this study is to evaluate the clinical consistency of three production lots of the Porcine circovirus (PCV)-free liquid formulation of oral live attenuated human rotavirus (HRV) vaccine and to evaluate the PCV-free liquid formulation of HRV vaccine as compared to the currently licensed lyophilised formulation of the HRV vaccine in terms of immunogenicity, reactogenicity and safety when administered as a two-dose vaccination in healthy infants starting at age 6-12 weeks. No new subjects will be enrolled in the extension phase of the study.

Read the detailed description

Experimental design: Phase IIIA, observer-blind, randomised (1:1:1:1), controlled, multi-centric, with four parallel groups and a staggered enrolment (Part A and Part B).
Duration of the study: The intended duration of the study, per subject, will be approximately 7-8 months including the 6 months of extended safety follow-up period after the last dose of HRV vaccine.
Epoch 001: Primary starting at Visit 1 (Day 0) and ending at the safety follow-up contact (Month 7-8).
Primary completion Date (PCD): Visit 3 (Month 2-4).
End of Study (EoS): Last testing results released of samples collected at Visit 3 or Last Subject Last Visit (LSLV) (Follow up contact at month 7-8).
Study Groups:
PCV-free HRV liquid formulation lot A (also referred to as Liq_A Group)
PCV-free HRV liquid formulation lot B (also referred to as Liq_B Group)
PCV-free HRV liquid formulation lot C (also referred to as Liq_C Group)
GSK Biologicals' currently licensed lyophilised HRV formulation (also referred to as Lyo Group)
Control:active control-GSK Biologicals' currently licensed lyophilised HRV vaccine
Vaccination schedule: Two doses of HRV vaccine to be administered according to a 0, 1-2 month schedule according to the immunisation schedule for RV vaccine.

Note that as a result of internal change in data standards terminology, the study data collected was converted to cDISC and the statistical analysis plan was amended accordingly. "Day 0" in the study design was replaced by "Day 1"; consequently, "Day n" was replaced by "Day n+1". Thus, the time frames (Day 0, Day n) of Outcome Measures described in this study record are different to that denoted in the full protocol document posted.

Conditions: Infections, Rotavirus, Rotavirus Vaccines
Being tested: HRV PCV-free liquid vaccine, Rotarix
Keywords: Safety, Healthy infants, Immunogenicity, Human Rotavirus (HRV)
Medical subject headings: Rotavirus Infections

What participants receive

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

HRV PCV-free liquid vaccineBiological
Subjects will receive two doses of PCV-free HRV vaccine at 6 and 12 weeks of age. The vaccine will be administered orally
RotarixBiological
Subjects will receive two doses of currently licensed lyophilised HRV vaccine at 6 and 12 weeks of age. The vaccine will be administered orally

Study groups in NCT02914184
Study group	Role	What they receive
Liq_A Group	Experimental	All subjects will receive two doses of PCV-free HRV liquid formulation lot A, at 6 and 12 weeks of age Receives: Biological: HRV PCV-free liquid vaccine
Liq_B Group	Experimental	All subjects will receive two doses of PCV-free HRV liquid formulation lot B, at 6 and 12 weeks of age Receives: Biological: HRV PCV-free liquid vaccine
Liq_C Group	Experimental	All subjects will receive two doses of PCV-free HRV liquid formulation lot C, at 6 and 12 weeks of age Receives: Biological: HRV PCV-free liquid vaccine
Lyo Group	Active comparator	All subjects will receive two doses of currently licensed lyophilised HRV vaccine, at 6 and 12 weeks of age Receives: Biological: Rotarix

What is being measured

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

Anti-Rota Virus (Anti-RV) Immunoglobulin A (IgA) Antibody Concentrations in the Human Rotavirus (HRV) Liquid Formulation Groups (Liq_A, Liq_B and Liq_C)
Antibody concentrations against Rota Virus (RV) were determined as Geometric Mean Antibody Concentration (GMC) and expressed as Units per milliliter (U/mL).
Measured: At Month 2-4 (i.e. approximately 1-month or 2-months after second dose of HRV vaccine according to the immunisation schedule for RV vaccine administration in participating countries)
Percentage of Seroconverted Subjects With RV Antibody Concentrations Above or Equal to Cut-off Value in Porcine Circovirus (PCV) -Free Liquid HRV Vaccine (Pooled HRV Liquid Group) and Control Group
Seroconversion rate (SCR) was defined as the percentage of subjects who were initially seronegative (i.e., with anti-RV IgA antibody concentration less than (<) 20 U/mL before the first dose of HRV vaccine) and developed anti-RV IgA antibody concentration greater than or equal to (≥) 20 U/mL at Month 2-4 (1-2 months after dose 2). SCR was analysed using Enzyme Linked Immunosorbent Assay (ELISA).
For this outcome measure, the three groups (Liq_A, Liq_B \& Liq_C) were pooled into a single group (Liq_Pool group) as they all received PCV free-liquid HRV vaccine, and as pre-specified in the protocol, the immunological non-inferiority of the Liq_Pool group was compared to the currently licensed lyophilized HRV vaccine (Lyo_Control group) in terms of seroconversion rates of 1-2 months after Dose 2.
Measured: At Month 2-4 (i.e. approximately 1-month or 2-months after second dose of HRV vaccine according to the immunisation schedule for RV vaccine administration in participating countries)
Percentage of Seroconverted Subjects With RV Antibody Concentrations Above or Equal to 20 U/mL in Porcine Circovirus (PCV)-Free Liquid HRV Vaccine (Individual HRV Liquid Groups) and Lyophilised Control Group
Seroconversion rate (SCR) was defined as the percentage of subjects who were initially seronegative (i.e., with anti-RV IgA antibody concentration less than (<) 20 U/mL before the first dose of HRV vaccine) and developed anti-RV IgA antibody concentration greater than or equal to (≥) 20 U/mL at Month 2-4 (1-2 months after dose 2). SCR was analysed using Enzyme Linked Immunosorbent Assay (ELISA).
The analysis was assessed to demonstrate the immunogenicity of PCV-free liquid HRV vaccine as compared to the currently licensed lyophilised HRV vaccine (individual HRV liquid groups) in terms of seroconversion rates 1-2 months after Dose 2.
Measured: At Month 2-4 (i.e. approximately 1-month or 2-months after second dose of HRV vaccine according to the immunisation schedule for RV vaccine administration in participating countries)
Anti-RV IgA Antibody Concentrations in the PCV-free Liquid HRV Vaccine (Pooled HRV Liquid Group) and Lyophilised Control Group
Antibody concentrations against RV were determined as GMCs and expressed as U/mL.
For this outcome measure, the three groups (Liq_A, Liq_B \& Liq_C) were pooled into a single group (Liq_Pool group) as they all received PCV free-liquid HRV vaccine, and as pre-specified in the protocol, the immunological non-inferiority of the Liq_Pool group was compared to the currently licensed lyophilized HRV vaccine (Lyo_Control group) in terms of antibody concentrations at 1-2 months after Dose 2.
Measured: At Month 2-4 (i.e. approximately 1-month or 2-months after second dose of HRV vaccine according to the immunisation schedule for RV vaccine administration in participating countries)
Anti-RV IgA Antibody Concentrations in the PCV-free Liquid HRV Vaccine (Individual HRV Liquid Groups) and Lyophilised Control Group
Antibody concentrations against RV were determined as GMCs and expressed as U/mL. The analysis was assessed to demonstrate the immunogenicity of the PCV-free liquid HRV vaccine (individual HRV liquid groups) to that of the currently licensed lyophilised HRV vaccine in terms of serum anti-RV IgA antibody concentrations 1-2 months after Dose 2.
Measured: At Month 2-4 (i.e. approximately 1-month or 2-months after second dose of HRV vaccine according to the immunisation schedule for RV vaccine administration in participating countries)

Secondary outcomes (5)

Percentage of Subjects With Anti-RV IgA Concentrations (Pooled HRV Liquid Group)
Antibody concentrations ≥90 U/mL were determined and expressed as GMCs, assessed for the pooled HRV liquid groups and Control Group. The GMC calculations were performed by taking the anti-log of the mean of the log concentration transformations.
For this outcome measure, the three groups (Liq_A, Liq_B \& Liq_C) were pooled into a single group (Liq_Pool group) as they all received PCV free-liquid HRV vaccine, and as pre-specified in the protocol, the immunogenicity of the Liq_Pool group was compared to the currently licensed lyophilized HRV vaccine (Lyo_Control group) in terms of percentage of subjects with anti-RV IgA antibody concentrations ≥ 90 U/mL, 1-2 months after Dose 2
Measured: At Month 2-4 (i.e. approximately 1-month or 2-months after second dose of HRV vaccine according to the immunisation schedule for RV vaccine administration in participating countries)
Percentage of Subjects With Anti-RV IgA Concentrations (Individual HRV Liquid Groups)
Antibody concentrations ≥90 U/mL were determined and expressed as GMCs, assessed for the individual HRV liquid groups and Control Group. The GMC calculations were performed by taking the anti-log of the mean of the log concentration transformations. The analysis was performed to assess the immunogenicity of the PCV-free liquid HRV vaccine (pooled HRV liquid groups) and the currently licensed lyophilised HRV vaccine, in terms of percentage of subjects with anti-RV IgA antibody concentrations ≥ 90 U/mL 1-2 months after Dose 2.
Measured: At Month 2-4 (i.e. approximately 1-month or 2-months after second dose of HRV vaccine according to the immunisation schedule for RV vaccine administration in participating countries)
Number of Subjects With Any Solicited General Adverse Events (AEs).
Assessed solicited general AEs were cough/runny nose, diarrhea, fever (defined as temperature ≥ 38.0°C), irritability/fussiness, loss of appetite and vomiting. Any solicited general AE is defined as any occurrence of the specified symptom, irrespective of intensity grade and relationship to vaccination.
Measured: During the 8 days (Day 1 to Day 8) follow-up period after each dose of HRV vaccine
Number of Subjects With Any Unsolicited AEs.
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any is defined as the occurrence of any unsolicited AE irrespective of its intensity grade and relationship to vaccination.
Measured: During the 31 day (Day 1 to Day 31) follow-up period after HRV vaccination across doses
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 7-8)

Timeline

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

27 Oct 201626 Nov 2018

First posted26 Sep 2016 (estimated)
Study start27 Oct 2016
Primary completion27 Jun 2018
Study completion26 Nov 2018

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Infections, RotavirusStudies 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: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 1,612 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02914184
Sponsor's protocol ID: 115461
Other IDs: 2016-000598-19, 2016
Status last verified: Jul 2020
First submitted: 16 Sep 2016
Last updated: 21 Jul 2020
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: IPD for this study will be made available via the Clinical Study Data Request site.

Publications

Salamanca de la Cueva I, Pahud B, Huang LM, Leonardi M, Garcia-Sicilia J, Cespedes J, Abdelnour A, Tamura T, Kuroki H, Chiu NC, Virta M, Kokko S, Horn M, Panzer F, Kim JH, Jin L, Moerman L, Debacq C, Parra J, Ugarte A, Bi D; Rota-081 Study Group. Immunogenicity and safety of porcine circovirus-free human rotavirus vaccine in healthy infants: a phase III, randomized trial. J Infect Dis. 2020 May 4;225(12):2106-15. doi: 10.1093/infdis/jiaa210. Online ahead of print.
PubMed 32365189

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?

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Study at a glance

From the registry record, last updated by the sponsor on 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Immunogenicity and Safety Study of Two Formulations of GlaxoSmithKline (GSK) Biologicals' Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 Weeks
ClinicalTrials.gov ID: NCT02914184
Acronym / sponsor ID: 115461
Conditions: Infections, Rotavirus, Rotavirus Vaccines
Keywords: Safety, Healthy infants, Immunogenicity, Human Rotavirus (HRV)
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,612 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 27 Oct 2016 (actual)
Primary completion: 27 Jun 2018 (actual)
Study completion: 26 Nov 2018 (actual)
First posted: 26 Sep 2016 (estimated)
Results: Posted 14 Oct 2019

Clinical summary

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

Detailed description

Experimental design: Phase IIIA, observer-blind, randomised (1:1:1:1), controlled, multi-centric, with four parallel groups and a staggered enrolment (Part A and Part B).
Duration of the study: The intended duration of the study, per subject, will be approximately 7-8 months including the 6 months of extended safety follow-up period after the last dose of HRV vaccine.
Epoch 001: Primary starting at Visit 1 (Day 0) and ending at the safety follow-up contact (Month 7-8).
Primary completion Date (PCD): Visit 3 (Month 2-4).
End of Study (EoS): Last testing results released of samples collected at Visit 3 or Last Subject Last Visit (LSLV) (Follow up contact at month 7-8).
Study Groups:
PCV-free HRV liquid formulation lot A (also referred to as Liq_A Group)
PCV-free HRV liquid formulation lot B (also referred to as Liq_B Group)
PCV-free HRV liquid formulation lot C (also referred to as Liq_C Group)
GSK Biologicals' currently licensed lyophilised HRV formulation (also referred to as Lyo Group)
Control:active control-GSK Biologicals' currently licensed lyophilised HRV vaccine
Vaccination schedule: Two doses of HRV vaccine to be administered according to a 0, 1-2 month schedule according to the immunisation schedule for RV vaccine.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Liq_A Group	Experimental	Biological: HRV PCV-free liquid vaccineAll subjects will receive two doses of PCV-free HRV liquid formulation lot A, at 6 and 12 weeks of age
Liq_B Group	Experimental	Biological: HRV PCV-free liquid vaccineAll subjects will receive two doses of PCV-free HRV liquid formulation lot B, at 6 and 12 weeks of age
Liq_C Group	Experimental	Biological: HRV PCV-free liquid vaccineAll subjects will receive two doses of PCV-free HRV liquid formulation lot C, at 6 and 12 weeks of age
Lyo Group	Active comparator	Biological: RotarixAll subjects will receive two doses of currently licensed lyophilised HRV vaccine, at 6 and 12 weeks of age

Who may qualify

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

Key inclusion criteria (5 listed)

Subjects' parent(s)/LAR(s) who, in the opinion of the investigator can and will comply with the requirements of the protocol.
Written informed consent obtained from the parent(s)/LAR(s) (Legally acceptable representatives) of the subject prior to performing any study specific procedure.
A male or female infant between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination.
Born full-term (i.e., between a gestation period of 37 weeks 0 days and 41 weeks 6 days).
Healthy subjects as established by medical history and clinical examination before entering into the study.

Key exclusion criteria (20 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 0), or planned use during the study period.
Chronic administration 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
HRV PCV-free liquid vaccineSubjects will receive two doses of PCV-free HRV vaccine at 6 and 12 weeks of age. The vaccine will be administered orally	Biological	Liq_A Group, Liq_B Group, Liq_C Group
RotarixSubjects will receive two doses of currently licensed lyophilised HRV vaccine at 6 and 12 weeks of age. The vaccine will be administered orally	Biological	Lyo Group

Primary outcome

Anti-Rota Virus (Anti-RV) Immunoglobulin A (IgA) Antibody Concentrations in the Human Rotavirus (HRV) Liquid Formulation Groups (Liq_A, Liq_B and Liq_C)
Time frame: At Month 2-4 (i.e. approximately 1-month or 2-months after second dose of HRV vaccine according to the immunisation schedule for RV vaccine administration in participating countries)
Antibody concentrations against Rota Virus (RV) were determined as Geometric Mean Antibody Concentration (GMC) and expressed as Units per milliliter (U/mL).
Percentage of Seroconverted Subjects With RV Antibody Concentrations Above or Equal to Cut-off Value in Porcine Circovirus (PCV) -Free Liquid HRV Vaccine (Pooled HRV Liquid Group) and Control Group
Time frame: At Month 2-4 (i.e. approximately 1-month or 2-months after second dose of HRV vaccine according to the immunisation schedule for RV vaccine administration in participating countries)
Seroconversion rate (SCR) was defined as the percentage of subjects who were initially seronegative (i.e., with anti-RV IgA antibody concentration less than (<) 20 U/mL before the first dose of HRV vaccine) and developed anti-RV IgA antibody concentration greater than or equal to (≥) 20 U/mL at Month 2-4 (1-2 months after dose 2). SCR was analysed using Enzyme Linked Immunosorbent Assay (ELISA). For this outcome measure, the three groups (Liq_A, Liq_B \& Liq_C) were pooled into a single group (Liq_Pool group) as they all received PCV free-liquid HRV vaccine, and as pre-specified in the protocol, the immunological non-inferiority of the Liq_Pool group was compared to the currently licensed lyophilized HRV vaccine (Lyo_Control group) in terms of seroconversion rates of 1-2 months after Dose 2.
Percentage of Seroconverted Subjects With RV Antibody Concentrations Above or Equal to 20 U/mL in Porcine Circovirus (PCV)-Free Liquid HRV Vaccine (Individual HRV Liquid Groups) and Lyophilised Control Group
Time frame: At Month 2-4 (i.e. approximately 1-month or 2-months after second dose of HRV vaccine according to the immunisation schedule for RV vaccine administration in participating countries)
Seroconversion rate (SCR) was defined as the percentage of subjects who were initially seronegative (i.e., with anti-RV IgA antibody concentration less than (<) 20 U/mL before the first dose of HRV vaccine) and developed anti-RV IgA antibody concentration greater than or equal to (≥) 20 U/mL at Month 2-4 (1-2 months after dose 2). SCR was analysed using Enzyme Linked Immunosorbent Assay (ELISA). The analysis was assessed to demonstrate the immunogenicity of PCV-free liquid HRV vaccine as compared to the currently licensed lyophilised HRV vaccine (individual HRV liquid groups) in terms of seroconversion rates 1-2 months after Dose 2.
Anti-RV IgA Antibody Concentrations in the PCV-free Liquid HRV Vaccine (Pooled HRV Liquid Group) and Lyophilised Control Group
Time frame: At Month 2-4 (i.e. approximately 1-month or 2-months after second dose of HRV vaccine according to the immunisation schedule for RV vaccine administration in participating countries)
Antibody concentrations against RV were determined as GMCs and expressed as U/mL. For this outcome measure, the three groups (Liq_A, Liq_B \& Liq_C) were pooled into a single group (Liq_Pool group) as they all received PCV free-liquid HRV vaccine, and as pre-specified in the protocol, the immunological non-inferiority of the Liq_Pool group was compared to the currently licensed lyophilized HRV vaccine (Lyo_Control group) in terms of antibody concentrations at 1-2 months after Dose 2.
Anti-RV IgA Antibody Concentrations in the PCV-free Liquid HRV Vaccine (Individual HRV Liquid Groups) and Lyophilised Control Group
Time frame: At Month 2-4 (i.e. approximately 1-month or 2-months after second dose of HRV vaccine according to the immunisation schedule for RV vaccine administration in participating countries)
Antibody concentrations against RV were determined as GMCs and expressed as U/mL. The analysis was assessed to demonstrate the immunogenicity of the PCV-free liquid HRV vaccine (individual HRV liquid groups) to that of the currently licensed lyophilised HRV vaccine in terms of serum anti-RV IgA antibody concentrations 1-2 months after Dose 2.

5 secondary outcomes

Percentage of Subjects With Anti-RV IgA Concentrations (Pooled HRV Liquid Group)
Time frame: At Month 2-4 (i.e. approximately 1-month or 2-months after second dose of HRV vaccine according to the immunisation schedule for RV vaccine administration in participating countries)
Percentage of Subjects With Anti-RV IgA Concentrations (Individual HRV Liquid Groups)
Time frame: At Month 2-4 (i.e. approximately 1-month or 2-months after second dose of HRV vaccine according to the immunisation schedule for RV vaccine administration in participating countries)
Number of Subjects With Any Solicited General Adverse Events (AEs).
Time frame: During the 8 days (Day 1 to Day 8) follow-up period after each dose of HRV vaccine
Number of Subjects With Any Unsolicited AEs.
Time frame: During the 31 day (Day 1 to Day 31) follow-up period after HRV vaccination across doses
Number of Subjects With Any Serious Adverse Events (SAEs)
Time frame: During the entire study period (Day 1 to Month 7-8)

Results and safety

Results posted to the registry on 14 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
Liq_A Group	400	386
Liq_B Group	396	383
Liq_C Group	402	385
Lyo Control Group	402	391

Primary outcome: Anti-Rota Virus (Anti-RV) Immunoglobulin A (IgA) Antibody Concentrations in the Human Rotavirus (HRV) Liquid Formulation Groups (Liq_A, Liq_B and Liq_C)

Time frame: At Month 2-4 (i.e. approximately 1-month or 2-months after second dose of HRV vaccine according to the immunisation schedule for RV vaccine administration in participating countries). Geometric mean (95% Confidence Interval). Unit: U/mL

Measure	Liq_A Group n = 332	Liq_B Group n = 326	Liq_C Group n = 326
Value	155.7 (125.6 to 193.1)	147.3 (118.4 to 183.3)	175.9 (142.8 to 216.8)

Liq_A Group vs Liq_B Group: GMC Ratio at At Month 2-4: 1.07 (95% CI 0.79 to 1.44), ANOVA
Liq_A Group vs Liq_C Group: GMC Ratio at At Month 2-4: 0.88 (95% CI 0.65 to 1.19), ANOVA
Liq_B Group vs Liq_C Group: GMC Ratio at At Month 2-4: 0.82 (95% CI 0.61 to 1.11), ANOVA

Population analysed: The analysis was performed on the Per-protocol analysis set (PPS) for immunogenicity that included all subjects who received both doses of study vaccine and for whom the liquid HRV vaccine or control vaccine was administered according to protocol and for whom immunogenicity data were available at the post-vaccination sampling time point.

Primary outcome: Percentage of Seroconverted Subjects With RV Antibody Concentrations Above or Equal to Cut-off Value in Porcine Circovirus (PCV) -Free Liquid HRV Vaccine (Pooled HRV Liquid Group) and Control Group

Time frame: At Month 2-4 (i.e. approximately 1-month or 2-months after second dose of HRV vaccine according to the immunisation schedule for RV vaccine administration in participating countries). Number (95% Confidence Interval). Unit: Percentage of subjects

Measure	Liq_Pool Group n = 984	Lyo Control Group n = 329
Value	79.3 (76.6 to 81.8)	81.8 (77.2 to 85.8)

Liq_Pool Group vs Lyo Control Group: SCR difference at Month 2-4: -2.49 (95% CI -7.15 to 2.63)

Population analysed: The analysis was performed on the PPS for immunogenicity that included all subjects who received both doses of study vaccine and for whom the liquid HRV vaccine or control vaccine was administered according to protocol and for whom immunogenicity data were available at the post-vaccination sampling time point.

Primary outcome: Percentage of Seroconverted Subjects With RV Antibody Concentrations Above or Equal to 20 U/mL in Porcine Circovirus (PCV)-Free Liquid HRV Vaccine (Individual HRV Liquid Groups) and Lyophilised Control Group

Time frame: At Month 2-4 (i.e. approximately 1-month or 2-months after second dose of HRV vaccine according to the immunisation schedule for RV vaccine administration in participating countries). Number (95% Confidence Interval). Unit: Percentage of subjects

Measure	Liq_A Group n = 332	Liq_B Group n = 326	Liq_C Group n = 326	Lyo Control Group n = 329
Value	77.7 (72.8 to 82.1)	77.6 (72.7 to 82.0)	82.5 (77.9 to 86.5)	81.8 (77.2 to 85.8)

Primary outcome: Anti-RV IgA Antibody Concentrations in the PCV-free Liquid HRV Vaccine (Pooled HRV Liquid Group) and Lyophilised Control Group

Measure	Liq_Pool Group n = 984	Lyo Control Group n = 329
Value	159.2 (140.7 to 180.1)	153.8 (125.1 to 189.0)

Liq_Pool Group vs Lyo Control Group: GMC Ratio at At Month 2-4: 1.04 (95% CI 0.82 to 1.33), ANOVA

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Liq_A Group	21 of 400 (5.3%)	333 of 400 (83.3%)	0 of 400
Liq_B Group	18 of 396 (4.5%)	242 of 396 (61.1%)	0 of 396
Liq_C Group	21 of 402 (5.2%)	338 of 402 (84.1%)	0 of 402
Lyo Control Group	18 of 402 (4.5%)	338 of 402 (84.1%)	0 of 402

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 32365189Salamanca de la Cueva I, Pahud B, Huang LM, Leonardi M, Garcia-Sicilia J, Cespedes J, Abdelnour A, Tamura T, Kuroki H, Chiu NC, Virta M, Kokko S, Horn M, Panzer F, Kim JH, Jin L, Moerman L, Debacq C, Parra J, Ugarte A, Bi D; Rota-081 Study Group. Immunogenicity and safety of porcine circovirus-free human rotavirus vaccine in healthy infants: a phase III, randomized trial. J Infect Dis. 2020 May 4;225(12):2106-15. doi: 10.1093/infdis/jiaa210. Online ahead of print.
Individual participant dataSharing planned: Yes. IPD for this study will be made 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

66 sites in 8 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing HRV PCV-free liquid vaccine and Rotarix in people with Infections, Rotavirus and Rotavirus Vaccines, run by GlaxoSmithKline at 66 sites in 8 countries.

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 5 inclusion and 20 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 21 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 66 sites in United States, Finland, Spain, Japan, Germany and 3 more countries. 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 14 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?

Anti-Rota Virus (Anti-RV) Immunoglobulin A (IgA) Antibody Concentrations in the Human Rotavirus (HRV) Liquid Formulation Groups (Liq_A, Liq_B and Liq_C) (time frame: At Month 2-4 (i.e. approximately 1-month or 2-months after second dose of HRV vaccine according to the immunisation schedule for RV vaccine administration in participating countries)). The study lists 5 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 NCT02914184, which also lists 1 linked publication.

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 21 Jul 2020.