Clinical trial NCT03954743: Safety Study of 2 Formulations of GSK's Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 Weeks
Official title: A Phase III, Observer-blind, Randomized, Multi-country Study to Assess the Reactogenicity and Safety of the Porcine Circovirus (PCV) Free Liquid Formulation of GSK's Oral Live Attenuated Human Rotavirus (HRV) Vaccine as Compared to the Lyophilized Formulation of the GSK's HRV Vaccine, When Administered as a 2-dose Vaccination in Infants Starting at Age 6-12 Weeks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infections, Rotavirus
Keywords: HRV
Lyophilized formulation
Liquid formulation
Human rotavirus vaccine
Rotarix
Healthy infants
PCV-free
Porcine circovirus-free
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2019-05-17
Enrollment: 1351
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to complete the total safety database size for GlaxoSmithKline Biologicals' (GSK's) human rotavirus (HRV) vaccine across the Porcine circovirus (PCV)-free development plan.

This study used a purposely selected lot for PCV-free liquid HRV vaccine that is in the upper range of the usual release potencies. The PCV-free liquid HRV vaccine lots used were stored frozen in order to keep the titer stable until administration during the study.

As the liquid formulation of GSK's HRV vaccine is not licensed in the US, the lyophilized formulation of the vaccine was used as a control in all phase III studies as part of the PCV-free development plan.


Eligibility criteria: Inclusion Criteria:

All subjects must satisfy all the following criteria at study entry:

* Subjects' parent(s)/LAR(s) who, in the opinion of the investigator, can and will comply, with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits).
* Written or witnessed/thumb printed informed consent obtained from the parent(s)/LAR(s) of the subject prior to performance of any study specific procedure.
* Healthy subjects as established by medical history and clinical examination before entering into the study.
* A male or female between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination.

Exclusion Criteria:

Medical conditions

* Uncorrected congenital malformation (such as Meckel's diverticulum) of the gastrointestinal tract that would predispose for Intussusception (IS).
* Very prematurely born infants (born ≤28 weeks of gestation).
* 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 (no laboratory testing required).
* Hypersensitivity to latex.
* Major congenital defects or serious chronic illness, as assessed by the investigator.
* Previous confirmed occurrence of Rotavirus Gastroenteritis (RV GE).
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
* History of Severe combined immunodeficiency (SCID). Prior/Concomitant therapy
* Use of any investigational or non-registered product (drug, vaccine or medical device) 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.
* Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose and ending 30 days after the last dose of study vaccine administration, with the exception of the inactivated influenza vaccine, which is allowed at any time during the study, and other licensed routine childhood vaccinations.
* Administration of long-acting immune-modifying drugs at any time during the study period (e.g. infliximab).
* Administration of immunoglobulins and/or any blood products from birth or planned administration 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.
* Previous vaccination against RV. Prior/Concurrent clinical study experience
* 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 (drug or medical device).

Other exclusions

• Child in care.

Primary outcomes:
measure: Number of Subjects With Any Solicited General Adverse Events (AEs) After the First Vaccination
timeFrame: During the 8-day follow-up period after the first vaccination (vaccines administered at Day 1)
measure: Number of Subjects With Any Solicited General Adverse Events (AEs) After the Second Vaccination
timeFrame: During the 8-day follow-up period after the second vaccination (vaccines administered at Month 1 or Month 2)
measure: Number of Subjects With Any Unsolicited AEs
timeFrame: During the 31-day follow-up period across doses (vaccines administered at Day 1 and at Month 1 or Month 2)
measure: Number of Subjects With Any Serious Adverse Events (SAEs)
timeFrame: Throughout the study period (from Day 1 up to Month 7 or Month 8)
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: GSK Investigational Site
state: Alabama
city: Colorado Springs
country: United States
facility: GSK Investigational Site
state: Colorado
city: Louisville
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Frederick
country: United States
facility: GSK Investigational Site
state: Maryland
city: Fall River
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Bingham Farms
country: United States
facility: GSK Investigational Site
state: Michigan
city: Lincoln
country: United States
facility: GSK Investigational Site
state: Nebraska
city: Lincoln
country: United States
facility: GSK Investigational Site
state: Nebraska
city: Lincoln
country: United States
facility: GSK Investigational Site
state: Nebraska
city: East Orange
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Syracuse
country: United States
facility: GSK Investigational Site
state: New York
city: Cincinnati
country: United States
facility: GSK Investigational Site
state: Ohio
city: Fairfield
country: United States
facility: GSK Investigational Site
state: Ohio
city: Corvallis
country: United States
facility: GSK Investigational Site
state: Oregon
city: Draper
country: United States
facility: GSK Investigational Site
state: Utah
city: Murray
country: United States
facility: GSK Investigational Site
state: Utah
city: Orem
country: United States
facility: GSK Investigational Site
state: Utah
city: South Jordan
country: United States
facility: GSK Investigational Site
state: Utah
city: Charlottesville
country: United States
facility: GSK Investigational Site
state: Virginia
city: Calgary
country: Canada
facility: GSK Investigational Site
state: Alberta
city: Surrey
country: Canada
facility: GSK Investigational Site
state: British Columbia
city: Halifax
country: Canada
facility: GSK Investigational Site
state: Nova Scotia
city: Truro
country: Canada
facility: GSK Investigational Site
state: Nova Scotia
city: Brampton
country: Canada
facility: GSK Investigational Site
state: Ontario
city: London
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Sarnia
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Québec
country: Canada
facility: GSK Investigational Site
city: Pokfulam
country: Hong Kong
facility: GSK Investigational Site
city: Shatin
country: Hong Kong
facility: GSK Investigational Site
city: Changhua
country: Taiwan
facility: GSK Investigational Site
city: Kaohsiung City
country: Taiwan
facility: GSK Investigational Site
city: Taipei
country: Taiwan
facility: GSK Investigational Site
city: Taipei
country: Taiwan
facility: GSK Investigational Site
city: Eskisehir
country: Turkey
facility: GSK Investigational Site
city: Izmir
country: Turkey
facility: GSK Investigational Site
city: Kayseri
country: Turkey
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: