Safety Study of 2 Formulations of GSK's Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 Weeks

Infections, Rotavirus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03954743
• Other study ID #: 208236
• Secondary ID: 2018-001986-18
• Status: Completed
• Phase: Phase 3
• Start date: July 19, 2019
• Est. completion date: November 30, 2020

Study information

• Verified date: February 2022
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1351
• Est. completion date: November 30, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Weeks to 12 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Infections, Rotavirus
• Rotavirus Infections

Intervention

Biological:
• PCV-free liquid formulation of GSK's oral live attenuated HRV vaccine
2 doses administered orally at Day 1 and at Month 1 or Month 2, according to the immunization schedule for RV vaccine administration in participating countries.
• Lyophilized formulation of GSK's oral live attenuated HRV vaccine
2 doses administered orally at Day 1 and at Month 1 or Month 2, according to the immunization schedule for RV vaccine administration in participating countries.

Locations

Country	Name	City	State
Canada	GSK Investigational Site	Brampton	Ontario
Canada	GSK Investigational Site	Calgary	Alberta
Canada	GSK Investigational Site	Halifax	Nova Scotia
Canada	GSK Investigational Site	London	Ontario
Canada	GSK Investigational Site	Montreal	Quebec
Canada	GSK Investigational Site	Québec
Canada	GSK Investigational Site	Sarnia	Ontario
Canada	GSK Investigational Site	Surrey	British Columbia
Canada	GSK Investigational Site	Truro	Nova Scotia
Hong Kong	GSK Investigational Site	Pokfulam
Hong Kong	GSK Investigational Site	Shatin
Taiwan	GSK Investigational Site	Changhua
Taiwan	GSK Investigational Site	Kaohsiung City
Taiwan	GSK Investigational Site	Taipei
Taiwan	GSK Investigational Site	Taipei
Turkey	GSK Investigational Site	Eskisehir
Turkey	GSK Investigational Site	Izmir
Turkey	GSK Investigational Site	Kayseri
United States	GSK Investigational Site	Bingham Farms	Michigan
United States	GSK Investigational Site	Birmingham	Alabama
United States	GSK Investigational Site	Charlottesville	Virginia
United States	GSK Investigational Site	Cincinnati	Ohio
United States	GSK Investigational Site	Colorado Springs	Colorado
United States	GSK Investigational Site	Corvallis	Oregon
United States	GSK Investigational Site	Draper	Utah
United States	GSK Investigational Site	East Orange	New Jersey
United States	GSK Investigational Site	Fairfield	Ohio
United States	GSK Investigational Site	Fall River	Massachusetts
United States	GSK Investigational Site	Frederick	Maryland
United States	GSK Investigational Site	Lincoln	Nebraska
United States	GSK Investigational Site	Lincoln	Nebraska
United States	GSK Investigational Site	Lincoln	Nebraska
United States	GSK Investigational Site	Louisville	Kentucky
United States	GSK Investigational Site	Murray	Utah
United States	GSK Investigational Site	Orem	Utah
United States	GSK Investigational Site	South Jordan	Utah
United States	GSK Investigational Site	Syracuse	New York

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Canada,  Hong Kong,  Taiwan,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects With Any Solicited General Adverse Events (AEs) After the First Vaccination	Assessed solicited general AEs were fever (defined as temperature = 38.0°C/100.4°F, the preferred location for measuring temperature in this study being the oral cavity, the axilla and the rectum), irritability/fussiness, diarrhea (defined as passage of three or more looser than normal stools within a day), vomiting (defined as one or more episodes of forceful emptying of partially digested stomach contents =1 hour after feeding within a day), loss of appetite and cough/runny nose. Any = occurrence of AE regardless of intensity grade or relation to study vaccination.	During the 8-day follow-up period after the first vaccination (vaccines administered at Day 1)
Primary	Number of Subjects With Any Solicited General Adverse Events (AEs) After the Second Vaccination	Assessed solicited general AEs were fever (defined as temperature = 38.0°C/100.4°F, the preferred location for measuring temperature in this study being the oral cavity, the axilla and the rectum), irritability/fussiness, diarrhea (defined as passage of three or more looser than normal stools within a day), vomiting (defined as one or more episodes of forceful emptying of partially digested stomach contents =1 hour after feeding within a day), loss of appetite and cough/runny nose. Any = occurrence of AE regardless of intensity grade or relation to study vaccination.	During the 8-day follow-up period after the second vaccination (vaccines administered at Month 1 or Month 2)
Primary	Number of Subjects With Any Unsolicited AEs	An unsolicited AE is defined as any untoward medical occurrence in a clinical study subject, temporally associated with the use of a study treatment, whether or not considered related to the study treatment, and reported in addition to those solicited during the clinical study and any 'solicited' AE with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of AE regardless of intensity grade or relation to study vaccination.	During the 31-day follow-up period across doses (vaccines administered at Day 1 and at Month 1 or Month 2)
Primary	Number of Subjects With Any Serious Adverse Events (SAEs)	An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization and/or results in disability/incapacity. Any = occurrence of SAE regardless of intensity grade or relation to study vaccination.	Throughout the study period (from Day 1 up to Month 7 or Month 8)