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

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ClinicalTrials.gov Identifier: NCT03954743
Recruitment Status : Completed
First Posted : May 17, 2019
Results First Posted : June 18, 2021
Last Update Posted : June 18, 2021
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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.


Condition or disease Intervention/treatment Phase
Infections, Rotavirus Biological: PCV-free liquid formulation of GSK's oral live attenuated HRV vaccine Biological: Lyophilized formulation of GSK's oral live attenuated HRV vaccine Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1351 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Data were collected in an observer-blind manner. By observer-blind, it is meant that during the study period, the vaccine(s) recipient and those responsible for the evaluation of any study endpoint (e.g. safety and reactogenicity) were all unaware of which vaccine was administered.
Primary Purpose: Prevention
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
Actual Study Start Date : July 19, 2019
Actual Primary Completion Date : November 30, 2020
Actual Study Completion Date : November 30, 2020

Arm Intervention/treatment
Experimental: HRV PCV-free Liq Group
Subjects aged 6 to 12 weeks at the time of first vaccination, who received two doses of oral live-attenuated human rotavirus (HRV) porcine circovirus (PCV)-free vaccine in liquid formulation, one at Day 1 and one at Month 1 or Month 2, according to the immunization schedule for rotavirus (RV) vaccine administration in participating countries. PCV-free implies no detection of PCV-1 and PCV-2 according to the limit of detection of the tests used.
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.

Active Comparator: HRV Lyo group
Subjects aged 6 to 12 weeks at the time of first vaccination, who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in lyophilized formulation, one at Day 1 and one at Month 1 or Month 2, according to the immunization schedule for rotavirus (RV) vaccine administration in participating countries.
Biological: 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.




Primary Outcome Measures :
  1. Number of Subjects With Any Solicited General Adverse Events (AEs) After the First Vaccination [ Time Frame: During the 8-day follow-up period after the first vaccination (vaccines administered at Day 1) ]
    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.

  2. Number of Subjects With Any Solicited General Adverse Events (AEs) After the Second Vaccination [ Time Frame: During the 8-day follow-up period after the second vaccination (vaccines administered at Month 1 or Month 2) ]
    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.

  3. Number of Subjects With Any Unsolicited AEs [ Time Frame: During the 31-day follow-up period across doses (vaccines administered at Day 1 and at Month 1 or Month 2) ]
    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.

  4. Number of Subjects With Any Serious Adverse Events (SAEs) [ Time Frame: Throughout the study period (from Day 1 up to Month 7 or Month 8) ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Weeks to 12 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03954743


Locations
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United States, Alabama
GSK Investigational Site
Birmingham, Alabama, United States, 35235
United States, Colorado
GSK Investigational Site
Colorado Springs, Colorado, United States, 80922
United States, Kentucky
GSK Investigational Site
Louisville, Kentucky, United States, 40291
United States, Maryland
GSK Investigational Site
Frederick, Maryland, United States, 21702
United States, Massachusetts
GSK Investigational Site
Fall River, Massachusetts, United States, 02721-1735
United States, Michigan
GSK Investigational Site
Bingham Farms, Michigan, United States, 48025
United States, Nebraska
GSK Investigational Site
Lincoln, Nebraska, United States, 68504
GSK Investigational Site
Lincoln, Nebraska, United States, 68516
GSK Investigational Site
Lincoln, Nebraska, United States, 68522
United States, New Jersey
GSK Investigational Site
East Orange, New Jersey, United States, 07108
United States, New York
GSK Investigational Site
Syracuse, New York, United States, 13210
United States, Ohio
GSK Investigational Site
Cincinnati, Ohio, United States, 45245
GSK Investigational Site
Fairfield, Ohio, United States, 45014
United States, Oregon
GSK Investigational Site
Corvallis, Oregon, United States, 97330
United States, Utah
GSK Investigational Site
Draper, Utah, United States, 84020
GSK Investigational Site
Murray, Utah, United States, 84107
GSK Investigational Site
Orem, Utah, United States, 84057
GSK Investigational Site
South Jordan, Utah, United States, 84095
United States, Virginia
GSK Investigational Site
Charlottesville, Virginia, United States, 22902
Canada, Alberta
GSK Investigational Site
Calgary, Alberta, Canada, T3B 6A8
Canada, British Columbia
GSK Investigational Site
Surrey, British Columbia, Canada, V3Z 2N6
Canada, Nova Scotia
GSK Investigational Site
Halifax, Nova Scotia, Canada, B3K 6R8
GSK Investigational Site
Truro, Nova Scotia, Canada, B2N 1L2
Canada, Ontario
GSK Investigational Site
Brampton, Ontario, Canada, L6T 0G1
GSK Investigational Site
London, Ontario, Canada, N5W 6A2
GSK Investigational Site
Sarnia, Ontario, Canada, N7T 4X3
Canada, Quebec
GSK Investigational Site
Montreal, Quebec, Canada, H3T 1C5
Canada
GSK Investigational Site
Québec, Canada, G1V 4G2
Hong Kong
GSK Investigational Site
Pokfulam, Hong Kong
GSK Investigational Site
Shatin, Hong Kong
Taiwan
GSK Investigational Site
Changhua, Taiwan, 500
GSK Investigational Site
Kaohsiung City, Taiwan, 83301
GSK Investigational Site
Taipei, Taiwan, 100
GSK Investigational Site
Taipei, Taiwan, 104
Turkey
GSK Investigational Site
Eskisehir, Turkey, 26040
GSK Investigational Site
Izmir, Turkey, 35340
GSK Investigational Site
Kayseri, Turkey, 38030
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
  Study Documents (Full-Text)

Documents provided by GlaxoSmithKline:
Study Protocol  [PDF] March 30, 2020
Statistical Analysis Plan  [PDF] October 15, 2020

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03954743    
Other Study ID Numbers: 208236
2018-001986-18 ( EudraCT Number )
First Posted: May 17, 2019    Key Record Dates
Results First Posted: June 18, 2021
Last Update Posted: June 18, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study
Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
URL: https://clinicalstudydatarequest.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GlaxoSmithKline:
HRV
Lyophilized formulation
Liquid formulation
Human rotavirus vaccine
Rotarix
Healthy infants
PCV-free
Porcine circovirus-free
Additional relevant MeSH terms:
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Rotavirus Infections
Reoviridae Infections
RNA Virus Infections
Virus Diseases
Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs