Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Safety Study of 2 Formulations of GlaxoSmithKline Biologicals' (GSK's) Human Rotavirus (HRV) Vaccine in Healthy Infants of Age 6-12 Weeks

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03954743
Recruitment Status : Not yet recruiting
First Posted : May 17, 2019
Last Update Posted : May 17, 2019
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 (ROTARIX) across the Porcine circovirus (PCV)-free development plan.

This study will use 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 will be stored frozen in order to keep the titre stable until administration during the study.

As the liquid formulation of ROTARIX is not licensed in the US, the lyophilized formulation of the vaccine will be 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: HRV Liquid Biological: HRV Lyophilized Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Data will be 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) will all be unaware of which vaccine was administered.
Primary Purpose: Prevention
Official Title: Safety Study of 2 Formulations of GSK's HRV Vaccine (444563), in Healthy Infants Starting at Age 6-12 Weeks
Estimated Study Start Date : July 19, 2019
Estimated Primary Completion Date : December 16, 2020
Estimated Study Completion Date : December 16, 2020

Arm Intervention/treatment
Experimental: HRV Liq group
Subjects aged 6 to 10 weeks at the time of first vaccination who receive two oral doses of liquid HRV vaccine according to a 0, 1-2-month schedule.
Biological: HRV Liquid
Two doses will be administered orally according to a 0, 1-2-month schedule.
Other Name: GSK Biologicals' HRV liquid vaccine

Active Comparator: HRV Lyo group
Subjects aged 6 to 10 weeks at the time of first vaccination who receive two oral doses of lyophilized HRV vaccine according to a 0, 1-2-month schedule.
Biological: HRV Lyophilized
Two doses will be administered orally according to a 0, 1-2-month schedule.
Other Name: GSK Biologicals' HRV lyophilized vaccine




Primary Outcome Measures :
  1. Percentages of subjects with any solicited general adverse events (AEs) [ Time Frame: During the 8-day follow-up period (Day 1-Day 8) after each vaccination ]
    Assessed solicited general AEs are fever, irritability/fussiness, diarrhea, vomiting, loss of appetite and cough/runny nose. Any = occurrence of AE regardless of intensity grade or relation to vaccination.

  2. Percentages of subjects with any unsolicited AEs [ Time Frame: During the 31-day follow-up period (Day1-Day 31) after each vaccination ]
    An unsolicited AE is defined as any AE 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 AE. Potential unsolicited AEs include medically attended visits (defined as symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider), or AEs that were of concern to the parent(s)/Legally acceptable representative [LAR(s)]. Any = occurrence of AE regardless of intensity grade or relation to vaccination.

  3. Percentages of subjects with any serious adverse events (SAEs) [ Time Frame: Throughout the study period (Dose 1 [Day1] up to study end [Month 7-8]) ]
    An SAE is 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 vaccination.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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


Contacts
Layout table for location contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Center +44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com

  Show 39 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Layout table for investigator information
Study Director: GSK Clinical Trials GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)

Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03954743     History of Changes
Other Study ID Numbers: 208236
2018-001986-18 ( EudraCT Number )
First Posted: May 17, 2019    Key Record Dates
Last Update Posted: May 17, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Layout table for additional information
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:
Layout table for MeSH terms
Rotavirus Infections
Reoviridae Infections
RNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs