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Clinical Trials List

Protocol NumberRota-081 (115461)

2017-05-15 - 2019-05-31

Others

Terminated6

ICD-10A08.0

Rotaviral enteritis

ICD-10Z23

Encounter for immunization

ICD-9008.61

Enteritis due to Rotavirus

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.

  • Trial Applicant

    GlaxoSmithKline

  • Sponsor

    GlaxoSmithKline Biologicals

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator Kao-Pin Hwang Division of Pediatrics
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Cheng-Hsun Chiu Division of Pediatrics
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator PO - YEN CHEN Division of Pediatrics
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator 李明達 Division of Pediatrics
Hsinchu Mackay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Nan-Chang Chiu Division of Pediatrics
MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Li-Min Huang Division of Pediatrics
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Condition/Disease

Active immunisation of infants against gastroenteritis (GE) due to rotavirus (RV).

Objectives

 To demonstrate the lot-to-lot consistency of the PCV-free liquid HRV vaccine in terms of immunogenicity as measured by serum anti-RV IgA antibody concentrations 1-2 months after Dose 2. To demonstrate the immunological non-inferiority of PCV-free liquid HRV vaccine as compared to the currently licensed lyophilised HRV vaccine in terms of seroconversion rates 1-2 months after Dose 2. To demonstrate the non-inferiority of the PCV-free liquid HRV vaccine to that of the currently licensed lyophilised HRV vaccine in terms of serum anti-RV IgA antibody concentrations 1-2 months after Dose 2.

Test Drug

HRV PCV-free vaccine

Active Ingredient

HRV PCV-free vaccine

Dosage Form

Dosage

PCV-free HRV RIX4144 live attenuated >=106.0CCID50

Endpoints

 Evaluation of immunogenicity in terms of anti-RV
antibody concentrations
 Serum anti-RV IgA antibody concentrations expressed
as GMCs 1-2 months after Dose 2 in each of the HRV
liquid formulation groups (Liq_A, Liq_B and Liq_C).
 Anti-RV IgA antibody seroconversion rate* 1-2
months after Dose 2 in the lyophilised and pooled
liquid groups.
 Serum anti-RV IgA antibody concentrations expressed
as GMCs 1-2 months after Dose 2 in the lyophilised
and pooled liquid groups.
*Seroconversion rate is defined as the percentage of subjects
who were initially seronegative (i.e., with anti-RV IgA antibody
concentration < 20 U/mL prior the first dose of HRV vaccine)
and developed anti-RV IgA antibody concentration ≥ 20 U/mL
at Visit 3.
Secondary
 Solicited adverse events
 Occurrence of each general solicited symptom within
the 8 days (Day 0-Day 7) follow-up period after each
dose of the lyophilised and PCV-free HRV liquid
vaccine
 Unsolicited adverse events.
 Occurrence of unsolicited AEs within 31 days (Day 0-
Day 30) after any dose of HRV vaccine, according to
the Medical Dictionary for Regulatory Activities
(MedDRA) classification.
 Serious adverse events
 Occurrence of serious adverse events from Dose 1 up
to study end.
 Evaluation of immunogenicity in terms of anti-RV
antibody concentrations.
 Serum anti-RV IgA antibody concentrations ≥ 90
U/mL 1-2 months after Dose 2 in the lyophilised and
pooled liquid groups.

Inclution Criteria

 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 informed consent obtained from the parent(s)/LAR(s) 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

Exclusion Criteria

 Child in care
Please refer to the glossary of terms for the definition of child in care.
 Use of any investigational or non-registered product (drug or vaccine) 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 (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.
 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 (e.g., infliximab).
 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.
 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 (pharmaceutical product or device).
 Uncorrected congenital malformation (such as Meckel’s diverticulum) 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 (no laboratory testing required).
 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 (warrants deferral of
the vaccination).
 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.

The Estimated Number of Participants

  • Taiwan

    120 participants

  • Global

    1600 participants

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