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Evaluation of Immunogenicity and Safety of Two Formulations of GSK Biologicals' Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 Weeks

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ClinicalTrials.gov Identifier: NCT02914184
Recruitment Status : Active, not recruiting
First Posted : September 26, 2016
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
The purpose of this study is to evaluate the clinical consistency of three production lots of the Porcine circovirus (PCV)-free liquid formulation of oral live attenuated human rotavirus (HRV) vaccine and to evaluate the PCV-free liquid formulation of HRV vaccine as compared to the currently licensed lyophilised formulation of the HRV vaccine in terms of immunogenicity, reactogenicity and safety when administered as a two-dose vaccination in healthy infants starting at age 6-12 weeks. No new subjects will be enrolled in the extension phase of the study

Condition or disease Intervention/treatment Phase
Rotavirus Vaccines Biological: HRV PCV-free liquid vaccine Biological: Rotarix Phase 3

Detailed Description:
  • Experimental design: Phase IIIA, observer-blind, randomised (1:1:1:1), controlled, multi-centric, with four parallel groups and a staggered enrolment (Part A and Part B).
  • Duration of the study: The intended duration of the study, per subject, will be approximately 7-8 months including the 6 months of extended safety follow-up period after the last dose of HRV vaccine.

    • Epoch 001: Primary starting at Visit 1 (Day 0) and ending at the safety follow-up contact (Month 7-8).
  • Primary completion Date (PCD): Visit 3 (Month 2-4).
  • End of Study (EoS): Last testing results released of samples collected at Visit 3 or Last Subject Last Visit (LSLV) (Follow up contact at month 7-8).
  • Study Groups:

    • PCV-free HRV liquid formulation lot A (also referred to as Liq_A Group)
    • PCV-free HRV liquid formulation lot B (also referred to as Liq_B Group)
    • PCV-free HRV liquid formulation lot C (also referred to as Liq_C Group)
    • GSK Biologicals' currently licensed lyophilised HRV formulation (also referred to as Lyo Group)
  • Control:active control-GSK Biologicals' currently licensed lyophilised HRV vaccine
  • Vaccination schedule: Two doses of HRV vaccine to be administered according to a 0, 1-2 month schedule according to the immunisation schedule for RV vaccine.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1613 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : October 27, 2016
Actual Primary Completion Date : June 27, 2018
Estimated Study Completion Date : December 7, 2018

Arm Intervention/treatment
Experimental: Liq_A Group
All subjects will receive two doses of PCV-free HRV liquid formulation lot A, at 6 and 12 weeks of age
Biological: HRV PCV-free liquid vaccine
Subjects will receive two doses of PCV-free HRV vaccine at 6 and 12 weeks of age. The vaccine will be administered orally

Experimental: Liq_B Group
All subjects will receive two doses of PCV-free HRV liquid formulation lot B, at 6 and 12 weeks of age
Biological: HRV PCV-free liquid vaccine
Subjects will receive two doses of PCV-free HRV vaccine at 6 and 12 weeks of age. The vaccine will be administered orally

Experimental: Liq_C Group
All subjects will receive two doses of PCV-free HRV liquid formulation lot C, at 6 and 12 weeks of age
Biological: HRV PCV-free liquid vaccine
Subjects will receive two doses of PCV-free HRV vaccine at 6 and 12 weeks of age. The vaccine will be administered orally

Active Comparator: Lyo Group
All subjects will receive two doses of currently licensed lyophilised HRV vaccine, at 6 and 12 weeks of age
Biological: Rotarix
Subjects will receive two doses of currently licensed lyophilised HRV vaccine at 6 and 12 weeks of age. The vaccine will be administered orally




Primary Outcome Measures :
  1. Evaluation of immunogenicity in terms of anti-RV antibody concentrations [ Time Frame: 1-2 months after Dose 2 ]
    Serum anti-RV IgA antibody concentrations expressed as GMCs in each of the HRV liquid formulation groups (Liq_A, Liq_B and Liq_C). Anti-RV IgA antibody seroconversion rate* in the lyophilised and pooled liquid groups. Serum anti-RV IgA antibody concentrations expressed as GMCs in the lyophilised and pooled liquid groups


Secondary Outcome Measures :
  1. Solicited adverse events [ Time Frame: Within the 8 days (Day 0-Day 7) follow-up period ]
    Occurrence of each general solicited symptom after each dose of the lyophilised and PCV-free HRV liquid vaccine

  2. Unsolicited adverse events [ Time Frame: Within 31 days (Day 0-Day 30) after any dose of HRV vaccine ]
    Occurrence of unsolicited AEs according to the Medical Dictionary for Regulatory Activities (MedDRA) classification

  3. Serious adverse events (SAEs) [ Time Frame: Dose 1 (Day 0) up to the study end (approximately 7-8 months) ]
    Occurrence of SAEs

  4. Evaluation of immunogenicity in terms of anti-RV antibody concentrations [ Time Frame: 1-2 months after Dose 2 ]
    Serum anti-RV IgA antibody concentrations ≥ 90 U/mL in the lyophilised and pooled liquid groups



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:

  • Subjects' parent(s)/LAR(s) who, in the opinion of the investigator can and will comply with the requirements of the protocol.
  • Written informed consent obtained from the parent(s)/LAR(s) (Legally acceptable representatives) 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
  • Use of any investigational or non-registered product 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 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.
  • 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.
  • Uncorrected congenital malformation 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.
  • 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.
  • 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.

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): NCT02914184


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Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02914184     History of Changes
Other Study ID Numbers: 115461
2016-000598-19 ( EudraCT Number )
First Posted: September 26, 2016    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018

Keywords provided by GlaxoSmithKline:
Safety
Healthy infants
Immunogenicity
Human Rotavirus (HRV)

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs