Last updated: 12/23/2020 03:50:05

This study will evaluate the immunogenicity, reactogenicity and safety of the routine infant vaccines Pediarix®, Hiberix® and Prevenar 13® when co-administered with GlaxoSmithKline (GSK) Biologicals’ liquid human rotavirus vaccine (HRV) as compared to GSK’s licensed lyophilized vaccine

GSK study ID
201663
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Immunogenicity, reactogenicity and safety study of Pediarix®, Hiberix® and Prevenar 13® co-administered with two different formulations of GSK Biologicals’ HRV vaccine (444563) in healthy infants 6-12 weeks of age
Trial description: The purpose of this study is to assess if there is any immune interference between the Porcine circovirus free (PCV-free) liquid Human rotavirus (HRV) vaccine and routine infant vaccinations currently in use in the US, namely Pediarix®, Hiberix® and Prevenar 13® as compared to the currently licensed lyophilized formulation of the HRV vaccine when co-administered with the same routine vaccinations in healthy infants 6-12 weeks of age
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Single (Participant)
Allocation:
Randomized
Primary outcomes:

Number of seroprotected subjects with anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibody concentrations above or equal to cut-off value.

Timeframe: One month after Dose 3 of co-administered vaccines (at Month 5).

Number of seroprotected subjects with anti-hepatitis B (anti-HBs) antibody concentrations above or equal to cut-off value.

Timeframe: One month after Dose 3 of co-administered vaccines (at Month 5).

Number of seroprotected subjects with anti-polio virus types 1, 2 and 3 antibody titers above or equal to cut-off value.

Timeframe: One month after Dose 3 of co-administered vaccines (at Month 5).

Immunogenicity in terms of anti-pertussis toxoid (anti-PT), anti-filamentous hemagglutinin (anti-FHA) and anti-pertactin (anti-PRN) antibody concentrations.

Timeframe: One month after Dose 3 of co-administered vaccines (at Month 5).

Immunogenicity in terms of anti-pneumococcal serotypes (anti-PnPS) antibody concentrations.

Timeframe: One month after Dose 3 of co-administered vaccines (at Month 5).

Number of seroprotected subjects with anti-polyribosyl ribitol phosphate (anti-PRP) antibody concentrations above or equal to cut-off value of 0.15 µg/mL.

Timeframe: One month after Dose 3 of co-administered vaccines (at Month 5).

Number of seroprotected subjects with anti-polyribosyl ribitol phosphate (anti-PRP) antibody concentrations above or equal to cut-off value of 1.0 µg/mL.

Timeframe: One month after Dose 3 of co-administered vaccines (at Month 5).

Number of subjects with seroresponse to anti-pertussis toxoid (anti-PT), anti-filamentous hemagglutinin (anti-FHA) and anti-pertactin (anti-PRN) antibodies.

Timeframe: One month after Dose 3 of co-administered vaccines (at Month 5).

Secondary outcomes:

Number of seropositive subjects with anti-Rota virus Immunoglobulin A (anti-RV IgA) antibody concentrations above or equal to cut-off value of 20 Units/milliliter (U/mL).

Timeframe: Three months after Dose 2 of HRV vaccine (at Month 5).

Number of seropositive subjects with anti-RV IgA antibody concentrations above or equal to cut-off value of 90 U/mL.

Timeframe: Three months after Dose 2 of HRV vaccine (at Month 5).

Number of seropositive subjects with anti-PT, anti-FHA and anti-PRN antibody concentrations above or equal to cut-off value.

Timeframe: One month after Dose 3 of co-administered vaccines (at Month 5).

Number of seropositive subjects with anti-PnPS antibody concentrations above or equal to cut-off value.

Timeframe: One month after Dose 3 of co-administered vaccines (at Month 5).

Immunogenicity in terms of anti-D and anti-T antibody concentrations.

Timeframe: One month after Dose 3 of co-administered vaccines (at Month 5).

Immunogenicity in terms of anti-PRP antibody concentrations.

Timeframe: One month after Dose 3 of co-administered vaccines (at Month 5).

Immunogenicity in terms of anti-HBs antibody concentrations.

Timeframe: One month after Dose 3 of co-administered vaccines (at Month 5).

Immunogenicity in terms of anti-poliovirus types 1, 2 and 3 antibody titers.

Timeframe: One month after Dose 3 of co-administered vaccines (at Month 5).

Number of subjects with any solicited general adverse events (AEs).

Timeframe: During the 8-day (Days 1-8) follow-up period after each HRV vaccination.

Number of subjects with any unsolicited AEs.

Timeframe: During the 31-day (Days 1-31) follow-up period after each HRV vaccination.

Number of subjects with any serious adverse events (SAEs).

Timeframe: During the entire study period (Day 1 to Month 10)

Interventions:
  • Biological/vaccine: Rotarix
  • Biological/vaccine: Pediarix
  • Biological/vaccine: Hiberix
  • Biological/vaccine: Prevenar 13
  • Enrollment:
    1280
    Primary completion date:
    2018-09-10
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Remon Abu-Elyazeed, Nicola Klein, Leentje Moerman, Michael Povey, Anthony Pruitt, Shelly Senders, Peter Silas and Dan Bi on behalf of the Rota-090 Study Group. CLI_Rota-090_ Concomitant administration of a liquid formulation of human rotavirus vaccine (porcine circovirus-free) with routine childhood vaccines in infants in the United States: Results from a phase 3, randomized trial. Vaccine. 2020 Oct 16;S0264-410X(20)31122-1. doi: 10.1016/j.vaccine.2020.08.070. Online ahead of print.
    Medical condition
    Rotavirus Infection
    Product
    SB444563
    Collaborators
    Not applicable
    Study date(s)
    September 2017 to March 2019
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    6 - 12 weeks
    Accepts healthy volunteers
    Yes
    • Subjects’ parent(s)/[LAR(s)] who, in the opinion of the investigator can and will comply with the requirements of the protocol.
    • A male or female between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination.
    • 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 1), or planned use during the study period.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Altamonte Springs, Florida, United States, 32701
    Status
    Study Complete
    Location
    GSK Investigational Site
    Bardstown, Kentucky, United States, 40004
    Status
    Study Complete
    Location
    GSK Investigational Site
    Bingham Farms, Michigan, United States, 48025
    Status
    Study Complete
    Location
    GSK Investigational Site
    Birmingham, Alabama, United States, 35205
    Status
    Study Complete
    Location
    GSK Investigational Site
    Boone, North Carolina, United States, 28607
    Status
    Study Complete
    Location
    GSK Investigational Site
    Boynton Beach, Florida, United States, 33435
    Status
    Study Complete
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    Study documents

    Clinical study report
    Available language(s): English
    Protocol
    Available language(s): English
    Statistical analysis plan
    Available language(s): English

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2018-09-10
    Actual study completion date
    2019-01-03

    Plain language summaries

    Summary of results in plain language
    Available language(s): English, Spanish (United States)

    To view plain language summaries on trialsummaries.com click here.

    Additional information about the trial

    Additional information
    Not applicable
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