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
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
2018-09-10
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
Location
GSK Investigational Site
Bronx, New York, United States, 10468
Status
Study Complete
Location
GSK Investigational Site
Charleston, South Carolina, United States, 29407
Status
Study Complete
Location
GSK Investigational Site
Charlottesville, Virginia, United States, 22902
Status
Study Complete
Location
GSK Investigational Site
Cleveland, Ohio, United States, 44121
Status
Study Complete
Location
GSK Investigational Site
Colorado Springs, Colorado, United States, 80922
Status
Study Complete
Location
GSK Investigational Site
Daly City, California, United States, 94015
Status
Study Complete
Location
GSK Investigational Site
Dayton, Ohio, United States, 45406
Status
Study Complete
Location
GSK Investigational Site
Dayton, Ohio, United States, 45414
Status
Study Complete
Location
GSK Investigational Site
Dayton, Ohio, United States, 45419
Status
Study Complete
Location
GSK Investigational Site
Fall River, Massachusetts, United States, 02721
Status
Study Complete
Location
GSK Investigational Site
Fayetteville, Arkansas, United States, 72703
Status
Study Complete
Location
GSK Investigational Site
Fort Worth, Texas, United States, 76107
Status
Study Complete
Location
GSK Investigational Site
Frederick, Maryland, United States, 21702
Status
Study Complete
Location
GSK Investigational Site
Galveston, Texas, United States, 77555
Status
Study Complete
Location
GSK Investigational Site
Grove City, Ohio, United States, 43123
Status
Study Complete
Location
GSK Investigational Site
Hermitage, Pennsylvania, United States, 16148
Status
Study Complete
Location
GSK Investigational Site
Jonesboro, Arkansas, United States, 72401
Status
Study Complete
Location
GSK Investigational Site
Kaysville, Utah, United States, 84037
Status
Study Complete
Location
GSK Investigational Site
Kingsport, Tennessee, United States, 37660
Status
Study Complete
Location
GSK Investigational Site
Layton, Utah, United States, 84041
Status
Study Complete
Location
GSK Investigational Site
Lincoln, Nebraska, United States, 68504
Status
Study Complete
Location
GSK Investigational Site
Lincoln, Nebraska, United States, 68505
Status
Study Complete
Location
GSK Investigational Site
Lincoln, Nebraska, United States, 68522
Status
Study Complete
Location
GSK Investigational Site
Louisville, Kentucky, United States, 40202
Status
Study Complete
Location
GSK Investigational Site
Marshfield, Wisconsin, United States, 54449
Status
Study Complete
Location
GSK Investigational Site
Miami, Florida, United States, 33142
Status
Study Complete
Location
GSK Investigational Site
Murray, Utah, United States, 84107
Status
Study Complete
Location
GSK Investigational Site
N Charleston, South Carolina, United States, 29406-9170
Status
Study Complete
Location
GSK Investigational Site
Nampa, Idaho, United States, 83686
Status
Study Complete
Location
GSK Investigational Site
Oakland, California, United States, 94611
Status
Study Complete
Location
GSK Investigational Site
Orem, Utah, United States, 84057
Status
Study Complete
Location
GSK Investigational Site
Provo, Utah, United States, 84604
Status
Study Complete
Location
GSK Investigational Site
Raleigh, North Carolina, United States, 27609
Status
Study Complete
Location
GSK Investigational Site
Roy, Utah, United States, 84067
Status
Study Complete
Location
GSK Investigational Site
South Jordan, Utah, United States, 84095
Status
Study Complete
Location
GSK Investigational Site
Syracuse, New York, United States, 13202
Status
Study Complete
Location
GSK Investigational Site
Syracuse, Utah, United States, 84075
Status
Study Complete
Location
GSK Investigational Site
Tampa, Florida, United States, 33617
Status
Study Complete
Location
GSK Investigational Site
Tomball, Texas, United States, 77375
Status
Study Complete
Location
GSK Investigational Site
Walnut Creek, California, United States, 94596
Status
Study Complete
Location
GSK Investigational Site
West Covina, California, United States, 91790
Status
Study Complete

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
Completed
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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