Last updated: 11/03/2018 08:40:28

Safety of Hib-MenCY-TT vaccine versus licensed Hib conjugate vaccine, given at 2, 4, 6 and 12 to 15 months of age

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GSK study ID
105987
See study documents
Clinicaltrials.gov ID
NCT00345579
See results summary
EudraCT ID
2005-006066-34
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: A single-blind, randomized, controlled, multinational study for the evaluation of safety of GlaxoSmithKline (GSK) Biologicals’ investigational vaccination regimen compared to monovalent Haemophilus influenzae type b (Hib) control vaccine in healthy infants at 2, 4, 6, and 12 to 15 months of age.
Trial description: The primary phase of this study is evaluating the safety of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine, when each are co-administered with Pediarix® to healthy infants at 2, 4, and 6 months of age.
This protocol posting deals with objectives & outcome measures of the primary phase of the study. The objectives & outcome measures of the Booster phase are presented in a separate protocol posting (NCT number = 00345683).
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Single (Participant)
Allocation:
Randomized
Primary outcomes:

Number of subjects reporting Serious Adverse Events (SAEs)

Timeframe: From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5)

Number of subjects reporting New Onset of Chronic Illnesses (NOCIs)

Timeframe: From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5)

Number of subjects reporting rash

Timeframe: From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5)

Number of subjects reporting Adverse Events resulting in Emergency Room (ER)

Timeframe: From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5)

Number of subjects with Serious Adverse Events (SAEs)

Timeframe: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)

Number of subjects with New Onset of Chronic illnesses (NOCIs)

Timeframe: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)

Number of subjects with rash

Timeframe: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)

Number of subjects with Adverse Events resulting in Emergency Room (ER)

Timeframe: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)

Secondary outcomes:
Not applicable
Interventions:
  • Biological/vaccine: GSK Biologicals’ Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine combined 792014
  • Biological/vaccine: ActHIB
  • Biological/vaccine: Pediarix/Infanrix Penta
    • Enrollment:
    4432
    Primary completion date:
    2007-27-10
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Bryant KA et al. (2011) Haemophilus influenzae type b–Neisseria meningitidis serogroups C and Y tetanus toxoid conjugate vaccine for infants and toddlers. Expert Rev Vaccines.10(7):941-950.
    Rinderknecht S et al. (2012) The safety profile of Haemophilus influenzae type b–Neisseria meningitidis serogroups C and Y tetanus toxoid conjugate vaccine (HibMenCY). Hum Vaccin Immunother. 8(3). [Epub ahead of print].
    Medical condition
    Haemophilus influenzae type b, Neisseria Meningitidis
    Product
    SB217744, SB792014
    Collaborators
    Not applicable
    Study date(s)
    September 2006 to March 2008
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    6 - 12 weeks
    Accepts healthy volunteers
    Yes
    • Subjects for whom the investigator believes that parents/guardians can and will comply with the requirements of the protocol.
    • A male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination.
    • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
    • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Subjects for whom the investigator believes that parents/guardians can and will comply with the requirements of the protocol.
    • A male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination.
    • Written informed consent obtained from the parent or guardian of the subject.
    • Healthy subjects as established by medical history and clinical examination before entering into the study.
    • Born after 36 weeks gestation.
    • Infants who have not received a previous dose of hepatitis B vaccine or those who have received only 1 dose of hepatitis B vaccine administered at least 30 days prior to enrolment.
    • Infants may have received a birth dose of Bacillus Calmette-Guérin (BCG) vaccine.
    Exclusion criteria:
    • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
    • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
    • Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of study vaccine(s).
    • Previous vaccination against Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, and/or poliovirus; more than one previous dose of hepatitis B vaccine.
    • In country(ies) where Prevnar will be provided by GSK Biologicals, previous vaccination with Prevnar.
    • History of Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, hepatitis B, and/or poliovirus disease.
    • Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
    • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, including dry natural latex rubber.
    • Major congenital defects or serious chronic illness.
    • History of any neurologic disorders or seizures.
    • Acute disease at time of enrollment.
    • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
    • Concurrent participation 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 product (pharmaceutical product or device).

    Trial location(s)

    Location
    Status
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    Location
    GSK Investigational Site
    Deerfield, North Carolina, United States, 28607
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Pittsburgh, Pennsylvania, United States, 15241
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Charleston, South Carolina, United States, 29406
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Jonesboro, Arkansas, United States, 72401
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Boulder, Colorado, United States, 80303
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Birmingham, Alabama, United States, 35244
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Pleasant Gorve, Utah, United States, 84062
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Birmingham, Alabama, United States, 35235
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Clyde, North Carolina, United States, 28721
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    South Jordan, Utah, United States, 84095
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Bardstown, Kentucky, United States, 40004
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Cleveland, Ohio, United States, 44121
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Akron, Ohio, United States, 44308-1062
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    New Hartford, New York, United States, 13413
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Bossier City, Louisiana, United States, 71111
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Madison, Wisconsin, United States, 53792
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Katy, Texas, United States, 77450
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Mexico, D.F., Mexico, 06720
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Pittsburgh, Pennsylvania, United States, 15202
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Kingsport, Tennessee, United States, 37660
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Boston, Massachusetts, United States, 02111
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Fresno, California, United States, 93726
    Status
    Study Complete
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    Location
    GSK Investigational Site
    West Jordan, Utah, United States, 84088
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Salt Lake City, Utah, United States, 84109
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Waukee, Iowa, United States, 50263
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Lexington, Kentucky, United States, 40503
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Pittsburgh, Pennsylvania, United States, 15236
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Little Rock, Arkansas, United States, 72201
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Fresno, California, United States, 93710
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Nies, Michigan, United States, 49120
    Status
    Study Complete
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    Location
    GSK Investigational Site
    North Canton, Ohio, United States, 44720
    Status
    Study Complete
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    Location
    GSK Investigational Site
    West Covina, California, United States, 91790
    Status
    Study Complete
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    Location
    GSK Investigational Site
    South Euclid, Ohio, United States, 44121
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Nampa, Idaho, United States, 208 463 3126
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Wexford, Pennsylvania, United States, 15090
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Layton, Utah, United States, 84041
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Raleigh, North Carolina, United States, 27609
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Sylva, North Carolina, United States, 28779
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Fayetteville, Arkansas, United States, 72703
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Portage, Michigan, United States, 49024
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Marshfield, Wisconsin, United States, 54449
    Status
    Study Complete
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    Location
    GSK Investigational Site
    St. Paul, Minnesota, United States, 55108
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Ogden, Utah, United States, 84405
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Kingsport, Tennessee, United States, 37664
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Orem, Utah, United States, 84057
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Plantation, Florida, United States, 33324
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Syracuse, New York, United States, 13210
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Jamaica Plain, Massachusetts, United States, 02130
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Slinas, California, United States, 93901
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Benton, Arkansas, United States, 72015
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Fountain Valley, California, United States, 92708
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Las Vegas, Nevada, United States, 89104
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Hot Springs, Arkansas, United States, 71913
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Oaklawn, Illinois, United States, 60453
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Pittsburgh, Pennsylvania, United States, 15227
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Stevensville, Michigan, United States, 49127
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Houston, Texas, United States, 77084
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Madera, California, United States, 93637
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Canton, Ohio, United States, 44718
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Little Rock, Arkansas, United States, 72205
    Status
    Study Complete
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    Location
    GSK Investigational Site
    West Desmoines, Iowa, United States, 50266
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Longmont, Colorado, United States, 80501
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Mexico city, Mexico, 04530
    Status
    Study Complete
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    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    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
    2007-27-10
    Actual study completion date
    2008-28-03

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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