Last updated: 06/11/2019 13:50:18

Primary vaccination course in children receiving the pneumococcal vaccine GSK 1024850A, Zilbrix™ Hib and Polio Sabin™

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GSK study ID
110521
See study documents
Clinicaltrials.gov ID
NCT00678301
See results summary
EudraCT ID
2011-004650-25
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: Primary vaccination course in children receiving the pneumococcal vaccine GSK 1024850A co-administered with Zilbrix™ Hib and Polio Sabin™
Trial description: The purpose of this study is to assess the immunogenicity in terms of antibody response and the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse events following primary vaccination of African Sub-Saharan infants with pneumococcal conjugate vaccine GSK 1024850A co-administered with a diphtheria, tetanus, whole cell pertussis (DTPw)-combined vaccine and oral polio vaccine in children during the first 4 months of life.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Concentrations of antibodies against vaccine pneumococcal serotypes

Timeframe: At Month 3, one month after the administration of the third dose of Synflorix vaccine

Antibody concentrations against protein D (anti-PD antibodies)

Timeframe: At Month 3, one month after the administration of the third dose of Synflorix vaccine

Secondary outcomes:

Concentrations of antibodies against cross-reactive pneumococcal serotypes 6A and 19A (Anti-6A and -19A)

Timeframe: At Month 3, one month after the administration of the third dose of Synflorix vaccine

Titers for opsonophagocytic activity (OPA) against vaccine pneumococcal serotypes

Timeframe: At Month 3, one month after the administration of the third dose of Synflorix vaccine

Titers for opsonophagocytic activity (OPA) against cross-reactive pneumococcal serotypes

Timeframe: At Month 3, one month after the administration of the third dose of Synflorix vaccine

Number of subjects seropositive for antibodies against vaccine pneumococcal serotypes

Timeframe: At Month 3, one month after the administration of the third dose of Synflorix vaccine

Number of subjects seroprotected as regards antibodies against vaccine pneumococcal serotypes

Timeframe: At Month 3, one month after the administration of the third dose of Synflorix vaccine

Number of subjects seropositive as regards antibodies against cross-reactive pneumococcal serotypes 6A and 19A (Anti-6A and -19A)

Timeframe: At Month 3, one month after the administration of the third dose of Synflorix vaccine

Number of subjects seroprotected as regards antibodies against cross-reactive pneumococcal serotypes 6A and 19A (Anti-6A and -19A)

Timeframe: At Month 3, one month after the administration of the third dose of Synflorix vaccine

Number of subjects seropositive as regards antibodies against protein D (Anti-PD antibodies)

Timeframe: At Month 3, one month after the administration of the third dose of Synflorix vaccine

Number of subjects seropositive as regards opsonophagocytic activity against vaccine pneumococcal serotypes

Timeframe: At Month 3, one month after the administration of the third dose of Synflorix vaccine

Number of subjects seropositive as regards opsonophagocytic activity against cross-reactive pneumococcal serotypes

Timeframe: At Month 3, one month after the administration of the third dose of Synflorix vaccine

Anti-Bordetella pertussis (anti-BPT) antibody concentrations

Timeframe: At Month 3, one month after the administration of the third dose of Synflorix vaccine

Number of subjects seropositive as regards anti-Bordetella pertussis (anti-BPT) antibodies

Timeframe: At Month 3, one month after the administration of the third dose of DTPw-HBV/Hib vaccine

Anti-diphtheria (Anti-D) and anti-tetanus toxoids (Anti-TT) antibody concentrations

Timeframe: At Month 3, one month after the administration of the third dose of Tritanrix -HepB/ Hiberix vaccine

Number of subjects seroprotected as regards anti-diphtheria (Anti D) and anti-tetanus toxoids (Anti TT) antibodies

Timeframe: At Month 3, one month after the administration of the third dose of Tritanrix -HepB/ Hiberix vaccine

Anti-polyribosyl-ribitol-phosphate (Anti-PRP) antibody concentrations

Timeframe: At Month 3, one month after the administration of the third dose of Tritanrix -HepB/ Hiberix vaccine

Number of subjects seroprotected as regards anti-polyribosyl-ribitol phosphate (anti-PRP) antibodies ≥ the cut-off.

Timeframe: At Month 3, one month after the administration of the third dose of Tritanrix -HepB/ Hiberix vaccine

Number of subjects seroprotected as regards anti-polyribosyl-ribitol phosphate (anti-PRP) antibodies ≥ the cut-off

Timeframe: At Month 3, one month after the administration of the third dose of Tritanrix -HepB/ Hiberix vaccine

Anti-hepatitis B surface antigen (HBs) antibody concentrations

Timeframe: At Month 3, one month after the administration of the third dose of Tritanrix -HepB /Hiberix vaccine

Number of subjects seroprotected as regards anti-Hepatitis B surface antigen (HBs) antibodies.

Timeframe: At Month 3, one month after the administration of the third dose of Tritanrix HepB/ Hiberix vaccine

Number of subjects with any and any Grade 3 solicited local symptoms

Timeframe: Within the 4-day (Days 0 to 3) follow-up periods after each vaccination, across doses and across vaccines

Number of subjects with any and any Grade 3 and related solicited general symptoms

Timeframe: Within the 4-day (Days 0 to 3) follow-up periods after each vaccination, across doses and across vaccines

Number of subjects with fever (temperature measured rectally) > the cut-off

Timeframe: Within the 4-day (Days 0 to 3) follow-up periods after each vaccination, across doses and across vaccines

Number of subjects with unsolicited adverse events (AEs)

Timeframe: Within the 31-day (Days 0-30) follow-up periods post vaccination, across doses and across vaccines

Number of subjects with serious adverse events (SAEs)

Timeframe: Throughout the entire study period, from Month 0 to Month 3

Interventions:
  • Biological/vaccine: GSK Biologicals’ Synflorix™
  • Biological/vaccine: GSK Biologicals’ Polio Sabin™
  • Biological/vaccine: GSK Biologicals’ Zilbrix™ Hib
    • Enrollment:
    365
    Primary completion date:
    2009-09-11
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Dicko A et al. (2011) Primary vaccination with the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in infants in Mali and Nigeria: a randomized controlled trial. BMC Public Health. 11(1):882.
    Odusanya OO et al. (2013) Immunogenicity, Safety and Reactogenicity of the 10-Valent Pneumococcal Non-typeable Haemophilus influenzae Protein D Conjugate Vaccine (PHiD-CV) in Nigerian Infants: A Randomized Trial. The Nigerian Postgraduate Medical Journal. 20(4):272-281.
    Silfverdal SA et al. (2016) Safety profile of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV). Expert Rev Vaccines. 2017 Feb;16(2):109-121.
    Medical condition
    Infections, Streptococcal
    Product
    GSK1024850A
    Collaborators
    Not applicable
    Study date(s)
    June 2008 to December 2009
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    6 - 10 weeks
    Accepts healthy volunteers
    Yes
    • Male or female subjects between, and including 6-10 weeks of age at the time of the first vaccination.
    • Subjects for whom the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol should be enrolled in the study.
    • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of the study vaccines, or planned use during the study period.
    • 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 product (pharmaceutical product or device).
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Male or female subjects between, and including 6-10 weeks of age at the time of the first vaccination.
    • Subjects for whom the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol should be enrolled in the study.
    • Written or oral, signed or thumb-printed informed consent obtained from the parent(s)/guardian(s) of the child/ward. Where parent(s)/guardian(s) are illiterate, the consent form will be countersigned by a witness.
    • Free of any known or suspected health problems (as established by medical history and clinical examination before entering into the study), that would contraindicate the initiation of routine immunizations outside a clinical trial context.
    Exclusion criteria:
    • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of the study vaccines, or planned use during the study period.
    • 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 product (pharmaceutical product or device).
    • Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
    • A family history of congenital or hereditary immunodeficiency.
    • Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
    • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period (Hepatitis B immunoglobulins at birth are allowed).
    • Previous vaccination against, diphtheria, tetanus, pertussis, Haemophilus influenzae type b and/or Streptococcus pneumoniae.
    • History of, or intercurrent diphtheria, tetanus, pertussis, hepatitis B, Streptococcus and Haemophilus influenzae type b disease.
    • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
    • History of any neurological disorders or seizures.
    • Major congenital defects or serious chronic illness.
    • Acute disease at the time of enrolment. Study entry should be delayed until the illness has improved.
    • Babies for which birth weight is < 2 kilogram (if known) at Visit 1

    Trial location(s)

    Location
    Status
    Contact us
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    Location
    GSK Investigational Site
    Bamako, Mali
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Ikeja / Lagos, Nigeria, P.M.B. 21266
    Status
    Study Complete
    Contact us

    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
    2009-09-11
    Actual study completion date
    2009-10-12

    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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