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Completed

NCT Number: NCT00678301

Primary Vaccination Course in Children Receiving the Pneumococcal Vaccine GSK 1024850A, Zilbrix™ Hib and Polio Sabin™

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.

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Key information

Conditions

Infections, Streptococcal Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Streptococcal Infections

Age range

6 week–10 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Bamako, Mali

Loading trial locations.

About this study

Vaccination course at 6, 10, 14 weeks of age.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GSK Biologicals' Synflorix™

Biological

3 IM doses.

Other names: 10Pn

GSK Biologicals' Polio Sabin™

Biological

3 oral doses

Other names: OPV

GSK Biologicals' Zilbrix™ Hib

Biological

3 IM doses.

Other names: DTPw-HBV/Hib vaccine

Primary outcomes

  1. Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes

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

    Pneumococcal serotypes assessed were vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Seropositivity cut-off for the assay was an anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) concentrations greater than or equal to (≥) 0.05 microgram per milliliter (μg/mL).

  2. Antibody Concentrations Against Protein D (Anti-PD Antibodies)

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

    Anti-PD antibody concentrations were expressed in enzyme-linked immunsorbent assay (ELISA) units per milliliter (EL.U/mL). Seropositivity cut-off for the assay was an anti-PD antibody concentrations ≥ 100 EL.U/mL.

Secondary outcomes

  1. Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and -19A)

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

    Seropositivity status was defined as anti-pneumococcal cross-reactive serotypes 6A/19A antibody concentrations (Anti-6A/19A) ≥ 0.05 microgram per milliliter (μg/mL).

  2. Titers for Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes

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

    Pneumococcal serotypes assessed were vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Seropositivity status was defined as an opsonophagocytic activity against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (OPA-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) ≥ 8.

  3. Titers for Opsonophagocytic Activity (OPA) Against Cross-reactive Pneumococcal Serotypes

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

    Pneumococcal serotypes assessed were cross-reactive pneumococcal serotypes 6A and 19A. Seropositivity status was defined as an opsonophagocytic activity against cross-reactive pneumococcal serotypes 6A and 19A (OPA-6A and 19A) ≥ 8.

  4. Number of Subjects Seropositive for Antibodies Against Vaccine Pneumococcal Serotypes

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

    Pneumococcal serotypes assessed were vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Seropositivity cut-off for the assay was an anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) concentrations ≥ 0.05 microgram per milliliter (μg/mL).

  5. Number of Subjects Seroprotected Against Vaccine Pneumococcal Serotypes

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

    Pneumococcal serotypes assessed were vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Seroprotection cut-off for the assay was an anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) concentrations ≥ 0.2 microgram per milliliter (μg/mL).

  6. Number of Subjects Seropositive for Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and -19A)

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

    Serotypes assessed were cross-reactive pneumococcal serotypes 6A and 19A. Seropositivity status was defined as anti-pneumococcal cross-reactive serotypes 6A/19A antibody concentrations (Anti-6A/19A) ≥ 0.05 microgram per milliliter (μg/mL).

  7. Number of Subjects Seroprotected Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and -19A)

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

    Serotypes assessed were cross-reactive pneumococcal serotypes 6A and 19 A. Seroprotection cut-off for the assay was an anti-6A/19A antibody concentrations ≥ 0.2 microgram per milliliter (μg/mL).

  8. Number of Subjects Seropositive for Antibodies Against Protein D (Anti-PD Antibodies)

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

    Seropositivity cut-off for the assay was an anti-PD antibody concentrations ≥ 100 EL.U/mL.

  9. Number of Subjects Seropositive for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes

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

    Pneumococcal serotypes assessed were vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Seropositivity status was defined as an opsonophagocytic activity against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (OPA-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) ≥ 8.

  10. Number of Subjects Seropositive for Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes

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

    Pneumococcal serotypes assessed were cross-reactive pneumococcal serotypes 6A and 19A. Seropositivity status was defined as an opsonophagocytic activity against cross-reactive pneumococcal serotypes 6A and 19A (OPA-6A and 19A) ≥ 8.

  11. Anti-Bordetella Pertussis (Anti-BPT) Antibody Concentrations

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

    Anti-BPT antibody concentrations were expressed in enzyme-linked immunosorbent assay (ELISA) unit per millilitre (EL.U/mL). Seropositivity cut-off for the assay was defined as an anti-BPT antibody concentrations ≥ 15 EL.U/mL

  12. Number of Subjects Seropositive for Antibodies Against Bordetella Pertussis (Anti-BPT)

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

    Seropositivity cut-off for the assay was defined as an anti-BPT antibody concentration ≥ 15 enzyme-linked immunosorbent assay (ELISA) unit per milliliter (EL.U/mL).

  13. Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations

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

    The seroprotection cut-off for the assay was an anti-diphtheria toxoid or anti-tetanus toxoid antibody concentrations ≥ 0.1 international unit per milliliter (IU/mL).

  14. Number of Subjects Seroprotected Against Diphtheria (D) and Tetanus Toxoids (TT) Antigens

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

    A subject seroprotected against D/TT antigens was defined as a subject with an Anti-D/-TT antibody concentration ≥ 0.1 IU/mL.

  15. Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations

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

    Anti-PRP antibody concentrations were measured and tabulated in microgram per milliliter (μg/mL). Cut-off for the assay was ≥ 0.15 μg/mL.

  16. Number of Subjects Seroprotected Against Polyribosyl-ribitol Phosphate (PRP)

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

    Anti-PRP antibody concentrations were expressed in microgram per milliliter (μg/mL). The seroprotection cut-off applied for the assay was ≥ 0.15 μg/mL.

  17. Number of Subjects Seroprotected Against Polyribosyl-ribitol Phosphate (PRP) Antigens

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

    Anti-PRP antibody concentrations were expressed in microgram per milliliter (μg/mL). The seroprotection cut-off applied for the assay was ≥ 1 μg/mL.

  18. Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations

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

    The seroprotection cut-off for the endpoint was an anti-HBs antibody concentration ≥ 10 milli-international units per milliliter (mIU/mL).

  19. Number of Subjects Seroprotected Against Anti-Hepatitis B Surface Antigens (HBs).

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

    The seroprotection cut-off values considered for this endpoint were an anti-HBs antibody concentration ≥ 10 and 100 milli-international units per milliliter (mIU/mL).

  20. Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms

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

    Solicited local symptoms assessed included pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/ spontaneously painful. Grade 3 swelling/ redness was defined as swelling/ redness greater than (>) 30 millimeters (mm). "Any" was defined as incidence of the specified symptom regardless of intensity.

  21. Number of Subjects With Any and Any Grade 3 and Related Solicited General Symptoms

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

    Solicited general symptoms assessed include drowsiness, fever (defined as rectal temperature ≥ 38.0°C), irritability, and loss of appetite. "Any" was defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (rectal temperature) greater than (>) 40.0 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/ preventing normal activity. Grade 3 loss of appetite was defined as the subject not eating at all.

  22. Number of Subjects With Fever (Temperature Measured Rectally) > the Cut-off

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

    The cut-off for the assay was > 39.0°C.

  23. Number of Subjects With Unsolicited Adverse Events (AEs)

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

    An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. "Any" was defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.

  24. Number of Subjects With Serious Adverse Events (SAEs)

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

    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/ incapacity.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Primary Vaccination Course in Children Receiving the Pneumococcal Vaccine GSK 1024850A Co-administered With Zilbrix™ Hib and Polio Sabin™

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
May 15, 2008
Registry last updated
Nov 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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