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

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ClinicalTrials.gov Identifier: NCT00678301
Recruitment Status : Completed
First Posted : May 15, 2008
Results First Posted : October 27, 2017
Last Update Posted : October 27, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Infections, Streptococcal Biological: GSK Biologicals' Synflorix™ Biological: GSK Biologicals' Polio Sabin™ Biological: GSK Biologicals' Zilbrix™ Hib Phase 3

Detailed Description:
Vaccination course at 6, 10, 14 weeks of age.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 365 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Primary Vaccination Course in Children Receiving the Pneumococcal Vaccine GSK 1024850A Co-administered With Zilbrix™ Hib and Polio Sabin™
Actual Study Start Date : June 18, 2008
Primary Completion Date : November 9, 2009
Study Completion Date : December 10, 2009


Arms and Interventions

Arm Intervention/treatment
Experimental: SYNFLORIX™ + ZILBRIX™ HIB + POLIO SABIN™
Subjects in this group received 3 doses of Synflorix™ vaccine, according to a 3-dose schedule at 6-10-14 weeks of age co-administered with 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to the same schedule. The Synflorix™ and Zilbrix™ Hib vaccines were administered by intramuscular injection, in the right and left thigh respectively. The Polio Sabin™ vaccine was administered orally.
Biological: GSK Biologicals' Synflorix™
3 IM doses.
Other Name: 10Pn
Biological: GSK Biologicals' Polio Sabin™
3 oral doses
Other Name: OPV
Biological: GSK Biologicals' Zilbrix™ Hib
3 IM doses.
Other Name: DTPw-HBV/Hib vaccine
Experimental: ZILBRIX™ HIB + POLIO SABIN™
Subjects in this group received 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to a 3-dose schedule at 6-10-14 weeks of age. The Zilbrix™ Hib vaccine was administered by intramuscular injection, in the left thigh. The Polio Sabin™ vaccine was administered orally.
Biological: GSK Biologicals' Polio Sabin™
3 oral doses
Other Name: OPV
Biological: GSK Biologicals' Zilbrix™ Hib
3 IM doses.
Other Name: DTPw-HBV/Hib vaccine


Outcome Measures

Primary Outcome Measures :
  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 immunorbent 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 Outcome Measures :
  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 as Regards 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. 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 as Regards 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 as Regards 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 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 as Regards 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 as Regards 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 as Regards 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 as Regards Anti-Bordetella Pertussis (Anti-BPT) Antibodies [ 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 millliter (IU/mL).

  14. Number of Subjects Seroprotected as Regards Anti-diphtheria (Anti D) and Anti-tetanus Toxoids (Anti TT) Antibodies [ Time Frame: At Month 3, one month after the administration of the third dose of Tritanrix -HepB/ Hiberix vaccine ]
    A seroprotected subject as regards anti-D/-TT antibodies 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 as Regards Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibodies ≥ the Cut-off. [ 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 as Regards Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibodies ≥ the Cut-off [ 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 millliter (mIU/mL).

  19. Number of Subjects Seroprotected as Regards Anti-Hepatitis B Surface Antigen (HBs) Antibodies. [ 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 millliter (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.


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   6 Weeks to 10 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00678301


Locations
Mali
GSK Investigational Site
Bamako, Mali
Nigeria
GSK Investigational Site
Ikeja / Lagos, Nigeria, P.M.B. 21266
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
More Information

Additional Information:
Publications:
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 110521
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 110521
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 110521
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 110521
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 110521
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 110521
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 110521
For additional information about this study please refer to the GSK Clinical Study Register

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00678301     History of Changes
Other Study ID Numbers: 110521
First Posted: May 15, 2008    Key Record Dates
Results First Posted: October 27, 2017
Last Update Posted: October 27, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:
pneumococcal conjugate vaccine
Streptococcus pneumoniae

Additional relevant MeSH terms:
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs