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

GlaxoSmithKline1 site in 1 country365 target enrollmentJune 18, 2008

ConditionsInfections, Streptococcal

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Infections, Streptococcal
Sponsor: GlaxoSmithKline
Enrollment: 365
Locations: 1
Primary Endpoint: Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Detailed Description

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

Registry

clinicaltrials.gov

Start Date

June 18, 2008

End Date

December 10, 2009

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility 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.

Outcomes

Primary Outcomes

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).

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

Number of Subjects Seroprotected Against Diphtheria (D) and Tetanus Toxoids (TT) Antigens(At Month 3, one month after the administration of the third dose of Tritanrix -HepB/ Hiberix vaccine)
Number of Subjects Seroprotected Against Anti-Hepatitis B Surface Antigens (HBs).(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(Within the 4-day (Days 0 to 3) follow-up periods after each vaccination, across doses and across vaccines)
Number of Subjects Seroprotected Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and -19A)(At Month 3, one month after the administration of the third dose of Synflorix vaccine)
Number of Subjects Seropositive for Antibodies Against Protein D (Anti-PD Antibodies)(At Month 3, one month after the administration of the third dose of Synflorix vaccine)
Number of Subjects Seropositive for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes(At Month 3, one month after the administration of the third dose of Synflorix vaccine)
Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations(At Month 3, one month after the administration of the third dose of Tritanrix -HepB/ Hiberix vaccine)
Number of Subjects Seroprotected Against Polyribosyl-ribitol Phosphate (PRP) Antigens(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(At Month 3, one month after the administration of the third dose of Tritanrix -HepB /Hiberix vaccine)
Number of Subjects With Unsolicited Adverse Events (AEs)(Within the 31-day (Days 0-30) follow-up periods post vaccination, across doses and across vaccines)
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and -19A)(At Month 3, one month after the administration of the third dose of Synflorix vaccine)
Titers for Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes(At Month 3, one month after the administration of the third dose of Synflorix vaccine)
Number of Subjects Seroprotected Against Vaccine Pneumococcal Serotypes(At Month 3, one month after the administration of the third dose of Synflorix vaccine)
Number of Subjects Seropositive for Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and -19A)(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(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(At Month 3, one month after the administration of the third dose of Synflorix vaccine)
Number of Subjects Seropositive for Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes(At Month 3, one month after the administration of the third dose of Synflorix vaccine)
Anti-Bordetella Pertussis (Anti-BPT) Antibody Concentrations(At Month 3, one month after the administration of the third dose of Synflorix vaccine)
Number of Subjects Seropositive for Antibodies Against Bordetella Pertussis (Anti-BPT)(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(At Month 3, one month after the administration of the third dose of Tritanrix -HepB/ Hiberix vaccine)
Number of Subjects Seroprotected Against Polyribosyl-ribitol Phosphate (PRP)(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 and Related Solicited General Symptoms(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(Within the 4-day (Days 0 to 3) follow-up periods after each vaccination, across doses and across vaccines)
Number of Subjects With Serious Adverse Events (SAEs)(Throughout the entire study period, from Month 0 to Month 3)