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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00678301
First received: May 13, 2008
Last updated: December 8, 2011
Last verified: December 2011
  Purpose

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 Intervention Phase
Pneumococcal Disease
Biological: Pneumococcal vaccine GSK1024850A
Biological: GSK Biologicals' Polio Sabin™
Biological: GSK Biologicals' Zilbrix™ Hib
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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™

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Antibody concentrations to pneumococcal serotypes contained in the vaccine [ Time Frame: 1 month after administration of 3rd vaccine dose of the pneumococcal conjugate vaccine ] [ Designated as safety issue: No ]
  • Antibody concentrations to protein D [ Time Frame: 1 month after administration of 3rd vaccine dose of the pneumococcal conjugate vaccine ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Opsonophagocytic activity against pneumococcal serotypes contained in the vaccine [ Time Frame: One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine ] [ Designated as safety issue: No ]
  • Anti-pneumococcal serotypes antibody concentrations [ Time Frame: One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine ] [ Designated as safety issue: No ]
  • Antibody concentrations against pneumococcal cross-reactive serotypes [ Time Frame: One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine ] [ Designated as safety issue: No ]
  • Seropositivity status (against protein D and defined pneumococcal serotypes) [ Time Frame: One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine ] [ Designated as safety issue: No ]
  • Anti-diphtheria and anti-tetanus toxoids, anti-PRP, anti-B. pertussis and anti-HBs antibody concentration. [ Time Frame: One month after the administration of the 3rd vaccine dose of DTPw-HBV/Hib vaccine ] [ Designated as safety issue: No ]
  • Seropositivity status (against B. pertussis) [ Time Frame: One month after the administration of the 3rd vaccine dose of DTPw-HBV/Hib vaccine ] [ Designated as safety issue: No ]
  • Seroprotection status (against diphtheria toxoid, tetanus toxoid, PRP and HBs). [ Time Frame: One month after the administration of the 3rd vaccine dose of DTPw-HBV/Hib vaccine ] [ Designated as safety issue: No ]
  • Occurrence of fever [ Time Frame: Within 4 days after at least one vaccination ] [ Designated as safety issue: No ]
  • Occurrence of solicited local symptoms (any and grade 3) [ Time Frame: Within 4 days after each vaccination ] [ Designated as safety issue: No ]
  • Occurrence of solicited general symptoms (any and grade 3) [ Time Frame: Within 4 days after each vaccination ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited adverse events [ Time Frame: Within 31 days after each vaccination ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events [ Time Frame: Following the administration of the first dose of the study vaccines throughout the entire study period up to study month 3 ] [ Designated as safety issue: No ]

Enrollment: 365
Study Start Date: June 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A Biological: Pneumococcal vaccine GSK1024850A
3 IM doses.
Biological: GSK Biologicals' Polio Sabin™
3 oral doses
Biological: GSK Biologicals' Zilbrix™ Hib
3 IM doses.
Other Name: DTPw-HBV/hib vaccine
No Intervention: Group B Biological: GSK Biologicals' Polio Sabin™
3 oral doses
Biological: GSK Biologicals' Zilbrix™ Hib
3 IM doses.
Other Name: DTPw-HBV/hib vaccine

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   6 Weeks to 10 Weeks
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00678301     History of Changes
Other Study ID Numbers: 110521
Study First Received: May 13, 2008
Last Updated: December 8, 2011
Health Authority: Mali: Ministry of Health

Keywords provided by GlaxoSmithKline:
pneumococcal conjugate vaccine
Streptococcus pneumoniae

ClinicalTrials.gov processed this record on April 17, 2014