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

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00678301

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: GSK Biologicals' Zilbrix™ Hib Biological: Pneumococcal vaccine GSK1024850A Biological: GSK Biologicals' Polio Sabin™	Phase III

MedlinePlus related topics: Diphtheria Polio and Post-Polio Syndrome Tetanus Whooping Cough

Drug Information available for: Heptavalent pneumococcal conjugate vaccine Pneumococcal Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment
Official Title:	Primary Vaccination Course in Children Receiving the Pneumococcal Vaccine GSK 1024850A co-Administered With Zilbrix™ Hib and Polio Sabin™

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: Yes ]
Occurrence of solicited local symptoms (any and grade 3) [ Time Frame: Within 4 days after each vaccination ] [ Designated as safety issue: Yes ]
Occurrence of solicited general symptoms (any and grade 3) [ Time Frame: Within 4 days after each vaccination ] [ Designated as safety issue: Yes ]
Occurrence of unsolicited adverse events [ Time Frame: Within 31 days after each vaccination ] [ Designated as safety issue: Yes ]
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: Yes ]

Estimated Enrollment:	345
Study Start Date:	June 2008
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group B: No Intervention	Biological: GSK Biologicals' Zilbrix™ Hib 3 IM doses. Biological: GSK Biologicals' Polio Sabin™ 3 oral doses
Group A: Experimental	Biological: GSK Biologicals' Zilbrix™ Hib 3 IM doses. Biological: Pneumococcal vaccine GSK1024850A 3 IM doses. Biological: GSK Biologicals' Polio Sabin™ 3 oral doses

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

Contacts

Contact: US GSK Clinical Trials Call Center

877-379-3718

Locations

Mali
GSK Investigational Site	Recruiting
Bamako, Mali
Nigeria
GSK Investigational Site	Not yet recruiting
Ikeja / Lagos, Nigeria, P.M.B. 21266

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	110521
Study First Received:	May 13, 2008
Last Updated:	October 30, 2008
ClinicalTrials.gov Identifier:	NCT00678301
Health Authority:	Mali: Ministry of Health

Keywords provided by GlaxoSmithKline:

Streptococcus pneumoniae
pneumococcal conjugate vaccine

Study placed in the following topic categories:

Poliomyelitis
Pneumonia

ClinicalTrials.gov processed this record on January 15, 2009