Evaluation of Effectiveness of GSK Biologicals' Pneumococcal Conjugate Vaccine 1024850A Against Invasive Disease. - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00861380

Purpose

The aim of this study is to assess the effectiveness of GSK Biologicals' pneumococcal conjugate vaccine (GSK1024850A), administered according to different vaccination schedules, against invasive disease caused by S.

pneumoniae or H. influenzae as well as vaccine impact on the occurrence of hospital-diagnosed pneumonia cases, tympanostomy tube placement and outpatient antimicrobial prescriptions. This study will also explore vaccine impact on occurrence of respiratory tract infections (RTIs), including acute otitis media (AOM) in a subset of children in Turku area.

Condition	Intervention	Phase
Haemophilus Influenzae Infections Pneumococcal Disease	Biological: Pneumococcal conjugate vaccine GSK1024850A Biological: GSK Biologicals' Engerix TM vaccine (Hepatitis B vaccine) Biological: GSK Biologicals' Havrix TM vaccine (Hepatitis A vaccine)	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study
Official Title:	Evaluation of Effectiveness of GSK Biologicals' Pneumococcal Conjugate Vaccine 1024850A Against Invasive Disease.

Resource links provided by NLM:

MedlinePlus related topics: Ear Infections Flu Hepatitis Pneumonia

Drug Information available for: Heptavalent pneumococcal conjugate vaccine Pneumococcal Vaccines

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Occurrence of culture-confirmed pneumococcal invasive diseases due to any of the vaccines-related pneumococcal serotypes (in children starting vaccination within the first 7 months of life). [ Time Frame: From the administration of the first vaccine dose up to study end. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Occurrence of culture-confirmed invasive diseases (ID) due to any bacterial pathogens (in all subjects) [ Time Frame: From the administration of the first vaccine dose up to study end. ] [ Designated as safety issue: No ]
Occurrence of probable cases of ID caused by any bacterial pathogen (in all subjects) [ Time Frame: From the administration of the first vaccine dose up to study end. ] [ Designated as safety issue: No ]
Occurrence of hospital-diagnosed pneumonia cases (in all subjects) [ Time Frame: From the administration of the first vaccine dose up to study end. ] [ Designated as safety issue: No ]
Occurrence of tympanostomy tube placements (in all subjects) [ Time Frame: From the administration of the first vaccine dose up to study end. ] [ Designated as safety issue: No ]
Occurrence of outpatient antibiotic prescriptions (in all subjects) [ Time Frame: From the administration of the first vaccine dose up to study end. ] [ Designated as safety issue: No ]
Antimicrobial susceptibility of S. pneumoniae and H. influenzae isolated from invasive disease (in vaccinated children) [ Time Frame: From the administration of the first vaccine dose up to study end. ] [ Designated as safety issue: No ]
Occurrence of upper and lower respiratory tract infections , including AOM (in a subset of vaccinated subjects in Turku area) [ Time Frame: From the administration of the first vaccine dose up to study end. ] [ Designated as safety issue: No ]

Estimated Enrollment:	91000
Study Start Date:	May 2009
Estimated Study Completion Date:	September 2011
Estimated Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Pn 2+1: Experimental Children receiving the GSK vaccine 1024850A. Children within the first 7 months of life enrolled in this group will receive a 2-dose primary vaccination schedule.	Biological: Pneumococcal conjugate vaccine GSK1024850A 2, 3 or 4 Intramuscular injections, depending on the age at the time of first vaccination
Pn 3+1: Experimental Children receiving the GSK vaccine 1024850A. Children within the first 7 months of life enrolled in this group will receive a 3-dose primary vaccination schedule	Biological: Pneumococcal conjugate vaccine GSK1024850A 2, 3 or 4 Intramuscular injections, depending on the age at the time of first vaccination
Control 2+1: Active Comparator Children receiving the control vaccine: Hepatitis B vaccine for children < 12 months of age at the time of first vaccination or Hepatitis A vaccine for children >= 12 months of age at the time of first vaccination. Children within the first 7 months of life enrolled in this group will receive a 2-dose primary vaccination schedule.	Biological: GSK Biologicals' Engerix TM vaccine (Hepatitis B vaccine) 3 or 4 Intramuscular injections, depending on the age at the time of first vaccination. Control 3+1 and Control 2+1 groups, only for children < 12 months of age at the time of first study vaccination. Biological: GSK Biologicals' Havrix TM vaccine (Hepatitis A vaccine) 2 Intramuscular injections. Control 3+1 and Control 2+1 groups, only for children >= 12 months of age at the time of first study vaccination.
Control 3+1: Active Comparator Children receiving the control vaccine: Hepatitis B vaccine for children < 12 months of age at the time of first vaccination or Hepatitis A vaccine for children >= 12 months of age at the time of first vaccination. Children within the first 7 months of life enrolled in this group will receive a 3-dose primary vaccination schedule.	Biological: GSK Biologicals' Engerix TM vaccine (Hepatitis B vaccine) 3 or 4 Intramuscular injections, depending on the age at the time of first vaccination. Control 3+1 and Control 2+1 groups, only for children < 12 months of age at the time of first study vaccination. Biological: GSK Biologicals' Havrix TM vaccine (Hepatitis A vaccine) 2 Intramuscular injections. Control 3+1 and Control 2+1 groups, only for children >= 12 months of age at the time of first study vaccination.

Eligibility

Ages Eligible for Study:	6 Weeks to 18 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Male or female between, and including, 6 weeks to 18 months of age at the time of the first vaccination.
Written informed consent obtained from parent(s) or from the guardian(s) of the subject.

Exclusion Criteria:

Previous vaccination with any registered, non-registered or investigational pneumococcal vaccine other than the study vaccine, or planned use during the study period. If a child belongs to a high risk group for pneumococcal infections for which a licensed pneumococcal conjugate vaccine is made locally available, the subject can not be enrolled in the study and should be referred to the specific immunization program.
Previous vaccination against Hepatitis B virus with any registered, non-registered or investigational vaccine, or planned use of such a vaccine other than the study vaccine during the study period.
Previous vaccination against Hepatitis A virus with any registered, non-registered or investigational vaccine, or planned use of such a vaccine other than the study vaccine during the study period.
Known severe hypersensitivity to any component of the study vaccines, including neomycin.
Any medical condition that would contraindicate the initiation of routine immunization outside a clinical trial context.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00861380

Contacts

Contact: US GSK Clinical Trials Call Center

877-379-3718

Locations

Finland
GSK Investigational Site	Recruiting
Helsinki, Finland, 00270

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	111442
Study First Received:	March 12, 2009
Last Updated:	June 4, 2009
ClinicalTrials.gov Identifier:	NCT00861380 History of Changes
Health Authority:	Finland: National Agency for Medicines

Keywords provided by GlaxoSmithKline:

Pneumococcal conjugate vaccine
Streptococcus pneumoniae
Haemophilus influenzae
Invasive disease

Pneumonia
Respiratory tract infections
Acute otitis media

Study placed in the following topic categories:

Bacterial Infections
Virus Diseases
Haemophilus Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Otitis

Haemophilus Influenzae
Otitis Media
Influenza, Human
Orthomyxoviridae Infections
Pneumonia
Gram-Negative Bacterial Infections

Additional relevant MeSH terms:

Bacterial Infections
Virus Diseases
Haemophilus Infections
Pasteurellaceae Infections
RNA Virus Infections
Respiratory Tract Diseases

Respiratory Tract Infections
Influenza, Human
Orthomyxoviridae Infections
Infection
Gram-Negative Bacterial Infections

ClinicalTrials.gov processed this record on September 10, 2009