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

Sponsor:	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
Pneumococcal Disease Haemophilus Influenzae Infections	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:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention
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 Hepatitis A Hepatitis B Pneumonia

Drug Information available for: Recombinant hepatitis B vaccine Heptavalent pneumococcal conjugate vaccine Hepatitis B Vaccines Hepatitis A Vaccines 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 vaccine-related pneumococcal serotypes (in children starting vaccination within the first 7 months of life in clusters assigned to a 3-dose primary vaccination course). [ Time Frame: From the administration of the first vaccine dose up to 31 January 2012. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Occurrence of culture-confirmed pneumococcal invasive diseases due to any of the vaccine-related pneumococcal serotypes (in children starting vaccination within the first 7 months of life in clusters assigned to a 2-dose primary vaccination course). [ Time Frame: From the administration of the first vaccine dose up 31 January 2012. ] [ Designated as safety issue: No ]
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 31 January 2012. ] [ 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 31 January 2012. ] [ 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 hospital-diagnosed pneumonia cases with abnormal pulmonary infiltrates on the chest X-ray (CXR pneumonia) based on the CXR reading according to World Health Organization (WHO) criteria (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 with alveolar consolidation/pleural effusion on the CXR (CXR-AC pneumonia) based on the CXR reading according to WHO criteria (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 without alveolar consolidation or pleural effusion on the CXR (CXR-NAC pneumonia) based on the CXR reading according to WHO criteria (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:	47000
Study Start Date:	May 2009
Estimated Study Completion Date:	February 2012
Estimated Primary Completion Date:	February 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Pn 3+1 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
Experimental: Pn 2+1 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
Active Comparator: Control 3+1 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.
Active Comparator: Control 2+1 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.

Detailed Description:

The protocol posting has been updated with regards to the enrolment of subjects and outcome measures following Protocol amendment 2, 22 August 2011.

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

Locations

Finland
GSK Investigational Site
Helsinki, Finland, 00270

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00861380 History of Changes
Other Study ID Numbers:	111442
Study First Received:	March 12, 2009
Last Updated:	February 2, 2012
Health Authority:	Finland: Finnish Medicines Agency

Keywords provided by GlaxoSmithKline:

Pneumococcal conjugate vaccine
Invasive disease
Respiratory tract infections
Haemophilus influenzae

Streptococcus pneumoniae
Acute otitis media
Pneumonia

Additional relevant MeSH terms:

Influenza, Human
Haemophilus Infections
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases

Respiratory Tract Infections
Respiratory Tract Diseases
Pasteurellaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on February 09, 2012