Impact on Carriage, Acute Otitis Media, Immuno & Safety of GSK Biologicals' Pneumococcal Conjugate Vaccine 1024850A - Full Text View

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00839254

Purpose

The aim of this study is to assess the effectiveness of GSK Biologicals' pneumococcal conjugate vaccine (GSK1024850A) in preventing invasive disease caused by S. pneumoniae or H. influenzae and in reducing occurrence of hospital-diagnosed pneumonia cases, tympanostomy tube placement and outpatient antimicrobial prescriptions in children starting vaccination below 18 months of age. These data will be collected from the national registers and will be analyzed in combination with data collected for subjects enrolled in a large scale cluster-randomized study 111442.

The study will also assess the immune response to the GSK1024850A vaccine and the impact of the vaccine on occurrence of acute otitis media, carriage, safety in children starting vaccination below 18 months of age.

Condition	Intervention	Phase
Streptococcus Pneumoniae 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:	Impact on Nasopharyngeal Carriage, Acute Otitis Media, Immunogenicity and Safety of GSK Biologicals' Pneumococcal Conjugate Vaccine 1024850A

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 mth of life in clusters assigned to a 3-dose primary vaccination schedule). [ Time Frame: From the administration of the first vaccine dose up to the end of ID follow-up in study 111442. ] [ 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 mth of life in clusters assigned to a 2-dose primary vaccination schedule). [ Time Frame: From the administration of the first vaccine dose up to the end of ID follow-up in study 111442. ] [ Designated as safety issue: No ]
Occurrence of culture-confirmed invasive diseases (ID) due to any bacterial pathogens. [ Time Frame: From the administration of the first vaccine dose up to the end of ID follow-up in study 111442. ] [ Designated as safety issue: No ]
Occurrence of culture-confirmed ID due to any bacterial pathogen. [ Time Frame: 2 weeks after primary vaccination (in children starting vaccination within the first 7 months of life). ] [ Designated as safety issue: No ]
Occurrence of probable cases of ID caused by any bacterial pathogen. [ Time Frame: From the administration of the first vaccine dose up to the end of ID follow-up in study 111442. ] [ Designated as safety issue: No ]
Occurrence of hospital-diagnosed pneumonia cases. [ 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. [ Time Frame: From the administration of the first vaccine dose up to study end. ] [ Designated as safety issue: No ]
Occurrence of outpatient antibiotic prescriptions. [ 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. [ Time Frame: From the administration of the first vaccine dose up to study end. ] [ Designated as safety issue: No ]
Occurrence of H. influenzae, S. pneumoniae and/or other bacterial pathogens in the nasopharynx. [ Time Frame: Prior to the first vaccination, one month post-dose 2 and post-dose 3, before the booster dose, three months post-booster and at the last scheduled visit. ] [ Designated as safety issue: No ]
Acquisition of new H. influenzae and/or S. pneumoniae strains in the nasopharynx. [ Time Frame: Prior to the first vaccination, one month post-dose 2 and post-dose 3, before the booster dose, three months post-booster and at the last scheduled visit. ] [ Designated as safety issue: No ]
Concentration of antibodies and opsonophagocytic activity against components of the investigational pneumococcal conjugate vaccine (in a subset of subjects from 6 weeks to 6 months of age). [ Time Frame: one month post-primary, before and one month after the booster dose and at the last scheduled visit. ] [ Designated as safety issue: No ]
Concentration of antibodies against components of the investigational pneumococcal conjugate vaccine (in a subset of subjects from 7-11 months of age). [ Time Frame: one month post-dose 2, before and one month after the booster dose and at the last scheduled visit. ] [ Designated as safety issue: No ]
Concentration of antibodies against components of the investigational pneumococcal conjugate vaccine (in a subset of subjects from 12-18 months of age). [ Time Frame: one month post-dose 1, one month post-dose 2 and at the last scheduled visit. ] [ Designated as safety issue: No ]
Occurrence of acute otitis media (AOM) based on protocol pre-defined levels of diagnostic certainty. [ Time Frame: From the administration of the first vaccine dose up to study end. ] [ Designated as safety issue: No ]
Occurrence of recurrent AOM based on protocol pre-defined levels of diagnostic certainty [ Time Frame: From the administration of the first vaccine dose up to study end. ] [ Designated as safety issue: No ]
Occurrence of AOM by severity [ Time Frame: From the administration of the first vaccine dose up to study end. ] [ Designated as safety issue: No ]
Occurrence of AOM based on protocol pre-defined levels of diagnostic certainty with documented antimicrobial prescription [ 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 ]
Occurrence of solicited local adverse events. [ Time Frame: Within 4 days after each vaccination. ] [ Designated as safety issue: No ]
Occurrence of solicited general adverse events. [ 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 administration of the first vaccine dose up to study end. ] [ Designated as safety issue: No ]

Enrollment:	6179
Study Start Date:	February 2009
Study Completion Date:	December 2011
Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Pn 3+1 Children receiving the pneumococcal conjugate vaccine 1024850A. Children within the first 7 months of life enrolled in this group of clusters 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 pneumococcal conjugate vaccine 1024850A. Children within the first 7 months of life enrolled in this group of clusters 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 study vaccination. Children within the first 7 months of life enrolled in this group of clusters 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 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 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 study vaccination. Children within the first 7 months of life enrolled in this group of clusters 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 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 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 outcome measures following Protocol amendment 4, 12 August 2011.

Eligibility

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

Criteria

Inclusion Criteria:

Subjects who 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.
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:

Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the first dose of study vaccine, or planned use of such a vaccine(s) other than the study vaccine(s) during the entire study period.
Previous vaccination with any registered, non-registered or investigational pneumococcal vaccine, or planned use of such a vaccine other than the study vaccine during the study period. If a child belongs to a high risk group for pneumococcal infections (such as children with an anatomic or functional asplenia, HIV infection, chronic cardiac or respiratory disease (not asthma), diabetes, cochlear implant, CSF fistula or with significant immunodeficiency) 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: NCT00839254

Locations

Finland
GSK Investigational Site
Espoo, Finland, 02100
GSK Investigational Site
Helsinki, Finland, 00100
GSK Investigational Site
Helsinki, Finland, 00930
GSK Investigational Site
Jarvenpaa, Finland, 04400
GSK Investigational Site
Kokkola, Finland, 67100
GSK Investigational Site
Kotka, Finland, 48600
GSK Investigational Site
Kuopio, Finland, 70210
GSK Investigational Site
Lahti, Finland, 15140
GSK Investigational Site
Oulu, Finland, 90220
GSK Investigational Site
Pori, Finland, 28100
GSK Investigational Site
Seinajoki, Finland, 60100
GSK Investigational Site
Tampere, Finland, 33100
GSK Investigational Site
Turku, Finland, 20520
GSK Investigational Site
Vantaa, Finland, 01600
GSK Investigational Site
Vantaa, Finland, 01300

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:	NCT00839254 History of Changes
Other Study ID Numbers:	112595
Study First Received:	February 5, 2009
Last Updated:	January 23, 2012
Health Authority:	Finland: Finnish Medicines Agency

Keywords provided by GlaxoSmithKline:

Streptococcus pneumoniae
acute otitis media
Pneumococcal conjugate vaccine
nasopharyngeal carriage

Haemophilus influenzae
immunogenicity
invasive disease

Additional relevant MeSH terms:

Influenza, Human
Otitis
Otitis Media
Pneumonia
Haemophilus Infections
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases

Respiratory Tract Infections
Respiratory Tract Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Lung Diseases
Pasteurellaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on February 09, 2012