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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00839254
First Posted: February 9, 2009
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  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
Infections, Streptococcal Biological: Pneumococcal conjugate vaccine GSK1024850A Biological: GSK Biologicals' Engerix TM vaccine (Hepatitis B vaccine) Biological: GSK Biologicals' Havrix TM vaccine (Hepatitis A vaccine) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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:


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. ]

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. ]
  • 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. ]
  • 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). ]
  • 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. ]
  • Occurrence of hospital-diagnosed pneumonia cases. [ Time Frame: From the administration of the first vaccine dose up to study end. ]
  • 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. ]
  • 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. ]
  • 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. ]
  • Occurrence of tympanostomy tube placements. [ Time Frame: From the administration of the first vaccine dose up to study end. ]
  • Occurrence of outpatient antibiotic prescriptions. [ Time Frame: From the administration of the first vaccine dose up to study end. ]
  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]
  • Occurrence of AOM by severity [ Time Frame: From the administration of the first vaccine dose up to study end. ]
  • 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. ]
  • 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. ]
  • Occurrence of solicited local adverse events. [ Time Frame: Within 4 days after each vaccination. ]
  • Occurrence of solicited general adverse events. [ Time Frame: Within 4 days after each vaccination. ]
  • Occurrence of unsolicited adverse events. [ Time Frame: Within 31 days after each vaccination. ]
  • Occurrence of serious adverse events [ Time Frame: Following administration of the first vaccine dose up to study end. ]

Enrollment: 6181
Study Start Date: February 2009
Study Completion Date: January 2012
Primary Completion Date: January 2012 (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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   6 Weeks to 18 Months   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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, 01300
GSK Investigational Site
Vantaa, Finland, 01600
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Study Data/Documents: Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 112595
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 112595
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 112595
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 112595
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 112595
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 112595
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 112595
For additional information about this study please refer to the GSK Clinical Study Register

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00839254     History of Changes
Other Study ID Numbers: 112595
First Submitted: February 5, 2009
First Posted: February 9, 2009
Last Update Posted: October 12, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:
Streptococcus pneumoniae
acute otitis media
Pneumococcal conjugate vaccine
nasopharyngeal carriage
Haemophilus influenzae
immunogenicity
invasive disease

Additional relevant MeSH terms:
Otitis
Otitis Media
Streptococcal Infections
Ear Diseases
Otorhinolaryngologic Diseases
Gram-Positive Bacterial Infections
Bacterial Infections
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs