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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00839254
First received: February 5, 2009
Last updated: February 14, 2013
Last verified: February 2013

February 5, 2009
February 14, 2013
February 2009
January 2012   (final data collection date for primary outcome measure)
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 ]
Occurrence of culture-confirmed pneumococcal invasive diseases due to any of the vaccines-related pneumococcal serotypes (in children starting vaccination within the first 7 mth of life). [ Time Frame: From the administration of the first vaccine dose up to study end. ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00839254 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Occurrence of culture-confirmed invasive diseases (ID) due to any bacterial pathogens. [ Time Frame: From the administration of the first vaccine dose up to study end. ] [ 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 study end. ] [ 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 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 1 and post-dose 2, 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 1 and post-dose 2, 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). [ Time Frame: one month post-dose 1, post-dose 2, and post-dose 3, before the booster dose 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 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 ]
Not Provided
Not Provided
 
Impact on Carriage, Acute Otitis Media, Immuno & Safety of GSK Biologicals' Pneumococcal Conjugate Vaccine 1024850A
Impact on Nasopharyngeal Carriage, Acute Otitis Media, Immunogenicity and Safety of GSK Biologicals' Pneumococcal Conjugate Vaccine 1024850A

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.

The protocol posting has been updated with regards to the outcome measures following Protocol amendment 4, 12 August 2011.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
  • Streptococcus Pneumoniae
  • Pneumococcal Disease
  • Haemophilus Influenzae Infections
  • Biological: Pneumococcal conjugate vaccine GSK1024850A
    2, 3 or 4 Intramuscular injections, depending on the age at the time of first vaccination
  • 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.
  • 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.
    Intervention: Biological: Pneumococcal conjugate vaccine GSK1024850A
  • 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.
    Intervention: Biological: Pneumococcal conjugate vaccine GSK1024850A
  • 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.
    Interventions:
    • Biological: GSK Biologicals' Engerix TM vaccine (Hepatitis B vaccine)
    • Biological: GSK Biologicals' Havrix TM vaccine (Hepatitis A vaccine)
  • 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.
    Interventions:
    • Biological: GSK Biologicals' Engerix TM vaccine (Hepatitis B vaccine)
    • Biological: GSK Biologicals' Havrix TM vaccine (Hepatitis A vaccine)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6181
January 2012
January 2012   (final data collection date for primary outcome measure)

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.
Both
6 Weeks to 18 Months
Yes
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT00839254
112595
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP