Evaluation of Effectiveness of GSK Biologicals' Pneumococcal Conjugate Vaccine 1024850A Against Invasive Disease (FinIP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00861380
First received: March 12, 2009
Last updated: November 7, 2013
Last verified: November 2013

March 12, 2009
November 7, 2013
May 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 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 ]
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 ]
Complete list of historical versions of study NCT00861380 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 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 ]
  • 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 ]
Not Provided
Not Provided
 
Evaluation of Effectiveness of GSK Biologicals' Pneumococcal Conjugate Vaccine 1024850A Against Invasive Disease
Evaluation of Effectiveness of GSK Biologicals' Pneumococcal Conjugate Vaccine 1024850A Against Invasive Disease

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.

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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Infections, Streptococcal
  • 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.

    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.
  • Experimental: Pn 3+1
    Children receiving the Pneumococcal conjugate vaccine GSK1024850A. Children within the first 7 months of life enrolled in this group will receive a 3-dose primary vaccination schedule.
    Intervention: Biological: Pneumococcal conjugate vaccine GSK1024850A
  • Experimental: Pn 2+1
    Children receiving the Pneumococcal conjugate vaccine GSK1024850A. Children within the first 7 months of life enrolled in this group will receive a 2-dose primary vaccination schedule.
    Intervention: Biological: Pneumococcal conjugate vaccine GSK1024850A
  • Active Comparator: Control 3+1
    Children receiving the control vaccine: Engerix TM (Hepatitis B vaccine) for children < 12 months of age at the time of first vaccination or Havrix TM (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.
    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: Engerix TM (Hepatitis B vaccine) for children < 12 months of age at the time of first vaccination or Havrix TM (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.
    Interventions:
    • Biological: GSK Biologicals' Engerix TM vaccine (Hepatitis B vaccine)
    • Biological: GSK Biologicals' Havrix TM vaccine (Hepatitis A vaccine)
Palmu AA, Jokinen J, Borys D, Nieminen H, Ruokokoski E, Siira L, Puumalainen T, Lommel P, Hezareh M, Moreira M, Schuerman L, Kilpi TM. Effectiveness of the ten-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10) against invasive pneumococcal disease: a cluster randomised trial. Lancet. 2013 Jan 19;381(9862):214-22. doi: 10.1016/S0140-6736(12)61854-6. Epub 2012 Nov 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
41188
October 2013
January 2012   (final data collection date for primary outcome measure)

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.
Both
6 Weeks to 18 Months
Yes
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT00861380
111442
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
November 2013

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