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Evaluation of effectiveness of GSK Biologicals’ pneumococcal conjugate vaccine 1024850A against invasive diseaseFinIP

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GSK study ID
111442
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Clinicaltrials.gov ID
NCT00861380
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EudraCT ID
2008-005149-48
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
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Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Evaluation of effectiveness of GSK Biologicals’ pneumococcal conjugate vaccine 1024850A against invasive disease
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Person Year Rate as regards subjects with culture-confirmed IPD due to any of the 10 pneumococcal vaccine serotypes. In children starting vaccination within 7 months of life and assigned to a 3-dose primary vaccination course

Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months)

Person Year Rate as regards subjects with culture-confirmed IPD due to any of the 10 pneumococcal vaccine serotypes. In children starting vaccination within 7 months of life and assigned to a 2-dose primary vaccination course

Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months)

Secondary outcomes:

Person Year Rate in the prevention of culture-confirmed invasive disease (ID)- In children starting vaccination within 7 months of life and assigned to a 3-dose primary vaccination course (till end of blinded ID FU period)

Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months)

Person Year Rate in the prevention of culture-confirmed invasive disease (ID)- In children starting vaccination within 7 months of life and assigned to a 2-dose primary vaccination course (till end of blinded ID FU period)

Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months)

Person Year Rate in the prevention of culture-confirmed invasive disease (ID)- In children starting vaccination in the 7-11 months schedule

Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months)

Person Year Rate in the prevention of culture-confirmed invasive disease (ID)- In children starting vaccination in the 12-18 months schedule (+ indirect effects on the unvaccinated population)

Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months)

Person Year Rate in the prevention of probable culture-confirmed invasive disease (ID)- In children starting vaccination within 7 months of life and assigned to a 3-dose primary vaccination course

Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months)

Person Year Rate in the prevention of probable or culture-confirmed invasive disease (ID)- In children starting vaccination within 7 months of life and assigned to a 2-dose primary vaccination course

Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months)

Person Year Rate in the prevention of probable or culture-confirmed invasive disease (ID)- In children starting vaccination in the 7-11 months schedule

Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months)

Person Year Rate in the prevention of probable or culture-confirmed invasive disease (ID)- In children starting vaccination in the 12-18 months schedule (+ indirect effects on the unvaccinated population)

Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months)

Person Year Rate in reducing hospital-diagnosed pneumonia- In children starting vaccination within 7 months of life and assigned to a 3-dose primary vaccination course

Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) – FU mean time=24 months

Person Year Rate in reducing hospital-diagnosed pneumonia - In children starting vaccination within 7 months of life and assigned to a 2-dose primary vaccination course

Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) – FU mean time=24 months

Person Year Rate in reducing hospital-diagnosed pneumonia- In children starting vaccination in the 7-11 months schedule

Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) – FU mean time=27 months

Person Year Rate in reducing hospital-diagnosed pneumonia - In children starting vaccination in the 12-18 months schedule (+ indirect effects on the unvaccinated population)

Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) – FU mean time=27 months

Person Year Rate in reducing hospital-diagnosed pneumonia with Chest X-ray (CXR) reading according to WHO criteria- In children starting vaccination within 7 months of life and assigned to a 3-dose primary vaccination course

Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) – FU mean time=24 months

Person Year Rate in reducing hospital-diagnosed pneumonia with CXR reading according to WHO criteria - In children starting vaccination within 7 months of life and assigned to a 2-dose primary vaccination course

Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) – FU mean time=24 months

Person Year Rate in reducing hospital-diagnosed pneumonia with CXR reading according to WHO criteria - In children starting vaccination in the 7-11 months schedule

Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) – FU mean time=27 months

Person Year Rate in reducing hospital-diagnosed pneumonia with CXR reading according to WHO criteria - In children starting vaccination in the 12-18 months schedule

Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) – FU mean time=27 months

Person Year Rate in prevention of all tympanostomy tube placements- In children starting vaccination within 7 months of life and assigned to a 3-dose primary vaccination course

Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) – FU mean time=24 months

Person Year Rate in prevention of all tympanostomy tube placements - In children starting vaccination within 7 months of life and assigned to a 2-dose primary vaccination course

Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) – FU mean time=24 months

Person Year Rate in prevention of all tympanostomy tube placements - In children starting vaccination in the 7-11 months schedule

Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) – FU mean time=27 months

Person Year Rate in prevention of all tympanostomy tube placements - In children starting vaccination in the 12-18 months schedule (+ indirect effects on the unvaccinated population)

Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) – FU mean time=27 months

Person Year Rate in prevention of all antimicrobial prescriptions- In children starting vaccination within 7 months of life and assigned to a 3-dose primary vaccination course

Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) – FU mean time=24 months

Person Year Rate in prevention of all antimicrobial prescriptions - In children starting vaccination within 7 months of life and assigned to a 2-dose primary vaccination course

Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) – FU mean time=24 months

Person Year Rate in prevention of all antimicrobial prescriptions - In children starting vaccination in the 7-11 months schedule

Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) – FU mean time=27 months

Person Year Rate in prevention of all antimicrobial prescriptions - In children starting vaccination in the 12-18 months schedule (+ indirect effects on the unvaccinated population)

Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) – FU mean time=27 months

Number of subjects classified by antimicrobial susceptiblity of IPD isolates in children starting vaccination within 7 months of life and assigned to a 2 or 3-dose primary vaccination course

Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) – mean FU time=24 months

Number of subjects with Lower respiratory tract infections (LRTIs) (in a subset of subjects in Turku area)

Timeframe: From the administration of the first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (at least 30 months)

Number of subjects with Upper respiratory tract infections (URTIs) (in a subset of subjects in Turku area)

Timeframe: From the administration of the first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (at least 30 months)

Number of subjects with SAEs reported during the blinded invasive disease phase, of the study

Timeframe: For Month 0 till the end of the blinded ID Follow-Up, (at least 30 months from study start)

Number of subjects enrolled and vaccinated in the 10PN-PD-DIT-043 and 10PN-PD-DIT-053 study with post-study SAEs reported via passive surveillance– Subjects enrolled aged 6 weeks to 6 months and 7 to 18 months

Timeframe: From the end of the blinded ID Follow-Up period(at least 30 months from study start) up to the end of 18-month period after study unblinding

Culture-confirmed Invasive Disease (ID) Person Year Rate - In children starting vaccination within 7 months of life and assigned to a 3-dose primary vaccination course till end of LT FU period

Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end of the long-term Follow-up period (The Follow-up period lasted at least 77 months)

Culture-confirmed Invasive Disease (ID) Person Year Rate - In children starting vaccination within 7 months of life and assigned to a 2-dose primary vaccination course till end of LT FU period

Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end of the long-term Follow-up period (The Follow-up period lasted at least 77 months)

Interventions:
  • Biological/vaccine: Pneumococcal conjugate vaccine GSK1024850A
  • Biological/vaccine: GSK Biologicals’ Engerix TM vaccine (Hepatitis B vaccine)
  • Biological/vaccine: GSK Biologicals’ Havrix TM vaccine (Hepatitis A vaccine)
    • Enrollment:
    41188
    Primary completion date:
    2012-31-01
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Palmu AA et al. (2013) Effectiveness of the ten-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10) against invasive pneumococcal disease: a cluster randomised trial. The Lancet. 381(9862):214-222.
    Palmu AA et al. (2013) Effect of pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10) on outpatient antimicrobial purchases: a double-blind, cluster randomised phase 3-4 trial. Lancet Infect Dis.14(3):205-212.
    Palmu AA et al. (2014) Vaccine effectiveness of the pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10) against clinically suspected invasive pneumococcal disease: a cluster-randomized trial. Lancet Respir Med. 2(9):717-727.
    Palmu AA et al. (2015) Effectiveness of the 10-valent pneumococcal conjugate vaccine against tympanostomy tube placements in a cluster-randomized trial. Pediatr Infect Dis J. 34(11):1230-1235.
    Palmu AA et al. (2018) Vaccine-preventable disease incidence of pneumococcal conjugate vaccine in the Finnish invasive pneumococcal disease vaccine trial. Vaccine. 36(14):1816-1822.
    Nieminen H et al. (2019) Effectiveness of the 10-valent pneumococcal conjugate vaccine among girls, boys, preterm and low-birth-weight infants – Results from a randomized, double-blind vaccine trial. Vaccine. 27(2019):3715-3721.
    Kilpi TM et al. (2018) Effectiveness of pneumococcal Haemophilus influenzae protein D conjugate vaccine against pneumonia in children: A cluster-randomised trial. Vaccine. 36(39):5891-5901. doi: 10.1016/j.vaccine.2018.08.020
    Nieminen H et al. (2019) Effectiveness of the 10-valent pneumococcal conjugate vaccine among girls, boys, preterm and low-birth-weight infants – Results from a randomized, double-blind vaccine trial. Vaccine. 37(28):3715-3721.
    Medical condition
    Infections, Streptococcal
    Product
    GSK1024850A
    Collaborators
    Not applicable
    Study date(s)
    May 2009 to October 2013
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    6 weeks - 18 months
    Accepts healthy volunteers
    Yes
    • 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.
    • 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.
    Inclusion and exclusion 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.

    Trial location(s)

    Location
    Status
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    Location
    GSK Investigational Site
    Helsinki, Finland, 00270
    Status
    Study Complete
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    Study documents

    Clinical study report
    Available language(s): English
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    Scientific result summary
    Available language(s): English
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    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2012-31-01
    Actual study completion date
    2013-05-10

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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