Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
280 participants
INTERVENTIONAL
2009-12-31
2012-09-30
Brief Summary
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Following consent and eligibility assessment, a baseline blood sample and nose swab will be taken, a 0.1ml dose of 23vPPV will be administered and a follow up blood sample and nose swab will be collected 28 days later. The investigators will also collect data on incidence of ALRI in all study participants by medical record review.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Neonatal PCV + PPV 9 months
Group 1: Children receiving 7VPCV at 0-1-2 months of age and PPV at 9 months of age
Prevenar + PPV
0.5mL dose of Prevenar at 0-1-2 months, 0.5mL Pneumovax at 9 months and 0.1mL Pneumovax at 3-5 yrs
Infant PCV + PPV at 9 months
Group 2: Children receiving 7VPCV at 1-2-3 months of age and PPV at 9 months of age
Infant PCV (Prevenar) + PPV at 9 months
0.5mL Prevenar at 1-2-3 months,0.5mL Pneumovax (PPV) at 9 months, 0.1mL Pneumovax at 3-5 yrs
No PCV + PPV at 9 months
Group 3: Children who only received PPV at 9 months of age
No Prevenar + PPV at 9 months
no Prevenar, 0.5mL Pneumovax at 9 months, 0.1mL Pneumovax at 3-5 yrs
Control
Group 4: Children who have not received any previous pneumococcal vaccine
Control
control, 0.1mL Pneumovax at 3-5yrs
Interventions
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Prevenar + PPV
0.5mL dose of Prevenar at 0-1-2 months, 0.5mL Pneumovax at 9 months and 0.1mL Pneumovax at 3-5 yrs
Infant PCV (Prevenar) + PPV at 9 months
0.5mL Prevenar at 1-2-3 months,0.5mL Pneumovax (PPV) at 9 months, 0.1mL Pneumovax at 3-5 yrs
No Prevenar + PPV at 9 months
no Prevenar, 0.5mL Pneumovax at 9 months, 0.1mL Pneumovax at 3-5 yrs
Control
control, 0.1mL Pneumovax at 3-5yrs
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Informed parental/guardian consent
Exclusion Criteria
* Prior receipt of 2 doses of pneumococcal polysaccharide vaccine
3 Years
5 Years
ALL
Yes
Sponsors
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The University of Western Australia
OTHER
William Pomat
OTHER_GOV
Responsible Party
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William Pomat
Senior Research Fellow
Principal Investigators
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Peter C Richmond, MD
Role: PRINCIPAL_INVESTIGATOR
School of Paediatrics and Child Health, University of Western Australia
Deborah Lehmann, MSc
Role: PRINCIPAL_INVESTIGATOR
Telethon Institute for Child Health Research
William S Pomat, PhD
Role: PRINCIPAL_INVESTIGATOR
Papua New Guinea Institute of Medical Research
Locations
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PNG Institute of Medical Research
Goroka, Eastern Highlands Province, Papua New Guinea
Countries
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References
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van den Biggelaar AHJ, Richmond PC, Fuery A, Anderson D, Opa C, Saleu G, Lai M, Francis JP, Alpers MP, Pomat WS, Lehmann D. Pneumococcal responses are similar in Papua New Guinean children aged 3-5 years vaccinated in infancy with pneumococcal polysaccharide vaccine with or without prior pneumococcal conjugate vaccine, or without pneumococcal vaccination. PLoS One. 2017 Oct 13;12(10):e0185877. doi: 10.1371/journal.pone.0185877. eCollection 2017.
Other Identifiers
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PCVFU927
Identifier Type: -
Identifier Source: org_study_id