A Phase 2 interventional study of Pneumococcal 7 valent conjugate vaccine (Prevenar®) in Pneumonia, Meningitis and Otitis Media, sponsored by Papua New Guinea Institute of Medical Research. Completed at 1 site in Papua New Guinea. Open to participants aged 1 Minute to 3 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-07-12.
Sponsored by Papua New Guinea Institute of Medical Research · Phase 2, Interventional, and Prevention
The National Health Plan 2001-2010 calls for investigation of the feasibility of pneumococcal vaccines for Papau New Guinea. The Papua New Guinea (PNG) Institute of Medical Research, the Telethon Institute for Child Health Research and the Department of Paediatrics, University of Western Australia will collaborate to examine very closely the safety of neonatal vaccination, particularly with regard to impact on the development of immunity and response to other vaccines given to infants. This study will also provide a unique opportunity for training of PNG and Australian scientists in both countries.
In order to obtain the earliest possible protection against invasive pneumococcal disease, achieve optimal coverage and reduce burden of early carriage, neonatal pneumococcal conjugate vaccine (PCV) immunization needs to be considered. This study in the PNG highlands will enrol 312 infants at birth, who will be randomised to receive PCV either at 1-2-3 months (infant schedule according to PNG national EPI schedule) or 0-1-2 months of age (neonatal schedule) or receive only routine immunizations (controls). Blood samples will be taken at birth-2-3-4 months of age, pre- and post-pneumococcal polysaccharide booster (23vPPV) at 9-10 months of age (to assess immune memory) and at 18 months at study completion. Carriage will be assessed weekly for the first month of life and at regular intervals thereafter. There will be ongoing surveillance for respiratory and other diseases throughout the study. In addition to serotype-specific IgG, we will examine IgG avidity, IgG subclasses, mucosal IgA and T-cell cytokine responses to PCV and pneumococcal protein antigens. To ensure immunological safety, particularly for neonatal PCV, immune responses to concomitant vaccines and viral and environmental antigens will also be examined as well as overall T-cell maturation.
284 studies on the registry are indexed under Otitis Media; 33 are open to participants now.
This study's enrollment of 318 is above the median of 126 across 194 interventional studies indexed under Otitis Media.
Browse Otitis Media studies →Papua New Guinea Institute of Medical Research is the lead sponsor of 7 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
New born babies with birth weight >2000 g (2 kgs) and parents giving consent
Exclusion Criteria:
Receive study vaccine (Prevnar) at birth, 1 and 2 months
Biological: Pneumococcal 7 valent conjugate vaccine (Prevenar®)
Receive the study vaccine (Prevnar) at 1, 2 and 3 months
Biological: Pneumococcal 7 valent conjugate vaccine (Prevenar®)
Do not receive study vaccine (Prevnar)
Biological: Pneumococcal 7 valent conjugate vaccine (Prevenar®)
Accelerated PCV vaccinaton.
Immunogenicity and Safety
Serum PCV serotype-specific IgG antibody at 2, 4 and 9 mths. Mucosal PCV serotype-specific IgG antibody at 1, 3, 4 and 9 mths. PCV-induced T-cell memory (against vaccine protein carrier) at 3 and 9 mths. Local and systemic reactogenicity 48-96 hrs after vaccination. Monitoring of serious adverse events during 18 mth follow-up. T-cell development to bystander antigens at 3 and 9 mths.
Time frame: 5 yrs
Immunogenicity
Serum PCV and non-PCV serotype specific IgG antibody at 10 mths, after 23vPPV vaccination at 9 mths
Time frame: 5 years
Pneumococcal-specific acquired immunity
Assessment of cellular immune responses to pneumococcal protein antigens at 9 and 18 months of age.
Time frame: 5 years
This study is completed, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.
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Papua New Guinea Institute of Medical Research