Neonatal Immunization With Pneumococcal Conjugate Vaccine in Papua New Guinea

NCT00219401 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 318

Last updated 2011-07-12

No results posted yet for this study

Summary

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.

Conditions

Interventions

BIOLOGICAL

Pneumococcal 7 valent conjugate vaccine (Prevenar®)

Accelerated PCV vaccinaton.

Sponsors & Collaborators

  • The University of Western Australia

    collaborator OTHER
  • Papua New Guinea Institute of Medical Research

    lead OTHER_GOV

Principal Investigators

  • Peter Siba, PhD · Papua New Guinea Institute of Medical Research

  • Deborah Lehmann, MBBS, Msc · Telethon Institute for Child Health Research

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Minute
Max Age
3 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-05-31
Primary Completion
2009-05-31
Completion
2010-05-31

Countries

  • Papua New Guinea

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00219401 on ClinicalTrials.gov