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Pneumococcal Vaccination of Fiji Infants

NCT00170612 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 552

Last updated 2008-10-21

No results posted yet for this study

Summary

Pneumonia is the most common reason for admission of Fijian children to hospitals. The most common germ causing pneumonia is "streptococcus pneumoniae." It is a common cause of meningitis (infection around the brain and spinal cord), ear infections, and blood infections and it lives in the nose of humans. A vaccine has been developed that will help prevent these common diseases but prevents only about one quarter of pneumonia cases and it is expensive. This study explores new ways of giving this vaccine that are affordable, safe, and effective in countries such as Fiji. About 550 Fijian infants presenting at 6 weeks of age, for their first diptheria, tetanus, toxoid, pertussis vaccine immunization, to one of the participating Health Centers or Colonial War Memorial Hospital in urban Suva, Fiji will be enrolled. Children will remain in the study for 2 years. Study procedures include full vaccination against 7 types of pneumococcus, blood tests, and nasal swabs.

Conditions

  • Pneumococcal Infections

Interventions

BIOLOGICAL

Pneumovax 23

23-valent PPS, 25 micrograms/serotype

BIOLOGICAL

Prevnar

7-valent PCV, 2 micrograms/serotype, except serotype 6B which is 4 micrograms/serotype

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • University of Melbourne

    lead OTHER

Principal Investigators

  • Fiona M Russell, FRACP · University of Melbourne

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Weeks
Max Age
8 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2008-01-31
Completion
2008-08-31

Countries

  • Fiji

Study Locations

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Entities

Companies

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 NCT00170612 on ClinicalTrials.gov