NCT00843895

Brief Summary

The purpose of this study is to identify the S. pneumoniae serotypes strains and to determine antibiotic susceptibility.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2009

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 13, 2009

Completed
16 days until next milestone

Study Start

First participant enrolled

March 1, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

February 13, 2009

Status Verified

February 1, 2009

Enrollment Period

5 months

First QC Date

February 9, 2009

Last Update Submit

February 11, 2009

Conditions

Pneumococcal Disease

Keywords

Laboratory based studyantibiotic susceptibiltyinvasive strains

Outcome Measures

Primary Outcomes (1)

  • Incidence and serotypes of invasive pneumococcal dis.

    6-8 months

Secondary Outcomes (1)

  • Antibiotic susceptibility

    6-8 months

Interventions

pneumococcal conjugate vaccine(prevenar)BIOLOGICAL

to see the vaccine impact on pneumococcal diseases

Eligibility Criteria

Age3 Weeks - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • age less than 5 years

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pneumococcal Infections

Interventions

Heptavalent Pneumococcal Conjugate Vaccine

Condition Hierarchy (Ancestors)

Streptococcal InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Pneumococcal VaccinesStreptococcal VaccinesBacterial VaccinesVaccinesBiological ProductsComplex MixturesVaccines, Combined

Central Study Contacts

Atef M. Shibl, PH D

CONTACT

00966505 30 2775amshibl@ksu.edu.sa

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 9, 2009

First Posted

February 13, 2009

Study Start

March 1, 2009

Primary Completion

August 1, 2009

Study Completion

December 1, 2009

Last Updated

February 13, 2009

Record last verified: 2009-02