Effect of Two Versus Three Pneumococcal Conjugate Vaccinations

NCT00189020 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1005

Last updated 2011-08-22

No results posted yet for this study

Summary

Two( 2) or three (3) instead of four vaccinations before the age of 6 months with pneumococcal conjugate vaccine are presumed to protect children against invasive pneumococcal disease like meningitis, at least on the short term till 18-24 months of age. The current hypothesis in this study is 2 or 3 vaccinations will protect against IPD but will not alter pneumococcal nasopharyngeal carriage in infants, and consequently not change pneumococcal transmission and induce no herd-immunity. Furthermore, antibody development and memory may benefit from carriage of vaccine type S. pneumoniae

Conditions

  • Streptococcus Pneumoniae Infection

Interventions

BIOLOGICAL

PCV7

PCV7 at age 2 and 4 months

BIOLOGICAL

PCV7

PCV7 at age 2, 4 and 11 months

Sponsors & Collaborators

  • Netherlands: Ministry of Health, Welfare and Sports

    collaborator OTHER_GOV
  • Netherlands Vaccine Institute

    collaborator UNKNOWN
  • UMC Utrecht

    lead OTHER

Principal Investigators

  • Elisabeth A. M. Sanders, MD, PhD · UMC Utrecht

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
2 Months
Max Age
3 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-06-30
Primary Completion
2008-02-29

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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 NCT00189020 on ClinicalTrials.gov