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Phase III Randomized, Double-Blind, Placebo-Controlled Study of Acellular and Whole-Cell Pertussis Vaccines

NCT00004800 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 13250

Last updated 2005-06-24

No results posted yet for this study

Summary

OBJECTIVES: I. Compare the efficacy of 2 acellular pertussis vaccines vs. whole-cell pertussis vaccine vs. placebo in infants living in Italy.

II. Compare the relative protection of each of the acellular vaccines vs. the whole-cell vaccine vs. laboratory-confirmed pertussis.

III. Assess the relative efficacy of the acellular vaccines with respect to one another.

IV. Assess the immunogenicity of acellular vs. whole-cell vaccines in the study population.

V. Compare the frequency of adverse events with each vaccine. VI. Compare the frequency of adverse events attributable to the pertussis component in each of the 3 vaccines.

VII. Assess alternative laboratory diagnostic techniques for pertussis in estimating vaccine efficacy, i.e., mucosal immune response, DNA probes, or antibody response to other components of the organism.

VIII. Assess the relative efficacy estimates of each vaccine, using clinical criteria to compare the relative incidence rates in each vaccine group.

Conditions

  • Pertussis

Interventions

BIOLOGICAL

diphtheria-tetanus-pertussis vaccine containing whole-cell pertussis

BIOLOGICAL

diphtheria-tetanus vaccine

Sponsors & Collaborators

  • Istituto Superiore di Sanità

    collaborator OTHER

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Donato Greco · Istituto Superiore di Sanità

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE

Eligibility

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

Timeline & Regulatory

Start
1992-09-30

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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 NCT00004800 on ClinicalTrials.gov