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

Brief Title

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

Brief 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.

Detailed Description

      PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by
      participating institution and randomly assigned to 1 of 3 vaccines and a placebo vaccine in a
      3:3:3:1 ratio.

      One group receives diphtheria-tetanus-pertussis (DPT) vaccine containing filamentous
      hemagglutinin (FHA), Pt-9K/129G, and 69 kDA outer membrane protein (OMP).

      A second group receives DPT containing FHA and OMP. The third group receives DPT containing
      whole-cell pertussis. The control group receives diphtheria-tetanus (DT) vaccine. All
      vaccines are administered as an intramuscular or deep subcutaneous injection at 6-12, 13-20,
      and 21-28 weeks of age. The first vaccine is given at week 12 if hepatitis B or other immune
      globulin was given at birth.

      All patients receive a DT booster at 11 months, and are followed every 4 weeks for
      approximately 20 months.

Study Phase

Phase 3

Study Type

Interventional

Condition

Pertussis

Intervention

diphtheria-tetanus-pertussis vaccine containing whole-cell pertussis

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Biological

Estimated Enrollment

Start Date

September 1992

Eligibility Criteria

        PROTOCOL ENTRY CRITERIA:

        --Population Characteristics-- Newborns enrolled at first vaccine clinic visit Weight at
        first vaccination at least third percentile, i.e.: Girls: 3.2 to 3.8 kg Boys: 3.4 to 4.0 kg
        No previous illness compatible with pertussis --Prior/Concurrent Therapy-- No prior
        pertussis vaccination --Patient Characteristics-- Age: Over 6 weeks to under 12 weeks
        Renal: No renal failure Other: No prior prolonged immunosuppressive therapy No prior
        systemic corticosteroids, unless duration less than 14 days and at least 48 hours since
        last dose No major congenital abnormality No failure to thrive No known or possible immune
        system deficit, e.g.: HIV-infected mother Autoimmune anemia Lymphoma Other erythropoietic
        disease No perinatal central nervous system disease or damage No history of convulsions
        Mother Italian-speaking and accessible by telephone Planned residence in clinic district
        for at least 1 year

Gender

All

Ages

6 Weeks - 12 Weeks

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Donato Greco, ,

Administrative Informations

NCT ID

NCT00004800

Organization ID

199/11954

Secondary IDs

ISS-RI-11954

Study Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

 Istituto Superiore di Sanità

Study Sponsor

Donato Greco, Study Chair, Istituto Superiore di Sanità

Verification Date

February 1998