Clinical Trials Logo

Clinical Trial Summary

OBJECTIVES:

Assess the efficacy of a single infusion of a high titer pertussis immune globulin for the treatment of severe pertussis in children.


Clinical Trial Description

PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are randomized to receive an infusion of either pertussis immune globulin or placebo (0.9% saline).

Patients are followed every 2 weeks for up to 6 months.

Completion date provided represents the completion date of the grant per OOPD records ;


Study Design

Allocation: Randomized, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00004422
Study type Interventional
Source FDA Office of Orphan Products Development
Contact
Status Completed
Phase Phase 3
Start date August 1997
Completion date September 2002

See also
  Status Clinical Trial Phase
Not yet recruiting NCT04056728 - A Phase IV Study to Assess the Safety of EupentaTM Inj Phase 4
Completed NCT02453048 - Study of BPZE1 (High Dose) Nasal Live Attenuated B. Pertussis Vaccine Phase 1
Completed NCT02526394 - Pertussis and Meningitis C Concomitant Vaccination in Adolescents Phase 4
Completed NCT01917357 - A Comparison of the Immunogenicity and Safety of Quinvaxem in Mono-dose Vials and Uniject Phase 3
Completed NCT01689324 - Study of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine (ADACEL®) as a Booster in Adolescents Phase 1/Phase 2
Completed NCT01214889 - Study of PENTAXIM™ Vaccine Versus TETRAXIM™ Vaccine Given With ACTHIB™ Vaccine in South Korean Infants. Phase 3
Completed NCT00804284 - Database Surveillance Safety Study of PENTACEL® Vaccine N/A
Completed NCT00514709 - Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB PRP~T Combined Vaccine in Filipino Infants Phase 3
Completed NCT00534833 - Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB-PRP~T Combined Vaccine or Tritanrix-HepB/Hib™ Phase 3
Completed NCT00524732 - Assessment of the Reactogenicity of ADACEL® (TdcP Vaccine) in Children and Adolescents 7 to 19 Years of Age N/A
Completed NCT00772369 - Retrospective Survey of Safety of Fourth Dose Pentacel® in Children Phase 4
Completed NCT01457495 - Immunogenicity and Safety of DTPa-HBV-IPV/Hib Compared to DTPa-IPV/Hib and HBV Administered Concomitantly Phase 2
Completed NCT01267058 - Booster Study of Combined Diphtheria-tetanus-acellular Pertussis Vaccine in Healthy Adults Phase 3
Completed NCT00004800 - Phase III Randomized, Double-Blind, Placebo-Controlled Study of Acellular and Whole-Cell Pertussis Vaccines Phase 3
Completed NCT02858440 - A Study to Assess the Immunogenicity and Safety of GSK Biologicals' Infanrix-IPV/Hib Vaccine Administered as a Three-dose Vaccination Course at 3, 4.5 and 6 Months of Age and a Booster Dose at 18 Months of Age in Healthy Infants in Russia Phase 3
Recruiting NCT04023929 - Sources of COmplement in Meningococcal and Pertussis Serum Bactericidal Antibody Assays
Completed NCT02946190 - The PertADO Geneva Trial Phase 2
Completed NCT03541499 - Safety and Immunogenicity of Intranasal BPZE1 Vaccination in Healthy Adults Phase 2
Completed NCT02587520 - Study of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed in Healthy Subjects Phase 1/Phase 2
Completed NCT04589312 - Maternal Pertussis Wholecell Responses Phase 2