Inactivated Pertussis Toxin and Filamentous Hemagglutinin Vaccines vs. Whole-Cell Pertussis Vaccine in Infants
This phase 3 study aims to compare the effectiveness of Inactivated Pertussis Toxin and Filamentous Hemagglutinin vaccines against the Whole-Cell Pertussis vaccine in preventing pertussis in infants.
whole-cell pertussis vaccine
+ diphtheria-tetanus vaccine
Bacterial Infections and Mycoses+11
+ Bordetella Infections
+ Infections
Prevention Study
Summary
Study start date: April 1, 1991
Actual date on which the first participant was enrolled.PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by participating institution. The first group of infants receives a vaccine composed of inactivated pertussis toxin (iPT) and filamentous hemagglutin (FHA). The second group receives a vaccine containing iPT, FHA, pertactin, agglutinogen 2, and agglutinogen 3. The third group receives a whole-cell pertussis vaccine. The fourth group receives a diphtheria-tetanus vaccine as the control. All vaccines are given as an intramuscular injection, at 2-3, 4, and 6 months of age. Close surveillance of infants and families continues for 2-3 years.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.10000 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 2 to 3 Months
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
PROTOCOL ENTRY CRITERIA: --Population Characteristics-- Infants aged 2 months at planned date of first vaccination No prior pertussis confirmed by culture The following do not exclude: Down syndrome Prematurity Healthy babies vaccinated according to chronological age Recent pertussis exposure Seizures in parent or sibling Sudden infant death in sibling Close relative with history of anaphylaxis or allergy Close relative with history of strong reaction to vaccination --Patient Characteristics-- Age: Under 3 months Renal: No renal failure Other: No prior gammaglobulin No requirement for immunosuppressives, e.g., HIV infection No manifest immunosuppression No serious chronic illness associated with failure to thrive No cardiac disease No progressive neurologic disease No uncontrolled epilepsy or infantile spasms No parental language or communication barrier