A clinical trial of a monocomponent pertussis toxoid vaccine.
We compared a monocomponent pertussis toxoid vaccine preparation (JNIH-7) in a double-blind, randomized study with another component vaccine (JNIH-6) containing pertussis toxoid and filamentous hemagglutinin in equal proportions. Monocomponent pertussis toxoid vaccines have not been tested previously in children. This trial comprised 255 previously nonimmunized children 6 to 10 months old who were given two 0.5-mL subcutaneous injections of either vaccine four to five weeks apart. Prevaccination and postvaccination serum samples from 235 infants showed an antitoxin seroconversion rate of 100% in both groups. Adverse reactions were few and mild, with local reactions occurring more often after administration of the second dose and among recipients of the two-component vaccine (P less than .05).
Hedenskog
S
S
Granström
M
M
Olin
P
P
Tiru
M
M
Sato
Y
Y
D000917:Antibody Formation; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D005069:Evaluation Studies as Topic; D006801:Humans; D007223:Infant; D010567:Pertussis Vaccine / Q000009:adverse effects / Q000276:immunology*; D011897:Random Allocation; D014611:Vaccination / Q000009:adverse effects
D010567:Pertussis Vaccine