Absence of a significant interaction between a Haemophilus influenzae conjugate vaccine combined with a diphtheria toxoid, tetanus toxoid and acellular pertussis vaccine in the same syringe and inactivated polio vaccine

Abstract

Whether polio immunization was accomplished with IPV or OPV did not significantly influence the antibody responses in sera obtained at 7 months of age for anti-PRP, anti-diphtheria and anti-tetanus toxoid antibodies and antibodies to pertussis antigens, when DTaP/PRP-T was given in the primary series.

Magnitude of Interference after Diphtheria‐Tetanus Toxoids–Acellular Pertussis/Haemophilus influenzaeType b Capsular Polysaccharide–Tetanus Vaccination Is Related to the Number of Doses Administered

“…On 16 June 1998, the US Food and Drug Administration (FDA) placed a "clinical hold" on further enrollment, because preliminary results from a similar clinical trial being conducted by the National Institutes of Health Vaccine Evaluation Units [10] had suggested that there was interference in the immune response to the PRP-T vaccine when the DTaP/PRP-T combination vaccine was administered concomitantly with IPV. Data from the infants who received all their primary series immunizations before the clinical hold were reported elsewhere [12], and similar interference between IPV and PRP responses was not found among our subjects. Infants who were enrolled but who had not received all their primary series immunizations were allowed to remain in the trial; however, they were given the identical lots of DTaP and PRP-T vaccines separately for the remainder of the primary series.…”

“…The DTaP/PRP-T (Tripedia/ActHIB) combination vaccine, TriHIBit (lots 0835860 and 0904810), was provided by Aventis Pasteur, as described elsewhere [12]. The vaccines were maintained in separate, single-dose vials.…”

“…We use the letter "C" to refer to the DTaP/PRP-T combination vaccine and "S" to refer to the regimen when the DTaP and PRP-T vaccines were given separately. The names and lots of IPV, OPV, and hepatitis B vaccines were identical to those described elsewhere [12].…”

“…The overall study design has been reported elsewhere [12]. In brief, 356 healthy infants were recruited from outpatient clinics and private pediatric practices in suburban Chicago (Child Life Center, Suniti Medical Corporation, and Meyer Medical Center) and New Orleans (Rothschild Ochsner Pediatric Center) (figure 1).…”

“…At the time of the FDA-imposed clinical hold, 246 of the 356 enrolled subjects had received the DTaP/PRP-T combination vaccine at ages 2, 4, and 6 months (C, C, C), including the 228 who completed the protocol and have been described elsewhere [12] (figure 1).…”