Changing the treatment paradigm for acute otitis media in children.
Explore the source record for details and available documents.
Acute Disease↗
Biomedical subjects
M E Pichichero
Publications and source records attributed to M E Pichichero.
Diagnosis of penicillin, amoxicillin, and cephalosporin allergy: reliability of examination assessed by skin testing and oral challenge.
The specificity of pediatrician-diagnosed allergy reactions to penicillin, amoxicillin, and oral cephalosporins, which was based on contemporaneous examination of the patient, was evaluated by an elective skin testing program. Children and adolescents (n = 247) experiencing an adverse reaction to penicillin, amoxicillin, and/or an oral cephalosporin sufficient to lead to the recommendation to avoid further use were enrolled. Skin testing with penicillin G, commercial benzylpenicilloyl phosphate, penicillin minor determinate mixture, ampicillin, cefazolin, cefuroxime, and ceftriaxone was performed according to the suspected drug allergy followed by an oral challenge, repeat testing, and prospective follow-up if no reactions were observed. Overall, 84 (34.0%) of 247 patients had an IgE-type reaction on skin testing or oral challenge. Twenty-seven (32%) of 85 suspected penicillin reactions, 53 (34%) of 156 suspected amoxicillin reactions, and 13 (50%) of 26 suspected cephalosporin reactions were shown to be IgE mediated. Positive skin tests were observed in 20 patients with non-IgE-type clinical adverse reactions, including 15 patients with only a pruritic polymorphous rash. No reactions to oral challenge were severe after negative skin testing. One hundred sixty-three patients received multiple treatment courses with beta-lactam antibiotics after a negative skin testing procedure and three (1.8%) had adverse IgE reactions, all of which were mild. Physician-diagnosed allergic reactions to beta-lactam antibiotics based on patient examination at the time of the reaction is more accurate than patient history alone but still overestimates the rate of possible true allergy in 66% of patients. Elective penicillin, amoxicillin, and cephalosporin skin testing and oral challenge protocols are necessary to identify patients not at risk.
Adolescent↗
Serum antibody responses of weanling mice and two-year-old children to pneumococcal-type 6A-protein conjugate vaccines of differing saccharide chain lengths.
Type 6A pneumococcal polysaccharide (PS) fractions having mean lengths 2, 7, or 14 repeat units were coupled to tetanus toxoid, giving conjugates T-6A-2, T-6A-7 or T-6A-14. In weanling outbred mice, type-6A serum antibody responses were minimal to T-6A-7 but significantly higher to T-6A-2 and T-6A-14. In contrast, two-year-old humans responded increasingly to T-6A-2, T-6A-7, and T-6A-14; type 6B antibody rose, but variably. Upon challenge with 6B PS at age 3 yr, conjugate-primed children made anamnestic responses. T-6A-14, containing the longest saccharide chains (and highest saccharide:protein mass ratio) excelled in priming as well as antibody induction.
Adult↗
Three-year follow-up of vaccine response in extremely preterm infants.
OBJECTIVE: To assess whether the adequate antibody response observed in former extremely premature infants after the primary series of immunizations is sustained after the first booster vaccines. SUBJECTS AND METHODS: Sixteen former extremely premature (<29 weeks, <1000 g at birth) and 17 former full-term (>37 weeks) infants had sera obtained for antibody titer measurement at 3 to 4 years of age. All had received the primary series and first booster vaccines for diphtheria, pertussis, tetanus, polio, and Haemophilus influenzae type b. Twelve preterm and 14 full-term children had completed the hepatitis B vaccine series. RESULTS: At 3 to 4 years of age, former preterm and full-term children had similar geometric mean titer (GMT) values of antibodies to tetanus, diphtheria, and pertussis. Preterm children had a lower GMT value of Haemophilus polyribosylribitol phosphate (PRP) antibody than did full-term children (0.99 vs 3.06 microg/mL). Fifty percent of preterm and 88% of full-term children had PRP antibody >1.0 microg/mL; 100% of preterm and 94% of full-term children had anti-PRP titers >0.15 microg/mL. GMT values of neutralizing antibodies to polio serotypes 1 and 2 were similar, with 94% to 100% of both groups above protective levels (>/=1:8). The difference in GMT values of polio serotype 3 approached significance (29 vs 73); fewer preterm children had protective titer values (75% vs 100%). Among children vaccinated against hepatitis B, 75% of preterm and 71% of full-term children were protected (10 mIU/mL). CONCLUSIONS: Preterm children immunized at the recommended chronological ages displayed antibody responses similar to those for full-term children for most immunizing antigens. Responses to PRP and polio serotype 3 were less robust than those of full-term children.
Antibodies, Viral↗
Economic impact of pertussis.
OBJECTIVE: To assess the economic consequences of pertussis in Monroe County, New York (population, 713969), during a 6-year period (1989-1994). METHODS: Cases of pertussis were identified retrospectively by passive reporting and diagnosis based on culture, positive results of direct fluorescent antibody testing, or Centers for Disease Control and Prevention clinical criteria (cough for > 14 days otherwise unexplained or for > 7 days with paroxysms or whoop epidemiologically linked to a laboratory-confirmed case). One hundred seven (50%) of 216 subjects with identified cases of pertussis completed questionnaires and had medical records reviewed to ascertain the costs of illness, including physician office visits, laboratory tests, medications, hospitalization, emergency department visits, additional child care, and lost days from school (children) or from work (parents or adult cases). RESULTS: Ninety-three (87%) of the pertussis case occurred in children. The average duration of illness before diagnosis was 21.3 days (range, 12-37 days). One hundred one patients (94%) saw a physician at least once; overall, the average number of visits per case was 3.2 (range, 1-15). Ninety-seven patients (91%) received at least 1 course of antibiotic therapy (average cost for all antibiotics, $95/case), and all took symptomatic treatment (average cost, $48/case). Fifteen patients (14%) required hospitalization; average cost per admission was $13425 (range, $1732-$69637). Thirty patients (28%) were seen in emergency departments; average cost was $202 (range, $69-$289). Additional child care costs ranged from $12 to $2688. For 50 families, 1 adult lost workdays because of illness or to provide child care for an average of 8.3 days (range, 1-45 days). For 4 families, 2 adults lost an average of 44 days from work (range, 10-120 days). The cumulative number of lost workdays was 758 in association with the 107 cases of pertussis. The average full recovery time from illness was 72.9 days (range, 25-115 days). CONCLUSIONS: Total direct and indirect cost for 107 cases of pertussis in Monroe County was $381052. The economic burden of pertussis is substantial and encourages broader use of vaccination to prevent disease.
Absenteeism↗
A study of 5-day cefdinir treatment for streptococcal pharyngitis in children. Cefdinir Pediatric Pharyngitis Study Group.
OBJECTIVE: To compare the safety and efficacy of a 5-day regimen of cefdinir with those a conventional 10-day regimen of penicillin V for the treatment of streptococcal pharyngitis in children. DESIGN: Investigator-blind, randomized controlled trial. SETTING: Primary care, ambulatory. PATIENTS: Children aged 1 to 12 years with signs and symptoms of pharyngitis and a positive result on a rapid screening test for Streptococcus pyogenes (ie, a convenience sample). Four hundred eighty-two patients were enrolled in the study, and 440 were clinically and microbiologically evaluable. The most common reasons patients were nonevaluable were failure to return for specified visits and noncompliance with the administration of the medication; 2 patients receiving penicillin V discontinued use of the drug because of adverse events. INTERVENTION: Patients were randomized to receive either 7-mg/kg cefdinir, twice daily, for 5 days or 10-mg/kg penicillin V potassium, 4 times daily, for 10 days. MAIN OUTCOME MEASURES: The eradication of S pyogenes and the clinical cure of the signs and symptoms of pharyngitis, both determined 5 to 10 days after the completion of therapy. RESULTS: Streptococcus pyogenes was eradicated in 201 (90%) of the 224 patients receiving cefdinir and 155 (72%) of the 216 patients receiving penicillin V (95% confidence interval [CI], 10.7%-25.1%; P < .001). The clinical cure rates were 92% and 91% in the groups receiving cefdinir and penicillin V, respectively (95% CI, -4.5% to 6.1%; P = .80). Adverse events, regardless of the opinion of the investigator about their relationship to the study medication, occurred in 12.5% of the patients receiving cefdinir and 13.6% of the patients receiving penicillin V (P = .69). CONCLUSIONS: A 5-day regimen of cefdinir eradicated a higher proportion of S pyogenes than a 10-day regimen of penicillin V. No difference was noted between the regimens for clinical outcomes or adverse event rates.
Adolescent↗
Administration of combined diphtheria and tetanus toxoids and pertussis vaccine, hepatitis B vaccine, and Haemophilus influenzae type b (Hib) vaccine to infants and response to a booster dose of Hib conjugate vaccine.
We compared antibody levels following separate but simultaneous administration of diphtheria and tetanus toxoids with acellular pertussis vaccine (DTaP) containing pertussis toxoid, filamentous hemagglutinin, and pertactin (PRN); hepatitis B vaccine; and Haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate; PRP) vaccine conjugated to tetanus toxoid (PRP-T) with those following administration of a combination of a DTaP-hepatitis B vaccine-PRP-T to infants at 2, 4, and 6 months of age. The antibody response to a booster dose of PRP conjugate vaccine (CRM197-OS) in infants with low (< 1 microgram/mL) or undetectable (< 0.10 microgram/mL) postpriming levels of antibody to PRP was also studied. Antibody levels were quantitated before and after dose 3 by enzyme-linked immunosorbent assay, radioimmunoassay, or neutralization assay. Seroresponse rates were not different between the two vaccine groups except for rates of response to PRP. There was a trend that levels of antibody to all the antigens included in the combination vaccine were lower than those of antibody to antigens in separate vaccines; for levels of antibody to diphtheria toxoid (P = .001), PRN (P < .0001), and PRP (P < .0001), the differences were significant. Despite low or undetectable postpriming levels of antibody to PRP, high-titered (geometric mean concentration, 9.02 micrograms/mL; range, 1.0-81.5 micrograms/mL), immunoglobulin G-predominant antibody to PRP was produced following a booster dose of CRM197-OS, a finding consistent with a memory response.
Diphtheria-Tetanus-Pertussis Vaccine↗
Evaluation of a pentavalent conjugated pneumococcal vaccine in toddlers.
Explore the source record for details and available documents.
Antibodies, Bacterial↗
Empiric antibiotic selection criteria for respiratory infections in pediatric practice.
BACKGROUND: Respiratory infections in children may occur as a consequence of resistant bacterial pathogens. Streptococcus pneumoniae organisms resistant to penicillin, trimethoprim/sulfamethoxazole and macrolides are increasingly prevalent. Amoxicillin- and macrolide-resistant Haemophilus influenzae and Moraxella (Branhamella) catarrhalis are also more commonly seen. Traditional agents such as amoxicillin and trimethoprim/sulfamethoxazole remain acceptable choices for most children with respiratory infections because currently most patients are not infected by resistant pathogens and there is a high spontaneous cure rate associated with these infections. OBJECTIVE: To analyze the criteria for the selection of extended spectrum antimicrobials as empiric therapy for respiratory infections. DISCUSSION: When an extended spectrum antimicrobial is appropriate for empiric therapy, selection should be based on: (1) efficacy; (2) adverse event profile; and (3) compliance-enhancing features (dosing with meals, once or twice daily administration, good palatability in suspension, shortened course of therapy and affordability). A new agent, ceftibuten, has recently joined other extended spectrum cephalosporins and newer macrolides (clarithromycin and azithromycin) as a choice to be considered for empiric therapy for respiratory infections. These antimicrobials are differentiated from each other and traditional agents by differences in activity in vitro against penicillin-resistant pneumococci, relative beta-lactamase stability against Gram-negative bacteria and pharmacodynamic properties. When resistant organisms are isolated or suspected in community-acquired respiratory infections, cautious use of newer antibiotics may have to be considered.
Anti-Bacterial Agents↗
Cefprozil treatment of persistent and recurrent acute otitis media.
OBJECTIVE: We identified the pathogens causing persistent and recurrent acute otitis media (AOM) and the clinical efficacy of cefprozil as treatment. STUDY DESIGN: This was a noncomparative, open label multicenter trial. Children ages 6 months to 12 years with signs and symptoms of AOM and evidence of middle ear effusion, as confirmed by pneumatic otoscopy or tympanometry, underwent tympanocentesis and subsequent treatment with cefprozil (15 mg/kg given twice daily) for 10 days. Patients with recurrent otitis media or failure of previous antibiotic therapy or prophylaxis were particularly sought for the study. RESULTS: Two hundred sixty-two (99%) of 265 enrolled children were considered evaluable. The median age of the study group was 1 year. Ninety-eight (37%) of the children had a history (within 30 days) of prior antibiotic use. Ninety-seven (37%) met our definition of recurrent AOM, 48 (18%) met our definition of persistent AOM and 132 (50%) children had 3 or more previous episodes of acute otitis media within 12 months before study. Eighty-two (31%) of the enrollment tympanocentesis had no growth, 150 (57%) had a single bacterial pathogen and 29 (11%) had multiple bacterial pathogens. Of the 93 Streptococcus pneumoniae pretreatment isolates, 50 (54%) were penicillin-susceptible, 12 (13%) were penicillin-intermediate resistant and 31 (33%) were penicillin-resistant. Of the 75 Haemophilus influenzae pretreatment isolates, 42 (56%) produced beta-lactamase as did 4 (27%) of the 15 Moraxella catarrhalis strains. A satisfactory clinical response by pathogen was found in 75% (70 of 93) with S. pneumoniae, 75% (56 of 75) with H. influenzae and 93% (13 of 14) with M. catarrhalis; the response with single pathogen infections was higher than those with multiple pathogens (118 of 150 (78%) and 17 of 29 (59%), respectively; P = 0.03). The response for patients with isolates of S. pneumoniae that were penicillin-susceptible, -intermediate or -resistant were 39 of 50 (78%), 11 of 12 (92%) and 21 of 31 (68%), respectively. Older children had a satisfactory clinical outcome more frequently than younger children (P < 0.001), and the response to therapy varied for persistent, recurrent and recently untreated AOM (P < 0.01). CONCLUSION: Persistent and recurrent AOM involves the same pathogens as recently untreated AOM but bacteria with reduced antibiotic susceptibility may be more frequently present. This noncomparative study suggests that cefprozil 30 mg/kg/day given in two divided doses for 10 days may be effective in the treatment of children with persistent and recurrent AOM.
Acute Disease↗
Shortened course of antibiotic therapy for acute otitis media, sinusitis and tonsillopharyngitis.
Explore the source record for details and available documents.
Acute Disease↗
Vaccine antigen interactions after a combination diphtheria-tetanus toxoid-acellular pertussis/purified capsular polysaccharide of Haemophilus influenzae type b-tetanus toxoid vaccine in two-, four- and six-month-old infants.
OBJECTIVE: The safety and immunogenicity of a diphtheria-tetanus toxoid-acellular pertussis vaccine (DTaP; Trepedia)/Haemophilus influenzae b polysaccharide (PRP-T; ActHib) combined vaccine (TriHibir; Pasteur Mérieux Connaught) was compared with DTaP and PRP-T given at the same visit but at separate sites in a prospective multicenter, open label trial. METHODS: Infants were randomized to four groups (three consistency lots of DTaP/PRP-T vs. one of the consistency lots given as separate vaccines); injections were administered at 2, 4 and 6 months of age. Pre-Dose 1 and post-Dose 3 sera were assayed for antibody titers against all antigens. Reactions to the vaccinations were assessed by parent questionnaire for 30 days after each injection visit. RESULTS: Four hundred eighty-five infants were enrolled; 296 evaluable infants were included in the DTaP/PRP-T group compared with 70 infants in the DTaP and PRP-T vaccine group. Infants who received the combined vaccine had higher post-Dose 3 geometric mean antibody titers to diphtheria antitoxin (P < 0.01) and pertussis filamentous hemagglutinin (P < 0.05) and lower geometric mean antibody titers to tetanus antitoxin (P < 0.05) and Haemophilus influenzae b (Hib) polysaccharide (PRP) (P < 0.05). The geometric mean anti-PRP antibody titer in the DTaP/PRP-T group was 4.3 micrograms/ml compared with 7.0 micrograms/ml in the separate vaccine group (P < 0.05), and the percentage of infants with antibody titers > or = 0.15 and 1 microgram/ml were, respectively, 95 and 86%, whereas they were 100% for both titers in the separate vaccines group. DTaP/ PRP-T vaccine given concomitantly or 1 month apart from hepatitis B vaccine and oral poliomyelitis vaccine caused no significant differences in immunogenicity or safety. The safety assessments for the DTaP/PRP-T vaccine showed no consistent differences in systemic or local injection site reactions compared with DTaP and PRP-T administered separately. CONCLUSION: Although the antibody responses to tetanus and Hib polysaccharide in the evaluated DTaP/PRP-T combined vaccine were significantly lower than those seen after separate DTaP and PRP-T administration, the combined vaccine elicited an immune response against diphtheria, tetanus, pertussis and Haemophilus influenzae b likely to confer protection.
Analysis of Variance↗
A safety and immunogenicity comparison of 12 acellular pertussis vaccines and one whole-cell pertussis vaccine given as a fourth dose in 15- to 20-month-old children.
OBJECTIVE: To compare the safety and immunogenicity of 12 different acellular pertussis vaccines combined with diphtheria and tetanus toxoids (DTaP) with one licensed diphtheria, tetanus, and whole-cell pertussis vaccine (DTwP) as a fourth-dose booster in children who had previously received DTaP or DTwP primary vaccinations. METHODS: Healthy 15- to 20-month-old children were enrolled at six National Institutes of Health Vaccine Treatment and Evaluation Units. All had been randomly assigned to receive three primary doses of DTaP or DTwP at 2, 4, and 6 months of age as part of an earlier National Institutes of Health multicenter trial of DTaP vaccines in the same Vaccine Treatment and Evaluation Units. Parents recorded the occurrence and magnitude of fever; irritability; and injection site redness, swelling, and pain for 3 days after vaccination. Sera obtained before and 1 month after the booster vaccination were analyzed for antibody to pertussis toxin (PT), filamentous hemagglutinin (FHA), fimbriae (FIM), and pertactin (PRN). Diphtheria and tetanus toxoid as well as PT neutralizing (Chinese hamster ovary cell) and whole-cell agglutinating antibodies were measured on a subset of sera. RESULTS: A total of 1293 children contributed fourth-dose reaction data. Reactions were less frequent after DTaP than after DTwP. For children vaccinated with a fourth dose of DTaP, which was the same DTaP as received in the primary series, fever and injection site redness, swelling, and pain increased in prevalence compared with the third dose in the primary series. For children receiving DTaP as a fourth dose, injection site redness and swelling occurred more frequently in DTaP-primed than in DTwP-primed children. Variation in the occurrence of reactions among DTaP vaccines was observed. A total of 1160 paired pre- and postvaccination sera were available for analysis. Serum antibody concentrations before boosting were lower than those obtained 1 month after the primary immunization. After the fourth dose, significant increases in antibodies directed against the included antigens were observed for all vaccines; postbooster vaccination antibody titers differed significantly among the DTaP vaccines. For children primed and boosted with the same DTaP, antibody levels were not directly related to the quantity of antigen included for PT, FHA, and FIM; for PRN, there was a closer relationship. Some DTaP vaccines given as fourth-dose boosters elicited antibody to PRN or FIM in some vaccinees, although the DTaP vaccines were not reported to contain these antigens; these responses were observed more frequently in DTwP-primed children. Agglutinin antibody rises were observed in all groups immunized with four doses of a DTaP vaccine containing FHA or PRN, regardless of whether the vaccine included FIM. Diphtheria and tetanus antibody levels exceeded the presumed protective concentration (0.1 IU/mL for diphtheria and 0.01 IU/mL for tetanus) after the fourth dose for all vaccinees. CONCLUSION: Although differences were observed in reaction rates among the DTaP vaccines given as a fourth dose, the DTaP vaccines were, in general, associated with fewer adverse events than a US-licensed DTwP. For DTaP vaccines, fever; irritability; and injection site pain, redness, and swelling occurred more frequently after the fourth dose than after the third dose of the same vaccine in the primary series. No DTaP was consistently most or least reactogenic or immunogenic. Although serologic correlates of pertussis immunity are not defined, it is clear that most DTaP vaccines can stimulate comparable or higher serum antibody responses than DTwP for those antigens contained in the vaccine.
Antibodies, Bacterial↗
Sore throat after sore throat after sore throat. Are you asking the critical questions?
In this discussion of recurrent group A streptococcal tonsillopharyngitis, the author notes that even at the peak of the streptococcal infection season, not more than 30% to 40% of children with sore throats actually have group A streptococci as the cause. Thus, it is vital to confirm clinical diagnosis of group A streptococcal tonsillopharyngitis with laboratory tests. When patients have recurrent infections with group A streptococci, possible causes include noncompliance, bacterial resistance, repeated exposure, alteration of the throat's microbial ecology, suppression of antibody response due to previous antibiotic therapy, and treatment failure. When noncompliance is an issue, an injection of penicillin G benzathine may be appropriate. In other circumstances, pharmacologic options for treatment of recurrent group A streptococcal tonsillopharyngitis include macrolides, clindamycin hydrochloride, rifampin (in combination with a second agent), and oral cephalosporins. If a patient has six or seven recurrences over 1 or 2 years despite antibiotic treatment, tonsillectomy should be considered.
Adult↗
Acellular pertussis vaccines. Towards an improved safety profile.
The common adverse reactions associated with diphtheria, tetanus and pertussis (DTP) vaccination are less frequent and less severe with acellular DTP (DTaP) vaccines than with whole cell DTP (DTwP) vaccines. Five key parameters have been identified whose prevalence through the first 48 hours following vaccination accurately characterise the common manifestations of DTaP and DTwP reactogenicity: fever > 37.8 degrees C, moderate or severe fussiness, injection site redness, injection site swelling, and moderate or severe injection site pain. For every DTaP vaccine evaluated, significantly less reactogenicity has been observed in comparison to DTwP vaccines. Although there are differences among the acellular DTaP vaccines in the frequency and severity of some of the adverse reactions, these differences are minor in degree and nature. For both DTaP and DTwP vaccines, local reactions increase in prevalence and severity with successive inoculations. The safety of DTaP vaccines has now been established in infants receiving inoculations at 2,4 and 6 months of age and in other 2 and 3 inoculation sequences below 1 year of age, as well as in toddlers (1 to 3 year olds), preschool children (4 to 6 year olds) and in adults. The increased purity of DTaP vaccines should lead to a reduction in the rare, serious adverse reactions associated with pertussis vaccination.
Adult↗
Antibody response and reactions to completion of a four-dose series with a two- or three-component acellular pertussis vaccine compared to whole cell pertussis vaccine.
We compared the reactions and immunogenicity of DT acellular pertussis (DTaP) vaccines containing pertussis toxoid (PT) and filamentous haemagglutinin (FHA) (2-component DTaP) or PT, FHA and pertactin (PRN) (3-component DTaP vaccine) with a whole cell (DTwP) vaccine as a fourth-dose booster in 158 children (15-20 months old) who had received 3 primary vaccine doses with the same vaccines at 2, 4 and 6 months of age. Randomization was 3:1 for DTaP:DTwP and all children received concomitant oral polio vaccine (OPV). Fever (> 38 degrees C), irritability, local injection site erythema (> 10 mm), swelling (> 10 mm), and pain (moderate or more) were assessed for 72 h after booster vaccination. DTwP vaccinees had a higher incidence of fever (29.4%) and injection-site pain (45.7%) than 3-component DTaP vaccinees (fever, 9.6%, p < 0.02; injection-site pain, 3.8%, p < 0.01); 2-component DTaP vaccinees had less injection-site pain (8.3%, p < 0.01). Pre- and post-vaccination immunoglobulin G (IgG) antibody was measured by enzyme-linked immunosorbent assay (ELISA). Pre- and post anti-PT levels were similar for all 3 vaccine groups. Anti-FHA antibody was higher pre- and post-vaccination for both DTaP vaccine groups compared with the DTwP vaccinees (p < 0.01 for all comparisons). For 3-component DTaP vaccinees, anti-PRN antibody was higher pre- and post-vaccination compared to DTwP vaccinees (p < 0.01 for both comparisons). Tetanus antibody was higher pre- and post-vaccination for DTwP versus both DTaP vaccine groups, and diphtheria antibody was similar pre- and post-vaccination for all 3 groups. These 2- and 3-component DTaP vaccines produce less common reactions and comparable or higher antibody to the components they contain (except tetanus) than DTwP vaccine when given as a booster to 15- to 20-month-old children previously primed with the same vaccine.
Adhesins, Bacterial↗
Safety and efficacy of high-dose rhesus-human reassortant rotavirus vaccines--report of the National Multicenter Trial. United States Rotavirus Vaccine Efficacy Group.
OBJECTIVE: Rotavirus is a leading cause of morbidity and mortality from dehydrating gastroenteritis in infants and young children worldwide. Virtually every child is infected by age 4 years, justifying universal childhood immunization when a safe and effective vaccine is available. We report the results of a multicenter, placebo-controlled field trial in the United States of monovalent serotype 1 and tetravalent (TV) rhesus-human reassortant rotavirus vaccines (RRVs). DESIGN: In this randomized, double-blind trial, 1278 healthy infants ages 5 to 25 weeks received three oral doses of RRV serotype 1, RRV-TV, or a placebo at approximately 2, 4, and 6 months of age. Vaccines contained 4 x 10(5) plaque-forming units of virus. Gastroenteritis episodes were monitored, and severity was graded throughout one rotavirus season. Two stool specimens per episode were tested for rotavirus. RESULTS: The incidence of reactions did not differ among treatment groups during the 5-day, postvaccination safety surveillance period for any of the three doses. Both vaccines significantly reduced the incidence of rotavirus gastroenteritis. Vaccination was most protective against serious rotavirus illness; RRV-TV prevented 49% of rotavirus episodes, 80% of very severe episodes, and 100% of dehydrating rotavirus illness. Reduction of rotavirus disease by RRV-TV resulted in significantly fewer total episodes of gastroenteritis of all causes and an 82% reduction in all cases of dehydrating diarrhea. CONCLUSION: RRV-TV is highly protective against very severe, dehydrating rotavirus gastroenteritis.
Administration, Oral↗
Streptococcal pharyngitis: is penicillin still the right choice?
Explore the source record for details and available documents.
Anti-Bacterial Agents↗