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Results for “Randomized trial”

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At least 1,135 records · Page 63Linked to original sources

PubMed2005

The effect on pediatric ophthalmologists of the randomized trial of patching regimens for treatment of moderate amblyopia.

PURPOSE: To investigate the implementation of the recommendations of the randomized trial of patching regimens for treatment of moderate amblyopia in children. METHODS: A questionnaire was e-mailed to 380 members of the American Association for Pediatric Ophthalmology and Strabismus. RESULTS: Ninety responses were received. The majority of questionnaire respondents did not alter their clinical practice of patching subsequent to publication of the results of the patching trial. Thirty-nine percent made no modification whatsoever; an additional 33% made rare adjustments, and only 12% claimed to have adapted the amount of patching hours to the recommendations of the study. CONCLUSIONS: It is evident from the questionnaire results that the majority of pediatric ophthalmologists that replied to the questionnaire did not alter their clinical practice of patching subsequent to publication of the results of the patching trial.

Amblyopia↗

PubMed1987

Randomized trial of the addition of cis-platin (DDP) and/or BCG to cyclophosphamide (CTX) chemotherapy for ovarian carcinoma.

A prospective randomized trial has compared cyclophosphamide (CTX) with CTX plus cis-diamminodichloroplatinum (DDP) as the initial chemotherapy for advanced ovarian carcinoma. A secondary randomization compared the addition of BCG treatment to either chemotherapy. The addition of DDP had no measurable impact on survival, but a small survival trend favoring BCG-treated patients was noted (P less than 0.08). Toxicity from BCG treatment was insignificant, but the addition of DDP increased both early nausea and vomiting and later hematologic toxicity. There were three long-term complete remission patients, and these all came from the group of six patients with pretreatment residual disease less than 2 cm. A univariate analysis of pretreatment prognostic factors indicated significantly better prognosis (P less than 0.02) for patients with no palpable tumor, platelet count less than 400,000/mm3, residual tumor less than 2 cm, resting pulse less than 91/min. and LDH less than 250 U/L. The authors conclude that for patients with large (greater than 2 cm) residual disease, there is no compelling evidence that initial combination therapy is superior to aggressive single alkylating agent treatment.

Antineoplastic Combined Chemotherapy Protocols↗

PubMed2004

The GETUG 70 Gy vs. 80 Gy randomized trial for localized prostate cancer: feasibility and acute toxicity.

PURPOSE: To describe treatments and acute tolerance in a randomized trial comparing 70 Gy and 80 Gy to the prostate in patients with localized prostate cancer. METHODS AND MATERIALS: Between September 1999 and February 2002, 306 patients were randomized to receive 70 Gy (153 patients) or 80 Gy (153 patients) in 17 institutions. Patients exhibited intermediate-prognosis tumors. If the risk of node involvement was greater than 10%, surgical staging was required. Previous prostatectomy was excluded, and androgen deprivation was not admitted. The treatment was delivered in two steps. PTV1-including seminal vesicles, prostate, and a 1-0.5-cm margin-received 46 Gy given with a 4-field conformal technique. PTV2, reduced to prostate with the same margins, irradiated with at least 5 fields. Dose was prescribed according to ICRU recommendations in the 70 Gy group, but adapted at the 80 Gy level. RESULTS: All patients but one in the 80 Gy arm completed the treatment. In the 70 Gy arm, the mean dose to the PTV2 was 69.5 Gy. In the 80 Gy arm, the mean dose in the PTV2 was 78.5 Gy. Acute toxicity according to Radiation Therapy Oncology Group scale during treatment was reported in 306 patients. There was no statistically significant difference between the two arms: 12% had no toxicity, 80% complained of bladder toxicity, and 70% complained of rectal symptoms. Two months after the end of treatment, 43% of the 70 Gy level and 48% of the 80 Gy level complained of side effects, including 24% and 20% of sexual disorders. There was 6% and 2% of Grade 3 urinary and rectal toxicity. Five patients required a 10-29-day suspension of the treatment. Acute Grade 2 and 3 side effects were related to PTV and CTV1 size, which was the only independent predictive factor in multivariate analysis. Toxicity was not related to the center, age, arm of treatment, or selected data from dose-volume histogram of organ at risk. CONCLUSION: Treatments were completed in respect to constraints. Acute toxicity was acceptable. Intensity of toxicity depended on target volumes.

Aged↗

PubMed1994

Which is more painful? A randomized trial comparing loop with laser excision of the cervical transformation zone.

We compared the pain of excisional cervical surgery by the laser or loop diathermy (LLETZ) in a randomised controlled clinical trial. Eighty women with CIN III were recruited from a laser colposcopy clinic specifically adapted to run randomized trials. They were scheduled for excision of their cervical transformation zone and both groups were matched for age, parity, and size of lesion. We measured linear analogue pain scores, subjective pain scores, and operative time. The laser and loop diathermy inflicts similar discomfort and there is no detectable difference between the median pain scores of women in either group (P = 0.99). However, in the hands of an experienced surgeon it takes 4 min extra to excise the cervical transformation zone with a laser compared to loop diathermy. The average time from sitting in the chair to the end of the procedure was 13.02 min (SD 3.65) for the group allocated diathermy surgery compared to 17.30 min (SD 5.33) for a laser excision log transformed t(log transformed data) = 3.7 (P < 0.001).

Adult↗

PubMed1982

Combination chemotherapy-radiotherapy with and without the methanol-extraction residue of Bacillus Calmette-Guerin (MER) in small cell carcinoma of the lung: a prospective randomized trial of the Piedmont Oncology Association.

The effect of addition of the nonspecific immunostimulant, MER, to combined treatment with chemotherapy and radiotherapy in small cell carcinoma of the lung was evaluated in a prospective randomized trial involving 102 evaluable patients. Chemotherapy consisted of cyclophosphamide, Adriamycin, vincristine, methotrexate, and CCNU; and radiotherapy was administered to the primary lesion, mediastinum, supraclavicular areas, and whole brain. Of 47 patients administered MER 400 mcg intradermally every six weeks, 12 (26%) attained complete remission with a median survival of 22.9 months. Complete remission was observed in 17 (31%) of 55 patients who received no MER with a median survival of 20.0 months (P greater than 0.05). Survival greater than or equal to 2 years has been observed in five patients who received MER and two patients who did not receive MER. The response rate and duration, survival, and toxicity of the two treatment arms were similar with the exception of cutaneous and occasional systemic reaction to MER. MER as used in this study has not influenced the overall results of a combined modality treatment program for patients with small cell carcinoma of the lung.

Adult↗

PubMed1976

The role of metoclopramide in peroral jejunal biopsy: a controlled randomized trial.

Metoclopramide is known to enhance gastric emptying and stimulate duodenal and small-intestinal peristaltic activity. The effect of the drug on peroral jejunal biopsy was examined in a controlled, double-blind, randomized trial. Forty-nine patients (24 females and 25 males) who required jejunal biopsy for diagnostic purposes were admitted to the study. All the biopsies were performed by the same operator using the Quinton multipurpose suction biopsy tube and applying the same technique. Twenty-four patients ranging in age from 18 to 67 years (mean 44.5) received placebo intravenously (sodium metabisulfite), and 25 patients from 16 to 73 years old (mean 39.9) received 10 mg of metoclopramide intravenously prior to the jejunal intubation. Objective parameters of the study were (1) time in minutes required for the intubation at the biopsy site, ie, the area at the ligament of Treitz, and (2) fluoroscopy time. Intubation time in the placebo group was 22.3 +/- 1.9 min (mean +/- SEM) vs 11.3 +/- 1.4 min in the metoclopramide group (P less than 0.001). Fluoroscopy exposure time was 2.47 +/- 0.25 in the placebo group vs 1.40 +/- 0.12 min in the metoclopramide group (P less than 0.001). Subjective clinical evaluation of the operator's assessment of the procedure was based on a 0-4 scale (much easier = 0, easier = 1, average = 2, harder = 3, and much harder = 4). Metoclopramide administration resulted in a significantly easier performance of the procedure (P less than 0.001) but did not influence patient tolerance. Three patients who received metoclopramide and one receiving placebo developed mild to moderate drowsiness of short duration. The results of this controlled trial indicate that metoclopramide significantly shortens the time required for jejunal biopsy and reduces fluoroscopy exposure. Its regulatory action on gastrointestinal motility contributes to the easier performance of a valuable diagnostic procedure.

Adolescent↗

PubMed1998

Computer network home care demonstration: a randomized trial in persons living with AIDS.

PURPOSE: As Internet-based health care applications grow, it is important to determine their acceptability to ill persons and the likely outcomes resulting from their use. This randomized field investigation demonstrated the use and effects of a specialized computer network, the ComputerLink, among persons living with AIDS (PLWA). HYPOTHESIS: This study was designed to determine whether a home-based computer network designed for people with AIDS (PLWA) would be used and whether it would reduce social isolation and improve confidence and skill in decision making without causing differential decline in health status among PLWA. INTERVENTION: Wyse 30 terminals were placed in private homes, linked via a 1200 baud modem to a public access computer network. Services available to PLWA included an on-line electronic encyclopedia, public and private communication and a decision support system; all services were coordinated by a registered nurse. DESIGN: A six-month randomized trial involved 57 community-dwelling PLWA; 31 were in the experimental group. Mean age was 33, 93% were male, 61% white, 34% working, 13.5 mean years education. Six participants were lost to follow-up. RESULTS: 8449 accesses to the system were made during the study period. Mean number of access per participant was 192, the median, 129. Duration of access averaged 12 min. PLWA used two services during each session. First order hypotheses testing revealed no significant difference between experimental and control group participants. Post hoc exploration indicated that use of the system did reduce social isolation once participants levels of depression were controlled and that decision making confidence improved as a function of number of accesses. CONCLUSION: Computer networks provide feasible alternatives for the delivery of health services to home-bound individuals. Communication services were used more extensively than other services, suggesting that the primary mechanism of intervention is peer contact. Similar to other experiments, system use improves confidence, though not skill, in decision making. The Internet represents a promising pathway to reaching home-bound patients and providing them with information, communication and decision assistance.

Acquired Immunodeficiency Syndrome↗

PubMed2002

CT fluoroscopy-assisted puncture of thoracic and abdominal masses: a randomized trial.

PURPOSE: We investigated the benefit of real-time guidance of interventional punctures by means of computed tomography fluoroscopy (CTF) compared with the conventional sequential acquisition guidance. MATERIAL AND METHODS: In a prospective randomized trial, 75 patients underwent either CTF-guided (group A, n = 50) or sequential CT-guided (group B, n = 25) punctures of thoracic (n = 29) or abdominal (n = 46) masses. CTF was performed on the CT machine (Somatom Plus 4 Power, Siemens Corp., Forchheim, Germany) equipped with the C.A.R.E. Vision application (tube voltage 120 kV, tube current 50 mA, rotational time 0.75 s, slice thickness 10 mm, 8 frames/s). RESULTS: The average procedure time showed a statistically significant difference between the two study groups (group A: 564 s, group B 795 s, P = 0.0032). The mean total mAs was 7089 mAs for the CTF and 4856 mAs for the sequential image-guided intervention, respectively. The sensitivity was 71% specificity 100% positive predictive value 100% and negative predictive value 60% for the CTF-guided puncture, and 68, 100, 100 and 50% for sequential CT, respectively. CONCLUSION: CTF guidance realizes a time-saving but increases the radiation exposure dosage.

Abdominal Neoplasms↗

PubMed1991

The effect of the benzodiazepine antagonist flumazenil on the sequels of diazepam given before upper gastrointestinal endoscopy. A double-blind randomized trial.

The prolonged sedation of benzodiazepines may be inconvenient for the patient. Reversal of sedation, therefore, would be desirable. Accordingly, we assessed the efficacy of the benzodiazepine antagonist flumazenil in a placebo-controlled randomized trial including 40 adults undergoing upper gastrointestinal endoscopy under diazepam (Diazemuls) sedation. We found no significant differences between groups with regard to either performance (two tests) or duration (within 240 min) of sedation. There were no noticeable side effects.

Adult↗

PubMed1983

Randomized trial of 5-fluorouracil and mitomycin C with or without streptozotocin for advanced pancreatic cancer. A Southwest Oncology Group study.

A prospective randomized trial comparing streptozotocin, mitomycin C, and 5-FU (SMF) with mitomycin C and 5-FU (MF) in patients with advanced pancreatic cancer was performed. In patients with measurable disease the response rates were 34% (19/56) to SMF, and 8% (5/60) to MF (P = 0.009). Median survivals were similar, however, 18 versus 17 weeks (P = 0.356). Median survival of patients responding to chemotherapy was 33 weeks, and for nonresponders it was 17 weeks (P = 0.002). In patients with nonmeasurable disease, median survivals were 21 weeks (SMF) and 18 weeks (MF) (P = 0.797). Patients surviving greater than or equal to 48 weeks, however, appeared to be increased in the SMF arm (14 patients) compared to the MF (7 patients). Toxicity was moderate for both regimens, with SMF having greater gastrointestinal and renal toxicity. Chemotherapy with SMF appears to produce objective responses in patients with pancreatic cancer, but does not improve survival compared to MF.

Adult↗

PubMed1991

Invasive reperfusion study. II. Multicentre European randomized trial of anistreplase vs streptokinase in acute myocardial infarction.

IRS II (Invasive reperfusion study II) was a multicentre randomized trial comparing the efficacy of a 2-5-min 30 U anistreplase intravenous injection with a 1,500,000 U 60-min streptokinase (SK) intravenous infusion in acute myocardial infarction. 116 patients were randomized within 6 h of onset of symptoms. Early coronary patency was assessable in 107 patients by coronary angiogram performed 102 min after thrombolytic treatment (range: 30-297 min) in the anistreplase group and 93 min (range: 22-330 min) in the SK group. The early coronary patency rate was significantly higher in the anistreplase group than in the SK group: respectively, 70% (38/54) and 51% (27/53), P less than 0.05). Fifty patients had assessable coronary angiograms at 90 min and 24 h. The 24-h patency rate was 92.3% (24/26) in the anistreplase group vs 87.5% (21/24) in the SK group. No early reocclusion occurred in the anistreplase group vs 15.4% (2/13) in the SK group (NS). Fibrinogen fell to 13.2 +/- 19.8% on anistreplase vs 9.4 +/- 10.3% on SK (NS). Bleeding complications occurred in 12% (7/58) of treated patients in the anistreplase group vs 20.7% (13/58) in the SK group (NS). Two cerebrovascular accidents occurred after thrombolytic treatment with anistreplase (3.4%) vs one after SK (1.7%) (NS). Thus, anistreplase is more effective than intravenous SK and easier to administer.

Adult↗

PubMed1987

Oxytocin- or low-dose prostaglandin F2 alpha-infusion for stimulation of labor after primary rupture of membranes. A prospective, randomized trial.

One hundred consecutive women with singleton pregnancies and primary rupture of membranes (PROM) after 36 weeks of gestation were included in a prospective, randomized trial of intravenous infusion of oxytocin (up to 30 mIU/min) versus low-dose prostaglandin F2 alpha(PGF2 alpha, up to 6.0 micrograms/min). Cesarean section was performed in 12 patients because of suspected disproportion or intra-uterine asphyxia. Effective contractions or labor progress failed to become established within 8 hours in another 4 women stimulated with PGF2 alpha and 2 stimulated by oxytocin. The stimulation delivery time (hours) for the remaining 82 women treated with PGF2 alpha or oxytocin, respectively was 8.7 against 12.1 for initial Bishop score less than 5 (p less than 0.01), (Mann-Whitney test), 7.2 vs. 7.1 for Bishop score 5-8 and 5.7 vs. 4.2 for Bishop score greater than 8. Patients with initial Bishop score less than 5 seemed to need analgetics less often when treated with PGF2 alpha than with oxytocin. Frequencies of side effects and instrumental deliveries as well as the fetal outcome were similar for the two treatment schedules. The results of the study suggest that low-dose PGF2 alpha infusion may be the more appropriate treatment for women with an unfavorable initial Bishop score.

Adolescent↗

PubMed1992

Multicenter prospective randomized trial comparing ceftazidime plus co-trimoxazole with chloramphenicol plus doxycycline and co-trimoxazole for treatment of severe melioidosis.

A prospective randomized trial was conducted at Srinagarind and Khon Kaen hospitals. Ceftazidime (100 mg/kg of body weight per day) and co-trimoxazole (trimethoprim, 8 mg/kg/day; sulfamethoxazole, 40 mg/kg/day) therapy was compared with conventional therapy (chloramphenicol, 100 mg/kg/day; doxycycline, 4 mg/kg/day; trimethoprim, 8 mg/kg/day; sulfamethoxazole, 40 mg/kg/day) in the treatment of 64 patients with bacteriologically confirmed cases of severe melioidosis who were admitted during September 1986 to January 1989. Of 61 evaluable patients (3 were excluded because of severe drug allergies), 42 were septicemic, and 31 of these patients had the most severe form, disseminated septicemic melioidosis. Their cumulative mortalities on day 7 were compared. There were significantly lower overall mortalities from melioidosis, septicemic melioidosis, and disseminated septicemic melioidosis in the group receiving the new treatment compared with those in the group receiving the conventional treatment (47 versus 18.5% [P = 0.039], 57.7 versus 25% [P = 0.039], and 82.3 versus 30.7% [P = 0.006], respectively); but the differences could have been influenced by the greater severity of illness, e.g., shock at initial presentation, in the patients who received the conventional treatment. Among patients with disseminated septicemia and initial shock, there was no significant difference in mortality between the regimens. Both regimens effectively eradicated bacteria from the circulation within 24 h (97 versus 96%, respectively). We recommend ceftazidime and co-trimoxazole as the drugs of choice for treatment of severe melioidosis, especially in those patients with disseminated septicemia.

Adult↗

PubMed1999

10-Year results after sector resection with or without postoperative radiotherapy for stage I breast cancer: a randomized trial.

PURPOSE: To study the long-term effectiveness of postoperative radiotherapy after sector resection for breast cancer in a randomized trial in which mammography is a major pathway to diagnosis. PATIENTS AND METHODS: Three hundred eighty-one women with a unifocal breast cancer < or = 20 mm in diameter on the preoperative mammogram and without histopathologic signs of axillary metastases were treated by sector resection plus axillary dissection. Of these patients, 184 women were randomized to receive postoperative radiotherapy to the breast (XRT group), and 197 women received no further treatment (non-XRT group). RESULTS: The local recurrence rate was 8.5% (95% confidence interval [CI], 3.9% to 13.1%) in the XRT group and 24.0% (95% CI, 17.6% to 30.4%) in the non-XRT group (P =.0001). Survival free from regional and distant recurrence was 83. 3% in the XRT group (95% CI, 77.5% to 89.1%) and 80.0% in the non-XRT group (95% CI, 73.9% to 86.1%) (P =.23). Overall survival was 77.5% in the XRT group (95% CI, 70.9% to 84.1%) and 78% in the non-XRT group (95% CI, 71.7% to 84.3%) (P =.99). A subgroup analysis suggested that women older than 55 years of age without comedo or lobular carcinomas had a low risk of local recurrence of 6.1% (95% CI, 0.1% to 9.1%) in the XRT-group and 11.0% (4.0% to 18.0%) in the non-XRT group (P =.16). CONCLUSION: Sector resection plus radiotherapy resulted in an absolute reduction in local recurrence of 16% at 10 years compared with surgery alone. Women older than 55 years of age without comedo or lobular carcinomas may have a low risk of local recurrence. Postoperative radiotherapy was not shown to reduce distant recurrences or improve overall survival.

Breast Neoplasms↗

PubMed1991

High survival rate in advanced-stage B-cell lymphomas and leukemias without CNS involvement with a short intensive polychemotherapy: results from the French Pediatric Oncology Society of a randomized trial of 216 children.

From April 1984 to December 1987, the French Pediatric Oncology Society (SFOP) organized a randomized trial for advanced-stage B-cell lymphoma without CNS involvement to study the possibility of reducing the length of treatment to 4 months. After receiving the same three intensive six-drug induction courses based on high-dose fractionated cyclophosphamide, high-dose methotrexate (HD MTX), and cytarabine in continuous infusion, patients were evaluated for remission. Those who achieved complete remission (CR) were randomized between a long arm (five additional courses with two additional drugs; 16 weeks of treatment) and a short arm (two additional courses; 5 weeks). For patients in partial remission (PR), intensification of treatment was indicated. Two hundred sixteen patients were registered: 15 stage II nasopharyngeal and extensive facial tumors, 167 stage III, and 34 stage IV, 20 of the latter having more than 25% blast cells in bone marrow. The primary sites of involvement were abdomen in 172, head and neck in 30, thorax in two, and other sites in 12. One hundred sixty-seven patients are alive in first CR with a minimum follow-up of 18 months; four are lost to follow-up. Eight patients died from initial treatment failure, 14 died from toxicity or deaths unrelated to tumor or treatment, and 27 relapsed. The event-free survival (EFS), with a median follow-up of 38 months, is 78% (SE 3) for all the patients, 73% (SE 11) for the stage II patients, 80% (SE 3) for the stage III patients, and 68% (SE 8) for the stage IV and acute lymphoblastic leukemia (ALL) patients. One hundred sixty-six patients were randomized: 82 in the short arm and 84 in the long arm. EFS is, respectively, 89% and 87%. Statistical analysis confirms equivalence of both treatment arms with regard to EFS. Moreover, morbidity was lower in the short arm. This study confirms the high survival rate obtained in the previous LMB 0281 study without radiotherapy or debulking surgery and demonstrates the effectiveness of short treatment.

Adolescent↗

PubMed2004

The effectiveness of a community-based program for reducing the incidence of falls in the elderly: a randomized trial.

OBJECTIVES: To test whether Stepping On, a multifaceted community-based program using a small-group learning environment, is effective in reducing falls in at-risk people living at home. DESIGN: A randomized trial with subjects followed for 14 months. SETTING: The interventions were conducted in community venues, with a follow-up home visit. PARTICIPANTS: Three hundred ten community residents aged 70 and older who had had a fall in the previous 12 months or were concerned about falling. INTERVENTION: The Stepping On program aims to improve fall self-efficacy, encourage behavioral change, and reduce falls. Key aspects of the program are improving lower-limb balance and strength, improving home and community environmental and behavioral safety, encouraging regular visual screening, making adaptations to low vision, and encouraging medication review. Two-hour sessions were conducted weekly for 7 weeks, with a follow-up occupational therapy home visit. MEASUREMENTS: The primary outcome measure was falls, ascertained using a monthly calendar mailed by each participant. RESULTS: The intervention group experienced a 31% reduction in falls (relative risk (RR)=0.69, 95% confidence interval (CI)=0.50-0.96; P=.025). This was a clinically meaningful result demonstrating that the Stepping On program was effective for community-residing elderly people. Secondary analysis of subgroups showed that it was particularly effective for men (n=80; RR=0.32, 95% CI=0.17-0.59). CONCLUSION: The results of this study renew attention to the idea that cognitive-behavioral learning in a small-group environment can reduce falls. Stepping On offers a successful fall-prevention option.

Accidental Falls↗

PubMedDate not supplied

Hyperthermia combined with chemotherapy and irradiation for patients with carcinoma of the oesophagus--a prospective randomized trial.

From 1988 to 1990, 53 patients with squamous cell carcinoma of the thoracic oesophagus underwent subtotal oesophagectomy after either preoperative hyperthermo-chemoradiotherapy (HCR therapy) or chemoradiotherapy without hyperthermia (CR therapy), in a prospective randomized trial carried out to examine the effects of hyperthermia given preoperatively. The two groups (27 patients given HCR therapy and 26 given CR therapy) were found to be comparable with regard to prognostic factors of age, site of carcinoma, TNM stage, etc. Following preoperative evaluation by an upper GI series and endoscopy, a subtotal oesophagectomy was done for all 53 patients. All the resected specimens, including the lymph nodes, were histopathologically examined, and the effects of preoperative treatment were evaluated by findings in the upper GI series and endoscopy, as well as based on the histopathology of the excised tissues. There were no viable cancer cells in the resected specimens of seven patients in the HCR therapy group (26.9%) and of two patients in the CR therapy group (7.7%). In addition, no hyperthermia complications were observed. The study suggests that preoperative HCR therapy may be a more beneficial therapy than preoperative CR therapy in patients with squamous cell carcinoma of the oesophagus who undergo a subtotal oesophagectomy.

Aged↗

PubMed2000

Randomized trial of the immunogenicity of fractional dose regimens of PRP-T Haemophilus influenzae type b conjugate vaccine.

To assess the immunogenicity of more economical regimens of Haemophilus influenzae type b (Hib) conjugate vaccine, a randomized trial of fractional doses of polyribosylribitol phosphate-tetanus toxoid (PRP-T) Hib vaccine was undertaken in the Dominican Republic. Six hundred children were assigned to one of six regimens with PRP-T vaccine: full-dose, half-dose, and one-third-dose of Hib vaccine given separately or combined with diphtheria, tetanus, and pertussis (DTP) vaccine at ages 2, 4, and 6 months. Regimens that elicited antibody levels > 1.0 microg/mL in >70% of children and < or = 0.15 microg/mL in > 90% of children were considered acceptable. At 1 month post Dose 3, all regimens met the criteria for acceptable response. Among those who received Hib as a separate injection, geometric mean concentrations of anti-PRP bodies (GMCs) at age 1 month post Dose 3 were 11.2, 11.9, and 16.3 in the full, half, and one-third dose groups, respectively. Among those who received Hib and DTP combined, the GMCs were 6.4, 5.2, and 5.7 in the full-, half-, and one-third-dose groups respectively.

Antibodies, Bacterial↗