Abstract | OBJECTIVE: DESIGN: Multicentre randomized controlled trial. SETTING: Four public health units in western Canada. PARTICIPANTS: Healthy infants 8 to 15 weeks old at entry who were able to receive routine primary vaccinations. Of 444 infants enrolled, 433 (98%) completed the study. INTERVENTIONS: All infants received PRP-T and DPT vaccines at 2, 4 and 6 months of age: half received them mixed in one injection and the others as separate, bilateral injections. MAIN OUTCOME MEASURES: Side-effects 24 and 48 hours after each dose and serologic responses to each vaccine component. RESULTS: Follow-up was obtained after all 1312 vaccinations. Fever was infrequent in the two treatment groups. Local adverse effects of the PRP-T vaccine were infrequent and mild (e.g., redness was noted in 5.9% of cases and the area of redness was more than 2.5 cm in diameter in 0.8%). The incidence rate of local effects of the DPT-containing vaccines was the same in the two groups except for tenderness, which was more frequent in the group given the mixed vaccine (26.6% v. 17.9%, p < 0.001). Serologic data were available for 97% of the subjects. After the three doses 98.1% of the subjects had a PRP antibody level of 0.15 micrograms/mL or more, and 87.9% had a level of 1.0 micrograms/mL or more, both levels compatible with protection against Hib. Responses to PRP-T were comparable between the treatment groups as were responses to the diphtheria and tetanus toxoids. Pertussis agglutinin titres were reduced after administration of one of two PRP-T lots mixed with DPT vaccine, but responses to four other pertussis antigens were not impaired. CONCLUSION:
PRP-T vaccine is well tolerated and immunogenic. Combined PRP-T and DPT vaccines performed satisfactorily and may be the preferred method of administration.
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Authors | D Scheifele, L Barreto, W Meekison, R Guasparini, B Friesen |
Journal | CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne
(CMAJ)
Vol. 149
Issue 8
Pg. 1105-12
(Oct 15 1993)
ISSN: 0820-3946 [Print] Canada |
PMID | 8221449
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antibodies, Bacterial
- Diphtheria-Tetanus-Pertussis Vaccine
- Haemophilus Vaccines
- Haemophilus influenza type b polysaccharide vaccine-tetanus toxin conjugate
- Tetanus Toxoid
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Topics |
- Antibodies, Bacterial
(blood)
- Diphtheria-Tetanus-Pertussis Vaccine
(administration & dosage, adverse effects, immunology)
- Drug Incompatibility
- Enzyme-Linked Immunosorbent Assay
- Female
- Haemophilus Vaccines
(administration & dosage, adverse effects, immunology)
- Humans
- Infant
- Male
- Tetanus Toxoid
(administration & dosage, adverse effects, immunology)
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