ABSTRACT
The safety and efficacy of simultaneous administration of measles-mumps-rubella (MMR), diphtheria-tetanus-pertussis (DTP), and trivalent oral poliovirus (OPV) vaccines in a test group of 405 children were compared with the safety and efficacy of sequential administration of the same vaccines in a control group of 410 children given MMR followed by booster doses of DTP and OPV 2 months later. The study was double blind and placebo controlled with respect to DTP and OPV. Seroconversion rates to measles, mumps, and rubella exceeded 96% in both groups. Geometric mean titers to measles (P = .05) and rubella (P = .004) were higher in the test group, and titers of antibodies to the other seven antigens were similar in both groups. Clinical reaction data were analyzed in 248 of 405 test children and 249 of 410 control children. The rates of serious vaccine-associated reactions were low and similar in the two groups. Some minor side effects were reported more frequently in the test group, but these differences were judged to be related to study design rather than to differences in the safety of the two vaccine schedules. The results indicate that the safety and serologic efficacy of administering MMR simultaneously with reinforcing doses of DTP and OPV in the second year of life is equivalent to the safety and efficacy observed after administering these antigens separately.
Subject(s)
Diphtheria-Tetanus-Pertussis Vaccine , Immunization Schedule , Vaccines/administration & dosage , Antibodies/analysis , Diphtheria Toxoid/administration & dosage , Double-Blind Method , Drug Combinations/administration & dosage , Humans , Immunization, Secondary , Infant , Measles Vaccine/administration & dosage , Measles-Mumps-Rubella Vaccine , Mumps Vaccine/administration & dosage , Pertussis Vaccine/administration & dosage , Poliovirus Vaccine, Inactivated/administration & dosage , Random Allocation , Rubella Vaccine/administration & dosage , Tetanus Toxoid/administration & dosage , Vaccines/adverse effects , Vaccines, CombinedABSTRACT
The incidence of antigenuria was documented after vaccination of 75 children 15 to 60 months of age with one of three Haemophilus influenzae type b conjugate vaccines, PRP-D (ProHIBiT), PRP-T and HbOC (HibTITER). Unconcentrated and concentrated urine was tested on the first, third, fifth and seventh days after vaccination. Antigenuria occurred on Day 1 in 100% of PRP-D, 43% of PRP-T and 12% of HbOC recipients. The percentages of children excreting antigen on Day 3 were 95, 17 and 8%; on Day 5 they were 36, 4 and 12%; and on Day 7 they were 14, 0 and 18% for PRP-D, PRP-T and HbOC, respectively. The difference in the occurrence of antigenuria resulting from each vaccine was statistically significant on Day 1 and for PRP-D compared with PRP-T or HbOC on Day 3. It is important for clinicians to be aware of the frequency with which antigenuria occurs after these vaccines so that appropriate therapeutic decisions can be made.
Subject(s)
Antigens, Bacterial/urine , Bacterial Proteins/immunology , Bacterial Vaccines/immunology , Diphtheria Toxoid/immunology , Haemophilus Vaccines , Haemophilus influenzae/immunology , Tetanus Toxoid/immunology , Child, Preschool , Haemophilus Infections/diagnosis , Haemophilus Infections/prevention & control , Humans , Infant , Latex Fixation Tests , Time Factors , Vaccination , Vaccines, Synthetic/immunologySubject(s)
Physician's Role , Physician-Patient Relations , Religion and Medicine , Religion , Humans , United StatesABSTRACT
OBJECTIVE: To evaluate the immunologic potential of infants 7 to 15 months of age to respond to Haemophilus influenzae type b polysaccharide vaccine following immunization with H influenzae b oligosaccharide-CRM197 conjugate vaccine. STUDY DESIGN: One hundred seventy-one infants, aged 7 to 15 months, were consecutively and alternatively assigned to one of three immunization protocols. Group 1 (n = 71) received three doses of H influenzae b oligosaccharide-CRM197 conjugate vaccine, group 2 (n = 47) received two doses of H influenzae b oligosaccharide-CRM197 conjugate vaccine followed by one dose of H influenzae type b polysaccharide vaccine, and group 3 received one dose of H influenzae b oligosaccharide-CRM197 conjugate vaccine followed by two doses of H influenzae type b polysaccharide vaccine. Immunizations were given on day 0 and at 2 months and 6 months. Anti-H influenzae type b polysaccharide antibody levels were measured on day 0 and 2, 3, 6, 7, and 12 months after the study began. RESULTS: Haemophilus influenzae type b polysaccharide vaccine given as a second dose stimulated an antibody rise but did so less effectively than H influenzae b oligosaccharide-CRM197 conjugate vaccine. Two doses of H influenzae b oligosaccharide-CRM197 conjugate vaccine were highly immunogenic; geometric means were 31 and 35 micrograms/mL in the 7- to 11-month and 12- to 15-month age groups, respectively. Following two doses of H influenzae b oligosaccharide-CRM197 conjugate vaccine, both immunization protocols resulted in (1) equally high geometric mean antibody levels 1 month after immunization and (2) similar geometric mean antibody levels 6 months after immunization. CONCLUSIONS: Haemophilus influenzae b oligosaccharide-CRM197 conjugate vaccine induces antibody levels that would be expected to protect infants from initial invasion and primes the immune system for an anamnestic response. Our data indicate that if a booster immunization is needed, H influenzae type b polysaccharide vaccine could be an alternative to H influenzae b oligosaccharide-CRM197 conjugate vaccine.