Abstract
An open, randomized study evaluated the immune response and safety of two different regimens of diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus-Haemophilus influenzae type b (DTPa-HBV-IPV-Hib) immunization in infants primed at birth with hepatitis B vaccine. One-half of the 150 healthy, full-term infants received a DTPa HBV-IPV-Hib vaccine at 1 1/2, 3 and 5 months of age; the other received a DTPa-IPV-Hib vaccine at 1 1/2, 3 and 5 months of age with separate HBV vaccine at 1 and 5 months of age. Immune response was similar following the two regimens with 100% of the vaccinees seroprotected for HBV, diphtheria, tetanus, Hib and poliovirus types 2 and 3 diseases after the full vaccination course. One vaccinee in the DTPa HBV-HPV- Hib group failed to respond to the poliovirus type 1 antigen. Response to the three pertussis antigens ranged from 92-97% in the DTPa-IPV-Hib plus separate HBV group and 100% in the DTPa HBV-IPV-Hib group. The most frequently reported post-vaccination symptoms were irritability in the DTPa-IPV-Hib plus separate HBV group (49% of vaccinees) and fever, defined as axillary temperature > or =37.5 degrees C, in the DTPa HBV- IPV-Hib group (50% of vaccinees).
Publication types
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Clinical Trial
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Randomized Controlled Trial
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Research Support, Non-U.S. Gov't
MeSH terms
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Antibodies, Bacterial / biosynthesis
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Antibodies, Bacterial / blood
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Antibodies, Viral / biosynthesis
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Antibodies, Viral / blood
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Diphtheria-Tetanus-Pertussis Vaccine / administration & dosage
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Diphtheria-Tetanus-Pertussis Vaccine / adverse effects*
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Diphtheria-Tetanus-Pertussis Vaccine / immunology*
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Drug Interactions
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Female
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Haemophilus Vaccines / administration & dosage
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Haemophilus Vaccines / adverse effects*
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Haemophilus Vaccines / immunology*
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Hepatitis B Vaccines / administration & dosage
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Hepatitis B Vaccines / adverse effects*
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Hepatitis B Vaccines / immunology*
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Humans
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Immunization Schedule
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Infant
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Infant, Newborn
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Male
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Poliovirus Vaccine, Inactivated / administration & dosage
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Poliovirus Vaccine, Inactivated / adverse effects*
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Poliovirus Vaccine, Inactivated / immunology*
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Safety
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Vaccines, Combined / adverse effects*
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Vaccines, Combined / immunology*
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Vaccines, Conjugate / adverse effects
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Vaccines, Conjugate / immunology
Substances
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Antibodies, Bacterial
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Antibodies, Viral
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Diphtheria-Tetanus-Pertussis Vaccine
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Haemophilus Vaccines
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Hepatitis B Vaccines
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Poliovirus Vaccine, Inactivated
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Vaccines, Combined
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Vaccines, Conjugate