91128
document
Safety and immunogenicity of a combined pentavalent diphtheria , tetanus , acellular pertussis , inactivated poliovirus and Haemophilus influenzae type b-tetanus conjugate vaccine in infants , compared with a whole cell pertussis pentavalent vaccine . BACKGROUND We compared the safety and immunogenicity of two combined diphtheria-tetanus-pertussis-inactivated poliovirus vaccines containing either acellular ( Pa , SmithKline Beecham Biologicals ) or whole cell ( Pw , Pasteur Merieux Connaught ) pertussis components , mixed with a Haemophilus influenzae type b polysaccharide polyribosylribitol phosphate-tetanus conjugate vaccine in an open , randomized study in healthy infants . DESIGN The combined vaccines were given at 2 , 4 , 6 and 12 months of age , and serum samples were obtained at ages 2 , 6 , 7 , 12 and 13 months . Adverse events were obtained by diary cards . RESULTS The Pa group ( n = 101 ) had a clearly lower incidence of both local and systemic adverse events than the Pw group ( n = 100 ) . Immunogenicity was comparable for the diphtheria and tetanus components , but significantly superior for pertussis toxin , filamentous hemagglutinin , pertactin and polioviruses 1 , 2 and 3 in the Pa group . Both groups had an appropriate response with regard to H. influenzae type b polysaccharide polyribosylribitol phosphate , but the dynamics of the response were significantly different : geometric mean concentrations ( micrograms per ml ) after the second , third and booster doses were 1.27 , 5.06 and 23.12 in the Pa group and 2.72 , 6.66 and 13.59 in the Pw group , respectively ( P = 0.0002 after second dose ; P = 0.0005 after booster ) . CONCLUSION The presently studied diphtheria , tetanus , acellular pertussis-H. influenzae b vaccine conjugated to tetanus toxoid combination was at least as immunogenic as the diphtheria , tetanus , whole cell pertussis-H. influenzae b vaccine conjugated to tetanus toxoid combination , with a significantly better safety profile . This is of obvious importance in countries where inactivated poliovirus vaccine is part of the routine infant immunization programs .
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Intervention_Pharmacological
pentavalent diphtheria
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Intervention_Pharmacological
tetanus
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Intervention_Pharmacological
acellular pertussis
91132
Intervention_Pharmacological
inactivated poliovirus and Haemophilus influenzae type b-tetanus conjugate vaccine
91133
Intervention_Pharmacological
whole cell pertussis pentavalent vaccine
91134
Intervention_Pharmacological
combined diphtheria-tetanus-pertussis-inactivated poliovirus vaccines containing either acellular
91135
Intervention_Pharmacological
Pa , SmithKline Beecham Biologicals
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Intervention_Pharmacological
whole cell ( Pw , Pasteur Merieux Connaught ) pertussis components
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Intervention_Pharmacological
mixed with a Haemophilus influenzae type b polysaccharide polyribosylribitol phosphate-tetanus conjugate vaccine
91138
Intervention_Pharmacological
tetanus toxoid combination
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Intervention_Pharmacological
diphtheria , tetanus , whole cell pertussis-H. influenzae b vaccine conjugated to tetanus toxoid combination
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Outcome_Adverse-effects
lower incidence of both local and systemic adverse events
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Outcome_Physical
Immunogenicity
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Outcome_Physical
pertussis toxin , filamentous hemagglutinin , pertactin and polioviruses 1 , 2 and 3 in the Pa group .
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Outcome_Physical
geometric mean concentrations
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Participant_Age
infants
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Participant_Condition
healthy
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Participant_Age
infants
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Participant_Sample-size
101
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Participant_Condition
local and systemic adverse events
91149
Participant_Sample-size
100