A randomised controlled study of the reactogenicity of an acellular pertussis-containing pentavalent infant vaccine compared to a quadrivalent whole cell pertussis-containing vaccine and oral poliomyelitis vaccine, when given concurrently with meningococcal group C conjugate vaccine to healthy UK infants at 2, 3 and 4 months of age.
Two hundred forty-one healthy infants were enrolled in an open randomised controlled study of three doses of DTaP-IPV-Hib (Group 1) or DTwP/Hib+OPV (Group 2) at 2, 3 and 4 months of age given concurrently with a meningitis C conjugate vaccine. After each dose, local reactions (any grade) were less common in Group 1 than Group 2 (p<0.03). Axillary temperature >37.5 degrees C, decreased feeding, reduced activity, irritability and crying in the week after vaccination were also less common in Group 1 than Group 2 (p<0.05 for each symptom, all doses combined). Severe local reactions and systemic symptoms were uncommon and occurred equally in both groups. The pentavalent DTaP-IPV-Hib vaccine was less reactogenic than the quadrivalent DTwP-Hib vaccine, as expected when changing from whole cell pertussis (wP) to an acellular pertussis (aP) component.
Kitchin
Nicholas
N
Sanofi Pasteur MSD Ltd., Mallards Reach, Bridge Avenue, Maidenhead, Berkshire SL6 1QP, UK. nkitchin@spmsd.com
Southern
Joanna
J
Morris
Rhonwen
R
Hemme
Fabienne
F
Cartwright
Keith
K
Watson
Michael
M
Miller
Elizabeth
E
D001428:Bacterial Vaccines / Q000008:administration & dosage / Q000009:adverse effects*; D001831:Body Temperature; D003448:Crying; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000008:administration & dosage / Q000009:adverse effects*; D005247:Feeding Behavior; D005260:Female; D006801:Humans; D007223:Infant; D007508:Irritable Mood; D008297:Male; D022401:Meningococcal Vaccines / Q000008:administration & dosage*; D009043:Motor Activity; D011054:Poliovirus Vaccine, Inactivated; D011055:Poliovirus Vaccine, Oral / Q000008:administration & dosage / Q000009:adverse effects; D006113:United Kingdom; D022282:Vaccines, Acellular / Q000008:administration & dosage / Q000009:adverse effects*; D017778:Vaccines, Combined / Q000008:administration & dosage / Q000009:adverse effects
D001428:Bacterial Vaccines; C500334:DT5aP-Hib-IPV vaccine; D015721:Diphtheria-Tetanus-Pertussis Vaccine; D022401:Meningococcal Vaccines; D011054:Poliovirus Vaccine, Inactivated; D011055:Poliovirus Vaccine, Oral; D022282:Vaccines, Acellular; D017778:Vaccines, Combined; C410218:serogroup C meningococcal conjugate vaccine