title: Safety and immunogenicity of coadministering a combined meningococcal serogroup C and Haemophilus influenzae type b conjugate vaccine with 7-valent pneumococcal conjugate vaccine and measles, mumps, and rubella vaccine at 12 months of age.
abstract: The coadministration of the combined meningococcal serogroup C conjugate (MCC)/Haemophilus influenzae type b (Hib) vaccine with pneumococcal conjugate vaccine (PCV7) and measles, mumps, and rubella (MMR) vaccine at 12 months of age was investigated to assess the safety and immunogenicity of this regimen compared with separate administration of the conjugate vaccines. Children were randomized to receive MCC/Hib vaccine alone followed 1 month later by PCV7 with MMR vaccine or to receive all three vaccines concomitantly. Immunogenicity endpoints were MCC serum bactericidal antibody (SBA) titers of ≥8, Hib-polyribosylribitol phosphate (PRP) IgG antibody concentrations of ≥0.15 μg/ml, PCV serotype-specific IgG concentrations of ≥0.35 μg/ml, measles and mumps IgG concentrations of >120 arbitrary units (AU)/ml, and rubella IgG concentrations of ≥11 AU/ml. For safety assessment, the proportions of children with erythema, swelling, or tenderness at site of injection or fever or other systemic symptoms for 7 days after immunization were compared between regimens. No adverse consequences for either safety or immunogenicity were demonstrated when MCC/Hib vaccine was given concomitantly with PCV and MMR vaccine at 12 months of age or separately at 12 and 13 months of age. Any small differences in immunogenicity were largely in the direction of a higher response when all three vaccines were given concomitantly. For systemic symptoms, there was no evidence of an additive effect; rather, any differences between schedules showed benefit from the concomitant administration of all three vaccines, such as lower overall proportions with postvaccination fevers. The United Kingdom infant immunization schedule now recommends that these three vaccines may be offered at one visit at between 12 and 13 months of age.
authors.affiliation: Immunisation, Hepatitis and Blood Safety Department, Health Protection Agency, Colindale, London NW9 5EQ, United Kingdom.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Miller
authors.forename: Nick
authors.initials: N
authors.lastname: Andrews
authors.forename: Pauline
authors.initials: P
authors.lastname: Waight
authors.forename: Helen
authors.initials: H
authors.lastname: Findlow
authors.forename: Lindsey
authors.initials: L
authors.lastname: Ashton
authors.forename: Anna
authors.initials: A
authors.lastname: England
authors.forename: Elaine
authors.initials: E
authors.lastname: Stanford
authors.forename: Mary
authors.initials: M
authors.lastname: Matheson
authors.forename: Joanna
authors.initials: J
authors.lastname: Southern
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Sheasby
authors.forename: David
authors.initials: D
authors.lastname: Goldblatt
authors.forename: Ray
authors.initials: R
authors.lastname: Borrow
mesh_terms: D000907:Antibodies, Bacterial / Q000097:blood; D018073:Haemophilus Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D000069443:Heptavalent Pneumococcal Conjugate Vaccine; D006801:Humans; D007115:Immunization Schedule; D007117:Immunization, Secondary / Q000379:methods*; D007074:Immunoglobulin G / Q000097:blood; D007223:Infant; D022542:Measles-Mumps-Rubella Vaccine / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D022401:Meningococcal Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D022242:Pneumococcal Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D006113:United Kingdom; D014611:Vaccination / Q000379:methods*
chemical_list: D000907:Antibodies, Bacterial; D018073:Haemophilus Vaccines; D000069443:Heptavalent Pneumococcal Conjugate Vaccine; D007074:Immunoglobulin G; D022542:Measles-Mumps-Rubella Vaccine; D022401:Meningococcal Vaccines; D022242:Pneumococcal Vaccines