title: Immunogenicity, reactogenicity and safety of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Mexican infants.
abstract: The immunogenicity and safety of the 10-valent pneumococcal conjugate vaccine, PHiD-CV, have been documented in European and Asian studies. In this open study conducted in Mexico (NCT00489554), 230 healthy infants received three doses of PHiD-CV and DTPa-HBV-IPV/Hib vaccines at 2, 4 and 6 months of age and two doses of oral human rotavirus vaccine at 2 and 4 months. Serotype-specific pneumococcal responses and opsonophagocytic activity (OPA) were measured one month post-dose 3. PHiD-CV's primary vaccination course was highly immunogenic against each of the 10 pneumococcal vaccine serotypes and carrier protein D. Antibody responses against pneumococcal serotypes and protein D were generally higher in Mexican infants compared with European antibody responses, and functional OPA responses were also higher or in the same range. The most frequent solicited local symptom was pain, with high but similar incidences of grade 3 pain reported at both injection sites (up to 15% of all doses). PHiD-CV was well tolerated, with no serious adverse events considered as causally related to vaccination. Most solicited symptoms were mild and there was no increase in incidence of solicited symptoms with successive vaccine doses.
authors: Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Tlalpan, México. gmrps@servidor.unam.mx
authors: Guillermo M
authors: GM
authors: Ruiz-Palacios
authors: M Lourdes
authors: ML
authors: Guerrero
authors: Lorena
authors: L
authors: Hernández-Delgado
authors: Antonio
authors: A
authors: Lavalle-Villalobos
authors: Abigail
authors: A
authors: Casas-Muñoz
authors: Yolanda
authors: Y
authors: Cervantes-Apolinar
authors: Marta
authors: M
authors: Moreira
authors: Lode
authors: L
authors: Schuerman
mesh_terms: D000907:Antibodies, Bacterial / Q000097:blood*; D001426:Bacterial Proteins / Q000276:immunology*; D002352:Carrier Proteins / Q000276:immunology*; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D005260:Female; D006192:Haemophilus Infections / Q000276:immunology / Q000517:prevention & control; D018073:Haemophilus Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D006193:Haemophilus influenzae / Q000276:immunology; D017325:Hepatitis B Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D006801:Humans; D007115:Immunization Schedule; D007072:Immunoglobulin D / Q000276:immunology*; D007223:Infant; D008074:Lipoproteins / Q000276:immunology*; D008297:Male; D008800:Mexico; D009895:Opsonin Proteins / Q000378:metabolism; D010587:Phagocytosis; D011008:Pneumococcal Infections / Q000276:immunology / Q000517:prevention & control; D022242:Pneumococcal Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D011054:Poliovirus Vaccine, Inactivated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D022243:Rotavirus Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D012703:Serotyping; D013296:Streptococcus pneumoniae / Q000145:classification / Q000276:immunology*; D016896:Treatment Outcome; D017778:Vaccines, Combined / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D018074:Vaccines, Conjugate / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
chemical_list: D000907:Antibodies, Bacterial; D001426:Bacterial Proteins; D002352:Carrier Proteins; C451839:DTPa-HBV-IPV combined vaccine; D015721:Diphtheria-Tetanus-Pertussis Vaccine; D018073:Haemophilus Vaccines; D017325:Hepatitis B Vaccines; D007072:Immunoglobulin D; D008074:Lipoproteins; D009895:Opsonin Proteins; C547294:PHiD-CV vaccine; D022242:Pneumococcal Vaccines; D011054:Poliovirus Vaccine, Inactivated; D022243:Rotavirus Vaccines; D017778:Vaccines, Combined; D018074:Vaccines, Conjugate; C067989:glpQ protein, Haemophilus influenzae