title: Concomitant administration of a fully liquid, ready-to-use DTaP-IPV-HB-PRP-T hexavalent vaccine with a meningococcal serogroup C conjugate vaccine in infants.
abstract: DTaP-IPV-HB-PRP-T or hexavalent vaccines are indicated for primary and booster vaccination of infants and toddlers against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type b (Hib). The present study evaluates the safety and immunogenicity of a ready-to-use hexavalent vaccine when co-administered with a meningococcal serogroup C conjugate (MenC) vaccine in infants. This was a phase III, open-label, randomised, multicentre study conducted in Finland. Healthy infants, aged 46-74days (n=350), were randomised in a ratio of 1:1 to receive DTaP-IPV-HB-PRP-T vaccine at two, three and four months, either with a MenC vaccine co-administered at two and four months (Group 1; n=175) or without MenC vaccine (Group 2; n=175). All infants also received routine rotavirus and 13-valent pneumococcal conjugate vaccines. The proportion of participants with an anti-HBs concentration ⩾10mIU/mL assessed one month after the third dose of DTaP-IPV-HB-PRP-T vaccine was 97.5% [95%CI: 93.1-99.3] in the coadministration group and 96.1% [95%CI: 91.8-98.6] in the group without MenC vaccine. The proportion of participants with an anti-MenC SBA titre ⩾8 assessed one month after the second dose of MenC vaccine was 100% in the coadministration group. Both primary objectives were achieved. Secondary immunogenicity and safety analyses showed that co-administration of DTaP-IPV-HB-PRP-T and MenC vaccines did not impact the immune response to the antigens of each of the two vaccines. All vaccines were well tolerated and the safety profile of DTaP-IPV-HB-PRP-T vaccine was similar in both groups. ClinicalTrials.gov identifier: NCT01839175; EudraCT number: 2012-005547-24.
authors.affiliation: Vaccine Research Center, FM3/Biokatu 10, 33014 University of Tampere, Tampere, Finland. Electronic address: timo.vesikari@uta.fi.
authors.forename: Timo
authors.initials: T
authors.lastname: Vesikari
authors.affiliation: Vaccine Evaluation Unit, Public Health England, Clinical Sciences Building 2, Manchester Royal Infirmary, Manchester, UK. Electronic address: ray.borrow@phe.gov.uk.
authors.forename: Ray
authors.initials: R
authors.lastname: Borrow
authors.affiliation: Sanofi Pasteur Inc., Global Clinical Immunology, Discovery Drive, Swiftwater, PA, USA. Electronic address: xavier.dacosta@sanofipasteur.com.
authors.forename: Xavier
authors.initials: X
authors.lastname: Da Costa
authors.affiliation: Sanofi Pasteur MSD, 162 avenue Jean Jaures, CS 50712, 69367 Lyon Cedex 07, France. Electronic address: pr.richard@laposte.net.
authors.forename: Patrick
authors.initials: P
authors.lastname: Richard
authors.affiliation: Sanofi Pasteur MSD, 162 avenue Jean Jaures, CS 50712, 69367 Lyon Cedex 07, France. Electronic address: cecile.eymin@neuf.fr.
authors.forename: Cécile
authors.initials: C
authors.lastname: Eymin
authors.affiliation: Sanofi Pasteur MSD, 162 avenue Jean Jaures, CS 50712, 69367 Lyon Cedex 07, France. Electronic address: fboisnard@spmsd.com.
authors.forename: Florence
authors.initials: F
authors.lastname: Boisnard
authors.affiliation: Sanofi Pasteur MSD, 162 avenue Jean Jaures, CS 50712, 69367 Lyon Cedex 07, France. Electronic address: slockhart@spmsd.com.
authors.forename: Stephen
authors.initials: S
authors.lastname: Lockhart
mesh_terms: D000907:Antibodies, Bacterial / Q000097:blood; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D005387:Finland; D018073:Haemophilus Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D064368:Healthy Volunteers; D006510:Hepatitis B Antibodies / Q000097:blood; D017325:Hepatitis B Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D006801:Humans; D007115:Immunization Schedule; D007223:Infant; D022401:Meningococcal Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D022242:Pneumococcal Vaccines / Q000008:administration & dosage; D011054:Poliovirus Vaccine, Inactivated / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D022243:Rotavirus Vaccines / Q000008:administration & dosage; D017778:Vaccines, Combined / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
chemical_list: C538862:13-valent pneumococcal vaccine; D000907:Antibodies, Bacterial; C000625558:DTaP-IPV-HB-PRP-T vaccine; D015721:Diphtheria-Tetanus-Pertussis Vaccine; D018073:Haemophilus Vaccines; D006510:Hepatitis B Antibodies; D017325:Hepatitis B Vaccines; D022401:Meningococcal Vaccines; D022242:Pneumococcal Vaccines; D011054:Poliovirus Vaccine, Inactivated; D022243:Rotavirus Vaccines; D017778:Vaccines, Combined; C410218:serogroup C meningococcal conjugate vaccine
keywords: Co-administration; Hexavalent; Immunogenicity; Meningococcal C; Safety; Vaccination