title: Concomitant use of VAQTA with PedvaxHIB and Infanrix in 12 to 17 month old children.
abstract: Open-label, multicenter, randomized study (NCT00289913) evaluated immunogenicity, safety, and tolerability of Vaqta (hepatitis A vaccine) administered with PedvaxHIB (Haemophilus b conjugate vaccine [Meningococcal protein conjugate]) & Infanrix (diphtheria/tetanus/acellular pertussis vaccine) in healthy, 15-month-old children. Five groups were evaluated: Group 1 received Vaqta/Infanrix PedvaxHIB on Day-1 and Vaqta at Week-24; Group 2 received Infanrix PedvaxHIB on Day-1, Vaqta at Week-4, and Vaqta at Week-28; Group 3 received Vaqta/PedvaxHIB on Day-1 and Vaqta Week-24; Group 4 received PedvaxHIB on Day-1, Vaqta at Week-4, and Vaqta at Week-28; and Group 5 (safety only) received Vaqta on Day-1 and Vaqta at Week-24. Hepatitis A seropositivity rate (SPR: ≥10 mIU/mL), Hib capsular polyribosylribitol phosphate (PRP) antibody response (>1.0 μg/mL), and geometric mean titers (GMT) to pertussis toxin (PT), pertussis filamentous hemagglutinin antibody (FHA), and pertactin were examined. Non-inferiority statistical criteria required a difference >10% in Hepatitis A SPR, PRP >1.0 μg/mL, and a GMT ratio of >0.67 for pertussis antigens. Injection-site and systemic adverse events (AEs) and daily temperatures were collected. Hepatitis A SPRs were 100% for Groups 1-4, regardless of initial serostatus. Anti-PRP titers were comparable (98.1% - 97.0%) for Groups 1-4. GMT and mean fold-rise were comparable for all 3 pertussis antigen components between concomitant and nonconcomitant groups. Criteria for non-inferiority of immune responses for concomitant vs nonconcomitant administration were met for Hepatitis A, Hib, and pertussis antigens. No statistically significant incidence differences of individual AEs were found between concomitant and nonconcomitant groups. No serious vaccine-related AEs or deaths were reported; no subject discontinued due to an AE. Immune responses to Vaqta, PedvaxHIB, and Infanrix given concomitantly were non-inferior to nonconcomitant responses. Vaqta administered with PedvaxHIB & Infanrix had an acceptable safety profile in 15-month-old children.
authors: a Merck & Co., Inc. ; Kenilworth , NJ USA.
authors: Maria
authors: M
authors: Petrecz
authors: b Jordan Ridge Kids & Teens ; West Jordan , UT USA.
authors: Keith P
authors: KP
authors: Ramsey
authors: a Merck & Co., Inc. ; Kenilworth , NJ USA.
authors: Jon E
authors: JE
authors: Stek
authors: a Merck & Co., Inc. ; Kenilworth , NJ USA.
authors: Jason C
authors: JC
authors: Martin
authors: a Merck & Co., Inc. ; Kenilworth , NJ USA.
authors: Stephanie O
authors: SO
authors: Klopfer
authors: a Merck & Co., Inc. ; Kenilworth , NJ USA.
authors: Barbara
authors: B
authors: Kuter
authors: a Merck & Co., Inc. ; Kenilworth , NJ USA.
authors: Florian P
authors: FP
authors: Schödel
authors: a Merck & Co., Inc. ; Kenilworth , NJ USA.
authors: Andrew W
authors: AW
authors: Lee
mesh_terms: D000907:Antibodies, Bacterial / Q000097:blood; D001425:Bacterial Outer Membrane Proteins / Q000009:adverse effects / Q000276:immunology*; D004165:Diphtheria / Q000276:immunology / Q000517:prevention & control; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines / Q000009:adverse effects / Q000276:immunology*; D006192:Haemophilus Infections / Q000276:immunology / Q000517:prevention & control; D018073:Haemophilus Vaccines / Q000009:adverse effects / Q000276:immunology*; D006506:Hepatitis A / Q000276:immunology / Q000517:prevention & control; D022362:Hepatitis A Vaccines / Q000009:adverse effects / Q000276:immunology*; D006801:Humans; D000071497:Immunogenicity, Vaccine / Q000276:immunology*; D007223:Infant; D011135:Polysaccharides, Bacterial / Q000009:adverse effects / Q000276:immunology*; D013742:Tetanus / Q000276:immunology / Q000517:prevention & control; D017778:Vaccines, Combined / Q000009:adverse effects* / Q000276:immunology*; D018074:Vaccines, Conjugate / Q000009:adverse effects / Q000276:immunology; D010566:Virulence Factors, Bordetella / Q000276:immunology; D014917:Whooping Cough / Q000276:immunology / Q000517:prevention & control
chemical_list: D000907:Antibodies, Bacterial; D001425:Bacterial Outer Membrane Proteins; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines; D018073:Haemophilus Vaccines; C061964:Haemophilus influenzae-type b polysaccharide-Neisseria meningitidis outer membrane protein conjugate vaccine; D022362:Hepatitis A Vaccines; D011135:Polysaccharides, Bacterial; D017778:Vaccines, Combined; D018074:Vaccines, Conjugate; D010566:Virulence Factors, Bordetella; C068929:pertactin
keywords: H. influenzae type b; concomitant use; diphtheria; hepatitis A; immunogenicity; pertussis; safety; tetanus; vaccine