625. Concomitant Use of Vaqta™ with PedvaxHIB™ and Infanrix™in 15 Month Old Children
Session: Poster Abstract Session: Pediatric Vaccines
Friday, October 21, 2011
Room: Poster Hall B1
Handouts
  • Poster 625.pdf (433.8 kB)
  • Background: 

    An open-label, multicenter, randomized study evaluated immunogenicity, safety, and tolerability of Vaqta™ (hepatitis A vaccine) given concomitantly with PedvaxHIB™ (Haemophilus b conjugate vaccine [Meningococcal protein conjugate]) & Infanrix™ (diphtheria/tetanus/acellular pertussis vaccine) in healthy, 15 month old children.

    Methods: 

    Group 1 (n=155): Vaqta™/Infanrix™/PedvaxHIB™ on Day 1; Vaqta™ at Week 24.

    Group 2 (n=151): Infanrix™/PedvaxHIB™ on Day 1; Vaqta™ at Week 4; Vaqta™ at Week 28.

    Group 3 (n=159): Vaqta™/PedvaxHIB™ on Day 1; Vaqta™ at Week 24.

    Group 4 (n=152): PedvaxHIB™ on Day 1; Vaqta™ at Week 4; Vaqta™ at Week 28.

    Group 5 (n=654) (followed for safety only): Vaqta™ on Day 1; Vaqta™ at Week 24.

    HepA seropositivity rate (SPR: ≥10 mIU/mL), Hib capsular PRP antibody response (>1.0 mcg/mL), and geometric mean titers (GMT) to pertussis PT, FHA, and pertactin were examined.  The statistical criteria for non-inferiority required a difference of less than 10% in Hep A SPR, PRP >1.0 mcg/mL, and a GMT ratio of >0.67 for pertussis antigens between the concomitant and non-concomitant groups. Injection site & systemic adverse experiences (AEs) and daily temperatures were collected.

    Results: 

    HepA SPR were 100% for Groups 1 through 4, regardless of initial serostatus. Anti-PRP titers were comparable: 98.1%, 97.0%, 97.3% and 97.2% for Groups 1-4, respectively.  GMT and mean fold-rise were comparable for all three pertussis antigen components between concomitant and nonconcomitant groups. The criteria for non-inferiority of immune responses with concomitant administration as compared to separate administration were met for Hepatitis A, Hib, and pertussis antigens.

    No statistically significant incidence differences of individual AEs were seen when Vaqta™ was administered concomitantly vs nonconcomitantly. No serious vaccine-related AEs or deaths were reported, and no subjects discontinued due to AE.

    Conclusion: 

    Immune responses to Vaqta™, PedvaxHIB™ and Infanrix™ given concomitantly were non-inferior to each vaccine given nonconcomitantly. Concomitant administration of Vaqta™ with PedvaxHIB™ & Infanrix™ had an acceptable safety profile in 15 month old children.


    Subject Category: I. Adult and Pediatric Vaccines

    Keith Ramsey, DO1, Maria Petrecz, BSBA, MLT(ASCP)2, Stephanie Klopfer, PhD2, Anthony Grosso, BS2, Florian Schödel, MD2 and Andrew Wen-Tseng Lee, MD2, (1)Jordan Ridge Kids & Teens, West Jordan, UT, (2)Merck Sharp & Dohme Corp., Whitehouse Station, NJ

    Disclosures:

    K. Ramsey, Merck: Investigator, Research support

    M. Petrecz, Merck: Employee and Shareholder, Salary

    S. Klopfer, Merck: Employee and Shareholder, Salary

    A. Grosso, Merck: Employee and Shareholder, Salary

    F. Schödel, Merck: Employee and Shareholder, Salary

    A. W. T. Lee, Merck: Employee and Shareholder, Salary

    See more of: Pediatric Vaccines
    See more of: Poster Abstract Session

    Findings in the abstracts are embargoed until 12:01 a.m. EST Thursday, Oct. 20 with the exception of research findings presented at IDSA press conferences.