Program Schedule

1112
A Phase III Study of the Safety, Tolerability and Immunogenicity of an Investigational Combination Vaccine against Diphtheria, Tetanus, Pertussis (DTaP5), Polio (IPV), Haemophilus influenzae type b (Hib; PRP-OMPC), and Hepatitis B (HepB) in US Infants

Session: Poster Abstract Session: Vaccines: Rabies, CMV, Combined
Friday, October 10, 2014
Room: The Pennsylvania Convention Center: IDExpo Hall BC
Posters
  • Marshall et al_IDWeek 2014_poster 1112.pdf (436.7 kB)
  • Background: Combination vaccines simplify vaccination visits and improve coverage and timeliness. DTaP5-IPV-Hib-HepB is an investigational, fully-liquid, combination vaccine designed to protect against 6 diseases.

    Methods:

    In this multicenter, open-label, comparator-controlled, Phase III study, healthy infants were randomized 2:1 to receive one of the following immunization regimens:

     

    Group

    Age

    2, 4 and 6 mo.

    15 mo.

    1

    DTaP5-IPV-Hib-HepB

    Prevnar 13 (PCV13)

    RotaTeq (RV5)

    Daptacel (DTaP5)

    PedvaxHIB (PRP-OMPC)

    Prevnar 13 (PCV13)

    2

    Pentacel (DTaP5-IPV/Hib)

    Recombivax HB (HepB)

    Prevnar 13 (PCV13)

    RotaTeq (RV5)

    Daptacel (DTaP5)

    ActHIB (PRP-T)

    Prevnar 13 (PCV13)

    Dose not given at 4 mo.

    Results:

    All infants received HepB in the first month of life. A total of 981 subjects were vaccinated in Group 1 and 484 in Group 2. In a per-protocol analysis, immune responses to all DTaP5-IPV-Hib-HepB antigens 1 mo after dose 3 were non-inferior in Group 1 as compared to Group 2, with the exception of anti-filamentous hemagglutinin (FHA, a pertussis antigen) GMTs (46.59 vs 72.28, ratio 0.64 [95% CI 0.59, 0.70]). Vaccine response rates for FHA were non-inferior to control. After the toddler dose, Group 1 was non-inferior to Group 2 for all pertussis antigens. Group 1 response to concomitant RV5, measured as anti-rotavirus IgA GMT 1 month after dose 3, was also non-inferior.

    Solicited adverse event rates after any dose were similar in both groups, with the exceptions of increased injection-site erythema (48.8% vs 42.2%, difference 6.5% [1.1, 11.9]), increased fever (47.4% vs 34.4%, difference 13.1% [7.7, 18.3]), and decreased appetite (48.9% vs 43.3%, difference 5.6% [0.2, 11.0]) in Group 1. Most adverse events were mild-to-moderate and did not lead to subject withdrawal. Fever was not associated with hospitalization or seizures.

    Conclusion: The safety and immunogenicity of DTaP5-IPV-Hib-HepB is comparable to the analogous licensed component vaccines. Decreased anti-FHA GMTs and increased injection-site reactions and fever are unlikely to be clinically significant. DTaP5-IPV-Hib-HepB provides a new hexavalent option for pediatric combination vaccines, aligned with recommended US immunizations.

    Gary S. Marshall, MD1, Gregory Adams, MD2, Michael Leonardi, MD3, Maria Petrecz, BSBA, MLT(ASCP)4, Sheryl Flores4, Angela Ngai, BS, MT(ASCP)4, Jin Xu, PhD4, Ginamarie Foglia, DO, MPH5, Andrew Wen-Tseng Lee, MD4 and Protocol 005 Study Team (NCT01337167), (1)Pediatrics, University of Louisville School of Medicine, Louisville, KY, (2)Blue Ridge Pediatric and Adolescent Medicine, Boone, NC, (3)Palmetto Pediatrics PA, Charleston, SC, (4)Merck & Co., Inc., Whitehouse Station, NJ, (5)Clinical Development, Sanofi Pasteur, Swiftwater, PA

    Disclosures:

    G. S. Marshall, Merck: Investigator, Research grant and Research support

    G. Adams, Merck: Investigator, Research grant and Research support

    M. Leonardi, Merck: Investigator, Research grant and Research support

    M. Petrecz, Merck: Employee and Shareholder, Salary

    S. Flores, Merck: Employee and Shareholder, Salary

    A. Ngai, Merck: Employee and Shareholder, Salary

    J. Xu, Merck: Employee and Shareholder, Salary

    G. Foglia, Sanofi Pasreur: Employee, Salary

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

    Findings in the abstracts are embargoed until 12:01 a.m. EDT, Oct. 8th with the exception of research findings presented at the IDWeek press conferences.

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