629. An Open-label, Randomized, Multicenter Study of the Immunogenicity and Safety of DTaP-IPV (Kinrix®) Co-administered with MMR Vaccine with or without Varicella Vaccine in Healthy Pre-school Age Children (4–6 Years Old)
Session: Poster Abstract Session: Pediatric Vaccines
Friday, October 21, 2011
Room: Poster Hall B1

Background:

US guidelines recommend vaccinating children 4–6 years old with diphtheria, tetanus and acellular pertussis (DTaP), inactivated poliovirus (IPV), measles-mumps-rubella (MMR) and varicella (V) vaccines. Data are limited regarding concomitant administration of combination DTaP-IPV (Kinrix®, GlaxoSmithKline) and V vaccines.

 

Methods:

Phase IIIb, open-label study in which healthy children (4–6 years of age) were randomized (1:1) to receive:

·          Group 1: DTaP-IPV  + V (Varivax®, Merck and Company) + MMR (M-M-RII, Merck and Company) on Day 0

·          Group 2: DTaP-IPV + MMR on Day 0, followed by V at Month 1

We collected blood pre-vaccination (Day 0) and at Month 1 post-vaccination (for Group 2, samples were taken before V vaccination). DTaP-IPV + V + MMR was non-inferior to DTaP-IPV + MMR one month post-vaccination if the 95% CI LL for between-group differences in booster responses to D, T, pertussis toxoid (PT), filamentous hemagglutinin (FHA) and pertactin (PRN) were all ≥-10% and GMT ratios for the three poliovirus antigens were all ≥0.67. We recorded solicited local and general symptoms within 4 days after vaccination and serious adverse events (SAEs) through 6 months post-vaccination.

Results:

We enrolled 478 subjects. One month post-vaccination, antibodies to all vaccine antigens were increased, over 95% of subjects in both groups had booster responses to D, T, PT, FHA, PRN and poliovirus, and all children were seroprotected against D, T and all poliovirus types. DTaP-IPV + V + MMR was shown to be non-inferior to DTaP-IPV + MMR with regards to all antigens as per the criteria defined above.

Figure 1. Booster responses to the D, T, acellular pertussis and poliovirus one month post-booster (ATP cohort for immunogenicity) 

Figure 2. GMTs for antibodies to poliovirus, before and one month post-booster (ATP cohort for immunogenicity) 

Local and general solicited symptoms were similar between groups and no vaccine related SAEs were reported. Both vaccine regimens were well tolerated.

Conclusion:

Concomitant administration of varicella vaccine with DTaP-IPV and MMR did not impact immunogenicity of diphtheria, tetanus, pertussis or poliovirus antigens.

Kinrix is a trademark of the GlaxoSmithKline group of companies. Varivax is a trademark of Merck and Company.

 


Subject Category: I. Adult and Pediatric Vaccines

Nicola Klein, MD, PhD1, Wayde Weston, PhD2, Sherine Kuriyakose, MSc3, Barbara Howe, MD2, Leonard Friedland, MD4 and Olivier Van Der Meeren, MD5, (1)Kaiser Permanente Vaccine Study Center, Oakland, CA, (2)GlaxoSmithKline Biologicals, King of Prussia, PA, (3)GlaxoSmithKline Pharmaceuticals Ltd , Bangalore, India, (4)GlaxoSmithKline, King of Prussia, PA, (5)GlaxoSmithKline Biologicals, Wavre, Belgium

Disclosures:

N. Klein, Sanofi Pasteur: Grant Investigator, Research grant
Merck & Co.: Grant Investigator, Research grant
GSK: Grant Investigator, Research grant
Novartis: Grant Investigator, Research grant
MedImmune: Grant Investigator, Research grant
Pfizer: Grant Investigator, Research grant

W. Weston, GlaxoSmithKline Biologicals: Employee, Salary

S. Kuriyakose, GlaxoSmithKline Pharmaceuticals: Employee, Salary

B. Howe, GlaxoSmithKline Biologicals: Employee, Salary

L. Friedland, GlaxoSmithKline Biologicals: Employee, Salary

O. Van Der Meeren, GlaxoSmithKline Biologicals: Employee, Salary

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