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Concomitant Use of the 3-Dose Oral Pentavalent Rotavirus Vaccine With a 3-Dose Primary Vaccination Course of a Diphtheria-Tetanus-Acellular Pertussis-Hepatitis B-Inactivated Polio-Haemophilus influenzae Type b Vaccine: Immunogenicity and Reactogenicity

Ciarlet, Max PhD*; He, Su BS, MS*; Lai, Sherry BS, MEng*; Petrecz, Maria BS, MLT*; Yuan, Guojun BS, MS†; Liu, Guanghan F. PhD†; Mikviman, Elena BS, MBA*; Heaton, Penny M. MD*; Panzer, Falko MD‡; Rose, Thomas MD§; Koller, Dieter Y. MD¶; Van Damme, Pierre MD, PhD∥; Schödel, Florian MD*

Pediatric Infectious Disease Journal: March 2009 - Volume 28 - Issue 3 - pp 177-181
doi: 10.1097/INF.0b013e31818c0161
Original Studies

Background: The pentavalent rotavirus vaccine (PRV), RotaTeq, can be concomitantly administered with most routine childhood vaccines. This study evaluated the immunogenicity and reactogenicity of PRV when used concomitantly with a hexavalent vaccine containing diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus, and Haemophilus influenzae type b.

Methods: Healthy infants (N = 403) received hexavalent vaccine concomitantly with either PRV or placebo at 2, 3, and 4 months of age. Antibody responses were measured immediately before and 42 ± 3 days after vaccination. Parents/legal guardians recorded all adverse events for 14 days after vaccination.

Results: Seroprotective titers for hepatitis B (hepatitis B surface antigen ≥10 mIU/mL) were achieved by 97.8% of subjects in both vaccine treatment groups. Seroprotective titers to H. influenzae type b (polyribosylribitol phosphate ≥0.15 μg/mL) were achieved by 91.4% of subjects receiving both vaccines and 95.1% of subjects receiving only hexavalent vaccine. Seroprotective titers to diphtheria, tetanus, and poliovirus were also comparable between the vaccine treatment groups, as were geometric mean antibody titers to the pertussis antigens. Among PRV recipients, 92% had a ≥3-fold rise in serum antirotavirus immunoglobulin A levels. Concomitant administration was well tolerated. The incidence of adverse events was similar for both groups, with no statistically significant increases in fever, vomiting, diarrhea, or irritability.

Conclusions: In this study, concomitant administration of PRV with hexavalent vaccine was well tolerated and the immune responses to the antigens of the hexavalent vaccine were noninferior when compared with those of the control group. In addition, PRV was immunogenic when administered concomitantly with hexavalent vaccine.

From the *Vaccine Biologics–Clinical Research, Merck Research Laboratories, North Wales, PA; †Vaccine CBARDS, Merck Research Laboratories, North Wales, PA; ‡Max-Joseph-Str. 1, Mannheim, Germany; §Mühlendamm 1, Wildeshausen, Germany; ¶University Clinic for Paediatrics and Adolescent Medicine, Vienna, Austria; and ∥Centre for the Evaluation of Vaccination, Vaccine and Infectious Disease Institute, University of Antwerp, Antwerp, Belgium.

Accepted for publication August 28, 2008.

Supported by Merck and Co., Inc.

Address for correspondence: Max Ciarlet, PhD, Vaccine Biologics–Clinical Research, Merck Research Laboratories, Mailstop: UG3CD-28, 351 N. Sumneytown Pike, North Wales, PA 19454. E-mail: max_ciarlet@merck.com.

© 2009 Lippincott Williams & Wilkins, Inc.