Concomitant Use of an Oral Live Pentavalent Human-Bovine Reassortant Rotavirus Vaccine With Licensed Parenteral Pediatric Vaccines in the United States

Abstract

In this study, antibody responses to the concomitantly administered vaccines were generally similar in PRV and placebo recipients. PRV was efficacious and well tolerated when given concomitantly with pediatric vaccines licensed in the United States.

Assessing the interest to participate in a dengue vaccine efficacy trial among residents of Puerto Rico

“…While clinical trials, including vaccine trials, have been conducted in Puerto Rico with children, only one was double blinded and placebo controlled. [18][19][20][21][22][23][24] The difficulty in recruiting and retaining participants in clinical trials is well documented, [25][26][27][28] particularly among children. This has resulted in cost increases, implementation delays, failure to complete trials, and biased results.…”

Results from a Randomized Clinical Trial of Coadministration of RotaTeq, a Pentavalent Rotavirus Vaccine, and NeisVac-C, a Meningococcal Serogroup C Conjugate Vaccine

“…It is a live attenuated human-bovine reassortant rotavirus vaccine consisting of the genes encoding the G1, G2, G3, G4, and P1A [8] outer capsid proteins of human rotaviruses in monoreassortants containing a bovine rotavirus genetic background. RotaTeq has been demonstrated to be efficacious, immunogenic, and well tolerated when it is given alone or concomitantly with routine childhood vaccines (4,5,17,21,22,23,24). On the basis of the current summary of product characteristics (SmPC) for RotaTeq in Europe, the first dose should be given at between 6 weeks and 12 weeks of age and all three doses should be given before 26 weeks of age (13).…”

“…The concomitant use of RotaTeq with licensed pediatric vaccines, including diphtheria and tetanus toxoids and acellular pertussis vaccine (DTaP), inactivated poliovirus vaccine (IPV), Haemophilus influenzae type b conjugate vaccine (Hib), hepatitis B vaccine, hexavalent vaccine (combined vaccine against diphtheria, tetanus, pertussis, poliomyelitis, H. influenzae type b, and hepatitis B), pneumococcal conjugate vaccine, and oral poliomyelitis vaccine, has been evaluated in phase III clinical trials (4,5,17). Meningococcal serogroup C conjugate vaccine (MenCC) was not used routinely in the countries in which the initial studies with RotaTeq were undertaken; consequently, the concomitant administration of RotaTeq with MenCC has not been investigated (2,21,23).…”

Prevention of Rotavirus Disease: Updated Guidelines for Use of Rotavirus Vaccine

“…Both RV1 and RV5 can be coadministered with diphtheria and tetanus toxoids and acellular pertussis vaccine (DTaP), Haemophilus influenzae type b vaccine (Hib), inactivated poliovirus vaccine (IPV), hepatitis B vaccine (HPV), and pneumococcal conjugate vaccine with no observed immune interference. 16,17 Few data are available on the efficacy, safety, and reactogenicity of rotavirus vaccine in infants with underlying conditions. Studies of HIV-infected infants are ongoing for RV1 and are planned for RV5.…”

“…They do not cause clinically significant increases in reactogenicity when coadministered with other routine childhood vaccines. 16,17 For both vaccines, the incidence of fever, vomiting, diarrhea, and irritability were measured in the clinical trials. For RV5, no significant difference versus placebo was observed in the incidence of fever or severe fever and irritability or severe irritability.…”