TY - JOUR
T1 - Concomitant administration of a liquid formulation of human rotavirus vaccine (porcine circovirus-free) with routine childhood vaccines in infants in the United States
T2 - Results from a phase 3, randomized trial
AU - Abu-Elyazeed, Remon
AU - Klein, Nicola P.
AU - Moerman, Leentje
AU - Povey, Michael
AU - Pruitt, Anthony
AU - Senders, Shelly
AU - Silas, Peter
AU - Bi, Dan
AU - Acevedo, Armando
AU - Amisola, Rogelio
AU - Anschutz, Luke
AU - Bataille, Regine
AU - Campbell, James
AU - Cornish, Matthew
AU - Domachowske, Joseph
AU - Fling, John
AU - Franklin, Earl
AU - Fuller, Joshua
AU - Gabrielsen, Alvin
AU - Garscadden, Alan
AU - Guido, Giancarlo
AU - Hedrick, James
AU - Hurley, David
AU - Hurley, Donald
AU - Johnston, William
AU - Kulshrestha, Aarti
AU - Leonardi, Michael
AU - Levinson, Martin
AU - Livingston, Sean
AU - Marshall, Gary
AU - Pirrotta, Paola
AU - Rok, Walter
AU - Russell, Stephen
AU - Schear, Martin
AU - Shepard, Julie
AU - Sigg, Laurent
AU - Singh, Tina
AU - Tipton, Mary
AU - Ugarte, Ana
AU - Wisman, Paul
AU - Zissman, Edward
N1 - Funding Information:
This work was sponsored by GlaxoSmithKline Biologicals SA. GlaxoSmithKline Biologicals SA was involved in all stages of the conduct and analysis of the studies. GlaxoSmithKline Biologicals SA covered the costs associated with the development and the publishing of the present manuscript.
Funding Information:
RAE, MP, LM and DB are employees of the GSK group of companies, and DB holds shares in the GSK group of companies as part of the employee remuneration. NPK declares receipt of research grants from GSK group of companies, Merck, Pfizer, Sanofi Pasteur, MedImmune, and Protein Science.
Publisher Copyright:
© 2020 GlaxoSmithKline Biologicals SA
PY - 2021/3/5
Y1 - 2021/3/5
N2 - Background: In response to the detection of porcine circovirus type 1 (PCV-1) in the human rotavirus vaccine (HRV), a PCV-free HRV (no detection of PCV-1 and PCV-2 according to the detection limit of tests used) was developed. Liquid (Liq) PCV-free HRV previously showed immunogenicity and safety profiles comparable to lyophilized (Lyo) HRV. Methods: This was a phase 3a, randomized, single-blind study (NCT03207750) conducted in the United States. Healthy infants aged 6–12 weeks received 2 doses (0, 2 months) of either Liq PCV-free HRV or Lyo HRV with routine vaccines (0, 2, 4 months): diphtheria-tetanus-acellular pertussis, hepatitis B and inactivated poliovirus combination vaccine (DTaP-HBV-IPV), monovalent tetanus toxoid-conjugated vaccine against Haemophilus influenzae type b (Hib-TT), and 13-valent pneumococcal conjugate vaccine. Co-primary objectives were: (i) to assess non-inferiority of immune responses to routine vaccine antigens 1 month post-dose 3 following co-administration with Liq PCV-free HRV compared to Lyo HRV; (ii) to rule out a 10% decrease in seroresponse to pertussis antigens after dose 3. Other objectives were to evaluate immunogenicity and safety of HRV vaccines. Results: Of 1272 vaccinated infants, 990 (489 in Liq PCV-free HRV and 501 in Lyo HRV group) were included in the per-protocol set. All statistical criteria were met, thus co-primary objectives were demonstrated. Seroprotection/seropositivity rates in both groups were high: 100% for diphtheria/tetanus, ≥99.3% for HBV, ≥99.8% for polio, ≥99.8% for each pertussis antigen, ≥90.8% for all pneumococcal serotypes except serotype 3 (≥69.1%), and ≥ 97.4% for Hib. Most infants seroconverted for anti-RV antibodies (76.3% of Liq PCV-free HRV and 78.9% of Lyo HRV recipients). Geometric mean concentrations/titers were comparable between groups. Incidences of adverse events and serious adverse events were similar between groups. Conclusion: Routine pediatric vaccines co-administered with Liq PCV-free HRV showed non-inferior immune responses and similar safety profiles to those following co-administration with Lyo HRV.
AB - Background: In response to the detection of porcine circovirus type 1 (PCV-1) in the human rotavirus vaccine (HRV), a PCV-free HRV (no detection of PCV-1 and PCV-2 according to the detection limit of tests used) was developed. Liquid (Liq) PCV-free HRV previously showed immunogenicity and safety profiles comparable to lyophilized (Lyo) HRV. Methods: This was a phase 3a, randomized, single-blind study (NCT03207750) conducted in the United States. Healthy infants aged 6–12 weeks received 2 doses (0, 2 months) of either Liq PCV-free HRV or Lyo HRV with routine vaccines (0, 2, 4 months): diphtheria-tetanus-acellular pertussis, hepatitis B and inactivated poliovirus combination vaccine (DTaP-HBV-IPV), monovalent tetanus toxoid-conjugated vaccine against Haemophilus influenzae type b (Hib-TT), and 13-valent pneumococcal conjugate vaccine. Co-primary objectives were: (i) to assess non-inferiority of immune responses to routine vaccine antigens 1 month post-dose 3 following co-administration with Liq PCV-free HRV compared to Lyo HRV; (ii) to rule out a 10% decrease in seroresponse to pertussis antigens after dose 3. Other objectives were to evaluate immunogenicity and safety of HRV vaccines. Results: Of 1272 vaccinated infants, 990 (489 in Liq PCV-free HRV and 501 in Lyo HRV group) were included in the per-protocol set. All statistical criteria were met, thus co-primary objectives were demonstrated. Seroprotection/seropositivity rates in both groups were high: 100% for diphtheria/tetanus, ≥99.3% for HBV, ≥99.8% for polio, ≥99.8% for each pertussis antigen, ≥90.8% for all pneumococcal serotypes except serotype 3 (≥69.1%), and ≥ 97.4% for Hib. Most infants seroconverted for anti-RV antibodies (76.3% of Liq PCV-free HRV and 78.9% of Lyo HRV recipients). Geometric mean concentrations/titers were comparable between groups. Incidences of adverse events and serious adverse events were similar between groups. Conclusion: Routine pediatric vaccines co-administered with Liq PCV-free HRV showed non-inferior immune responses and similar safety profiles to those following co-administration with Lyo HRV.
KW - Concomitant administration
KW - Human rotavirus vaccine
KW - Non-inferiority
KW - Porcine virus-free rotavirus vaccine
KW - Routine childhood vaccines
UR - http://www.scopus.com/inward/record.url?scp=85092939664&partnerID=8YFLogxK
U2 - 10.1016/j.vaccine.2020.08.070
DO - 10.1016/j.vaccine.2020.08.070
M3 - Article
C2 - 33077301
AN - SCOPUS:85092939664
SN - 0264-410X
VL - 39
SP - 1534
EP - 1543
JO - Vaccine
JF - Vaccine
IS - 10
ER -