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Efficacy and safety of a pentavalent live human-bovine reassortant rotavirus vaccine (RV5) in healthy Chinese infants: A randomized, double-blind, placebo-controlled trial.
Vaccine. 2017 10 13; 35(43):5897-5904.V

Abstract

BACKGROUND

A randomized, double-blind, placebo-controlled multicenter trial was conducted in healthy Chinese infants to assess the efficacy and safety of a pentavalent live human-bovine reassortant rotavirus vaccine (RotaTeq™, RV5) against rotavirus gastroenteritis (RVGE).

METHODS

4040 participants aged 6-12weeks were enrolled and randomly assigned to either 3 oral doses of RV5 (n=2020) or placebo (n=2020), administered ∼4weeks apart. The participants also received OPV and DTaP in a concomitant or staggered fashion. The primary objective was to evaluate vaccine efficacy (VE) against naturally-occurring RVGE at least 14days following the third dose. Key secondary objectives included: VE against naturally-occurring severe RVGE and VE against severe and any-severity RVGE caused by rotavirus serotypes contained in the vaccine, occurring at least 14days after the third dose. All adverse events (AEs) were collected for 30days following each dose. Serious AEs (SAEs) and intussusception cases were collected during the entire study. (ClinicalTrials.gov registry: NCT02062385).

RESULTS

VE against RVGE of any-severity caused by any serotype was 69.3% (95% CI: 54.5, 79.7). The secondary efficacy analysis showed an efficacy of: 78.9% (95% CI: 59.1, 90.1) against severe RVGE caused by any serotype; 69.9% (95% CI: 55.2, 80.3) and 78.9% (95% CI: 59.1, 90.1) against any-severity and severe RVGE caused by serotypes contained in the vaccine, respectively. Within 30days following any vaccination, 53.5% (1079/2015) and 53.3% (1077/2019) of participants reported at least one AE, and 5.8% (116/2015) and 5.7% (116/2019) reported SAEs in the vaccine and placebo groups, respectively. No SAEs were considered vaccine-related in recipients of RV5. Two intussusception cases were reported in recipients of RV5 who recovered after receiving treatment. Neither was considered vaccine-related.

CONCLUSIONS

In Chinese infants, RV5 was efficacious against any-severity and severe RVGE caused by any serotype and generally well-tolerated with respect to AEs.

Authors+Show Affiliations

Guangxi Center for Disease Control and Prevention, Nanning, Guangxi, China.Guangxi Center for Disease Control and Prevention, Nanning, Guangxi, China.Liuzhou City Center for Disease Control and Prevention, Liuzhou, Guangxi, China.Liujiang County Center for Disease Control and Prevention, Liuzhou, Guangxi, China.Sanjiang County Center for Disease Control and Prevention, Liuzhou, Guangxi, China.Liucheng County Center for Disease Control and Prevention, Liuzhou, Guangxi, China.Rongan County Center for Disease Control and Prevention, Liuzhou, Guangxi, China.Luzhai County Center for Disease Control and Prevention, Liuzhou, Guangxi, China.Merck Sharp & Dohme R&D (China) Co., Ltd., Beijing, China.Merck Sharp & Dohme R&D (China) Co., Ltd., Beijing, China.Merck Sharp & Dohme R&D (China) Co., Ltd., Beijing, China.Merck & Co., Inc., Kenilworth, NJ, USA.Merck & Co., Inc., Kenilworth, NJ, USA.Merck & Co., Inc., Kenilworth, NJ, USA. Electronic address: susan_kaplan@merck.com.

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

28935470

Citation

Mo, Zhaojun, et al. "Efficacy and Safety of a Pentavalent Live Human-bovine Reassortant Rotavirus Vaccine (RV5) in Healthy Chinese Infants: a Randomized, Double-blind, Placebo-controlled Trial." Vaccine, vol. 35, no. 43, 2017, pp. 5897-5904.
Mo Z, Mo Y, Li M, et al. Efficacy and safety of a pentavalent live human-bovine reassortant rotavirus vaccine (RV5) in healthy Chinese infants: A randomized, double-blind, placebo-controlled trial. Vaccine. 2017;35(43):5897-5904.
Mo, Z., Mo, Y., Li, M., Tao, J., Yang, X., Kong, J., Wei, D., Fu, B., Liao, X., Chu, J., Qiu, Y., Hille, D. A., Nelson, M., & Kaplan, S. S. (2017). Efficacy and safety of a pentavalent live human-bovine reassortant rotavirus vaccine (RV5) in healthy Chinese infants: A randomized, double-blind, placebo-controlled trial. Vaccine, 35(43), 5897-5904. https://doi.org/10.1016/j.vaccine.2017.08.081
Mo Z, et al. Efficacy and Safety of a Pentavalent Live Human-bovine Reassortant Rotavirus Vaccine (RV5) in Healthy Chinese Infants: a Randomized, Double-blind, Placebo-controlled Trial. Vaccine. 2017 10 13;35(43):5897-5904. PubMed PMID: 28935470.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of a pentavalent live human-bovine reassortant rotavirus vaccine (RV5) in healthy Chinese infants: A randomized, double-blind, placebo-controlled trial. AU - Mo,Zhaojun, AU - Mo,Yi, AU - Li,Mingqiang, AU - Tao,Junhui, AU - Yang,Xu, AU - Kong,Jilian, AU - Wei,Dingkai, AU - Fu,Botao, AU - Liao,Xueyan, AU - Chu,Jianli, AU - Qiu,Yuanzheng, AU - Hille,Darcy A, AU - Nelson,Micki, AU - Kaplan,Susan S, Y1 - 2017/09/19/ PY - 2017/05/02/received PY - 2017/08/21/revised PY - 2017/08/29/accepted PY - 2017/9/25/pubmed PY - 2018/3/10/medline PY - 2017/9/23/entrez KW - Efficacy KW - Rotavirus gastroenteritis KW - Rotavirus vaccine KW - Safety SP - 5897 EP - 5904 JF - Vaccine JO - Vaccine VL - 35 IS - 43 N2 - BACKGROUND: A randomized, double-blind, placebo-controlled multicenter trial was conducted in healthy Chinese infants to assess the efficacy and safety of a pentavalent live human-bovine reassortant rotavirus vaccine (RotaTeq™, RV5) against rotavirus gastroenteritis (RVGE). METHODS: 4040 participants aged 6-12weeks were enrolled and randomly assigned to either 3 oral doses of RV5 (n=2020) or placebo (n=2020), administered ∼4weeks apart. The participants also received OPV and DTaP in a concomitant or staggered fashion. The primary objective was to evaluate vaccine efficacy (VE) against naturally-occurring RVGE at least 14days following the third dose. Key secondary objectives included: VE against naturally-occurring severe RVGE and VE against severe and any-severity RVGE caused by rotavirus serotypes contained in the vaccine, occurring at least 14days after the third dose. All adverse events (AEs) were collected for 30days following each dose. Serious AEs (SAEs) and intussusception cases were collected during the entire study. (ClinicalTrials.gov registry: NCT02062385). RESULTS: VE against RVGE of any-severity caused by any serotype was 69.3% (95% CI: 54.5, 79.7). The secondary efficacy analysis showed an efficacy of: 78.9% (95% CI: 59.1, 90.1) against severe RVGE caused by any serotype; 69.9% (95% CI: 55.2, 80.3) and 78.9% (95% CI: 59.1, 90.1) against any-severity and severe RVGE caused by serotypes contained in the vaccine, respectively. Within 30days following any vaccination, 53.5% (1079/2015) and 53.3% (1077/2019) of participants reported at least one AE, and 5.8% (116/2015) and 5.7% (116/2019) reported SAEs in the vaccine and placebo groups, respectively. No SAEs were considered vaccine-related in recipients of RV5. Two intussusception cases were reported in recipients of RV5 who recovered after receiving treatment. Neither was considered vaccine-related. CONCLUSIONS: In Chinese infants, RV5 was efficacious against any-severity and severe RVGE caused by any serotype and generally well-tolerated with respect to AEs. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/28935470/Efficacy_and_safety_of_a_pentavalent_live_human_bovine_reassortant_rotavirus_vaccine__RV5__in_healthy_Chinese_infants:_A_randomized_double_blind_placebo_controlled_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(17)31181-7 DB - PRIME DP - Unbound Medicine ER -