The ORVAC trial: a phase IV, double-blind, randomised, placebo-controlled clinical trial of a third scheduled dose of Rotarix rotavirus vaccine in Australian Indigenous infants to improve protection against gastroenteritis: a statistical analysis plan
DiscussionA detailed, prospective statistical analysis plan is presented for this Bayesian adaptive design. The plan was written by the trial statistician and details the study design, pre-specified adaptative elements, decision thresholds, statistical methods and the simulations used to evaluate the operating characteristics of the trial. As at August 2020, four interim analyses have been run, but no stopping rules have been triggered. Application of this SAP will minimise bias and supports transparent and reproducible research.Trial registrationClinicaltrials.gov NCT02941107. Registered on 21 October 2016Original protoco...
Source: Trials - August 25, 2020 Category: Research Source Type: clinical trials
Immunogenicity and Safety of Concomitant and Non-Concomitant Administration of RotaTeq ® (V260) and Inactivated Poliomyelitis Vaccine in Healthy Chinese Infants (V260-074)
Condition: Prevention of Rotavirus Gastroenteritis in Infants and Children Caused by Serotypes G1, G2, G3, G4, and G9 Interventions: Biological: RotaTeq (V260); Biological: IPV Sponsor: Merck Sharp & Dohme Corp. Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - July 22, 2020 Category: Research Source Type: clinical trials
Study of DTwP-HepB-Hib-IPV (SHAN6 ™) Vaccine Administered Concomitantly With Routine Pediatric Vaccines to Healthy Infants and Toddlers in Thailand
Conditions: Pertussis Immunisation; Diphtheria Immunisation; Polio Immunisation; Hepatitis B Immunisation; Haemophilus Influenzae Type B Immunisation; Tetanus Immunisation; Rotavirus Immunisation; Pneumococcal Immunisation Interventions: Biological: DTwP-HepB-Hib-IPV hexavalent vaccine (Diphtheria toxoid, Tetanus toxoid, whole cell pertussis, Hepatitis B surface antigen (HBsAg), Haemophilus influenzae type b, inactivated poliovirus); Biological: DTwP-HepB-Hib pentavalent vaccine (Diphtheria toxoid, Tetanus toxoid, whole cell pertussis, Hepatitis B surface antigen (HBsAg), Haemophil...
Source: ClinicalTrials.gov - June 12, 2020 Category: Research Source Type: clinical trials
