Trial	Number of doses	Time between doses (weeks)	Number of arms: vaccine/placebo	Infant vaccination status	Note
RV1 Anh 2011‐PHL	2	4 or 8	2/1	Commercially available diphtheria, tetanus, whole‐cell pertussis (DTPw), hepatitis B (HBV) and oral poliovirus (OPV) vaccines were administered concomitantly with the study vaccine/placebo as part of the routine Expanded Programme of Immunization (EPI) in the Philippines	Compares different schedules: (1) vaccine dose at month 1 and 2, and placebo at day 0; and (2) vaccine dose at day 0 and month 2, and placebo at month 1
RV1 Anh 2011‐VNM	2	4 or 8	2/1	Commercially available diphtheria, tetanus, whole‐cell pertussis (DTPw), hepatitis B (HBV) and oral poliovirus (OPV) vaccines were administered concomitantly with the study vaccine/placebo as part of the routine Expanded Programme of Immunization (EPI) in Vietnam	Compares different schedules: (1) vaccine dose at day 0 and month 1, and placebo at month 2; and (2) vaccine dose at day 0 and month 2, and placebo at month 1
RV1 Bernstein 1998‐USA	2	6 to 10	1/1	Rotavirus vaccine was separated from all other infant vaccines by at least 2 weeks	—
RV1 Bernstein 1999‐USA	2	6 to 10	1/1	Other vaccines separated from the trial vaccines by at least 2 weeks	—
RV1 Colgate 2016‐BGD	2	7	1/1 (no RV1)	Alongside Rotarix at 10 and 17 weeks of age the polio vaccine intervention was the administration of an injected, inactivated polio vaccine (IPV) dose replacing the 4th dose of tOPV at 39 weeks of age. Study children also received all standard EPI vaccines (BCG at birth; pentavalent vaccine (DPT, HepB, Hib) at 6, 10, and 14 weeks; bivalent Measles‐Rubella at 40 weeks; and monovalent Measles at 65 weeks)	RV1 plus polio vacccine (IPV), observational control group only
RV1 Dennehy 2005‐NA	2	7	2/1	Vaccine or placebo given concomitantly with diphtheria‐tetanus‐acellular pertussis, inactivated poliovirus, H influenzae type b, and S pneumoniae conjugate vaccines for participants in USA or with a diphtheria‐tetanus‐acellular pertussis/inactivated poliovirus/H influenza type b combination vaccine for participants in Canada "Routine hepatitis B vaccinations were administered according to local practice."	2 different PFUs compared
RV1 GSK[021] 2007‐PAN	3	8	2/2	Use of other vaccines not mentioned	Licensed formulation versus modified formulation
RV1 GSK[033] 2007‐LA	2	8	3/1	Use of other vaccines not mentioned	3 ‘Lots’ of RV1 vaccine compared
RV1 GSK[041] 2007‐KOR	2	8	1/1	H influenzae type b vaccine administered concomitantly along with the 2 doses of vaccine/placebo and at 2 months after dose 2; other routine childhood vaccines were to be given at least 14 days before trial vaccine/placebo	—
RV1 GSK[101555] 2008‐PHL	2	8	2/2	No mention of whether infants received other vaccines	Data from the lyophilized formulation, which is not yet approved or marketed, are not reported
RV1 Kawamura 2011‐JPN	2	4	1/1	Combined diphtheria and tetanus toxoids and acellular pertussis (DTPa) and Hepatitis B (HBV) vaccines were allowed to be co‐administered along with RV1 vaccine/placebo	—
RV1 Kerdpanich 2010‐THA	2	8	3/2	Diphtheria toxoid, tetanus toxoid, acellular pertussis, inactivated polio and H influenzae type b combination vaccine (Infanrix™‐IPV/Hib) at 2 and 4 months of age and diphtheria toxoid, tetanus toxoid, acellular pertussis, hepatitis B, inactivated polio andH influenzae type b combination vaccine (Infanrix hexaTM) at 6 months of age	Compares: regular vaccine reconstituted in buffer; vaccine reconstituted in water; vaccine stored above recommended temperature; placebo reconstituted in water; placebo reconstituted in buffer
RV1 Kim 2012‐KOR	2	4	1/1	Routine childhood vaccines as recommended by the local vaccination schedule were allowed to be administered concomitantly with RIX4414/placebo. These vaccines included the combined diphtheria‐tetanus‐acellular pertussis vaccine, Hemophilus influenzae type b vaccine, inactivated poliovirus vaccine and pneumococcal vaccine. The infants had received the BCG vaccine and 2 doses of hepatitis B vaccine prior to study enrolment	—
RV1 Li 2013a‐CHN	1	‐	1/1	Children were allowed to receive routine childhood vaccinations according to local immunization practice during the study period, with a minimum interval of at least 7 days between the administration of routine vaccines and the study vaccine or placebo	Child arm (2 ‐ 6 years of age) of the same study as RV1 Li 2013b‐CHN
RV1 Li 2013b‐CHN	1	‐	1/1	Infants were allowed to receive routine childhood vaccinations according to local immunization practice during the study period, with a minimum interval of at least 7 days between the administration of routine vaccines and the study vaccine or placebo	Infant arm (6‐16 weeks of age) of the same study as RV1 Li 2013a‐CHN
RV1 Li 2014‐CHN	2	4	2/2	As part of the routine childhood vaccination according to the EPI recommendations in China, participants also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine. The Infanrix™ and the OPV vaccines were administered independently of (Sub‐cohort 1) or concomitantly with (Sub‐cohort 2) the Rotarix™ vaccine. When administered concomitantly, participants received the 3 doses of Infanrix™ vaccine at months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2	—
RV1 Madhi 2010‐AF	2 or 3	5 to 10	2/1	All participants received routine infant vaccinations according to EPI recommendations	—
RV1 Narang 2009‐IND	2	8	1/1	Routine vaccinations (diphtheria‐tetanus‐whole cell pertussis‐hepatitis b, H influenzae type b, and oral poliovirus vaccine) were administered at 6, 10, and 14 weeks of age (given with a 2‐week separation from the first and subsequent dose of the RV1 vaccine or placebo)	—
RV1 NCT00158756‐RUS	3	6	5	GlaxoSmithKline (GSK) Biologicals' Tritanrix™HepB and GSK Biologicals Kft's DTPwHBV vaccines as compared to concomitant administration of Commonwealth Serum Laboratory's (CSL's) DTPw (Triple Antigen™) and GSK Biologicals' HBV (Engerix™B), when coadministered With GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) vaccine, to healthy infants at 3, 4½ and 6 months of age, after a birth dose of Hepatitis B vaccine	Hep B and DTPw‐HBV vaccines in combination with other vaccines/placebo were compared in the study arms
RV1 Omenaca 2012‐EU	2	4 or 8	1/1	All participants received routine infant vaccinations in accordance with the local National Plan of Immunization schedule in each of the respective participating countries	—
RV1 Phua 2005‐SGP	2	4	3/1	Hepatitis B vaccine, diphtheria‐tetanus‐acellular pertussis, poliovirus, and H influenzae type b co‐administered with interventions	3 different PFUs compared
RV1 Phua 2009‐AS	2	6 to 10	1/1	Infants received other routine paediatric immunizations (combined diphtheria toxoid‐tetanus toxoid‐acellular pertussis (DTPa) – inactivated poliovirus [IPV] and H influenzae type B (Hib) vaccine and hepatitis B vaccine (HBV)) during the study period according to local schedules. Almost all infants received BCG dose at birth. If oral polio vaccine (OPV) was given as part of the routine schedule in the participating countries, a time interval of 2 weeks was observed between the OPV doses and RIX4414 vaccine/placebo doses	—
RV1 Rivera 2011‐DOM	2	7	1/1	All infants received 3 doses of combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus and H influenzae vaccine.	1 complimentary dose of RV1 was administered to all infants enrolled in this study (both study groups) who were aged < 6 months at Visit 3 (Week 13) as a benefit to the placebo group for participation in the study
RV1 Ruiz‐Palac 06‐LA/EU	2	4 or 8	1/1	Routine immunizations according to local regulations; oral poliovirus vaccination at least 2 weeks before or after rotavirus vaccine	—
RV1 Salinas 2005‐LA	2	8	3/1	Oral polio vaccine given after 2 weeks, not together with RV1	3 different PFUs compared   Main publication did not report that the trial included 2 subsets: 2 doses of human rotavirus or placebo subset: these participants received 2 oral doses of RV1 vaccine or placebo according to a 0, 2 months schedule, and routine vaccinations (DTPw‐ Hepatitis B vaccine (HBV) + Hib vaccine) at a 0, 2, and 4 months schedule 3 doses of RV1 or placebo subset: these participants received 3 oral doses of RV1 vaccine or placebo, and routine vaccinations (DTPw‐HBV + Hib vaccine) concomitantly with each dose of human rotavirus vaccine and placebo at a 0, 2, and 4 months schedule
RV1 Steele 2008‐ZAF	2	4	3/1	RV1 plus (1) oral polio vaccine (OPV) + diphtheria‐tetanus‐acellular pertussis/H influenzae type b (DTPA/HIB) vaccine; (2) OPV placebo + diphtheria‐tetanus‐acellular pertussis inactivated polio‐H influenzae type b (DTPA‐IPV/HIB) vaccine; or (3) OPV + DTPA/HIB vaccine	Compares different co‐administration combinations (see previous column)
RV1 Steele 2010a‐ZAF	3	4	1/1	RV1 vaccine was concomitantly administered with 3 doses of combined diphtheria, tetanus and whole‐cell pertussis, hepatitis B, and H influenzae type b vaccine (TritanrixHepBHib) and OPV (PolioSabin)	For infants who developed clinical symptoms of HIV (WHO stages III or IV disease) any time after enrolment, access to antiretroviral therapy (cotrimoxazole) according to the South African national guidelines was facilitated. Infants who needed treatment were referred to antiretroviral therapy centres by the investigators
RV1 Steele 2010b‐ZAF	2 or 3	4	2/1	Infants received routine vaccinations according to the local EPI schedule in South Africa. BCG and OPV vaccinations were given at birth; all other routine vaccinations (including diphtheria‐tetanus toxoids‐whole cell pertussis, hepatitis B, H influenzae type b, and OPV) were administered concomitantly with the study vaccine	Compares number of doses (2 or 3)
RV1 Tregnaghi 2011‐LA	2	4 or 8	1/1	All participants received routine infant vaccinations (Hepatitis B vaccine), diphtheria‐tetanus‐acellular pertussis, poliovirus, and H influenzae type b) according to EPI recommendations in each country. First 2 doses of routine EPI vaccinations were co‐administered with the RV1 vaccine or placebo doses; the 3ird routine EPI vaccination was administered 1 to 2 months later according to the national plan of immunization in each country	—
RV1 Vesikari 2004a‐FIN	2	8	3/1	Infant routine vaccinations were separated from the study vaccines by 2 weeks	3 different PFUs compared
RV1 Vesikari 2004b‐FIN	2	8	1/1	Infant routine vaccinations (diphtheria tetanus toxoids‐pertussis, H influenzae type b, and inactivated poliovirus vaccines) were separated from the study vaccines by at least 2 weeks	—
RV1 Vesikari 2007a‐EU	2	4 or 8	1/1	Concomitant vaccines included 7 valent pneumococcal polysaccharide conjugate vaccine (Prevenar) and meningococcal group c conjugate vaccine (Meningitec); Hepatitis B vaccine, diphtheria‐tetanus‐acellular pertussis, polio virus, and H influenzae type b vaccines were co‐administered	—
RV1 Vesikari 2011‐FIN	2	4	2/2	Routine childhood vaccinations were allowed according to local practice, but at least 14 days apart from each dose of study vaccine	Compares liquid and lyophilized vaccine formulations
RV1 Ward 2006‐USA	2	4	2/1	Not specified	2 different PFUs compared
RV1 Zaman 2009‐BGD	2	—	2/2	All children in the study received the standard EPI vaccines starting at 6 weeks of age. Oral polio vaccine (OPV) co‐administered in trial: either concomitantly with RV1 or 15 days before RV1.	Compared RV1 plus oral polio vaccine with RV1 alone
RV1 Zaman 2017‐BGD	2	4	1/1 (no RV1 vaccine)	HRV was scheduled to be given along with other standard infant vaccines including OPV at the DTP1 and DTP2 immunization visits, recommended in Bangladesh to occur at 6 and 10 weeks of age	Cluster randomised trial
RV5 Armah 2010‐AF	3	4	1/1	All children in the study received the standard EPI vaccines (including oral poliovirus vaccine) starting at 6 weeks of age	—
RV5 Block 2007‐EU/USA	3	4 to 10	1/1	Use of oral poliovirus vaccine during the course of the study or within 42 days before first dose of vaccine/placebo was an exclusion criterion; administration of other vaccines permitted	—
RV5 Ciarlet 2009‐EU	3	4 to 6	1/1	Hepatitis B vaccine, diphtheria‐tetanus‐acellular pertussis, polio virus, and H influenzae type b co‐administered	—
RV5 Clark 2003‐USA	3	6 to 8	1/1	Children that had recently received oral polio vaccine were excluded from the study	Breastfed; infants in the vaccine control group (Group 1) received the reassortants as administered in previous studies within 30 mins of feeding Enfamil formula (30 ml) or Mylanta Double Strength (0.5 ml/kg). Infants in a corresponding placebo group (Group 2) were pre‐fed as in Group 1
RV5 Clark 2004‐USA	3	6 to 8	1/1	Receipt of any other vaccines within 14 days was not allowed.	—
RV5 Dhingra 2014‐IND	3	4	4/1	Infants in Cohort 2 concomitantly received a combined DTPw‐HB‐Hib pentavalent vaccine and Trivalent Oral Polio Vaccine	BRV‐TV at 3 different concentrations, compared to RV5 or placebo
RV5 Iwata 2013‐JPN	3	4 to 10	1/1	No information about use of other vaccines	—
RV5 Kim 2008‐KOR	3	4 to 10	1/1	Infants excluded if they had or were to receive oral poliovirus vaccine at any time during the study or in the 42 days before the first dose; concomitant administration of other licensed vaccines and breastfeeding was not restricted	—
RV5 Lawrence 2012‐CHN	3	4‐10	1/1	Other live vaccines 14 days before or after study vaccine were not allowed	—
RV5 Levin 2017‐AF	3	4‐10	1/1	Enrolment was closed in participating countries when RV1 was added to national vaccine schedules.	—
RV5 Merck[009] 2005‐USA	3	4 to 10	1/1	Infants were excluded if they had or were to receive oral poliovirus vaccine at any time during the study or in the 42 days before the first dose; concomitant administration of other licensed vaccines and breastfeeding was not reported	—
RV5 Mo 2017‐CHN	3	4	2/2	The routine China EPI vaccines (oral poliovirus vaccine and diphtheria, tetanus, and acellular pertussis vaccine) either staggered or concomitantly with RV5 or placebo.	—
RV5 Vesikari 2006a‐FIN	3	4 to 8	3/1	Licensed vaccines could be administered throughout the study, but were not given on the same day as study vaccine; inactivated poliovirus vaccine was exclusively used in Finland at the time of the study	Compares different RV5 components: G1‐4, P1A; G1‐4; and P1A
RV5 Vesikari 2006b‐INT	3	4 to 10	1/1	Administration of other licensed childhood vaccines and breastfeeding were not restricted; for a subset of participants in the USA (U.A. concomitant use cohort), Merck also provided the licensed paediatric vaccines that were administered concomitantly (same day) with RV5 or placebo, which included Comvax, Infanrix, Ipol, and Prevnar	—
RV5 Zaman 2010‐AS	3	4	1/1	All children in the study received the standard EPI vaccines (including oral poliovirus vaccine) starting at 6 weeks of age	—
VAC Bhandari 2006‐IND	1	‐	1/1 (/1)	Infants were vaccinated with DPT, Hep B and OPV separately from rotavirus vaccine	Included an additional vaccine arm for a rotavirus vaccine candidate (I321) that was not included for anaysis in this review
VAC Bhandari 2009‐IND	3	4	2/2	Infants received 3 doses of DTP; OPV; and Hep B at 6, 10, and 14 weeks of age; Rotavac was administered at 8, 12, and 16 weeks of age	Randomized participants to high‐ (1 x 105 ffu) and low‐dose (1 x 104 ffu) vaccine arms which were combined in this review
VAC Bhandari 2014‐IND	3	4	1/1	Other childhood vaccines (DTPw, Hib, Hep B, and OPV) given concurrently	—
VAC Chandola 2017‐IND	3	4‐8	3/1	Co‐administered with EPI vaccines: OPV and combined DPT, HepB and Hib	Randomized participants to 3 vaccine production lots as well as to placebo; we combined the different production lot arms in our analyses