| Author- Year- Country | Study Design | McHarm Score | Population | Vaccine | Timing | OR, 95% CI, Versus Unvaccinated Group |
|---|---|---|---|---|---|---|
| Armah G. E. et al.,2010146 Ghana, Kenya, Mali | Controlled Clinical Trial | 5 | Sample size: 5,560, Age range: 4 - 12, Conditions: HIV | Rotavirus, RotaTeq, Merck, 2×107infectious units per reassortant rotavirus, Adjuvant: Not Reported, Preservative: Not reported, Delivery: Oral | Dose1: 6 Weeks Dose2: 10 Weeks Dose3: 14 Weeks | Bronchiolitis: OR 1 (0.063-16.002) Bronchopneumonia: OR 1.669 (0.398-6.989) Gastroenteritis: OR 1 (0.51-1.964) One or more serious adverse event: OR 0.933 (0.61-1.425) Other: OR 0.714 (0.226-2.253) Pneumonia: OR 1.302 (0.57-2.974) Respiratory tract infection: OR 0.6 (0.143-2.512) Upper respiratory tract infection: OR 0.5 (0.045-5.518) |
| Block S. L. et al.,2007147 United States, Finland | Controlled Clinical Trial | 5 | Sample size: 1,312, Age range: 6 - 13, Percent female: 47.8% | Rotavirus, RotaTeq, Merck, ©1.1×10 infectious U per dose. Pentavalent (G1–G4, and P[8]) human bovine(WC3) reassortant rotavirus vaccine (PRV), Adjuvant: Not Reported, Preservative: Not reported, Delivery: Oral | Dose1: 0 Days Dose2: 4-10 Weeks Dose3: 8-20 Weeks | Bronchiolitis/bronchitis/bronchospasm: OR 1.162 (0.419-3.224) Decreased appetite: OR 1.015 (0.063-16.269) Dehydration: OR 0.253 (0.028-2.267) Gastroenteritis: OR 0.507 (0.046-5.605) Gastrointestinal system: OR 0.301 (0.083-1.1) Influenza: OR 0.507 (0.046-5.605) Pneumonia: OR 3.056 (0.317-29.453) Respiratory syncytial virus infection: OR 6.778 (0.03-1543.45) Respiratory: OR 1.905 (0.755-4.806) Serious Adverse Event: OR 0.783 (0.438-1.399) |
| Chang C.-C. et al.,2009148 Taiwan | Controlled Clinical Trial | NC | Sample size: 189, Age range: 6 - 12, Percent female: 47.6% | Rotavirus, RotaTeq, Merck, five human-bovine reassortant rotaviruses, each of which contained the WC3 bovine strain backbone with different human viral surface proteins G1, G2, G3, G4 and P[8]. An estimated final concentration of 6.5 × 107 IU to 1.2 × 108 IU was included in a 2 mL dose solution, Adjuvant: Not Reported, Preservative: Not reported, Delivery: Oral | Dose1: 0 Days Dose2: 4-10 Weeks Dose3: 8-20 Weeks | Diarrhea: OR 2.015 (0.972-4.178) Fever, rectal temperature > 38.0°C: OR 0.875 (0.492-1.555) Irritable crying: OR 0.979 (0.06-15.882) Vomiting: OR 1.13 (0.392-3.252) |
| Christie C. D. C. et al.,2010149 Jamaica | Controlled Clinical Trial | 4 | Sample size: 1,804, Mean age: 7.7, Age range: 6 - 12, Percent female: 48.4% | Rotavirus, Routine Vaccines, RotaTeq, Merck, Adjuvant: Not Reported, Preservative: Not reported, Delivery: Oral | Dose1: 0 Days Dose2: 2 Month Dose3: 2 Month | Bronchiolitis: OR 1.081 (0.475-2.463) Convulsions: OR 0.99 (0.139-7.044) Death: OR 0.329 (0.034-3.172) Femur fracture: OR 0.99 (0.062-15.854) Gastroenteritis: OR 0.99 (0.199-4.918) Otitis media: OR 1.322 (0.295-5.922) Urinary Tract Infection: OR 1.389 (0.439-4.393) Viral infections: OR 3.973 (0.443-35.62) |
| Dennehy P. H. et al.,2005150 United States, Canada | Controlled Clinical Trial | 6 | Sample size: 529, Mean age: 8.7, Age range: 5 - 15, Percent female: 51% | Rotavirus, Routine Vaccines, RIX4414, GlaxoSmithKline, Adjuvant: Not Reported, Preservative: Not reported, Delivery: Oral | Dose1: 0 Days Dose2: 2 Month | Bronchiolitis: OR 0.502 (0.1-2.532) Hypovolemia/dehydration: OR 0.507 (0.031-8.187) |
| Goveia M. G. et al.,2007151 11 countries | Controlled Clinical Trial | 8 | Sample size: 2,074, Mean age: NR, Age range: 6 - 12, Conditions: Premature babies | Rotavirus, RotaTeq, Merck, vaccine contained 5live human-bovine reassortant rotaviruses, each consisting of the WC3 bovine strain expressing a viral surface protein corresponding to human rotavirus serotypes G1, G2, G3, G4,or P1A, Adjuvant: Not Reported, Preservative: Not reported, Delivery: Oral | Dose1: 0 Days Dose2: 4-10 Weeks Dose3: 4-10 Weeks | Apneic attack (extreme preemie): OR 1.056 (0.066-16.901) At least one SAE (extreme preemie): OR 0.702 (0.249-1.979) Bronchiolitis (all subjects, most frequent AE): OR 0.7 (0.354-1.383) Bronchiolitis (extreme preemie): OR 1.056 (0.148-7.509) Deaths (total, all subjects): OR 1.056 (0.148-7.509) Death due to SIDS (all subjects): OR 1.056 (0.066-16.901) Pneumonia (extreme preemie): OR 2.113 (0.191-23.345) |
| Grant L. R. et al.,2012152 United States | Controlled Clinical Trial | 5 | Sample size: 1,003, Age range: 6 - 12 | Rotavirus, RotaTeq, Merck, PRV is a live, pentavalent, vaccine that contains human bovine (WC3 strain) reassortant rotaviruses expressing the G1, G2, G3, G4, and P[8] human rotavirus antigens, Adjuvant: Not Reported, Preservative: Not reported, Delivery: Oral | Dose1: 0 Days Dose2: 4-10 Weeks Dose3: 8-20 Weeks | Deaths, (Were outside of 42 day safety window and not associated with vaccine): OR 1.945 (0.176-21.517) Diarrhea, all events: OR 1.208 (0.939-1.555) Diarrhea, vaccine related: OR 1.113 (0.851-1.456) Fever, all events: OR 0.943 (0.736-1.21) Fever, vaccine related: OR 1.047 (0.804-1.364) Vomiting, all events: OR 1.097 (0.788-1.527) Vomiting, vaccine related: OR 1.384 (0.911-2.102) |
| Kawamura N. et al.,2011153 Japan | Controlled Clinical Trial | 4 | Sample size: 764, Mean age: 7.7, Age range: 6 - 14, Percent female: 50% | Rotavirus, Rotarix, GlaxoSmithKline, Each dose (1ml) of the lyophilized RIX4414 vaccine (Rotarix TM) contained at least 10-6.0 median Cell Culture Infective Dose (CCID50) of live attenuated human rotavirus RIX4414 strain, Adjuvant: Not Reported, Preservative: Not reported, Delivery: Oral | Dose1: 0 Days Dose2: 1 Month | # of patients with any AE (31-day post vacc): OR 0.96 (0.71-1.299) Cough/runny nose: OR 1.045 (0.762-1.434) Diarrhea: OR 1.652 (0.866-3.153) Eczema: OR 1.299 (0.82-2.057) Fever: OR 1.421 (0.837-2.414) Irritability: OR 1.128 (0.835-1.523) Loss of appetite: OR 1.397 (0.895-2.179) Upper respiratory tract infection: OR 1.011 (0.61-1.678) Vomiting: OR 1.084 (0.706-1.664) |
| Kerdpanich A. et al.,2010154 Thailand | Controlled Clinical Trial | 9 | Sample size: 400, Age range: 6 - 12 | Rotavirus, Routine Vaccines, Rotarix, GlaxoSmithKline, RIX4414 vaccine contained at least 106.0 cell culture infective dose 50 (CCID50) of the RIX4414 strain. CaCO3 buffer based reconstitution., Adjuvant: Not Reported, Preservative: Not reported, Delivery: Oral | Dose1: 0 Days Dose2: 2 Month | Loss of appetite: OR 0.487 (0.205-1.16) SAE - UTI: OR 0.145 (0.009-2.384) |
| Kim D. S. et al.,2008155 Korea | Controlled Clinical Trial | 3 | Sample size: 178, Age range: 6 - 12, Percent female: 42.7% | Rotavirus, RotaTeq, Merck, PRV contained 5 WC3 reassortant rotaviruses, each consisting of the WC3 bovine strain with viral surface proteins corresponding to human rotavirus serotypes G1, G2, G3, G4, and P1A_8 suspended in a liquid sodium citrate and phosphate buffer at an aggregate viral titer of approximately 6.9 _ 107 to 8.6 _ 107 infectious units per dose., Adjuvant: Not Reported, Preservative: Not reported, Delivery: Oral | Dose1: 0 Days Dose2: 4-10 Weeks Dose3: 8-20 Weeks | One or more serious adverse events: OR 0.44 (0.141-1.373) |
| Kim J. S. et al.,2012156 South Korea | Controlled Clinical Trial | 5 | Sample size: 684, Mean age: 8.8, Percent female: 45.3% | Rotavirus, Routine Vaccines, RIX4414, NR, >=10*6.0 median Cell Culture Infective Dose per ml, Adjuvant: Not Reported, Preservative: Not reported, Delivery: Oral | Dose1: 8 Weeks Dose2: 16 Weeks | Bronchiolitis (total study period): OR 0.409 (0.123-1.356) Bronchiolitis (unsolicited/31d): OR 0.77 (0.327-1.811) Gastroenteritis (total study period): OR 0.427 (0.113-1.61) Patients with unsolicited AE over 31d: OR 0.815 (0.565-1.176) URI (unsolicited/31d): OR 0.861 (0.371-2) gastroenteritis (unsolicited/31d): OR 0.843 (0.467-1.521) nasopharyngitis (unsolicited/31d): OR 0.563 (0.301-1.051) |
| Laserson K. F. et al.,2012157 Kenya | Controlled Clinical Trial | 7 | Sample size: 297, Age range: 0 - 12, Percent female: 51.8%, Conditions: HIV | Rotavirus, RotaTeq, Merck, Adjuvant: Not Reported, Preservative: Not reported, Delivery: Oral | Dose1: 6 Weeks Dose2: 10 Weeks Dose3: 14 Weeks | Gastrointestinal disorders: OR 1.534 (0.968-2.431) General disorders and administration site conditions: OR 0.97 (0.599-1.57) Infections: OR 0.684 (0.332-1.412) Infections Dose 2: OR 0.524 (0.301-0.912)** One of more serious adverse events: OR 0.581 (0.286-1.179) Respiratory, thoracic and mediastinal disorders: OR 337.733 (45.817-2489.554)** |
| Madhi S. A. et al.,2010158 South Africa and Malawi | Controlled Clinical Trial | 3 | Sample size: 4,939, Mean age: 6.4 Percent female: 49.6%, Conditions: HIV | Rotavirus, Routine Vaccines, Rotarix, GlaxoSmithKline, Calcium carbonate buffer, Adjuvant: Not Reported, Preservative: Not reported, Delivery: Oral | Dose1: 6 Weeks Dose2: 10 Weeks Dose3: 14 Weeks | Bronchiolitis: OR 1.027 (0.563-1.871) Bronchopneumonia: OR 0.995 (0.601-1.647) Deaths: OR 0.959 (0.661-1.393) Gastroenteritis: OR 0.779 (0.584-1.039) Overall SAE: OR 0.823 (0.68-0.995)** Pneumonia: OR 0.818 (0.564-1.185) Sepsis: OR 1.234 (0.722-2.11) |
| Narang A. et al.,2009159 India | Controlled Clinical Trial | 5 | Sample size: 363, Mean age: 8.7, Age range: 8 - 10, Percent female: 47.1% | Rotavirus, Routine Vaccines, Rotarix, GlaxoSmithKline, Vaccine contained at least 106.0 median cell culture infectious dose (CCID50) of the vaccine strain per dose. The placebo contained the same constituents as the study vaccine but without the virus component. The lyophilized vaccine and placebo were reconstituted with a diluent containing Calcium Carbonate as a buffer, Adjuvant: Not Reported, Preservative: Not reported, Delivery: Oral | Dose1: 0 Days Dose2: 1 Month | Cough/runny nose: OR 1.515 (0.276-8.315) Cough/runny nose: OR 4.472 (2.02-9.902)** Diarrhea: OR 1 (0.218-4.597) Diarrhea: OR 0.89 (0.366-2.164) Fever: OR 0.675 (0.346-1.319) GE episodes from dose 1 to one month post-dose 2: OR 0.94 (0.433-2.04) Irritability: OR 0.242 (0.031-1.913) Irritability: OR 2.316 (1.135-4.723)** Loss of appetite: OR 1.136 (0.5-2.584) Serious adverse event: OR 1.473 (0.241-8.988) Vomiting: OR 0.093 (0.034-0.256)** |
| Omenaca F. et al.,2012160 France, Portugal, Poland and Spain | Controlled Clinical Trial | 6 | Sample size: 1,009, Mean age: 8.5, Age range: 5 - 14, Percent female: 49%, Conditions: Premature babies | Rotavirus, Rotarix, GlaxoSmithKline, A single dose of RIX4414 vaccine contained at least 106.0 median cell culture infective dose of the live-attenuated RIX4414 human rotavirus strain., Adjuvant: Not Reported, Preservative: Not reported, Delivery: Oral | Dose1: 0 Days Dose2: 30-83 Days | At least 1 unsolicited symptom: OR 0.602 (0.458-0.792)** At least 1 unsolicited symptom (grade 3): OR 0.285 (0.142-0.573)** At least 1 unsolicited symptom (vaccine-related): OR 0.608 (0.401-0.92)** infection - Gastroenteritis: OR 0.744 (0.341-1.625) infection - Upper resp infection: OR 0.649 (0.291-1.448) |
| Phua K. B. et al.,2005161 Singapore | Controlled Clinical Trial | 3 | Sample size: 2,464, Mean age: 13.3, Age range: 11 - 17, Percent female: 50.2% | Rotavirus, Routine Vaccines, Rotarix, GlaxoSmithKline, 10.7 ffu group. To produce RIX4414, the parent 89–12 vaccine strain was further passaged in Vero cells and cloned [18, 20]. The vaccine was a lyophilized preparation supplied in single-dose vials with calcium carbonate buffer for reconstitution. Adjuvant: Not Reported, Preservative: Not reported, Delivery: Oral | Dose1: 0 Days Dose2: 1 Month | Severe Vomiting (Dose 1): OR 1 (0.312-3.203) Severe Vomiting (Dose 2): OR 1 (0.312-3.203) |
| Phua K. B. et al.,2009162 Hong Kong, Singapore, Thailand | Controlled Clinical Trial | 8 | Sample size: 10,708, Mean age: 11.6, Age range: 5 - 20, Percent female: 49.1% | Rotavirus, Routine Vaccines, Rotarix, GlaxoSmithKline, contained at least 106.0 median cell culture infectious dose (CCID50) of the vaccine strain per dose, Adjuvant: Not Reported, Preservative: Not reported, Delivery: Oral | Dose1: 0 Days Dose2: 1-2 Month | Death: OR 0.332 (0.035-3.195) Intussusception (from Dose 1 to age 2): OR 1.996 (0.601-6.632) Withdrawal due to AE: OR 0.581 (0.229-1.477) |
| Phua K. B. et al.,2012163 Singapore, Hong Kong, Taiwan | Controlled Clinical Trial | 1 | Sample size: 8,407, Mean age: 35.3, Age range: 23 - 44, Percent female: 49%, Percent pregnant: Percent Pregnant: 0% | Rotavirus, Routine Vaccines, Rotarix, GlaxoSmithKline, reconstitution of lyophilized vaccine in calcium carbonate buffer to a concentration of at least 10*6.0 cell culture infective dose (CCID50) of live-attenuated virus (median), Adjuvant: Not Reported, Preservative: Not reported, Delivery: Oral | Dose1: 0 Days Dose2: 1-2 Month | Intussusception: OR 1.983 (0.18-21.878) gastroenteritis (failed treatment?): OR 1.487 (0.248-8.905) |
| Rodriguez Z. M. et al.,2007164 United States | Controlled Clinical Trial | 1 | Sample size: 1,358, Mean age: 9.35, Age range: 6 - 13, Percent female: 51.1% | Rotavirus, Routine Vaccines, RotaTeq, Merck, Adjuvant: Not Reported, Preservative: Not reported, Delivery: Oral | Dose1: 0 Days Dose2: 28-70 Days Dose3: 56-140 Days | Cough: OR 1.027 (0.748-1.41) Diarrhea: OR 0.711 (0.535-0.946)** Fever: OR 0.901 (0.728-1.115) Nasal congestion: OR 0.957 (0.699-1.311) Nasopharyngitis: OR 0.891 (0.664-1.197) Otitis media: OR 0.786 (0.561-1.103) Upper respiratory infection: OR 0.827 (0.647-1.056) Vomiting: OR 0.747 (0.528-1.055) |
| Ruiz-Palacios G. M. et al.,2006165 Finland, Argentina, Brazil, Chile, Colombia, the Dominican Republic, Honduras, Mexico,Nicaragua, Panama, Peru, Venezuela | Controlled Clinical Trial | 6 | Sample size: 63,225, Mean age: 8.2, Percent female: 49% | Rotavirus, Routine Vaccines, Rotarix, GlaxoSmithKline, Contained 10.5 median cell-culture infective doses of the RIX4414 vaccine strain. Vaccine was reconstituted with 1.3 ml of liquid calcium carbonate buffer., Adjuvant: Not Reported, Preservative: Not reported, Delivery: Oral | Dose1: 2 Month Dose2: 4 Month | Death: OR 1.298 (0.872-1.932) Definite intussusception, 31 days or less after dose 1: OR 0.498 (0.045-5.493) Definite intussusception, 31 days or less after dose 2: OR 0.996 (0.288-3.441) Definite intussusception, 31 days or less after either dose: OR 0.854 (0.287-2.541) Definite intussusception, between dose 1 and visit 3: OR 0.56 (0.248-1.268) Hospitalization: OR 0.877 (0.8-0.961)** Serious adverse events: OR 0.879 (0.804-0.962)** |
| Sow S. O. et al.,2012166 Vietnam, Bangladesh, Ghana, Kenya, Mali | Controlled Clinical Trial | 5 | Sample size: 1,960, Mean age: NR, Age range: 6 - 14, Percent female: 48.3% | Rotavirus, RotaTeq, Merck, Adjuvant: Not Reported, Preservative: Not reported, Delivery: Oral | Dose1: 6 Weeks Dose2: 10 Weeks Dose3: 14 Weeks | Bronchiolitis: OR 1.002 (0.063-16.044) Deaths: OR 0.6 (0.143-2.518) One or more serious adverse events: OR 0.834 (0.254-2.742) Pneumonia: OR 0.667 (0.111-4.003) |
| Steele A. D. et al.,2010167 South Africa | Controlled Clinical Trial | 4 | Sample size: 475, Mean age: 6.3 | Rotavirus, Rotarix, GlaxoSmithKline, RIX4414 developed from 89-12 parent vaccine strain that was cloned and passaged on Vero cells. Viral concentration of 1 dose contained at least 1×10*6.0 medial cell culture infective dose and lyophilized vaccine was reconstituted with calcium carbonate as buffer, Adjuvant: Not Reported, Preservative: Not reported, Delivery: Oral | Dose1: 10 Weeks Dose2: 14 Weeks | Serious adverse events (any): OR 1.011 (0.336-3.046) |
| Steele A. D. et al.,2011168 South Africa | Controlled Clinical Trial | 5 | Sample size: 100, Mean age: 7, Age range: 6 - 10, Percent female: 53%, Conditions: HIV | Rotavirus, Rotarix, GlaxoSmithKline, Each dose of the vaccine contained at least 106.0 median cell culture infective dose (CCID 50) of the active virus strain. Adjuvant: Not Reported, Preservative: Not reported, Delivery: Oral | Dose1: 0 Days Dose2: 1 Month Dose3: 1 Month | At least 1 Grade 3 unsolicited symptom w/in 31 d): OR 1 (0.425-2.352) Bronchopneumonia: OR 1.872 (0.512-6.848) Bronchopneumonia - Grade 3: OR 1 (0.236-4.242) Cough: OR 1.43 (0.622-3.286) Fatality: OR 0.621 (0.203-1.899) GE: OR 2.136 (0.503-9.068) GE - Grade 3: OR 2.087 (0.365-11.949) Irritability: OR 1.17 (0.39-3.515) Oral candidiasis - Grade 3: OR 2.087 (0.365-11.949) |
| Tregnaghi M. W. et al.,2011169 Argentina, Brazil, Colombia, Dominican Republic, Honduras, and Panama | Controlled Clinical Trial | 4 | Sample size: 6,568, Mean age: 8.6, Age range: 6 - 12 | Rotavirus, Rotarix, GlaxoSmithKline, Contained at least 106.0 median Cell Culture Infective Dose (CCID50) of live attenuated human rotavirus RIX4414 strain. The lyophilized vaccine was reconstituted with the supplied buffer before oral administration., Adjuvant: Not Reported, Preservative: Not reported, Delivery: Oral | Dose1: 0 Days Dose2: 1-2 Month | Bronchiolitis: OR 1.178 (0.874-1.588) Intussusception: OR 1 (0.183-5.464) Death: OR 2.503 (0.548-11.436) Gastroenteritis: OR 0.727 (0.529-1)** Pneumonia: OR 1 (0.699-1.43) |
| Vesikari T. et al.,2004170 Finland | Controlled Clinical Trial | 5 | Sample size: 405, Mean age: 8.3, Age range: 6 - 12 | Rotavirus, Rotarix, GlaxoSmithKline, The vaccine was a lyophilized product; it was reconstituted with a diluent containing calcium carbonate as buffer. Each reconstituted vaccine dose contained 104.7 focus forming units of the RIX4414 strain rotavirus vaccine, Adjuvant: Not Reported, Preservative: Not reported, Delivery: Not reported | Dose1: 2 Month Dose2: 4 Month | Diarrhea, Dose 1: OR 1.652 (0.685-3.984) Diarrhea: OR 2.042 (0.538-7.745) Fever greater than or equal to 38.0°C, Dose 2: OR 1.11 (0.694-1.773) Fever greater than or equal to 38.0°C, Dose 1: OR 1.103 (0.578-2.105) Irritability, Dose 1: OR 1.088 (0.715-1.654) Irritability: OR 1.276 (0.845-1.928) Loss of appetite, Dose 1: OR 1.542 (0.914-2.602) Vomiting, Dose 1: OR 1.879 (0.788-4.48) Vomiting: OR 0.645 (0.299-1.393) |
| Vesikari T. et al.,2006171 Finland | Controlled Clinical Trial | 5 | Sample size: 1,946, Age range: 2 - 8 | Rotavirus, NR, Low-potency pentavalent RotaTeq G1, G2, G3, G4, P1A 2.41×106., Adjuvant: Not Reported, Preservative: Not reported, Delivery: Oral | Dose1: 0 Days Dose2: 4-8 Weeks Dose3: 8-16 Weeks | Post-vaccination fever greater than or equal to 38.1 C rectally after dose 1: OR 1.479 (0.982-2.229) Post-vaccination fever greater than or equal to 38.1 C rectally after dose 2: OR 1.171 (0.788-1.74) Post-vaccination fever greater than or equal to 38.1 C rectally after dose 3: OR 1.286 (0.873-1.894) |
| Vesikari T. et al.,2006172 11 countries | Controlled Clinical Trial | 8 | Sample size: 69,274, Mean age: 9.8, Age range: 6 - 12, Percent female: 49.3% | Rotavirus, RotaTeq, Merck, Pentavalent, Adjuvant: Not Reported, Preservative: Not reported, Delivery: Oral | Dose1: 0 Days Dose2: 4-10 Weeks Dose3: 4-10 Weeks | Not calculable |
| Vesikari T. et al.,2011173 Finland | Controlled Clinical Trial | 3 | Sample size: 250, Mean age: 9.1, Age range: 6 - 12, Percent female: 50% | Rotavirus, Rotarix, GlaxoSmithKline, RIX4414 oral suspension (liquid formulation). Contained at least 10-6median cell culture infective dose (CCID50) of live attenuated RIX4414 human rotavirus strain. The liquid formulation of RIX4414 contained sucrose as excipient and the content of sucrose in the liquid formulation is higher than one in the lyophilized formulation., Adjuvant: Not Reported, Preservative: Not reported, Delivery: Oral | Dose1: 0 Days Dose2: 1 Month | Cough/runny nose: OR 0.959 (0.477-1.927) Diarrhea: OR 0.49 (0.066-3.639) Fever: OR 1.652 (0.381-7.173) Irritability: OR 1.199 (0.582-2.47) Loss of appetite: OR 0.778 (0.334-1.814) Vomiting: OR 1.098 (0.404-2.984) |
| Vesikari T. et al.,2004174 Belgium, Germany | Controlled Clinical Trial | 5 | Sample size: 59, Age range: 1 - 44 | Rotavirus, Rotarix, GlaxoSmithKline, Derived from the parent strain 89-12 single dose of a minimum of 10(6.1) focus forming unit (ffu) of RIX4414 or placebo, with prior administration of Mylanta® as buffer, Adjuvant: Not Reported, Preservative: Not reported, Delivery: Oral | Dose1: 0 Days | Not calculable |
| Zaman K. et al.,2009175 Bangladesh | Controlled Clinical Trial | 7 | Sample size: 294, Mean age: 6.1, Age range: 6 - 7, Percent female: 53.4% | Rotavirus, Routine Vaccines, Rotarix, GlaxoSmithKline, 10.5 median cell culture infective dose of the G1P strain., Adjuvant: Not Reported, Preservative: Not reported, Delivery: Oral | Dose1: 6 Weeks Dose2: 10 Weeks Dose3: 14 Weeks | fever: rectal temperature =38 ?C: OR 0.3 (0.134-0.675)** Any diarrhea: =6/day: OR 0.66 (0.074-5.862) Gastroenteritis: OR 0.49 (0.03-8.001) Loss of appetite: OR 1.138 (0.553-2.341) Unsolicited symptoms: OR 0.603 (0.272-1.336) Vomiting: =1 episode of forceful emptying of partially digested stomach contents =1 h after feeding within a day: OR 1.377 (0.564-3.364) |
| Zaman K. et al.,2010176 Bangladesh and Vietnam | Controlled Clinical Trial | 8 | Sample size: 2,035, Mean age: 8.9, Age range: 5.9 - 25.9, Percent female: 47% | Rotavirus, RotaTeq, Merck, Pentavalent rotavirus vaccine containing 5 human-bovine reassortant rotaviruses with the WC3 bovine strain as backbone and viral surface proteins corresponding to human rotavirus serotypes G1, G2 G3, G4, P1A[8], Adjuvant: Not Reported, Preservative: Not reported, Delivery: Oral | Dose1: 6 Weeks Dose2: 10 Weeks Dose3: 14 Weeks | Death: OR 0.75 (0.167-3.36) |
| Zaman K. et al.,2012177 Bangladesh | Controlled Clinical Trial | 5 | Sample size: 1,136, Mean age: 8.2, Percent female: 48.6% | Rotavirus, Routine Vaccines, RotaTeq, GlaxoSmithKline, Adjuvant: Not Reported, Preservative: Not reported, Delivery: Oral | Dose1: 6 Weeks Dose2: 10 Weeks Dose3: 14 Weeks | Accidental drowning: OR 1 (0.062-16.027) Acute diarrhea: OR 1 (0.062-16.027) All Serious Adverse Events: OR 0.939 (0.47-1.878) Death, All causes: OR 3.011 (0.312-29.031) Pneumonia: OR 0.728 (0.331-1.599) |
| Sow, S.O. et al. 2012178 Sub-Saharan Africa (Ghana, Kenya and Mali) | Controlled Clinical Trial | 2 | Sample size: 1960, Mean age: 48, Age range: 0 - 14, Percent female: 48% | Rotavirus, RotaTeqTM , Merck, Not reported , Adjuvant: Not Reported, Preservative: Not reported, Delivery: Oral | Dose1: 6 Weeks Dose2: 10 Weeks Dose3: 14 Weeks | Bronchiolitis: OR 1.002 (0.063-16.044) Pneumonia: OR 0.667 (0.111-4.003) Total deaths: OR 0.6 (0.143-2.518) |
| Lau, Y.L. et al. 2013179 China | Controlled Clinical Trial | 1 | Sample size: 3025, Mean age: 11.6, Age range: 6 - 12, Percent female: Not reported% | Rotavirus, RotarixTM , GlaxoSmithKline , Each dose of the lyophilized formulation of RIX4414 (RotarixTM, GlaxoSmithKline, Belgium) vaccine contained at least 106.0 median cell culture infectious dose (CCID50) of live, attenuated human G1P rotavirus. The RIX4414 vaccine was reconstituted in a calcium carbonate buffer before oral administration. , Adjuvant: Not Reported, Preservative: Not reported, Delivery: Oral | Dose1: 2 Month Dose2: 4 Month | Gastroenteritis-related symptoms requiring <=1 hospitalization: OR 0.793 (0.616-1.021) Intussusception: OR 2.001 (0.366-10.943) |
| Zaman, K. et al. 2012180 Bangladesh | Controlled Clinical Trial | 2 | Sample size: 1136, Mean age: NR, Age range: 4 - 12 | Rotavirus, RotaTeq, Merck, Adjuvant: Not Reported, Preservative: Not reported, Delivery: Oral | Dose1: 0 Days Dose2: 4 Weeks Dose3: 4 Weeks | Acute diarrhea: OR 1 (0.062-16.027) Death: OR 1 (0.201-4.976) Pneumonia: OR 0.728 (0.331-1.599) |
AE = adverse event; CCID = cell culture infective dose; CI = confidence interval; FFU = focus forming unit; H = Hour; HIV = human immunodeficiency virus; IU = international unit; OR = odds ratio; PRV = pentavalent rotavirus vaccine; SAE = serious adverse events
Note: Additional study details presented in Appendix C evidence tables.
From: Results
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