GSK Medicine: Study No.: Title: Rationale: Study Period Objectives: Indication: Study Investigators/Centers: Research Methods: Data Source:
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1 The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product. Before prescribing any product mentioned in this Register, healthcare professionals should consult prescribing information for the product approved in their country. GSK Medicine: Rotarix TM (HRV): GlaxoSmithKline (GSK) Biologicals oral live attenuated human rotavirus (HRV) vaccine. Study No.: (EPI-ROTA ) Title: Case-control study to evaluate the vaccine effectiveness of Rotarix TM against rotavirus severe gastroenteritis (RV SGE) among hospitalized children born after 6 March 2006 and at least 12 weeks of age, in Belem, Brazil. Rationale: To evaluate the vaccine effectiveness (VE) of HRV full series (2 doses) vaccination in preventing rotavirus (RV) severe gastroenteritis (SGE) hospitalizations among infants in Brazil. The study was conducted in 2 parts: a Case-Control Part (for a period of 12 months from the date of study initiation) and a RV Strain Surveillance Part (for a period of 36 months from the date of study initiation), which was conducted for the hospitalized subjects enrolled and for whom stool samples were tested positive for RV. Study Period: 14-May-2008 to 11-May-2011 Objectives: Primary objective To estimate the effectiveness of HRV full series (2 doses) vaccination in preventing RV SGE among children hospitalized at four clinics/hospitals in Belem area, who were born after 6 March 2006 and were at least 12 weeks of age. Secondary objectives To estimate the proportion of SGE among all clinic/hospital admissions in children born after 6 March 2006 and at least 12 weeks of age. To estimate the proportion of all RV SGE admissions in children born after 6 March 2006 and at least 12 weeks of age. To determine the distribution of RV SGE clinics/hospitals admissions by the age of the child and month of year. To determine the RV serotypes causing RV SGE among hospitalized children born after 6 March 2006 and at least 12 weeks of age. To estimate the effectiveness of HRV vaccine in preventing RV SGE hospitalization in children born after 6 March 2006 and at least 12 weeks of age, when used in typical real life situations (i.e. 1 or 2 doses). Indication: Prevention of RV SGE in infants aged at least 12 weeks. Study Investigators/Centers: GSK conducted study, 4 centers in Brazil. Research Methods: Data Source: Parents/guardians interview, review of medical records and vaccination cards, stool sampling Study Design: A hospital-based, multi-centered, matched case-control study. Study Population: Cases: Male or female children born after 6 March 2006 and at least 12 weeks of age, admitted to the study clinics/hospitals for SGE during the study period with onset of SGE 14 days prior to admission, whose stool samples tested positive (by Enzyme-Linked Immunosorbent Assay [ELISA]) for RV at hospital admission or during the first 48 hours of hospitalization. Controls: Children born within 6 weeks (maximum) from the date of birth of the case, admitted for non-gastroenteritis (GE) causes at the same clinic/hospital as the case were included in the study as hospital controls. Children born within 8 weeks from the date of birth of the case, living in the same neighborhood as the case for at least 3 consecutive months without any GE or SGE symptoms were included in the study as neighborhood controls. For all the subjects, written informed consent was obtained from the subjects parents or guardians. Study Exposures, Outcomes: The study groups were as follows: : included subjects hospitalized for SGE and tested positive for RV. Hos-con (Hospitalized controls) Group: included subjects hospitalized for non-ge causes in the same hospital as the case Nei-con (Neighborhood controls) Group: included subjects residing in the same area as the case at least for 3 consecutive months, without any symptoms of GE or SGE Primary outcome:
2 Risk of ELISA-confirmed RV SGE in children fully vaccinated with HRV vaccine (born after 6 March 2006 and at least 12 weeks of age), compared to risk of ELISA-confirmed RV SGE in children (born after 6 March 2006 and at least 12 weeks of age). Secondary outcome(s): Risk of ELISA-confirmed RV SGE in children vaccinated with at least one dose of HRV vaccine (born after 6 March 2006 and at least 12 weeks of age), compared to risk of ELISA-confirmed RV SGE in children (born after 6 March 2006 and at least 12 weeks of age). Occurrence of SGE among children born after 6 March 2006 and at least 12 weeks of age and admitted to study clinics/hospitals for SGE. Occurrence of RV genotypes among children born after 6 March 2006 and at least 12 weeks of age. Data Analysis Methods: The analyses were performed on the Screened cohort, the Total enrolled cohort, the According To Protocol (ATP) cohort, the ATP cohort for and matched neighborhood controls and the ATP cohort for and matched hospital controls: - The Screened cohort included all children born after 6 March 2006 and at least 12 weeks of age who were admitted to the hospital for symptoms of SGE. - The Total enrolled cohort included all children ( and controls) enrolled into the study. - The ATP cohort included all children ( and controls) who were enrolled into the surveillance until the study end, meeting all inclusion/exclusion criteria and complying with the study procedures. - The ATP cohort for and matched neighborhood controls included all valid and their matched neighborhood controls (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol). - The ATP cohort for and matched hospital controls included all valid and their matched hospital controls (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol). Primary objective: The VE (estimated as 1 minus the matched odds ratio multiplied by 100%) of full vaccination series of HRV vaccine in preventing RV SGE associated hospital admissions for against matched neighborhood controls and matched hospital controls was calculated using 95% Confidence Interval (CI) for the Case Control Part. Only who received HRV vaccine at least 14 days before the onset of SGE were considered as vaccinated for analysis purposes. Secondary objectives: The following analyses were performed for the Case-Control Part and/ or the RV Strain surveillance Part : - The proportion of all hospital admissions caused by SGE was calculated, with its 95% confidence interval (CI), as the total number of SGE hospitalizations out of total number of hospitalizations. - The proportion of SGE hospitalizations among children attributable to RV was calculated, with its, as the total number of confirmed RV SGE hospitalizations out of total number of SGE hospitalizations. - The percentage of RVSGE hospitalizations by age groups and RVSGE seasonal distribution by month of a year and by month and age group were tabulated.by - The VE of partial vaccination series was calculated as the VE for the full vaccination series. - The distribution of RV genotypes was also tabulated. Limitations: Not applicable. Study Results: Demographics/Baseline Characteristics Case-Control Part Hos-con Group Nei-con Group Planned, N N (Total enrolled cohort) Females: Males 265: : :190 Mean Age, months (SD) 16.9 (6.98) 18.3 (7.35) 17.5 (7.04) Demographics/Baseline Characteristics Strain Surveillance Part Planned, N* 230 N (Total enrolled cohort) 1078 Females: Males 509:569 Mean Age, months (SD) 18.5 (9.38) *Planned number of for the Case Control part of the study Primary Outcome Measure: Effectiveness of HRV vaccine full series vaccination ( against neighborhood control) (ATP cohort for and matched neighborhood controls) Case-Control Part VE (in %) LL UL Sens. + Sens. -
3 fully HRV vaccine fully HRV vaccine Neicon Group Nei-con Group = 95% confidence interval; LL= lower limit, UL= upper limit Sens. + = and controls with other or unknown Rotavirus vaccination status are assumed respectively and vaccinated Sens. - = and controls with other or unknown Rotavirus vaccination status are assumed respectively vaccinated and Primary Outcome Measure: Effectiveness of HRV vaccine full series vaccination ( against hospital controls) (ATP cohort for and matched hospital controls) Case-Control Part fully HRV vaccine fully HRV vaccine Hoscon Group Hos-con Group VE (in %) LL UL Sens. + Sens = 95% confidence interval; LL= lower limit, UL= upper limit Sens. + = and controls with other or unknown Rotavirus vaccination status are assumed respectively and vaccinated Sens. - = and controls with other or unknown Rotavirus vaccination status are assumed respectively vaccinated and Secondary Outcome Measure: Effectiveness of HRV vaccine partial or full series vaccination ( against neighborhood controls) (ATP cohort for and matched neighborhood controls) Case-Control Part partial or full HRV vaccine partial or full HRV vaccine Nei-con Group Nei-con Group VE (in %) LL UL Sens. + Sens = 95% confidence interval; LL= lower limit, UL= upper limit Sens. + = and controls with other or unknown Rotavirus vaccination status were assumed respectively and vaccinated Sens. - = and controls with other or unknown Rotavirus vaccination status were assumed respectively vaccinated and Secondary Outcome Measure: Effectiveness of HRV vaccine partial or full series vaccination ( against hospital controls) (ATP cohort for and matched hospital controls) Case-Control Part partial or full HRV vaccine partial or full HRV Hos-con Group Hos-con Group VE (in %) LL UL Sens. + Sens = 95% confidence interval; LL= lower limit, UL= upper limit Sens. + = and controls with other or unknown Rotavirus vaccination status were assumed respectively and vaccinated Sens. - = and controls with other or unknown Rotavirus vaccination status were assumed respectively vaccinated and Secondary Outcome Measure: Proportion of hospitalizations attributable to SGE (Screened cohort) Case-Control Part SGE hospitalizations hospitalizations Proportion (in %) LL UL = 95% confidence interval; LL= lower limit, UL= upper limit Secondary Outcome Measure: Proportion of SGE hospitalizations attributable to RV (Screened cohort) Case-Control Part RV SGE hospitalizations SGE hospitalizations Proportion (in %) LL UL
4 = 95% confidence interval; LL= lower limit, UL= upper limit Secondary Outcome Measure: Distribution of RV serotypes (G-type) (ATP Cohort) Case-Control Part N = 538 Characteristics Categories n % LL UL Serotype G G G G G G1 G Untypeable N = number of RV SGE subjects % = n/n x 100 = 95% confidence interval; LL= lower limit, UL= upper limit Secondary Outcome Measure: Distribution of RV genotypes (P-type) (ATP Cohort) Case-Control Part N = 538 Characteristics Categories n % LL UL Genotype P[4] P[6] P[8] P[4] P[6] P[4] P[8] P[6] P[8] P[4] P[6] P[8] Untypeable N = number of RV SGE subjects % = n/n x 100 = 95% confidence interval; LL= lower limit, UL= upper limit Secondary Outcome Measure: Distribution of RV genotypes (G&P-type) (ATP cohort) Case-Control Part N = 538 Characteristics Categories n % LL UL Genotype G1 P[6] G1 P[8] G2 P[4] G2 P[6] G9 P[4] G9 P[6] G9 P[8] G12 P[6] G1-Mixed G2-Mixed G4-Mixed G12-Mixed G2-UNTYP Mixed-P[4] Mixed-P[8] Mixed-Mixed
5 UNTYP-P[6] UNTYP-Mixed UNTYP-UNTYP N = number of RV SGE subjects % = n/n x 100 = 95% confidence interval; LL= lower limit, UL= upper limit Mixed = Mixed sero or geno types Mixed-Mixed = both mixed sero and geno types UNTYP = Untypeable UNTYP-UNTYP = Untypeable of both sero and geno type Secondary Outcome Measure: Seasonal distribution of RV SGE by month and age group (ATP Cohort) Case- Control Part Month and Year Age group (months) SGE tested for RV* MAY Others 1 JUN Others 1 JUL Others 1 AUG Others 4 SEP Others 2 OCT Others 2 NOV DEC Others 3 JAN
6 Others 4 FEB Others 5 MAR Others 2 APR MAY Others 1 *From the SGE logbook Secondary Outcome Measure: Proportion of hospitalizations attributable to SGE (Screened cohort) Strain Surveillance Part SGE hospitalizations (n) hospitalizations (N) Proportion (in %) LL UL % = n/ subjects with available results x 100 LL, UL = 95% Lower and Upper exact confidence limits Secondary Outcome Measure: Proportion of SGE hospitalizations attributable to RV (Screened cohort) Strain Surveillance Part RV SGE hospitalizations (n) SGE hospitalizations (N) Proportion (in %) LL UL % = n/ subjects with available results x 100 = 95% confidence interval; LL= lower limit, UL= upper limit Secondary Outcome Measure: hospitalizations of RV SGE by age groups (ATP cohort) Strain Surveillance Part N = 1078 Age (months) n % N = RV SGE hospitalizations n = subjects in a given category % = n/n*100 Secondary Outcome Measure: Distribution of RV serotypes (G-type) (ATP cohort) Strain Surveillance Part N = 1076 Characteristics Categories n % Serotype G G G
7 G G G UNTYP Others N = number of RV SGE hospitalizations that were serotyped % = n / N x 100 UNTYP = Untypeable Secondary Outcome Measure: Distribution of RV genotypes (P-type) (ATP cohort) Strain Surveillance Part N = 1076 Characteristics Categories n % Genotype P P P P UNTYP Others N = number of RV SGE hospitalizations that were serotyped % = n / N x 100 UNTYP = Untypeable Secondary Outcome Measure: Distribution of RV genotypes (G&P-type) (ATP cohort) Strain Surveillance Part N = 1076 Characteristics Categories n % Genotype G-Mixed P-Mixed G-Mixed P[4] G-Mixed P[6] G-Mixed P[8] G-Mixed UNTYP G12 P-Mixed G12 P[6] G1 P-Mixed G1 P[4] G1 P[6] G1 P[8] G1 UNTYP G2 P-Mixed G2 P[4] G2 P[6] G2 UNTYP G3 P[8] G4 P-Mixed G9 P[4] G9 P[6] G9 P[8] G9 UNTYP UNTYP P-Mixed UNTYP P[6] UNTYP UNTYP N = number of RV SGE hospitalizations that were serotyped % = n / N x 100 UNTYP = Untypeable
8 Note: G-Mixed includes more than one G types and P-Mixed includes more than one P types Secondary Outcome Measure: Seasonal distribution of RV SGE by month of a year (ATP cohort*) Strain Surveillance Part Month & Year of RV+ (n) SGE hospitalizations % of RV+ hospitalization tested for RV (N) MAY JUN JUL AUG SEP OCT NOV DEC JAN FEB MAR APR MAY JUN JUL AUG SEP OCT NOV DEC JAN FEB MAR APR MAY JUN JUL AUG SEP OCT NOV DEC JAN FEB MAR APR MAY *From the SGE logbook % = n/n x 100 Conclusion: The VE of HRV vaccine in preventing RV SGE associated hospital admissions was 75.76% for against matched neighborhood controls and 40.00% for against matched hospital controls. Date Updated: 06-September-2013
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