Trial Outcomes & Findings for Safety Study of GSK Biologicals' Rotavirus Vaccine (Rotarix®) Administered to Children Aged <1 Year in the United States (NCT NCT00875641)

Results Overview

Incidence rates were calculated following the first 2 doses of study vaccine as the number of events divided by the sum of the person-time in that risk period. Person-time was defined as the number of days at risk for the study outcomes. Person-time was calculated in months by dividing the number of person-days by (365.25/12).

Recruitment status

COMPLETED

Target enrollment

390659 participants

Primary outcome timeframe

60 days following each vaccination

Results posted on

2019-01-25

Participant Flow

Subjects were identified through the automated corresponding health insurance plan databases, OptumInsight Life Sciences Research Database (from United Healthcare) and the HealthCore Integrated Research Database (HIRDSM) (part of Anthem, formerly known as WellPoint).

Participant milestones

Participant milestones
Measure	HRV Cohort HRV (Human Rotavirus) cohort consisted of infants aged less than 1 year, enrolled in the participating health insurance plans within 30 days of birth and who received at least one dose of Rotarix vaccination as part of their normal health care (with no previous dose of RotaTeq prior to or concurrent with the first Rotarix vaccination).	Concurrent Control Cohort Concurrent control cohort consisted of infants aged less than 1 year, enrolled in the participating health insurance plans, who were contemporaneous with the Rotarix vaccinees and who received at least one dose of IPV (Inactivated Poliovirus vaccine) with or without RotaTeq vaccination (with no previous dose of Rotarix prior to or concurrent with the first IPV vaccination).	Recent Historical Control Cohort Recent historical control cohort consisted of infants aged less than 1 year of age, enrolled in participating health insurance plans, vaccinated with at least one dose of IPV (Inactivated Poliovirus vaccine) between 1 January 2004 (OptumInsight) or 1 January 2006 (HealthCore) and 31 July 2008 and who did not receive any dose of rotavirus vaccination during the study period.
Overall Study STARTED	57931	173384	159344
Overall Study COMPLETED	57931	173384	159344
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety Study of GSK Biologicals' Rotavirus Vaccine (Rotarix®) Administered to Children Aged <1 Year in the United States

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HRV Cohort n=57931 Participants HRV (Human Rotavirus) cohort consisted of infants aged less than 1 year, enrolled in the participating health insurance plans within 30 days of birth and who received at least one dose of Rotarix vaccination as part of their normal health care (with no previous dose of RotaTeq prior to or concurrent with the first Rotarix vaccination).	Concurrent Control Cohort n=173384 Participants Concurrent control cohort consisted of infants aged less than 1 year, enrolled in the participating health insurance plans, who were contemporaneous with the Rotarix vaccinees and who received at least one dose of IPV (Inactivated Poliovirus vaccine) with or without RotaTeq vaccination (with no previous dose of Rotarix prior to or concurrent with the first IPV vaccination).	Recent Historical Control Cohort n=159344 Participants Recent historical control cohort consisted of infants aged less than 1 year of age, enrolled in participating health insurance plans, vaccinated with at least one dose of IPV (Inactivated Poliovirus vaccine) between 1 January 2004 (OptumInsight) or 1 January 2006 (HealthCore) and 31 July 2008 and who did not receive any dose of rotavirus vaccination during the study period.	Total n=390659 Participants Total of all reporting groups
Age, Continuous	2.0 Months STANDARD_DEVIATION 0.7 • n=5 Participants	2.0 Months STANDARD_DEVIATION 0.7 • n=7 Participants	2.0 Months STANDARD_DEVIATION 0.7 • n=5 Participants	2.0 Months STANDARD_DEVIATION 0.7 • n=4 Participants
Sex: Female, Male Female	27929 Participants n=5 Participants	83528 Participants n=7 Participants	77128 Participants n=5 Participants	188585 Participants n=4 Participants
Sex: Female, Male Male	30002 Participants n=5 Participants	89856 Participants n=7 Participants	82216 Participants n=5 Participants	202074 Participants n=4 Participants
Race/Ethnicity, Customized US Geographic Region · Northeast	8461 Participants n=5 Participants	18093 Participants n=7 Participants	22171 Participants n=5 Participants	48725 Participants n=4 Participants
Race/Ethnicity, Customized US Geographic Region · South/Southeast	19875 Participants n=5 Participants	59167 Participants n=7 Participants	61965 Participants n=5 Participants	141007 Participants n=4 Participants
Race/Ethnicity, Customized US Geographic Region · Midwest	17101 Participants n=5 Participants	51046 Participants n=7 Participants	41114 Participants n=5 Participants	109261 Participants n=4 Participants
Race/Ethnicity, Customized US Geographic Region · West	12494 Participants n=5 Participants	45078 Participants n=7 Participants	34094 Participants n=5 Participants	91666 Participants n=4 Participants

PRIMARY outcome

Timeframe: 60 days following each vaccination

Population: Analysis was performed on study population comprising of birth cohorts affiliated with 2 participating health insurance plans, United Healthcare \& WellPoint, which were eligible for rotavirus vaccination according to routine recommendations. Within this population of infants, HRV, Concurrent Control \& Recent Historical Control cohorts were defined.

Incidence rates were calculated following the first 2 doses of study vaccine as the number of events divided by the sum of the person-time in that risk period. Person-time was defined as the number of days at risk for the study outcomes. Person-time was calculated in months by dividing the number of person-days by (365.25/12).

Outcome measures

Outcome measures
Measure	HRV Cohort n=57931 Participants HRV (Human Rotavirus) cohort consisted of infants aged less than 1 year, enrolled in the participating health insurance plans within 30 days of birth and who received at least one dose of Rotarix vaccination as part of their normal health care (with no previous dose of RotaTeq prior to or concurrent with the first Rotarix vaccination).	Concurrent Control Cohort n=173384 Participants Concurrent control cohort consisted of infants aged less than 1 year, enrolled in the participating health insurance plans, who were contemporaneous with the Rotarix vaccinees and who received at least one dose of IPV (Inactivated Poliovirus vaccine) with or without RotaTeq vaccination (with no previous dose of Rotarix prior to or concurrent with the first IPV vaccination).	Recent Historical Control Cohort n=159344 Participants Recent historical control cohort consisted of infants aged less than 1 year of age, enrolled in participating health insurance plans, vaccinated with at least one dose of IPV (Inactivated Poliovirus vaccine) between 1 January 2004 (OptumInsight) or 1 January 2006 (HealthCore) and 31 July 2008 and who did not receive any dose of rotavirus vaccination during the study period.
Incidence Rates of Intussusceptions (IS) Among the HRV Cohort and Comparator Cohorts 0-59 days, Any Dose	0.021 Incidences/Person-Month Interval 0.006 to 0.055	0.022 Incidences/Person-Month Interval 0.012 to 0.037	0.021 Incidences/Person-Month Interval 0.01 to 0.037
Incidence Rates of Intussusceptions (IS) Among the HRV Cohort and Comparator Cohorts 0-59 days, Dose 1	0.028 Incidences/Person-Month Interval 0.006 to 0.082	0.012 Incidences/Person-Month Interval 0.003 to 0.032	0.017 Incidences/Person-Month Interval 0.006 to 0.04
Incidence Rates of Intussusceptions (IS) Among the HRV Cohort and Comparator Cohorts 0-59 days, Dose 2	0.013 Incidences/Person-Month Interval 0.0 to 0.07	0.032 Incidences/Person-Month Interval 0.015 to 0.061	0.025 Incidences/Person-Month Interval 0.009 to 0.054

PRIMARY outcome

Timeframe: 7 days following each vaccination

Population: Analysis was performed on study population comprising of birth cohorts affiliated with 2 participating health insurance plans, United Healthcare \& WellPoint, which were eligible for rotavirus vaccination according to routine recommendations. Within this population of infants, HRV, Concurrent Control \& Recent Historical Control cohorts were defined.

Incidence rates were calculated following the first 2 doses of study vaccine as the number of events divided by the sum of the person-time in that risk period. Person-time was defined as the number of days at risk for the study outcomes. Person-time was calculated in months by dividing the number of person-days by (365.25/12).

Outcome measures

Outcome measures
Measure	HRV Cohort n=57931 Participants HRV (Human Rotavirus) cohort consisted of infants aged less than 1 year, enrolled in the participating health insurance plans within 30 days of birth and who received at least one dose of Rotarix vaccination as part of their normal health care (with no previous dose of RotaTeq prior to or concurrent with the first Rotarix vaccination).	Concurrent Control Cohort n=173384 Participants Concurrent control cohort consisted of infants aged less than 1 year, enrolled in the participating health insurance plans, who were contemporaneous with the Rotarix vaccinees and who received at least one dose of IPV (Inactivated Poliovirus vaccine) with or without RotaTeq vaccination (with no previous dose of Rotarix prior to or concurrent with the first IPV vaccination).	Recent Historical Control Cohort n=159344 Participants Recent historical control cohort consisted of infants aged less than 1 year of age, enrolled in participating health insurance plans, vaccinated with at least one dose of IPV (Inactivated Poliovirus vaccine) between 1 January 2004 (OptumInsight) or 1 January 2006 (HealthCore) and 31 July 2008 and who did not receive any dose of rotavirus vaccination during the study period.
Incidence Rates of IS Among the HRV Cohort and Comparator Cohorts 0-6 days, Any Dose	0.000 Incidences/Person-Month Interval 0.0 to 0.161	0.014 Incidences/Person-Month Interval 0.0 to 0.075	0.000 Incidences/Person-Month Interval 0.0 to 0.056
Incidence Rates of IS Among the HRV Cohort and Comparator Cohorts 0-6 days, Dose 1	0.000 Incidences/Person-Month Interval 0.0 to 0.278	0.000 Incidences/Person-Month Interval 0.0 to 0.093	0.000 Incidences/Person-Month Interval 0.0 to 0.101
Incidence Rates of IS Among the HRV Cohort and Comparator Cohorts 0-6 days, Dose 2	0.000 Incidences/Person-Month Interval 0.0 to 0.383	0.029 Incidences/Person-Month Interval 0.001 to 0.162	0.000 Incidences/Person-Month Interval 0.0 to 0.124

PRIMARY outcome

Timeframe: 30 days following each vaccination

Population: Analysis was performed on study population comprising of birth cohorts affiliated with 2 participating health insurance plans, United Healthcare \& WellPoint, which were eligible for rotavirus vaccination according to routine recommendations. Within this population of infants, HRV, Concurrent Control \& Recent Historical Control cohorts were defined.

Incidence rates were calculated following the first 2 doses of study vaccine as the number of events divided by the sum of the person-time in that risk period. Person-time was defined as the number of days at risk for the study outcomes. Person-time was calculated in months by dividing the number of person-days by (365.25/12).

Outcome measures

Outcome measures
Measure	HRV Cohort n=57931 Participants HRV (Human Rotavirus) cohort consisted of infants aged less than 1 year, enrolled in the participating health insurance plans within 30 days of birth and who received at least one dose of Rotarix vaccination as part of their normal health care (with no previous dose of RotaTeq prior to or concurrent with the first Rotarix vaccination).	Concurrent Control Cohort n=173384 Participants Concurrent control cohort consisted of infants aged less than 1 year, enrolled in the participating health insurance plans, who were contemporaneous with the Rotarix vaccinees and who received at least one dose of IPV (Inactivated Poliovirus vaccine) with or without RotaTeq vaccination (with no previous dose of Rotarix prior to or concurrent with the first IPV vaccination).	Recent Historical Control Cohort n=159344 Participants Recent historical control cohort consisted of infants aged less than 1 year of age, enrolled in participating health insurance plans, vaccinated with at least one dose of IPV (Inactivated Poliovirus vaccine) between 1 January 2004 (OptumInsight) or 1 January 2006 (HealthCore) and 31 July 2008 and who did not receive any dose of rotavirus vaccination during the study period.
Incidence Rates of IS Among the HRV Cohort and Comparator Cohorts 0-29 days, Any Dose	0.010 Incidences/Person-Month Interval 0.0 to 0.058	0.026 Incidences/Person-Month Interval 0.011 to 0.05	0.022 Incidences/Person-Month Interval 0.008 to 0.047
Incidence Rates of IS Among the HRV Cohort and Comparator Cohorts 0-29 days, Dose 1	0.000 Incidences/Person-Month Interval 0.0 to 0.066	0.006 Incidences/Person-Month Interval 0.0 to 0.033	0.020 Incidences/Person-Month Interval 0.004 to 0.057
Incidence Rates of IS Among the HRV Cohort and Comparator Cohorts 0-29 days, Dose 2	0.025 Incidences/Person-Month Interval 0.001 to 0.137	0.048 Incidences/Person-Month Interval 0.019 to 0.099	0.024 Incidences/Person-Month Interval 0.005 to 0.07

SECONDARY outcome

Timeframe: 60 days following each vaccination

Population: Analysis was performed on study population comprising of birth cohorts affiliated with 2 participating health insurance plans, United Healthcare \& WellPoint, which were eligible for rotavirus vaccination according to routine recommendations. Within this population of infants, HRV, Concurrent Control \& Recent Historical Control cohorts were defined.

Incidence rates were calculated following the first 2 doses of study vaccine as the number of events divided by the sum of the person-time in that risk period. Person-time was defined as the number of days at risk for the study outcomes. Person-time was calculated in months by dividing the number of person-days by (365.25/12).

Outcome measures

Outcome measures
Measure	HRV Cohort n=57931 Participants HRV (Human Rotavirus) cohort consisted of infants aged less than 1 year, enrolled in the participating health insurance plans within 30 days of birth and who received at least one dose of Rotarix vaccination as part of their normal health care (with no previous dose of RotaTeq prior to or concurrent with the first Rotarix vaccination).	Concurrent Control Cohort n=173384 Participants Concurrent control cohort consisted of infants aged less than 1 year, enrolled in the participating health insurance plans, who were contemporaneous with the Rotarix vaccinees and who received at least one dose of IPV (Inactivated Poliovirus vaccine) with or without RotaTeq vaccination (with no previous dose of Rotarix prior to or concurrent with the first IPV vaccination).	Recent Historical Control Cohort n=159344 Participants Recent historical control cohort consisted of infants aged less than 1 year of age, enrolled in participating health insurance plans, vaccinated with at least one dose of IPV (Inactivated Poliovirus vaccine) between 1 January 2004 (OptumInsight) or 1 January 2006 (HealthCore) and 31 July 2008 and who did not receive any dose of rotavirus vaccination during the study period.
Incidence Rates of Kawasaki Disease Among the HRV Cohort and Comparator Cohorts 0-59 days, Any Dose	0.000 Incidences/Person-Month Interval 0.0 to 0.02	0.008 Incidences/Person-Month Interval 0.003 to 0.019	0.009 Incidences/Person-Month Interval 0.003 to 0.022
Incidence Rates of Kawasaki Disease Among the HRV Cohort and Comparator Cohorts 0-59 days, Dose 1	0.000 Incidences/Person-Month Interval 0.0 to 0.034	0.006 Incidences/Person-Month Interval 0.001 to 0.023	0.014 Incidences/Person-Month Interval 0.004 to 0.035
Incidence Rates of Kawasaki Disease Among the HRV Cohort and Comparator Cohorts 0-59 days, Dose 2	0.000 Incidences/Person-Month Interval 0.0 to 0.046	0.011 Incidences/Person-Month Interval 0.002 to 0.031	0.004 Incidences/Person-Month Interval 0.0 to 0.023

SECONDARY outcome

Timeframe: 60 days following each vaccination

Population: Analysis was performed on study population comprising of birth cohorts affiliated with 2 participating health insurance plans, United Healthcare \& WellPoint, which were eligible for rotavirus vaccination according to routine recommendations. Within this population of infants, HRV, Concurrent Control \& Recent Historical Control cohorts were defined.

Incidence rates were calculated following the first 2 doses of study vaccine as the number of events divided by the sum of the person-time in that risk period. Person-time was defined as the number of days at risk for the study outcomes. Person-time was calculated in months by dividing the number of person-days by (365.25/12).

Outcome measures

Outcome measures
Measure	HRV Cohort n=57931 Participants HRV (Human Rotavirus) cohort consisted of infants aged less than 1 year, enrolled in the participating health insurance plans within 30 days of birth and who received at least one dose of Rotarix vaccination as part of their normal health care (with no previous dose of RotaTeq prior to or concurrent with the first Rotarix vaccination).	Concurrent Control Cohort n=173384 Participants Concurrent control cohort consisted of infants aged less than 1 year, enrolled in the participating health insurance plans, who were contemporaneous with the Rotarix vaccinees and who received at least one dose of IPV (Inactivated Poliovirus vaccine) with or without RotaTeq vaccination (with no previous dose of Rotarix prior to or concurrent with the first IPV vaccination).	Recent Historical Control Cohort n=159344 Participants Recent historical control cohort consisted of infants aged less than 1 year of age, enrolled in participating health insurance plans, vaccinated with at least one dose of IPV (Inactivated Poliovirus vaccine) between 1 January 2004 (OptumInsight) or 1 January 2006 (HealthCore) and 31 July 2008 and who did not receive any dose of rotavirus vaccination during the study period.
Incidence Rates of Convulsions Among the HRV Cohort and Comparator Cohorts 0-59 days, Any Dose	0.230 Incidences/Person-Month Interval 0.166 to 0.31	0.142 Incidences/Person-Month Interval 0.113 to 0.175	0.146 Incidences/Person-Month Interval 0.116 to 0.183
Incidence Rates of Convulsions Among the HRV Cohort and Comparator Cohorts 0-59 days, Dose 1	0.252 Incidences/Person-Month Interval 0.166 to 0.366	0.121 Incidences/Person-Month Interval 0.086 to 0.166	0.124 Incidences/Person-Month Interval 0.087 to 0.171
Incidence Rates of Convulsions Among the HRV Cohort and Comparator Cohorts 0-59 days, Dose 2	0.200 Incidences/Person-Month Interval 0.115 to 0.326	0.165 Incidences/Person-Month Interval 0.121 to 0.22	0.174 Incidences/Person-Month Interval 0.125 to 0.235

SECONDARY outcome

Timeframe: 60 days following each vaccination

Population: Analysis was performed on study population comprising of birth cohorts affiliated with 2 participating health insurance plans, United Healthcare \& WellPoint, which were eligible for rotavirus vaccination according to routine recommendations. Within this population of infants, HRV, Concurrent Control \& Recent Historical Control cohorts were defined.

Incidence rates were calculated following the first 2 doses of study vaccine as the number of events divided by the sum of the person-time in that risk period. Person-time was defined as the number of days at risk for the study outcomes. Person-time was calculated in months by dividing the number of person-days by (365.25/12).

Outcome measures

Outcome measures
Measure	HRV Cohort n=57931 Participants HRV (Human Rotavirus) cohort consisted of infants aged less than 1 year, enrolled in the participating health insurance plans within 30 days of birth and who received at least one dose of Rotarix vaccination as part of their normal health care (with no previous dose of RotaTeq prior to or concurrent with the first Rotarix vaccination).	Concurrent Control Cohort n=173384 Participants Concurrent control cohort consisted of infants aged less than 1 year, enrolled in the participating health insurance plans, who were contemporaneous with the Rotarix vaccinees and who received at least one dose of IPV (Inactivated Poliovirus vaccine) with or without RotaTeq vaccination (with no previous dose of Rotarix prior to or concurrent with the first IPV vaccination).	Recent Historical Control Cohort n=159344 Participants Recent historical control cohort consisted of infants aged less than 1 year of age, enrolled in participating health insurance plans, vaccinated with at least one dose of IPV (Inactivated Poliovirus vaccine) between 1 January 2004 (OptumInsight) or 1 January 2006 (HealthCore) and 31 July 2008 and who did not receive any dose of rotavirus vaccination during the study period.
Incidence Rates of Acute Lower Respiratory Tract Infection (LRTI) Hospitalisation Among the HRV Cohort and Comparator Cohorts 0-59 days, Any Dose	1.518 Incidences/Person-Month Interval 1.346 to 1.705	1.320 Incidences/Person-Month Interval 1.23 to 1.415	1.669 Incidences/Person-Month Interval 1.561 to 1.782
Incidence Rates of Acute Lower Respiratory Tract Infection (LRTI) Hospitalisation Among the HRV Cohort and Comparator Cohorts 0-59 days, Dose 1	1.696 Incidences/Person-Month Interval 1.459 to 1.962	1.529 Incidences/Person-Month Interval 1.397 to 1.671	2.008 Incidences/Person-Month Interval 1.848 to 2.177
Incidence Rates of Acute Lower Respiratory Tract Infection (LRTI) Hospitalisation Among the HRV Cohort and Comparator Cohorts 0-59 days, Dose 2	1.278 Incidences/Person-Month Interval 1.042 to 1.551	1.079 Incidences/Person-Month Interval 0.961 to 1.208	1.260 Incidences/Person-Month Interval 1.123 to 1.41

SECONDARY outcome

Timeframe: 7 days following each vaccination

Population: Analysis was performed on study population comprising of birth cohorts affiliated with 2 participating health insurance plans, United Healthcare \& WellPoint, which were eligible for rotavirus vaccination according to routine recommendations. Within this population of infants, HRV, Concurrent Control \& Recent Historical Control cohorts were defined.

Incidence rates were calculated following the first 2 doses of study vaccine as the number of events divided by the sum of the person-time in that risk period. Person-time was defined as the number of days at risk for the study outcomes. Person-time was calculated in months by dividing the number of person-days by (365.25/12).

Outcome measures

Outcome measures
Measure	HRV Cohort n=57931 Participants HRV (Human Rotavirus) cohort consisted of infants aged less than 1 year, enrolled in the participating health insurance plans within 30 days of birth and who received at least one dose of Rotarix vaccination as part of their normal health care (with no previous dose of RotaTeq prior to or concurrent with the first Rotarix vaccination).	Concurrent Control Cohort n=173384 Participants Concurrent control cohort consisted of infants aged less than 1 year, enrolled in the participating health insurance plans, who were contemporaneous with the Rotarix vaccinees and who received at least one dose of IPV (Inactivated Poliovirus vaccine) with or without RotaTeq vaccination (with no previous dose of Rotarix prior to or concurrent with the first IPV vaccination).	Recent Historical Control Cohort n=159344 Participants Recent historical control cohort consisted of infants aged less than 1 year of age, enrolled in participating health insurance plans, vaccinated with at least one dose of IPV (Inactivated Poliovirus vaccine) between 1 January 2004 (OptumInsight) or 1 January 2006 (HealthCore) and 31 July 2008 and who did not receive any dose of rotavirus vaccination during the study period.
Incidence Rates of Acute LTRI Hospitalisation Among the HRV Cohort and Comparator Cohorts 0-6 days, Any Dose	1.397 Incidences/Person-Month Interval 0.955 to 1.972	0.932 Incidences/Person-Month Interval 0.725 to 1.18	1.406 Incidences/Person-Month Interval 1.135 to 1.722
Incidence Rates of Acute LTRI Hospitalisation Among the HRV Cohort and Comparator Cohorts 0-6 days, Dose 1	1.960 Incidences/Person-Month Interval 1.28 to 2.871	1.184 Incidences/Person-Month Interval 0.87 to 1.575	1.921 Incidences/Person-Month Interval 1.497 to 2.427
Incidence Rates of Acute LTRI Hospitalisation Among the HRV Cohort and Comparator Cohorts 0-6 days, Dose 2	0.622 Incidences/Person-Month Interval 0.228 to 1.354	0.641 Incidences/Person-Month Interval 0.401 to 0.97	0.774 Incidences/Person-Month Interval 0.491 to 1.162

SECONDARY outcome

Timeframe: 30 days following each vaccination

Population: Analysis was performed on study population comprising of birth cohorts affiliated with 2 participating health insurance plans, United Healthcare \& WellPoint, which were eligible for rotavirus vaccination according to routine recommendations. Within this population of infants, HRV, Concurrent Control \& Recent Historical Control cohorts were defined.

Incidence rates were calculated following the first 2 doses of study vaccine as the number of events divided by the sum of the person-time in that risk period. Person-time was defined as the number of days at risk for the study outcomes. Person-time was calculated in months by dividing the number of person-days by (365.25/12).

Outcome measures

Outcome measures
Measure	HRV Cohort n=57931 Participants HRV (Human Rotavirus) cohort consisted of infants aged less than 1 year, enrolled in the participating health insurance plans within 30 days of birth and who received at least one dose of Rotarix vaccination as part of their normal health care (with no previous dose of RotaTeq prior to or concurrent with the first Rotarix vaccination).	Concurrent Control Cohort n=173384 Participants Concurrent control cohort consisted of infants aged less than 1 year, enrolled in the participating health insurance plans, who were contemporaneous with the Rotarix vaccinees and who received at least one dose of IPV (Inactivated Poliovirus vaccine) with or without RotaTeq vaccination (with no previous dose of Rotarix prior to or concurrent with the first IPV vaccination).	Recent Historical Control Cohort n=159344 Participants Recent historical control cohort consisted of infants aged less than 1 year of age, enrolled in participating health insurance plans, vaccinated with at least one dose of IPV (Inactivated Poliovirus vaccine) between 1 January 2004 (OptumInsight) or 1 January 2006 (HealthCore) and 31 July 2008 and who did not receive any dose of rotavirus vaccination during the study period.
Incidence Rates of Acute LTRI Hospitalisation Among the HRV Cohort and Comparator Cohorts 0-29 days, Any Dose	1.593 Incidences/Person-Month Interval 1.351 to 1.865	1.383 Incidences/Person-Month Interval 1.255 to 1.519	1.788 Incidences/Person-Month Interval 1.634 to 1.952
Incidence Rates of Acute LTRI Hospitalisation Among the HRV Cohort and Comparator Cohorts 0-29 days, Dose 1	1.858 Incidences/Person-Month Interval 1.518 to 2.252	1.523 Incidences/Person-Month Interval 1.341 to 1.721	2.166 Incidences/Person-Month Interval 1.939 to 2.412
Incidence Rates of Acute LTRI Hospitalisation Among the HRV Cohort and Comparator Cohorts 0-29 days, Dose 2	1.228 Incidences/Person-Month Interval 0.911 to 1.619	1.221 Incidences/Person-Month Interval 1.048 to 1.414	1.327 Incidences/Person-Month Interval 1.132 to 1.544

SECONDARY outcome

Timeframe: 60 days following each vaccination

Population: Analysis was performed on study population comprising of birth cohorts affiliated with 2 participating health insurance plans, United Healthcare \& WellPoint, which were eligible for rotavirus vaccination according to routine recommendations. Within this population of infants, HRV, Concurrent Control \& Recent Historical Control cohorts were defined.

Incidence rates were calculated following the first 2 doses of study vaccine as the number of events divided by the sum of the person-time in that risk period. Person-time was defined as the number of days at risk for the study outcomes. Person-time was calculated in months by dividing the number of person-days by (365.25/12).

Outcome measures

Outcome measures
Measure	HRV Cohort n=57931 Participants HRV (Human Rotavirus) cohort consisted of infants aged less than 1 year, enrolled in the participating health insurance plans within 30 days of birth and who received at least one dose of Rotarix vaccination as part of their normal health care (with no previous dose of RotaTeq prior to or concurrent with the first Rotarix vaccination).	Concurrent Control Cohort n=173384 Participants Concurrent control cohort consisted of infants aged less than 1 year, enrolled in the participating health insurance plans, who were contemporaneous with the Rotarix vaccinees and who received at least one dose of IPV (Inactivated Poliovirus vaccine) with or without RotaTeq vaccination (with no previous dose of Rotarix prior to or concurrent with the first IPV vaccination).	Recent Historical Control Cohort n=159344 Participants Recent historical control cohort consisted of infants aged less than 1 year of age, enrolled in participating health insurance plans, vaccinated with at least one dose of IPV (Inactivated Poliovirus vaccine) between 1 January 2004 (OptumInsight) or 1 January 2006 (HealthCore) and 31 July 2008 and who did not receive any dose of rotavirus vaccination during the study period.
Incidence Rates of All-cause Mortality Among the HRV Cohort and Comparator Cohorts 0-59 days, Any Dose	0.048 Incidences/Person-Month Interval 0.022 to 0.091	0.045 Incidences/Person-Month Interval 0.03 to 0.065	0.062 Incidences/Person-Month Interval 0.043 to 0.087
Incidence Rates of All-cause Mortality Among the HRV Cohort and Comparator Cohorts 0-59 days, Dose 1	0.047 Incidences/Person-Month Interval 0.015 to 0.109	0.059 Incidences/Person-Month Interval 0.036 to 0.092	0.075 Incidences/Person-Month Interval 0.047 to 0.114
Incidence Rates of All-cause Mortality Among the HRV Cohort and Comparator Cohorts 0-59 days, Dose 2	0.050 Incidences/Person-Month Interval 0.014 to 0.128	0.029 Incidences/Person-Month Interval 0.012 to 0.057	0.045 Incidences/Person-Month Interval 0.023 to 0.081

Adverse Events

HRV Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 9 deaths

Concurrent Control Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 27 deaths

Recent Historical Control Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 33 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER