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| Study Type: | Interventional |
|---|---|
| Study Design: | Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment |
| Conditions: |
Prophylaxis Rotavirus Gastroenteritis Caused by Rotavirus |
| Interventions: |
Biological: Placebo Biological: Rotarix™ |
Participant Flow
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| No text entered. |
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| Of the total of 4941 subjects enrolled in this study, 2 subjects were allocated a subject number but did not get any study vaccine administered. Hence, only 4939 subjects were considered as 'started'. |
| Description | |
|---|---|
| Rotarix 2-dose Group | Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine). |
| Rotarix 3-dose Group | Subjects received 3 doses of Rotarix™ (rotavirus vaccine). |
| Placebo Group | Subjects received 3 doses of placebo. |
| Rotarix 2-dose Group | Rotarix 3-dose Group | Placebo Group | |
|---|---|---|---|
| STARTED | 1647 | 1651 | 1641 |
| COMPLETED | 1420 | 1383 | 1392 |
| NOT COMPLETED | 227 | 268 | 249 |
| Adverse Event | 46 | 45 | 45 |
| Protocol Violation | 3 | 5 | 4 |
| Withdrawal by Subject | 59 | 74 | 81 |
| Lost to Follow-up | 116 | 142 | 116 |
| Non-compliance | 2 | 1 | 2 |
| Return dates not reliable | 1 | 0 | 0 |
| Vaccinated at regular clinic | 0 | 0 | 1 |
| Subject's parent passed away | 0 | 1 | 0 |
Baseline Characteristics
| Description | |
|---|---|
| Rotarix 2-dose Group | Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine). |
| Rotarix 3-dose Group | Subjects received 3 doses of Rotarix™ (rotavirus vaccine). |
| Placebo Group | Subjects received 3 doses of placebo. |
| Rotarix 2-dose Group | Rotarix 3-dose Group | Placebo Group | Total | |
|---|---|---|---|---|
|
Number of Participants [units: participants] |
1647 | 1651 | 1641 | 4939 |
|
Age [units: weeks] Mean ± Standard Deviation |
6.3 ± 0.92 | 6.4 ± 0.98 | 6.4 ± 0.97 | 6.4 ± 0.95 |
|
Gender [units: subjects] |
||||
| Female | 811 | 839 | 800 | 2450 |
| Male | 836 | 812 | 841 | 2489 |
Outcome Measures
| 1. Primary: | Number of Subjects With Severe Rotavirus Gastroenteritis (RV GE) Caused by the Circulating Wild-type Rotavirus Strain [ From 2 weeks after the last vaccine or placebo dose up to 1 year of age ] |
| Measure Type | Primary |
|---|---|
| Measure Title | Number of Subjects With Severe Rotavirus Gastroenteritis (RV GE) Caused by the Circulating Wild-type Rotavirus Strain |
| Measure Description | Number of subjects presenting with three or more looser than normal stools or watery stools within a day, occurring after administration of dose 1 of study vaccine in which rotavirus other than vaccine strain was identified in a stool sample with a score ≥ 11 on the 20-point Vesikari scoring system. |
| Time Frame | From 2 weeks after the last vaccine or placebo dose up to 1 year of age |
| Safety Issue | No |
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy |
| Description | |
|---|---|
| Rotarix 2-dose Group | Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine). |
| Rotarix 3-dose Group | Subjects received 3 doses of Rotarix™ (rotavirus vaccine). |
| Rotarix Pooled Group | For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group. |
| Placebo Group | Subjects received 3 doses of placebo. |
| Rotarix 2-dose Group | Rotarix 3-dose Group | Rotarix Pooled Group | Placebo Group | |
|---|---|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
1496 | 1478 | 2974 | 1443 |
|
Number of Subjects With Severe Rotavirus Gastroenteritis (RV GE) Caused by the Circulating Wild-type Rotavirus Strain
[units: subjects] |
30 | 26 | 56 | 70 |
| 2. Secondary: | Number of Subjects With Severe Rotavirus Gastroenteritis Caused by the Circulating Wild-type Rotavirus Strain, Classified by Rotavirus Type [ From 2 weeks after the last vaccine or placebo dose up to 1 year of age ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Number of Subjects With Severe Rotavirus Gastroenteritis Caused by the Circulating Wild-type Rotavirus Strain, Classified by Rotavirus Type |
| Measure Description |
Number of subjects presenting with three or more looser than normal stools within a day, occurring after administration of dose 1 of study vaccine in which rotavirus other than vaccine strain was identified in a stool sample with a score ≥ 11 on the 20-point Vesikari scoring system. Rotavirus types were G1 wild type (WT) and non-G1. |
| Time Frame | From 2 weeks after the last vaccine or placebo dose up to 1 year of age |
| Safety Issue | No |
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Analysis was performed on the ATP cohort for efficacy |
| Description | |
|---|---|
| Rotarix 2-dose Group | Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine). |
| Rotarix 3-dose Group | Subjects received 3 doses of Rotarix™ (rotavirus vaccine). |
| Rotarix Pooled Group | For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group. |
| Placebo Group | Subjects received 3 doses of placebo. |
| Rotarix 2-dose Group | Rotarix 3-dose Group | Rotarix Pooled Group | Placebo Group | |
|---|---|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
1496 | 1478 | 2974 | 1443 |
|
Number of Subjects With Severe Rotavirus Gastroenteritis Caused by the Circulating Wild-type Rotavirus Strain, Classified by Rotavirus Type
[units: subjects] |
||||
| G1 WT | 8 | 9 | 17 | 23 |
| Non-G1 | 22 | 17 | 39 | 47 |
| 3. Secondary: | Number of Subjects Reporting Any Rotavirus Gastroenteritis Caused by the Circulating Wild-type Rotavirus Strain [ From 2 weeks after the last vaccine or placebo dose up to 1 year of age ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Number of Subjects Reporting Any Rotavirus Gastroenteritis Caused by the Circulating Wild-type Rotavirus Strain |
| Measure Description | Number of subjects presenting with three or more looser than normal stools or watery stools within a day, occurring after administration of dose 1 of study vaccine in which rotavirus other than vaccine strain was identified in a stool sample. |
| Time Frame | From 2 weeks after the last vaccine or placebo dose up to 1 year of age |
| Safety Issue | No |
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Analysis was performed on the ATP cohort for efficacy |
| Description | |
|---|---|
| Rotarix 2-dose Group | Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine). |
| Rotarix 3-dose Group | Subjects received 3 doses of Rotarix™ (rotavirus vaccine). |
| Rotarix Pooled Group | For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group. |
| Placebo Group | Subjects received 3 doses of placebo. |
| Rotarix 2-dose Group | Rotarix 3-dose Group | Rotarix Pooled Group | Placebo Group | |
|---|---|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
1496 | 1478 | 2974 | 1443 |
|
Number of Subjects Reporting Any Rotavirus Gastroenteritis Caused by the Circulating Wild-type Rotavirus Strain
[units: subjects] |
93 | 74 | 167 | 174 |
| 4. Secondary: | Number of Subjects With Severe Rotavirus Gastroenteritis Caused by the Circulating Wild-type Rotavirus Strain [ From the first vaccine or placebo dose up to 1 year of age ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Number of Subjects With Severe Rotavirus Gastroenteritis Caused by the Circulating Wild-type Rotavirus Strain |
| Measure Description | Number of subjects presenting with three or more looser than normal stools or watery stools within a day, occurring after administration of dose 1 of study vaccine in which rotavirus other than vaccine strain was identified in a stool sample with a score ≥ 11 on the 20-point Vesikari scoring system. |
| Time Frame | From the first vaccine or placebo dose up to 1 year of age |
| Safety Issue | No |
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| No text entered. |
| Description | |
|---|---|
| Rotarix 2-dose Group | Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine). |
| Rotarix 3-dose Group | Subjects received 3 doses of Rotarix™ (rotavirus vaccine). |
| Rotarix Pooled Group | For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group. |
| Placebo Group | Subjects received 3 doses of placebo. |
| Rotarix 2-dose Group | Rotarix 3-dose Group | Rotarix Pooled Group | Placebo Group | |
|---|---|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
1647 | 1651 | 3298 | 1641 |
|
Number of Subjects With Severe Rotavirus Gastroenteritis Caused by the Circulating Wild-type Rotavirus Strain
[units: subjects] |
37 | 31 | 68 | 83 |
| 5. Secondary: | In South Africa, Number of Subjects With Severe Rotavirus Gastroenteritis Caused by the Circulating Wild-type Rotavirus Strain [ From 2 weeks after the third dose of vaccine or placebo up to 1 year of age ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | In South Africa, Number of Subjects With Severe Rotavirus Gastroenteritis Caused by the Circulating Wild-type Rotavirus Strain |
| Measure Description | Number of subjects presenting with three or more looser than normal stools or watery stools within a day, occurring after administration of dose 1 of study vaccine in which rotavirus other than vaccine strain was identified in a stool sample with a score ≥ 11 on the 20-point Vesikari scoring system. |
| Time Frame | From 2 weeks after the third dose of vaccine or placebo up to 1 year of age |
| Safety Issue | No |
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
|
Analysis was performed on the ATP cohort for efficacy, only for the subset of subjects in South Africa who were fully vaccinated before the beginning of the rotavirus season. For this analysis, data from Rotarix 2-dose Group and Rotarix 3-dose Group were pooled into one group (Rotarix pooled Group). |
| Description | |
|---|---|
| Rotarix 2-dose Group | Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine). |
| Rotarix 3-dose Group | Subjects received 3 doses of Rotarix™ (rotavirus vaccine). |
| Rotarix Pooled Group | For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group. |
| Placebo Group | Subjects received 3 doses of placebo. |
| Rotarix 2-dose Group | Rotarix 3-dose Group | Rotarix Pooled Group | Placebo Group | |
|---|---|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
478 | 468 | 946 | 468 |
|
In South Africa, Number of Subjects With Severe Rotavirus Gastroenteritis Caused by the Circulating Wild-type Rotavirus Strain
[units: subjects] |
5 | 3 | 8 | 20 |
| 6. Secondary: | Number of Subjects Reporting Severe Gastroenteritis of Any Cause [ From 2 weeks after the last vaccine or placebo dose up to 1 year of age ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Number of Subjects Reporting Severe Gastroenteritis of Any Cause |
| Measure Description | Number of subjects with gastroenteritis (three or more looser than normal stools or watery stools within a day) that scored ≥ 11 on the 20-point Vesikari scoring system. |
| Time Frame | From 2 weeks after the last vaccine or placebo dose up to 1 year of age |
| Safety Issue | No |
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Analysis was performed on the ATP cohort for efficacy. |
| Description | |
|---|---|
| Rotarix 2-dose Group | Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine). |
| Rotarix 3-dose Group | Subjects received 3 doses of Rotarix™ (rotavirus vaccine). |
| Rotarix Pooled Group | For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group. |
| Placebo Group | Subjects received 3 doses of placebo. |
| Rotarix 2-dose Group | Rotarix 3-dose Group | Rotarix Pooled Group | Placebo Group | |
|---|---|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
1496 | 1478 | 2974 | 1443 |
|
Number of Subjects Reporting Severe Gastroenteritis of Any Cause
[units: subjects] |
134 | 122 | 256 | 178 |
| 7. Secondary: | Number of Subjects With Adverse Events (AEs) or Serious Adverse Events (SAEs) Leading to Drop Out [ From the first dose of vaccine or placebo up to 1 year of age ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Number of Subjects With Adverse Events (AEs) or Serious Adverse Events (SAEs) Leading to Drop Out |
| Measure Description |
An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above. |
| Time Frame | From the first dose of vaccine or placebo up to 1 year of age |
| Safety Issue | No |
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| No text entered. |
| Description | |
|---|---|
| Rotarix 2-dose Group | Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine). |
| Rotarix 3-dose Group | Subjects received 3 doses of Rotarix™ (rotavirus vaccine). |
| Rotarix Pooled Group | For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group. |
| Placebo Group | Subjects received 3 doses of placebo. |
| Rotarix 2-dose Group | Rotarix 3-dose Group | Rotarix Pooled Group | Placebo Group | |
|---|---|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
1647 | 1651 | 3298 | 1641 |
|
Number of Subjects With Adverse Events (AEs) or Serious Adverse Events (SAEs) Leading to Drop Out
[units: subjects] |
46 | 45 | 91 | 44 |
| 8. Secondary: | Number of Subjects Reporting Serious Adverse Events (SAEs) [ From the first dose of vaccine or placebo up to 1 year of age ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Number of Subjects Reporting Serious Adverse Events (SAEs) |
| Measure Description | An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above. |
| Time Frame | From the first dose of vaccine or placebo up to 1 year of age |
| Safety Issue | No |
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| No text entered. |
| Description | |
|---|---|
| Rotarix 2-dose Group | Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine). |
| Rotarix 3-dose Group | Subjects received 3 doses of Rotarix™ (rotavirus vaccine). |
| Rotarix Pooled Group | For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group. |
| Placebo Group | Subjects received 3 doses of placebo. |
| Rotarix 2-dose Group | Rotarix 3-dose Group | Rotarix Pooled Group | Placebo Group | |
|---|---|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
1647 | 1651 | 3298 | 1641 |
|
Number of Subjects Reporting Serious Adverse Events (SAEs)
[units: subjects] |
170 | 149 | 319 | 189 |
| 9. Secondary: | Geometric Mean Concentration of Anti-rotavirus Immunoglobulin A (IgA) Antibodies in Initially Seronegative Subjects [ One month after the last vaccine dose ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Geometric Mean Concentration of Anti-rotavirus Immunoglobulin A (IgA) Antibodies in Initially Seronegative Subjects |
| Measure Description | An initially seronegative subject is a subject whose IgA antibody concentration was below the assay cut-off value of 20 Units per milliliter (U/mL) before administration of the first vaccine dose. |
| Time Frame | One month after the last vaccine dose |
| Safety Issue | No |
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Analysis was performed on the ATP cohort for immunogenicity, only for initially seronegative subjects. |
| Description | |
|---|---|
| Rotarix 2-dose Group | Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine). |
| Rotarix 3-dose Group | Subjects received 3 doses of Rotarix™ (rotavirus vaccine). |
| Rotarix Pooled Group | For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group. |
| Placebo Group | Subjects received 3 doses of placebo. |
| Rotarix 2-dose Group | Rotarix 3-dose Group | Rotarix Pooled Group | Placebo Group | |
|---|---|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
106 | 115 | 221 | 111 |
|
Geometric Mean Concentration of Anti-rotavirus Immunoglobulin A (IgA) Antibodies in Initially Seronegative Subjects
[units: Units per milliliter (U/mL)] Geometric Mean ( 95% Confidence Interval ) |
56.6 ( 38.9 to 82.3 ) |
79.4 ( 54.7 to 115.2 ) |
67.5 ( 51.9 to 87.8 ) |
23.4 ( 16.8 to 32.5 ) |
| 10. Secondary: | Number of Seroconverted Subjects [ One month after the last vaccine or placebo dose ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Number of Seroconverted Subjects |
| Measure Description | Seroconverted subjects are defined as subjects with appearance of anti-rotavirus IgA antibody concentration ≥ 20 U/mL in subjects initially (i.e. prior to the first dose of vaccine or placebo) seronegative for rotavirus. |
| Time Frame | One month after the last vaccine or placebo dose |
| Safety Issue | No |
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Analysis was performed on the ATP cohort for immunogenicity, only for inititally seronegative subjects. |
| Description | |
|---|---|
| Rotarix 2-dose Group | Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine). |
| Rotarix 3-dose Group | Subjects received 3 doses of Rotarix™ (rotavirus vaccine). |
| Rotarix Pooled Group | For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group. |
| Placebo Group | Subjects received 3 doses of placebo. |
| Rotarix 2-dose Group | Rotarix 3-dose Group | Rotarix Pooled Group | Placebo Group | |
|---|---|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
106 | 115 | 221 | 111 |
|
Number of Seroconverted Subjects
[units: subjects] |
57 | 72 | 129 | 25 |
| 11. Secondary: | Geometric Mean Concentration of Anti-rotavirus Immunoglobulin A (IgA) Antibodies [ One month after the last vaccine or placebo dose ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Geometric Mean Concentration of Anti-rotavirus Immunoglobulin A (IgA) Antibodies |
| Measure Description | Geometric mean concentrations are given as Units per milliliter (U/mL). |
| Time Frame | One month after the last vaccine or placebo dose |
| Safety Issue | No |
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Analysis was performed on the ATP cohort for immunogenicity. |
| Description | |
|---|---|
| Rotarix 2-dose Group | Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine). |
| Rotarix 3-dose Group | Subjects received 3 doses of Rotarix™ (rotavirus vaccine). |
| Rotarix Pooled Group | For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group. |
| Placebo Group | Subjects received 3 doses of placebo. |
| Rotarix 2-dose Group | Rotarix 3-dose Group | Rotarix Pooled Group | Placebo Group | |
|---|---|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
1160 | 1138 | 2298 | 1125 |
|
Geometric Mean Concentration of Anti-rotavirus Immunoglobulin A (IgA) Antibodies
[units: U/mL] Geometric Mean ( 95% Confidence Interval ) |
72.5 ( 65.2 to 80.6 ) |
67.9 ( 60.8 to 75.9 ) |
70.2 ( 65.0 to 75.8 ) |
21.8 ( 19.8 to 24.0 ) |
| 12. Secondary: | Number of Seropositive Subjects [ One month after the last vaccine or placebo dose ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Number of Seropositive Subjects |
| Measure Description | Seropositive subjects are defined as subjects with anti-rotavirus IgA antibody concentration ≥ 20 U/mL. |
| Time Frame | One month after the last vaccine or placebo dose |
| Safety Issue | No |
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Analysis was performed on the ATP cohort for immunogenicity. |
| Description | |
|---|---|
| Rotarix 2-dose Group | Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine). |
| Rotarix 3-dose Group | Subjects received 3 doses of Rotarix™ (rotavirus vaccine). |
| Rotarix Pooled Group | For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group. |
| Placebo Group | Subjects received 3 doses of placebo. |
| Rotarix 2-dose Group | Rotarix 3-dose Group | Rotarix Pooled Group | Placebo Group | |
|---|---|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
1160 | 1138 | 2298 | 1125 |
|
Number of Seropositive Subjects
[units: subjects] |
756 | 706 | 1462 | 262 |
| 13. Secondary: | Number of Subjects Hospitalized and/or With Supervised Re-hydration Therapy Due to Rotavirus Gastroenteritis (RV GE) Caused by the Circulating Wild-type Rotavirus Strain [ From 2 weeks after the last vaccine or placebo dose up to 1 year of age ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Number of Subjects Hospitalized and/or With Supervised Re-hydration Therapy Due to Rotavirus Gastroenteritis (RV GE) Caused by the Circulating Wild-type Rotavirus Strain |
| Measure Description | RV GE caused by the circulating wild-type rotavirus strain: three or more looser than normal stools or watery stools within a day, occurring after administration of dose 1 of study vaccine in which rotavirus other than vaccine strain was identified in a stool sample collected as soon as possible after the symptoms begin. |
| Time Frame | From 2 weeks after the last vaccine or placebo dose up to 1 year of age |
| Safety Issue | No |
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Analysis was performed on the ATP cohort for efficacy |
| Description | |
|---|---|
| Rotarix 2-dose Group | Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine). |
| Rotarix 3-dose Group | Subjects received 3 doses of Rotarix™ (rotavirus vaccine). |
| Rotarix Pooled Group | For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group. |
| Placebo Group | Subjects received 3 doses of placebo. |
| Rotarix 2-dose Group | Rotarix 3-dose Group | Rotarix Pooled Group | Placebo Group | |
|---|---|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
1496 | 1478 | 2974 | 1443 |
|
Number of Subjects Hospitalized and/or With Supervised Re-hydration Therapy Due to Rotavirus Gastroenteritis (RV GE) Caused by the Circulating Wild-type Rotavirus Strain
[units: subjects] |
78 | 64 | 142 | 156 |
More Information
| Principal Investigators are NOT employed by the organization sponsoring the study. | ||||||
| There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. | ||||||
The agreement is:
|
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| No text entered. |
| Responsible Party: | GSK ( Study Director ) |
| Study ID Numbers: | 102248, 111274 |
| Study First Received: | October 18, 2005 |
| Results First Received: | June 18, 2009 |
| Last Updated: | August 13, 2009 |
| ClinicalTrials.gov Identifier: | NCT00241644 History of Changes |
| Health Authority: | South Africa: Medicines Control Council |
