Trial · NCT01171963
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects With Severe Episode(s) of Rotavirus Gastroenteritis (RVGE) Caused by the Circulating Wild Type (WT) Strains | From Month 1 ½ to Month 21 | A gastroenteritis episode was classified positive for rotavirus (RV) and caused by the circulating wild-type (WT) RV strains if RV other than the vaccine strain was identified in a stool sample collected during the episode. Severe RVGE was defined as an episode of RV GE with score equal to or higher than (\>=) 11 on a 20-point Vesikari scoring system. |
| Secondary | Number of Subjects With Any Episode(s) of Rotavirus Gastroenteritis (RVGE) Caused by the Circulating Wild-type Strains | From Month 1 ½ to Month 21 | A gastroenteritis episode was classified positive for rotavirus (RV) and caused by the circulating wild-type (WT) RV strains if RV other than the vaccine strain was identified in a stool sample collected during the episode. |
| Secondary | Number of Subjects With Any Episode(s) of Rotavirus Gastroenteritis (RVGE) of Any Type. | From Month 1 ½ to Month 21 | A gastroenteritis episode was classified positive for rotavirus (RV) if RV was identified in a stool sample collected during the episode. RV types assessed were G1 Wild Type (G1WT), G2, G3, G9, GX (G type unknown, but not vaccine strain), P4, P8 Wild Type (P8WT), P9, PX (P type unknown, but not vaccine strain) and Pooled Non-G1WT. |
| Secondary | Number of Subjects With Severe Episode(s) of Rotavirus Gastroenteritis (RVGE) of Any Type. | From Month 1 ½ to Month 21 | A gastroenteritis episode was classified positive for rotavirus (RV) if RV was identified in a stool sample collected during the episode. Severe RVGE was defined as an episode of RVGE with score equal to or higher than (\>=) 11 on a 20-point Vesikari scoring system. RV types assessed were G1 Wild Type (G1WT), G2, G3, G9, GX (G type unknown, but not vaccine strain), P4, P8 Wild Type (P8WT), P9, PX (P type unknown, but not vaccine strain) and Pooled Non-G1WT. |
| Secondary | Number of Subjects With Episodes of Rotavirus Gastroenteritis (RVGE) Caused by the Circulating Wild Type (WT) Strains Requiring Hospitalization | From Month 1 ½ to Month 21 | A gastroenteritis episode was classified positive for rotavirus (RV) and caused by the circulating WT RV strains if RV other than the vaccine strain was identified in a stool sample collected during the episode. |
| Secondary | Number of Subjects With Any and Severe Gastroenteritis (GE) Due to Any Cause | From Month 1 ½ to Month 21 | Severe GE was defined as an episode of GE with score equal to or higher than (\>=) 11 on a 20-point Vesikari scoring system. This outcome measure concerns results for GE episodes due to any cause. |
| Secondary | Number of Subjects With Any Solicited General Symptoms Following Vaccination With the Rotarix Vaccine/Placebo | Within the 8-day (Days 0-7) follow-up periods after any dose of Rotarix vaccine/placebo | Assessed solicited general symptoms were fever,defined as axillary temperature (T) above or equal to \[\>=\] 37.5 degrees Celsius \[°C\] (if GSK scale) or \>= 37.1°C (if Chinese scale), fussiness/irritability, loss of appetite, cough/runny nose, diarrhea and vomiting. Any = any occurrence of the specified solicited general symptom regardless of the intensity grade or relationship to vaccination. This outcome measure was only assessed in subjects from Sub-cohort 1, who received the EPI vaccination independently of study vaccination with the Rotarix vaccine/placebo. |
| Secondary | Number of Subjects With Any Solicited General Symptoms Following Administration of the Co-administered EPI Vaccines | Within the 8-day (Days 0-7) follow-up periods following Doses 1 and 2 of the OPV vaccine and Dose 1 of the Infanrix vaccine | Solicited general symptoms assessed following administration of the co-administered EPI vaccines were drowsiness, gastrointestinal symptoms, fussiness/irritability, loss of appetite, and fever, defined as axillary temperature (T) above or equal to \[\>=\] 37.5 degrees Celsius \[°C\] (if GSK scale) or \>= 37.1°C (if Chinese scale ). Any = any occurrence of the specified solicited general symptom regardless of the intensity grade or relationship to vaccination. This outcome measure was only assessed in subjects from Sub-cohort 2, who received the EPI vaccination concomitantly with study vaccination with the Rotarix vaccine/placebo. |
| Secondary | Number of Subjects With Any Solicited Local Symptoms Following Dose 2 of the Rotarix Vaccine/Placebo | Within the 8-day (Days 0-7) follow-up periods following Dose 2 of the Rotarix vaccine/placebo | Solicited local symptoms assessed following administration of the co-administered EPI vaccines were pain, swelling, and redness. Any = any occurrence of the specified solicited local symptom regardless of the intensity grade. This outcome measure was only assessed in subjects from Sub-cohort 2, who received the EPI vaccination concomitantly with study vaccination with the Rotarix vaccine/placebo. |
| Secondary | Number of Subjects With Any Unsolicited Adverse Events (AEs) | Within the 31-day (Days 0-30) follow-up periods following any dose of the Rotarix vaccine or placebo | An unsolicited AE is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of an unsolicited AE regardless of the intensity grade or relationship to vaccination. |
| Secondary | Number of Subjects With Any Serious Adverse Events (SAEs) | Throughout the entire study period (from Day 0 to Study End at Month 21) | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, or result in disability/incapacity. Any = occurrence of an SAE regardless of the intensity grade or relationship to vaccination. |
| Secondary | Number of Seroconverted Subjects for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibodies | At Month 2 and at 12 months of age | A seroconverted subject was defined as a subject seronegative at baseline (Day 0) with the appearance of anti-RV IgA antibody concentration greater than or equal to (≥) 20 units per milliliter (U/mL) at the time point assessed. A seronegative subject was defined as a subject with anti-RV IgA antibody concentration lower than (\<) 20 U/mL. |
| Secondary | Number of Seroconverted Subjects for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibodies. | At Month 2 and at 12 months of age | A seroconverted subject was defined as a subject seronegative at baseline (Day 0) with the appearance of anti-RV IgA antibody concentration greater than or equal to (≥) 20 units per milliliter (U/mL) at the time point assessed. A seronegative subject was defined as a subject with anti-RV IgA antibody concentration lower than (\<) 20 U/mL. |
| Secondary | Number of Subjects Seropositive for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibodies. | At Day 0, Month 2 and at 12 months of age | A subject seropositive for anti-rotavirus (anti-RV) immunoglobulin A (IgA) antibodies was defined as a subject anti-RV IgA antibody concentration greater than or equal to (≥) the seropositivity cut-off of 20 units per milliliter (U/mL). |
| Secondary | Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibody Concentrations | At Day 0, Month 2 and at 12 months of age | Concentrations were expressed as geometric mean concentrations (GMCs), in units per milliliter (U/mL). The cut-off of the assay was the seropositivity cut-off (≥ 20 U/mL). |
| Secondary | Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibody Concentrations. | At Day 0, Month 2 and at 12 months of age. | Concentrations were expressed as geometric mean concentrations (GMCs), in units per milliliter (U/mL). The cut-off of the assay was the seropositivity cut-off (≥ 20 U/mL). |
| Secondary | Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibody Concentrations. | At Day 0, Month 2 and at 12 months of age | Concentrations were expressed as geometric mean concentrations (GMCs), in units per milliliter (U/mL). The cut-off of the assay was the seropositivity cut-off (≥ 20 U/mL). |
| Secondary | Number of Subjects Seroprotected Against Diphtheria and Tetanus | At Day 0 and at Month 4 | A subject seroprotected against diphtheria/tetanus was defined as a subject with an anti-diphtheria (anti-D)/anti-tetanus (anti-T) antibody concentrations greater than or equal to (≥) 0.1 international units per milliliter (IU/mL). This outcome measure concerns solely subjects in Sub-cohort 2, who received the EPI vaccination concomitantly with study vaccination with the Rotarix vaccine/placebo |
| Secondary | Anti-Diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations | At Day 0 and at Month 4 | Concentrations were expressed as geometric mean concentrations (GMCs) in international unit per milliliter (IU/mL). The cut-off of the assay was the seroprotection cut-off assay (≥ 0.1 IU/mL). This outcome measure concerns solely subjects in Sub-cohort 2, who received the EPI vaccination concomitantly with study vaccination with the Rotarix vaccine/placebo. |
| Secondary | Number of Subjects Seroprotected Against Poliovirus Types 1, 2 and 3. | At Day 0 and at Month 4 | A subject seroprotected against poliovirus types 1, 2 and 3 was defined as a subject with anti-poliovirus type 1 (anti-polio 1)/anti-polio 2/anti-polio 3 antibody titer greater than or equal to (≥) 8 estimated doses 50% (ED50). This outcome measure concerns solely subjects in Sub-cohort 2, who received the EPI vaccination concomitantly with study vaccination with the Rotarix vaccine/placebo (cf. population definition below). |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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