Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Rotarix (primary vaccination study), Rotarix™ vaccine, GSK Biologicals' HRV vaccine, Paracetamol, Infanrix Hexa, 10 valent pneumococcal conjugate vaccine, GSK's liquid oral live attenuated HRV
Rotarix · 21 trials · 10 indications
Immunogenicity was assessed using Enzyme Linked Immunosorbent Assay (ELISA) in terms of seroprotection rates against diphtheria toxoid. A seroprotected subject is a subject whose antibody concentration is greater than or equal to (≥) the level defining clinical protection. The following seroprotection thresholds were applicable:anti-D antibody concentrations ≥ 0.1 International Units/milliliter (IU/mL), anti-T antibody concentrations ≥ 0.1 IU/mL.
Immunogenicity was assessed using ChemiLuminescence ImmunoAssay (CLIA) in terms of seroprotection rates against Hepatitis B. A seroprotected subject is a subject whose antibody concentration is ≥ the level defining clinical protection. The following seroprotection thresholds were applicable:anti-HB antibody concentrations ≥ 10 milli International Units/milliliter (mIU/mL).
Immunogenicity was assessed using virus micro-neutralization test in terms of seroprotection rates against polio virus types 1, 2 and 3. A seroprotected subject is a subject whose antibody concentration is ≥ the level defining clinical protection. The following seroprotection thresholds were applicable:anti-polio virus types 1, 2 and 3 types antibody titers ≥ 8 Estimated Dose 50% (ED50).
Antibody concentrations against PT, FHA and PRN were determined and expressed as Geometric Mean Concentrations (GMCs).The GMC calculations were performed by taking the anti-log of the mean of the log concentration transformations.
Antibody concentrations against pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) were determined and expressed as GMCs in micrograms per milliliter (µg/mL).The GMC calculations were performed by taking the anti-log of the mean of the log concentration transformations.
Immunogenicity was assessed in terms of seroprotection rates against PRP antibodies. A seroprotected subject is a subject whose antibody concentration is ≥ the level defining clinical protection. The following seroprotection thresholds were applicable:anti-PRP antibody concentrations ≥ 0.15 µg/mL.
Immunogenicity was assessed in terms of seroprotection rates against PRP antibodies. A seroprotected subject is a subject whose antibody concentration is ≥ the level defining clinical protection. The following seroprotection thresholds were applicable:anti-PRP antibody concentrations ≥ 1.0 µg/mL.
Seroresponse is defined as the percentage of subjects showing an antibody concentration above a threshold that leads to 95% seroresponse in the HRV lyophilized Group. The cut-offs used were as follows: anti-PT (18.566 IU/mL), anti-FHA (35.711 IU/mL) and anti-PRN (11.034 IU/mL).
Concentrations were expressed as geometric mean concentrations (GMCs) for the following cut-offs:2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA, and 2.187 IU/mL for anti-PRN. The results for the Infanrix hexa Group and Pediarix Group were the primary outcome variables.
A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentration greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).
A seroprotected subject was defined as a vaccinated subject with anti-HBS antibody concentration ≥ 10 milli-international units per milliliter (mIU/mL).
A seroprotected subject was defined as a subject with anti-Poliovirus 1,2 and 3 antibody titers ≥ 8 effective dose, for 50% of people receiving the vaccine (ED50).
A seroprotected subject was defined as a subject with anti-PRP antibody concentration ≥ 0.15 micrograms per milliliter (µg/mL).
Vaccine response was defined as : For initially seronegative subjects (S-), antibody concentration ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL) at 1 month after the third dose; For initially seropositive subjects (S+): antibody concentration at 1 month after the third dose ≥ 1 fold increase in the pre-vaccination antibody concentration.
Rotavirus (RV) gastroenteritis (GE) was defined as an episode of any severity GE leading to a medical intervention occurring at least two weeks after dose 2 in which rotavirus other than vaccine strain is identified in a stool sample collected as soon as possible but preferably not later than 7 days after the start of the episode.
Occurence of any rotavirus gastroenteritis (RVGE) caused by the circulating wild-type rotavirus strain was assessed in terms of number of subjects experiencing diarrhoea with or without vomiting. Two occurrences of diarrhoea were classified as separate episodes if there were 5 or more diarrhoea-free days between the episodes.
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.
Number of subjects in the Placebo Group with rotavirus vaccine strain in at least one stool sample.
Severe RV GE is an episode of severe GE in which rotavirus other than vaccine strain was identified in a GE stool sample. Note that this outcome measure is secondary in the study protocol. We have reported it here as primary outcome measure, since none of the primary outcome measures in the study protocol pertain to the time point (Year 3 follow-up) presented in this summary.
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.
A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).
A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).
A seroprotected subject was a subject whose antibody concentration was greater than or equal to the level defining clinical protection of 10 milli-international units per millilitre (mIU/mL).
A seroprotected subject was a subject whose antibody concentration was greater than or equal to the level defining clinical protection of 10 milli-international units per millilitre (mIU/mL).
A seroprotected subject was a subject whose antibody titre was greater than or equal to the level defining clinical protection of 8.
A seroprotected subject was a subject whose antibody titre was greater than or equal to the level defining clinical protection of 8.
A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).
A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).
Concentrations were expressed as geometric mean concentrations (GMCs). Seropositivity cut-off assay was 5 EL.U/mL.
Concentrations were expressed as geometric mean concentrations (GMCs). Seropositivity cut-off assay was 5 EL.U/mL.
A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliters (EL.U/mL).
A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).
A seroprotected subject was defined as a vaccinated subject who had anti-HBs antibody concentrations ≥ 10 mIU/mL. A decrease in the specificity of the anti-HB enzyme-linked immunosorbent assay (ELISA) had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis.
A decrease in the specificity of the anti-HB enzyme-linked immunosorbent assay (ELISA) had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis. Concentrations were expressed as geometric mean concentrations (GMCs) in milli-International units per milliliter (mIU/mL).
A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).
A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 milli international units per milliliter (mIU/mL). Also reported are the number of participants with anti-HBs antibody concentrations ≥ 100 mIU/mL.
A seroprotected subject was defined as a subject with anti-Polio 1, 2 and 3 antibody titers ≥ the value of 8.
A seroprotected subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
A seroprotected subject was defined as a subject with anti-PRP antibody concentrations greater than or equal to (≥) 0.15 micrograms per milliliter (µg/mL). Also reported are the number of participants with anti-PRP antibody concentrations ≥ 1.0 µg/mL.
Vaccine response was defined as the appearance of antibodies in subjects who were initially seronegative (S-) \[i.e. with concentrations lower than (\<) the cut-off value\] or at least doubling of pre-vaccination antibody concentrations in subjects who were initially seropositive (S+) \[i.e. with concentrations greater than (\>) the cut-off value).
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.
Antibody titers were presented as geometric mean titers (GMTs).
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (µg/mL).
Seroconversion was defined as the appearance of anti-RV IgA antibody concentrations greater than or equal to (≥) 20 units per milliliter (U/mL) in subjects initially (i.e. prior to the first dose of Rotarix™ vaccine or placebo) seronegative, when administered concomitantly with the second and third routine EPI immunization. This outcome measure only concerns subjects in the Placebo-Rotarix-Rotarix Group.
Symptoms reported in the table include: Fever: temperature (axillary route) \> 38.0 degree Celsius (°C); Diarrhea: ≥ 4 looser than normal stools/day; Vomiting: ≥ 2 episodes of vomiting/day.
| Arm | Type | Description |
|---|---|---|
| HRV PCV-free Liq Group | EXPERIMENTAL | Healthy female or male subjects, between and including 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in PCV-free liquid formulation, according to a 0, 2-month schedule, co-administered with one dose of each Pediarix, Hiberix and Prevnar-13 at three timepoints (day 1, month 2 and month 4). PCV-free implies no detection of PCV-1 and PCV-2 according to the limit of detection of the tests used. |
| HRV Lyo Group | ACTIVE_COMPARATOR | Healthy female or male subjects, between and including 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in lyophilized formulation, according to a 0, 2-month schedule, co-administered with one dose of each Pediarix, Hiberix and Prevnar-13 at three timepoints (day 1, month 2 and month 4). |
| Infanrix hexa Group | EXPERIMENTAL | Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh. |
| Pediarix Group | ACTIVE_COMPARATOR | Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh. |
| Pentacel Group | ACTIVE_COMPARATOR | Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh. |
| INFANRIX HEXA 6-10-14 GROUP | EXPERIMENTAL | Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh. |
| INFANRIX HEXA 2-4-6 GROUP | ACTIVE_COMPARATOR | Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh. |
| Rotarix Group | EXPERIMENTAL | Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule. |
| Placebo Group | PLACEBO_COMPARATOR | Subjects received 2 oral doses of placebo according to a 0, 1 month schedule. |
| Rotarix 3-Dose Group | EXPERIMENTAL | Subjects received 3 doses of Rotarix™ vaccine given concomitantly with routine EPI vaccines. |
| Rotarix 2-Dose Group | EXPERIMENTAL | Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ vaccine given concomitantly with routine EPI vaccines. |
| Group HRV Lot A | EXPERIMENTAL | - |
| Group HRV Lot B | EXPERIMENTAL | - |
| Group HRV Lot C | EXPERIMENTAL | - |
| Group Placebo | ACTIVE_COMPARATOR | - |
| GSK217744 Group 1 | EXPERIMENTAL | Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. |
| GSK217744 Group 2 | EXPERIMENTAL | Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. |
| INFANRIX HEXA PF GROUP | EXPERIMENTAL | Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh. |
| INFANRIX HEXA PC GROUP | EXPERIMENTAL | Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh. |
| CONTROL GROUP | ACTIVE_COMPARATOR | Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh. |
| PLACEBO-ROTARIX-ROTARIX GROUP | EXPERIMENTAL | Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Month 1 and Month 2, and a single oral dose of placebo at Day 0. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines. |
| ROTARIX-PLACEBO-ROTARIX GROUP | EXPERIMENTAL | Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Day 0 and Month 2, and a single oral dose of placebo at Month 1. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines. |
| Rotavirus Group | EXPERIMENTAL | Subjects will receive Rotarix™ |
| Name | Type | Description |
|---|---|---|
| Rotarix | BIOLOGICAL | Two doses administered orally according to a 0, 2 month schedule as per the immunization schedule for HRV vaccine administration in the US. |
| Pediarix | BIOLOGICAL | Three doses administered intramuscularly according to a 0, 2, 4 month schedule. |
| Hiberix | BIOLOGICAL | Three doses administered intramuscularly according to a 0, 2, 4 month schedule. |
| Prevenar 13 | BIOLOGICAL | Three doses administered intramuscularly according to a 0, 2, 4 month schedule. |
| Infanrix hexa | BIOLOGICAL | 3 doses administered intramuscularly in the right thigh. |
| ActHIB | BIOLOGICAL | 4 doses administered intramuscularly in the upper left thigh |
| Pentacel | BIOLOGICAL | 4 doses administered intramuscularly in the right thigh |
| Engerix-B | BIOLOGICAL | 2 or 3 doses administered intramuscularly in the upper left thigh |
| Infanrix | BIOLOGICAL | 1 dose administered intramuscularly in the right thigh |
| Prevnar13 | BIOLOGICAL | 3 doses administered intramuscularly in the lower left thigh |
| Infanrix hexa™ | BIOLOGICAL | Intramuscular, three doses |
| Placebo | BIOLOGICAL | Two-dose oral administration. |
| Rotarix (primary vaccination study) | BIOLOGICAL | GlaxoSmithKline Biologicals' oral live attenuated human rotavirus vaccine. |
| Placebo (primary vaccination study) | BIOLOGICAL | Two liquid oral doses of placebo |
| Rotarix™ | BIOLOGICAL | Two-dose oral vaccination. |
| Infanrix-Hexa | BIOLOGICAL | - |
| GSK217744 | BIOLOGICAL | Single dose, investigational formulation A or B, intramuscular into right thigh |
| Prevenar 13® | BIOLOGICAL | 3 co-administered doses, intramuscular into right thigh |
| Infanrix hexa Vaccine | BIOLOGICAL | - |
| Tritanrix-HB+Hib | BIOLOGICAL | Concomitant routine vaccination, IM administration |
| Polio Sabin | BIOLOGICAL | Oral administration, concomitant routine vaccination |
| Rotarix ™ | BIOLOGICAL | Oral, single dose |
Inclusion Criteria: * Subjects' parent(s)/\[LAR(s)\] who, in the opinion of the investigator can and will comply with the requirements of the protocol. * A male or female between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination. * Written or witnessed/th...
Rotarix is a vaccine used to prevent rotavirus infection, a condition studied in infants and children in its clinical program. It has also been studied in hepatitis B. The Rotarix trials enrolled healthy volunteers, including infants from six weeks of age and adults, across multiple countries.
Rotarix is developed and manufactured by GSK plc, which trades under the ticker GSK. GSK Biologicals conducted the clinical development program for the vaccine, including studies of a liquid human rotavirus vaccine formulation compared with the licensed lyophilized version.
Rotarix has been studied across Phase 1 and Phase 3 clinical trials, with 13 completed trials and no active trials. The program includes Phase 1 studies in Chinese adults and children and Phase 3 studies in the United States, Colombia, Mexico, and Peru.
Rotarix has been evaluated in 13 completed trials, including NCT03207750, a Phase 3 study of co-administration with routine infant vaccines; NCT00757770, a Phase 3 consistency study of three production lots; and NCT01162590 and NCT01086436, Phase 1 studies in Chinese adults and children.
Yes, Rotarix, Rotarix vaccine, Rotarix™, Rotarix®, and Rotarix™ vaccine all refer to the same product. The terms are alternative names for the rotavirus vaccine developed by GSK, and searches using any of these names point to the same asset.
Rotarix clinical trials have enrolled a total of 17,479 participants across 13 completed studies. The trials were randomized and double-blind, and included healthy volunteers ranging from infants as young as six weeks to adults, with enrollment in the United States, China, Colombia, Mexico, and Peru.