Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Lyophilized formulation of HRV vaccine, HRV Lyophilized, Rotarix
HRV vaccine · 17 trials · 4 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).
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.
A seroconverted subject was defined as a vaccinated subject who had an anti-rotavirus IgA antibody concentration equal to or above (≥) 20 units per milliliter (U/mL) and who was initially (i.e. prior to the first dose of Rotarix™ vaccine) negative for rotavirus.
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.
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). |
| 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. |
| Liquid Rotarix Group | EXPERIMENTAL | Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the liquid formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule. |
| Lyophilized Rotarix Group | EXPERIMENTAL | Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the lyophilized formulation of the Rotarix™ vaccine, according to a 0, 2 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 | - |
| 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. |
| 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. |
| Lyophilized formulation of HRV vaccine | BIOLOGICAL | Lyophilized formulation of HRV vaccine |
| Liquid formulation of HRV vaccine | BIOLOGICAL | Liquid formulation of HRV vaccine |
| Tritanrix-HB+Hib | BIOLOGICAL | Concomitant routine vaccination, IM administration |
| Polio Sabin | BIOLOGICAL | Oral administration, concomitant routine vaccination |
| HRV vaccine | BIOLOGICAL | Two or three oral doses |
| 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...
The HRV vaccine is a vaccine developed to prevent rotavirus infections in infants. It is designed to be given as a two-dose vaccination series to healthy infants starting around 5 to 6 weeks of age. Rotavirus is a leading cause of severe diarrhea in young children worldwide.
The HRV vaccine is being developed by GSK plc, which trades under the ticker GSK. GSK conducted the clinical trial program for this vaccine, including studies in South Africa and Panama, evaluating different formulations and dose schedules in healthy infants.
The HRV vaccine is in Phase 3 clinical development. Three trials have been completed, including one Phase 3 study and two Phase 2 studies, with a total enrollment of 4,386 infants. The vaccine is investigational and has not been approved by the FDA.
The HRV vaccine has been studied in three completed clinical trials: NCT00385320, a Phase 2 trial with 2,640 infants; NCT00383903, a Phase 2 trial with 472 infants in South Africa; and NCT00363545, a Phase 3 trial with 1,274 infants in Panama. All trials are completed.
Yes, the HRV vaccine is also known as the lyophilized formulation of HRV vaccine, or HRV Lyophilized. These names refer to the same GSK vaccine candidate for preventing rotavirus infections in infants, which was evaluated in both lyophilized and liquid formulations during clinical development.