Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Rotarix · 1 trial · 1 indication
An AE is any untoward medical occurrence in a participant temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of a study intervention. Injection-site AEs solicited on the Vaccine Report Card (VRC) consisted of erythema (redness), induration (hard lump), pain (tenderness) and swelling.
An AE is any untoward medical occurrence in a participant temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of a study intervention. Systemic AEs solicited on the VRC consisted of decreased appetite (loss of appetite), irritability, somnolence (drowsiness) and urticaria (hive/welts).
A serious adverse event (SAE) is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, is a cancer, is an overdose, or is another important medical event. The relatedness of a vaccine to a SAE is determined by an investigator who is a qualified physician.
Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for each serotype using pneumococcal electrochemiluminescence (PnECL). The Geometric Mean Concentration (GMC) for each of the 13 serotypes shared by both V114 and Prevenar 13™ (Serotypes 1 to 23F); and the 2 serotypes unique to V114 (Serotypes 22F and 33F) was assessed. Per protocol, within-group CIs were not calculated.
Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for the 15 serotypes using pneumococcal electrochemiluminescence (PnECL). The percentage of participants that achieve the threshold value of ≥0.35 μg/mL for each of the 13 serotypes shared by both V114 and Prevenar 13™ (Serotypes 1 to 23F); and the 2 serotypes unique to V114 (Serotypes 22F and 33F) was assessed.
| Arm | Type | Description |
|---|---|---|
| V114 | EXPERIMENTAL | Full-term infants received a 0.5 mL intramuscular injection of V114 at approximately 2, 4, and 11-15 months of age (Study Day 1, Month 2, and Month 9-13). Preterm infants received a 0.5 mL intramuscular injection of V114 at approximately 2, 3, 4, and 11-15 months of age (Study Day 1, Month 1, Month 2, and Month 9-13). All infants also received intramuscular injection of 0.5 mL Infanrix™ hexa at approximately 2, 3, 4, and 11-15 months of age and 1.5 mL oral dose of Rotarix™ at 2 and 4 months of age. |
| Prevenar 13™ | ACTIVE_COMPARATOR | Full-term infants received a 0.5 mL intramuscular injection of Prevenar 13™ at approximately 2, 4, and 11-15 months of age (Study Day 1, Month 2, and Month 9-13). Preterm infants received a 0.5 mL intramuscular injection of Prevenar 13™ at approximately 2, 3, 4, and 11-15 months of age (Study Day 1, Month 1, Month 2, and Month 9-13). All infants also received intramuscular injection of 0.5 mL Infanrix™ hexa at approximately 2, 3, 4, and 11-15 months of age and 1.5 mL oral dose of Rotarix™ at 2 and 4 months of age. |
| Name | Type | Description |
|---|---|---|
| Rotarix™ | DRUG | Single 1.5 mL oral dose at 2 and 4 months of age (Study Day 1 and Month 2) |
| Infanrix™ hexa | DRUG | Single 0.5 mL intramuscular injection at 2, 3, 4, and 11-15 months of age (Study Day 1, Month 1, Month 2, and Month 9-13) |
| V114 | DRUG | 15-valent pneumococcal conjugate vaccine (PCV) containing 13 serotypes present in Prevenar 13™ (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) and 2 unique serotypes (22F and 33F) in each 0.5 mL intramuscular administration, |
| Prevenar 13™ | DRUG | 13-valent PCV containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) in each 0.5 mL intramuscular administration. |
Inclusion Criteria * Healthy * Has a legally acceptable representative who understands the study procedures, alternate treatments available, and risks involved with the study and voluntarily agrees to participate by giving written informed consent Exclusion Criteria * History of invasive pneumoco...
Rotarix is being studied in the setting of pneumococcal infections. The clinical program described here is a Phase 3 evaluation in healthy infants, with the completed trial enrolling 1,184 participants. Rotarix is an investigational product in this program and is not described as approved for this use.
Rotarix is developed by Merck & Company, Inc., which trades under the ticker MRK. Merck is the sponsor of the Phase 3 clinical program evaluating Rotarix in healthy infants for pneumococcal infections.
Rotarix is in Phase 3 development for pneumococcal infections. The program includes one completed Phase 3 trial with 1,184 enrolled participants. No active trials are listed for Rotarix in this program, and the compound is investigational rather than approved for this indication.
Rotarix has been evaluated in the Phase 3 trial NCT04031846, titled Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-025). The trial was completed, enrolled 1,184 healthy infants, and was conducted in Australia, Belgium, Czechia, Estonia, Germany, Greece, Poland, Russia, and Spain.
Yes, Rotarix and Rotarix™ refer to the same product. Rotarix™ is the trademarked form of the name, and both are used for the Merck & Company, Inc. development program in pneumococcal infections.
The Rotarix Phase 3 trial NCT04031846 was a randomized, double-blind study with an active control. It enrolled 1,184 healthy infants aged 42 days and older, included both sexes, and was conducted across nine countries. The trial has been completed.