Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Rotavirus Vaccine, Live, Pentavalent · 6 trials · 5 indications
Geometric Mean Titer (GMT)/antibody responses to RotaTeq™ and INFANRIX™ in relation to anti-hepatitis B surface antigen HBsAg at start of a 3-dose regimen
GMT/antibody responses to RotaTeq™ and INFANRIX™ in relation to anti-hepatitis B surface antigen HBsAg at 42 days after 3-dose regimen
GMT/antibody responses to RotaTeq™ and INFANRIX™ hexa in relation to serum anti-polyribosylribitol phosphate PRP at start of 3-dose regimen
GMT/antibody responses to RotaTeq™ and INFANRIX™ hexa in relation to serum anti-polyribosylribitol phosphate PRP at 42 days after a 3-dose regimen
GMT of poliovirus type 1, 2, and 3, measured at postdose 3 in subjects receiving RotaTeq™ and OPV concomitantly compared to staggered.
GMT of serum anti-rotavirus IgA measured at postdose 3 in subjects receiving RotaTeq™ and OPV concomitantly compared to staggered
Rotavirus SNA response to serotypes G1, G2, G3, G4, and P1A measured at postdose 3 in subjects receiving RotaTeq™ and OPV concomitantly compared to staggered.
Number of subjects with ≥ 3-fold rise from baseline (Predose 1) in Serum IgA 14 days Postdose 3
Antibody response to 3 manufactured lots of RotaTeq™ and placebo groups, based on the SNA PostDose 3 geometric mean titers (GMTs) (expressed in dilution units) against rotavirus serotypes G1, G2, G3, G4 and P1A\[8\]
All serious adverse events (SAEs) were collected for 14 days following each dose to obtain the number of participants with serious adverse events.
The total number of serious adverse experiences (events) in participants up to 14 days post vaccination.
| Arm | Type | Description |
|---|---|---|
| RotaTeq™ Vaccine (V260) | EXPERIMENTAL | Evaluation of Safety, Tolerability and Immunogenicity of Vaccination with RotaTeq™ in Healthy Infants in India. |
| 1 | EXPERIMENTAL | RotaTeq/Infanrix Hexa |
| 2 | PLACEBO_COMPARATOR | Placebo/Infanrix Hexa |
| RotaTeq™ Lot 1 | EXPERIMENTAL | \~8.81 X 10\^7 IU/Dose of RotaTeq™ |
| RotaTeq™ Lot 2 | EXPERIMENTAL | \~8.01 X 10\^7 IU/Dose of RotaTeq™ |
| RotaTeq™ Lot 3 | EXPERIMENTAL | \~6.91 X 10\^7 IU/Dose of RotaTeq™ |
| Placebo | PLACEBO_COMPARATOR | - |
| Cohort I - RotaTeq™, Adults | EXPERIMENTAL | Adults randomized to receive a single dose of RotaTeq™. |
| Cohort I - Placebo, Adults | PLACEBO_COMPARATOR | Adults randomized to receive a single dose of matching placebo to RotaTeq™. |
| Cohort II - RotaTeq™, Children | EXPERIMENTAL | Children randomized to receive a single dose of RotaTeq™. |
| Cohort II - Placebo, Children | PLACEBO_COMPARATOR | Children randomized to receive a single dose of matching placebo to RotaTeq™. |
| Cohort III - RotaTeq™, Infants | EXPERIMENTAL | Infants randomized to receive 3 doses of RotaTeq™. |
| Cohort III - Placebo, Infants | PLACEBO_COMPARATOR | Infants randomized to receive 3 doses of matching placebo to RotaTeq™. |
| Name | Type | Description |
|---|---|---|
| Rotavirus Vaccine, Live, Oral, Pentavalent | BIOLOGICAL | Pentavalent vaccine 9G1, G2, G3, G4 \& P1) given 3 times. Dose 1 will be administered at study entry; Dose 2 will be administered 4 to 10 weeks (28 to 70 days) after Dose 1; and Dose 3 will be administered 4 to 10 weeks (28 to 70 days) after Dose 2. |
| Comparator: placebo | BIOLOGICAL | 3 doses of placebo to rotavirus vaccine live, oral, pentavalent on Day 1, 28 to 42 days post dose 1 and 28 to 42 days post dose 2 |
| Comparator: Infanrix(tm) Hexa | BIOLOGICAL | 3 doses of oral Infanrix(tm) Hexa on Day 1, 28 to 42 days post dose 1 and 28 to 42 days post dose 2 |
| Comparator: Oral Poliovirus Vaccine (OPV) | BIOLOGICAL | Three doses OPV. Dose 1 was given on Day 1, Dose 2 was given 56 to 84 days post Dose 1, and Dose 3 was given 56 to 84 days post Dose 2. |
| Comparator: Oral Poliovirus Vaccine (OPV) (staggered) | BIOLOGICAL | Three doses OPV. Dose 1 was given 14 to 28 days post Dose 1 of RotaTeq, Dose 2 was given 14 to 28 days post Dose 2 of RotaTeq, and Dose 3 was given 14 to 28 days post Dose 3 of RotaTeq. |
| Placebo | BIOLOGICAL | Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination |
Inclusion Criteria: * Age 6 weeks through exactly 12 weeks * Healthy infants Exclusion Criteria: * Clinical evidence of active gastrointestinal illness * Fever, with a rectal temperature of greater than and equal to thirty eight degree celsius at the time of immunization * History of congenital a...
Rotavirus Vaccine, Live, Pentavalent is used for the prevention of rotavirus gastroenteritis, rotavirus infections, and rotavirus disease. It is being developed by Merck & Company, Inc. for use in infants as young as 6 weeks of age. The vaccine is currently in Phase 3 clinical development.
Rotavirus Vaccine, Live, Pentavalent is a live, pentavalent vaccine that works by exposing the immune system to weakened rotavirus strains, stimulating an immune response that protects against rotavirus infection. It is designed to prevent rotavirus gastroenteritis, a common cause of severe diarrhea in infants and young children.
Rotavirus Vaccine, Live, Pentavalent is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The vaccine is currently in Phase 3 clinical trials for the prevention of rotavirus gastroenteritis and related conditions.
Rotavirus Vaccine, Live, Pentavalent is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. Clinical trials are being conducted to evaluate its safety and efficacy in preventing rotavirus gastroenteritis in infants.
Rotavirus Vaccine, Live, Pentavalent has completed several clinical trials, including NCT00166517, NCT00258154, NCT00496054, and NCT00953056. These trials evaluated the vaccine's safety, tolerability, and immunogenicity in healthy infants and children across various regions, including India and China.
Rotavirus Vaccine, Live, Pentavalent is also known as RotaTeq, a brand name for the vaccine developed by Merck. Clinical trials referenced in the development program, such as NCT00496054, use the name RotaTeq in their titles, confirming that these names refer to the same vaccine product.