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RotaTeq · 3 trials · 3 indications
The immunogenicity of IPV was measured using poliovirus serum neutralizing antibody assay of the National Institutes for Food and Drug Control (NIFDC), Beijing, China. Serum conversion was defined as antibody titer ≥1:8 post-vaccination in baseline seronegative participants or ≥4-fold increase in titer post-vaccination in baseline seropositive participants.
Antibody seroprotection to meningiococcal Group C serotype was measured by serum bactericidal antibody with rabbit complement (sRBA). The criterion for seroresponse was an sRBA titer \>=1:8.
Number of participants with confirmed intussusception within 42 days after each vaccination with RotaTeq™/placebo.
Rotavirus gastroenteritis cases consist of all participants with one or more episodes classified as positive. Multiple positive episodes for one participant are counted as a single case.
| Arm | Type | Description |
|---|---|---|
| Concomitant RotaTeq and IPV | EXPERIMENTAL | Participants will receive RotaTeq (2 mL oral dose) and IPV (0.5 mL intramuscular \[IM\] injection ) concomitantly at Visit 2 (15 to 21 days after Visit 1 \[Day 1\]), Visit 4 (30 to 42 days after Visit 2), and Visit 6 (30 to 42 days after Visit 4). |
| Staggered RotaTeq and IPV | ACTIVE_COMPARATOR | Participants will receive RotaTeq (2 mL oral dose) at Visit 1 (Day 1), Visit 3 (30 to 42 days after Visit 1), and Visit 5 (30 to 42 days after Visit 3); and IPV (0.5 mL IM injection) at Visit 2 (15 to 21 days Visit 1), Visit 4 (30 to 42 days after Visit 2), and Visit 6 (30 to 42 days after Visit 4). |
| Group 1: Concomitant Administration | EXPERIMENTAL | Participants received 2 concomitant doses of RotaTeq® and MCC vaccine at 10-11 weeks of age and 20-21 weeks of age and a third dose of RotaTeq® at 24-25 weeks of age (and 28 to 42 days after the vaccine administration at 20-21 weeks of age). |
| Group 2: Sequential Administration | ACTIVE_COMPARATOR | Participants received 3 doses of RotaTeq® at 6-7 weeks of age, 15-16 weeks of age, and 24-25 weeks of age (and 28 to 42 days after the MMC vaccine administered at 20-21 weeks of age), and MCC vaccine at 10-11 weeks of age and 20-21 weeks of age. |
| 1 | EXPERIMENTAL | RotaTeq |
| 2 | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| RotaTeq (V260) | BIOLOGICAL | Live, pentavalent rotavirus vaccine administered as a 2 mL-dose oral solution |
| IPV | BIOLOGICAL | 0.5 mL dose IPV (Sabin strain based), administered via IM injection |
| RotaTeq® | BIOLOGICAL | Rotavirus vaccine, live, oral, pentavalent, 2 mL solution for oral administration. |
| NeisVac-C® | BIOLOGICAL | Meningiococcal Group C Polysaccharide Conjugate Vaccine Absorbed, 0.5 mL suspension for intramuscular injection. |
| Rotateq™ | BIOLOGICAL | 3 doses of 2.0 mL RotaTeq administered orally. Dose 1 will be given at study entry, Dose 2 will be given 4-10 weeks after Dose 1, Dose 3 will be given 4-10 weeks after Dose 2. |
| Comparator: Placebo | BIOLOGICAL | 3 doses of 2.0 mL Placebo to RotaTeq administered orally. Dose 1 will be given at study entry, Dose 2 will be given 4-10 weeks after Dose 1, Dose 3 will be given 4-10 weeks after Dose 2. |
Inclusion Criteria: * Healthy Chinese infant 48 days to 63 days of age. * Infant's legally acceptable representative provides written informed consent for the study. Exclusion Criteria: * History of rotavirus disease, congenital gastrointestinal disorders, chronic diarrhea, failure to thrive, or ...
RotaTeq is a vaccine used for the prevention of rotavirus gastroenteritis in infants and children caused by serotypes G1, G2, G3, G4, and G9. It is also studied in the context of rotavirus infections and meningococcal meningitis. RotaTeq is developed by Merck & Company, Inc. (MRK).
RotaTeq is a monoclonal antibody modality vaccine. It works by stimulating the immune system to produce a protective response against rotavirus serotypes G1, G2, G3, G4, and G9, which are common causes of gastroenteritis in infants and children.
RotaTeq is developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. Merck is responsible for the clinical development and manufacturing of this rotavirus vaccine.
RotaTeq is in Phase 3 clinical development. It has completed three Phase 3 trials, including the large Rotavirus Efficacy and Safety Trial (REST) with 69,274 participants. RotaTeq is an investigational vaccine and is not yet approved by regulatory authorities.
RotaTeq has completed three Phase 3 clinical trials: NCT00090233 (Rotavirus Efficacy and Safety Trial, REST), NCT00443846 (RotaTeq and Meningococcus C Vaccine in Healthy Infants), and NCT04481191 (Immunogenicity and Safety of Concomitant and Non-Concomitant Administration of RotaTeq and Inactivated Poliomyelitis Vaccine in Healthy Chinese Infants).
RotaTeq is also known as V260 in clinical trial nomenclature. The trials NCT00090233, NCT00443846, and NCT04481191 refer to RotaTeq as V260, with study numbers V260-006, V260-016, and V260-074 respectively.