Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as RotaTeq (V260), V260
RotaTeq · 6 trials · 7 indications
The percentage of participants with an anti-HBsAg antibody titer ≥10 mill-International Units/mL (mIU/mL) was assessed. Participant serum samples were collected for analysis with an enhanced chemiluminescence assay to determine the concentration of antibodies to HBsAg.
The percentage of participants with an anti-Polyribosylribitol Phosphate (PRP) antibody titer ≥0.15 µg/mL was assessed. Participant serum samples were collected for analysis by radioimmunoassay to determine the concentration of antibodies to PRP, a Haemophilus influenzae type b (Hib) capsular polysaccharide.
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.
The number of participants with rotavirus gastroenteritis (RVGE) caused by naturally-occurring wild-type rotavirus (regardless of serotype or disease severity) was assessed. The case definition of RVGE included 1) 3 or more watery or looser-than-normal stools within a 24-hour period and/or forceful vomiting, and 2) naturally-occurring wild-type rotavirus must be detected in a stool specimen taken within 7 days after the onset of symptoms.
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.
G1, G2, G3, and G4 Serotype Rotavirus Gastroenteritis Cases Occurring at Least 14 Days Postdose 3 Through the First Rotavirus Season Postvaccination in the Per-Protocol Population Using Per-Protocol Case Definition
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 |
|---|---|---|
| PR5I (V1); Pediacel® (V2); PR5I (V3) | EXPERIMENTAL | \[Vaccination 1\]: Single doses of PR5I (V419) + NeisVac-C® + Prevenar 13® by intramuscular (IM) injection + oral RotaTeq®, given at 2 months of age. \[Vaccination 2\]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age. \[Vaccination 3\]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age. |
| 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). |
| V260 with staggered EPI | EXPERIMENTAL | V260 administered as a 2 mL oral solution at age \~2, 3, and 4 months, and staggered China Expanded Program on Immunizations (EPI) as follows: Oral poliovirus vaccine (OPV) administered as a 1 g oral solution at age \~2.5, 3.5, and 4.5 months, and diphtheria, tetanus, acellular pertussis vaccine (DTaP) administered as a 0.5 mL intramuscular injection at age \~3.5, 4.5, and 5.5 months |
| Placebo with staggered EPI | PLACEBO_COMPARATOR | Placebo administered as a 2 mL oral solution at age \~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age \~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age \~3.5, 4.5, and 5.5 months |
| V260 with concomitant EPI | EXPERIMENTAL | V260 administered as a 2 mL oral solution at age \~2, 3, and 4 months, and concomitant EPI as follows: OPV administered as a 1 g oral solution at age \~2, 3, and 4 months and DTaP administered as a 0.5 mL intramuscular injection at age \~3, 4, and 5 months |
| Placebo with concomitant EPI | PLACEBO_COMPARATOR | Placebo administered as a 2 mL oral solution at age \~2, 3, and 4 months, and concomitant EPI as follows: OPV administered as a 1 g oral solution at age \~2, 3, and 4 months and DTaP administered as a 0.5 mL intramuscular injection at age \~3, 4, and 5 months |
| 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. |
| RotaTeq™ at Expiry Potency (≈1.1 x 10^7 IU/Dose) | EXPERIMENTAL | Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart. |
| Placebo matching RotaTeq™ | PLACEBO_COMPARATOR | Placebo matching RotaTeq™ administered 28 to 70 days apart. |
| 1 | EXPERIMENTAL | RotaTeq |
| 2 | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| PR5I | BIOLOGICAL | Hexavalent PR5I vaccine (DTaP-HB-IPV-Hib = Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed \[DTaP\], Hepatitis B \[HB; Recombinant DNA\], Inactivated Poliovirus \[IPV\], and Haemophilus influenzae type b \[Hib\] conjugate vaccine \[adsorbed\]) at 0.5 mL for IM injection (left upper thigh) at 2 and 6 months of age. |
| Pediacel® | BIOLOGICAL | Pentavalent Pediacel® vaccine (DTaP-IPV-Hib = Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed \[DTaP\], Inactivated Poliovirus \[IPV\], and Haemophilus influenzae type b \[Hib\] conjugate vaccine \[adsorbed\]) at 0.5 mL for IM injection (left upper thigh) at 4 months of age. |
| NeisVac-C® | BIOLOGICAL | Meningococcal group C (MCC) polysaccharide conjugate vaccine (adsorbed) at 0.5 mL for IM injection (right upper thigh) at 2 and 4 months of age. |
| RotaTeq® | BIOLOGICAL | Human-bovine rotavirus reassortants (live) vaccine 2 mL oral administration at 2, 4 and 6 months of age. RotaTeq® administered prior to any other vaccine administration to avoid having the infant participants spit up the RotaTeq® when crying. |
| Prevenar 13® | BIOLOGICAL | Pneumococcal polysaccharide conjugate vaccine \[PCV; 13-valent, adsorbed\]) at 0.5 mL for IM injection (right upper thigh) at 2 and 4 months of age. |
| 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 |
| V260 | BIOLOGICAL | V260 (RotaTeq™; live, oral, pentavalent rotavirus vaccine) |
| Placebo to V260 | BIOLOGICAL | Placebo control |
| OPV | BIOLOGICAL | Oral poliovirus vaccine administered according to the standard of care |
| DTaP | BIOLOGICAL | Diphtheria, Tetanus, Acellular Pertussis vaccine administered according to the standard of care |
| RotaTeq™, rotavirus vaccine, live, oral, pentavalent | BIOLOGICAL | Three doses of RotaTeq™ administered 28 to 70 days apart. |
| Comparator: Placebo matching RotaTeq™ | BIOLOGICAL | Placebo matching RotaTeq™ administered 28 to 70 days apart. |
| 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 infant 46 to 74 days (both inclusive) * Documented receipt of only one dose of monovalent hepatitis B vaccine within the 3 days after birth * Parent(s)/legal representative able to comply with the study procedures Exclusion Criteria: * Participation in any study with...
RotaTeq is used to prevent rotavirus gastroenteritis in infants and children caused by serotypes G1, G2, G3, G4, and G9. It is also studied in combination with other infant vaccines, including meningococcal and poliomyelitis immunization schedules. It is an infectious disease product developed by Merck & Company, Inc.
RotaTeq is made by Merck & Company, Inc., which trades under the ticker MRK. Merck develops and sponsors the RotaTeq clinical program, including the Phase 3 trials listed under the V260 study code.
RotaTeq is in Phase 3 development. Its registered trials are Phase 3 studies, and all four listed trials have completed. The program includes a total enrollment of 70,586 participants across randomized, active-controlled studies.
RotaTeq trials include NCT04481191, a Phase 3 immunogenicity and safety study with inactivated poliomyelitis vaccine in healthy Chinese infants; NCT01839188, a Spanish mixed HEXA/PENTA/HEXA schedule study; NCT00443846, evaluating RotaTeq with meningococcus C vaccine; and NCT00092443, a dose confirmation efficacy study.
Yes. RotaTeq is also known as RotaTeq (V260), RotaTeq, rotavirus vaccine, live, oral, pentavalent, and rotavirus vaccine, live, pentavalent. These names refer to the same Merck product, so searches using any of these terms point to the same asset.
RotaTeq is a monoclonal antibody modality directed at rotavirus gastroenteritis prevention, covering serotypes G1, G2, G3, G4, and G9. Its clinical program also involves co-administration with meningococcal and poliomyelitis vaccines in infant immunization schedules.