Data updated: May 26, 2026
Rotateq (rotavirus vaccine, live, oral, pentavalent)
Approved 2006-02-02
1
Indication
--
Phase 3 Trials
20
Years on Market
Details
- Status
- Prescription
- First Approved
- 2006-02-02
- Revenue
- $771M (FY-2024)
- Routes
- Oral
- Dosage Forms
- Suspension
Rotateq Approval History
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2006 to 2006
Feb 2006 ORIGINAL
Update · CBER biologic (Purple Book)
What Rotateq Treats
1 FDA approvalsOriginally approved for its first indication in 2006 .
- Other (1)
Other
(1 approval)- • Approved indication (Feb 2006)
📋
Clinical Trial Registry
12 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06736041 | PSK03 U1111-1294-7860 | Ph 3 | active not recruiting | Study of a 4-Dose Regimen of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age |
| NCT06824194 | PSK05 U1111-1295-5983 | Ph 3 | active not recruiting | Study of the Safety of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age |
| NCT06824181 | PSK00031 U1111-1294-7911 | Ph 3 | active not recruiting | Study of Mixed Vaccination Schedules With a 21-valent Pneumococcal Conjugate Vaccine and a 20-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age |
| NCT04398706 results posted | PSK00008 U1111-1238-1638, PSK00008 | Ph 2 | completed | Study of a Pneumococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Toddlers and Infants |
| NCT03691610 results posted | MET61 U1111-1205-2836, MET61 | Ph 3 | completed | Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers |
| NCT00880698 results posted | P1072 10638, IMPAACT P1072 | Ph 2 | completed | Safety and Immune Response of a Rotavirus Vaccine in HIV-infected and Uninfected Children Born to HIV-infected Mothers |
| NCT01341639 results posted | V419-007 2010-021490-37 | Ph 3 | completed | Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 3, 4 and 12 Months (V419-007) |
| NCT02193061 | Rota/CeNSIA | Ph 3 | completed | Randomized, Controlled Single-blind Clinical Study to Assess Vaccine Interchangeability Between RV5 and RV1 Using Seven Combined Anti-rotavirus Prevention Programs |
| NCT01839175 | HXM01C 2012-005547-24 | Ph 3 | completed | Concomitant Administration of a New Hexavalent Vaccine With a Meningococcal Serogroup C Conjugate Vaccine in Healthy Infants During Primary Series Immunisation Followed by Booster Vaccination |
| NCT00496054 results posted | V260-021 2007_020 | Ph 3 | completed | Safety,Tolerability and Immunogenicity of Vaccination With Rotateq in Healthy Infants in India (V260-021) |
| NCT00953056 results posted | V260-028 2009_627 | Ph 1 | completed | A Study of V260 in Healthy Chinese Adults, Children and Infants (V260-028)(COMPLETED) |
| NCT01003431 | V260-036 V260-036 | Ph 3 | withdrawn | A Study of the Immunogenicity and Safety of Whole-Cell Pertussis Containing Vaccine Administered Concomitantly With RotaTeq™ (V260) or Rotarix™ (V260-036)(WITHDRAWN) |
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
Loading...
⭐
Pro Key Completed Trials
Completed studies with published results, ranked by significance
Loading...
📊
Trial Timeline
Full development history with FDA approval milestones
|
Loading...
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
Rotateq FDA Label Details
Pro Intelligence Preview
Deep insights for Rotateq
Revenue Insights
- • FY-2024: $771M
- • Historical trend analysis
Patent Timeline
- • Patent expiration dates
- • Generic/biosimilar risk
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
Unlock Full Intelligence
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.