RotaTeq Vaccine Clinical Trials, Dosage, Indication, Side Effects

RotaTeq is a live, oral pentavalent vaccine that contains five reassortant viruses. Four reassortant rotaviruses express one of the outer capsid proteins (G1, G2, G3, or G4) from the human rotavirus parent strain and the attachment protein (serotype P7) from the bovine rotavirus parent strain. The fifth reassortant virus expresses the attachment protein, P1A (genotype P), referred to as serotype P1A, from the human rotavirus parent strain and the outer capsid protein of serotype G6 from the bovine rotavirus parent strain. 

On September 10, 2024, an American Academy of Pediatrics study found the effectiveness of a single dose of the rotavirus vaccine against emergency department visits or hospitalizations for inflammation of the gastrointestinal tract was 78% in children younger than five years and 53% in older children.

RotaTeq was extensively tested and was approved by the U.S. Food and Drug Administration (FDA) in February 2006. The FDA's BL 125122 was issued to New Jersey-based Merck Sharp & Dohme Corp.

RotaTeq Indication

RotaTeq is indicated to prevent rotavirus gastroenteritis in infants and children caused by Types G1, G2, G3, G4, and G9. It is approved for use in infants aged six to 32 weeks.

RotaTeq Dosage

The vaccination series is administered as an oral 3-dose series to infants between the ages of 6 and 32 weeks. The first dose of RotaTeq should be administered between 6 and 12 weeks, and the third dose should not be given after 32 weeks.

RotaTeq Vaccine News

August 9, 2022 - The Lancet published - Head-to-head comparison of the immunogenicity of RotaTeq and Rotarix rotavirus vaccines and factors associated with seroresponse in infants in Bangladesh: a randomized, controlled, open-label, parallel, phase 4 clinical trial.

January 20, 2022 - In a Lancet article, researchers reported on a study that showed RV3-BB was well tolerated and immunogenic when co-administered with Expanded Programme on Immunisation vaccines in a neonatal or infant schedule.

May 10, 2021 - A study published by JAMA Pediatrics found a high protection and low risk of serious adverse events for rotavirus vaccine fully vaccinated children named, emphasizing the importance of worldwide rotavirus vaccinations. This study's findings from a meta-analysis revealed that RotaTeq vaccinations reduced rotavirus gastroenteritis in children younger than five years by 63.6%.

April 29, 2021 - Merck reported RotaTeq vaccine sales decreased 29% last year. 

RotaTeq Clinical Trials

RotaTeq wasFDA-approvedoved in 2006. However, this rotavirus vaccine continues to be challenged in clinical trials today.