A Study of the Immunogenicity, Tolerability, and Safety of a New Formulation of RotaTeq™ in Infants (V260-035)

Rotavirus Gastroenteritis Clinical Trial

Official title:

A Double-blind, Randomized, Controlled, Multicenter Study to Evaluate the Safety, Tolerability, and Immunogenicity of a New Formulation of RotaTeq™

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01600092
• Other study ID #: V260-035
• Status: Completed
• Phase: Phase 3
• Start date: April 29, 2013
• Est. completion date: March 25, 2014

Study information

• Verified date: October 2018
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A study to compare safety, tolerability, and immunogenicity of a new formulation of RotaTeq™ with the existing formulation in infants. The primary hypothesis of the study is that the new formulation will be noninferior to the existing formulation on the basis of immunogenicity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1020
• Est. completion date: March 25, 2014
• Est. primary completion date: March 25, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Weeks to 12 Weeks

Eligibility

Inclusion Criteria:

• Parent or legal guardian agrees to have infant participate by giving written informed consent

Exclusion Criteria:

• History of congenital abdominal disorders, prior rotavirus gastroenteritis, chronic diarrhea, failure to thrive, or abdominal surgery

• History of intussusception

• Known or suspected impairment of immunological function, including Severe

Combined Immunodeficiency (SCID)

• Prior administration of any rotavirus vaccine

• Clinical evidence of active gastrointestinal illness, with the exception of well-controlled gastroesophageal reflux disease (GERD)

• Receipt of 1) systemic corticosteroids (= 2mg/kg total daily dose of prednisone or equivalent) for 14 consecutive days or more since birth, or 2) systemic corticosteroids = 2mg/kg/dose within 7 days prior to the administration of the first dose of study vaccine. Participant using non-systemic corticosteroids will be eligible for vaccination.

• Residing in a household with an immunocompromised person

• Prior receipt of a blood transfusion or blood products, including immunoglobulins

• Participation in another interventional study within 14 days prior to the first study vaccination or expected anytime during the study

• Receipt of investigational inactivated vaccines within 14 days or investigational live vaccines within 28 days prior to the first study vaccination or expected anytime during the study

Related Conditions & MeSH terms

• Gastroenteritis
• Rotavirus Gastroenteritis

Intervention

Biological:
• RotaTeq™ experimental formulation

• RotaTeq™ existing formulation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Martinón-Torres F, Greenberg D, Varman M, Killar JA, Hille D, Strable EL, Stek JE, Kaplan SS. Safety, Tolerability and Immunogenicity of Pentavalent Rotavirus Vaccine Manufactured by a Modified Process. Pediatr Infect Dis J. 2017 Apr;36(4):417-422. doi: 1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Geometric Mean Titer of Serum Neutralizing Antibody Response to Human Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]		42 days after vaccination 3 (up to 185 days)
Secondary	Number of Participants With Tier-1 Adverse Events: Diarrhea, Vomiting, Elevated Temperature, and Irritability	An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse event. Protocol-defined Tier-1 adverse events to be collected up to 7 days after any vaccination were diarrhea, vomiting, elevated temperature (rectal >=38.1° C, >=100.5° F), and irritability.	Up to 7 days after any vaccination (up to 147 days)
Secondary	Number of Participants With Tier-1 Adverse Events: Intussusception	The protocol-defined Tier-1 adverse event to be collected for the duration of the study (up to Day 185) was intussusception	Up to Day 185
Secondary	Geometric Mean Titer of Serum Anti-Rotavirus Immunoglobulin A		42 days after vaccination 3 (up to 185 days)
Secondary	Percentage of Participants With >=3-fold Rise From Baseline in GMT of Serum Neutralizing Antibody to Human Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]		Baseline and 42 days after vaccination 3 (up to 185 days)