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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01600092
First received: May 14, 2012
Last updated: February 17, 2017
Last verified: February 2017

May 14, 2012
February 17, 2017
April 2013
March 2014   (Final data collection date for primary outcome measure)
Geometric Mean Titer of Serum Neutralizing Antibody Response to Human Rotavirus Serotypes G1, G2, G3, G4, and P1A[8] [ Time Frame: 42 days after vaccination 3 (up to 185 days) ]
Geometric Mean Titer of Serum Neutralizing Antibody Response to Human Rotavirus Serotype G1 [ Time Frame: 14 days after vaccination 3 ]
Complete list of historical versions of study NCT01600092 on ClinicalTrials.gov Archive Site
  • Number of Participants With Tier-1 Adverse Events: Diarrhea, Vomiting, Elevated Temperature, and Irritability [ Time Frame: Up to 7 days after any vaccination (up to 147 days) ]
    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.
  • Number of Participants With Tier-1 Adverse Events: Intussusception [ Time Frame: Up to Day 185 ]
    The protocol-defined Tier-1 adverse event to be collected for the duration of the study (up to Day 185) was intussusception
  • Geometric Mean Titer of Serum Anti-Rotavirus Immunoglobulin A [ Time Frame: 42 days after vaccination 3 (up to 185 days) ]
  • 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] [ Time Frame: Baseline and 42 days after vaccination 3 (up to 185 days) ]
  • Number of participants with Tier-1 Adverse Events [ Time Frame: Through 14 days after vaccination 3 ]
    Prespecified tier-1 adverse events are diarrhea, vomiting, elevated temperature, irritability, and intusussception
  • Geometric Mean Titer of Serum Neutralizing Antibody Response to Human Rotavirus Serotypes G2, G3, G4, P1A[8], and Serum Anti-Rotavirus IgA [ Time Frame: 14 days after vaccination 3 ]
  • Number of participants with ≥ 3-Fold Rise in Titers of Serum Neutralizing Antibody Titer Against Human Rotavirus Serotypes G1, G2, G3, G4, P1A[8], and Serum Anti-Rotavirus IgA [ Time Frame: From Day 1 before vaccination 1 to 14 days after vaccination 3 ]
Not Provided
Not Provided
 
A Study of the Immunogenicity, Tolerability, and Safety of a New Formulation of RotaTeq™ in Infants (V260-035)
A Double-blind, Randomized, Controlled, Multicenter Study to Evaluate the Safety, Tolerability, and Immunogenicity of a New Formulation of RotaTeq™
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Prevention
Rotavirus Gastroenteritis
  • Biological: RotaTeq™ experimental formulation
    Other Name: V260
  • Biological: RotaTeq™ existing formulation
    Other Name: V260
  • Experimental: RotaTeq™ Experimental Formulation
    Three 2.0 mL oral doses of RotaTeq™ experimental formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days)
    Intervention: Biological: RotaTeq™ experimental formulation
  • Active Comparator: RotaTeq™ Existing Formulation
    Three 2.0 mL oral doses of RotaTeq™ existing formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
    Intervention: Biological: RotaTeq™ existing formulation
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: 10.1097/INF.0000000000001511.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1020
March 2014
March 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
6 Weeks to 12 Weeks   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
Canada,   Czech Republic,   Denmark,   Finland,   Israel,   Mexico,   Poland,   Spain,   Sweden,   United States
 
NCT01600092
V260-035
No
Not Provided
Yes

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php

Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Director Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP