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: April 22, 2014
Last verified: April 2014

May 14, 2012
April 22, 2014
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 ] [ Designated as safety issue: No ]
Geometric Mean Titer of Serum Neutralizing Antibody Response to Human Rotavirus Serotype G1 [ Time Frame: 14 days after vaccination 3 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01600092 on ClinicalTrials.gov Archive Site
  • Number of participants with Tier-1 Adverse Events [ Time Frame: Through 42 days after vaccination 3 ] [ Designated as safety issue: Yes ]
    Prespecified tier-1 adverse events are diarrhea, vomiting, elevated temperature, irritability, and intussusception
  • Geometric Mean Titer of Serum Anti-Rotavirus Immunoglobulin A [ Time Frame: 42 days after vaccination 3 ] [ Designated as safety issue: No ]
  • 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 Immunoglobulin A [ Time Frame: From Day 1 before vaccination 1 to 42 days after vaccination 3 ] [ Designated as safety issue: No ]
  • Number of participants with Tier-1 Adverse Events [ Time Frame: Through 14 days after vaccination 3 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
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 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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Rotavirus Gastroenteritis
  • Biological: 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)
    Other Name: V260
  • Biological: 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)
    Other Name: V260
  • Experimental: RotaTeq™ Experimental Formulation
    Intervention: Biological: RotaTeq™ experimental formulation
  • Active Comparator: RotaTeq™ Existing Formulation
    Intervention: Biological: RotaTeq™ existing formulation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1021
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
Both
6 Weeks to 12 Weeks
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01600092
V260-035
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
April 2014

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