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V260 Study: Concomitant Use of V260 and INFANRIX(tm) Hexa in Healthy Infants
This study has been completed.
Sponsored by: Merck
Information provided by: Merck
ClinicalTrials.gov Identifier: NCT00258154
  Purpose

The study is being conducted to demonstrate that the vaccine to prevent gastroenteritis due to rotavirus may be administered concomitantly with INFANRIX(tm)hexa without impairing the safety and immunogenicity of either vaccine.


Condition Intervention
Rotavirus Disease
Biological: V260, rotavirus vaccine, live, oral, pentavalent / Duration of Treatment 3-6 months
Drug: Comparator: INFANRIX (tm) hexa/Duration of Treatment 3-6 months

MedlinePlus related topics: Rotavirus Infections
Drug Information available for: RotaTeq
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study
Official Title: Safety and Immunogenicity of Concomitant Use of V260 and INFANRIX(tm) Hexa in Healthy Infants

Further study details as provided by Merck:

Primary Outcome Measures:
  • Immunogenicity of INFANRIX(tm)hexa(serum anti-polyribosylribitol phosphate and anti-hepatitis B surface antigen); Safety of V260; Measured at start and 42 days after a 3-dose regimen.

Secondary Outcome Measures:
  • Immunogenicity of V260 (serum anti-rotavirus IgA and SNA responses to rotavirus serotypes) and of INFANRIX(tm)hexa(serum antibody levels to DTP toxoids,Pertussis FHA,Pertussis PRN,Poliovirus types 1,2,3);At start and 42 days after a 3-dose regimen.

Enrollment: 522
Study Start Date: February 2006
Study Completion Date: June 2007
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   6 Weeks to 12 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy infant per investigator, 6 through 12 weeks of age

Exclusion Criteria:

  • History of congenital abdominal disorders, intussusception, or abdominal surgery.
  • Known or suspected impairment of immunological function.
  • Known hypersensitivity to any component of the rotavirus vaccine.
  • Prior administration of any rotavirus vaccine.
  • Known hypersensitivity or contraindication to any component of INFANRIX(tm) hexa.
  • Any infant born from a known HBsAg-positive mother.
  • Prior administration of any oral polio vaccine.
  • Receipt of one or more doses of inactivated poliovirus vaccine, diptheria, tetanus and acellular pertussis vaccine, diptheria, tetanus and pertussis vaccine, Haemophilus influenzae type b vaccine, or any hepatitis B vaccine prior to the first vaccination, or receipt of any vaccines with these antigens at any time during the course of the study.
  • Fever, with a rectal temperature greater than or equal to 38.1 degree C (greater than or equal to 100.5 degree F) at the time of immunization.
  • History of known prior rotavirus gastroenteritis, chronic diarrhea, or failure to thrive.
  • Clinical evidence of active gastrointestinal illness.
  • Receipt of intramuscular, oral, or intravenous corticosteroid treatment within the 2 weeks prior to vaccination.
  • Infants residing in a household with an immunocompromised person.
  • Prior receipt of a blood transfusion or blood products.
  • Participation in another clinical study within 42 days before the beginning or anytime during the duration of the current clinical study.
  • Any infant who cannot be adequately followed for safety by a contact visit.
  • History of seizure disorders or prior history followed for safety by a contact visit.
  • Any condition that, in the opinion of the investigator, may interfere with the evaluation of the study objectives.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00258154

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

Responsible Party: Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers: 2005_046, V260-010
Study First Received: November 15, 2005
Last Updated: September 30, 2008
ClinicalTrials.gov Identifier: NCT00258154  
Health Authority: Belgium: Directorate general for the protection of Public health: Medicines

Study placed in the following topic categories:
Virus Diseases
Rotavirus Infections
Healthy

Additional relevant MeSH terms:
RNA Virus Infections
Reoviridae Infections

ClinicalTrials.gov processed this record on January 14, 2009