RotaTeq is an oral pentavalent vaccine indicated for the prevention of rotavirus gastroenteritis in infants and children caused by the serotypes G1, G2, G3, G4, and G-serotypes that contain P1 (e.g., G9). MedDRA version: 10 Level: LLT Classification code 10017913
Conditions
Interventions
Product Name: RotaTeq
Product Code: V260
Pharmaceutical Form: Oral solution
Pharmaceutical form of the placebo: Oral solution
Route of administration of the placebo: Oral use
Product Name: INFANRIX h
Sponsors
Merck and Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Infants in good health, 6 to 12 weeks of age. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 the INFANRIX™ hexa vaccine. 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, diphtheria, tetanus and acellular pertussis vaccine, diphtheria, tetanus and pertussis vaccine, Haemophilus influenzae type b vaccine, or any hepatitis B vaccine prior to the first vaccination. Fever, with a rectal temperature greater than/equal to 38.1 degrees C (great than/equal to 100.5 degrees 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. History of seizure disorders or prior history of seizure disorders with or without fever.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Main objective : (1) To evaluate the immunogenicity of intramuscular INFANRIX™ hexa (in relation to serum anti-polyribosylribitol phosphate [PRP] and anti-hepatitis B surface antigen [HBsAg]) when administered concomitantly with RotaTeq™†; (2) To assess the safety of RotaTeq™ when administered concomitantly with intramuscular INFANRIX™ hexa. ;Secondary Objective: Secondary objectives : (1) To evaluate the immunogenicity of RotaTeq™ (as measured by serum anti-rotavirus IgA and serum neutralizing antibody [SNA] responses to rotavirus serotypes G1, G2, G3, G4, and P1A) when administered concomitantly with intramuscular INFANRIX™ hexa; (2) To evaluate the immunogenicity of intramuscular INFANRIX™ hexa (in relation to serum antibody levels to Diphtheria toxoid, Tetanus toxoid, Pertussis toxoid [PTxd], Pertussis filamentous hemagglutinin [FHA], Pertussis pertactin [PRN], and poliovirus types 1, 2, and 3) when administered concomitantly with RotaTeq™.;Primary end point(s): (1) The seroprotection rate for polyribosylribitol phosphate (PRP), the proportion of subjects who achieve serum antibody levels of =0.15 µg/mL, as measured post dose 3, in subjects receiving RotaTeq™ concomitantly with INFANRIX™ hexa is non-inferior to those in subjects receiving placebo concomitantly with INFANRIX™ hexa [Non-inferiority criterion corresponds to the lower bound of the two-sided 95% confidence interval on the difference in proportion, excluding a decrease of =10 percentage points]. (2) The seroprotection rate for hepatitis B surface antigen (HBsAg), the proportion of subjects who achieve serum antibody levels =10 mIU/mL, as measured post dose 3, in subjects receiving RotaTeq™ concomitantly with INFANRIX™ hexa is non-inferior to those in subjects receiving placebo concomitantly with INFANRIX™ hexa [Non-inferiority criterion corresponds to the lower bound of the two-sided 95% confidence interval on the difference in proportion+, excluding a decrease of =10 percentage poin | — |
Countries
Germany
Outcome results
None listed