Clinical trial NCT00258154: V260 Study: Concomitant Use of V260 and INFANRIX™ Hexa in Healthy Infants (V260-010)
Official title: Safety and Immunogenicity of Concomitant Use of V260 and INFANRIX™ Hexa in Healthy Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rotavirus Disease
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2005-11-24
Enrollment: 403
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Immunogenicity of INFANRIX™ Hexa in Relation to Anti-hepatitis B Surface Antigen HBsAg, Predose 1
timeFrame: Day 1 of a 3-dose regimen
measure: Immunogenicity of INFANRIX™ Hexa in Relation to Anti-hepatitis B Surface Antigen HBsAg , at 42 Days After a 3-dose Regimen
timeFrame: 42 days after 3-dose regimen
measure: Immunogenicity of INFANRIX™ Hexa in Relation to Serum Anti-polyribosylribitol Phosphate PRP, Predose 1
timeFrame: Day 1 of 3-dose regimen
measure: Immunogenicity of INFANRIX™ Hexa in Relation to Serum Anti-polyribosylribitol Phosphate PRP at 42 Days After a 3-dose Regimen
timeFrame: 42 days after a 3-dose regimen
Secondary outcomes:
measure: Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Poliovirus Type 1 When Administered Concomitantly With RotaTeq™, Predose 1
timeFrame: Predose (Day 1 of a 3-dose regimen)
measure: Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Poliovirus Type 1 When Administered Concomitantly With RotaTeq™, 42 Days After a 3-dose Regimen
timeFrame: 42 days after a 3-dose regimen
measure: Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Poliovirus Type 2 When Administered Concomitantly With RotaTeq™, Predose 1
timeFrame: Pre-dose (Day 1 of a 3-dose regimen)
measure: Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Poliovirus Type 2 When Administered Concomitantly With RotaTeq™, 42 Days After a 3-dose Regimen
timeFrame: 42 days after in a 3-dose regimen
measure: Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Poliovirus Type 3 When Administered Concomitantly With RotaTeq™, Predose 1
timeFrame: Predose (Day 1 of a 3-dose regimen)
measure: Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Poliovirus Type 3 When Administered Concomitantly With RotaTeq™, 42 Days After a 3-dose Regimen
timeFrame: 42 days after a 3-dose regimen
measure: Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Diphtheria Toxoid When Administered Concomitantly With RotaTeq™, Predose 1
timeFrame: Predose (Day 1 of a 3-dose regimen)
measure: Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Diphtheria Toxoid When Administered Concomitantly With RotaTeq™, 42 Days After a 3-dose Regimen
timeFrame: 42 days after a 3-dose regimen
measure: Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Tetanus Toxoid When Administered Concomitantly With RotaTeq™, Predose 1
timeFrame: Predose (Day 1 of a 3-dose regimen)
measure: Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Tetanus Toxoid When Administered Concomitantly With RotaTeq™, 42 Days After a 3-dose Regimen
timeFrame: 42 days after a 3-dose regimen
measure: Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Pertussis FHA When Administered Concomitantly With RotaTeq™, Predose 1
timeFrame: Predose (Day 1 of a 3-dose regimen)
measure: Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Pertussis FHA When Administered Concomitantly With RotaTeq™, 42 Days After a 3-dose Regimen
timeFrame: 42 days after a 3-dose regimen
measure: Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Pertussis Pertactin When Administered Concomitantly With RotaTeq™, Predose 1
timeFrame: Predose (Day 1 of a 3-dose regimen)
measure: Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Pertussis Pertactin When Administered Concomitantly With RotaTeq™, 42 Days After a 3-dose Regimen
timeFrame: 42 days after a 3-dose regimen
measure: Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Pertussis Toxoid When Administered Concomitantly With RotaTeq™, Predose 1
timeFrame: Predose (Day 1 of a 3-dose regimen)
measure: Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Pertussis Toxoid When Administered Concomitantly With RotaTeq™, 42 Days After a 3-dose Regimen
timeFrame: 42 days after a 3-dose regimen
measure: Serum Neutralizing Antibody (SNA) Response to Serotype G1 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa, Predose 1
timeFrame: Predose (Day 1 of a 3-dose regimen)
measure: Serum Neutralizing Antibody (SNA) Response to Serotype G1 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa, 42 Days After a 3-dose Regimen
timeFrame: 42 days after a 3-dose regimen
measure: Serum Neutralizing Antibody (SNA) Response to Serotype G2 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa, Predose 1
timeFrame: Predose (Day 1 of a 3-dose regimen)
measure: Serum Neutralizing Antibody (SNA) Response to Serotype G2 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa 42 Days After a 3-dose Regimen
timeFrame: 42 days after a 3-dose regimen
measure: Serum Neutralizing Antibody (SNA) Response to Serotype G3 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa Predose 1
timeFrame: Predose (Day 1 of a 3-dose regimen)
measure: Serum Neutralizing Antibody (SNA) Response to Serotype G3 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa 42 Days After a 3-dose Regimen
timeFrame: 42 days after a 3-dose regimen
measure: Serum Neutralizing Antibody (SNA) Response to Serotype G4 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa Predose 1
timeFrame: Predose (Day 1 of a 3-dose regimen)
measure: Serum Neutralizing Antibody (SNA) Response to Serotype G4 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa 42 Days After a 3-dose Regimen
timeFrame: 42 days after a 3-dose regimen
measure: Serum Neutralizing Antibody (SNA) Response to Serotype P1A in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa Predose 1
timeFrame: Predose (Day 1 of a 3-dose regimen)
measure: Serum Neutralizing Antibody (SNA) Response to Serotype P1A in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa 42 Days After a 3-dose Regimen
timeFrame: 42 days after a 3-dose regimen
measure: Serum Neutralizing Antibody (SNA) Response to Serum Anti-rotavirus IgA in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa Predose 1
timeFrame: Predose (Day 1 of a 3-dose regimen)
measure: Serum Neutralizing Antibody (SNA) Response to Serum Anti-rotavirus IgA in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa 42 Days After a 3-dose Regimen
timeFrame: 42 days after a 3-dose regimen
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Ciarlet M, He S, Lai S, Petrecz M, Yuan G, Liu GF, Mikviman E, Heaton PM, Panzer F, Rose T, Koller DY, Van Damme P, Schodel F. Concomitant use of the 3-dose oral pentavalent rotavirus vaccine with a 3-dose primary vaccination course of a diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated polio-Haemophilus influenzae type b vaccine: immunogenicity and reactogenicity. Pediatr Infect Dis J. 2009 Mar;28(3):177-81. doi: 10.1097/INF.0b013e31818c0161.