Safety and Immunogenicity of Concomitant Use of V260 and INFANRIX™ Hexa in Healthy Infants

Merck Sharp & Dohme LLC0 sites403 target enrollmentFebruary 2006

ConditionsRotavirus Disease

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Rotavirus Disease
Sponsor: Merck Sharp & Dohme LLC
Enrollment: 403
Primary Endpoint: Immunogenicity of INFANRIX™ Hexa in Relation to Anti-hepatitis B Surface Antigen HBsAg, Predose 1
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 2006

End Date

November 2006

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Merck Sharp & Dohme LLC

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

Immunogenicity of INFANRIX™ Hexa in Relation to Anti-hepatitis B Surface Antigen HBsAg, Predose 1

Time Frame: Day 1 of a 3-dose regimen

Geometric Mean Titer (GMT)/antibody responses to RotaTeq™ and INFANRIX™ in relation to anti-hepatitis B surface antigen HBsAg at start of a 3-dose regimen

Immunogenicity of INFANRIX™ Hexa in Relation to Anti-hepatitis B Surface Antigen HBsAg , at 42 Days After a 3-dose Regimen

Time Frame: 42 days after 3-dose regimen

GMT/antibody responses to RotaTeq™ and INFANRIX™ in relation to anti-hepatitis B surface antigen HBsAg at 42 days after 3-dose regimen

Immunogenicity of INFANRIX™ Hexa in Relation to Serum Anti-polyribosylribitol Phosphate PRP, Predose 1

Time Frame: Day 1 of 3-dose regimen

GMT/antibody responses to RotaTeq™ and INFANRIX™ hexa in relation to serum anti-polyribosylribitol phosphate PRP at start of 3-dose regimen

Immunogenicity of INFANRIX™ Hexa in Relation to Serum Anti-polyribosylribitol Phosphate PRP at 42 Days After a 3-dose Regimen

Time Frame: 42 days after a 3-dose regimen

GMT/antibody responses to RotaTeq™ and INFANRIX™ hexa in relation to serum anti-polyribosylribitol phosphate PRP at 42 days after a 3-dose regimen

Secondary Outcomes

Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Poliovirus Type 1 When Administered Concomitantly With RotaTeq™, Predose 1(Predose (Day 1 of a 3-dose regimen))
Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Pertussis FHA When Administered Concomitantly With RotaTeq™, Predose 1(Predose (Day 1 of a 3-dose regimen))
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(42 days after a 3-dose regimen)
Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Poliovirus Type 3 When Administered Concomitantly With RotaTeq™, Predose 1(Predose (Day 1 of a 3-dose regimen))
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(42 days after a 3-dose regimen)
Serum Neutralizing Antibody (SNA) Response to Serotype G1 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa, 42 Days After a 3-dose Regimen(42 days after a 3-dose regimen)
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(42 days after a 3-dose regimen)
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(42 days after in a 3-dose regimen)
Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Diphtheria Toxoid When Administered Concomitantly With RotaTeq™, Predose 1(Predose (Day 1 of a 3-dose regimen))
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(42 days after a 3-dose regimen)
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(42 days after a 3-dose regimen)
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(42 days after a 3-dose regimen)
Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Poliovirus Type 2 When Administered Concomitantly With RotaTeq™, Predose 1(Pre-dose (Day 1 of a 3-dose regimen))
Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Tetanus Toxoid When Administered Concomitantly With RotaTeq™, Predose 1(Predose (Day 1 of a 3-dose regimen))
Serum Neutralizing Antibody (SNA) Response to Serotype G2 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa 42 Days After a 3-dose Regimen(42 days after a 3-dose regimen)
Serum Neutralizing Antibody (SNA) Response to Serotype P1A in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa Predose 1(Predose (Day 1 of a 3-dose regimen))
Serum Neutralizing Antibody (SNA) Response to Serotype P1A in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa 42 Days After a 3-dose Regimen(42 days after a 3-dose regimen)
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(42 days after a 3-dose regimen)
Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Pertussis Pertactin When Administered Concomitantly With RotaTeq™, Predose 1(Predose (Day 1 of a 3-dose regimen))
Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Pertussis Toxoid When Administered Concomitantly With RotaTeq™, Predose 1(Predose (Day 1 of a 3-dose regimen))
Serum Neutralizing Antibody (SNA) Response to Serotype G1 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa, Predose 1(Predose (Day 1 of a 3-dose regimen))
Serum Neutralizing Antibody (SNA) Response to Serotype G3 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa Predose 1(Predose (Day 1 of a 3-dose regimen))
Serum Neutralizing Antibody (SNA) Response to Serotype G3 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa 42 Days After a 3-dose Regimen(42 days after a 3-dose regimen)
Serum Neutralizing Antibody (SNA) Response to Serotype G2 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa, Predose 1(Predose (Day 1 of a 3-dose regimen))
Serum Neutralizing Antibody (SNA) Response to Serum Anti-rotavirus IgA in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa Predose 1(Predose (Day 1 of a 3-dose regimen))
Serum Neutralizing Antibody (SNA) Response to Serotype G4 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa Predose 1(Predose (Day 1 of a 3-dose regimen))
Serum Neutralizing Antibody (SNA) Response to Serotype G4 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa 42 Days After a 3-dose Regimen(42 days after a 3-dose regimen)
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(42 days after a 3-dose regimen)