V260 Study: Concomitant Use of V260 and INFANRIX™ Hexa in Healthy Infants (V260-010)

Study Overview
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Brief Summary
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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.

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

Conditions
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Rotavirus Disease

Intervention / Treatment
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* Biological: Rotavirus Vaccine, Live, Oral, Pentavalent
* Biological: Comparator: placebo
* Biological: Comparator: Infanrix(tm) Hexa


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Weeks
Maximum Age: 12 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>RotaTeq/Infanrix Hexa | Biological: Rotavirus Vaccine, Live, Oral, Pentavalent<br>* 3 doses of rotavirus vaccine live, oral, pentavalent on Day 1, 28 to 42 days post dose 1 and 28 to 42 days post dose 2<br>Biological: Comparator: Infanrix(tm) Hexa<br>* 3 doses of oral Infanrix(tm) Hexa on Day 1, 28 to 42 days post dose 1 and 28 to 42 days post dose 2<br>|
| Placebo Comparator: 2<br>Placebo/Infanrix Hexa | Biological: Comparator: placebo<br>* 3 doses of placebo to rotavirus vaccine live, oral, pentavalent on Day 1, 28 to 42 days post dose 1 and 28 to 42 days post dose 2<br>Biological: Comparator: Infanrix(tm) Hexa<br>* 3 doses of oral Infanrix(tm) Hexa on Day 1, 28 to 42 days post dose 1 and 28 to 42 days post dose 2<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity of INFANRIX™ Hexa in Relation to Anti-hepatitis B Surface Antigen HBsAg, Predose 1 | 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 | Day 1 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 | GMT/antibody responses to RotaTeq™ and INFANRIX™ in relation to anti-hepatitis B surface antigen HBsAg at 42 days after 3-dose regimen | 42 days after 3-dose regimen | 
| Immunogenicity of INFANRIX™ Hexa in Relation to Serum Anti-polyribosylribitol Phosphate PRP, Predose 1 | GMT/antibody responses to RotaTeq™ and INFANRIX™ hexa in relation to serum anti-polyribosylribitol phosphate PRP at start of 3-dose regimen | Day 1 of 3-dose regimen | 
| Immunogenicity of INFANRIX™ Hexa in Relation to Serum Anti-polyribosylribitol Phosphate PRP at 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 | 42 days after a 3-dose regimen | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Poliovirus Type 1 When Administered Concomitantly With RotaTeq™, Predose 1 | GMT of Poliovirus Type 1 in subjects with even allocation numbers, receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa at the start of a 3-dose regimen | Predose (Day 1 of 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 | GMT of Poliovirus Type 1 in subjects with even allocation numbers, receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + 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 2 When Administered Concomitantly With RotaTeq™, Predose 1 | GMT of Poliovirus Type 2 in subjects with even allocation numbers, receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa at the start of a 3-dose regimen | Pre-dose (Day 1 of 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 | GMT of Poliovirus Type 2 in subjects with even allocation numbers, receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 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 Poliovirus Type 3 When Administered Concomitantly With RotaTeq™, Predose 1 | GMT of Poliovirus Type 3 in subjects with even allocation numbers, receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa at the start of a 3-dose regimen | 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 | GMT of Poliovirus Type 3 in subjects with even allocation numbers, receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + 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 Diphtheria Toxoid When Administered Concomitantly With RotaTeq™, Predose 1 | GMT of diphtheria toxoid in subjects with odd allocation numbers, receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa at the start of a 3-dose regimen | 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 | GMT of diphtheria toxoid in subjects with odd allocation numbers, receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + 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™, Predose 1 | GMT of tetanus toxoid in subjects with odd allocation numbers, receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa at the start of a 3-dose regimen | Predose (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™, 42 Days After a 3-dose Regimen | GMT of tetanus toxoid in subjects with odd allocation numbers, receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + 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 Pertussis FHA When Administered Concomitantly With RotaTeq™, Predose 1 | GMT of pertussis FHA in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa at the start of a 3-dose regimen | 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™, 42 Days After a 3-dose Regimen | GMT of pertussis FHA in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + 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 Pertussis Pertactin When Administered Concomitantly With RotaTeq™, Predose 1 | GMT of pertussis Pertactin in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa at the start of a 3-dose regimen | Predose (Day 1 of 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 | GMT of pertussis Pertactin in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + 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 Pertussis Toxoid When Administered Concomitantly With RotaTeq™, Predose 1 | GMT of pertussis toxoid in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa at the start of a 3-dose regimen | 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 | GMT of pertussis toxoid in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 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, Predose 1 | GMT of serotype G1 in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa at the start of a 3-dose regimen | Predose (Day 1 of 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 | GMT of serotype G1 in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + 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 | GMT of serotype G2 in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa at the start of a 3-dose regimen | 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 | GMT of serotype G2 in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen | 42 days after a 3-dose regimen | 
| Serum Neutralizing Antibody (SNA) Response to Serotype G3 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa Predose 1 | GMT of serotype G3 in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + 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 | GMT of serotype G3 in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen | 42 days after a 3-dose regimen | 
| Serum Neutralizing Antibody (SNA) Response to Serotype G4 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa Predose 1 | GMT of serotype G4 in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + 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 | GMT of serotype G4 in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + 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 | GMT of serotype P1A in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + 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 | GMT of serotype P1A in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + 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 Predose 1 | GMT of serum anti-rotavirus IgA in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + 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 42 Days After a 3-dose Regimen | GMT of serum anti-rotavirus IgA in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen | 42 days after a 3-dose regimen |