A Study of the Immunogenicity and Safety of Whole-Cell Pertussis Containing Vaccine Administered Concomitantly With RotaTeq™ (V260) or Rotarix™ (V260-036)(WITHDRAWN)

Study Overview
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Brief Summary
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This study will evaluate the immunogenicity and safety of the pertussis component of DTwP (whole-cell pertussis containing vaccine) when administered concomitantly with RotaTeq™ or Rotatrix™.

Official Title
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A Randomized, Open-Label Clinical Study to Assess the Immunogenicity and Safety of Whole-Cell Pertussis Containing Vaccine When Administered Concomitantly With RotaTeq™ or Rotarix™ in Healthy Infants in South Africa

Conditions
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Rotavirus Gastroenteritis, Diphtheria, Tetanus, Pertussis

Intervention / Treatment
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* Biological: Rotavirus Vaccine, Live, Oral, Pentavalent
* Biological: Comparator: Rotarix™ administered concomitantly with Tritanrix™ HepB (DTwP)
* Biological: Comparator: RotaTeq™ administered concomitantly with INFANRIX™ (DTaP)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy infants Exclusion Criteria: History of abdominal disorders, intestinal folding, or abdominal surgery Impaired immune system Prior administration of any rotavirus vaccine or DTwP/DTaP Fever of >= 38.1C (100.5F) at the time of vaccination History of prior rotavirus infection, chronic diarrhea, or failure to thrive Evidence of active gastrointestinal illness

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>RotaTeq™ + DTwP | Biological: Rotavirus Vaccine, Live, Oral, Pentavalent<br>* [Intervention name: RotaTeq™ administered concomitantly with Tritanrix™ HepB (DTwP)] Three 2.0 mL oral doses of RotaTeq™ and three 0.5 mL intramuscular injections of Tritanrix™ HepB will be given at the same time with about 1 month between each administration.<br>|
| Active Comparator: 2<br>Rotarix™ + DTwP | Biological: Comparator: Rotarix™ administered concomitantly with Tritanrix™ HepB (DTwP)<br>* Two 1.0 mL oral doses of Rotarix™ and three 0.5 mL intramuscular injections of Tritanrix™ HepB will be given at the same time with about 1 month between each administration (the second administration will be Tritanrix™ HepB only).<br>|
| Active Comparator: 3<br>RotaTeq™ + DTaP | Biological: Comparator: RotaTeq™ administered concomitantly with INFANRIX™ (DTaP)<br>* Three 2.0 mL oral doses of RotaTeq™ and three 0.5 mL intramuscular injections of INFANRIX™ will be given at the same time with about 1 month between each administration.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric Mean Titer (GMT) for Pertussis Toxoid |  | 1 month post dose 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric Mean Titer (GMT) for rotavirus serotypes G1, G2, G3, G4 and P1A |  | 1 month post dose 3 |