Concomitant Use and Staggered Use of Vaccine and Oral Poliovirus (OPV) in Healthy Infants (V260-014)(COMPLETED)

Study Overview
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Brief Summary
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The study is being conducted to demonstrate that vaccine to prevent gastroenteritis due to rotavirus may be administered concomitantly with oral polio vaccine (OPV) without impairing the safety or immunogenicity of either vaccine.

Official Title
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Safety and Immunogenicity of Concomitant Use and Staggered Use of Vaccine and Oral Poliovirus (OPV) in Healthy Infants

Conditions
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Rotavirus Infections, Gastroenteritis

Intervention / Treatment
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* Biological: Rotavirus Vaccine, Live, Oral, Pentavalent
* Biological: Comparator: Oral Poliovirus Vaccine (OPV)
* Biological: Comparator: Oral Poliovirus Vaccine (OPV) (staggered)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infants in good health Exclusion Criteria: Previous administration of any oral poliovirus vaccine (OPV) and rotavirus vaccine Receipt of inactivated poliovirus vaccine (IPV) prior to the first dose of either study vaccine, or at any time during the course of the study Any condition resulting in depressed immunity Any allergy to any vaccine component as stated in the package circulars Allergies to polymyxin B, neomycin or any other antibiotics Receipt of intramuscular, oral, or intravenous corticosteroid treatment History of congenital abdominal disorders, intussusception, or abdominal surgery; clinical evidence of active gastrointestinal illness History of known prior rotavirus gastroenteritis, chronic diarrhea, or failure to thrive Prior receipt of a blood transfusion or blood products, including immunoglobulin Fever, with a rectal temperature of ≥38.1°C (≥ 100.5°F) at the time of immunization Infants residing in a household with an immunocompromised person

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>RotaTeq and OPV concomitantly | Biological: Rotavirus Vaccine, Live, Oral, Pentavalent<br>* Three doses of rotavirus vaccine, live, oral, pentavalent. Dose 1 was given on Day 1, Dose 2 was given 56 to 84 days post Dose 1, and Dose 3 was given 56 to 84 days post Dose 2.<br>Biological: Comparator: Oral Poliovirus Vaccine (OPV)<br>* Three doses OPV. Dose 1 was given on Day 1, Dose 2 was given 56 to 84 days post Dose 1, and Dose 3 was given 56 to 84 days post Dose 2.<br>|
| Experimental: 2<br>RotaTeq and OPV on staggered schedule | Biological: Rotavirus Vaccine, Live, Oral, Pentavalent<br>* Three doses of rotavirus vaccine, live, oral, pentavalent. Dose 1 was given on Day 1, Dose 2 was given 56 to 84 days post Dose 1, and Dose 3 was given 56 to 84 days post Dose 2.<br>Biological: Comparator: Oral Poliovirus Vaccine (OPV) (staggered)<br>* Three doses OPV. Dose 1 was given 14 to 28 days post Dose 1 of RotaTeq, Dose 2 was given 14 to 28 days post Dose 2 of RotaTeq, and Dose 3 was given 14 to 28 days post Dose 3 of RotaTeq.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric Mean Titer(s) of Poliovirus Types 1, 2, and 3, Measured Approximately 42 Days Postdose 3 | GMT of poliovirus type 1, 2, and 3, measured at postdose 3 in subjects receiving RotaTeq™ and OPV concomitantly compared to staggered. | Approximately 42 days Postdose 3 | 
| GMT of Serum Anti-rotavirus Immunoglobulin A (IgA) | GMT of serum anti-rotavirus IgA measured at postdose 3 in subjects receiving RotaTeq™ and OPV concomitantly compared to staggered | Approximately 42 days Postdose 3 | 
| Immunogenicity of RotaTeq™ as Measured by Serum Neutralizing Antibody [SNA] Responses to Rotavirus Serotypes G1, G2, G3, G4, and P1A When Administered With OPV Concomitantly or Staggered | Rotavirus SNA response to serotypes G1, G2, G3, G4, and P1A measured at postdose 3 in subjects receiving RotaTeq™ and OPV concomitantly compared to staggered. | Approximately 42 days Postdose 3 |