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

Phase 3

Completed

• Conditions: Rotavirus Infections; Gastroenteritis
• Interventions: Biological: Rotavirus Vaccine, Live, Oral, Pentavalent

• Registration Number: NCT00130832
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-08-12
• Study First Submitted QC: 2005-08-12
• Study First Posted: 2005-08-16
• Study Start: 2005-10
• Primary Completion: 2006-07
• Study Completion: 2006-07
• Results First Submitted: 2009-08-07
• Results First Submitted QC: 2010-08-17
• Results First Posted: 2010-09-09
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-12
• Last Update Posted: 2015-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 735

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Rotavirus Vaccine, Live, Oral, Pentavalent	RotaTeq and OPV on staggered schedule
1	Rotavirus Vaccine, Live, Oral, Pentavalent	RotaTeq and OPV concomitantly

Primary Outcome Measures

Name	Time	Method
GMT of Serum Anti-rotavirus Immunoglobulin A (IgA)	Approximately 42 days Postdose 3	GMT of serum anti-rotavirus IgA measured at postdose 3 in subjects receiving RotaTeq™ and OPV concomitantly compared to staggered
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	Approximately 42 days Postdose 3	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.
Geometric Mean Titer(s) of Poliovirus Types 1, 2, and 3, Measured Approximately 42 Days Postdose 3	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.