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of Whole-Cell Pertussis Containing Vaccine Administered Concomitantly With RotaTeq™ (V260) or Rotarix™ (V260-036)(WITHDRAWN)

Phase 3

Withdrawn

• Conditions: Diphtheria; Pertussis; Rotavirus Gastroenteritis; Tetanus
• Interventions: Biological: Rotavirus Vaccine, Live, Oral, Pentavalent

• Registration Number: NCT01003431
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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™.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-10-27
• Study First Submitted QC: 2009-10-27
• Study First Posted: 2009-10-28
• Study Start: 2009-12
• Primary Completion: 2010-08
• Study Completion: 2010-09
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-08
• Last Update Posted: 2015-10-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Rotavirus Vaccine, Live, Oral, Pentavalent	RotaTeq™ + DTwP

Primary Outcome Measures

Name	Time	Method
Geometric Mean Titer (GMT) for Pertussis Toxoid	1 month post dose 3

Secondary Outcome Measures

Name	Time	Method
Geometric Mean Titer (GMT) for rotavirus serotypes G1, G2, G3, G4 and P1A	1 month post dose 3