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of Whole-Cell Pertussis Containing Vaccine Administered Concomitantly With RotaTeq™ (V260) or Rotarix™ (V260-036)(WITHDRAWN)

Merck Sharp & Dohme (MSD)

Status and phase: Withdrawn; Phase 3

Conditions: Rotavirus Gastroenteritis; Diphtheria; Pertussis; Tetanus

Treatments: Biological: Rotavirus Vaccine, Live, Oral, Pentavalent; Biological: Comparator: Rotarix™ administered concomitantly with Tritanrix™ HepB (DTwP); Biological: Comparator: RotaTeq™ administered concomitantly with INFANRIX™ (DTaP)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01003431

V260-036

Details and patient eligibility

About

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™.

Sex: All

Ages: 6 to 12 weeks old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

1

Experimental group

Description:

RotaTeq™ + DTwP

Treatment:

Biological: Rotavirus Vaccine, Live, Oral, Pentavalent

2

Active Comparator group

Description:

Rotarix™ + DTwP

Treatment:

Biological: Comparator: Rotarix™ administered concomitantly with Tritanrix™ HepB (DTwP)

3

Active Comparator group

Description:

RotaTeq™ + DTaP

Treatment:

Biological: Comparator: RotaTeq™ administered concomitantly with INFANRIX™ (DTaP)