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of Whole-Cell Pertussis Containing Vaccine Administered Concomitantly With RotaTeq™ (V260) or Rotarix™ (V260-036)(WITHDRAWN)

Tetanus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01003431
• Other study ID #: V260-036
• Secondary ID: V260-036
• Status: Withdrawn
• Phase: Phase 3
• First received: October 27, 2009
• Last updated: October 8, 2015
• Start date: December 2009
• Est. completion date: September 2010

Study information

• Verified date: October 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: Medicines Control Council
• Study type: Interventional

Clinical Trial 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™.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Weeks to 12 Weeks

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diphtheria
• Gastroenteritis
• Pertussis
• Rotavirus Gastroenteritis
• Tetanus
• Whooping Cough

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Geometric Mean Titer (GMT) for Pertussis Toxoid		1 month post dose 3	No
Secondary	Geometric Mean Titer (GMT) for rotavirus serotypes G1, G2, G3, G4 and P1A		1 month post dose 3	No

External Links

•   MedWatch - FDA maintained medical product safety Information
•   Merck: Patient & Caregiver U.S. Product Web Site