A Study of the Immunogenicity and Safety of Whole-Cell Pertussis Containing Vaccine Administered Concomitantly With RotaTeq™ (V260) or Rotarix™ (V260-036)(WITHDRAWN)
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
1 other identifier
interventional
N/A
0 countries
N/A
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™.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Dec 2009
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 27, 2009
CompletedFirst Posted
Study publicly available on registry
October 28, 2009
CompletedStudy Start
First participant enrolled
December 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedOctober 9, 2015
October 1, 2015
8 months
October 27, 2009
October 8, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Geometric Mean Titer (GMT) for Pertussis Toxoid
1 month post dose 3
Secondary Outcomes (1)
Geometric Mean Titer (GMT) for rotavirus serotypes G1, G2, G3, G4 and P1A
1 month post dose 3
Study Arms (3)
1
EXPERIMENTALRotaTeq™ + DTwP
2
ACTIVE COMPARATORRotarix™ + DTwP
3
ACTIVE COMPARATORRotaTeq™ + DTaP
Interventions
\[Intervention name: RotaTeq™ administered concomitantly with Tritanrix™ HepB (DTwP)\] 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.
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).
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.
Eligibility Criteria
You may qualify if:
- Healthy infants
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Merck Sharp & Dohme LLC
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 27, 2009
First Posted
October 28, 2009
Study Start
December 1, 2009
Primary Completion
August 1, 2010
Study Completion
September 1, 2010
Last Updated
October 9, 2015
Record last verified: 2015-10