Concomitant Use and Staggered Use of Vaccine and Oral Poliovirus (OPV) in Healthy Infants (V260-014)(COMPLETED)
Safety and Immunogenicity of Concomitant Use and Staggered Use of Vaccine and Oral Poliovirus (OPV) in Healthy Infants
2 other identifiers
interventional
735
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2005
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
August 12, 2005
CompletedFirst Posted
Study publicly available on registry
August 16, 2005
CompletedStudy Start
First participant enrolled
October 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2006
CompletedResults Posted
Study results publicly available
September 9, 2010
CompletedApril 1, 2015
March 1, 2015
9 months
August 12, 2005
August 7, 2009
March 12, 2015
Conditions
Outcome Measures
Primary Outcomes (3)
Geometric Mean Titer(s) of Poliovirus Types 1, 2, and 3, Measured 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.
Approximately 42 days Postdose 3
GMT of Serum Anti-rotavirus Immunoglobulin A (IgA)
GMT of serum anti-rotavirus IgA measured at postdose 3 in subjects receiving RotaTeq™ and OPV concomitantly compared to staggered
Approximately 42 days Postdose 3
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
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.
Approximately 42 days Postdose 3
Study Arms (2)
1
EXPERIMENTALRotaTeq and OPV concomitantly
2
EXPERIMENTALRotaTeq and OPV on staggered schedule
Interventions
Three doses of rotavirus vaccine, live, oral, pentavalent. Dose 1 was given on Day 1, Dose 2 was given 56 to 84 days post Dose 1, and Dose 3 was given 56 to 84 days post Dose 2.
Three doses OPV. Dose 1 was given on Day 1, Dose 2 was given 56 to 84 days post Dose 1, and Dose 3 was given 56 to 84 days post Dose 2.
Three doses OPV. Dose 1 was given 14 to 28 days post Dose 1 of RotaTeq, Dose 2 was given 14 to 28 days post Dose 2 of RotaTeq, and Dose 3 was given 14 to 28 days post Dose 3 of RotaTeq.
Eligibility Criteria
You may qualify if:
- Infants in good health
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Ciarlet M, Sani-Grosso R, Yuan G, Liu GF, Heaton PM, Gottesdiener KM, Arredondo JL, Schodel F. Concomitant use of the oral pentavalent human-bovine reassortant rotavirus vaccine and oral poliovirus vaccine. Pediatr Infect Dis J. 2008 Oct;27(10):874-80. doi: 10.1097/INF.0b013e3181782780.
PMID: 18756184RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Vice President, Global Clinical Development
- Organization
- Merck Sharp & Dohme Corp.
Study Officials
- STUDY DIRECTOR
Medical Monitor
Merck Sharp & Dohme LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 12, 2005
First Posted
August 16, 2005
Study Start
October 1, 2005
Primary Completion
July 1, 2006
Study Completion
July 1, 2006
Last Updated
April 1, 2015
Results First Posted
September 9, 2010
Record last verified: 2015-03