Gastroenteritis Clinical Trial
Official title:
Safety and Immunogenicity of Concomitant Use and Staggered Use of Vaccine and Oral Poliovirus (OPV) in Healthy Infants
Verified date | March 2015 |
Source | Merck Sharp & Dohme Corp. |
Contact | n/a |
Is FDA regulated | No |
Health authority | Brazil: Ministry of Health |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 735 |
Est. completion date | July 2006 |
Est. primary completion date | July 2006 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 6 Weeks to 12 Weeks |
Eligibility |
Inclusion Criteria: - Infants in good health Exclusion Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Merck Sharp & Dohme Corp. |
Ciarlet M, Sani-Grosso R, Yuan G, Liu GF, Heaton PM, Gottesdiener KM, Arredondo JL, Schödel 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. do — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Primary | 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 | No |
Primary | 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 | No |
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