Concomitant Use and Staggered Use of Vaccine and Oral Poliovirus (OPV) in Healthy Infants (V260-014)(COMPLETED)

Gastroenteritis Clinical Trial

Official title:

Safety and Immunogenicity of Concomitant Use and Staggered Use of Vaccine and Oral Poliovirus (OPV) in Healthy Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00130832
• Other study ID #: V260-014
• Secondary ID: 2005_030
• Status: Completed
• Phase: Phase 3
• First received: August 12, 2005
• Last updated: March 12, 2015
• Start date: October 2005
• Est. completion date: July 2006

Study information

• 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

Clinical Trial 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.

Recruitment information / eligibility

• 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

Study Design

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

Related Conditions & MeSH terms

• Gastroenteritis
• Rotavirus Infections

Intervention

Biological:
• Rotavirus Vaccine, Live, Oral, Pentavalent
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.
• Comparator: Oral Poliovirus Vaccine (OPV)
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.
• Comparator: Oral Poliovirus Vaccine (OPV) (staggered)
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

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

Outcome

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

External Links

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