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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00130832
First received: August 12, 2005
Last updated: May 5, 2014
Last verified: May 2014

August 12, 2005
May 5, 2014
October 2005
July 2006   (final data collection date for primary outcome measure)
  • Geometric Mean Titer(s) of Poliovirus Types 1, 2, and 3, Measured Approximately 42 Days Postdose 3 [ Time Frame: Approximately 42 days Postdose 3 ] [ Designated as safety issue: No ]
    GMT of poliovirus type 1, 2, and 3, measured at postdose 3 in subjects receiving RotaTeq™ and OPV concomitantly compared to staggered.
  • GMT of Serum Anti-rotavirus Immunoglobulin A (IgA) [ Time Frame: Approximately 42 days Postdose 3 ] [ Designated as safety issue: No ]
    GMT of serum anti-rotavirus IgA measured at postdose 3 in subjects receiving RotaTeq™ and OPV concomitantly compared to staggered
  • 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 [ Time Frame: Approximately 42 days Postdose 3 ] [ Designated as safety issue: No ]
    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.
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Complete list of historical versions of study NCT00130832 on ClinicalTrials.gov Archive Site
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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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Rotavirus Infections
  • Gastroenteritis
  • 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.
  • Biological: 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.
  • Biological: 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.
  • Experimental: 1
    RotaTeq and OPV concomitantly
    Interventions:
    • Biological: Rotavirus Vaccine, Live, Oral, Pentavalent
    • Biological: Comparator: Oral Poliovirus Vaccine (OPV)
  • Experimental: 2
    RotaTeq and OPV on staggered schedule
    Interventions:
    • Biological: Rotavirus Vaccine, Live, Oral, Pentavalent
    • Biological: Comparator: Oral Poliovirus Vaccine (OPV) (staggered)
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. doi: 10.1097/INF.0b013e3181782780.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
735
July 2006
July 2006   (final data collection date for primary outcome measure)

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
Both
6 Weeks to 12 Weeks
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00130832
V260-014, 2005_030
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP