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: November 4, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Rotavirus Infections
Gastroenteritis
Biological: Rotavirus Vaccine, Live, Oral, Pentavalent
Biological: Comparator: Oral Poliovirus Vaccine (OPV)
Biological: Comparator: Oral Poliovirus Vaccine (OPV) (staggered)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Immunogenicity of Concomitant Use and Staggered Use of Vaccine and Oral Poliovirus (OPV) in Healthy Infants

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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.


Enrollment: 735
Study Start Date: October 2005
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
RotaTeq and OPV concomitantly
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.
Experimental: 2
RotaTeq and OPV on staggered schedule
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) (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.

  Eligibility

Ages Eligible for Study:   6 Weeks to 12 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00130832

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Additional Information:
No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00130832     History of Changes
Other Study ID Numbers: V260-014, 2005_030
Study First Received: August 12, 2005
Results First Received: August 7, 2009
Last Updated: November 4, 2013
Health Authority: Brazil: Ministry of Health

Additional relevant MeSH terms:
Gastroenteritis
Rotavirus Infections
Gastrointestinal Diseases
Digestive System Diseases
Reoviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on April 15, 2014