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Phase 3 N=735 Randomized Treatment

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

Rotavirus Infections · Gastroenteritis

Bottom Line

View on ClinicalTrials.gov: NCT00130832 ↗
Enrolled (actual)
735
Serious AEs
1.8%
Results posted
Sep 2010
Primary outcome: Primary: Geometric Mean Titer(s) of Poliovirus Types 1, 2, and 3, Measured Approximately 42 Days Postdose 3 — 888.0; 1139; 814.9; 814.5 Geometric Mean Titer (GMT) — p=<0.001

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Rotavirus Vaccine, Live, Oral, Pentavalent (Biological); Comparator: Oral Poliovirus Vaccine (OPV) (Biological); Comparator: Oral Poliovirus Vaccine (OPV) (staggered) (Biological)
Age
Pediatric · 0+ yrs
Sex
All
Sponsor
Merck Sharp & Dohme LLC
Primary completion
Jul 2006

Outcome Measures

OutcomeResultp-value
PRIMARY
Geometric Mean Titer(s) of Poliovirus Types 1, 2, and 3, Measured Approximately 42 Days Postdose 3		 888.0; 1139; 814.9; 814.5; 233.6; 269.2 <0.001 sig
PRIMARY
GMT of Serum Anti-rotavirus Immunoglobulin A (IgA)		 154.9; 292.7 0.277
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		 125.8; 182.6; 27.1; 30.0; 21.2; 22.5 —

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.

Eligibility 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00130832). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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