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Completed

NCT Number: NCT00130832

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

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.

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Key information

Conditions

Rotavirus Infections Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Infections RNA Virus Infections Reoviridae Infections Virus Diseases

Age range

6 week–12 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rotavirus Vaccine, Live, Oral, Pentavalent

Biological

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)

Biological

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)

Biological

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.

Primary outcomes

  1. Geometric Mean Titer(s) of Poliovirus Types 1, 2, and 3, Measured Approximately 42 Days Postdose 3

    Time frame: 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.

  2. GMT of Serum Anti-rotavirus Immunoglobulin A (IgA)

    Time frame: Approximately 42 days Postdose 3

    GMT of serum anti-rotavirus IgA measured at postdose 3 in subjects receiving RotaTeq™ and OPV concomitantly compared to staggered

  3. 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

    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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Aug 16, 2005
Registry last updated
Apr 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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