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Completed

NCT Number: NCT00362648

Developing World Study for RotaTeq™ (V260-015)(COMPLETED)

The purpose of the current study is to evaluate whether the vaccine is effective, well-tolerated and immunogenic among infants in developing countries.

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Key information

Conditions

Vomiting Body Temperature Changes Diarrhea Fever Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

4 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

  • Age 4 weeks through 12 weeks at Dose 1
  • Parent able to understand study procedures and give consent

Exclusion criteria

  • Clinical evidence of active gastrointestinal disease
  • Subjects who are currently or expected to participate in other studies of investigational products during the 6 weeks after receiving the last dose of RotaTeq™/placebo

Treatment and study plan

RotaTeq™ - Rotavirus Vaccine, Live, Oral, Pentavalent

Biological

2.0 mL oral dose of RotaTeq™. 14 week treatment period

Other names: RotaTeq™, V260

Comparator: Placebo

Biological

Arm 2: Placebo. 14 week treatment period

Primary outcomes

  1. Occurrence of Severe Clinical Rotavirus Disease Caused by Any Rotavirus Serotype More Than 14 Days Following the Third Dose

    Time frame: At least 14 days following the third vaccination

Secondary outcomes

  1. Africa - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]

    Time frame: 14 days following the 3rd vaccination

    Induction of postdose 3 SNA response (Number of subjects with ≥ 3 fold rise in antibody titer)

  2. Asia - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]

    Time frame: 14 days following the 3rd vaccination

    Induction of postdose 3 SNA response (Number of subjects with ≥ 3 fold rise in antibody titer)

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

Efficacy, Safety, and Immunogenicity of RotaTeq™ Among Infants in Asia and Africa

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Aug 10, 2006
Registry last updated
Apr 13, 2017

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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