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OpenTrials
Completed

NCT Number: NCT00496054

Safety,Tolerability and Immunogenicity of Vaccination With Rotateq in Healthy Infants in India (V260-021)

To observe the safety, tolerability and immunogenicity of the administration of 3 doses of rotateq in healthy Indian infants between 6 weeks through exactly 12 weeks of age at entry.

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Key information

Conditions

Gastroenteritis Digestive System Diseases Gastrointestinal Diseases Rotavirus

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

  • Age 6 weeks through exactly 12 weeks
  • Healthy infants

Exclusion criteria

  • Clinical evidence of active gastrointestinal illness
  • Fever, with a rectal temperature of greater than and equal to thirty eight degree celsius at the time of immunization
  • History of congenital abdominal disorders, intussusception, or abdominal surgery
  • History of known prior rotavirus disease
  • Known or suspected impairment of immunological function
  • Prior administration of any rotavirus vaccine
  • Known hypersensitivity to any component of the rotavirus vaccine, e.g. trypsin

Treatment and study plan

Rotavirus Vaccine, Live, Oral, Pentavalent

Biological

Pentavalent vaccine 9G1, G2, G3, G4 & P1) given 3 times. Dose 1 will be administered at study entry; Dose 2 will be administered 4 to 10 weeks (28 to 70 days) after Dose 1; and Dose 3 will be administered 4 to 10 weeks (28 to 70 days) after Dose 2.

Other names: RotaTeq™ Vaccine, V260

Primary outcomes

  1. The Percentage of Participants Who Exhibit a 3 Fold Rise or Greater From Baseline to Approximately 6 Months in Rotavirus Specific Serum in IgA

    Time frame: Baseline and Approximately 6 Months

  2. The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G1 Serum Neutralizing Antibodies (SNA)

    Time frame: Baseline and Approximately 6 Months

  3. The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G2 Serum Neutralizing Antibodies(SNA)

    Time frame: Baseline and Approximately 6 Months

  4. The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G3 Serum Neutralizing Antibodies(SNA)

    Time frame: Baseline and Approximately 6 Months

  5. The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G4 Serum Neutralizing Antibodies(SNA)

    Time frame: Baseline and Approximately 6 Months

  6. The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in P1 Serum Neutralizing Antibodies(SNA)

    Time frame: Baseline and Approximately 6 Months

  7. The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G1 Serum Neutralizing Antibodies(SNA)

    Time frame: Baseline and Approximately 6 Months

  8. The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for IgA

    Time frame: Baseline and Approximately 6 Months

  9. The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G1

    Time frame: Baseline and Approximately 6 Months

  10. The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G2

    Time frame: Baseline and Approximately 6 Months

  11. The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G3

    Time frame: Baseline and Approximately 6 Months

  12. The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G4

    Time frame: Baseline and Approximately 6 Months

  13. The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for P1

    Time frame: Baseline and Approximately 6 Months

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

Evaluation of Safety,Tolerability and Immunogenicity of Vaccination With Rotateq (V260) in Healthy Infants in India

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jul 4, 2007
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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