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

NCT00496054 | Completed Phase 3 Results

• 2 other identifiers: V260-0212007_020
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Gastroenteritis; Rotavirus

Outcome Measures

Primary Outcomes (13)

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

  Baseline and Approximately 6 Months

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

  Baseline and Approximately 6 Months

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

  Baseline and Approximately 6 Months

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

  Baseline and Approximately 6 Months

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

  Baseline and Approximately 6 Months

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

  Baseline and Approximately 6 Months

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

  Baseline and Approximately 6 Months

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

  Baseline and Approximately 6 Months

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

  Baseline and Approximately 6 Months

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

  Baseline and Approximately 6 Months

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

  Baseline and Approximately 6 Months

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

  Baseline and Approximately 6 Months

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

  Baseline and Approximately 6 Months

Study Arms (1)

RotaTeq™ Vaccine (V260)

EXPERIMENTAL

Evaluation of Safety, Tolerability and Immunogenicity of Vaccination with RotaTeq™ in Healthy Infants in India.

Biological: Rotavirus Vaccine, Live, Oral, Pentavalent

Interventions

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.

Also known as: RotaTeq™ Vaccine, V260

RotaTeq™ Vaccine (V260)

Eligibility Criteria

• Age: 6 Weeks - 12 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age 6 weeks through exactly 12 weeks
• Healthy infants

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Lokeshwar MR, Bhave S, Gupta A, Goyal VK, Walia A. Immunogenicity and safety of the pentavalent human-bovine (WC3) reassortant rotavirus vaccine (PRV) in Indian infants. Hum Vaccin Immunother. 2013 Jan;9(1):172-6. doi: 10.4161/hv.22341.

  PMID: 23442588 DERIVED

MeSH Terms

Conditions

Gastroenteritis

Interventions

Rotavirus Vaccines

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2007
• First Posted: July 4, 2007
• Study Start: May 1, 2008
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: April 13, 2017
• Results First Posted: March 11, 2010

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share