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

NCT00362648 | Completed Phase 3 Results

• 2 other identifiers: V260-0152006_027
• Study Type: interventional
• Target: 7,504
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Vomiting; Diarrhea; Fever

Outcome Measures

Primary Outcomes (1)

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

  At least 14 days following the third vaccination

Secondary Outcomes (2)

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

  14 days following the 3rd vaccination

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

  14 days following the 3rd vaccination

Study Arms (2)

1

EXPERIMENTAL

RotaTeq™

Biological: RotaTeq™ - Rotavirus Vaccine, Live, Oral, Pentavalent

2

PLACEBO COMPARATOR

Placebo

Biological: Comparator: Placebo

Interventions

RotaTeq™ - Rotavirus Vaccine, Live, Oral, Pentavalent BIOLOGICAL

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

Also known as: RotaTeq™, V260

1

Comparator: Placebo BIOLOGICAL

Arm 2: Placebo. 14 week treatment period

2

Eligibility Criteria

• Age: 4 Weeks - 12 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (4)

• Gruber JF, Becker-Dreps S, Hudgens MG, Brookhart MA, Thomas JC, Jonsson Funk M. Timing and predictors of severe rotavirus gastroenteritis among unvaccinated infants in low- and middle-income countries. Epidemiol Infect. 2018 Apr;146(6):698-704. doi: 10.1017/S0950268818000626. Epub 2018 Mar 22.

  PMID: 29564996 DERIVED

• Gruber JF, Hille DA, Liu GF, Kaplan SS, Nelson M, Goveia MG, Mast TC. Heterogeneity of Rotavirus Vaccine Efficacy Among Infants in Developing Countries. Pediatr Infect Dis J. 2017 Jan;36(1):72-78. doi: 10.1097/INF.0000000000001362.

  PMID: 27755463 DERIVED

• Zaman K, Dang DA, Victor JC, Shin S, Yunus M, Dallas MJ, Podder G, Vu DT, Le TP, Luby SP, Le HT, Coia ML, Lewis K, Rivers SB, Sack DA, Schodel F, Steele AD, Neuzil KM, Ciarlet M. Efficacy of pentavalent rotavirus vaccine against severe rotavirus gastroenteritis in infants in developing countries in Asia: a randomised, double-blind, placebo-controlled trial. Lancet. 2010 Aug 21;376(9741):615-23. doi: 10.1016/S0140-6736(10)60755-6. Epub 2010 Aug 6.

  PMID: 20692031 DERIVED

• Armah GE, Sow SO, Breiman RF, Dallas MJ, Tapia MD, Feikin DR, Binka FN, Steele AD, Laserson KF, Ansah NA, Levine MM, Lewis K, Coia ML, Attah-Poku M, Ojwando J, Rivers SB, Victor JC, Nyambane G, Hodgson A, Schodel F, Ciarlet M, Neuzil KM. Efficacy of pentavalent rotavirus vaccine against severe rotavirus gastroenteritis in infants in developing countries in sub-Saharan Africa: a randomised, double-blind, placebo-controlled trial. Lancet. 2010 Aug 21;376(9741):606-14. doi: 10.1016/S0140-6736(10)60889-6. Epub 2010 Aug 6.

  PMID: 20692030 DERIVED

MeSH Terms

Conditions

Vomiting; Diarrhea; Fever

Interventions

RotaTeq; Rotavirus Vaccines

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Temperature Changes

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.

ClinicalTrialsDisclosure@merck.com

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: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2006
• First Posted: August 10, 2006
• Study Start: March 1, 2007
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: April 13, 2017
• Results First Posted: May 13, 2010

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share