A Study of the Immunogenicity, Tolerability, and Safety of a New Formulation of RotaTeq™ in Infants (V260-035)

NCT01600092 | Completed Phase 3 Results

• 1 other identifier: V260-035
• Study Type: interventional
• Target: 1,020
• Locations: 0 countries
• Sites: N/A

Brief Summary

A study to compare safety, tolerability, and immunogenicity of a new formulation of RotaTeq™ with the existing formulation in infants. The primary hypothesis of the study is that the new formulation will be noninferior to the existing formulation on the basis of immunogenicity.

Conditions

Rotavirus Gastroenteritis

Outcome Measures

Primary Outcomes (1)

• Geometric Mean Titer of Serum Neutralizing Antibody Response to Human Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]

  42 days after vaccination 3 (up to 185 days)

Secondary Outcomes (4)

• Number of Participants With Tier-1 Adverse Events: Diarrhea, Vomiting, Elevated Temperature, and Irritability

  Up to 7 days after any vaccination (up to 147 days)

• Number of Participants With Tier-1 Adverse Events: Intussusception

  Up to Day 185

• Geometric Mean Titer of Serum Anti-Rotavirus Immunoglobulin A

  42 days after vaccination 3 (up to 185 days)

• Percentage of Participants With >=3-fold Rise From Baseline in GMT of Serum Neutralizing Antibody to Human Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]

  Baseline and 42 days after vaccination 3 (up to 185 days)

Study Arms (2)

RotaTeq™ Experimental Formulation

EXPERIMENTAL

Three 2.0 mL oral doses of RotaTeq™ experimental formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days)

Biological: RotaTeq™ experimental formulation

RotaTeq™ Existing Formulation

ACTIVE COMPARATOR

Three 2.0 mL oral doses of RotaTeq™ existing formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).

Biological: RotaTeq™ existing formulation

Interventions

RotaTeq™ experimental formulation BIOLOGICAL

Also known as: V260

RotaTeq™ Experimental Formulation

RotaTeq™ existing formulation BIOLOGICAL

Also known as: V260

RotaTeq™ Existing Formulation

Eligibility Criteria

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

You may qualify if:

• Parent or legal guardian agrees to have infant participate by giving written informed consent

You may not qualify if:

• History of congenital abdominal disorders, prior rotavirus gastroenteritis, chronic diarrhea, failure to thrive, or abdominal surgery
• History of intussusception
• Known or suspected impairment of immunological function, including Severe
• Combined Immunodeficiency (SCID)
• Prior administration of any rotavirus vaccine
• Clinical evidence of active gastrointestinal illness, with the exception of well-controlled gastroesophageal reflux disease (GERD)
• Receipt of 1) systemic corticosteroids (≥ 2mg/kg total daily dose of prednisone or equivalent) for 14 consecutive days or more since birth, or 2) systemic corticosteroids ≥ 2mg/kg/dose within 7 days prior to the administration of the first dose of study vaccine. Participant using non-systemic corticosteroids will be eligible for vaccination.
• Residing in a household with an immunocompromised person
• Prior receipt of a blood transfusion or blood products, including immunoglobulins
• Participation in another interventional study within 14 days prior to the first study vaccination or expected anytime during the study
• Receipt of investigational inactivated vaccines within 14 days or investigational live vaccines within 28 days prior to the first study vaccination or expected anytime during the study

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Martinon-Torres F, Greenberg D, Varman M, Killar JA, Hille D, Strable EL, Stek JE, Kaplan SS. Safety, Tolerability and Immunogenicity of Pentavalent Rotavirus Vaccine Manufactured by a Modified Process. Pediatr Infect Dis J. 2017 Apr;36(4):417-422. doi: 10.1097/INF.0000000000001511.

  PMID: 28141698 RESULT

MeSH Terms

Interventions

Rotavirus Vaccines

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 Director

  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: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2012
• First Posted: May 16, 2012
• Study Start: April 29, 2013
• Primary Completion: March 25, 2014
• Study Completion: March 25, 2014
• Last Updated: November 14, 2018
• Results First Posted: March 19, 2015

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will share