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

Primary Purpose

Rotavirus Gastroenteritis

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

RotaTeq™ experimental formulation

RotaTeq™ existing formulation

About this trial

This is an interventional prevention trial for Rotavirus Gastroenteritis

Eligibility Criteria

6 Weeks - 12 Weeks (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

RotaTeq™ Experimental Formulation

RotaTeq™ Existing Formulation

Arm Description

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)

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse event. Protocol-defined Tier-1 adverse events to be collected up to 7 days after any vaccination were diarrhea, vomiting, elevated temperature (rectal >=38.1° C, >=100.5° F), and irritability.

Number of Participants With Tier-1 Adverse Events: Intussusception

The protocol-defined Tier-1 adverse event to be collected for the duration of the study (up to Day 185) was intussusception

Geometric Mean Titer of Serum Anti-Rotavirus Immunoglobulin A

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]

Full Information

NCT ID

NCT01600092

First Posted

May 14, 2012

Last Updated

October 19, 2018

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT01600092

Brief Title

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

Official Title

A Double-blind, Randomized, Controlled, Multicenter Study to Evaluate the Safety, Tolerability, and Immunogenicity of a New Formulation of RotaTeq™

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Completed

Study Start Date

April 29, 2013 (Actual)

Primary Completion Date

March 25, 2014 (Actual)

Study Completion Date

March 25, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rotavirus Gastroenteritis

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Care ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

1020 (Actual)

8. Arms, Groups, and Interventions

Arm Title

RotaTeq™ Experimental Formulation

Arm Type

Experimental

Arm Description

Arm Title

RotaTeq™ Existing Formulation

Arm Type

Active Comparator

Arm Description

Intervention Type

Biological

Intervention Name(s)

RotaTeq™ experimental formulation

Other Intervention Name(s)

V260

Intervention Type

Biological

Intervention Name(s)

RotaTeq™ existing formulation

Other Intervention Name(s)

V260

Primary Outcome Measure Information:

Title

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

Time Frame

42 days after vaccination 3 (up to 185 days)

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

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

Title

Number of Participants With Tier-1 Adverse Events: Intussusception

Description

The protocol-defined Tier-1 adverse event to be collected for the duration of the study (up to Day 185) was intussusception

Time Frame

Up to Day 185

Title

Geometric Mean Titer of Serum Anti-Rotavirus Immunoglobulin A

Time Frame

42 days after vaccination 3 (up to 185 days)

Title

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]

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Weeks

Maximum Age & Unit of Time

12 Weeks

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Parent or legal guardian agrees to have infant participate by giving written informed consent Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Merck Sharp & Dohme LLC

Official's Role

Study Director

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

IPD Sharing URL

http://engagezone.msd.com/ds_documentation.php

Citations:

PubMed Identifier

28141698

Citation

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.

Results Reference

result

Available IPD and Supporting Information:

Available IPD/Information Type

CSR Synopsis

Available IPD/Information URL

http://www.merck.com/clinical-trials/study.html?id=V260-035&kw=V260-035&tab=access

Learn more about this trial

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

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