Modified Process Hepatitis B Vaccine in Healthy Neonates... | NCT00322361

Studies
Modified Process Hepatitis B Vaccine in Healthy Neonates (V232-056)

NCT00322361

Sponsor

Merck Sharp & Dohme LLC

Status

Completed

Last Update Posted

Mar 16, 2017Actual

Enrollment

566Actual

Phase

Phase 2

Conditions

Hepatitis B
Hepatocellular Carcinoma

Interventions

Comparator: RECOMBIVAX HB™
Comparator: Modified process Hepatitis B Vaccine

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2006_007

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2006

Primary Completion Date

Jul 2007Actual

Completion Date

Jul 2007Actual

First Submitted Date

May 2, 2006

First Submission Date that Met QC Criteria

May 4, 2006

First Posted Date

May 5, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 15, 2017

Last Update Posted Date

Mar 16, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Hepatitis B Vaccine [Recombinant] is a well-established vaccine which has been used extensively, worldwide since its initial licensure in 1986. Hepatitis B vaccines: [1] induce protection against the morbidity and mortality of acute hepatitis B virus infection, [2] reduce the incidence of chronic infection in vaccinated populations, and [3] thereby, reduce the incidence of hepatocellular carcinoma. The purpose of the trial is to assess if the new manufacturing process of the Hepatitis B Vaccine [Recombinant] vaccine shows the same level of hepatitis B antibody response or better as the currently licensed Hepatitis B Vaccine [Recombinant] vaccine. This study will also confirm that the new process vaccine is as well tolerated as the current vaccine.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

566Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Modified Process Hepatitis B Vaccine	Biological: Comparator: Modified process Hepatitis B Vaccine
2	Active Comparator	Recombivax HB™	Biological: Comparator: RECOMBIVAX HB™

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Comparator: RECOMBIVAX HB™	Biological	RECOMBIVAX HB™ 3 x 5-mcg regimen administered via intramuscular injection.	2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Geometric mean titer to hepatitis B surface antigen at Month 7		4 weeks Post Dose 3

Secondary Outcomes

Measure	Description	Time Frame
Safety and tolerability including use of Vaccination Report Card		Follow-up 14 days Post Vaccination 1, 2, & 3 (Via Vaccination Report Card)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy male and female full-term (37-42 weeks gestation) neonates (birth to 10 days of age)
Born to mothers with documented negative test for HBsAg within 9 months prior to delivery

Exclusion Criteria:

Infant born to mother with no prenatal care
Known or suspected impairment of immunologic function
Prior vaccination with any hepatitis B vaccine for infant or mother(within 6 months prior to the birth of infant.)
Recent(<72 hours) history of febrile illness >/= 99.5 degrees F (>/= 37.5 degrees C) axillary or >/= 100.5 degrees F (>/= 38.1 degrees C) rectal
Any prior administration of hepatitis B immune globulin (HBIG), serum immune globulin, or any other blood-derived product, or the receipt by the mother of either immunoglobulin or HBIG within 6 months prior to birth of the infant
Receipt of investigational vaccines by mother or infant within 3 months prior to first injection with study vaccine or if scheduled to be given to the infant during the study
Known or suspected hypersensitivity to any component of study vaccine (e.g., aluminum, yeast)
Any infant who cannot be adequately followed for study visits during the course of the clinical study
Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

10 Days

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Medical Monitor	Merck Sharp & Dohme LLC	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22227229	Derived	Minervini G, McCarson BJ, Reisinger KS, Martin JC, Stek JE, Atkins BM, Nadig KB, Liska V, Schodel FP, Bhuyan PK. Safety and immunogenicity of a modified process hepatitis B vaccine in healthy neonates. Vaccine. 2012 Feb 14;30(8):1476-80. doi: 10.1016/j.vaccine.2011.12.095. Epub 2012 Jan 5.

ID	Term
D006509	Hepatitis B
D006528	Carcinoma, Hepatocellular

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D018347	Hepadnaviridae Infections