A Study of 2 Doses of a Hepatitis B Vaccine (V232 RECOMBIVAX HB) in Healthy Infants (V232-057)

NCT00414050 | Completed Phase 3 Results

• 3 other identifiers: V232-0572006_0532006-001638-42
• Study Type: interventional
• Target: 1,718
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study was conducted in healthy infants and will provide new immunogenicity and safety data for the modified process hepatitis B vaccine. This study was conducted to address the following: to evaluate the immunogenicity and safety data of the 5 microgram dose of the modified process hepatitis B vaccine compared with a 10 microgram dose of the modified process hepatitis B vaccine, to evaluate another dosing schedule of 2, 4, and 6 months, and to provide descriptive immunogenicity data of another marketed vaccine (ENGERIX-B®).

Conditions

Hepatitis B

Outcome Measures

Primary Outcomes (1)

• The Percentage of Seroresponders to the Modified Process Hepatitis B Vaccine (5 μg and 10 μg Dose), RECOMBIVAX HB™ Hepatitis B Vaccine (Currently Licensed Vaccine), and ENGERIX-B®

  The percentage of participants as measured by Seroresponse. Seroresponse was defined as anti-hepatitis B surface antibodies greater than or equal to 10 milli-International Units (mIU)/mL. Success on the primary immunogenicity hypothesis required demonstrating an adequate anti-HBs seroprotection rate response for either modified process hepatitis B 5 μg vaccine or RECOMBIVAX HB™. Specifically, the lower bound of the multiplicity adjusted 95% confidence interval (CI) on the seroprotection rate for either vaccine was required to be above 90.0%.

  7 months of age (1 month after 3 doses)

Secondary Outcomes (1)

• Antibody to Hepatitis B Surface Antigen Geometric Mean Titer (Anti-HBs GMT) Responses for Modified Process Vaccine (5 μg and 10 μg), RECOMBIVAX™ Hepatitis B (Currently Licensed Vaccine), and ENGERIX-B®

  7 months of age (1 month after 3 doses)

Study Arms (4)

Modified Process Hepatitis B vaccine 5 μg

EXPERIMENTAL

Infants received a primary series of 3 doses of experimental vaccine (5 μg per dose) at 2, 4 and 6 months of age.

Biological: Modified Process Hepatitis B Vaccine (Experimental)

RECOMBIVAX HB™ Hepatitis B Vaccine

ACTIVE COMPARATOR

Infants received a primary series of 3 doses of currently licensed vaccine (5 μg per dose) at 2, 4 and 6 months of age.

Biological: Hepatitis B Vaccine (Recombinant)

Modified Process Hepatitis B vaccine 10 μg

EXPERIMENTAL

Infants received a primary series of 3 doses of experimental vaccine (10 μg per dose) at 2, 4 and 6 months of age.

Biological: Modified Process Hepatitis B Vaccine (Experimental)

ENGERIX-B®

ACTIVE COMPARATOR

Infants received a primary series of 3 doses of currently licensed vaccine (10 μg per dose) at 2, 4 and 6 months of age.

Biological: Hepatitis B Vaccine (Recombinant)

Interventions

Modified Process Hepatitis B Vaccine (Experimental) BIOLOGICAL

Modified Process Hepatitis B Vaccine given intramuscularly (IM) in 3 injections of 5 ug (micrograms)/0.5 mL each over 4 months (Modified Process Hepatitis B vaccine 5 μg arm). Modified Process Hepatitis B Vaccine given IM in 3 Injections of 10 ug (micrograms)/0.5 mL each over 4 months (Modified Process Hepatitis B vaccine 10 μg arm).

Modified Process Hepatitis B vaccine 10 μg; Modified Process Hepatitis B vaccine 5 μg

Hepatitis B Vaccine (Recombinant) BIOLOGICAL

RECOMBIVAX HB™ (currently licensed product) given IM in 3 Injections of 5 ug/0.5 mL each over 4 months.

Also known as: RECOMBIVAX HB™

RECOMBIVAX HB™ Hepatitis B Vaccine

Eligibility Criteria

• Age: 2 Months - 2 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Participant is a healthy infant approximately 2 months of age

You may not qualify if:

• Birth mother is a known carrier of hepatitis B virus or another known carrier has lived in close contact with the participant
• Participant's birth mother did not receive any prenatal care
• Participant has previous history of hepatitis B infection
• Participant has been vaccinated against hepatitis B or birth mother was vaccinated within 6 months before birth of participant
• Participant has had a fever within 72 hours of study start
• Participant has received any blood-derived product or birth mother received blood-derived product within 6 months of birth of participant

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Vesikari T, Martin JC, Liss CL, Liska V, Schodel FP, Bhuyan PK. Safety and immunogenicity of a modified process hepatitis B vaccine in healthy infants. Pediatr Infect Dis J. 2011 Jul;30(7):e109-13. doi: 10.1097/INF.0b013e31821ed1a4.

  PMID: 21552183 RESULT

MeSH Terms

Conditions

Hepatitis B

Interventions

Hepatitis B Vaccines; Recombivax HB; Engerix-B

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Viral Hepatitis Vaccines; 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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2006
• First Posted: December 21, 2006
• Study Start: October 6, 2006
• Primary Completion: October 22, 2007
• Study Completion: October 24, 2007
• Last Updated: May 23, 2017
• Results First Posted: April 14, 2009

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share