Study of Modified Process Hib/Hep B Vaccine in Infants (V121-019)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00441012
First received: February 26, 2007
Last updated: April 29, 2014
Last verified: April 2014
  Purpose

To determine if there is an improvement in the immune response to HBsAg (hepatitis B virus) in healthy infants using a modified process in a combination Haemophilus Influenzae, type b/Hepatitis B vaccine and a currently licensed Haemophilus Influenzae, type b/Hepatitis B vaccine


Condition Intervention Phase
Haemophilus Influenzae Type B
Hepatitis B
Biological: Comparator: Modified Process Vaccine
Biological: Comparator: COMVAX™
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: A Study in Healthy Infants of the Safety, Tolerability, and Immunogenicity of Haemophilus Influenzae, Type b/Hepatitis B Vaccine Manufactured With a Modified Process

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • The Number of Anti-HBs Seroprotected Participants 1 Month After the Third Dose. [ Time Frame: 11 months (1 month after the third dose) ] [ Designated as safety issue: No ]
    The number of participants as measured by the seroprotection rate (anti-hepatitis B surface antibodies greater than or equal to 10 mIU/mL). Anti-HBs (Antibodies against hepatitis B surface antigen) titers were measured from blood samples taken at Month 11 (1 month after the third dose)

  • The Anti-HBs GMT (Geometric Mean Titer) 1 Month After the Third Dose. [ Time Frame: 11 months (1 month after the third dose) ] [ Designated as safety issue: No ]
    Geometric Mean Titer (GMT) - This is an Antibody titer that is measured using a laboratory test to detect the presence and amount of antibodies in a person's blood. Anti-HBs (Antibodies against hepatitis B surface antigen) and Geometric Mean Titers were measured from blood samples taken at Month 11 (1 month after the third dose).


Secondary Outcome Measures:
  • The Total Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences [ Time Frame: 0-11 months (recorded from first dose until the participant completes or discontinues) ] [ Designated as safety issue: Yes ]
    Participants with adverse experiences considered possibly, probably, or definitely related to study vaccines and considered serious (death, persistent disability, life threatening, hospitalization, birth defects, cancer, or overdose)

  • The Number of Anti-PRP Seroprotected Participants 1 Month After the Third Dose. [ Time Frame: 11 months (1 month after the third dose) ] [ Designated as safety issue: No ]

    The number of participants as measured by the seroprotection rate (anti-polyribosylribitol phosphate antibodies greater than 1 µg/mL). Anti-PRP (Antibodies against polyribosylribitol phosphate) titers were measured from blood samples taken at Month 11 (1 month after

    the third dose)


  • The Anti-PRP GMT (Geometric Mean Titer) 1 Month After the Third Dose. [ Time Frame: 11 months (1 month after the third dose) ] [ Designated as safety issue: No ]
    Geometric Mean Titer (GMT) - This is an Antibody titer that is measured using a laboratory test to detect the presence and amount of antibodies in a person's blood. Anti-PRP (Antibodies against polyribosylribitol phosphate) titers were measured from blood samples taken at Month 11 (1 month after the third dose)


Enrollment: 546
Study Start Date: December 2006
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Modified process Hib/Hep B vaccine
Biological: Comparator: Modified Process Vaccine
Modified process vaccine HBsAg 5 ug/0.5 mL and PRP [OMPC] 7.5 ug/0.5 mL in a 3-dose regimen at 2, 4 & 12 months of age. Duration of treatment is 11 months.
Active Comparator: 2
COMVAX™
Biological: Comparator: COMVAX™
COMVAX™ HBsAg 5 ug/0.5 mL and PRP [OMPC] 7.5 ug/0.5 mL in a 3-dose regimen at 2, 4, and 12 months of age. Duration of treatment is 11 months.

  Eligibility

Ages Eligible for Study:   40 Days to 80 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy 2-month-old full term infants born to non-HBs Ag (hepatitis B virus) carrier mothers

Exclusion Criteria:

  • Birth mother known to be a carrier of hepatitis B virus (HBsAg+) or known carriers ever living in close contact with the subject
  • History of previous hepatitis B infection; history of vaccination with any hepatitis B vaccine
  • Recent (<72 hours) history of febrile illness (rectal temperature >=38.1°C/>=100.5°F)
  • Known or suspected hypersensitivity to any component of RECOMBIVAXHB™ or COMVAX™ (e.g., aluminum, yeast)
  • Recent administration (w/i 3 months prior to study start) of hepatitis B immune globulin (HBIg), serum immune globulin, or any other blood-derived product
  • Receipt of investigational drugs or investigational vaccines within 3 months prior to study start or if planned within the study period;
  • Known or suspected impairment of immunologic function or recent use (within 3 months prior to study start) of immunomodulatory medications (does not include topical and inhaled steroids);
  • Any condition that, in the opinion of the investigator, might interfere with the evaluation of study objectives; or inability to comply with the study schedule and/or inability to attend all required study visits
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00441012

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Additional Information:
Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00441012     History of Changes
Other Study ID Numbers: V121-019, 2007_513
Study First Received: February 26, 2007
Results First Received: May 11, 2009
Last Updated: April 29, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
Haemophilus Influenza, type b and Hepatitis B

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Influenza, Human
Digestive System Diseases
DNA Virus Infections
Enterovirus Infections
Hepadnaviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Orthomyxoviridae Infections
Picornaviridae Infections
Respiratory Tract Diseases
Respiratory Tract Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 23, 2014