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

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ClinicalTrials.gov Identifier: NCT00441012
Recruitment Status : Completed
First Posted : February 27, 2007
Results First Posted : July 10, 2009
Last Update Posted : March 19, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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 or disease Intervention/treatment Phase
Haemophilus Influenzae Type B Hepatitis B Biological: Comparator: Modified Process Vaccine Biological: Comparator: COMVAX™ Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 546 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : December 2006
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. The Number of Anti-HBs Seroprotected Participants 1 Month After the Third Dose. [ Time Frame: 11 months (1 month after the third dose) ]
    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)

  2. The Anti-HBs GMT (Geometric Mean Titer) 1 Month After the Third Dose. [ Time Frame: 11 months (1 month after the third dose) ]
    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 :
  1. 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) ]
    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)

  2. The Number of Anti-PRP Seroprotected Participants 1 Month After the Third Dose. [ Time Frame: 11 months (1 month after the third dose) ]

    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)


  3. The Anti-PRP GMT (Geometric Mean Titer) 1 Month After the Third Dose. [ Time Frame: 11 months (1 month after the third dose) ]
    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)



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Ages Eligible for Study:   40 Days to 80 Days   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00441012


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

Additional Information:
Publications of Results:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00441012     History of Changes
Other Study ID Numbers: V121-019
2007_513
First Posted: February 27, 2007    Key Record Dates
Results First Posted: July 10, 2009
Last Update Posted: March 19, 2015
Last Verified: March 2015

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

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Influenza, Human
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Orthomyxoviridae Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Hepadnaviridae Infections
DNA Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs