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

NCT00441012 | Completed Phase 3 Results

• 2 other identifiers: V121-0192007_513
• Study Type: interventional
• Target: 546
• Locations: 0 countries
• Sites: N/A

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

Conditions

Haemophilus Influenzae Type B; Hepatitis B

Keywords

Haemophilus Influenza, type b and Hepatitis B

Outcome Measures

Primary Outcomes (2)

• The Number of Anti-HBs Seroprotected Participants 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)

  11 months (1 month after the third dose)

• The Anti-HBs GMT (Geometric Mean Titer) 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).

  11 months (1 month after the third dose)

Secondary Outcomes (3)

• The Total Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences

  0-11 months (recorded from first dose until the participant completes or discontinues)

• The Number of Anti-PRP Seroprotected Participants 1 Month After the Third Dose.

  11 months (1 month after the third dose)

• The Anti-PRP GMT (Geometric Mean Titer) 1 Month After the Third Dose.

  11 months (1 month after the third dose)

Study Arms (2)

1

EXPERIMENTAL

Modified process Hib/Hep B vaccine

Biological: Comparator: Modified Process Vaccine

2

ACTIVE COMPARATOR

COMVAX™

Biological: Comparator: COMVAX™

Interventions

Comparator: Modified Process Vaccine BIOLOGICAL

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.

1

Comparator: COMVAX™ BIOLOGICAL

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.

2

Eligibility Criteria

• Age: 40 Days - 80 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Lee AW, Vesikari T, Gilbert CL, Klopfer SO, Schodel FP, Bhuyan PK. Immunogenicity and safety of a Haemophilus influenzae B (Hib)-hepatitis B vaccine with a modified process hepatitis B component administered with concomitant pneumococcal conjugate vaccine to infants. Vaccine. 2011 Oct 19;29(45):7942-8. doi: 10.1016/j.vaccine.2011.08.071. Epub 2011 Aug 27.

  PMID: 21875633 RESULT

MeSH Terms

Conditions

Haemophilus Infections; Hepatitis B

Condition Hierarchy (Ancestors)

Pasteurellaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Blood-Borne Infections; Communicable Diseases; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

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 Monitor

  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: February 26, 2007
• First Posted: February 27, 2007
• Study Start: December 1, 2006
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: March 19, 2015
• Results First Posted: July 10, 2009

Record last verified: 2015-03