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

Hepatitis B Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00441012
• Other study ID #: V121-019
• Secondary ID: 2007_513
• Status: Completed
• Phase: Phase 3
• First received: February 26, 2007
• Last updated: March 2, 2015
• Start date: December 2006
• Est. completion date: June 2008

Study information

• Verified date: March 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 546
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Days to 80 Days

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Haemophilus Influenzae Type B
• Hepatitis
• Hepatitis B
• Influenza, Human

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Lee AW, Vesikari T, Gilbert CL, Klopfer SO, Schödel 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	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)	No
Secondary	The Total Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences	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)	0-11 months (recorded from first dose until the participant completes or discontinues)	Yes
Secondary	The Number of Anti-PRP Seroprotected Participants 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)	11 months (1 month after the third dose)	No
Secondary	The Anti-PRP 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-PRP (Antibodies against polyribosylribitol phosphate) titers were measured from blood samples taken at Month 11 (1 month after the third dose)	11 months (1 month after the third dose)	No

External Links

•   MedWatch - FDA maintained medical product safety Information
•   Merck: Patient & Caregiver U.S. Product Web Site