A Study in Healthy Infants of the Safety, Tolerability, and Immunogenicity ofHaemophilus influenzae, Type b/Hepatitis B Vaccine Manufactured With a ModifiedProcess - Healthy Infant Study
- Conditions
- Hepatitis-B infection
- Registration Number
- EUCTR2006-003648-46-FI
- Lead Sponsor
- Merck & Co. Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 546
Healthy 2-month-old infants (40 to 80 days of age) born to mothers who are not carriers of hepatitis B surface antigen (HbsAg seronegative).
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years)
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range
1.History of previous hepatitis B infection or invasive Hib disease. This includes the birth mother of the subject. Subjects with mothers known to be a carrier of hepatitis B surface antigen (HBsAg seropositive) or subjects ever living in close contact with a known carrier may not be enrolled.
2.Prior vaccination with any hepatitis B vaccine or Hib vaccine for subject (or for mother within 6 months prior to birth of infant).
3.Birth mother who did not receive prenatal care during the course of this pregnancy.
4.Recent (<72 hours) history of febrile illness (rectal temperature =38.1°C [=100.5°F]).
5.Prior vaccination with Prevenar™ or any pneumococcal vaccine.
6.Known or suspected hypersensitivity to any component of RECOMBIVAX HB™ (e.g., aluminum, yeast), Pedvax HIB™, or COMVAX™ (e.g., yeast).
7.Known or suspected hypersensitivity to any component of Prevenar™ (e.g., diphtheria toxoid).
8.Administration since birth of: hepatitis B immune globulin (HBIG), serum immune globulin, or any other blood-derived product (e.g., blood transfusion) to subject or receipt by mother within 6 months prior to birth of infant (or if scheduled during the study period).
9.Receipt of any live virus vaccine within 4 weeks prior to immunization.
10.Prior receipt of investigational drugs or vaccines since birth or if scheduled to be given during the study or receipt by the mother if breastfeeding within 14 days prior to Dose 1.
11.Known or suspected impairment of immunologic function or any use of immunomodulatory medications since birth (e.g., systemic corticosteroids). Does not include topical and inhaled steroids.
12.Any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
13. Inability to comply with the study schedule and inability to attend all required study visits as outlined in the Study Flow Chart.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Main objective : <br>(1a) To demonstrate that at 1 month after the third dose of vaccine, both the modified process vaccine and COMVAX™ will induce adequate seroprotection rates (SPR, % of subjects with titer = 10 mIU/mL) to hepatitis (1b) Conditional upon meeting (1a), to demonstrate that at 1 month after the third dose of vaccine, the modified process vaccine will induce similar (non-inferior) anti-HBs geometric mean titers (GMTs) as COMVAX™.<br>;Secondary Objective: Secondary objectives : <br>(1) To assess the safety and tolerability of modified process vaccine in healthy infants.<br>(2) To evaluate the anti-PRP immune response to modified process vaccine.<br>;Primary end point(s): Primary end point(s) : Development of gastric and/or duodenal ulcers<br>
- Secondary Outcome Measures
Name Time Method