Phase 3
N=546
Study of Modified Process Hib/Hep B Vaccine in Infants (V121-019)(COMPLETED)
Haemophilus Influenzae Type B · Hepatitis B
Bottom Line
View on ClinicalTrials.gov: NCT00441012 ↗Enrolled (actual)
546
Serious AEs
—
Results posted
Jul 2009
Primary outcome: Primary: The Number of Anti-HBs Seroprotected Participants 1 Month After the Third Dose. — 230; 226 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Comparator: Modified Process Vaccine (Biological); Comparator: COMVAX™ (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Anti-HBs Seroprotected Participants 1 Month After the Third Dose. |
230; 226 | — |
| PRIMARY The Anti-HBs GMT (Geometric Mean Titer) 1 Month After the Third Dose. |
4204.4; 1683.4 | — |
| SECONDARY The Total Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences |
0; 0 | — |
| SECONDARY The Number of Anti-PRP Seroprotected Participants 1 Month After the Third Dose. |
216; 210 | — |
| SECONDARY The Anti-PRP GMT (Geometric Mean Titer) 1 Month After the Third Dose. |
7.1; 8.0 | — |
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
Eligibility 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 ( =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
Data sourced from ClinicalTrials.gov (NCT00441012). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.