Phase 3
Completed N=4,020
Safety of Hib-MenCY-TT Vaccine Versus Licensed Hib Conjugate Vaccine, Given at 12 to 15 Months of Age.
Source: ClinicalTrials.gov NCT00345683 ↗Enrolled (actual)
4,020
Serious AEs
2.2%
Results posted
Jul 2012
Primary outcomePrimary: Number of Subjects Reporting Serious Adverse Events (SAEs) — 12; 1 Subjects
Summary
The booster phase of the study will evaluate the safety of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine at 12 to 15 months of age.
This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00345579).
No new recruitment will take place during this booster phase of the study. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Reporting Serious Adverse Events (SAEs) |
12; 1 | — |
| PRIMARY Number of Subjects Reporting New Onset of Chronic Illnesses (NOCIs) |
12; 6 | — |
| PRIMARY Number of Subjects Reporting Rash |
123; 41 | — |
| PRIMARY Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits |
29; 16 | — |
| PRIMARY Number of Subjects With Serious Adverse Events (SAEs) |
72; 18 | — |
| PRIMARY Number of Subjects With New Onset of Chronic Illnesses (NOCIs) |
50; 18 | — |
| PRIMARY Number of Subjects With Rash |
227; 82 | — |
| PRIMARY Number of Subjects With Adverse Events Resulting in Emergency Room (ER) Visits |
129; 48 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects enrolled in the primary study (NCT00345579) are eligible for participating in the booster study
Exclusion Criteria
Subjects should not be administered M-M-R II and Varivax if any of these criteria apply:
- History of measles, mumps, rubella or varicella.
- Previous vaccination against measles, mumps, rubella or varicella.
- Hypersensitivity to any component of the vaccines, including gelatin or neomycin.
- Patients receiving immunosuppressive therapy.
- Individuals with blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems.
- Individuals with primary and acquired immunodeficiency states.
- Individuals with a family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated.
- Individuals with active tuberculosis.
- Acute disease at time of booster vaccination
Data sourced from ClinicalTrials.gov (NCT00345683). 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. Informational only — not medical advice.