Phase 3
N=4,391
Safety of Hib-MenCY-TT Vaccine Versus Licensed Hib Conjugate Vaccine, Given at 2, 4, 6 and 12 to 15 Months of Age
Haemophilus Influenzae Type b · Neisseria Meningitidis
Bottom Line
View on ClinicalTrials.gov: NCT00345579 ↗Enrolled (actual)
4,391
Serious AEs
4.7%
Results posted
Jul 2012
Primary outcome: Primary: Number of Subjects Reporting Serious Adverse Events (SAEs) — 109; 33 Subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine combined 792014 (Biological); ActHIB (Biological); Pediarix/Infanrix Penta (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Oct 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Reporting Serious Adverse Events (SAEs) |
109; 33 | — |
| PRIMARY Number of Subjects Reporting New Onset of Chronic Illnesses (NOCIs) |
50; 18 | — |
| PRIMARY Number of Subjects Reporting Rash |
243; 81 | — |
| PRIMARY Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) |
114; 44 | — |
| PRIMARY Number of Subjects With Serious Adverse Events (SAEs) |
157; 48 | — |
| PRIMARY Number of Subjects With New Onset of Chronic Illnesses (NOCIs) |
66; 25 | — |
| PRIMARY Number of Subjects With Rash |
386; 134 | — |
| PRIMARY Number of Subjects With Adverse Events Resulting in Emergency Room (ER) |
198; 69 | — |
Summary
The primary phase of this study is evaluating the safety of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine, when each are co-administered with Pediarix® to healthy infants at 2, 4, and 6 months of age.
This protocol posting deals with objectives & outcome measures of the primary phase of the study. The objectives & outcome measures of the Booster phase are presented in a separate protocol posting (NCT number = 00345683).
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007
Eligibility Criteria
Inclusion Criteria
- Subjects for whom the investigator believes that parents/guardians can and will comply with the requirements of the protocol.
- A male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination.
- Written informed consent obtained from the parent or guardian of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Born after 36 weeks gestation.
- Infants who have not received a previous dose of hepatitis B vaccine or those who have received only 1 dose of hepatitis B vaccine administered at least 30 days prior to enrolment.
- Infants may have received a birth dose of Bacillus Calmette-Guérin (BCG) vaccine.
Exclusion criteria
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
- Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of study vaccine(s).
- Previous vaccination against Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, and/or poliovirus; more than one previous dose of hepatitis B vaccine.
- In country(ies) where Prevnar will be provided by GSK Biologicals, previous vaccination with Prevnar.
- History of Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, hepatitis B, and/or poliovirus disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, including dry natural latex rubber.
- Major congenital defects or serious chronic illness.
- History of any neurologic disorders or seizures.
- Acute disease at time of enrollment.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- Concurrent participation in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
Data sourced from ClinicalTrials.gov (NCT00345579). 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.