Phase 3
N=433
Immune Response & Safety of a Hepatitis A Vaccine Given Together With a Pneumococcal Vaccine in Healthy Children 15 m of Age
Hepatitis A
Bottom Line
View on ClinicalTrials.gov: NCT00197002 ↗Enrolled (actual)
433
Serious AEs
4.6%
Results posted
Feb 2017
Primary outcome: Primary: Number of Seropositive Subjects for Anti-HAV Antibodies — 106; 94 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- GSK Biologicals 2-dose inactivated hepatitis A vaccine (Havrix) (Biological); Prevnar™ (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Jan 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Seropositive Subjects for Anti-HAV Antibodies |
113 | — |
| PRIMARY Concentrations for Anti-HAV Antibodies |
1391.2 | — |
| SECONDARY Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-19F and Anti-23F Antibody Concentrations |
3.3; 3.1; 7.1; 6.1; 6.8; 7.4 | — |
| SECONDARY Number of Subjects With an Immune Response to Anti-pneumococcal Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F |
102; 115; 100; 115; 101; 116 | — |
| SECONDARY Number of Seropositive Subjects for Anti-HAV Antibodies |
113 | — |
| SECONDARY Concentrations for Anti-HAV Antibodies |
1391.2 | — |
| SECONDARY Number of Seropositive Subjects for Anti-HAV Antibodies |
113 | — |
| SECONDARY Concentrations for Anti-HAV Antibodies |
1391.2 | — |
| SECONDARY Number of Subjects With Vaccine Response to Anti-HAV Antibodies |
102; 89; 110 | — |
| SECONDARY Number of Subjects With Any and Grade 3 Solicited Local Symptoms |
39; 48; 61; 0; 2; 1 | — |
| SECONDARY Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms |
40; 35; 45; 2; 2; 3 | — |
| SECONDARY Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) |
82; 72; 87; 3; 5; 8 | — |
| SECONDARY Number of Subjects With Serious Adverse Events (SAEs), New Chronic Illnesses (NCIs) and Medically Significant Events (MSEs) |
3; 5; 5; NA; NA; NA | — |
| SECONDARY Number of Subjects With SAEs, NCIs and MSEs |
0; 2; 3; NA; NA; NA | — |
Summary
This is a study to evaluate the immunogenicity and safety of GSK Biologicals 2-dose inactivated hepatitis A vaccine when administered with a pneumococcal conjugate vaccine in children as young as 15 months of age.
Eligibility Criteria
Inclusion Criteria
- A male or female child 12 or 13 months of age at the time of entry into the Enrollment Phase,
- Free of obvious health problems,
- Subjects must have previously received three doses of Prevnar in his/her first year of life.
Exclusion Criteria
- Use of any investigational or non-registered drug or vaccine within 42 days preceding the first dose of study vaccine, or planned use during the study period,
- Chronic administration of immuno-suppressant or other immune-modifying drugs within six months prior to vaccination or planned administration at any time during the study period. (For corticosteroids, this will mean prednisone, or equivalent, less than 0.5 mg/kg/day. Inhaled, nasal and topical steroids are allowed.),
- Administration of the ACIP-recommended fourth dose of Prevnar prior to entering the Enrollment Phase of the study,
- Planned administration or administration of any vaccine not foreseen by the study protocol within the period of 42 days before and 30 days after each dose of study vaccine(s),
- Previous vaccination against hepatitis A,
- History of hepatitis A or known exposure to hepatitis A,
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection,
- A family history of congenital, hereditary or infectious immunodeficiency or parental risk factors for HIV infection,
- History of allergic disease/reactions or hypersensitivity likely to be exacerbated by any component of Havrix (e.g., neomycin, 2-phenoxyethanol) or Prevnar (e.g., diphtheria toxoid),
- Major congenital defects or serious chronic illness,
- History of any neurologic disorder (history of febrile seizures not associated with an underlying neurological disorder does not exclude the subject),
- Acute disease, defined as the presence of a moderate or severe illness with or without fever, at the time of vaccination,
- Administration of immunoglobulins and/or any blood products within three months prior to the first dose of study vaccine or planned administration at any time during the entire study period.
Data sourced from ClinicalTrials.gov (NCT00197002). 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.