Phase 4
N=297
Hepatitis B Antibody Persistence and Immune Response to Hepatitis B Vaccine Challenge in Previously Vaccinated Children
Hepatitis B
Bottom Line
View on ClinicalTrials.gov: NCT01333813 ↗Enrolled (actual)
297
Serious AEs
0.7%
Results posted
Aug 2012
Primary outcome: Primary: Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentration Equal to or Above (≥) 100 Milli-International Units Per Milliliter (mIU/mL) — 251 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Engerix-B™ Kinder (Biological)
- Age
- Pediatric · 7+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Sep 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentration Equal to or Above (≥) 100 Milli-International Units Per Milliliter (mIU/mL) |
251 | — |
| SECONDARY Anti-HBs Antibody Concentrations After Previous Vaccination With Infanrix Hexa Vaccine. |
36.6 | — |
| SECONDARY Number of Subjects With Anti-HBs Antibody Concentrations Equal to or Above the Protocol Specified Cut-off Values After Previous Vaccination With Infanrix Hexa Vaccine |
225; 207; 118; 89 | — |
| SECONDARY Number of Subjects With Anti-HBs Antibody Concentrations Equal to or Above Protocol Specified Cut-off Values |
259; 259 | — |
| SECONDARY Anti-HBs Antibody Concentrations |
4819.1 | — |
| SECONDARY Number of Subjects Demonstrating an Anamnestic Response to the Engerix-B Kinder Challenge Dose |
253 | — |
| SECONDARY Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) |
91; 2; 84; 0; 49; 0 | — |
| SECONDARY Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs |
37; 1; 21; 27; 5; 5 | — |
| SECONDARY Number of Subjects Reporting Any Unsolicited AEs |
42 | — |
| SECONDARY Number of Subjects Reporting Any Serious Adverse Events (SAEs) |
2 | — |
Summary
This study will evaluate the persistence of immunity to hepatitis B in healthy children aged 7 to 8 years, after previous vaccination with Infanrix hexa™ in the first two years of life, and also their ability to mount an immune response to the challenge dose of Engerix-B™ Kinder.
Eligibility Criteria
Inclusion Criteria
- Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol.
- A male or female 7 to 8 years of age at the time of enrolment.
- Subjects with documented evidence of previous vaccination with four consecutive doses of Infanrix hexa™ as part of routine vaccination in Germany: three doses of primary vaccination received by 9 months of age and one booster dose received between 11 and 18 months of age.
- Written informed consent obtained from the parents/Legally Acceptable Representative(s) of the subject at the time of enrolment.
- In addition to the informed consent that will be signed by the parent(s)/Legally Acceptable Representative(s), written informed assent of the subject will be sought when the subject is judged able to understand by the investigator.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
Exclusion Criteria
- Child in care
- Use of any investigational or non-registered product, other than the study vaccine, within 30 days preceding the dose of study vaccine, or planned use during the study period.
- Concurrently participating 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.
- Evidence of previous hepatitis B booster vaccination since administration of the fourth dose of Infanrix hexa™ booster in the second year of life.
- History of or intercurrent hepatitis B disease.
- Hepatitis B vaccination at birth.
- Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before and ending 30 days after the hepatitis B vaccine challenge dose.
- Administration of immunoglobulins and/or any blood products within the three months preceding challenge dose or planned administration during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the challenge dose of HBV vaccine.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the hepatitis B vaccine, or evidence of hypersensitivity after previous immunisation with a vaccine containing the hepatitis B component.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- Acute disease and/or fever at the time of enrolment.
Data sourced from ClinicalTrials.gov (NCT01333813). 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.