Phase 4
Completed N=58
Study to Evaluate Antibody Persistence in Children Previously Vaccinated With Infanrix Hexa™ or Infanrix-IPV/Hib™
Source: ClinicalTrials.gov NCT01358825 ↗Enrolled (actual)
58
Serious AEs
0.0%
Results posted
Dec 2016
Primary outcomePrimary: Number of Seroprotected Subjects Against Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T). — 7; 28; 10; 34 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The aim of this study is to assess antibody persistence in infants who received three doses of Infanrix hexa™ (DTPa-HBV-IPV/Hib) or Infanrix-IPV/Hib™ (DTPa-IPV/Hib) at 3, 5 and 11 months of age in study NCT00307034.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Seroprotected Subjects Against Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T). |
7; 28; 10; 34 | — |
| PRIMARY Concentrations of Antibodies Against Anti-D and Anti-T |
0.13; 0.196; 0.29; 0.352 | — |
| PRIMARY Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Antifilamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations ≥5 ELISA Units Per Milliliter (EL.U/mL). |
0; 9; 12; 41; 8; 34 | — |
| PRIMARY Concentrations of Antibodies Against Anti-PT, Anti-FHA and Anti-PRN. |
2.5; 4.2; 32.6; 50.7; 6.2; 11.9 | — |
| PRIMARY Number of Seroprotected Subjects Against Anti-hepatitis B Surface Antigen (Anti-HBs). |
5 | — |
| PRIMARY Concentrations of Antibodies Against Anti-HBs. |
9 | — |
| PRIMARY Number of Seroprotected Subjects Against Anti-polyribosyl Ribitol Phosphate (Anti-PRP). |
10; 40 | — |
| PRIMARY Concentrations of Antibodies Against Anti-PRP. |
0.404; 0.886 | — |
| PRIMARY Number of Subjects With Serious Adverse Events (SAEs). |
0; 0 | — |
| PRIMARY Number of Subjects With Anti-HBs Antibody Concentrations ≥ 6.2 mIU/mL |
6 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects who had received 3 doses of Infanrix hexa™ or Infanrix-IPV/Hib™ in study NCT00307034.
- Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) LAR(s) can and will comply with the requirements of the protocol.
- A male or female subject aged 5 years at the time of study entry.
- Written informed consent obtained from the parent(s)/LAR(s) of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
Exclusion Criteria
- Child in care.
- 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.
- Use of any investigational or non-registered product within 30 days prior to blood sampling.
- Evidence of previous or intercurrent diphtheria, tetanus, pertussis, polio, hepatitis B, and Hib vaccination or disease since the study NCT00307034, with the exception of hepatitis B vaccination in the DTPa-IPV/Hib group.
- Administration of immunoglobulins and/or any blood products within the 3 months prior to blood sampling.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- Family history of congenital or hereditary immunodeficiency.
Data sourced from ClinicalTrials.gov (NCT01358825). 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.