Phase 2
Completed N=403
Immunogenicity and Reactogenicity of a Booster Dose of GSK Bio's DTPa-HBV-IPV/Hib Vaccine
Source: ClinicalTrials.gov NCT00627458 ↗Enrolled (actual)
403
Serious AEs
1.0%
Results posted
Jun 2017
Primary outcomePrimary: Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids — 22; 35; 93; 103 Participants
Summary
The purpose of this booster study is to evaluate, in subjects primed in the primary study 106786, the persistence, at the time of the booster vaccination, of antibodies elicited by the different formulation of DTPa-HBV-IPV/ Hib vaccine (Infanrix Hexa TM). The study will also evaluate the immune response of these subjects to a DTPa-HBV-IPV/Hib booster. This protocol posting deals with the objectives and outcome measures of the booster phase. The objectives and outcomes measures of the primary phase are presented in a separate protocol posting (NCT = 00376779).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids |
40; 119; 95; 119 | — |
| PRIMARY Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs) |
106; 118; 67; 114 | — |
| PRIMARY Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3 |
84; 112; 56; 112; 82; 113 | — |
| PRIMARY Number of Seroprotected Subjects Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) |
111; 118; 112; 118; 113; 117 | — |
| PRIMARY Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP) |
92; 119; 32; 118 | — |
| PRIMARY Number of Subjects With a Vaccine Response to PT, FHA and PR |
17; 93; 110; 0; 105; 105 | — |
| PRIMARY Anti-D and Anti-T Antibody Concentrations |
0.084; 3.952; 0.261; 10.833 | — |
| PRIMARY Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations |
150.9; 117.1; 609.6; 533.7; 308.5; 311.7 | — |
| PRIMARY Anti-HBs Antibody Concentrations |
139.8; 6132.7 | — |
| PRIMARY Anti-poliovirus Type 1, Type 2 and Type 3 Antibody Titers |
726.3; 942.4; 712.8; 812.9; 780; 1145.8 | — |
| PRIMARY Anti-PRP Antibody Concentrations |
0.487; 77.087 | — |
| SECONDARY Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids |
40; 119; 95; 119 | — |
| SECONDARY Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs) |
106; 118; 67; 114 | — |
| SECONDARY Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3 |
84; 112; 56; 112; 82; 113 | — |
| SECONDARY Number of Seroprotected Subjects Against PT, FHA and PRN |
93; 119; 109; 119; 99; 119 | — |
| SECONDARY Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP) |
92; 119; 32; 118 | — |
| SECONDARY Anti-D and Anti-T Antibody Concentrations |
0.084; 3.952; 0.261; 10.833 | — |
| SECONDARY Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations |
8.9; 153.7; 33.7; 791.9; 15.3; 564.1 | — |
| SECONDARY Anti-HBs Antibody Concentrations |
139.8; 6132.7 | — |
| SECONDARY Anti-poliovirus Type 1, 2 and 3 Antibody Titers |
21.6; 1288.8; 11.8; 1231; 21.3; 1794.8 | — |
| SECONDARY Anti-PRP Antibody Concentrations |
0.487; 77.087 | — |
| SECONDARY Number of Subjects With a Vaccine Response to PT, FHA and PR |
17; 93; 110; 0; 105; 105 | — |
| SECONDARY Number of Subjects With Any Solicited Local Symptoms |
74; 76; 82; 66; 79; 94 | — |
| SECONDARY Number of Subjects With Any Solicited General Symptoms |
50; 48; 58; 22; 34; 31 | — |
| SECONDARY Number of Subjects With Unsolicited Adverse Events (AEs) |
51; 54; 61 | — |
| SECONDARY Number of Subjects With Serious Adverse Events (SAEs) |
1; 2; 1 | — |
| SECONDARY Number of Subjects Reporting Concomitant Medications |
105; 111; 116; 34; 35; 33 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol
- Subjects must have completed the full three-dose primary vaccination course with one of the formulations of the DTPa-HBV-IPV/Hib vaccine in primary study 106786.
- A male or female between, and including, 16 and 20 months of age at the time of booster 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.
Exclusion Criteria
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the booster dose of study vaccine, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccine dose.
- Participation in another clinical study, between the primary study 106786 and the present booster study, or at any time during the study, in which the subject has been or will be exposed to an investigational or a non-investigational product.
- Planned administration or administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the administration of the booster dose and ending 30 days after the booster dose.
- Evidence of previous diphtheria, tetanus, pertussis, polio, hepatitis B and/or Hib booster vaccination or disease since the conclusion visit of study 106786.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on physical examination.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
- Acute disease at the time of enrolment.
- Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose or planned administration during the study period.
Data sourced from ClinicalTrials.gov (NCT00627458). 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.