E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Primary immunisation of healthy infants in the first year of life against diphtheria, tetanus, pertussis, hepatitis B, polio, Haemophilus influenzae type b diseases. |
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E.1.1.1 | Medical condition in easily understood language |
Diphtheria
Tetanus
Whooping cough
Meningitis
Polio |
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E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess the antibody response to pertussis toxin (PT), filamentous haemagglutinin (FHA), pertactin (PRN) and poliovirus types 1, 2, 3 after a three-dose primary vaccination course with Infanrix hexa. |
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E.2.2 | Secondary objectives of the trial |
To assess the antibody response to recombinant hepatitis B surface antigen, diphtheria toxoid, tetanus toxoid and Haemophilus influenzae type b (Hib) capsular poly-saccharide polyribosyl-ribitol phosphate (PRP) after a three-dose primary vaccination course with Infanrix hexa.
To evaluate the reactogenicity and safety of GSK Biologicals’ Infanrix™ hexa when administered as a three-dose primary vaccination course.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
A male or female infant between, and including, 6 to 10 weeks of age at the time of the first vaccination.
Written informed consent obtained from the parent or guardian of the subject.
Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Born after a normal gestation period
Should have received a birth dose of hepatitis B vaccine, as evidenced by vaccination/ immunisation certificate.
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E.4 | Principal exclusion criteria |
Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Chronic administration of immunosuppressants or other immune-modifying drugs prior to the first vaccine dose.
Any chronic drug therapy to be continued during the study period.
Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the administration of the first vaccine dose and ending 30 days after the last dose.
Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis and Haemophilus influenzae type b diseases.
Known exposure to diphtheria, tetanus, Bordetella pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b diseases since birth.
Known immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection.
A family history of congenital or hereditary immunodeficiency.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Major congenital defects or serious chronic illness.
History of any neurologic disorders or seizures.
Acute disease at the time of enrolment.
Acute or chronic, clinically significant pulmonary, cardio-vascular, hepatic or renal functional abnormality, as determined by physical examination.
Hepatomegaly, right upper quadrant abdominal pain or tenderness.
Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
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E.5 End points |
E.5.1 | Primary end point(s) |
Vaccine response to PT, FHA, and PRN.
Seroprotection against poliovirus types 1, 2, and 3, defined as anti-poliovirus neutralizing antibody titres more than or equal to 8 for all three types. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
One month after third dose of vaccination in both the groups (Week 18/Month 7). |
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E.5.2 | Secondary end point(s) |
Seroprotection defined as:
anti-HBs antibody concentration more than or equal to 10 mIU/ml.
anti-PRP antibody concentration more than or equal to 0.15 microgm/ml and more than or equal to 1.0 µg/ml.
Anti-diphtheria and anti-tetanus antibody concentrations more than or equal to 0.1 IU/ml.
Anti-diphtheria, anti-tetanus, anti-PT, anti-FHA, anti-PRN, anti-HBs, anti-poliovirus 1, 2 and 3 and anti-PRP antibody concentrations or titres.
Occurrence of solicited local and general symptoms.
Occurrence of unsolicited symptoms.
Occurrence of serious adverse events. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Seroprotection status: One month after third dose of vaccination in both the groups (Week 18/Month 7).
Occurrence of solicited local and general symptoms: For 4 days [Day 0 – Day3]after each vaccination dose.
Occurrence of unsolicited symptoms: For 31 days [Day 0 – Day30] after each vaccination dose.
Occurrence of serious adverse events:During the entire study period (Month 0 to Week 18/Month 7). |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Subjects receiving Infanrix hexa with 2-4-6 month schedule act as comparators in the study. |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
Will this trial be conducted at a single site globally?
| No |
E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |