Primary and booster immunisation of healthy infants in the first year of life against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Haemophilus influenzae type b, serogroup C meningococcal, rotavirus and pneumococcal diseases. MedDRA version: 14.0 Level: PT Classification code 10061353 Term: Pneumococcal infection System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.0 Level: PT Classification code 10027274 Term: Meningococcal infection System Organ Class:
Conditions
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits). -A male or female infant between, and including, 8 and 12 weeks at the time of the first vaccination. -Born after a gestation period of 36 to 42 weeks inclusive. -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. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study: • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone = 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed. • Child in care. • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. • Administration of a vaccine not foreseen by the study protocol within 30 days prior to randomisation, or planned administration from randomisation to the end of the study with the exception of inactivated influenza vaccines. The administration of diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Hib, pneumococcal, rotavirus and/or MenC vaccines is not allowed at any time during the study period but other vaccines are allowed during the period from one day after study Visit 3 to 31 days before study Visit 4. • 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 (pharmaceutical product or device). • Evidence of previous diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Hib, pneumococcal, rotavirus and/or MenC vaccination or disease, including HBV vaccination at birth. • History of seizures or progressive neurological disease. • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s). • Major congenital defects or serious chronic illness. The following condition is temporary or self-limiting, and a subject may be vaccinated once the condition has resolved if no other exclusion criteria is met: • Current febrile illness (axillary temperature = 38.5 ºC or rectal temperature = 39.0°C) or other moderate to severe illness within 24 hours of study vaccine administration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: -To demonstrate non-inferiority of the DTPa-HBV-IPV/Hib-MenC-TT vaccine when compared to the control group, in terms of immune response to Hib and MenC antigens, one month after the second vaccine dose.;Primary end point(s): -Immunogenicity with respect to components of the study vaccines. One month after the second vaccine dose: ? Anti-PRP antibody concentrations >=0.15 µg/ml. ? rSBA-MenC titres >= 8. ;Secondary Objective: -To demonstrate non-inferiority of the DTPa-HBV-IPV/Hib-MenC-TT vaccine when compared to the control group, in terms of immune response to D, T, HBs, IPV1, IPV2, IPV3 and pertussis, one month after the second vaccine dose. -To demonstrate non-inferiority of the DTPa-HBV-IPV/Hib-MenC-TT vaccine when compared to the control group, in terms of immune response to Hib, MenC, D, T, HBs, IPV1, IPV2, IPV3 and pertussis, one month after the third vaccine dose. -To assess the response to the study vaccines, one month after the second vaccine dose. -To assess the persistence of the response to the DTPa-HBV-IPV/Hib-MenC-TT vaccine and Infanrix hexa and Menjugate, before the third vaccine dose. -To assess the response to the study vaccines, one month after the third vaccine dose. -To assess the safety of the study vaccines, in terms of solicited symptoms, unsolicited symptoms and serious adverse events. | — |
Countries
France, Germany
Outcome results
None listed