Invasive disease caused by Haemophilus type b and Neisseria meningitidis serogroups C and Y MedDRA version: 18.0 Level: LLT Classification code 10028910 Term: Neisseria meningitides meningitis System Organ Class: 100000004862 MedDRA version: 18.0 Level: LLT Classification code 10051931 Term: Neisseria infection NOS System Organ Class: 100000004862
Conditions
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Subjects for whom the investigator believes that parents/guardians can and will comply with the requirements of the protocol •A male or female between, and including, 6 and 12 weeks of age at the time of the first 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. •Born after 36 weeks gestation. •Infants who have not received a previous dose of hepatitis B vaccine or those who have received only 1 dose of hepatitis B vaccine administered at least 30 days prior to enrollment. •Infants may have received a birth dose of Bacillus Calmette-Guérin (BCG) vaccine. Are the trial subjects under 18? yes Number of subjects for this age range: 4441 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: •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. •Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of study vaccine(s). (Synagis® [palivizumab, MedImmune], Prevnar (Prevenar), rotavirus vaccine, and influenza vaccine are allowed. •Previous vaccination against Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, and/or poliovirus; more than one previous dose of hepatitis B vaccine. •History of Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, hepatitis B, and/or poliovirus disease. •Any confirmed or suspected immunosuppressive or immuno-deficient condition based on medical history and physical ex-amination (no laboratory testing is required). •History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, including dry natural latex rubber. •Major congenital defects or serious chronic illness. •History of any neurologic disorders or seizures. •Acute disease at time of enrollment. •Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. •Concurrent participation 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). Additional specific criteria for the US subjects in Cohort 1. In addition, for Cohorts 2 and 3, subjects should not be adminis-tered M-M-R II and Varivax if any of these criteria apply: •History of measles, mumps, rubella or varicella. •Previous vaccination against measles, mumps, rubella or varicella. •Hypersensitivity to any component of the vaccines, including gelatin or neomycin. •Patients receiving immunosuppressive therapy. •Individuals with blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems. •Individuals with primary and acquired immunodeficiency states. •Individuals with a family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated. •Individuals with active tuberculosis. •Acute disease at time of booster vaccination.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1.To demonstrate the lot-to-lot consistency of 3 lots of Hib-MenCY-TT in terms of immunogenicity for PRP by ELISA and MenC and MenY by hSBA. 2.To demonstrate non-inferiority of PRP after a fourth dose of Hib-MenCY-TT compared to 3 doses of ActHIB. 3.To evaluate the immunogenicity of a fourth dose of Hib-MenCY-TT as measured by hSBA for MenC and MenY. 4.To evaluate the vaccine response of a fourth dose of Hib-MenCY-TT measured by hSBA-MenC and hSBA-MenY. 5.To demonstrate the non-inferiority of Hib-MenCY-TT compared to ActHIB with respect to PRP by ELISA. 6.To demonstrate non-inferiority of M-M-RII with a fourth dose of Hib-MenCY-TT compared to M-M-RII with a fourth dose of PedvaxHIB. 7.To demonstrate the non-inferiority of Varivax with a fourth dose of Hib-MenCY-TT compared to Varivax with a fourth dose of PedvaxHIB, as measured by FAMA.;Secondary Objective: None;Primary end point(s): Anti-PRP antibody concentrations. hSBA-MenC and hSBA-MenY titres. Anti-diphtheria and Anti-Tetanus antibody concentrations. Anti-pertussis toxoid antibody concentrations. Anti-Filamentous Haemagglutinin and Anti-Peractin antibody concentrations. Anti-poliovirus 1, 2 and 3 antibody titers. Anti-measles, Anti-mumps and Anti-Rubella antibody concen-trations. Anti-varicella antibody titres.;Timepoint(s) of evaluation of this end point: 1 month after 3-doses and post-fourth dose vaccination. 1 month after 3-doses and post-fourth dose vaccination. 1 month after the primary vaccination course. 1 month after the primary vaccination course. 1 month after the primary vaccination course. Post-booster vaccination. Post-booster vaccination. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): hSBA-MenC and hSBA-MenY titres. Anti-PRP antibody concentrations. rSBA-MenC and rSBA-MenY titres. Anti-PSC and Anti-PSY antibody concentrations. Anti-diphtheria and Anti-tetanus antibody concentrations. Anti-Hepatitis B surface antigen antibody concentrations. Anti-pertussis, anti-filamentous haemagglutinin and anti-pertactin antibody concentrations. Anti-poliovirus types 1, 2, and 3 antibody titres. Anti-measles, Anti-mumps and Anti-rubella antibody concentra-tions in initially seronegative subjects. Anti-varicella antibody titres in initially seronegative subjects. Fever > 39.5C/103.1F Incidence of local and general solicited adverse events. Incidence of unsolicited symptoms. Incidence of Serious Adverse Events. Occurrence of specific adverse events of new onset of chronic illness(es), rash, and conditions prompting emergency room visits and physician office visits not related to common illnesses. Percent of subjects achieving a 4-fold rise in anti-H1N1, anti-H3N2, and anti-B antibody titers, as measured HIA, in subjects who received 1 or 2 doses of influenza vaccine within the same influenza season concomitantly with study vaccine. Incidence of increased circumferential swelling at the injected limb(s). Incidence of general symptoms specific to measles, mumps, rubella, and varicella vaccination (fever, rash/exanthem, pa-rotid/salivary gland swelling, and any suspected signs of men-ingism including febrile convulsions).;Timepoint(s) of evaluation of this end point: 1 month after the 3 doses, prior to the fourth and post-fourth dose 1 month after the 3 doses, prior to the fourth and post-fourth dose 1 month after the 3 doses, prior to the fourth and post-fourth dose 1 month after the 3 doses, prior to the fourth and post-fourth dose 1 month after the primary vaccination course 1 month after the primary vaccination course 1 month after the primary vaccination course 1 month after the primary vaccination course Post-b | — |
Countries
Australia, Mexico, United States
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed