Safety of Hib-MenCY-TT Vaccine Versus Licensed Hib Conjugate Vaccine, Given at 12 to 15 Months of Age.

Study Overview
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Brief Summary
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The booster phase of the study will evaluate the safety of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine at 12 to 15 months of age. This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00345579). No new recruitment will take place during this booster phase of the study. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Detailed Description
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Hib-MenCY-TT = GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine. The study will be conducted in a single blind manner up to 30 days after administration of the booster dose; the extended safety follow-up after the booster dose will be conducted in an unblinded manner. All subjects will receive Prevnar, M-M-R II and Varivax as study vaccines, preferencially co-administered with the booster dose of Hib-MenCY-TT/PedvaxHIB. Note: This protocol posting deals with the objectives & outcome measures for the booster phase of the study. The objectives & outcome measures for the primary phase are presented in a separate protocol posting (NCT00345579)

Official Title
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Single-blind, Randomized, Controlled, Multinational Study for the Evaluation of Safety of GSK Biologicals' Hib-MenCY-TT Vaccine Compared to Monovalent Hib Control Vaccine in Healthy Infants at 2, 4, 6, and 12 to 15 Months of Age.

Conditions
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Haemophilus Influenzae Type b, Neisseria Meningitidis

Intervention / Treatment
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* Biological: GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine combined (792014)
* Biological: PedvaxHIB
* Biological: Prevnar
* Biological: M-M-R II
* Biological: Varivax


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects enrolled in the primary study (NCT00345579) are eligible for participating in the booster study Exclusion Criteria: Subjects should not be administered 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

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 15 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Menhibrix Group<br>Subjects received 3 doses of Menhibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and a fourth dose of Menhibrix vaccine at 12-15 months of age in this study (study Month 10-13). Menhibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh. | Biological: GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine combined (792014)<br>* Booster dose by intramuscular injection<br>Biological: Prevnar<br>* Booster dose by intramuscular injection<br>Biological: M-M-R II<br>* Single dose by subcutaneous injection<br>* Other names: mumps and rubella vaccine.;Biological: Varivax<br>* Single dose by subcutaneous injection<br>* Other names: Varicella vaccine;|
| Active Comparator: ActHIB Group<br>Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in this study (study Month 10-13). ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh. | Biological: PedvaxHIB<br>* Booster dose by intramuscular injection<br>* Other names: Monovalent Hib conjugate vaccine.;Biological: Prevnar<br>* Booster dose by intramuscular injection<br>Biological: M-M-R II<br>* Single dose by subcutaneous injection<br>* Other names: mumps and rubella vaccine.;Biological: Varivax<br>* Single dose by subcutaneous injection<br>* Other names: Varicella vaccine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects Reporting Serious Adverse Events (SAEs) | SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. | From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14) | 
| Number of Subjects Reporting New Onset of Chronic Illnesses (NOCIs) | NOCIs include autoimmune disorders, asthma, type I diabetes, allergies. | From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14) | 
| Number of Subjects Reporting Rash | Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae | From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14) | 
| Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits |  | From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14) | 
| Number of Subjects With Serious Adverse Events (SAEs) | SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. | From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19) | 
| Number of Subjects With New Onset of Chronic Illnesses (NOCIs) | NOCIs include autoimmune disorders, asthma, type I diabetes, allergies. | From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19) | 
| Number of Subjects With Rash | Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae | From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19) | 
| Number of Subjects With Adverse Events Resulting in Emergency Room (ER) Visits |  | From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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H. influenzae type B vaccine, Infants, Neisseria meningitidis, Vaccines, conjugate, Meningococcal vaccines, Prophylaxis, Comparative study, Safety, Humans