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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Haemophilus Influenzae Type b; Neisseria Meningitidis

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00345683

105988

Details and patient eligibility

About

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.

Full description

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)

Enrollment: 4,021 patients

Sex: All

Ages: 12 to 15 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

4,021 participants in 2 patient groups

Menhibrix Group

Experimental group

Description:

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.

Treatment:

Biological: M-M-R II

Biological: Prevnar

Biological: Varivax

Biological: GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine combined (792014)

ActHIB Group

Active Comparator group

Description:

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.

Treatment:

Biological: PedvaxHIB

Biological: M-M-R II

Biological: Prevnar

Biological: Varivax