Safety of Hib-MenCY-TT Vaccine Versus Licensed Hib Conjugate Vaccine, Given at 2, 4, 6 and 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: Pediarix/Infanrix Penta; Biological: ActHIB

Study type: Interventional

Funder types: Industry

Identifiers

NCT00345579

105987

Details and patient eligibility

About

The primary phase of this study is evaluating the safety of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine, when each are co-administered with Pediarix® to healthy infants at 2, 4, and 6 months of age.

This protocol posting deals with objectives & outcome measures of the primary phase of the study. The objectives & outcome measures of the Booster phase are presented in a separate protocol posting (NCT number = 00345683).

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007

Full description

Pediarix/Infanrix Penta and Prevnar should be co-administered to all subjects in all study groups according to a 2, 4, and 6 month schedule concomitantly with study vaccines.

Enrollment: 4,432 patients

Sex: All

Ages: 6 to 12 weeks old

Volunteers: Accepts Healthy Volunteers

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 enrolment.
• Infants may have received a birth dose of Bacillus Calmette-Guérin (BCG) vaccine.

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).
• Previous vaccination against Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, and/or poliovirus; more than one previous dose of hepatitis B vaccine.
• In country(ies) where Prevnar will be provided by GSK Biologicals, previous vaccination with Prevnar.
• History of Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, hepatitis B, and/or poliovirus disease.
• Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
• 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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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4,432 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 and a fourth dose of Menhibrix vaccine at 12-15 months of age in the study NCT00345683. 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: GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine combined 792014

Biological: Pediarix/Infanrix Penta

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 and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. 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: ActHIB

Biological: Pediarix/Infanrix Penta