Comparison of GSKBiologicals' Hib-MenCY-TT Vaccine vs Licensed Hib Conjugate or Meningococcal Vaccine

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Haemophilus Influenzae Type b; Neisseria Meningitidis

Treatments: Biological: Prevnar; Biological: Pediarix; Biological: GSK Biologicals' Haemophilus influenza type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine 792014 vaccine; Biological: Menomune; Biological: ActHIB

Study type: Interventional

Funder types: Industry

Identifiers

NCT00129129

101858

102015 (Other Identifier)

Details and patient eligibility

About

This study is evaluating the safety and immunogenicity of GSK Biologicals' Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine, each administered at 2, 4, and 6 months of age, and compared to licensed meningococcal serogroups A, C, Y, and W-135 polysaccharide vaccine administered at 3 to 5 years of age.

The safety and immunogenicity of a booster dose of Hib-MenCY-TT vaccine will be compared to a booster dose of licensed Hib conjugate vaccine, each administered at 12 to 15 months of age. The group primed with the Hib conjugate vaccine will re-randomized at 12-15 months of age to receive a booster dose of Hib-MenCY-TT or a booster dose of the Hib conjugate vaccine.

Full description

The non-inferiority of the immunogenicity, safety, and antibody persistence of Hib-MenCY-TT vaccine will be compared to ActHIB®, a monovalent Hib conjugate vaccine licensed in the US.

All subjects will be vaccinated at 2, 4, 6, and 12 to 15 months. The immunogenicity of the MenC and MenY antigens will be summarized.

MenC and MenY immunogenicity will be compared to Menomune® (a quadrivalent meningococcal A, C, Y, and W-135 plain polysaccharide vaccine licensed in the US) administered to children 3 to 5 years of age.

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

Enrollment: 756 patients

Sex: All

Ages: 6 weeks to 15 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• For Groups A and B

  • Subjects for whom the investigator believes that parents/guardians can and will comply with the requirements of the protocol.
  • Healthy 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.
  • Free of obvious health problems as established by medical history and clinical examination before entering the study.
  • Born after a gestation period between 36 and 42 weeks.
  • 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.

• For Group C

  • Subjects for whom the investigator believes that parents/guardians can and will comply with the requirements of the protocol.
  • Healthy male or female between, and including, 3 and 5 years of age at the time of the first vaccination.
  • Written informed consent obtained from the parent or guardian of the subject.
  • Free of obvious health problems as established by medical history and clinical examination before entering the study.

Exclusion criteria

-For Groups A and B

• 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 within six months prior to the first vaccine dose.
• 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, poliovirus, and/or Streptococcus pneumoniae; more than one previous dose of hepatitis B vaccine.
• History of Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, hepatitis B, poliovirus, and/or Streptococcus pneumoniae 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 vaccine(s), 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.

For Group C

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the 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 within six months prior to the vaccine dose.
• Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the dose of study vaccine.
• Previous vaccination against Neisseria meningitidis.
• History of Neisseria meningitidis 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 vaccine, including dry natural latex rubber
• Major congenital defects or serious chronic illness.
• Acute disease at time of enrollment.
• Administration of immunoglobulins and/or any blood products within the 3 months preceding vaccination or planned administration during the study period.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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756 participants in 5 patient groups

MenHibrix Group

Experimental group

Description:

Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccinationDuring Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of Menhibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of Menhibrix™ during the Primary Phase received one dose of Menhibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, Menhibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, Menhibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.

Treatment:

Biological: Prevnar

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

Biological: Pediarix

ActHIB Group

Active Comparator group

Description:

During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either Menhibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.

Treatment:

Biological: Prevnar

Biological: Pediarix

Biological: ActHIB

Menomune Group

Active Comparator group

Description:

Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.

Treatment:

Biological: Prevnar

Biological: Menomune

Biological: Pediarix

ActHIB/Menhibrix Group

Experimental group

Description:

Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of Menhibrix™ and a concomitant fourth dose of Prevnar™. Menhibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.

Treatment:

Biological: Prevnar

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

Biological: Pediarix

Biological: ActHIB

ActHIB/ActHIB Group

Experimental group

Description:

Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.

Treatment:

Biological: Prevnar

Biological: Pediarix

Biological: ActHIB