Hib-MenCY-TT Vaccine Study Compared to Licensed Hib and Meningococcal Serogroup C Conjugate Vaccines

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

1104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-11

Study Completion Date

2007-02-21

Brief Summary

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This study is evaluating the safety and immunogenicity of Hib-MenCY-TT vaccine compared to control groups receiving licensed Hib or MenC conjugate vaccines, each administered at 2, 4, 6, and 12 to 15 months of age. Co-administration with live, attenuated measles, mumps, and rubella combination vaccine; and with live, attenuated varicella vaccine will be assessed with administration of the booster dose. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, September 2007.

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Detailed Description

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The study will be conducted in 2 stages: a 3-dose primary vaccination at 2, 4 and 6 months of age and a booster vaccination at 12 to 15 months of age. All subjects will have 3 blood samples taken. Half of the subjects of each group will have a blood sample taken just prior to the administration of the third dose of the primary vaccination and the other half of the subjects of each group will have a blood sample taken at one month after the third vaccine dose of the primary vaccination phase. In addition, all subjects of all groups will have a blood sample taken before and 42 days after administration of the booster dose.

Conditions

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Neisseria Meningitidis Haemophilus Influenzae Type b

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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MenHibrix Group

Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.

Group Type EXPERIMENTAL

MenHibrix (Hib-MenCY-TT)

Intervention Type BIOLOGICAL

One intramuscular dose at 2, 4 and 6 months of age ( group A) and one intramuscular dose at 12 to 15 months of age (groups A and B)

Infanrix® Penta

Intervention Type BIOLOGICAL

One intramuscular dose at 2, 4 and 6 months of age

Prevenar®

Intervention Type BIOLOGICAL

One intramuscular dose at 2, 4 and 6 months of age

M-M-R®II

Intervention Type BIOLOGICAL

One subcutaneous dose at 12-15 months of age

Varivax®

Intervention Type BIOLOGICAL

One subcutaneous dose at 12 to 15 months of age

ActHIB + Meningitec Group

Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.

Group Type ACTIVE_COMPARATOR

MenHibrix (Hib-MenCY-TT)

Intervention Type BIOLOGICAL

One intramuscular dose at 2, 4 and 6 months of age ( group A) and one intramuscular dose at 12 to 15 months of age (groups A and B)

Infanrix® Penta

Intervention Type BIOLOGICAL

One intramuscular dose at 2, 4 and 6 months of age

Prevenar®

Intervention Type BIOLOGICAL

One intramuscular dose at 2, 4 and 6 months of age

ActHIB®

Intervention Type BIOLOGICAL

One intramuscular dose at 2, 4 and 6 months of age

Meningitec®

Intervention Type BIOLOGICAL

One intramuscular dose at 2, 4 and 6 months of age

M-M-R®II

Intervention Type BIOLOGICAL

One subcutaneous dose at 12-15 months of age

Varivax®

Intervention Type BIOLOGICAL

One subcutaneous dose at 12 to 15 months of age

ActHIB/PedvaxHIB Group

Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.

Group Type ACTIVE_COMPARATOR

Infanrix® Penta

Intervention Type BIOLOGICAL

One intramuscular dose at 2, 4 and 6 months of age

Prevenar®

Intervention Type BIOLOGICAL

One intramuscular dose at 2, 4 and 6 months of age

ActHIB®

Intervention Type BIOLOGICAL

One intramuscular dose at 2, 4 and 6 months of age

M-M-R®II

Intervention Type BIOLOGICAL

One subcutaneous dose at 12-15 months of age

Varivax®

Intervention Type BIOLOGICAL

One subcutaneous dose at 12 to 15 months of age

PedvaxHIB®

Intervention Type BIOLOGICAL

One intramuscular dose at 12 to 15 months of age

Interventions

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MenHibrix (Hib-MenCY-TT)

One intramuscular dose at 2, 4 and 6 months of age ( group A) and one intramuscular dose at 12 to 15 months of age (groups A and B)

Intervention Type BIOLOGICAL

Infanrix® Penta

One intramuscular dose at 2, 4 and 6 months of age

Intervention Type BIOLOGICAL

Prevenar®

One intramuscular dose at 2, 4 and 6 months of age

Intervention Type BIOLOGICAL

ActHIB®

One intramuscular dose at 2, 4 and 6 months of age

Intervention Type BIOLOGICAL

Meningitec®

One intramuscular dose at 2, 4 and 6 months of age

Intervention Type BIOLOGICAL

M-M-R®II

One subcutaneous dose at 12-15 months of age

Intervention Type BIOLOGICAL

Varivax®

One subcutaneous dose at 12 to 15 months of age

Intervention Type BIOLOGICAL

PedvaxHIB®

One intramuscular dose at 12 to 15 months of age

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

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

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 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. Vaccination with hepatitis B at birth is accepted (although not mandatory). Influenza vaccination is allowed 30 days after administration of the third vaccine dose to 30 days preceding the booster dose.
* History of Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, hepatitis B, poliovirus, Streptococcus pneumoniae and/or varicella invasive 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, tetanus toxoid, diphtheria toxoid, neomycin, polymyxin.
* Major congenital defects or serious chronic illness.
* History of any neurologic disorders or seizures.
* Acute disease at the time of enrolment.
* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
* Additional specific criteria for the booster part of the study
* History of or previous vaccination against measles, mumps, rubella or varicella.
* Previous booster vaccination with Hib or meningococcal serogroup C vaccine since the last visit of the primary phase.

Minimum Eligible Age

6 Weeks

Maximum Eligible Age

12 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

North Adelaide, South Australia, Australia

Site Status

GSK Investigational Site

Carlton, Victoria, Australia

Site Status

GSK Investigational Site

Perth, Western Australia, Australia

Site Status

Countries

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Australia

References

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Bryant KA, Marshall GS. Haemophilus influenzae type b-Neisseria meningitidis serogroups C and Y tetanus toxoid conjugate vaccine for infants and toddlers. Expert Rev Vaccines. 2011 Jul;10(7):941-50. doi: 10.1586/erv.11.90.

Reference Type BACKGROUND

PMID: 21806393 (View on PubMed)

Bryant K, McVernon J, Marchant C, Nolan T, Marshall G, Richmond P, Marshall H, Nissen M, Lambert S, Aris E, Mesaros N, Miller J. Immunogenicity and safety of measles-mumps-rubella and varicella vaccines coadministered with a fourth dose of Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine in toddlers: a pooled analysis of randomized trials. Hum Vaccin Immunother. 2012 Aug;8(8):1036-41. doi: 10.4161/hv.20357. Epub 2012 Aug 1.

Reference Type BACKGROUND

PMID: 22617844 (View on PubMed)

Nolan T, Richmond P, Marshall H, McVernon J, Alexander K, Mesaros N, Aris E, Miller J, Poolman J, Boutriau D. Immunogenicity and safety of an investigational combined haemophilus influenzae type B-Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine. Pediatr Infect Dis J. 2011 Mar;30(3):190-6. doi: 10.1097/INF.0b013e3181fcb2bf.

Reference Type BACKGROUND

PMID: 20948453 (View on PubMed)

Study Documents

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Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

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Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

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Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

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Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register. The results of this study 102370 are summarised with study 102371 on the GSK Clinical Study Register.

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