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Safety of Hib-MenCY-TT Vaccine Versus Licensed Hib Conjugate Vaccine, Given at 2, 4, 6 and 12 to 15 Months of Age

NCT ID: NCT00345579

Last Updated: 2016-12-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

4432 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2008-03-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Haemophilus Influenzae Type b Neisseria Meningitidis

Keywords

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Prophylaxis Neisseria meningitidis Vaccines, conjugate Infants Meningococcal vaccines H. influenzae type B vaccine Humans Safety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Menhibrix Group

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.

Group Type EXPERIMENTAL

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

Intervention Type BIOLOGICAL

3-dose intramuscular injection

Pediarix/Infanrix Penta

Intervention Type BIOLOGICAL

3-dose intramuscular injection

ActHIB Group

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.

Group Type ACTIVE_COMPARATOR

ActHIB

Intervention Type BIOLOGICAL

3-dose intramuscular injection

Pediarix/Infanrix Penta

Intervention Type BIOLOGICAL

3-dose intramuscular injection

Interventions

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

3-dose intramuscular injection

Intervention Type BIOLOGICAL

ActHIB

3-dose intramuscular injection

Intervention Type BIOLOGICAL

Pediarix/Infanrix Penta

3-dose intramuscular injection

Intervention Type BIOLOGICAL

Eligibility Criteria

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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).
Minimum Eligible Age

6 Weeks

Maximum Eligible Age

12 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

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

Birmingham, Alabama, United States

Site Status

GSK Investigational Site

Birmingham, Alabama, United States

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GSK Investigational Site

Benton, Arkansas, United States

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GSK Investigational Site

Fayetteville, Arkansas, United States

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GSK Investigational Site

Hot Springs, Arkansas, United States

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GSK Investigational Site

Jonesboro, Arkansas, United States

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GSK Investigational Site

Little Rock, Arkansas, United States

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GSK Investigational Site

Little Rock, Arkansas, United States

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GSK Investigational Site

Fountain Valley, California, United States

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GSK Investigational Site

Fresno, California, United States

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GSK Investigational Site

Fresno, California, United States

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GSK Investigational Site

Madera, California, United States

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GSK Investigational Site

Slinas, California, United States

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GSK Investigational Site

West Covina, California, United States

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GSK Investigational Site

Boulder, Colorado, United States

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GSK Investigational Site

Longmont, Colorado, United States

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GSK Investigational Site

Plantation, Florida, United States

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GSK Investigational Site

Nampa, Idaho, United States

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GSK Investigational Site

Oak Lawn, Illinois, United States

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GSK Investigational Site

Waukee, Iowa, United States

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GSK Investigational Site

West Desmoines, Iowa, United States

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GSK Investigational Site

Bardstown, Kentucky, United States

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GSK Investigational Site

Lexington, Kentucky, United States

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GSK Investigational Site

Bossier City, Louisiana, United States

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GSK Investigational Site

Boston, Massachusetts, United States

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GSK Investigational Site

Jamaica Plain, Massachusetts, United States

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GSK Investigational Site

Nies, Michigan, United States

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GSK Investigational Site

Portage, Michigan, United States

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GSK Investigational Site

Stevensville, Michigan, United States

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GSK Investigational Site

Saint Paul, Minnesota, United States

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GSK Investigational Site

Las Vegas, Nevada, United States

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GSK Investigational Site

New Hartford, New York, United States

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GSK Investigational Site

Syracuse, New York, United States

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GSK Investigational Site

Clyde, North Carolina, United States

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GSK Investigational Site

Deerfield, North Carolina, United States

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GSK Investigational Site

Raleigh, North Carolina, United States

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GSK Investigational Site

Sylva, North Carolina, United States

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GSK Investigational Site

Akron, Ohio, United States

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GSK Investigational Site

Canton, Ohio, United States

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GSK Investigational Site

Cleveland, Ohio, United States

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GSK Investigational Site

North Canton, Ohio, United States

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GSK Investigational Site

South Euclid, Ohio, United States

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GSK Investigational Site

Pittsburgh, Pennsylvania, United States

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GSK Investigational Site

Pittsburgh, Pennsylvania, United States

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GSK Investigational Site

Pittsburgh, Pennsylvania, United States

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GSK Investigational Site

Pittsburgh, Pennsylvania, United States

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GSK Investigational Site

Wexford, Pennsylvania, United States

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GSK Investigational Site

Charleston, South Carolina, United States

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GSK Investigational Site

Kingsport, Tennessee, United States

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GSK Investigational Site

Kingsport, Tennessee, United States

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GSK Investigational Site

Houston, Texas, United States

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GSK Investigational Site

Katy, Texas, United States

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GSK Investigational Site

Layton, Utah, United States

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GSK Investigational Site

Ogden, Utah, United States

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GSK Investigational Site

Orem, Utah, United States

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GSK Investigational Site

Pleasant Gorve, Utah, United States

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GSK Investigational Site

Salt Lake City, Utah, United States

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GSK Investigational Site

South Jordan, Utah, United States

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GSK Investigational Site

West Jordan, Utah, United States

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GSK Investigational Site

Madison, Wisconsin, United States

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GSK Investigational Site

Marshfield, Wisconsin, United States

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GSK Investigational Site

Mexico City, , Mexico

Site Status

GSK Investigational Site

Mexico City, , Mexico

Site Status

Countries

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United States Mexico

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)

Rinderknecht S, Bryant K, Nolan T, Pavia-Ruz N, Doniz CA, Weber MA, Cohen C, Aris E, Mesaros N, Miller JM. The safety profile of Haemophilus influenzae type b-Neisseria meningitidis serogroups C and Y tetanus toxoid conjugate vaccine (HibMenCY). Hum Vaccin Immunother. 2012 Mar;8(3):304-11. doi: 10.4161/hv.18752. Epub 2012 Feb 13.

Reference Type BACKGROUND
PMID: 22327493 (View on PubMed)

Study Documents

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Document Type: Clinical Study Report

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Dataset Specification

View Document

Document Type: Individual Participant Data Set

View Document

Document Type: Informed Consent Form

View Document

Document Type: Study Protocol

View Document

Related Links

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https://www.clinicalstudydatarequest.com

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Other Identifiers

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105987

Identifier Type: -

Identifier Source: org_study_id