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

NCT ID: NCT00345683

Last Updated: 2016-11-29

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

4021 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2008-11-30

Brief Summary

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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.

Detailed Description

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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)

Conditions

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Haemophilus Influenzae Type b Neisseria Meningitidis

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Caregivers

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 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.

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

Booster dose by intramuscular injection

Prevnar

Intervention Type BIOLOGICAL

Booster dose by intramuscular injection

M-M-R II

Intervention Type BIOLOGICAL

Single dose by subcutaneous injection

Varivax

Intervention Type BIOLOGICAL

Single dose by subcutaneous 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 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.

Group Type ACTIVE_COMPARATOR

PedvaxHIB

Intervention Type BIOLOGICAL

Booster dose by intramuscular injection

Prevnar

Intervention Type BIOLOGICAL

Booster dose by intramuscular injection

M-M-R II

Intervention Type BIOLOGICAL

Single dose by subcutaneous injection

Varivax

Intervention Type BIOLOGICAL

Single dose by subcutaneous 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)

Booster dose by intramuscular injection

Intervention Type BIOLOGICAL

PedvaxHIB

Booster dose by intramuscular injection

Intervention Type BIOLOGICAL

Prevnar

Booster dose by intramuscular injection

Intervention Type BIOLOGICAL

M-M-R II

Single dose by subcutaneous injection

Intervention Type BIOLOGICAL

Varivax

Single dose by subcutaneous injection

Intervention Type BIOLOGICAL

Other Intervention Names

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Monovalent Hib conjugate vaccine. Measles mumps and rubella vaccine. Varicella vaccine

Eligibility Criteria

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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
Minimum Eligible Age

12 Months

Maximum Eligible Age

15 Months

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

Jonesboro, 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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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

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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Bossier City, Louisiana, United States

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GSK Investigational Site

Boston, 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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Stevensville, Michigan, United States

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GSK Investigational Site

Saint Paul, Minnesota, United States

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Las Vegas, Nevada, United States

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GSK Investigational Site

Ithaca, New York, United States

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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

Raleigh, North Carolina, United States

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GSK Investigational Site

Boardman, 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

Erie, Pennsylvania, United States

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GSK Investigational Site

Greenville, Pennsylvania, United States

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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

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

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

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

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GSK Investigational Site

Mexico City, , Mexico

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Countries

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United States Mexico

References

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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 DERIVED
PMID: 22327493 (View on PubMed)

Study Documents

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Document Type: Informed Consent Form

View Document

Document Type: Individual Participant Data Set

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Document Type: Clinical Study Report

View Document

Document Type: Annotated Case Report Form

View Document

Document Type: Dataset Specification

View Document

Related Links

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http://www.clinicaltrials.gov/ct/show/NCT00345579

Primary Study

Other Identifiers

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105988

Identifier Type: -

Identifier Source: org_study_id