MedDataX Logo

Long-Term Antibody Persistence at 1, 3 and 5 Years After a Fourth Dose of GSK Biologicals' Hib-MenCY-TT Vaccine Compared to ActHIB

NCT ID: NCT00359983

Last Updated: 2016-12-16

Study Results

Results available

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

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

270 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2011-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study is evaluating antibody persistence at 1, 3 \& 5 years post-fourth dose (i.e., at 2, 4 \& 6 years of age, respectively) in subjects vaccinated in a previous study.

This protocol posting deals with objectives \& outcome measures of the extension phase at years 1, 3 and 5. The objectives \& outcome measures of the first four doses are presented in a separate protocol posting (NCT00129129).

This protocol posting has been amended in order to comply with the FDA Amendment Act of September 26, 2007.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

In this long-term follow-up study, no new subjects will be recruited. All subjects participating in this long-term follow-up study should have already participated in a previous study. No vaccine will be administered during the persistence phase of the study.

This Protocol Posting has been updated following Protocol amendment 3, September 2009.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neisseria Meningitidis Haemophilus Influenzae Type b

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Humans Meningococcal vaccines Immunogenicity Vaccines H. influenzae type b vaccine Conjugate Toddlers Comparative study Neisseria meningitidis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

MenHibrix 4-dose group

Subjects received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.

Group Type EXPERIMENTAL

MenHibrix (Hib-MenCY-TT)

Intervention Type BIOLOGICAL

First three doses: 3 intramuscular doses Fourth dose: 1 intramuscular dose

ActHIB 4-dose group

Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study.

Group Type ACTIVE_COMPARATOR

Hib conjugate vaccine (ActHIB)

Intervention Type BIOLOGICAL

First three doses: 3 intramuscular doses Fourth dose: 1 intramuscular dose

ActHIB 3-dose + MenHibrix 4th-dose group

Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.

Group Type EXPERIMENTAL

MenHibrix (Hib-MenCY-TT)

Intervention Type BIOLOGICAL

First three doses: 3 intramuscular doses Fourth dose: 1 intramuscular dose

Hib conjugate vaccine (ActHIB)

Intervention Type BIOLOGICAL

First three doses: 3 intramuscular doses Fourth dose: 1 intramuscular dose

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MenHibrix (Hib-MenCY-TT)

First three doses: 3 intramuscular doses Fourth dose: 1 intramuscular dose

Intervention Type BIOLOGICAL

Hib conjugate vaccine (ActHIB)

First three doses: 3 intramuscular doses Fourth dose: 1 intramuscular dose

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

GSK biologicals' Hib-MenCY-TT ActHIB

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Healthy male and female children who completed the previous four dose vaccination series study (NCT00129129). The age of the child at the 3 post-fourth dose timelines are as follows:

* Year 1: 22 to 36 months of age.
* Year 3: 44 to 60 months of age.
* Year 5: 5 years post-dose 4 +/- 8 weeks
* 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
* Having completed the fourth dose vaccination of study Hib-MenCY-TT-005/006

Exclusion Criteria

Children should not have:

* received more than 4 doses of Hib or meningococcal serogroup C and Y vaccine
* had a history of H. influenzae type b, meningococcal serogroup C and Y diseases
Minimum Eligible Age

22 Months

Maximum Eligible Age

60 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

GSK Investigational Site

Little Rock, Arkansas, United States

Site Status

GSK Investigational Site

Fountain Valley, California, United States

Site Status

GSK Investigational Site

Norwich, Connecticut, United States

Site Status

GSK Investigational Site

Marietta, Georgia, United States

Site Status

GSK Investigational Site

Woodstock, Georgia, United States

Site Status

GSK Investigational Site

Waukee, Iowa, United States

Site Status

GSK Investigational Site

Bardstown, Kentucky, United States

Site Status

GSK Investigational Site

Louisville, Kentucky, United States

Site Status

GSK Investigational Site

Louisville, Kentucky, United States

Site Status

GSK Investigational Site

Bossier City, Louisiana, United States

Site Status

GSK Investigational Site

Boston, Massachusetts, United States

Site Status

GSK Investigational Site

Fall River, Massachusetts, United States

Site Status

GSK Investigational Site

Pittsford, New York, United States

Site Status

GSK Investigational Site

Rochester, New York, United States

Site Status

GSK Investigational Site

Boardman, Ohio, United States

Site Status

GSK Investigational Site

Cleveland, Ohio, United States

Site Status

GSK Investigational Site

Erie, Pennsylvania, United States

Site Status

GSK Investigational Site

Greenville, Pennsylvania, United States

Site Status

GSK Investigational Site

Pittsburgh, Pennsylvania, United States

Site Status

GSK Investigational Site

Pittsburgh, Pennsylvania, United States

Site Status

GSK Investigational Site

Pittsburgh, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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)

Marshall GS, Marchant CD, Blatter M, Aris E, Boutriau D, Poolman JT, Friedland LR, Miller JM. Immune response and one-year antibody persistence after a fourth dose of a novel Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine (HibMenCY) at 12 to 15 months of age. Pediatr Infect Dis J. 2010 May;29(5):469-71. doi: 10.1097/INF.0b013e3181cdd379.

Reference Type BACKGROUND
PMID: 20072077 (View on PubMed)

Marshall GS et al. Antibody persistence 5 years after the fourth dose of a US-licensed Heamophilus influenzae type B and Neisseria meningitidis serogroups C and Y tetanus toxoid (HIBMENCY-TT) conjugate vaccine. Abstract presented at the 50th Annual Meeting of the Infectious Diseases Society of America - (IDSA-IDWeek), San Diego, 17-21 October 2012.

Reference Type BACKGROUND

Marshall GS et al. Persistence of Immunity three years after an Investigational Haemophilus influenzae type b and Neisseria meningitidis Serogroups C and Y Tetanus Toxoid (HibMenCY-TT) Conjugate Vaccine. Abstract presented at the 45th National Immunization Conference (NIC). Washington, D.C, USA, 28-31 March 2011.

Reference Type BACKGROUND

Marshall GS, Blatter M, Marchant C, Aris E, Mesaros N, Miller JM. Antibody persistence for up to 5 years after a fourth dose of Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine (HibMenCY-TT) given at 12-15 months of age. Pediatr Infect Dis J. 2013 Jun;32(6):662-8. doi: 10.1097/INF.0b013e3182840e35.

Reference Type DERIVED
PMID: 23340564 (View on PubMed)

Study Documents

Access uploaded study-related documents such as protocols, statistical analysis plans, or lay summaries.

Document Type: Informed Consent Form

View Document

Document Type: Clinical Study Report

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Dataset Specification

View Document

Document Type: Study Protocol

View Document

Document Type: Individual Participant Data Set

View Document

Related Links

Access external resources that provide additional context or updates about the study.

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

107826

Identifier Type: OTHER

Identifier Source: secondary_id

107829

Identifier Type: OTHER

Identifier Source: secondary_id

107824

Identifier Type: -

Identifier Source: org_study_id

NCT00360113

Identifier Type: -

Identifier Source: nct_alias

NCT00360165

Identifier Type: -

Identifier Source: nct_alias