Long-Term Antibody Persistence at 1, 3 and 5 Years After a Fourth Dose of GSK Biologicals' Hib-MenCY-TT Vaccine Compared to ActHIB
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00359983
First received: July 31, 2006
Last updated: September 6, 2012
Last verified: August 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Meningococcal Infection Haemophilus Influenzae Type b Infections |
Biological: MenHibrix (Hib-MenCY-TT) Biological: Hib conjugate vaccine (ActHIB) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | A Study to Evaluate the Long-term Antibody Persistence at 1, 3 & 5 Years After the Administration of a Fourth Dose of Hib-MenCY-TT Vaccine Compared to ActHIB in Subjects Boosted in a Previous Study. |
Resource links provided by NLM:
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Number of Subjects With Anti- Polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to 0.15 Microgram Per Milliliter [ Time Frame: One year, three years, and five years after the fourth dose vaccination. ] [ Designated as safety issue: No ]Results up to 5 years after the fourth dose are presented.
- Number of Subjects With Neisseria Meningitidis Serogroup C (MenC) Antibody Titers Greater Than or Equal to 1:8 as Measured by Serum Bactericidal Assay Using Human Complement (hSBA) [ Time Frame: One year, three years, and five years after the fourth dose vaccination. ] [ Designated as safety issue: No ]Results up to 5 years after the fourth dose are presented.
- Number of Subjects With Neisseria Meningitidis Serogroup Y (MenY) Antibody Titers Greater Than or Equal to 1:8 as Measured by Serum Bactericidal Assay Using Human Complement (hSBA) [ Time Frame: One year, three years, and five years after the fourth dose vaccination. ] [ Designated as safety issue: No ]Results up to 5 years after the fourth dose are presented.
Secondary Outcome Measures:
- Anti-PRP Geometric Mean Concentrations (GMCs) [ Time Frame: One year, three years, and five years after the fourth dose vaccination. ] [ Designated as safety issue: No ]
Concentration were measured as Geometric Mean Concentrations expressed as microgram per milliliter (µg/mL).
Results up to 5 years after the fourth dose are presented.
- Number of Subjects With Anti-PRP Antibody Concentrations Greater Than or Equal to 1.0 Microgram Per Milliliter [ Time Frame: One year, three years, and five years after the fourth dose vaccination. ] [ Designated as safety issue: No ]Results up to 5 years after the fourth dose are presented.
- hSBA-MenC Geometric Mean Titers (GMTs) [ Time Frame: One year, three years, and five years after the fourth dose vaccination. ] [ Designated as safety issue: No ]
Titers are given as Geometric Mean Titers as measured by human serum bactericidal assay (hSBA) and expressed as the reciprocal of the dilution resulting in 50% inhibition.
Results up to 5 years after the fourth dose are presented.
- Number of Subjects With hSBA-MenC Titers Greater Than or Equal to 1:4 [ Time Frame: One year, three years, and five years after the fourth dose vaccination. ] [ Designated as safety issue: No ]Results up to 5 years after the fourth dose are presented.
- hSBA-MenY Geometric Mean Titers (GMTs) [ Time Frame: One year, three years, and five years after the fourth dose vaccination. ] [ Designated as safety issue: No ]
Titers are given as Geometric Mean Titers as measured by human serum bactericidal assay (hSBA) and expressed as the reciprocal of the dilution resulting in 50% inhibition.
Results up to 5 years after the fourth dose are presented.
- Number of Subjects With hSBA-MenY Titers Greater Than or Equal to 1:4 [ Time Frame: One year, three years, and five years after the fourth dose vaccination. ] [ Designated as safety issue: No ]Results up to 5 years after the fourth dose are presented.
| Enrollment: | 270 |
| Study Start Date: | September 2006 |
| Study Completion Date: | May 2011 |
| Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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.
|
Biological: MenHibrix (Hib-MenCY-TT)
First three doses: 3 intramuscular doses Fourth dose: 1 intramuscular dose
Other Name: GSK biologicals' Hib-MenCY-TT
|
|
Active Comparator: 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.
|
Biological: Hib conjugate vaccine (ActHIB)
First three doses: 3 intramuscular doses Fourth dose: 1 intramuscular dose
Other Name: ActHIB
|
|
Experimental: 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.
|
Biological: MenHibrix (Hib-MenCY-TT)
First three doses: 3 intramuscular doses Fourth dose: 1 intramuscular dose
Other Name: GSK biologicals' Hib-MenCY-TT
Biological: Hib conjugate vaccine (ActHIB)
First three doses: 3 intramuscular doses Fourth dose: 1 intramuscular dose
Other Name: ActHIB
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 22 Months to 60 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00359983
Locations
| United States, Arkansas | |
| GSK Investigational Site | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| GSK Investigational Site | |
| Fountain Valley, California, United States, 92708 | |
| United States, Connecticut | |
| GSK Investigational Site | |
| Norwich, Connecticut, United States, 06360 | |
| United States, Georgia | |
| GSK Investigational Site | |
| Marietta, Georgia, United States, 30062 | |
| GSK Investigational Site | |
| Woodstock, Georgia, United States, 30189 | |
| United States, Iowa | |
| GSK Investigational Site | |
| Waukee, Iowa, United States, 50263 | |
| United States, Kentucky | |
| GSK Investigational Site | |
| Bardstown, Kentucky, United States, 40004 | |
| GSK Investigational Site | |
| Louisville, Kentucky, United States, 40202 | |
| GSK Investigational Site | |
| Louisville, Kentucky, United States, 40272 | |
| United States, Louisiana | |
| GSK Investigational Site | |
| Bossier City, Louisiana, United States, 71111 | |
| United States, Massachusetts | |
| GSK Investigational Site | |
| Boston, Massachusetts, United States, 02118 | |
| GSK Investigational Site | |
| Fall River, Massachusetts, United States, 02724 | |
| United States, New York | |
| GSK Investigational Site | |
| Pittsford, New York, United States, 14534 | |
| GSK Investigational Site | |
| Rochester, New York, United States, 14620 | |
| United States, Ohio | |
| GSK Investigational Site | |
| Boardman, Ohio, United States, 44512 | |
| GSK Investigational Site | |
| Cleveland, Ohio, United States, 44121 | |
| United States, Pennsylvania | |
| GSK Investigational Site | |
| Erie, Pennsylvania, United States, 16505 | |
| GSK Investigational Site | |
| Greenville, Pennsylvania, United States, 16125 | |
| GSK Investigational Site | |
| Pittsburgh, Pennsylvania, United States, 15241 | |
| GSK Investigational Site | |
| Pittsburgh, Pennsylvania, United States, 15236 | |
| GSK Investigational Site | |
| Pittsburgh, Pennsylvania, United States, 15217 | |
Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
Publications:
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00359983 History of Changes |
| Obsolete Identifiers: | NCT00360113, NCT00360165 |
| Other Study ID Numbers: | 107824, 107826, 107829 |
| Study First Received: | July 31, 2006 |
| Results First Received: | June 15, 2012 |
| Last Updated: | September 6, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by GlaxoSmithKline:
|
Humans Meningococcal vaccines Immunogenicity Vaccines H. influenzae type b vaccine |
Conjugate Toddlers Comparative study Neisseria meningitidis |
Additional relevant MeSH terms:
|
Influenza, Human Meningococcal Infections Orthomyxoviridae Infections RNA Virus Infections Virus Diseases |
Respiratory Tract Infections Respiratory Tract Diseases Neisseriaceae Infections Gram-Negative Bacterial Infections Bacterial Infections |
ClinicalTrials.gov processed this record on May 21, 2013