Long-Term Antibody Persistence at 1, 3 and 5 Years After... | NCT00359983

ID	Type	Description	Link
107826	Other Identifier	GSK
107829	Other Identifier	GSK

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MenHibrix 4-dose group	Experimental	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)
ActHIB 4-dose group	Active Comparator	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)
ActHIB 3-dose + MenHibrix 4th-dose group	Experimental	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) Biological: Hib conjugate vaccine (ActHIB)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MenHibrix (Hib-MenCY-TT)	Biological	First three doses: 3 intramuscular doses Fourth dose: 1 intramuscular dose	ActHIB 3-dose + MenHibrix 4th-dose group MenHibrix 4-dose group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Subjects With Anti- Polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to 0.15 Microgram Per Milliliter	Results up to 5 years after the fourth dose are presented.	One year, three years, and five years after the fourth dose vaccination.
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)	Results up to 5 years after the fourth dose are presented.	One year, three years, and five years after the fourth dose vaccination.
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)	Results up to 5 years after the fourth dose are presented.	One year, three years, and five years after the fourth dose vaccination.

Secondary Outcomes

Measure	Description	Time Frame
Anti-PRP Geometric Mean Concentrations (GMCs)	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.	One year, three years, and five years after the fourth dose vaccination.
Number of Subjects With Anti-PRP Antibody Concentrations Greater Than or Equal to 1.0 Microgram Per Milliliter

Eligibility Module

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Little Rock	Arkansas	72205	United States
GSK Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21806393	Background	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.
20072077	Background	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.

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

ID	Type	URL	Comment
107824	Informed Consent Form	View IPD

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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.
FG001	ActHIB 4-dose Group

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	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.
BG001	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.
BG002	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.
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Months

Title

Denominators

Categories

Year 1 (N=116; 51; 46)

Title	Measurements
	OG000116 OG00149 OG00246

Year 3 (N=61; 28; 36)

Primary

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)

Results up to 5 years after the fourth dose are presented.

Posted

Number

Subjects

One year, three years, and five years after the fourth dose vaccination.

ID	Title	Description
OG000	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.
OG001	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.
OG002	ActHIB 3-dose + MenHibrix 4th-dose Group

Primary

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)

Results up to 5 years after the fourth dose are presented.

Posted

Number

Subjects

One year, three years, and five years after the fourth dose vaccination.

ID	Title	Description
OG000	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.
OG001	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.
OG002	ActHIB 3-dose + MenHibrix 4th-dose Group

Secondary

Anti-PRP Geometric Mean Concentrations (GMCs)

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.

Posted

Geometric Mean

95% Confidence Interval

µg/mL

One year, three years, and five years after the fourth dose vaccination.

ID	Title	Description
OG000	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.
OG001	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.
OG002	ActHIB 3-dose + MenHibrix 4th-dose Group

Secondary

Number of Subjects With Anti-PRP Antibody Concentrations Greater Than or Equal to 1.0 Microgram Per Milliliter

Results up to 5 years after the fourth dose are presented.

Posted

Number

Subjects

One year, three years, and five years after the fourth dose vaccination.

ID	Title	Description
OG000	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.
OG001	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.
OG002	ActHIB 3-dose + MenHibrix 4th-dose Group

Secondary

hSBA-MenC Geometric Mean Titers (GMTs)

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.

Posted

Geometric Mean

95% Confidence Interval

Titer

One year, three years, and five years after the fourth dose vaccination.

ID	Title	Description
OG000	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.
OG001	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.
OG002

Secondary

Number of Subjects With hSBA-MenC Titers Greater Than or Equal to 1:4

Results up to 5 years after the fourth dose are presented.

Posted

Number

Subjects

One year, three years, and five years after the fourth dose vaccination.

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

Secondary

hSBA-MenY Geometric Mean Titers (GMTs)

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.

Posted

Geometric Mean

95% Confidence Interval

Titer

One year, three years, and five years after the fourth dose vaccination.

ID	Title	Description
OG000	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.
OG001	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.
OG002

Secondary

Number of Subjects With hSBA-MenY Titers Greater Than or Equal to 1:4

Results up to 5 years after the fourth dose are presented.

Posted

Number

Subjects

One year, three years, and five years after the fourth dose vaccination.

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

Arm/Groups

ID	Title	Description	Serious Events (At Risk)
EG000	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.	138
EG001	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.	70
EG002	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.	62

ID	Term
D016871	Pasteurellaceae Infections
D016905	Gram-Negative Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections

ID	Term
C527605	Hib-MenCY-TT vaccine
C055753	Haemophilus influenza type b polysaccharide vaccine-tetanus toxin conjugate