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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00891176
Other study ID # 112830
Secondary ID
Status Completed
Phase Phase 3
First received April 30, 2009
Last updated August 22, 2017
Start date May 14, 2009
Est. completion date November 21, 2012

Study information

Verified date September 2016
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This protocol posting deals with objectives & outcome measures of an extension phase when subjects are aged 3, 4 and 6 years of age. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00334334). The objectives & outcome measures of the booster phase are presented in a separate protocol posting (NCT number = NCT00463437).

The purpose of this study is to evaluate the persistence of pneumococcal, meningococcal serogroup C, Hib and Hepatits B antibodies after booster vaccination, when the subjects are aged 3, 4 and 6 years. No vaccine will be administered during this persistence phase of the study.


Description:

This multicenter study is open. No vaccine will be administered during this persistence phase of the study. The subjects were randomized in the primary vaccination study 107005 and will not be further randomized in this study.


Recruitment information / eligibility

Status Completed
Enrollment 582
Est. completion date November 21, 2012
Est. primary completion date November 21, 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 36 Months to 76 Months
Eligibility Inclusion Criteria:

- Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.

- A male or female between, and including, 36 and 40 months of age at the time of Visit 1; between, and including, 48 and 52 months of age at the time of Visit 2; and between, and including, 72 and 76 months of age at the time of Visit 3.

- 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.

- Subjects who previously participated in the primary and booster studies, who received a full vaccination course with the vaccines corresponding to their group during the primary and booster studies and who were part, in the booster study, of the blood sampling subset.

Exclusion Criteria:

- Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the first blood sampling.

- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.

- Administration of any additional meningococcal serogroup C, Hib, hepatitis B and pneumococcal vaccine since the end of the booster study

- History of meningococcal serogroup C, Haemophilus influenzae type b, hepatitis B and invasive pneumococcal diseases since the end of booster study.

- Any confirmed or suspected immunosuppressive or immunodeficient condition since the end of booster study, based on medical history and physical examination (no laboratory testing required).

- Administration of immunoglobulins and/or any blood products within the three months preceding the first blood sampling.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
MenitorixTM
Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age and as booster dose at 11-18 months of age. No vaccine was administered during this long-term follow up study.
Pneumococcal conjugate vaccine GSK1024850A
Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age and as booster dose at 11-18 months of age. No vaccine was administered during this long-term follow up study.
PrevenarTM
Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age and as booster dose at 11-18 months of age. No vaccine was administered during this long-term follow up study.
MeningitecTM
Intramuscular injection into the thigh as primary vaccination at 2 and 4 months of age and as booster dose at 11-18 months of age. No vaccine was administered during this long-term follow up study
NeisVac-CTM
Intramuscular injection into the thigh as primary vaccination at 2 and 4 months of age and as booster dose at 11-18 months of age. No vaccine was administered during this long-term follow up study
InfanrixTM hexa
Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age (all countries) and as booster dose at 11-18 months of age (Germany and Poland). No vaccine was administered during this long-term follow up study
InfanrixTM penta
Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age (all countries) and as booster dose at 11-18 months of age (Germany and Poland). No vaccine was administered during this long-term follow up study
InfanrixTM IPV/Hib
Intramuscular injection into the thigh as booster dose at 11-18 months of age (Spain). No vaccine was administered during this long-term follow up study
InfanrixTM IPV
Intramuscular injection into the thigh as booster dose at 11-18 months of age (Spain). No vaccine was administered during this long-term follow up study

Locations

Country Name City State
Germany GSK Investigational Site Bad Saulgau Baden-Wuerttemberg
Germany GSK Investigational Site Berlin
Germany GSK Investigational Site Berlin
Germany GSK Investigational Site Bretten Baden-Wuerttemberg
Germany GSK Investigational Site Doebeln Sachsen
Germany GSK Investigational Site Ettenheim Baden-Wuerttemberg
Germany GSK Investigational Site Frankenthal Rheinland-Pfalz
Germany GSK Investigational Site Hille Nordrhein-Westfalen
Germany GSK Investigational Site Karlsruhe Baden-Wuerttemberg
Germany GSK Investigational Site Kehl Baden-Wuerttemberg
Germany GSK Investigational Site Lobenstein Thueringen
Germany GSK Investigational Site Loehne Nordrhein-Westfalen
Germany GSK Investigational Site Mannheim Baden-Wuerttemberg
Germany GSK Investigational Site Muenchen Bayern
Germany GSK Investigational Site Muenchen Bayern
Germany GSK Investigational Site Muenster Nordrhein-Westfalen
Germany GSK Investigational Site Noerdlingen Bayern
Germany GSK Investigational Site Oberstenfeld Baden-Wuerttemberg
Germany GSK Investigational Site Porta Westfalica Nordrhein-Westfalen
Germany GSK Investigational Site Schwaebisch-Hall Baden-Wuerttemberg
Germany GSK Investigational Site Tettnang Baden-Wuerttemberg
Germany GSK Investigational Site Trier Rheinland-Pfalz
Germany GSK Investigational Site Weimar Thueringen
Poland GSK Investigational Site Debica
Poland GSK Investigational Site Krakow
Poland GSK Investigational Site Siemianowice Slaskie
Spain GSK Investigational Site Madrid
Spain GSK Investigational Site Móstoles/Madrid

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Germany,  Poland,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Titers Using Rabbit Complement (rSBA-MenC) Equal to or Above Cut-off Value rSBA-MenC antibody cut-off value assessed was equal to or above 1:8. The rSBA-MenC assay was performed at the Public Health England (PHE) laboratory at 6 years of age while the GSK laboratory was used for testing at 3 and 4 years of age. At 3 years of age
Primary Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Titers Using Rabbit Complement (rSBA-MenC) Equal to or Above Cut-off Value rSBA-MenC antibody cut-off value assessed was equal to or above 1:8. The rSBA-MenC assay was performed at the Public Health England (PHE) laboratory at 6 years of age while the GSK laboratory was used for testing at 3 and 4 years of age. At 6 years of age
Primary Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Titers Using Rabbit Complement (rSBA-MenC) Equal to or Above Cut-off Value rSBA-MenC antibody cut-off value assessed was equal to or above 1:8. The rSBA-MenC assay was performed at the Public Health England (PHE) laboratory at 6 years of age while the GSK laboratory was used for testing at 3 and 4 years of age. At 4 years of age
Secondary Number of Subjects With an rSBA-MenC Titer Equal to or Above Cut-off Value The cut-off value was defined as a titer equal to or above 1:128. At 3 years of age
Secondary rSBA-MenC Titers Titers are given as Geometric Mean Titers (GMTs). At 3 years of age
Secondary Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations Equal to or Above Cut-off Values The cut-off values were defined as a concentration equal to or above 0.15 microgram per milliliter (µg/mL) and equal to or above 1.0 µg/mL. At 3 years of age
Secondary Anti-PRP Concentrations Concentrations were defined as Geometric Mean Concentrations (GMCs) in µg/mL, At 3 years of age
Secondary Antibody Concentrations Against Vaccine Pneumococcal Serotypes Antibody concentrations were expressed as GMCs in µg/mL.
Vaccine pneumococcal serotypes assessed included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
At 3 years of age
Secondary Number of Subjects With Opsonophagocytic Activity Opsonophagocytic activity was measured by a killing-assay. The results were presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay was an opsonic titre of 8. At 3 years of age
Secondary Concentration of Antibodies Against Protein D Concentrations were expressed as GMCs in enzyme-linked immunosorbent-assay (ELISA) units per milliliter (EL.U/mL). At 3 years of age
Secondary Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values Cut-off values assessed were defined as equal to or above 10 milli-international units per milliliter (mIU/mL) or equal to or above 100 mIU/mL. At 3 years of age
Secondary Anti-HBs Antibody Concentrations Concentrations were expressed as GMCs in mIU/mL. At 3 years of age
Secondary Number of Subjects With Serious Adverse Events (SAEs) SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Related = SAE assessed by the investigator as being related to the study procedures. From last study contact of the study (NCT00463437) at 17-24 months of age until 3 years of age
Secondary rSBA-MenC Titers Titers are given as Geometric Mean Titers (GMTs). At 4 years of age
Secondary Number of Subjects With an rSBA-MenC Titer Equal to or Above Cut-off Value rSBA-MenC antibody cut-off value assessed was equal to or above 1:128. At 4 years of age
Secondary Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations Equal to or Above Cut-off Values The cut-off values were defined as a concentration equal to or above 0.15 microgram per milliliter (µg/mL) and equal to or above 1.0 µg/mL. At 4 years of age
Secondary Anti-PRP Concentrations Concentrations were defined as Geometric Mean Concentrations (GMCs) in µg/mL At 4 years of age
Secondary Antibody Concentrations Against Vaccine Pneumococcal Serotypes Antibody concentrations were expressed as GMCs in µg/mL. Vaccine pneumococcal serotypes assessed included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. At 4 years of age
Secondary Number of Subjects With Opsonophagocytic Activity Opsonophagocytic activity was measured by a killing-assay. The results were presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay was an opsonic titer of 8. At 4 years of age
Secondary Concentration of Antibodies Against Protein D Concentrations were expressed as GMCs in enzyme-linked immunosorbent-assay (ELISA) units per milliliter (EL.U/mL). At 4 years of age
Secondary Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values Cut-off values assessed were defined as equal to or above 10 milli-international units per milliliter (mIU/mL) or equal to or above 100 mIU/mL. At 4 years of age
Secondary Anti-HBs Antibody Concentrations Concentrations were expressed as GMCs in mIU/mL. At 4 years of age
Secondary Number of Subjects With Serious Adverse Events (SAEs) SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Related = SAE assessed by the investigator as being related to the study procedures. From last study contact of the study (NCT00463437) at 17-24 months of age until 4 years of age
Secondary Number of Subjects With rSBA-MenC Titer Equal to or Above Cut-off Value rSBA-MenC antibody cut-off value assessed was equal to or above 1:128. At 6 years of age
Secondary rSBA-MenC Titers Titers are given as Geometric Mean Titers (GMTs). At 6 years of age
Secondary Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations Equal to or Above Cut-off Values The cut-off values were defined as a concentration = 0.15 microgram per milliliter (µg/mL) and = 1.0 µg/mL. At 6 years of age
Secondary Anti-PRP Concentrations Concentrations were defined as Geometric Mean Concentrations (GMCs) in µg/mL At 6 years of age
Secondary Antibody Concentrations Against Vaccine Pneumococcal Serotypes Antibody concentrations were expressed as GMCs in µg/mL. Vaccine pneumococcal serotypes assessed included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. At 6 years of age
Secondary Concentration of Antibodies Against Protein D Concentrations were expressed as GMCs in enzyme-linked immunosorbent-assay (ELISA) units per milliliter (EL.U/mL). At 6 years of age
Secondary Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values as Measured by ELISA. Cut-off values assessed were defined as equal to or above 10 milli-international units per milliliter (mIU/mL) or equal to or above 100 mIU/mL. At 3 and 4 years of age
Secondary Anti-HBs Antibody Concentrations as Measured by ELISA Concentrations were expressed as GMCs in mIU/mL. At 3 and 4 years of age
Secondary Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values Cut-off values assessed were defined as equal to or above (=) 6.2 milli-international units per milliliter (mIU/mL), 10 mIU/mL and 100 mIU/mL.
Note: A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL) when tested by Enzyme-Linked Immunosorbent Assay (ELISA). The tables show both the results obtained by ELISA as well as updated results following complete retesting and reanalysis by a Chemiluminescence immunoassay (CLIA). Anti-HBs seroprotection was redefined as CLIA concentration above 10 mIU/mL.
At 3, 4 and 6 years of age
Secondary Anti-HBs Antibody Concentrations Concentrations were expressed as GMCs in mIU/mL. Note: A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL) when tested by ELISA. The tables show both the results obtained by ELISA as well as updated results following complete retesting and reanalysis by a Chemiluminescence immunoassay (CLIA). At 3, 4 and 6 years of age
Secondary Number of Subjects With Serious Adverse Events (SAEs) SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Related = SAE assessed by the investigator as being related to the study procedures. From last study contact of the study (NCT00463437) at 17-24 months of age until 6 years of age
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