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Completed

NCT Number: NCT00891176

Persistence of Antibodies at 3, 4 and 6 Years of Age After Vaccination With Meningococcal, Pneumococcal and Hib Vaccines

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.

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Key information

Conditions

Neisseria Meningitidis Bacterial Infections Bacterial Infections and Mycoses Gram-Negative Bacterial Infections Haemophilus Infections Haemophilus Influenzae Type b Infections Pasteurellaceae Infections

Age range

36 month–76 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Bad Saulgau, Baden-Wurttemberg, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MenitorixTM

Biological

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

Biological

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

Biological

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

Biological

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

Biological

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

Biological

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

Biological

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

Biological

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

Biological

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

Primary outcomes

  1. Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Titers Using Rabbit Complement (rSBA-MenC) Equal to or Above Cut-off Value

    Time frame: At 3 years of age

    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.

  2. Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Titers Using Rabbit Complement (rSBA-MenC) Equal to or Above Cut-off Value

    Time frame: At 6 years of age

    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.

  3. Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Titers Using Rabbit Complement (rSBA-MenC) Equal to or Above Cut-off Value

    Time frame: At 4 years of age

    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.

Secondary outcomes

  1. Number of Subjects With an rSBA-MenC Titer Equal to or Above Cut-off Value

    Time frame: At 3 years of age

    The cut-off value was defined as a titer equal to or above 1:128.

  2. rSBA-MenC Titers

    Time frame: At 3 years of age

    Titers are given as Geometric Mean Titers (GMTs).

  3. Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations Equal to or Above Cut-off Values

    Time frame: At 3 years of age

    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.

  4. Anti-PRP Concentrations

    Time frame: At 3 years of age

    Concentrations were defined as Geometric Mean Concentrations (GMCs) in μg/mL,

  5. Antibody Concentrations Against Vaccine Pneumococcal Serotypes

    Time frame: At 3 years of age

    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.

  6. Number of Subjects With Opsonophagocytic Activity

    Time frame: At 3 years of age

    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.

  7. Concentration of Antibodies Against Protein D

    Time frame: At 3 years of age

    Concentrations were expressed as GMCs in enzyme-linked immunosorbent-assay (ELISA) units per milliliter (EL.U/mL).

  8. Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values

    Time frame: At 3 years of age

    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.

  9. Anti-HBs Antibody Concentrations

    Time frame: At 3 years of age

    Concentrations were expressed as GMCs in mIU/mL.

  10. Number of Subjects With Serious Adverse Events (SAEs)

    Time frame: From last study contact of the study (NCT00463437) at 17-24 months of age until 3 years of age

    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.

  11. rSBA-MenC Titers

    Time frame: At 4 years of age

    Titers are given as Geometric Mean Titers (GMTs).

  12. Number of Subjects With an rSBA-MenC Titer Equal to or Above Cut-off Value

    Time frame: At 4 years of age

    rSBA-MenC antibody cut-off value assessed was equal to or above 1:128.

  13. Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations Equal to or Above Cut-off Values

    Time frame: At 4 years of age

    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.

  14. Anti-PRP Concentrations

    Time frame: At 4 years of age

    Concentrations were defined as Geometric Mean Concentrations (GMCs) in μg/mL

  15. Antibody Concentrations Against Vaccine Pneumococcal Serotypes

    Time frame: At 4 years of age

    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.

  16. Number of Subjects With Opsonophagocytic Activity

    Time frame: At 4 years of age

    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.

  17. Concentration of Antibodies Against Protein D

    Time frame: At 4 years of age

    Concentrations were expressed as GMCs in enzyme-linked immunosorbent-assay (ELISA) units per milliliter (EL.U/mL).

  18. Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values

    Time frame: At 4 years of age

    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.

  19. Anti-HBs Antibody Concentrations

    Time frame: At 4 years of age

    Concentrations were expressed as GMCs in mIU/mL.

  20. Number of Subjects With Serious Adverse Events (SAEs)

    Time frame: From last study contact of the study (NCT00463437) at 17-24 months of age until 4 years of age

    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.

  21. Number of Subjects With rSBA-MenC Titer Equal to or Above Cut-off Value

    Time frame: At 6 years of age

    rSBA-MenC antibody cut-off value assessed was equal to or above 1:128.

  22. rSBA-MenC Titers

    Time frame: At 6 years of age

    Titers are given as Geometric Mean Titers (GMTs).

  23. Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations Equal to or Above Cut-off Values

    Time frame: At 6 years of age

    The cut-off values were defined as a concentration ≥ 0.15 microgram per milliliter (μg/mL) and ≥ 1.0 μg/mL.

  24. Anti-PRP Concentrations

    Time frame: At 6 years of age

    Concentrations were defined as Geometric Mean Concentrations (GMCs) in μg/mL

  25. Antibody Concentrations Against Vaccine Pneumococcal Serotypes

    Time frame: At 6 years of age

    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.

  26. Concentration of Antibodies Against Protein D

    Time frame: At 6 years of age

    Concentrations were expressed as GMCs in enzyme-linked immunosorbent-assay (ELISA) units per milliliter (EL.U/mL).

  27. Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values as Measured by ELISA.

    Time frame: At 3 and 4 years of age

    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.

  28. Anti-HBs Antibody Concentrations as Measured by ELISA

    Time frame: At 3 and 4 years of age

    Concentrations were expressed as GMCs in mIU/mL.

  29. Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values

    Time frame: At 3, 4 and 6 years of age

    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.

  30. Anti-HBs Antibody Concentrations

    Time frame: At 3, 4 and 6 years of age

    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).

  31. Number of Subjects With Serious Adverse Events (SAEs)

    Time frame: From last study contact of the study (NCT00463437) at 17-24 months of age until 6 years of age

    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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Persistence of Antibodies After Full Vaccination Course With GSK Biologicals' Menitorix or MenC Conjugate Vaccine, Co-administered With DTPa or DTPa/Hib Containing Vaccine and Pneumococcal Conjugate Vaccine, in Children up to 6 Years of Age

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
May 1, 2009
Registry last updated
Feb 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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