Skip to main content
OpenTrials
Completed

NCT Number: NCT00322335

Long-term Persistence Study to Assess a Booster Dose of GSK Biologicals' Hib-MenC

This protocol posting deals with objectives & outcome measures of the extension phase at Months 18, 30, 42, 54 and 66 post booster. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00352963). The objectives & outcome measures of the Booster phase/study are presented in a separate protocol posting (NCT number =NCT00323050).

The purpose of this study is to evaluate the persistence of meningococcal serogroup C and Hib antibodies on a yearly basis for a period of 5.5 years after booster vaccination. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

31 month–33 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Almería, Spain

Loading trial locations.

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 217744/097 (DTPa-HBV-IPV-097) and will not be further randomized in this study. The study has 3 groups with Meningitec™ primed group as control. The protocol was amended to allow for enrollment of subjects of the Meningitec™ primed control group who were boosted with Meningitec™ after the end of the booster study as per new local reccommendation in Spain.

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.
  • A male or female in their third year of life at the time of the study initiation for the subjects who enter the study at Visit 1. The subjects who enter the study at Visit 2 should be in their fourth year of life at the time of the study initiation.
  • 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 booster vaccination study Hib-MenC-TT-010 BST:DTPA-HBV-IPV-097 (NCT=00323050).
  • Subjects who are part of the Meningitec™ control group and who were not enrolled at Visit 1 can be enrolled at Visit 2 if they have completed the booster vaccination study Hib-MenC-TT-010 BST:DTPA-HBV-IPV-097 (NCT=00323050) and if they have received a fourth dose of Meningitec™ in their second year of life, after the booster study Hib-MenC-TT-010 BST:DTPA-HBV-IPV-097 (NCT=00323050)

Exclusion criteria

  • Previous administration of a booster dose of Hib or meningococcal serogroup C except booster study vaccines during the study Hib-MenC-TT-010 BST:DTPA-HBV-IPV-097. Subjects who received a 4th dose of Meningitec™ should be included in the study.
  • History of H. influenzae type b, meningococcal serogroup C diseases.

Treatment and study plan

Haemophilus influenzae type b- and meningococcal (vaccine)

Biological

Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age (group HibMenC) and as booster dose at 14 months of age (groups HibMenC and group NeisPoo).

Infanrix™ penta

Biological

Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age

Infanrix™ hexa

Biological

Intramuscular injection into the thigh as primary vaccination at 2, 4 and/or 6 months of age (groups NeisPoo and MenCCRM) and/or as booster dose at 14 months of age (group MenCCRM).

Engerix-B

Biological

Intramuscular injection into the thigh as a birth dose

NeisVac-C™

Biological

Intramuscular injection into the thigh as primary vaccination at 2 and 4 months of age.

Infanrix™ IPV/HIB

Biological

Intramuscular injection into the thigh as primary vaccination at 4 months of age

Meningitec™

Biological

Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age

Primary outcomes

  1. Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:8

    Time frame: 18, 30, 42, 54 and 66 months after booster dose (day 0)

    The cut-off value for the rSBA-MenC titers was equal to or above 1:8.

    0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section.

  2. Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:32

    Time frame: 18, 30, 42, 54 and 66 months after booster dose (day 0)

    The cut-off value for the rSBA-MenC titers was equal to or above 1:32.

    0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section.

  3. Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:128

    Time frame: 18, 30, 42, 54 and 66 months after booster dose (day 0)

    The cut-off value for the rSBA-MenC titers was equal to or above 1:128.

    0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section.

  4. rSBA-MenC Titers

    Time frame: 18, 30, 42, 54 and 66 months after booster dose (day 0)

    Titers are expressed as Geometric Mean Titers (GMTs).

    0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section.

  5. Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Concentrations Equal to or Above Cut-off Value of 0.15 µg/mL (Microgram Per Milliliter)

    Time frame: 18, 30, 42, 54 and 66 months after the booster dose (day 0)

    The cut-off value was an anti-PRP concentration equal to or above 0.15 µg/mL (microgram per milliliter).

  6. Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Concentrations Equal to or Above Cut-off Value of 1.0 µg/mL (Microgram Per Milliliter)

    Time frame: 18, 30, 42, 54 and 66 months after the booster dose (day 0)

    The cut-off value was an anti-PRP concentration equal to or above 1.0 µg/mL (microgram per milliliter).

  7. Anti-PRP Concentrations

    Time frame: 18, 30, 42, 54 and 66 months after the booster dose (day 0)

    Concentrations are expressed as Geometric Mean Concentrations (GMCs) in µg/mL (microgram per milliliter).

  8. Number of Subjects With Anti-polysaccharide C (Anti-PSC) Concentrations Equal to or Above Cut-off Value of 0.3 µg/mL (Microgram Per Milliliter)

    Time frame: 18, 30, 42, 54 and 66 months after the booster dose (day 0)

    The cut-off value was an anti-PSC concentration equal to or above 0.3 µg/mL (microgram per milliliter).

    0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section.

  9. Number of Subjects With Anti-polysaccharide C (Anti-PSC) Concentrations Equal to or Above Cut-off Value of 2.0 µg/mL (Microgram Per Milliliter)

    Time frame: 18, 30, 42, 54 and 66 months after the booster dose (day 0)

    The cut-off value was an anti-PSC concentration equal to or above 2.0 µg/mL (microgram per milliliter).

    0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section.

  10. Anti-PSC Concentrations

    Time frame: 18, 30, 42, 54 and 66 months after the booster dose (day 0)

    Concentrations for anti-PSC antibody were expressed as GMCs.

  11. Number of Subjects With Serious Adverse Events

    Time frame: From last study contact of the booster study (NCT00323050) to Month 66 after booster dose (day 0)

    Serious adverse events 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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Phase III, Open, Multicenter Study to Assess the Long-Term Persistence of a Booster Dose of GSK Biologicals' Hib-MenC Compared to a Booster Dose of Infanrix™ Hexa When Given to 14 Month-old Subjects Primed in Study DTPa-HBV-IPV-097 & Boosted in Study Hib-MenC-TT-010 BST: DTPa-HBV-IPV-097

Important dates

Study start
2006
Primary completion
2006
Study completion
2010
First posted
May 5, 2006
Registry last updated
Oct 20, 2016

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.