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

GlaxoSmithKline230 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

230

Conditions

Haemophilus Influenzae Type b Neisseria Meningitidis

Interventions

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™ pentaBIOLOGICAL

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

Infanrix™ hexaBIOLOGICAL

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-BBIOLOGICAL

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/HIBBIOLOGICAL

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

Eligibility

Sex: ALLMin age: 31 MonthsMax age: 33 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (12)

GSK Investigational Site

Almería, Spain

GSK Investigational Site

Burgos, Spain

GSK Investigational Site

Getafe/Madrid, Spain

GSK Investigational Site

Girona, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Marid, Spain

GSK Investigational Site

Málaga, Spain

GSK Investigational Site

Móstoles/Madrid, Spain

...and 2 more locations

Outcomes

Primary Outcomes

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

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.

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

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

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.

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

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

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.

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

rSBA-MenC Titers

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.

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

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)

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