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

Phase 3

Completed

• Conditions: Haemophilus Influenzae Type b; Neisseria Meningitidis
• Interventions: Biological: Haemophilus influenzae type b- and meningococcal (vaccine); Biological: Infanrix™ penta; Biological: Meningitec™; Biological: Infanrix™ hexa; Biological: Engerix-B; Biological: NeisVac-C™; Biological: Infanrix™ IPV/HIB

• Registration Number: NCT00322335
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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.

Detailed 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 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2006-05-04
• Study First Submitted QC: 2006-05-04
• Study First Posted: 2006-05-05
• Primary Completion: 2006-07
• Study Completion: 2010-09
• Results First Submitted: 2010-09-17
• Results First Submitted QC: 2010-12-15
• Results First Posted: 2011-01-14
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-23
• Last Update Posted: 2016-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 230

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)

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Menitorix/Pediarix Group	Infanrix™ penta	Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
Infanrix hexa/Meningitec Group	Meningitec™	Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
Menitorix/Pediarix Group	Haemophilus influenzae type b- and meningococcal (vaccine)	Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
Infanrix hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group	Infanrix™ hexa	Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
Infanrix hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group	Haemophilus influenzae type b- and meningococcal (vaccine)	Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
Infanrix hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group	Infanrix™ IPV/HIB	Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
Infanrix hexa/Meningitec Group	Infanrix™ hexa	Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
Infanrix hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group	Engerix-B	Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
Infanrix hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group	NeisVac-C™	Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.

Primary Outcome Measures

Name	Time	Method
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	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.
rSBA-MenC Titers	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.
Anti-PRP Concentrations	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).
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)	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.
Number of Subjects With Serious Adverse Events	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.
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)	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).
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)	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).
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)	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.
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	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.
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	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.
Anti-PSC Concentrations	18, 30, 42, 54 and 66 months after the booster dose (day 0)	Concentrations for anti-PSC antibody were expressed as GMCs.

Trial Locations

Locations (1)

GSK Investigational Site; 🇪🇸 Vélez-Málaga / Málaga, Spain