Long-Term Persistence Study to Assess a Booster Dose of GSK Biologicals' Hib-MenC. - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00322335

Purpose

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.

Condition	Intervention	Phase
Haemophilus Influenzae Type b Disease Meningococcal Serogroup C Diseases	Biological: Engerix-B Biological: Infanrix™ hexa Biological: Meningitec™ Biological: Infanrix™ IPV/HIB Biological: Haemophilus influenzae type b- and meningococcal (vaccine) Biological: Infanrix™ penta Biological: NeisVac-C™	Phase III

MedlinePlus related topics: Flu

Drug Information available for: Infanrix hexa

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Phase III Study to Assess Long-Term Persistence of a Booster Dose of GSK Biologicals' Hib-MenC vs a Booster Dose of Infanrix™ Hexa When Given to Subjects (14m) Primed in DTPa-HBV-IPV-097 & Boosted in Hib-MenC-TT-010 BST: DTPa-HBV-IPV-097

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

SBA-MenC titres [ Time Frame: At the start of this persistence study and 12, 24, 36 and 48 months later ] [ Designated as safety issue: No ]
Anti-PRP concentrations [ Time Frame: At the start of this persistence study and 12, 24, 36 and 48 months later ] [ Designated as safety issue: No ]
Anti-PSC concentrations [ Time Frame: At the start of this persistence study and 12, 24, 36 and 48 months later ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Related SAEs [ Time Frame: From last study contact of the booster study to end of this persistence study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	357
Study Start Date:	May 2006
Study Completion Date:	July 2006
Primary Completion Date:	July 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group MenCCRM: Active Comparator Subjects were primed with Infanrix™ hexa + Meningitec™ at 2, 4 and 6 months of age, followed by a booster dose of Infanrix™ hexa at 14 months of age. No vaccines were administered during this long-term persistence phase of the study	Biological: Infanrix™ hexa 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). Biological: Meningitec™ Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age
Group NeisPoo: Active Comparator Subjects were either primed with Infanrix™ hexa + NeisVac-C™ at 2 and 4 months of age and Infanrix™ hexa alone at 6 months of age or with Engerix-B at birth, Infanrix™ hexa + NeisVac-C™ at 2 months of age, Infanrix™ IPV/Hib + NeisVac-C™ at 4 months of age and Infanrix™ hexa alone at 6 months of age. All subjects were boosted with Hib-MenC at 14 months of age. No vaccines were administered during this long-term persistence phase of the study.	Biological: Engerix-B Intramuscular injection into the thigh as a birth dose Biological: Infanrix™ hexa 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). Biological: Infanrix™ IPV/HIB Intramuscular injection into the thigh as primary vaccination at 4 months of age Biological: Haemophilus influenzae type b- and meningococcal (vaccine) 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). Biological: NeisVac-C™ Intramuscular injection into the thigh as primary vaccination at 2 and 4 months of age.
Group HibMenC: Experimental Subjects were primed with Infanrix™ penta + Hib-MenC at 2, 4 and 6 months of age, followed by a booster dose of Hib-MenC at 14 months of age. No vaccines were administered during this long-term persistence phase of the study	Biological: Haemophilus influenzae type b- and meningococcal (vaccine) 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). Biological: Infanrix™ penta Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age

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 enrolment 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.

Eligibility

Ages Eligible for Study:	31 Months to 33 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00322335

Locations

Spain
GSK Investigational Site
Marid, Spain, 28040
GSK Investigational Site
Madrid, Spain, 28007
GSK Investigational Site
Madrid, Spain, 28047
GSK Investigational Site
Gerona, Spain, 17002
GSK Investigational Site
Almería, Spain, 04009
GSK Investigational Site
Vélez-Málaga / Málaga, Spain, 29700
GSK Investigational Site
Valladolid, Spain, 47010
GSK Investigational Site
Getafe/Madrid, Spain, 28905
GSK Investigational Site
Madrid, Spain, 28041
GSK Investigational Site
Burgos, Spain, 09005
GSK Investigational Site
Málaga, Spain, 29011
GSK Investigational Site
Móstoles/Madrid, Spain, 28935

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	106672, 106673, 106675, 106679, 106680
Study First Received:	May 4, 2006
Last Updated:	October 27, 2008
ClinicalTrials.gov Identifier:	NCT00322335
Health Authority:	Spain: Agencia Española del Medicamento

Keywords provided by GlaxoSmithKline:

H.influenzae type b Disease

Study placed in the following topic categories:

Virus Diseases
Haemophilus influenzae
Respiratory Tract Diseases

Respiratory Tract Infections
Influenza, Human
Orthomyxoviridae Infections

Additional relevant MeSH terms:

RNA Virus Infections

ClinicalTrials.gov processed this record on January 14, 2009