Immune Response & Safety of GSK Biologicals' Mencevax™ ACWY in Subjects Primed in the DTPW-HBV=HIB-MENAC-TT-011 Study - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00291343

Purpose

This study will be conducted in three stages. In the DTP booster stage at 15 to 24 months of age, all subjects will receive a booster dose of Tritanrix™-HepB/Hiberix™. In the Mencevax™ ACWY "full dose" stage at 24 to 30 months of age all subjects will receive a dose of Mencevax™ ACWY. In the Mencevax™ ACWY "small dose" stage at 30 to 36 months of age, the first 75 subjects in each of the two centers will be tested for boostability of the MenA and MenC immune response by giving a fifth of a dose of a Mencevax™ ACWY vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Condition	Intervention	Phase
Diphtheria Tetanus Pertussis Hepatitis B Hib Disease Neisseria Meningitidis Serogroup Diseases	Biological: Tritanrix™- HepB Biological: Hiberix™ Biological: Mencevax™ ACWY	Phase III

MedlinePlus related topics: Diphtheria Hepatitis Hepatitis B Tetanus Whooping Cough

Drug Information available for: Hepatitis B Vaccines Meningococcal Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Booster Vaccination Study to Assess Immunogenicity & Safety of a Dose of GSK Biologicals' Mencevax™ ACWY & 1/5th of a Dose of Mencevax™ ACWY in Subjects Primed in the DTPW-HBV=HIB-MENAC-TT-011 Study

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

SBA-MenA and SBA-MenC titres [ Time Frame: At 25 tot 31 months of age, i.e., one month after Mencevax™ ACWY vaccine at 24 to 30 months of age ]

Secondary Outcome Measures:

SBA-MenA and SBA-MenC titres [ Time Frame: At 24 to 30 months of age ]
Anti-PSA and Anti-PSC concentrations [ Time Frame: At 24 to 30 months of age, prior to full dose of Mencevax™ ACWY vaccine and at 25 to 31 months of age ]
Anti-HBs concentration [ Time Frame: At 24 to 30 months of age ]
Booster/vaccine response to meningococcal antigens [ Time Frame: At 25 to 31 months of age ]
SBA-MenA and SBA-MenC titres [ Time Frame: At 30 to 36 months of age, prior to small dose of Mencevax™ ACWY vaccine and at 31 to 37 months of age ]
Anti-PSA and Anti-PSC concentrations [ Time Frame: At 30 to 36 months of age, prior to small dose of Mencevax™ ACWY vaccine and at 31 to 37 months of age ]
Anti-HBs concentration [ Time Frame: At 30 to 36 months of age ]
Booster/vaccine response to meningococcal antigens [ Time Frame: At 31 to 37 months of age ]
Occurrence of solicited local and general symptoms [ Time Frame: During the 4-day follow-up period after a full dose of Mencevax™ ACWY vaccine, at 24 to 30 months of age and after a small dose of Mencevax™ ACWY vaccine, at 30 to 36 months ]
Occurrence of unsolicited symptoms [ Time Frame: During the 31-day follow-up period after a full dose of Mencevax™ ACWY vaccine, at 24 to 30 months of age and after a small dose of Mencevax™ ACWY vaccine, at 30 to 36 months of age ]
Occurrence of serious adverse events [ Time Frame: During the entire study period ]

Enrollment:	296
Study Start Date:	February 2006
Primary Completion Date:	August 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group B: Active Comparator AC unprimed group	Biological: Tritanrix™- HepB One intramuscular dose during the booster vaccination study in subjects aged 15 to 24 months Biological: Hiberix™ One intramuscular dose during the booster vaccination study in subjects aged 15 to 24 months Biological: Mencevax™ ACWY One full subcutaneous dose in subjects aged 24 to 30 months or 1/5th of a dose intramuscular in subjects aged 30 to 36 months
Group A: Experimental AC primed group	Biological: Tritanrix™- HepB One intramuscular dose during the booster vaccination study in subjects aged 15 to 24 months Biological: Hiberix™ One intramuscular dose during the booster vaccination study in subjects aged 15 to 24 months Biological: Mencevax™ ACWY One full subcutaneous dose in subjects aged 24 to 30 months or 1/5th of a dose intramuscular in subjects aged 30 to 36 months

Detailed Description:

Subjects in the group that was previously primed with Tritanrix™-HepB/Hiberix™ will be the control group for the group that was previously primed with Tritanrix™-HepB/Hib-MenAC.

Blood samples will be drawn from subjects as follows:

prior to and one month after the full dose of the Mencevax™ ACWY vaccine.
prior to and one month after 1/5th of a dose of Mencevax™ ACWY vaccine (only for the first 75 subjects in each of the two centers).

Eligibility

Ages Eligible for Study:	15 Months to 24 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 between, and including, 15 and 24 months of age at the time of vaccination.
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 participated in the primary vaccination study DTPW-HBV=HIB-MENAC-TT-011 (eTrack No. 100478) in Center No. 4328 or Center No.4329.

Exclusion criteria:

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the vaccination, or planned use during the study period.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to vaccination.
Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of vaccination; with the exception of oral poliovirus vaccine (OPV).
Booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b (Hib) and/or meningococcal serogroups A and/or C disease, after the date of the study conclusion visit of the primary vaccination study DTPW-HBV=HIB-MENAC-TT-011 (eTrack No. 100478).
History of diphtheria, tetanus, pertussis, hepatitis B, Hib and/or meningococcal serogroup A or C disease.
Known exposure to diphtheria, tetanus, pertussis, hepatitis B, Hib and/or meningococcal serogroup A or C disease.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
A family history of congenital or hereditary immunodeficiency.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Major congenital defects or serious chronic illness.
History of any neurologic disorders or seizures including febrile seizures in infancy.
Acute disease at the time of enrolment.
Planned or actual administration of immunoglobulins and/or any blood products within the three months preceding Mencevax™ ACWY vaccination.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00291343

Locations

Philippines
GSK Investigational Site
Manila, Philippines, 1000
GSK Investigational Site
Manila, Philippines

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	105239 (mth24-30), 105245 (mth30-36)
Study First Received:	February 13, 2006
Last Updated:	November 20, 2008
ClinicalTrials.gov Identifier:	NCT00291343
Health Authority:	Philippines: Bureau of Food and Drugs

Keywords provided by GlaxoSmithKline:

Prophylaxis diphtheria
tetanus
pertussis
hepatitis B

Haemophilus influenzae type b
meningococcal serogroups A and C diseases
meningococcal vaccine

Study placed in the following topic categories:

Bacterial Infections
Liver Diseases
Haemophilus influenzae
Hepatitis, Viral, Human
Whooping Cough
Cough
Neisseria meningitidis
Diphtheria
Tetanus
Whooping cough
Gram-Negative Bacterial Infections

Virus Diseases
Hepatitis
Gram-Positive Bacterial Infections
Digestive System Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Hepatitis B
Influenza, Human
DNA Virus Infections
Clostridium Infections

Additional relevant MeSH terms:

Bordetella Infections
Corynebacterium Infections
Infection
Hepadnaviridae Infections
Actinomycetales Infections

ClinicalTrials.gov processed this record on January 16, 2009