Hib-MenCY-TT Vaccine Study Compared to Licensed Hib and Meningococcal Serogroup C Conjugate Vaccines - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00134719

Purpose

This study is evaluating the safety and immunogenicity of Hib-MenCY-TT vaccine compared to control groups receiving licensed Hib or MenC conjugate vaccines, each administered at 2, 4, 6, and 12 to 15 months of age. Co-administration with live, attenuated measles, mumps, and rubella combination vaccine; and with live, attenuated varicella vaccine will be assessed with administration of the booster dose. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, September 2007.

Condition	Intervention	Phase
Haemophilus Infections Meningococcal Infections	Biological: GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine combined 792014 Biological: Infanrix® Penta Biological: Prevenar® Biological: ActHIB® Biological: Meningitec® Biological: M-M-R®II Biological: Varivax® Biological: PedvaxHIB®	Phase II

MedlinePlus related topics: Chickenpox Measles Mumps Rubella Shingles

Drug Information available for: Tetanus Vaccine Heptavalent pneumococcal conjugate vaccine Pneumococcal Vaccines Chickenpox Vaccine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	A Multicentre Pry &Booster Vaccination Study of GSK Biologicals' Hib-MenCY-TT Conjugate Vaccine vs ActHIB® &MenC Conjugate Licensed Vaccine When Given According to the 2-4-6 Mth Schedule to Healthy Infants With Booster Dose at 12 to 15 Mths

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

In half of the subjects of group A and group C: • Anti-PRP concentration [ Time Frame: One month after the 3-dose primary vaccination course ]
In half of the subjects of group A and group B: • SBA-MenC titre [ Time Frame: One month after the 3-dose primary vaccination course ]
In group A and group C: • Measles, Mumps, Varicella seroconversion [ Time Frame: 42 days after booster vaccination ]
In group A and group C: • Rubella seroresponse [ Time Frame: 42 days after booster vaccination ]

Secondary Outcome Measures:

In the other half of the subjects of groups A, B and C • rSBA-MenC titre [ Time Frame: After the second vaccine doses, just prior to the administration of the third vaccine dose ]
In the other half of the subjects of groups A, B and C • rSBA-MenY titre [ Time Frame: After the second vaccine doses, just prior to the administration of the third vaccine dose ]
In the first 30% of the other half of the subjects of groups A, B and C • hSBA-MenC titre [ Time Frame: After the second vaccine doses, just prior to the administration of the third vaccine dose ]
In the first 30% of the other half of the subjects of groups A, B and C • hSBA-MenY titre [ Time Frame: After the second vaccine doses, just prior to the administration of the third vaccine dose ]
In the other half of the subjects in groups A, B and C • Anti-PSC concentration [ Time Frame: After the second vaccine doses, just prior to the administration of the third vaccine dose ]
In the other half of the subjects in groups A, B and C • Anti-PSY concentration [ Time Frame: After the second vaccine doses, just prior to the administration of the third vaccine dose ]
In the other half of the subjects in groups A, B and C • Anti-PRP concentration [ Time Frame: After the second vaccine doses, just prior to the administration of the third vaccine dose ]
In half of the subjects in groups A, B and C • rSBA-MenC titre [ Time Frame: One month after the 3-dose primary vaccination course ]
In half of the subjects of groups A, B and C • rSBA-MenY titre [ Time Frame: One month after the 3-dose primary vaccination course ]
In the first 30% of half of the subjects in groups A, B and C • hSBA-MenC titre [ Time Frame: One month after the 3-dose primary vaccination course ]
In the first 30% of half of the subjects in groups A, B and C • hSBA-MenY titre [ Time Frame: One month after the 3-dose primary vaccination course ]
In half of the subjects in groups A, B and C • Anti-PSC concentration [ Time Frame: One month after the 3-dose primary vaccination course ]
In half of the subjects in groups A, B and C • Anti-PSY concentration [ Time Frame: One month after the 3-dose primary vaccination course ]
In half of the subjects in groups A, B and C • Anti-PRP concentration [ Time Frame: One month after the 3-dose primary vaccination course ]
In subjects in groups A, B and C: • Anti-PRP concentration [ Time Frame: Just prior to and 42 days after booster vaccination ]
In subjects in groups A, B and C: • rSBA-MenC titre [ Time Frame: Just prior to and 42 days after booster vaccination ]
In subjects in groups A, B and C: • rSBA-MenY titre [ Time Frame: Just prior to and 42 days after booster vaccination ]
In the first 30% of the subjects in groups A, B and C: • hSBA-MenC titre [ Time Frame: Just prior to and 42 days after booster vaccination ]
In the first 30% of the subjects in groups A, B and C: • hSBA-MenY titre [ Time Frame: Just prior to and 42 days after booster vaccination ]
In subjects in groups A, B and C: • Anti-PSC concentration [ Time Frame: Just prior to and 42 days after booster vaccination ]
In subjects in groups A, B and C: • Anti-PSY concentration [ Time Frame: Just prior to and 42 days after booster vaccination ]
In subjects in groups A, B and C: • Anti-measles seropositivity and concentration [ Time Frame: Just prior the vaccination ]
In subjects in groups A, B and C: • Anti-mumps seropositivity and titres [ Time Frame: Just prior to the vaccination ]
In subjects in groups A, B and C: • Anti-rubella seropositivity and concentration [ Time Frame: Just prior to the vaccination ]
In subjects in groups A, B and C: • Anti-varicella seropositivity and concentration [ Time Frame: Just prior to the vaccination ]
In all subjects in groups A, B and C: • Anti-measles seroconversion and concentration [ Time Frame: 42 days after the vaccination ]
In all subjects in groups A, B and C: • Anti-mumps seroconversion and titres [ Time Frame: 42 days after the vaccination ]
In all subjects in groups A, B and C: • Anti-rubella seroresponse and concentration [ Time Frame: 42 days after the vaccination ]
In all subjects in groups A, B and C: • Anti-varicella seroconversion and concentration [ Time Frame: 42 days after the vaccination ]
Incidence of local and general solicited adverse events [ Time Frame: During a 4-day period after each vaccine dose ]
Incidence of unsolicited adverse events [ Time Frame: During a 31-day period after each vaccine dose ]
measles, mumps, rubella and varicella specific solicited general adverse events [ Time Frame: During a 43-day period after the booster doses ]
Incidence of serious adverse events [ Time Frame: From enrolment up to last study contact at 18 to 21 months of age. ]
Occurrence of specific adverse events of rash, new onset of chronic illness(es) and conditions prompting emergency room visits and physician office visits not related to common illnesses [ Time Frame: From enrolment up to last study contact at 18 to 21 months of age. ]

Enrollment:	1038
Study Start Date:	April 2005
Primary Completion Date:	February 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group A: Experimental	Biological: GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine combined 792014 One intramuscular dose at 2, 4 and 6 months of age ( group A) and one intramuscular dose at 12 to 15 months of age (groups A and B) Biological: Infanrix® Penta One intramuscular dose at 2, 4 and 6 months of age Biological: Prevenar® One intramuscular dose at 2, 4 and 6 months of age Biological: M-M-R®II One subcutaneous dose at 12-15 months of age Biological: Varivax® One subcutaneous dose at 12 to 15 months of age
Group B: Active Comparator	Biological: GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine combined 792014 One intramuscular dose at 2, 4 and 6 months of age ( group A) and one intramuscular dose at 12 to 15 months of age (groups A and B) Biological: Infanrix® Penta One intramuscular dose at 2, 4 and 6 months of age Biological: Prevenar® One intramuscular dose at 2, 4 and 6 months of age Biological: ActHIB® One intramuscular dose at 2, 4 and 6 months of age Biological: Meningitec® One intramuscular dose at 2, 4 and 6 months of age Biological: M-M-R®II One subcutaneous dose at 12-15 months of age Biological: Varivax® One subcutaneous dose at 12 to 15 months of age
Group C: Active Comparator	Biological: Infanrix® Penta One intramuscular dose at 2, 4 and 6 months of age Biological: Prevenar® One intramuscular dose at 2, 4 and 6 months of age Biological: ActHIB® One intramuscular dose at 2, 4 and 6 months of age Biological: M-M-R®II One subcutaneous dose at 12-15 months of age Biological: Varivax® One subcutaneous dose at 12 to 15 months of age Biological: PedvaxHIB® One intramuscular dose at 12 to 15 months of age

Detailed Description:

The study will be conducted in 2 stages: a 3-dose primary vaccination at 2, 4 and 6 months of age and a booster vaccination at 12 to 15 months of age. All subjects will have 3 blood samples taken. Half of the subjects of each group will have a blood sample taken just prior to the administration of the third dose of the primary vaccination and the other half of the subjects of each group will have a blood sample taken at one month after the third vaccine dose of the primary vaccination phase. In addition, all subjects of all groups will have a blood sample taken before and 42 days after administration of the booster dose.

Eligibility

Ages Eligible for Study:	6 Weeks to 12 Weeks
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
A male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination.
Written informed consent obtained from the parent or guardian of the subject.
Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Born after a gestation period between 36 and 42 weeks.

Exclusion Criteria:

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine(s).
Previous vaccination against Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, poliovirus, and/or Streptococcus pneumoniae; more than one previous dose of hepatitis B vaccine. Vaccination with hepatitis B at birth is accepted (although not mandatory). Influenza vaccination is allowed 30 days after administration of the third vaccine dose to 30 days preceding the booster dose.
History of Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, hepatitis B, poliovirus, Streptococcus pneumoniae and/or varicella invasive disease.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s), including dry natural latex rubber, tetanus toxoid, diphtheria toxoid, neomycin, polymyxin.
Major congenital defects or serious chronic illness.
History of any neurologic disorders or seizures.
Acute disease at the time of enrolment.
Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Additional specific criteria for the booster part of the study
History of or previous vaccination against measles, mumps, rubella or varicella.
Previous booster vaccination with Hib or meningococcal serogroup C vaccine since the last visit of the primary phase.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00134719

Locations

Australia
GSK Clinical Trials Call Center
Victoria, Australia

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

Clinical Trials

GlaxoSmithKline

More Information

Responsible Party:	GSK Biologicals ( Isabelle Harpigny )
Study ID Numbers:	102370 (primary study), 102371 (Booster study)
Study First Received:	August 10, 2005
Last Updated:	September 3, 2008
ClinicalTrials.gov Identifier:	NCT00134719
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Invasive Hib & N. meningitidis diseases

Study placed in the following topic categories:

Bacterial Infections
Haemophilus Infections
Meningococcal Infections
Neisseria meningitidis

Healthy
Meningococcal infection
Neisseriaceae Infections
Gram-Negative Bacterial Infections

Additional relevant MeSH terms:

Pasteurellaceae Infections
Communicable Diseases
Infection

ClinicalTrials.gov processed this record on January 16, 2009