Comparison of GSKBiologicals' Hib-MenCY-TT Vaccine vs Licensed Hib Conjugate or Meningococcal Vaccine - Full Text View

Purpose

This study is evaluating the safety and immunogenicity of GSK Biologicals' Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine, each administered at 2, 4, and 6 months of age, and compared to licensed meningococcal serogroups A, C, Y, and W-135 polysaccharide vaccine administered at 3 to 5 years of age.

The safety and immunogenicity of a booster dose of Hib-MenCY-TT vaccine will be compared to a booster dose of licensed Hib conjugate vaccine, each administered at 12 to 15 months of age. The group primed with the Hib conjugate vaccine will re-randomized at 12-15 months of age to receive a booster dose of Hib-MenCY-TT or a booster dose of the Hib conjugate vaccine.

Condition	Intervention	Phase
Meningococcal Infections Haemophilus Influenzae Type b Infections	Biological: GSK Biologicals' Haemophilus influenza type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine 792014 vaccine Biological: ActHIB Biological: Pediarix Biological: Prevnar Biological: Menomune	Phase II

MedlinePlus related topics:

Flu Tetanus Whooping Cough

ChemIDplus related topics:

Tetanus Vaccine Heptavalent pneumococcal conjugate vaccine Pneumococcal Vaccines Meningococcal Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Subject), Parallel Assignment, Safety/Efficacy Study

Official Title:	Evaluate Immuno and Safety of GSKBiologicals' HibMenCYTT vs Licensed Hib Conjugate Vaccine, Each Coadministered With Pediarix® and Prevnar®, in Healthy Infants. An Exploratory Control Group Will Receive Licensed Menomune® at 3 to 5 Y

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

For all subjects in groups A and B, anti-polyribosyl-ribitol-phosphate (anti-PRP) antibody concentration [ Time Frame: 1 month after the 3-dose primary vaccination course ]
For all subjects in Groups A and B, anti-pneumococcal serotypes antibody concentrations [ Time Frame: 1 month after the 3-dose primary vaccination course ]
For all subjects in Groups A and B, anti-pertussis antibody concentrations [ Time Frame: 1 month after the 3-dose primary vaccination course ]
For all subjects in Groups A and B, incidence of any grade 3 symptom (solicited or unsolicited) [ Time Frame: During the 4-day follow-up period following each primary vaccination dose. ]
For all subjects in Groups A and B, anti-PRP antibody concentration [ Time Frame: 1 month after booster vaccination ]

Secondary Outcome Measures:

Groups A and B, serum bactericidal assay using baby rabbit complement against meningococcal serogroup C (rSBA-MenC) titers [ Time Frame: Prior to vaccination and 1 month after the primary vaccination course ]
For all subjects in Groups A and B, rSBA-MenY titers [ Time Frame: Prior to vaccination and 1 month after the primary vaccination course ]
For a subset of subjects in Groups A and B, serum bactericidal assay using human complement (hSBA)-MenC titers [ Time Frame: 1 month after the primary vaccination course ]
For a subset of subjects in Groups A and B, hSBA-MenY titers [ Time Frame: 1 month after the primary vaccination course ]
For all subjects in Groups A and B, anti-polysaccharide C (anti-PSC) antibody concentration [ Time Frame: Prior to vaccination and 1 month after the primary vaccination course ]
For all subjects in Groups A and B, anti-PSY antibody concentration [ Time Frame: Prior to vaccination and 1 month after the primary vaccination course ]
For all subjects in Groups A and B, anti-PRP antibody concentration [ Time Frame: Prior to vaccination and 1 month after primary vaccination ]
For all subjects in Groups A and B, S. pneumoniae antibody concentrations for the 7 serotypes [ Time Frame: Prior to vaccination and 1 month after the primary vaccination course ]
For all subjects in Groups A and B, anti-diphtheria antibody concentration [ Time Frame: Prior to vaccination and 1 month after the primary vaccination course ]
For all subjects in Groups A and B, anti-tetanus antibody concentration [ Time Frame: Prior to vaccination and 1 month after the primary vaccination course ]
For all subjects in Groups A and B, anti-hepatitis B antibody concentration [ Time Frame: Prior to vaccination and 1 month after the primary vaccination course ]
For all subjects in Groups A and B, anti-pertussis antibody concentrations [ Time Frame: Prior to vaccination and 1 month after the primary vaccination course ]
For all subjects in Groups A and B, anti-poliovirus types 1, 2, and 3 antibody titers [ Time Frame: Prior to vaccination and 1 month after the primary vaccination course ]
For all subjects in Groups A and B, vaccine response to pertussis antigens [ Time Frame: 1 month after the primary vaccination course ]
For all subjects in Group C, rSBA-MenC titers [ Time Frame: Prior to vaccination and 1 month after vaccination ]
For all subjects in Group C, rSBA-MenY titers [ Time Frame: Prior to vaccination and 1 month after vaccination ]
For a subset of subjects in Group C, hSBA-MenC titers [ Time Frame: 1 month after vaccination ]
For a subset of subjects in Group C, hSBA-MenY titers [ Time Frame: 1 month after vaccination ]
For all subjects in Group C, anti-PSC antibody concentration [ Time Frame: Prior to vaccination and 1 month after vaccination ]
For all subjects in Group C, anti-PSY antibody concentration [ Time Frame: Prior to vaccination and 1 month after vaccination ]
For all subjects in Groups A and B, incidence of solicited local symptoms of any intensity, grade 2 or grade 3, and grade 3 [ Time Frame: Wthin 4 days and within 8 days following each primary vaccine dose. ]
For all subjects in Groups A and B, incidence of solicited general symptoms of any intensity, grade 2 or grade 3, and grade 3 [ Time Frame: Within 4 days and within 8 days following each primary vaccine dose ]
For all subjects in Groups A and B, occurrence of unsolicited symptoms [ Time Frame: From Dose 1 through Day 30 following the last primary dose of Hib-MenCY-TT Vaccine and ActHIB. ]
For all subjects in Groups A and B, occurrence of SAEs [ Time Frame: During the entire study. ]
In Groups A and B, occurrence of specific adverse events of onset of chronic illness, rash & ER or physicians visits not related to child care, injury or common acute illnesses [ Time Frame: From Day 31 following the last primary dose of Hib-MenCY-TT Vaccine and ActHIB through the day preceding the booster dose ]
For all subjects in Group C, occurrence of medically attended visits [ Time Frame: During the 31-day follow-up period after vaccination ]
For all subjects in Group C, occurrence of rash [ Time Frame: During the 31-day follow-up period after vaccination ]
For all subjects in Group C, occurrence of SAEs [ Time Frame: During the 31-day follow-up period after vaccination ]
For all subjects in Groups A, D & E, rSBA-MenC and hSBA-MenC booster response [ Time Frame: 1 month post-booster vaccination ]
For all subjects in Groups A, D & E, rSBA-MenY and hSBA-MenY booster response [ Time Frame: 1 month post-booster vaccination ]
For all subjects in Groups A, D & E, anti-PRP antibody [ Time Frame: Prior to the booster vaccination and 1 month post-booster vaccination ]
For all subjects in Groups A, D & E, rSBA-MenC titers [ Time Frame: Prior to the booster vaccination and 1 month post-booster vaccination ]
For all subjects in Groups A, D & E, rSBA-MenY titers [ Time Frame: Prior to the booster vaccination and 1 month post-booster vaccination ]
For all subjects in Groups A, D & E, hSBA-MenC titers [ Time Frame: Prior to the booster vaccination and 1 month post-booster vaccination ]
For all subjects in Groups A, D & E, hSBA-MenY titers [ Time Frame: Prior to the booster vaccination and 1 month post-booster vaccination ]
For all subjects in Groups A, D & E, anti-PSC antibody concentrations [ Time Frame: Prior to the booster vaccination and 1 month post-booster vaccination ]
For all subjects in Groups A, D & E, anti-PSY antibody concentrations [ Time Frame: Prior to the booster vaccination and 1 month post-booster vaccination ]
For all subjects in Groups A, D & E, S. pneumoniae antibody concentrations for the 7 serotypes in Prevnar [ Time Frame: 1 month post-booster vaccination ]
For all subjects in Groups A, D & E, anti-tetanus antibody concentrations [ Time Frame: Prior to the booster vaccination and 1 month post-booster vaccination ]
For all subjects in Groups A, D & E, incidence of solicited local symptoms of any intensity, grade 2 or 3 and grade 3 [ Time Frame: Within 4 days and within 8 days following the booster dose ]
For all subjects in Groups A, D & E, incidence of large swelling reactions of the injected limb(s) [ Time Frame: Within 4 days and within 8 days following the booster dose ]
For all subjects in Groups A, D & E, incidence of solicited general symptoms of any intensity, grade 2 or 3 and grade 3 [ Time Frame: Within 4 days and within 8 days following the booster dose. ]
For all subjects in Groups A, D & E, occurrence of unsolicited symptoms [ Time Frame: During the 31-day follow-up period following the booster dose ]
In Groups A, D & E, occurrence of specific adverse events of onset of chronic illness, rash & ER or physicians visits not related to child care, injury or common acute illnesses [ Time Frame: From Day 31 following the booster dose through the end of the 6-month safety follow-up. ]

Enrollment:	759
Study Start Date:	August 2004
Primary Completion Date:	July 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group A (Primary & Booster phases): Experimental	Biological: GSK Biologicals' Haemophilus influenza type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine 792014 vaccine Primary phase: 3 IM doses Booster phase: 1 IM dose Biological: Pediarix Primary phase: 3 IM doses Biological: Prevnar Primary phase: 3 IM doses Booster phase: 1 IM dose
Group B (Primary phase): Active Comparator	Biological: ActHIB Primary phase: 3 IM doses Booster phase: 1 IM dose Biological: Pediarix Primary phase: 3 IM doses Biological: Prevnar Primary phase: 3 IM doses Booster phase: 1 IM dose
Group C (Primary phase): Active Comparator	Biological: Menomune Primary phase: 1 SC dose
Group D (Booster phase): Active Comparator Subjects from the Group B in the primary phase are randomized to either Group D or Group E in the booster phase	Biological: ActHIB Primary phase: 3 IM doses Booster phase: 1 IM dose Biological: Prevnar Primary phase: 3 IM doses Booster phase: 1 IM dose
Group E (Booster phase): Experimental Subjects from the Group B in the primary phase are randomized to either Group D or Group E in the booster phase.	Biological: GSK Biologicals' Haemophilus influenza type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine 792014 vaccine Primary phase: 3 IM doses Booster phase: 1 IM dose Biological: Prevnar Primary phase: 3 IM doses Booster phase: 1 IM dose

Detailed Description:

The non-inferiority of the immunogenicity, safety, and antibody persistence of Hib-MenCY-TT vaccine will be compared to ActHIB®, a monovalent Hib conjugate vaccine licensed in the US.

All subjects will be vaccinated at 2, 4, 6, and 12 to 15 months. The immunogenicity of the MenC and MenY antigens will be summarized.

MenC and MenY immunogenicity will be compared to Menomune® (a quadrivalent meningococcal A, C, Y, and W-135 plain polysaccharide vaccine licensed in the US) administered to children 3 to 5 years of age.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Eligibility

Ages Eligible for Study:	6 Weeks to 15 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

For Groups A and B
- Subjects for whom the investigator believes that parents/guardians can and will comply with the requirements of the protocol.
- Healthy 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 the study.
- Born after a gestation period between 36 and 42 weeks.
- Infants who have not received a previous dose of hepatitis B vaccine or those who have received only 1 dose of hepatitis B vaccine administered at least 30 days prior to enrollment.
For Group C
- Subjects for whom the investigator believes that parents/guardians can and will comply with the requirements of the protocol.
- Healthy male or female between, and including, 3 and 5 years 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 the study.

Exclusion Criteria:

-For Groups A and B

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 within six months prior to the first vaccine dose.
Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of study 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.
History of Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, hepatitis B, poliovirus, and/or Streptococcus pneumoniae 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.
Major congenital defects or serious chronic illness.
History of any neurologic disorders or seizures.
Acute disease at time of enrollment.
Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.

For Group C

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the 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 within six months prior to the vaccine dose.
Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the dose of study vaccine.
Previous vaccination against Neisseria meningitidis.
History of Neisseria meningitidis 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, including dry natural latex rubber
Major congenital defects or serious chronic illness.
Acute disease at time of enrollment.
Administration of immunoglobulins and/or any blood products within the 3 months preceding vaccination or planned administration during the study period.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00129129

Locations


United States, Louisiana
	GSK Clinical Trials Call Center
	Bossier City, Louisiana, United States

United States, Massachusetts
	GSK Clinical Trials Call Center
	Boston, Massachusetts, United States

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	Clinical Trials	GlaxoSmithKline

More Information

Responsible Party:	GSK ( Isabelle Harpigny )
Study ID Numbers:	101858, 102015
First Received:	August 10, 2005
Last Updated:	September 2, 2008
ClinicalTrials.gov Identifier:	NCT00129129
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Meningococcal vaccine

Meningococcal disease

Hib disease

Immunogenicity

Safety

Primary & booster vaccination

Infants

Children

Study placed in the following topic categories:

Bacterial Infections

Virus Diseases

Haemophilus influenzae

Respiratory Tract Diseases

Respiratory Tract Infections

Meningococcal Infections

Influenza, Human

Healthy

Orthomyxoviridae Infections

Meningococcal infection

Gram-Negative Bacterial Infections

Neisseriaceae Infections

Additional relevant MeSH terms:

Communicable Diseases

RNA Virus Infections

Infection

ClinicalTrials.gov processed this record on September 23, 2008

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00129129