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Safety of Hib-MenCY-TT Vaccine Versus Licensed Hib Conjugate Vaccine, Given at 2, 4, 6 and 12 to 15 Months of Age

This study has been completed.

Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00345579
  Purpose

The primary phase of this study is evaluating the safety of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine, when each are co-administered with Pediarix® to healthy infants at 2, 4, and 6 months of age.

This protocol posting deals with objectives & outcome measures of the primary phase of the study. The objectives & outcome measures of the Booster phase are presented in a separate protocol posting (NCT number = 00345683).

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


Condition Intervention Phase
Haemophilus Influenza Infections
Meningococcal Infections
Biological: GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine combined 792014
Biological: ActHIB
Biological: Pediarix/Infanrix Penta
Phase III

MedlinePlus related topics:   Flu   

ChemIDplus related topics:   Tetanus Vaccine    Meningococcal Vaccines   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized, Single Blind (Subject), Parallel Assignment, Safety Study
Official Title:   Single-Blind, Randomized, Controlled, Multinational Study for the Evaluation of Safety of GSK Biologicals' Hib-MenCY-TT Vaccine Compared to Monovalent Hib Control Vaccine in Healthy Infants at 2, 4, 6, and 12 to 15 Months of Age.

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence of SAEs [ Time Frame: From dose 1 up to Day 30 after dose 3 and from Dose 1 up to the day preceding the booster dose ]
  • Occurrence of specific adverse events of new onset of chronic illness(es), rash, and conditions prompting emergency room visits [ Time Frame: From dose 1 up to Day 30 after dose 3 and from Dose 1 up to the day preceding the booster dose ]

Secondary Outcome Measures:
  • No secondary outcome measures for the primary vaccination

Enrollment:   4429
Study Start Date:   September 2006
Primary Completion Date:   October 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
3-dose intramuscular injection
Biological: Pediarix/Infanrix Penta
3-dose intramuscular injection
Group B: Active Comparator Biological: ActHIB
3-dose intramuscular injection
Biological: Pediarix/Infanrix Penta
3-dose intramuscular injection

Detailed Description:

Pediarix/Infanrix Penta and Prevnar should be co-administered to all subjects in all study groups according to a 2, 4, and 6 month schedule concomitantly with study vaccines.

  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 parents/guardians can and will comply with the requirements of the protocol.
  • 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.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Born after 36 weeks gestation.
  • 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 enrolment.
  • Infants may have received a birth dose of Bacillus Calmette-Guérin (BCG) vaccine.

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 study vaccine(s).
  • Previous vaccination against Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, and/or poliovirus; more than one previous dose of hepatitis B vaccine.
  • In country(ies) where Prevnar will be provided by GSK Biologicals, previous vaccination with Prevnar.
  • History of Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, hepatitis B, and/or poliovirus 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 vaccines, 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.
  • Concurrent participation in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00345579

Show 23 study locations  Show 23 Study Locations

Sponsors and Collaborators
GlaxoSmithKline

Investigators
Study Director:     Clinical Trials     GlaxoSmithKline    
  More Information

Booster study  This link exits the ClinicalTrials.gov site
 

Responsible Party:   GSK Biologicals ( Isabelle Harpigny )
Study ID Numbers:   105987
First Received:   June 26, 2006
Last Updated:   September 2, 2008
ClinicalTrials.gov Identifier:   NCT00345579
Health Authority:   United States: Food and Drug Administration;   Mexico: Federal Commission for Protection Against Health Risks

Keywords provided by GlaxoSmithKline:
Infants  
Humans  
H. influenzae type B vaccine  
Meningococcal vaccines  
Neisseria meningitidis Vaccines, conjugate
Safety
Prophylaxis

Study placed in the following topic categories:
Bacterial Infections
Haemophilus influenzae
Orthomyxoviridae Infections
Healthy
Neisseria meningitidis
Gram-Negative Bacterial Infections
Meningococcal infection
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Meningococcal Infections
Influenza, Human
Neisseriaceae Infections

Additional relevant MeSH terms:
Communicable Diseases
RNA Virus Infections
Infection

ClinicalTrials.gov processed this record on September 05, 2008




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