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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.
Study NCT00345579   Information provided by GlaxoSmithKline
First Received: June 26, 2006   Last Updated: September 25, 2009   History of Changes

June 26, 2006
September 25, 2009
September 2006
March 2008   (final data collection date for primary outcome measure)
  • Number of Subjects Reporting Specific Adverse Events During the Active Phase of the Study [ Time Frame: From Day 0 after Dose 1 up to Day 30 after Dose 3 ] [ Designated as safety issue: No ]
  • Number of Subjects Reporting Specific Adverse Events Throughout the Entire Study [ Time Frame: From Day 0 until the end of the 6-month extended safety follow-up (ESFU) ] [ Designated as safety issue: No ]
Safety: Hib-MenCY-TT vaccine vs monovalent Hib vaccine with respect to AEs post primary vaccination.
Complete list of historical versions of study NCT00345579 on ClinicalTrials.gov Archive Site
No secondary outcome measures for the primary vaccination [ Designated as safety issue: No ]
See Booster study posting (NCT00345683)
 
Safety of Hib-MenCY-TT Vaccine Versus Licensed Hib Conjugate Vaccine, Given at 2, 4, 6 and 12 to 15 Months of Age
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

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

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.

Phase III
Interventional
Prevention, Randomized, Single Blind (Subject), Parallel Assignment, Safety Study
  • Haemophilus Influenza Infections
  • Meningococcal Infection
  • 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
  • Active Comparator: Subjects in both pooled studies received 3 intramuscular doses of Sanofi Pasteur's ActHIB vaccine co-administered with GSK Biologicals' Pediarix (Infanrix-Penta) and Wyeth's Prevnar.
  • Experimental: Subjects in both pooled studies received 3 intramuscular doses of experimental GSK792014 vaccine co-administered with GSK Biologicals' Pediarix (Infanrix-Penta) and Wyeth's Prevnar.
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
4429
March 2008
March 2008   (final data collection date for primary outcome measure)

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).
Both
6 Weeks to 12 Weeks
Yes
Contact information is only displayed when the study is recruiting subjects
United States,   Mexico
 
NCT00345579
Study Director, GSK
105987
GlaxoSmithKline
 
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP