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

Sponsor:	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
Meningococcal Infection Neisseria Meningitidis-Haemophilus Influenzae Type b Vaccine Haemophilus Influenza 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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention
Official Title:	A Single-blind, Randomized, Controlled, Multinational Study for the Evaluation of Safety of GlaxoSmithKline (GSK) Biologicals' Investigational Vaccination Regimen Compared to Monovalent Haemophilus Influenzae Type b (Hib) Control Vaccine in Healthy Infants at 2, 4, 6, and 12 to 15 Months of Age.

Resource links provided by NLM:

MedlinePlus related topics: Flu Meningococcal Infections

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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 ]

Enrollment:	4432
Study Start Date:	September 2006
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Experimental GSK792014 Vaccine Group 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.	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
Active Comparator: Licensed Haemophilus Influenzae Type b Vaccine Group 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.	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 52 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	E.D. Derilus; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00345579 History of Changes
Other Study ID Numbers:	105987
Study First Received:	June 26, 2006
Last Updated:	October 7, 2010
Health Authority:	Mexico: Federal Commission for Protection Against Health Risks; United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Prophylaxis
Neisseria meningitidis Vaccines, conjugate
Infants
Meningococcal vaccines

H. influenzae type B vaccine
Humans
Safety

Additional relevant MeSH terms:

Haemophilus Infections
Influenza, Human
Meningococcal Infections
Pasteurellaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

Neisseriaceae Infections
PENTA
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on February 12, 2012