Consistency & Immunogenicity Study of 3 Lots of GSK's Hib Conjugate Vaccine Versus ActHIB & Pentacel in Healthy Infants - Full Text View

Purpose

The purpose of this study is to evaluate safety, to demonstrate lot-to-lot consistency of the vaccine, to address the relevant concomitant vaccine administrations and to provide a comparison between GSK Biologicals' Hib conjugate vaccine and the licensed monovalent Hib vaccine ActHIB as well as the licensed combination product Pentacel in infants at 2, 4, 6 and 15-18 months of age. This study is designed with a primary and a booster phase.

Condition	Intervention	Phase
Meningitis Osteomyelitis Epiglottis Cellulitis Haemophilus Influenzae Type B Related Disease Pneumonia	Biological: GSK Biologicals' Haemophilus influenzae type b vaccine (GSK 208108) Biological: ActHIBTM Biological: PentacelTM Biological: PediarixTM Biological: Prevnar 13TM Biological: RotarixTM Biological: EngerixTM-B Biological: InfanrixTM	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Prevention
Official Title:	Phase III, Partially Double-blind Study to Evaluate Consistency and Immunogenicity of 3 Lots of GSK Biologicals' Hib Conjugate Vaccine 208108 Versus ActHIB and Pentacel at 2, 4, 6 and 15-18 Months of Age in Healthy Infants

Resource links provided by NLM:

MedlinePlus related topics: Cellulitis Flu Meningitis Pneumonia

Drug Information available for: Heptavalent pneumococcal conjugate vaccine Pneumococcal Vaccines

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Immunogenicity (primary read-outs) with respect to components of the study vaccines and the studied co-administered vaccines [ Time Frame: 1 month after last dose of primary vaccination ] [ Designated as safety issue: No ]
Immunogenicity (primary read-outs) with respect to components of the study vaccines [ Time Frame: 1 month after booster vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Immunogenicity (other parameters) with respect to the components of the study vaccines and the studied co-administered vaccines [ Time Frame: 1 month after last dose of primary vaccination ] [ Designated as safety issue: No ]
Solicited local and general symptoms [ Time Frame: during a 4-day follow-up period (i.e., day of vaccination and 3 subsequent days) following each primary vaccine dose ] [ Designated as safety issue: No ]
Unsolicited adverse events [ Time Frame: within 31 days following each primary vaccine dose ] [ Designated as safety issue: No ]
Serious adverse events [ Time Frame: from Day 0 until 6 months following the last primary dose or until receipt of the booster vaccination, whichever comes first ] [ Designated as safety issue: No ]
Specific adverse events [ Time Frame: from Day 0 until 6 months following the last primary dose or until receipt of the booster vaccination, whichever comes first ] [ Designated as safety issue: No ]
Immunogenicity (other parameters) with respect to the components of the study vaccines and the studied co-administered vaccines [ Time Frame: prior to the booster vaccination and one month after the booster vaccination ] [ Designated as safety issue: No ]
Solicited local and general symptoms [ Time Frame: within 4 days (i.e., day of vaccination and 3 subsequent days) following the booster dose ] [ Designated as safety issue: No ]
Unsolicited adverse events [ Time Frame: within 31 days following the booster dose ] [ Designated as safety issue: No ]
Serious adverse events [ Time Frame: from booster dose until 6 months following receipt of the booster dose ] [ Designated as safety issue: No ]
Specific adverse events [ Time Frame: from booster dose until 6 months following receipt of the booster dose ] [ Designated as safety issue: No ]

Estimated Enrollment:	4000
Study Start Date:	March 2010
Estimated Study Completion Date:	September 2013
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Group Hiberix A Subjects will be vaccinated with GSK Biologicals' Hib vaccine-Lot A in the primary study co-administered with PediarixTM, Prevnar 13TM and RotarixTM and will be boosted with GSK Biologicals' Hib vaccine	Biological: GSK Biologicals' Haemophilus influenzae type b vaccine (GSK 208108) Three doses of 3 different manufacturing lots in primary study at 2, 4 and 6 months of age as intramuscular injection and one dose as booster vaccination. Biological: PediarixTM Three doses in primary epoch at 2, 4 and 6 months of age as intramuscular injection Biological: Prevnar 13TM Three doses in primary epoch at 2, 4 and 6 months of age as intramuscular injection Biological: RotarixTM Two oral doses in primary epoch at 2 and 4 months of age Biological: InfanrixTM One dose in the booster epoch at 15-18 months of age as intramuscular injection
Experimental: Group Hiberix B Subjects will be vaccinated with GSK Biologicals' Hib vaccine-Lot B in the primary study co-administered with PediarixTM, Prevnar 13TM and RotarixTM and will be boosted with GSK Biologicals' Hib vaccine	Biological: GSK Biologicals' Haemophilus influenzae type b vaccine (GSK 208108) Three doses of 3 different manufacturing lots in primary study at 2, 4 and 6 months of age as intramuscular injection and one dose as booster vaccination. Biological: PediarixTM Three doses in primary epoch at 2, 4 and 6 months of age as intramuscular injection Biological: Prevnar 13TM Three doses in primary epoch at 2, 4 and 6 months of age as intramuscular injection Biological: RotarixTM Two oral doses in primary epoch at 2 and 4 months of age Biological: InfanrixTM One dose in the booster epoch at 15-18 months of age as intramuscular injection
Experimental: Group Hiberix C Subjects will be vaccinated with GSK Biologicals' Hib vaccine-Lot C in the primary study co-administered with PediarixTM, Prevnar 13TM and RotarixTM and will be boosted with GSK Biologicals' Hib vaccine	Biological: GSK Biologicals' Haemophilus influenzae type b vaccine (GSK 208108) Three doses of 3 different manufacturing lots in primary study at 2, 4 and 6 months of age as intramuscular injection and one dose as booster vaccination. Biological: PediarixTM Three doses in primary epoch at 2, 4 and 6 months of age as intramuscular injection Biological: Prevnar 13TM Three doses in primary epoch at 2, 4 and 6 months of age as intramuscular injection Biological: RotarixTM Two oral doses in primary epoch at 2 and 4 months of age Biological: InfanrixTM One dose in the booster epoch at 15-18 months of age as intramuscular injection
Active Comparator: Group ActHIB Subjects will be vaccinated with ActHIBTM in the primary study co-administered with PediarixTM, Prevnar 13TM and RotarixTM and will be boosted with ActHIBTM	Biological: ActHIBTM Three doses in primary epoch at 2, 4 and 6 months of age as intramuscular injection and one dose as a booster vaccination Biological: PediarixTM Three doses in primary epoch at 2, 4 and 6 months of age as intramuscular injection Biological: Prevnar 13TM Three doses in primary epoch at 2, 4 and 6 months of age as intramuscular injection Biological: RotarixTM Two oral doses in primary epoch at 2 and 4 months of age Biological: InfanrixTM One dose in the booster epoch at 15-18 months of age as intramuscular injection
Active Comparator: Group Pentacel Subjects will be vaccinated with PentacelTM in the primary study co-administered with Prevnar 13TM, Engerix-BTM and RotarixTM and will be boosted with PentacelTM	Biological: PentacelTM Three doses in primary epoch at 2, 4 and 6 months of age as intramuscular injection and one dose as a booster vaccination Biological: Prevnar 13TM Three doses in primary epoch at 2, 4 and 6 months of age as intramuscular injection Biological: RotarixTM Two oral doses in primary epoch at 2 and 4 months of age Biological: EngerixTM-B Two or three doses in primary epoch at 2,( 4) and 6 months of age as intramuscular injection

Detailed Description:

This protocol posting has been updated following protocol amendment 3, dated 12 April 2011. The impacted section is: Eligibility Criteria (Exclusion criteria).

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 parent(s)/Legally Acceptable Representative(s) (LAR[s]) can and will comply with the requirements of the protocol (e.g., completion of the diary card, return for follow-up visits).
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 subject's parent/LAR.
Healthy subjects as established by medical history and clinical examination before entering into the study.
Born after a gestation period of minimum 36 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.

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 of a vaccine not foreseen by the study protocol within 30 days of the first dose of study vaccine and until 30 days after the booster dose.
Previous vaccination against Haemophilus influenzae type b, diphtheria, tetanus, pertussis, Pneumococcus, rotavirus and/or poliovirus; more than one previous dose of hepatitis B vaccine.
History of Haemophilus influenzae type b, diphtheria, tetanus, pertussis, pneumococcal, rotavirus, poliovirus, and hepatitis B diseases.
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. All vaccines can be administered to persons with a minor illness.
Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Concurrent participation in another clinical study, up to 30 days prior to study entry or 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).
Child in care.
History of intussusception.
History of uncorrected congenital malformation of the gastrointestinal tract that would predispose the infant to intussusception.
History of Severe Combined Immunodeficiency Disease.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01000974

Show 64 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT01000974 History of Changes
Other Study ID Numbers:	112957
Study First Received:	October 22, 2009
Last Updated:	February 14, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

primary vaccination course
Haemophilus influenzae type b
infants, children
booster vaccination

immunogenicity
safety
Gram-negative bacterial infections
vaccines, conjugate

Additional relevant MeSH terms:

Cellulitis
Influenza, Human
Meningitis
Osteomyelitis
Pneumonia
Skin Diseases, Infectious
Infection
Suppuration
Connective Tissue Diseases
Inflammation
Pathologic Processes
Orthomyxoviridae Infections

RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Bone Diseases, Infectious
Bone Diseases
Musculoskeletal Diseases
Lung Diseases

ClinicalTrials.gov processed this record on May 19, 2013