Clinical trial NCT01000974: Consistency & Immunogenicity Study of 3 Lots of GSK's Hib Conjugate Vaccine Versus ActHIB & Pentacel in Healthy Infants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Haemophilus Influenzae Type b
Keywords: primary vaccination course
Haemophilus influenzae type b
infants, children
booster vaccination
immunogenicity
safety
Gram-negative bacterial infections
vaccines, conjugate
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2009-10-23
Enrollment: 4003
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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 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.

Primary outcomes:
measure: Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to (≥) 0.15 Microgram Per Milliliter (µg/mL) and ≥ 1.0 µg/mL
timeFrame: At 1 month after last dose of primary vaccination
measure: Number of Subjects With Anti-Protein-D (Anti-D) and Anti-Protein-T (Anti-T) Antibody Concentrations ≥ 0.1 International Units Per Milliliter (IU/mL)
timeFrame: At 1 month after last dose of primary vaccination
measure: Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations
timeFrame: At 1 month after last dose of primary vaccination
measure: Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibody Concentrations
timeFrame: At 1 month after last dose of primary vaccination
measure: Anti-Streptococcus Pneumoniae (S.Pneumoniae) Antibody Concentrations
timeFrame: At 1 month after last dose of primary vaccination
measure: Number of Subjects With Seroresponse (95%) to Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA)
timeFrame: At 1 month after last dose of primary vaccination
measure: Number of Subjects With Anti-Polio 1,2,3 Antibody Titres Greater Than or Equal to Cut-off Value
timeFrame: At 1 month after last dose of primary vaccination
measure: Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations ≥ 1.0 µg/mL
timeFrame: At 1 month after booster vaccination
Secondary outcomes:
measure: Anti-protein-D (Anti-D) and Anti-protein-T (Anti-T) Antibody Concentrations
timeFrame: At 1 month after last dose of primary vaccination
measure: Number of Subjects With Any Solicited Local Symptoms
timeFrame: During a 4-day follow-up period (Days 0-3) following any vaccination
measure: Number of Subjects With Any Solicited General Symptoms
timeFrame: During a 4-day follow-up period (Days 0-3) following any vaccination
measure: Number of Subjects With Any Unsolicited Adverse Events (AEs).
timeFrame: During the 31-day (Day 0-Day 30) follow-up period after primary vaccination
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: From Day 0 until 6 months following the last primary dose
measure: Number of Subjects With AEs of Specific Interest (AESIs)
timeFrame: From Day 0 until 6 months following the last primary dose or the receipt of the booster vaccination, whichever comes first
measure: Number of Subjects With Seroresponse (90%) to Anti-PT, Anti-PRN and Anti-FHA
timeFrame: At 1 month after last dose of primary vaccination
measure: Number of Subjects With Anti-PT, Anti-PRN and Anti-FHA Antibody Concentrations ≥ 5 EL.U/mL
timeFrame: At 1 month after last dose of primary vaccination
measure: Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations ≥ 0.15 µg/mL and ≥ 1.0 µg/mL
timeFrame: Prior to the booster vaccination and 1 month after the booster vaccination
measure: Anti-Hepatitis B (Anti-HBs) Antibody Concentrations
timeFrame: At 1 month after last dose of primary vaccination
measure: Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL
timeFrame: At 1 month after the last dose of primary vaccination
measure: Antibody Titers for Poliovirus Types 1, 2 and 3
timeFrame: At 1 month after last dose of primary vaccination
measure: Number of Subjects With Anti-HBs Antibody Concentrations Greater Than or Equal to Cut-off Values
timeFrame: At 1 month after last dose of primary vaccination
measure: Anti-polyribosylribitol Phosphate (PRP) Antibody Concentrations
timeFrame: Prior to the booster vaccination and 1 month after the booster vaccination
measure: Anti-Hepatitis B (Anti-HBs) Antibody Concentrations ≥10.0 mIU/mL and ≥6.2 mIU/mL
timeFrame: Prior to the booster vaccination
measure: Number of Subjects With Anti-HB Antibody Concentrations ≥10.0 mlU/mL and ≥6.2mLU/mL
timeFrame: Prior to booster vaccination
measure: Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations ≥ 5 EL.U/mL
timeFrame: Prior to the booster vaccination and 1 month after the booster vaccination
measure: Anti-poliovirus Types 1, 2, and 3 Antibody Titres and Titres ≥ 8
timeFrame: Prior to the booster vaccination
measure: Number of Subjects With Anti-Polio-1,2,3 Antibody Titers ≥ 8
timeFrame: Prior to booster vaccination
measure: Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL and ≥1.0 IU/mL, Respectively.
timeFrame: Prior to the booster vaccination and 1 month after the booster vaccination
measure: Number of Subjects With Any Solicited Local Symptoms
timeFrame: Within 4 days (Days 0-3) following the booster dose
measure: Number of Subjects With Any Solicited General Symptoms
timeFrame: Within 4 days (Days 0-3) following the booster dose
measure: Number of Subjects With AEs of Specific Interest (AESIs)
timeFrame: From booster dose until 6 months following receipt of the booster dose
measure: Number of Subjects With Any Unsolicited Adverse Events (AEs).
timeFrame: Within 31 days (Day 0 to Day 30) following the booster dose
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: From the booster dose until 6 months following receipt of the booster dose
measure: Anti-FHA, Anti-PRN and Anti-PT Antibody Concentrations
timeFrame: pre-booster and one month after booster vaccination
Other outcomes:
Locations:
city: Dothan
country: United States
facility: GSK Investigational Site
state: Alabama
city: Benton
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Fayetteville
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Jonesboro
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Little Rock
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Anaheim
country: United States
facility: GSK Investigational Site
state: California
city: Antioch
country: United States
facility: GSK Investigational Site
state: California
city: Daly City
country: United States
facility: GSK Investigational Site
state: California
city: Fountain Valley
country: United States
facility: GSK Investigational Site
state: California
city: Fremont
country: United States
facility: GSK Investigational Site
state: California
city: Fresno
country: United States
facility: GSK Investigational Site
state: California
city: Hayward
country: United States
facility: GSK Investigational Site
state: California
city: Huntington Beach
country: United States
facility: GSK Investigational Site
state: California
city: Oakland
country: United States
facility: GSK Investigational Site
state: California
city: Redwood City
country: United States
facility: GSK Investigational Site
state: California
city: Roseville
country: United States
facility: GSK Investigational Site
state: California
city: Sacramento
country: United States
facility: GSK Investigational Site
state: California
city: Sacramento
country: United States
facility: GSK Investigational Site
state: California
city: San Jose
country: United States
facility: GSK Investigational Site
state: California
city: Santa Clara
country: United States
facility: GSK Investigational Site
state: California
city: Santa Rosa
country: United States
facility: GSK Investigational Site
state: California
city: Vallejo
country: United States
facility: GSK Investigational Site
state: California
city: Walnut Creek
country: United States
facility: GSK Investigational Site
state: California
city: West Covina
country: United States
facility: GSK Investigational Site
state: California
city: Boulder
country: United States
facility: GSK Investigational Site
state: Colorado
city: Colorado Springs
country: United States
facility: GSK Investigational Site
state: Colorado
city: Orange City
country: United States
facility: GSK Investigational Site
state: Florida
city: Marietta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Woodstock
country: United States
facility: GSK Investigational Site
state: Georgia
city: Honolulu
country: United States
facility: GSK Investigational Site
state: Hawaii
city: Waipio
country: United States
facility: GSK Investigational Site
state: Hawaii
city: Nampa
country: United States
facility: GSK Investigational Site
state: Idaho
city: Bardstown
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Fall River
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Stevensville
country: United States
facility: GSK Investigational Site
state: Michigan
city: Saint Paul
country: United States
facility: GSK Investigational Site
state: Minnesota
city: Omaha
country: United States
facility: GSK Investigational Site
state: Nebraska
city: Mineola
country: United States
facility: GSK Investigational Site
state: New York
city: Syracuse
country: United States
facility: GSK Investigational Site
state: New York
city: Utica
country: United States
facility: GSK Investigational Site
state: New York
city: Fargo
country: United States
facility: GSK Investigational Site
state: North Dakota
city: Canton
country: United States
facility: GSK Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: GSK Investigational Site
state: Ohio
city: Cleveland
country: United States
facility: GSK Investigational Site
state: Ohio
city: Dayton
country: United States
facility: GSK Investigational Site
state: Ohio
city: Tulsa
country: United States
facility: GSK Investigational Site
state: Oklahoma
city: Erie
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Greenville
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Hermitage
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Charleston
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Amarillo
country: United States
facility: GSK Investigational Site
state: Texas
city: Fort Worth
country: United States
facility: GSK Investigational Site
state: Texas
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: Sugar Land
country: United States
facility: GSK Investigational Site
state: Texas
city: Bountiful
country: United States
facility: GSK Investigational Site
state: Utah
city: Layton
country: United States
facility: GSK Investigational Site
state: Utah
city: Roy
country: United States
facility: GSK Investigational Site
state: Utah
city: Salt Lake City
country: United States
facility: GSK Investigational Site
state: Utah
city: South Jordan
country: United States
facility: GSK Investigational Site
state: Utah
city: Syracuse
country: United States
facility: GSK Investigational Site
state: Utah
city: Madison
country: United States
facility: GSK Investigational Site
state: Wisconsin
city: Marshfield
country: United States
facility: GSK Investigational Site
state: Wisconsin
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: