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

NCT ID: NCT01000974

Last Updated: 2018-07-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 4003 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-18
• Study Completion Date: 2013-07-17

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).

Conditions

Haemophilus Influenzae Type b

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Hiberix Group

Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.

Group Type: EXPERIMENTAL

GSK Biologicals' Haemophilus influenzae type b vaccine (GSK 208108)

Intervention Type: BIOLOGICAL

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.

Pediarix™

Intervention Type: BIOLOGICAL

Three doses in primary epoch at 2, 4 and 6 months of age as intramuscular injection

Prevnar 13™

Intervention Type: BIOLOGICAL

Three doses in primary epoch at 2, 4 and 6 months of age as intramuscular injection

Rotarix™

Intervention Type: BIOLOGICAL

Two oral doses in primary epoch at 2 and 4 months of age

Infanrix™

Intervention Type: BIOLOGICAL

One dose in the booster epoch at 15-18 months of age as intramuscular injection

ActHIB Group

Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.

Group Type: ACTIVE_COMPARATOR

ActHIB™

Intervention Type: BIOLOGICAL

Three doses in primary epoch at 2, 4 and 6 months of age as intramuscular injection and one dose as a booster vaccination

Pediarix™

Intervention Type: BIOLOGICAL

Three doses in primary epoch at 2, 4 and 6 months of age as intramuscular injection

Prevnar 13™

Intervention Type: BIOLOGICAL

Three doses in primary epoch at 2, 4 and 6 months of age as intramuscular injection

Rotarix™

Intervention Type: BIOLOGICAL

Two oral doses in primary epoch at 2 and 4 months of age

Infanrix™

Intervention Type: BIOLOGICAL

One dose in the booster epoch at 15-18 months of age as intramuscular injection

Pentacel Group

Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.

Group Type: ACTIVE_COMPARATOR

Pentacel™

Intervention Type: BIOLOGICAL

Three doses in primary epoch at 2, 4 and 6 months of age as intramuscular injection and one dose as a booster vaccination

Prevnar 13™

Intervention Type: BIOLOGICAL

Three doses in primary epoch at 2, 4 and 6 months of age as intramuscular injection

Rotarix™

Intervention Type: BIOLOGICAL

Two oral doses in primary epoch at 2 and 4 months of age

Engerix™-B

Intervention Type: BIOLOGICAL

Two or three doses in primary epoch at 2,( 4) and 6 months of age as intramuscular injection

Interventions

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.

Intervention Type: BIOLOGICAL

ActHIB™

Three doses in primary epoch at 2, 4 and 6 months of age as intramuscular injection and one dose as a booster vaccination

Intervention Type: BIOLOGICAL

Pentacel™

Three doses in primary epoch at 2, 4 and 6 months of age as intramuscular injection and one dose as a booster vaccination

Intervention Type: BIOLOGICAL

Pediarix™

Three doses in primary epoch at 2, 4 and 6 months of age as intramuscular injection

Intervention Type: BIOLOGICAL

Prevnar 13™

Three doses in primary epoch at 2, 4 and 6 months of age as intramuscular injection

Intervention Type: BIOLOGICAL

Rotarix™

Two oral doses in primary epoch at 2 and 4 months of age

Intervention Type: BIOLOGICAL

Engerix™-B

Two or three doses in primary epoch at 2,( 4) and 6 months of age as intramuscular injection

Intervention Type: BIOLOGICAL

Infanrix™

One dose in the booster epoch at 15-18 months of age as intramuscular injection

Intervention Type: BIOLOGICAL

Other Intervention Names

Hiberix®

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.

• Minimum Eligible Age: 6 Weeks
• Maximum Eligible Age: 12 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Dothan, Alabama, United States

GSK Investigational Site

Benton, Arkansas, United States

GSK Investigational Site

Fayetteville, Arkansas, United States

GSK Investigational Site

Jonesboro, Arkansas, United States

GSK Investigational Site

Little Rock, Arkansas, United States

GSK Investigational Site

Anaheim, California, United States

GSK Investigational Site

Antioch, California, United States

GSK Investigational Site

Daly City, California, United States

GSK Investigational Site

Fountain Valley, California, United States

GSK Investigational Site

Fremont, California, United States

GSK Investigational Site

Fresno, California, United States

GSK Investigational Site

Hayward, California, United States

GSK Investigational Site

Huntington Beach, California, United States

GSK Investigational Site

Oakland, California, United States

GSK Investigational Site

Redwood City, California, United States

GSK Investigational Site

Roseville, California, United States

GSK Investigational Site

Sacramento, California, United States

GSK Investigational Site

Sacramento, California, United States

GSK Investigational Site

San Jose, California, United States

GSK Investigational Site

Santa Clara, California, United States

GSK Investigational Site

Santa Rosa, California, United States

GSK Investigational Site

Vallejo, California, United States

GSK Investigational Site

Walnut Creek, California, United States

GSK Investigational Site

West Covina, California, United States

GSK Investigational Site

Boulder, Colorado, United States

GSK Investigational Site

Colorado Springs, Colorado, United States

GSK Investigational Site

Orange City, Florida, United States

GSK Investigational Site

Marietta, Georgia, United States

GSK Investigational Site

Woodstock, Georgia, United States

GSK Investigational Site

Honolulu, Hawaii, United States

GSK Investigational Site

Waipio, Hawaii, United States

GSK Investigational Site

Nampa, Idaho, United States

GSK Investigational Site

Bardstown, Kentucky, United States

GSK Investigational Site

Louisville, Kentucky, United States

GSK Investigational Site

Fall River, Massachusetts, United States

GSK Investigational Site

Stevensville, Michigan, United States

GSK Investigational Site

Saint Paul, Minnesota, United States

GSK Investigational Site

Omaha, Nebraska, United States

GSK Investigational Site

Mineola, New York, United States

GSK Investigational Site

Syracuse, New York, United States

GSK Investigational Site

Utica, New York, United States

GSK Investigational Site

Fargo, North Dakota, United States

GSK Investigational Site

Canton, Ohio, United States

GSK Investigational Site

Cincinnati, Ohio, United States

GSK Investigational Site

Cleveland, Ohio, United States

GSK Investigational Site

Dayton, Ohio, United States

GSK Investigational Site

Tulsa, Oklahoma, United States

GSK Investigational Site

Erie, Pennsylvania, United States

GSK Investigational Site

Greenville, Pennsylvania, United States

GSK Investigational Site

Hermitage, Pennsylvania, United States

GSK Investigational Site

Charleston, South Carolina, United States

GSK Investigational Site

Amarillo, Texas, United States

GSK Investigational Site

Fort Worth, Texas, United States

GSK Investigational Site

Houston, Texas, United States

GSK Investigational Site

Sugar Land, Texas, United States

GSK Investigational Site

Bountiful, Utah, United States

GSK Investigational Site

Layton, Utah, United States

GSK Investigational Site

Roy, Utah, United States

GSK Investigational Site

Salt Lake City, Utah, United States

GSK Investigational Site

South Jordan, Utah, United States

GSK Investigational Site

Syracuse, Utah, United States

GSK Investigational Site

Madison, Wisconsin, United States

GSK Investigational Site

Marshfield, Wisconsin, United States

Countries

United States

Related Links

https://clinicalstudydatarequest.com

IPD for this study will be made available via the Clinical Study Data Request site.

Other Identifiers

112957

Identifier Type: -

Identifier Source: org_study_id