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Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants

Primary Purpose

Tetanus, Hepatitis B, Haemophilus Influenzae Type b

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

GSK2202083A vaccine

Prevenar 13®

Infanrix hexa™

Menjugate®

Rotarix™

About this trial

This is an interventional prevention trial for Tetanus

Eligibility Criteria

8 Weeks - 12 Weeks (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol.
A male or female infant between, and including, 8 and 12 weeks at the time of the first vaccination.
Born after a gestation period of 36 to 42 weeks inclusive.
Written informed consent obtained from the parent(s), Legally Acceptable Representative(s) of the subject.
Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

Use of any investigational or non-registered product 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 of immunosuppressants or other immune-modifying drugs since birth.
Child in care.
Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Administration of a vaccine not foreseen by the study protocol within 30 days prior to randomisation, or planned administration from randomisation to the end of the study with the exception of inactivated influenza vaccines. The administration of diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Haemophilus influenzae type b, pneumococcal, rotavirus and/or MenC vaccines is not allowed at any time during the study period but other vaccines are allowed during the period from one day after study Visit 3 to 31 days before study Visit 4.
Concurrently participating 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.
Evidence of previous diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Hib, pneumococcal, rotavirus and/or MenC vaccination or disease, including Hepatitis B virus vaccination at birth.
History of seizures or progressive neurological disease.
Subjects with history of intussusception or uncorrected congenital malformation of the gastrointestinal tract that would predispose for intussusception.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
Major congenital defects or serious chronic illness.

The following condition is temporary or self-limiting, and a subject may be vaccinated once the condition has resolved if no other exclusion criteria is met:

Current febrile illness or other moderate to severe illness within 24 hours of study vaccine administration.
Current gastrointestinal infection.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

GSK2202083A Group

Infanrix hexa Group

Arm Description

Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.

Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.

Outcomes

Primary Outcome Measures

Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Above the Cut-off

The anti-PRP antibody concentration cut-off for this assay was greater than or equal to (≥) 0.15 micrograms per milliliter (µg/mL).

Number of Subjects With Neisseria Meningitidis Using Baby Rabbit Complement (rSBA-MenC) Antibody Titers Above the Cut-off

The rSBA-MenC antibody titers cut-off for this assay was ≥ 1:8.

Secondary Outcome Measures

Number of Subjects With Anti-PRP Antibody Concentrations Above the Cut-offs

The anti-PRP antibody concentration cut-offs for this assay were ≥ 0.15 µg/mL and 1.0 µg/mL. Values concerning the cut-off of 0.15 µg/mL at Month 3 were listed for a primary outcome, hence they were not reported under this outcome.

Number of Subjects With rSBA-MenC Antibody Titers Above the Cut-offs

The rSBA-MenC antibody titers cut-off for this assay were ≥ 1:8 and ≥ 1:128. Values concerning the cut-off of 1:8 at Month 3 were listed for a primary outcome, hence they were not reported under this outcome.

Concentrations for Anti-PRP.

Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection reference cut-off values were ≥ 0.15 µg/mL and ≥ 1.0 µg/mL.

Titers for rSBA-MenC.

Titers were expressed as geometric mean titers (GMCs). The seropositivity reference cut-off values were ≥ 1:8 and ≥ 1:128.

Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies Above the Cut-off.

The anti-D and anti-T antibody cut-off was ≥ 0.1 international units per milliliter (IU/mL).

Concentrations for Anti-T and Anti-D.

Concentrations were expressed as geometric mean concentrations (GMCs). The reference cut-off value was ≥ 0.1 IU/mL.

Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentration Equal to or Above (≥) 10 and 100 Milli-International Units Per Milliliter (mIU/mL)

A decrease in the specificity of the anti-HB enzyme-linked immunosorbent assay (ELISA) had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis.

Concentrations for Anti-HBs.

Number of Subjects With Anti-poliovirus (Anti-polio) Types 1, 2 and 3 Above the Cut-off.

The anti-polio 1, 2 and 3 antibody concentrations cut-off value was ≥ 1:8.

Titers for Anti-polio 1, 2 and 3.

Titers were expressed as geometric mean titers (GMTs). The reference cut-off value was ≥ 1:8.

Number Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Above the Cut-off.

The reference cut-off for anti-PT, anti-FHA and anti-PRN antibody concentrations was ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliters (EL.U/mL).

Concentrations for Anti-PT, Anti-FHA and Anti-PRN.

Concentrations were expressed as geometric mean concentrations (GMCs). The reference cut-off value was ≥ 5 EL.U/mL.

Number of Subjects With a Booster Response to Anti-PT, Anti-FHA and Anti-PRN.

Booster response defined as: for initially seronegative subjects, antibody concentration ≥ 5 EL.U/mL at Month 11; for initially seropositive subjects: antibody concentration at Month 11 ≥ 2 fold the pre-vaccination antibody concentration

Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs.

The anti-PNE antibody concentrations reference cut-offs were ≥ 0.2 and ≥ 0.05 micrograms per milliliter (µg/mL). The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.

Concentrations for Anti-PNE Serotypes.

Concentrations were expressed as geometric mean concentreations (GMCs). The reference cut-off value was ≥ 0.2 µg/mL.

Number of Subjects With Anti-PRP and rSBA-MenC Fold Increase Distribution.

The fold increase distribution cut-offs were: ≥2, ≥4, ≥6, ≥8 and ≥10.

Number of Subjects Reporting Any Solicited Local Symptoms.

Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.

Number of Subjects Reporting Any Solicited General Symptoms.

Solicited local symptoms assessed were drowsiness, irritability/fussiness, loss of appetite and fever [axillary temperature above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of any local symptom regardless of intensity grade.

Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).

An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of an AE regardless of intensity grade or relationship to study vaccination.

Number of Subjects Reporting Any Serious Adverse Events (SAEs).

SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Any SAE = any SAE regardless of assessment of relationship to study vaccination.

Full Information

NCT ID

NCT01090453

First Posted

March 18, 2010

Last Updated

June 28, 2018

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT01090453

Brief Title

Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants

Official Title

Feasibility Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants at 2, 4 and 12 Months of Age

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Completed

Study Start Date

May 17, 2010 (undefined)

Primary Completion Date

October 11, 2011 (Actual)

Study Completion Date

October 11, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary

This study will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083 vaccine co-administered with Prevenar 13® at 2, 4 and 12 months of age and with Rotarix™ at 2 and 4 months of age.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tetanus, Hepatitis B, Haemophilus Influenzae Type b, Poliomyelitis, Acellular Pertussis, Diphtheria, Neisseria Meningitidis

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

480 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GSK2202083A Group

Arm Type

Experimental

Arm Description

Arm Title

Infanrix hexa Group

Arm Type

Active Comparator

Arm Description

Intervention Type

Biological

Intervention Name(s)

GSK2202083A vaccine

Intervention Description

3 doses given at 2, 4 and 12 months of age

Intervention Type

Biological

Intervention Name(s)

Prevenar 13®

Intervention Description

3 co-administered doses

Intervention Type

Biological

Intervention Name(s)

Infanrix hexa™

Intervention Description

3 doses given at 2, 4 and 12 months of age

Intervention Type

Biological

Intervention Name(s)

Menjugate®

Intervention Description

3 co-administered doses

Intervention Type

Biological

Intervention Name(s)

Rotarix™

Intervention Description

Oral, two doses

Primary Outcome Measure Information:

Title

Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Above the Cut-off

Description

The anti-PRP antibody concentration cut-off for this assay was greater than or equal to (≥) 0.15 micrograms per milliliter (µg/mL).

Time Frame

At Month 3

Title

Number of Subjects With Neisseria Meningitidis Using Baby Rabbit Complement (rSBA-MenC) Antibody Titers Above the Cut-off

Description

The rSBA-MenC antibody titers cut-off for this assay was ≥ 1:8.

Time Frame

At Month 3

Secondary Outcome Measure Information:

Title

Number of Subjects With Anti-PRP Antibody Concentrations Above the Cut-offs

Description

Time Frame