Immunogenicity and Safety of GlaxoSmithKline (GSK) Biolog... | NCT01738477

NCT01738477

Status Module

Sponsor/Collaborators Module

Oversight Module

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Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Boostrix Group 2	Experimental	Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix in this study.	Biological: Boostrix
Boostrix Group 1	Active Comparator	Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix in this study.	Biological: Boostrix

Name	Type	Description	Arm Group Labels	Other Names
Boostrix	Biological	Single dose intramuscular administration.	Boostrix Group 1 Boostrix Group 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T).	A seroprotected subject was defined as a subject with anti-D/anti-T antibody concentrations above or equal (≥) to 0.1 IU/mL (international units per milliliter)	At Month 1
Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Against Filamentous Hemagglutinin (Anti-FHA) and Against Pertactin (Anti-PRN).	Concentrations were expressed in geometric mean concentrations (GMCs).	At Month 1

Secondary Outcomes

Measure	Description	Time Frame
Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T).	A seroprotected subject was defined as a subject with anti-D/anti-T antibody concentrations above or equal (≥) to 0.1 IU/mL (international units per milliliter)	At Month 0
Number of Subjects With Anti-D and Anti-T Concentrations Above the Cut-off.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visit).
Subjects who have received a dose of Tdap or Td vaccines 10 years (+/-300 days) back, in study NCT00109330.
Written informed consent obtained from the subject.
Healthy subjects as established by medical history and clinical examination before entering into the study.
Female subjects of non-childbearing potential may be enrolled in the study.
- Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.
Female subjects of childbearing potential may be enrolled in the study, if the subject
- has practiced adequate contraception for 30 days prior to vaccination, and
- has a negative pregnancy test on the day of vaccination, and
- has agreed to continue adequate contraception during the entire treatment period and for 1 month after completion of the vaccine dose.

Exclusion Criteria:

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period.
Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccine dose . For corticosteroids, this will mean prednisone (≥ 20 mg/day (for adult subjects), or equivalent. Inhaled and topical steroids are allowed.
Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before and ending 31 days after the dose of vaccine, with the exception of Influenza vaccine which is allowed throughout the study period.
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 vaccine/product (pharmaceutical product or device).
Previous vaccination against diphtheria, tetanus or pertussis since the last dose received in the Study NCT00109330.
History of diphtheria, tetanus or pertussis diseases following the receipt of booster dose in the Study NCT00109330.
Severe allergic reaction (e.g. anaphylaxis) after previous administration of any tetanus toxoid, diphtheria toxoid, or pertussis-antigen containing vaccines, or any component of Boostrix.
Hypersensitivity to latex.
Encephalopathy (e.g. coma, decreased level of consciousness, prolonged seizures) of unknown etiology occurring within 7 days following previous vaccination with pertussis-containing vaccine.
History of any neurological disorders or seizures.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
Acute disease and/or fever at the time of enrolment.
- Fever is defined as temperature ≥ 99.5°F for oral, axillary or tympanic route, or ≥ 100.4°F for rectal route. The preferred route for recording temperature in this study will be oral.
- Subjects with a minor illness (such as mild diarrhea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.
Administration of immunoglobulins and/or any blood products within the 3 months preceding the booster dose of study vaccine or planned administration during the study period.
Pregnant or lactating female.
Female planning to become pregnant or planning to discontinue contraceptive precautions up to 1 month post-vaccination.

Contacts/Locations Module

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Mesa	Arizona	85213	United States
GSK Investigational Site

References Module

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No data is available for this block.

IPD Sharing Statement Module

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No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Boostrix Group 1	Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix in this study.
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

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No data is available for this block.

Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Boostrix Group 1	Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix in this study.
BG001	Boostrix Group 2	Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix in this study.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00023.3± 2.4 BG00123.5± 2.1 BG00223.5± 2.1

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00018 BG00157 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Black

Title	Measurements
	BG0001 BG0016 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T).

A seroprotected subject was defined as a subject with anti-D/anti-T antibody concentrations above or equal (≥) to 0.1 IU/mL (international units per milliliter)

The analysis was done on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who had met the eligibility criteria, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one study vaccine antigen.

Posted

Count of Participants

Participants

At Month 1

ID	Title	Description
OG000	Boostrix Group 1	Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix in this study.
OG001	Boostrix Group 2	Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix in this study.

Units	Counts
Participants	OG00035 OG001115

Title

Denominators

Categories

Anti-D

Title	Measurements
	OG00035 OG001115

Anti-T

Title	Measurements
	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Non-inferiority in terms of seroprotection rates to diphtheria.					Mean Difference (Final Values)	0				95	-3.25	9.95					Non-Inferiority	To assess the non-inferiority of the second dose of Boostrix (Boostrix 2 Group) minus first dose of Boostrix (Boostrix 1 Group) for anti-diphtheria. Objective of non-inferiority was considered to be met if the lower limit (LL) of the 95% confidence interval (CI) was greater than, or equal to -10%.

Primary

Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Against Filamentous Hemagglutinin (Anti-FHA) and Against Pertactin (Anti-PRN).

Concentrations were expressed in geometric mean concentrations (GMCs).

Posted

Geometric Mean

95% Confidence Interval

IU/mL

At Month 1

ID	Title	Description
OG000	Boostrix Group 1	Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix in this study.
OG001	Boostrix Group 2	Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix in this study.

Units

Secondary

Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T).

A seroprotected subject was defined as a subject with anti-D/anti-T antibody concentrations above or equal (≥) to 0.1 IU/mL (international units per milliliter)

Posted

Count of Participants

Participants

At Month 0

ID	Title	Description
OG000	Boostrix Group 1	Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix in this study.
OG001	Boostrix Group 2	Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix in this study.

Secondary

Number of Subjects With Anti-D and Anti-T Concentrations Above the Cut-off.

The cut-off of the assay was ≥ 1.0 IU/mL.

Posted

Count of Participants

Participants

At Month 0 and Month 1

ID	Title	Description
OG000	Boostrix Group 1	Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix in this study.
OG001	Boostrix Group 2	Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix in this study.

Units	Counts
Participants

Secondary

Anti-D and Anti-T Antibody Concentrations.

Concentrations were expressed as GMCs.

Posted

Geometric Mean

95% Confidence Interval

IU/mL

At Month 0 and Month 1

ID	Title	Description
OG000	Boostrix Group 1	Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix in this study.
OG001	Boostrix Group 2	Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix in this study.

Units	Counts
Participants

Secondary

Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Against Filamentous Hemagglutinin (Anti-FHA) and Against Pertactin (Anti-PRN).

Concentrations were expressed in geometric mean concentrations (GMCs).

Posted

Geometric Mean

95% Confidence Interval

IU/mL

At Month 0

ID	Title	Description
OG000	Boostrix Group 1	Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix in this study.
OG001	Boostrix Group 2	Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix in this study.

Units

Secondary

Number of Subjects With a Booster Response to Anti-D and Anti-T.

Booster response to anti-D and anti-T antigens was defined as:

for initially seronegative subjects with pre-booster antibody concentration below 0.1 IU/mL, an increase of at least four times 0.1 IU/mL one month after vaccination,
for initially seropositive subjects with pre-booster antibody concentration ≥ 0.1 IU/mL, an increase of at least four times the pre-booster antibody concentration one month after vaccination.

Posted

Count of Participants

Participants

At Month 1

ID	Title	Description
OG000	Boostrix Group 1	Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix in this study.
OG001	Boostrix Group 2	Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix in this study.

Secondary

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

Booster response to pertussis antigens was defined as:

for initially seronegative subjects (pre-booster antibody concentration below the assay cut-off) with an increase of at least four times the assay cut-off one month after vaccination;
for initially seropositive subjects with anti-body concentration < four times the assay cut-off with an increase of at least four times the pre-booster antibody concentration one month after vaccination;
for initially seropositive subjects with anti-body concentration ≥ four times the assay cut-off with an increase of at least two times the pre-booster antibody concentration one month after vaccination.

Posted

Count of Participants

Participants

At Month 1.

ID	Title	Description
OG000	Boostrix Group 1	Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix in this study.
OG001	Boostrix Group 2

Secondary

Number of Subjects With Solicited Local Symptoms.

The solicited local symptoms assessed were Pain, Redness and Swelling. Any = any solicited local symptom regardless of intensity.

The analysis was performed on the Total Vaccinated cohort, which included all subjects with a study vaccine administration dose documented and the symptom sheet filled-in.

Posted

Count of Participants

Participants

During the 4 days (Day 0 - 3) follow-up period after vaccination.

ID	Title	Description
OG000	Boostrix Group 1	Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix™ in this study.
OG001	Boostrix Group 2	Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix™ in this study.

Units	Counts
Participants

Secondary

Number of Subjects With Solicited General Symptoms.

The solicited local symptoms assessed were Fatigue, Gastrointestinal, Headache and Fever. Any = any solicited general symptom regardless of intensity.

The analysis was performed on the Total Vaccinated cohort, which included all subjects with a study vaccine administration dose documented and the symptom sheet filled-in.

Posted

Count of Participants

Participants

During the 4 days (Day 0 - 3) follow-up period after vaccination.

ID	Title	Description
OG000	Boostrix Group 1	Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix™ in this study.
OG001	Boostrix Group 2	Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix™ in this study.

Units	Counts
Participants

Secondary

Number of Subjects With Unsolicited Adverse Events (AEs).

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.

The analysis was performed on the Total Vaccinated cohort, which included all subjects with a study vaccine administration dose documented.

Posted

Count of Participants

Participants

During the 31 days (Day 0 - 30) after vaccination.

ID	Title	Description
OG000	Boostrix Group 1	Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix™ in this study.
OG001	Boostrix Group 2	Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix™ in this study.

Secondary

Number of Subjects With Serious Adverse Events (SAEs).

SAEs assessed include medical occurrences that results in death, are life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject.

The analysis was performed on the Total Vaccinated cohort, which included all subjects with a study vaccine administration dose documented.

Posted

Count of Participants

Participants

From Day 0 to 31 days post-vaccination.

ID	Title	Description
OG000	Boostrix Group 1	Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix™ in this study.
OG001	Boostrix Group 2	Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix™ in this study.

Units	Counts

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Boostrix Group 1	Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix in this study.	0	37	0	37	30	37
EG001	Boostrix Group 2	Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix in this study.	0	128	0	128	107	128

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Dysmenorrhoea	Reproductive system and breast disorders	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected37 at risk EG0012 events2 affected128 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG00015 events15 affected37 at risk EG00147 events47 affected128 at risk
Fatigue	General disorders	MedDRA 20.1	Systematic Assessment	EG0008 events8 affected37 at risk EG00138 events38 affected128 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected37 at risk EG00111 events11 affected128 at risk
Headache	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG00015 events11 affected37 at risk EG00156 events46 affected128 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected37 at risk EG0011 events1 affected128 at risk
Pain	General disorders	MedDRA 20.1	Systematic Assessment	EG00021 events21 affected37 at risk EG00197 events97 affected128 at risk
Swelling	General disorders	MedDRA 20.1	Systematic Assessment	EG0007 events7 affected37 at risk EG00130 events30 affected128 at risk

ID	Term
D013742	Tetanus
D004165	Diphtheria

Ancestor Terms

ID	Term
D003015	Clostridium Infections
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections
D003354	Corynebacterium Infections
D000193	Actinomycetales Infections

ID	Term
C505143	Boostrix

Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix in this study.

Units	Counts
Participants	OG00037 OG001128