Safety and Immunogenicity of a Booster Dose of New Formulations of GlaxoSmithKline Biologicals' DTPa-HBV-IPV/Hib Vaccine (GSK217744)

July 3, 2020 updated by: GlaxoSmithKline
The purpose of this study is to assess the immunogenicity, safety and reactogenicity of the booster vaccine dose of 2 new formulations of DTPa-HBV-IPV/Hib administered between 12 and 15 months of age, and the immune persistence following the primary series. All children in this booster study received a primary vaccination at 2, 3 and 4 months of age in study 113948 (NCT01248884). No new subjects will be enrolled in this booster study.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
657

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Dominican Republic
      • Santo Domingo, Dominican Republic
        • GSK Investigational Site
      • Santo Domingo, Distrito Nacional, Dominican Republic
        • GSK Investigational Site
  • Finland
      • Espoo, Finland, 02100
        • GSK Investigational Site
      • Helsinki, Finland, 00100
        • GSK Investigational Site
      • Helsinki, Finland, 00930
        • GSK Investigational Site
      • Jarvenpaa, Finland, 04400
        • GSK Investigational Site
      • Kokkola, Finland, 67100
        • GSK Investigational Site
      • Kuopio, Finland, 70210
        • GSK Investigational Site
      • Lahti, Finland, 15140
        • GSK Investigational Site
      • Oulu, Finland, 90220
        • GSK Investigational Site
      • Pori, Finland, 28100
        • GSK Investigational Site
      • Seinajoki, Finland, 60100
        • GSK Investigational Site
      • Tampere, Finland, 33100
        • GSK Investigational Site
      • Turku, Finland, 20520
        • GSK Investigational Site
      • Vantaa, Finland, 01300
        • GSK Investigational Site
      • Vantaa, Finland, 01600
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 years to 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects who participated in the study 113948 (NCT01248884) and received three doses of the new or licensed DTPa-HBV-IPV/Hib study vaccine.
  • A male or female child between, and including, 12 and 15 months of age at the time of the booster vaccination.
  • Subjects who the investigator believes that parent(s)/ Legally Acceptable Representative(s) (LAR(s)) can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visit).
  • Written informed consent obtained from the parent(s)/LAR(s) of the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

  • Child in care.
  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the booster dose of study vaccine, or planned use during the study period.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster dose.
  • Administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during the study period.
  • Participation in another clinical study within three months prior to enrolment in the present booster study or at any time during the present booster study, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
  • Evidence of previous or intercurrent diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Hib vaccination or disease since the conclusion visit of study 113948 (NCT01248884).
  • Serious chronic illness.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
  • History of any neurological disorders or seizures.
  • 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.

  • Occurrence of any of the following events following previous administration of the study vaccine constitutes an absolute contraindication to further dosing.

    • Anaphylactic or other hypersensitivity reaction.
    • Encephalopathy defined as an acute, severe central nervous system disorder occurring within 7 days following vaccination and generally consisting of major alterations in consciousness, unresponsiveness, generalized or focal seizures that persist more than a few hours, with failure to recover within 24 hours.
    • Temperature of ≥ 40.0°C (axillary) or 40.5°C (rectal) within 48 hours of vaccination, not due to another identifiable cause.
    • Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours of vaccination.
    • Persistent, inconsolable crying occurring within 48 hours of vaccination and lasting ≥ 3 hours.
    • Seizures with or without fever occurring within 3 days of vaccination.

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:

• Acute disease and/or fever at the time of enrolment.

  • Fever is defined as temperature ≥ 37.5°C on oral, axillary or tympanic setting, or ≥ 38.0° on rectal setting.
  • Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: GSK217744 Group 1
Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Biological: Infanrix hexa
Single dose, licensed formulation, intramuscular into right thigh
Other Names:
  • DTPa-HBV-IPV/Hib
Biological: Prevenar 13
Single co-administered dose, intramuscular into left thigh
Other Names:
  • Pfizer's 13-valent pneumococcal polysaccharide conjugate vaccine
Biological: GSK217744
Single dose, investigational formulation A or B, intramuscular into right thigh
Experimental: GSK217744 Group 2
Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Biological: Infanrix hexa
Single dose, licensed formulation, intramuscular into right thigh
Other Names:
  • DTPa-HBV-IPV/Hib
Biological: Prevenar 13
Single co-administered dose, intramuscular into left thigh
Other Names:
  • Pfizer's 13-valent pneumococcal polysaccharide conjugate vaccine
Biological: GSK217744
Single dose, investigational formulation A or B, intramuscular into right thigh
Active Comparator: Infanrix hexa Group
Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Biological: Infanrix hexa
Single dose, licensed formulation, intramuscular into right thigh
Other Names:
  • DTPa-HBV-IPV/Hib
Biological: Prevenar 13
Single co-administered dose, intramuscular into left thigh
Other Names:
  • Pfizer's 13-valent pneumococcal polysaccharide conjugate vaccine

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies
Time Frame: 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).
1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
Number of Seroprotected Subjects for Anti-D and Anti-T Antibodies
Time Frame: 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).
1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
Number of Seroprotected Subjects Against Anti-Hepatitis B (Anti-HBs) Antigens
Time Frame: 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
A seroprotected subject was a subject whose antibody concentration was greater than or equal to the level defining clinical protection of 10 milli-international units per millilitre (mIU/mL).
1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
Number of Seroprotected Subjects Against Anti-HBs Antigens
Time Frame: 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
A seroprotected subject was a subject whose antibody concentration was greater than or equal to the level defining clinical protection of 10 milli-international units per millilitre (mIU/mL).
1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3
Time Frame: 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
A seroprotected subject was a subject whose antibody titre was greater than or equal to the level defining clinical protection of 8.
1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
Number of Seroprotected Subjects for Anti-poliovirus Type 1, 2 and 3
Time Frame: 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
A seroprotected subject was a subject whose antibody titre was greater than or equal to the level defining clinical protection of 8.
1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
Number of Seroprotected Subjects for Anti-polyribosyl-ribitol Phosphate (Anti-PRP)
Time Frame: 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).
1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
Number of Seroprotected Subjects for Anti-PRP
Time Frame: 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).
1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
Concentrations for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN)
Time Frame: 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
Concentrations were expressed as geometric mean concentrations (GMCs). Seropositivity cut-off assay was 5 EL.U/mL.
1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
Concentrations for Anti-PT, Anti-FHA and Anti-PRN
Time Frame: 1 month post booster vaccination (subjects enrolled after protocol amendment 2)
Concentrations were expressed as geometric mean concentrations (GMCs). Seropositivity cut-off assay was 5 EL.U/mL.
1 month post booster vaccination (subjects enrolled after protocol amendment 2)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Concentrations for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies
Time Frame: Before (PRE) and 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL.
Before (PRE) and 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
Concentrations for Anti-D and Anti-T Antibodies
Time Frame: Before (PRE) 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL.
Before (PRE) 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies
Time Frame: Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)
A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).
Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)
Number of Seroprotected Subjects for Anti-D and Anti-T Antibodies
Time Frame: Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)
A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).
Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)
Concentrations for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN)
Time Frame: Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)
Concentrations were expressed as geometric mean concentrations (GMCs). Seropositivity cut-off assay was 5 EL.U/mL.
Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)
Concentrations for Anti-PT, Anti-FHA and Anti-PRN
Time Frame: Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)
Concentrations were expressed as geometric mean concentrations (GMCs). Seropositivity cut-off assay was 5 EL.U/mL.
Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)
Number of Seropositive Subjects for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN)
Time Frame: 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the assay cut-off of 5 ELISA units per milliliter (EL.U/mL).
1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
Number of Seropositive Subjects for Anti-PT, Anti-FHA, Anti-PRN
Time Frame: 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the assay cut-off of 5 ELISA units per milliliter (EL.U/mL).
1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
Anti-Hepatitis B (Anti-HBs) Antibody Concentrations
Time Frame: 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2))
Concentrations were expressed as geometric mean concentrations (GMCs). Seroprotection cut-off assay was 10 mIU/mL.
1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2))
Anti-HBs Antibody Concentrations
Time Frame: 1 month post booster vaccination (POST) ( subjects enrolled after protocol amendment 2)
Concentrations were expressed as geometric mean concentrations (GMCs). Seroprotection cut-off assay was 10 mIU/mL.
1 month post booster vaccination (POST) ( subjects enrolled after protocol amendment 2)
Anti-Hepatitis B (Anti-HBs) Antibody Concentration
Time Frame: Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)
Concentrations were expressed as geometric mean concentrations (GMCs). Seroprotection cut-off assay was 10 mIU/mL.
Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)
Anti-HBs Antibody Concentrations
Time Frame: Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)
Concentrations were expressed as geometric mean concentrations (GMCs). Seroprotection cut-off assay was 10 mIU/mL.
Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)
Number of Seroprotected Subjects Against Anti-Hepatitis B (Anti-HBs) Antigens
Time Frame: Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)
A seroprotected subject was a subject whose antibody concentration was greater than or equal to the level defining clinical protection of 10 milli-international units per millilitre (mIU/mL).
Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)
Number of Seroprotected Subjects Against Anti-HBs Antigens
Time Frame: Before (PRE) booaster vaccination (subjects enrolled after protocol amendment 2)
A seroprotected subject was a subject whose antibody concentration was greater than or equal to the level defining clinical protection of 10 milli-international units per millilitre (mIU/mL).
Before (PRE) booaster vaccination (subjects enrolled after protocol amendment 2)
Concentrations for Anti-poliovirus Types 1, 2, 3
Time Frame: Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)
Concentrations were expressed as geometric mean titers (GMTs). The seroprotection cut-off of the assay was 8.
Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)
Concentration for Anti-poliovirus Types 1, 2, 3
Time Frame: 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
Concentrations were expressed as geometric mean titers (GMTs). The seroprotection cut-off of the assay was 8.
1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
Concentrations for Anti-poliovirus Types 1, 2 and 3
Time Frame: 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
Concentrations were expressed as geometric mean titers (GMTs). The seroprotection cut-off of the assay was 8.
1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
Concentration for Anti-poliovirus Type 1, 2 and 3
Time Frame: Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)
Concentrations were expressed as geometric mean titers (GMTs). The seroprotection cut-off of the assay was 8.
Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)
Number of Seroprotected Subjects for Anti-poliovirus Type 1, 2 and 3
Time Frame: Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)
A seroprotected subject was a subject whose antibody titre was greater than or equal to the level defining clinical protection of 8.
Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)
Number of Seroprotected Subjects Against Anti-Poliovirus Type 1, 2 and 3
Time Frame: Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)
A seroprotected subject was a subject whose antibody titre was greater than or equal to the level defining clinical protection of 8.
Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)
Concentrations for Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibodies
Time Frame: 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.15 µg /mL.
1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
Concentrations for Anti-PRP Antibodies
Time Frame: 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.15 µg /mL.
1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
Concentrations for Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibodies
Time Frame: Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.15 µg /mL.
Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)
Concentrations for Anti-polyribosyl-ribitol Phosphate Antibodies
Time Frame: Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2))
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.15 µg /mL.
Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2))
Number of Seropositive Subjects for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN)
Time Frame: Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)
A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the assay cut-off of 5 ELISA units per milliliter (EL.U/mL).
Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)
Number of Seropositive Subjects for Anti-PT, Anti-FHA, Anti-PRN
Time Frame: Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)
A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the assay cut-off of 5 ELISA units per milliliter (EL.U/mL).
Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)
Number of Seroprotected Subjects for Anti-polyribosyl-ribitol Phosphate (Anti-PRP)
Time Frame: Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)
A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).
Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)
Number of Seroprotected Subjects for Anti-PRP
Time Frame: Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)
A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).
Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)
Concentrations for Anti-pneumococcal (Anti-PNE) Antibodies
Time Frame: 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 0.15 µg /mL. The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.
1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
Concentrations for Anti-PNE Antibodies
Time Frame: 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 0.15 µg /mL. The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.
1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes
Time Frame: 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
A seropositive subject was defined as a vaccinated subject who had anti- pneumococcal antibody concentrations ≥ 0.15 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.
1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
Number of Seropositive Subjects for Anti-PNE Serotypes
Time Frame: 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
A seropositive subject was defined as a vaccinated subject who had anti- pneumococcal antibody concentrations ≥ 0.15 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.
1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
Number of Subjects With Booster Response to Anti-pertussis Antigens (Anti-PT, Anti-FHA and Anti-PRN)
Time Frame: 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
Booster response defined as : - For initially seronegative subjects, antibody concentration ≥ 5 EL.U/mL one month after booster vaccination - For initially seropositive subjects, antibody concentration at Post-booster ≥ 2 fold the pre-vaccination antibody concentration
1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
Number of Subjects With Booster Response to Anti-pertussis Antigens
Time Frame: 1 month poste booster vaccination (POST) (subjects enrolled after protocol amendment 2)
Booster response defined as : - For initially seronegative subjects, antibody concentration ≥ 5 EL.U/mL one month after booster vaccination - For initially seropositive subjects, antibody concentration at Post-booster ≥ 2 fold the pre-vaccination antibody concentration
1 month poste booster vaccination (POST) (subjects enrolled after protocol amendment 2)
Number of Subjects Reporting Any Solicited Local Symptoms
Time Frame: During the 4-day (Days 0-3) post-vaccination period. (subjects enrolled before protocol amendment 2)
Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.
During the 4-day (Days 0-3) post-vaccination period. (subjects enrolled before protocol amendment 2)
Number of Subjects Reporting Any Solicited Local Symptom
Time Frame: During the 4-day (Days 0-3) post-vaccination period. (subjects enrolled after protocol amendment 2)
Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.
During the 4-day (Days 0-3) post-vaccination period. (subjects enrolled after protocol amendment 2)
Number of Subjects Reporting Any Solicited General Symptoms
Time Frame: During the 4-day (Days 0-3) post-vaccination period. (subjects enrolled before protocol amendment 2)
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.
During the 4-day (Days 0-3) post-vaccination period. (subjects enrolled before protocol amendment 2)
Number of Subjects Reporting Any Solicited General Symptom
Time Frame: During the 4-day (Days 0-3) post-vaccination period. (subjects enrolled after protocol amendment 2)
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.
During the 4-day (Days 0-3) post-vaccination period. (subjects enrolled after protocol amendment 2)
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)
Time Frame: Within the 31-day (Days 0-30) follow up period after vaccination. (subjects enrolled before protocol amendment 2)
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.
Within the 31-day (Days 0-30) follow up period after vaccination. (subjects enrolled before protocol amendment 2)
Number of Subjects Reporting Any Unsolicited AEs
Time Frame: Within the 31-day (Days 0-30) follow up period after vaccination. (subjects enrolled after protocol amendment 2)
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.
Within the 31-day (Days 0-30) follow up period after vaccination. (subjects enrolled after protocol amendment 2)
Number of Subjects Reporting Any Serious Adverse Events (SAEs)
Time Frame: During the entire study period (Days 0-30). (subjects enrolled before protocol amendment 2)
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.
During the entire study period (Days 0-30). (subjects enrolled before protocol amendment 2)
Number of Subjects Reporting Any SAEs
Time Frame: During the entire study period (Days 0-30). (subjects enrolled after protocol amendment 2)
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.
During the entire study period (Days 0-30). (subjects enrolled after protocol amendment 2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 14, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 12, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 12, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 6, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 18, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 17, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 3, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 114843
  • 2011-000876-33 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

IPD is available via the Clinical Study Data Request site (click on the link provided below)

IPD Sharing Time Frame

IPD is available via the Clinical Study Data Request site (click on the link provided below)

IPD Sharing Access Criteria

Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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