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Prophylactic Antipyretic Treatment in Children Receiving Booster Dose of Pneumococcal Conjugate Vaccine GSK1024850A

Primary Purpose

Infections, Streptococcal

Status

Completed

Phase

Phase 3

Locations

Czechia

Study Type

Interventional

Intervention

Pneumococcal conjugate vaccine GSK1024850A.

Infanrix hexa.

Meningococcal vaccine GSK134612.

Paracetamol.

About this trial

This is an interventional prevention trial for Infections, Streptococcal focused on measuring Streptococcus Pneumoniae Vaccines, Meningococcal disease, Carriage, Prophylactic antipyretic, Safety, Pneumococcal vaccine, Fever, Pneumococcal disease, Immunogenicity, Meningococcal vaccine, Booster vaccination

Eligibility Criteria

12 Months - 15 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
A male or female between, and including, 12-15 months of age at the time of the vaccination.
Written informed consent obtained from the parent or guardian of the subject.
Free of obvious health problems as established by medical history and clinical examination before entering into the study.

Subjects in the unprimed group

• A male or female who previously participated in study 107017 and received 3 doses of pneumococcal conjugate vaccine GSK1024850A.

Exclusion Criteria:

For all subjects:

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
Indication, other than specified in the protocol, for prophylactic antipyretic treatment.
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within one month preceding the dose of study vaccines, or planned use during the entire study period.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the dose of study vaccines.
Planned administration/administration of a vaccine not foreseen by the study protocol, during the period starting one month before the dose of study vaccines and up to one month after the dose of study vaccines.
History of, or intercurrent, diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b disease.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
History of seizures (this criterion does not apply to subjects who have had a single, uncomplicated febrile convulsion in the past) or progressive neurological disease.
Acute disease at the time of enrolment.
Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
A family history of congenital or hereditary immunodeficiency.
Major congenital defects or serious chronic illness.
Administration of immunoglobulins and/or any blood products within three months preceding administration of the dose of study vaccines or planned administration during the study period.
Subjects of which both parents have a history of atopia.
Subject has received systemic antibiotic therapy for acute illness within 24 hours prior to the vaccination.
Subject is likely to receive antipyretic treatment as a result of a concomitant illness or has been treated with paracetamol within the past 24 hours.

DTPa-HBV-IPV/Hib vaccine:

Known hypersensitivity after previous administration of diphtheria, tetanus, pertussis, polio, hepatitis B and Hib vaccines or to any component of the vaccines.
Encephalopathy.
As with other vaccines, administration of DTPa-HBV-IPV/Hib should be postponed in subjects suffering from acute mild, moderate or severe illness.

For subjects in the AP-AP, AP-NAP and NAP groups:

• Administration of any pneumococcal, diphtheria, tetanus, pertussis, polio, hepatitis B and/or Haemophilus influenzae type b vaccines other than allowed and used in study 107017.

For subjects in the AP-AP group:

• Subject with any contraindication to treatment with paracetamol.

For subjects in the unprimed group:

Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C, W-135 and/or Y.
Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroups A, C, W-135 and/or Y.
Planned administration of a hepatitis B vaccine not foreseen by the study protocol during the period starting one month after the dose of study vaccines and up to study end.
Previous vaccination with tetanus toxoid containing vaccines including T, DTP, DT, DTP-IPV, DTP-HBV-IPV and Hib-TT vaccines six months prior to study entry.
History of meningococcal disease due to serogroup A, C, W, or Y.
Administration of any pneumococcal vaccine since birth.
Full vaccination history since birth not available.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Arm Label

Synflorix I Group

Synflorix II Group

Synflorix PRE Group

Synflorix POST Group

Mencevax + Infanrix Hexa Group

Arm Description

Subjects were vaccinated with 3 primary vaccination doses of Synflorix™ vaccine with prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa along with prophylactic antipyretic treatment.

Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment

Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (before the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.

Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (after the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.

Age-matched pneumococcal vaccine unprimed group receiving a single dose of Mencevax™ vaccine co-administered with Infanrix™ hexa vaccine.

Outcomes

Primary Outcome Measures

Number of Subjects Reported With Core Fever (Rectal Temperature) Greater Than or Equal to (≥) the Cut-off

The cut-off for core fever was 38.0 degrees Celsius (ºC).

Secondary Outcome Measures

Number of Subjects Reported With Core Fever (Rectal Temperature) Greater Than (>) the Cut-off

The cut-off value for core fever (rectal temperature) was 39.0ºC.

Number of Subjects Reported With Any and Grade 3 Solicited Local Symptoms.

Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any occurrence of the specified symptom regardless of intensity. Grade 3 pain was defined as cried when limb was moved/spontaneously painful. Grade 3 redness/swelling was defined as redness/swelling > 30 millimeters (mm) from injection site.

Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms

Solicited general symptoms assessed were drowsiness, fever (rectal temperature ≥ 38.5°C), irritability and loss of appetite. Any was defined as any occurrence of the specified symptom regardless of intensity and relation to vaccination. Grade 3 drowsiness was defined as drowsiness that prevented normal activity. Grade 3 fever was defined as rectal temperature >40.0°C. Grade 3 irritability was defined as crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite was defined as not eating at all. Related was defined as solicited symptoms assessed by the investigator as causally related to the study vaccination.

Number of Subjects Reported With Unsolicited Adverse Events (AEs)

The outcome measure was not reporting statistics for all the arms in the baseline period. Results were tabulated on baseline groups except for the Synforix PRE and Synforix POST groups, for which results were presented for the Pooled Synforix PRE and POST Group. 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 and 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 was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

Number of Subjects Reported With Serious Adverse Events (SAEs)

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Number of Subjects Reported With AEs Resulting in Rash, New Onset of Chronic Illness (NOCI), Emergency Room (ER) Visits and Non-routine Physician Office Visits.

Results were tabulated only on Mencevax + Infanrix Hexa Group, according to the outcome measure specification of the protocol.

Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off

Certain pneumococcal serotypes includes pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F). Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA). The seroprotection cut-off for the assay was ≥ 0.2 microgram per milliliter (μg/mL).

Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.

Certain pneumococcal serotypes included pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F). Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA). Seropositivity cut-off for the assay was ≥ 0.05 microgram per milliliter (μg/mL).

Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F

OPA titers against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Opsono-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) were calculated, expressed as geometric mean titers (GMTs) and tabulated. The seropositivity cut-off for the assay was ≥ 8.

Concentrations of Antibodies Against Protein D (Anti-PD)

The seropositivity cut-off for the assay was ≥ 100 Enzyme-Linked ImmunoSorbent Assay (ELISA) units per milliliter (EL.U/mL).

Antibody Concentrations Against Pneumococcal Serotypes 6A and 19A (Anti-6A and 19A)

Anti-6A and 19A antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA).

Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A

OPA titers against pneumococcal serotypes 6A and 19A (Opsono-6A and 19A) were calculated, expressed as geometric mean titers (GMTs) and tabulated. The seropositivity cut-off for the assay was ≥ 8.

Number of Subjects With Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay (rSBA) Titres ≥ the Cut-off Values

The cut-off values assessed were 1:8 and 1:128 for meningococcal polysaccharides A , C, W-135 and Y serum bactericidal antibodies, using baby rabbit complement for assay (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY). Results were only tabulated for subjects who received a vaccine including the respective antigens (Mencevax + Infanrix Hexa Group).

rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers in the Mencevax + Infanrix Hexa Group

Results were only tabulated for subjects who received a vaccine including the respective antigens (Mencevax + Infanrix Hexa Group).

Number of Subjects With Anti-polysaccharide N (Anti-PS) Concentrations ≥ the Cut-off Values

Anti-PS assessed were anti-PS meningitidis serogroup A (anti-PSA), C (anti-PSC), W (anti-PSW-135) and Y (anti-PSY). The cut-offs for anti-PS concentrations were 0.3 μg/mL and 2.0 μg/mL, tabulated for subjects who received a vaccine including the respective antigens (Mencevax + Infanrix Hexa Group).

Geometric Mean Antibody Concentration (GMCs) for Anti-polysaccharide N (Anti-PS) Antibody Concentrations

Anti-PS assessed were Anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY. Results were only tabulated for subjects who received a vaccine including the respective antigens (Mencevax + Infanrix Hexa Group).

Anti-tetanus Toxoids (Anti-T) Antibody Concentrations in the Mencevax + Infanrix Hexa Group

The seroprotection cut-off for the assay was ≥ 0.1 international units per milliliter (IU/mL).

Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations in the Mencevax + Infanrix Hexa Group

The seroprotection cut-off for the assay was ≥ 10 milli international units per milliliter (mIU/mL). Results were only tabulated for subjects who received a vaccine including the respective antigens (Mencevax + Infanrix Hexa Group). Dummy lower limit (LL) (0.0) and upper limit UL (99999.9) were entered when number of subjects analysed = 1.

Concentrations of Antibodies Against Diphtheria and Tetanus Toxoids (Anti-D and T).

The seroprotection cut-off for the assay was ≥ 0.1 international units per milliliter (IU/mL).

Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations

The seropositivity cut-off for the assay was ≥ 5 Enzyme-Linked ImmunoSorbent Assay (ELISA) units per millimiter (EL.U/mL).

Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations

The seroprotection cut-off for the assay was ≥ 10 mIU/mL.

Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations

The seroprotection cut-off for the assay was ≥ 0.15 μg/mL.

Anti-poliovirus (Anti-Polio) Types 1, 2 and 3 Titers

The seroprotection cut-off for the assay was ≥ 8.

Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations

The seroprotection cut-off for the assay was ≥ 10 mIU/mL.

Anti-poliovirus (Anti-Polio) Type 1, 2 and 3 Titers

The seroprotection cut-off for the assay was ≥ 8.

Number of Nasopharyngeal Swabs With S.Pneumoniae (Vaccine Serotypes)

Results were tabulated on Pooled Synflorix Group and on Mencevax + Infanrix Hexa Group.

Number of Nasopharyngeal Swabs With S.Pneumoniae (Cross-reactive Serotypes)

Results were tabulated on Pooled Synflorix Group and on Mencevax + Infanrix Hexa Group.

Number of Nasopharyngeal Swabs With S.Pneumoniae (Non-vaccine and Non-cross-reactive Serotypes)

Results were tabulated on Mencevax + Infanrix Hexa Group and on Pooled Synflorix Group.

Number of Nasopharyngeal Swabs With H. Influenzae

Results were tabulated on Mencevax + Infanrix Hexa Group and on Pooled Synflorix Group.

Number of Nasopharyngeal Swabs With S. Pneumoniae and H. Influenzae

Results were tabulated on Mencevax + Infanrix Hexa Group and on Pooled Synflorix Group.

Number of Subjects With New Acquisition Associated to S. Pneumoniae Detected in Nasopharyngeal Swabs

Results were tabulated on Mencevax + Infanrix Hexa Group and on Pooled Synflorix Group.

Number of Subjects With New Acquisition Associated to H. Influentzae Detected in Nasopharyngeal Swabs.

Results were tabulated on Mencevax + Infanrix Hexa Group and on Pooled Synflorix Group.

Full Information

NCT ID

NCT00496015

First Posted

July 3, 2007

Last Updated

August 7, 2018

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00496015

Brief Title

Prophylactic Antipyretic Treatment in Children Receiving Booster Dose of Pneumococcal Conjugate Vaccine GSK1024850A

Official Title

Prophylactic Antipyretic Treatment in Children Receiving Booster Dose of Pneumococcal Vaccine GSK1024850A and DTPa-HBV-IPV/Hib Vaccine (Infanrix Hexa) and Assessment of Impact of Pneumococcal Vaccination on Nasopharyngeal Carriage

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Completed

Study Start Date

July 2, 2007 (Actual)

Primary Completion Date

March 25, 2008 (Actual)

Study Completion Date

February 17, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary

The purpose of this trial is to assess if the rate of febrile reactions following the co-administration of a booster dose of pneumococcal conjugate vaccines with standard infant vaccines is lowered when paracetamol is given prophylactically and to assess the impact of pneumococcal conjugate vaccine on pneumococcal and H. influenzae nasopharyngeal carriage compared to control group receiving meningococcal conjugate vaccine (GSK134612). This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00370318).

Detailed Description

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

6. Conditions and Keywords

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

Infections, Streptococcal

Keywords

Streptococcus Pneumoniae Vaccines, Meningococcal disease, Carriage, Prophylactic antipyretic, Safety, Pneumococcal vaccine, Fever, Pneumococcal disease, Immunogenicity, Meningococcal vaccine, Booster vaccination

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

750 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Synflorix I Group

Arm Type

Experimental

Arm Description

Arm Title

Synflorix II Group

Arm Type

Experimental

Arm Description

Arm Title

Synflorix PRE Group

Arm Type

Experimental

Arm Description

Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (before the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.

Arm Title

Synflorix POST Group

Arm Type

Experimental

Arm Description

Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (after the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.

Arm Title

Mencevax + Infanrix Hexa Group

Arm Type

Active Comparator

Arm Description

Age-matched pneumococcal vaccine unprimed group receiving a single dose of Mencevax™ vaccine co-administered with Infanrix™ hexa vaccine.

Intervention Type

Biological

Intervention Name(s)

Pneumococcal conjugate vaccine GSK1024850A.

Intervention Description

1 intramuscular injection.

Intervention Type

Biological

Intervention Name(s)

Infanrix hexa.

Other Intervention Name(s)

DTPa-HBV-IPV/Hib

Intervention Description

1 intramuscular injection.

Intervention Type

Biological

Intervention Name(s)

Meningococcal vaccine GSK134612.

Other Intervention Name(s)

Mencevax™

Intervention Description

1 intramuscular injection.

Intervention Type

Drug

Intervention Name(s)

Paracetamol.

Intervention Description

Body weight of < 7 kg: none; Body weight of ≥ 7 kg to < 9 kg : 3 suppositories of 125 mg to be administered at 8h intervals after vaccination. Body weight of ≥ 9 kg: 4 suppositories of 125 mg to be administered at 6h intervals after vaccination.

Primary Outcome Measure Information:

Title

Number of Subjects Reported With Core Fever (Rectal Temperature) Greater Than or Equal to (≥) the Cut-off

Description

The cut-off for core fever was 38.0 degrees Celsius (ºC).

Time Frame

Within 4 days (Day 0-3) after primary vaccine dose.

Secondary Outcome Measure Information:

Title

Number of Subjects Reported With Core Fever (Rectal Temperature) Greater Than (>) the Cut-off

Description

The cut-off value for core fever (rectal temperature) was 39.0ºC.

Time Frame

Within 4 days (Day 0-3) after primary vaccination dose

Title

Number of Subjects Reported With Any and Grade 3 Solicited Local Symptoms.

Description

Time Frame

During the 4-day (Days 0-3) post-primary vaccination period

Title

Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms

Description

Time Frame

During the 4-day (Day 0-3) post-vaccination period

Title

Number of Subjects Reported With Unsolicited Adverse Events (AEs)

Description

Time Frame

Within 31 days (Days 0-30) after primary vaccine dose.

Title

Number of Subjects Reported With Serious Adverse Events (SAEs)

Description

Time Frame

Throughout the entire study period (Month 0-Month 12)

Title

Number of Subjects Reported With AEs Resulting in Rash, New Onset of Chronic Illness (NOCI), Emergency Room (ER) Visits and Non-routine Physician Office Visits.

Description

Results were tabulated only on Mencevax + Infanrix Hexa Group, according to the outcome measure specification of the protocol.

Time Frame

Up to 6 months after vaccination with Mencevax™

Title

Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off

Description

Time Frame

Prior to booster vaccination (PRE), 1 month (M1) and 12 months (M12) post-booster vaccination

Title

Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.

Description

Time Frame

Prior to booster vaccination (PRE), 1 month (M1) and 12 months (M12) post-booster vaccination

Title

Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F

Description

Time Frame

Prior to booster vaccination (PRE), 1 month (M1) and 12 months (M12) post-booster vaccination

Title

Concentrations of Antibodies Against Protein D (Anti-PD)

Description

The seropositivity cut-off for the assay was ≥ 100 Enzyme-Linked ImmunoSorbent Assay (ELISA) units per milliliter (EL.U/mL).

Time Frame

Prior to booster vaccination (PRE), 1 month (M1) and 12 months (M12) post-booster vaccination

Title

Antibody Concentrations Against Pneumococcal Serotypes 6A and 19A (Anti-6A and 19A)

Description

Anti-6A and 19A antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA).

Time Frame

Prior to booster vaccination (PRE), 1 month (M1) and 12 months (M12) post-booster vaccination

Title

Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A

Description

OPA titers against pneumococcal serotypes 6A and 19A (Opsono-6A and 19A) were calculated, expressed as geometric mean titers (GMTs) and tabulated. The seropositivity cut-off for the assay was ≥ 8.

Time Frame

Prior to booster vaccination (PRE), 1 month (M1) and 12 months (M12) post-booster vaccination

Title

Number of Subjects With Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay (rSBA) Titres ≥ the Cut-off Values

Description

Time Frame

Prior to vaccination (PRE), 1 month (M1) and 12 months (M12) post-vaccination

Title

rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers in the Mencevax + Infanrix Hexa Group

Description

Results were only tabulated for subjects who received a vaccine including the respective antigens (Mencevax + Infanrix Hexa Group).

Time Frame

Prior to vaccination(PRE), 1 month (M1) and 12 months (M12) post- vaccination.

Title

Number of Subjects With Anti-polysaccharide N (Anti-PS) Concentrations ≥ the Cut-off Values

Description

Time Frame

Prior to vaccination(PRE), 1 month (M1) and 12 months (M12) post-vaccination

Title

Geometric Mean Antibody Concentration (GMCs) for Anti-polysaccharide N (Anti-PS) Antibody Concentrations

Description

Time Frame

Prior to vaccination(PRE), 1 month (M1) and 12 months (M12) post- vaccination.

Title

Anti-tetanus Toxoids (Anti-T) Antibody Concentrations in the Mencevax + Infanrix Hexa Group

Description

The seroprotection cut-off for the assay was ≥ 0.1 international units per milliliter (IU/mL).

Time Frame

Prior to vaccination (Pre)

Title

Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations in the Mencevax + Infanrix Hexa Group

Description

Time Frame

Prior to vaccination (Pre)

Title

Concentrations of Antibodies Against Diphtheria and Tetanus Toxoids (Anti-D and T).

Description

The seroprotection cut-off for the assay was ≥ 0.1 international units per milliliter (IU/mL).

Time Frame

1 month post-vaccination (M1)

Title

Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations

Description

The seropositivity cut-off for the assay was ≥ 5 Enzyme-Linked ImmunoSorbent Assay (ELISA) units per millimiter (EL.U/mL).

Time Frame

1 month post-vaccination (M1)

Title

Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations

Description

The seroprotection cut-off for the assay was ≥ 10 mIU/mL.

Time Frame

1 month post-vaccination (M1)

Title

Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations

Description

The seroprotection cut-off for the assay was ≥ 0.15 μg/mL.

Time Frame

1 month post-vaccination (M1)

Title

Anti-poliovirus (Anti-Polio) Types 1, 2 and 3 Titers

Description

The seroprotection cut-off for the assay was ≥ 8.

Time Frame

1 month post-vaccination (M1)

Title

Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations

Description

The seroprotection cut-off for the assay was ≥ 10 mIU/mL.

Time Frame

12 month post-vaccination (M12)

Title

Anti-poliovirus (Anti-Polio) Type 1, 2 and 3 Titers

Description

The seroprotection cut-off for the assay was ≥ 8.

Time Frame

12 month post-vaccination (M12)

Title

Number of Nasopharyngeal Swabs With S.Pneumoniae (Vaccine Serotypes)

Description

Results were tabulated on Pooled Synflorix Group and on Mencevax + Infanrix Hexa Group.

Time Frame

Prior to vaccination(Pre), 1 month post-vaccination (M1), 3 months post-vaccination (M3), 7 months post-vaccination (M7), 12 months post-vaccination (M12) and across all time points (Overall)

Title

Number of Nasopharyngeal Swabs With S.Pneumoniae (Cross-reactive Serotypes)

Description

Results were tabulated on Pooled Synflorix Group and on Mencevax + Infanrix Hexa Group.

Time Frame

Prior to vaccination(Pre), 1 month post-vaccination (M1), 3 months post-vaccination (M3), 7 months post-vaccination (M7), 12 months post-vaccination (M12) and across all time points (Overall)

Title

Number of Nasopharyngeal Swabs With S.Pneumoniae (Non-vaccine and Non-cross-reactive Serotypes)

Description

Results were tabulated on Mencevax + Infanrix Hexa Group and on Pooled Synflorix Group.

Time Frame

Prior to vaccination(Pre), 1 month post-vaccination (M1), 3 months post-vaccination (M3), 7 months post-vaccination (M7), 12 months post-vaccination (M12) and across all time points (Overall)

Title

Number of Nasopharyngeal Swabs With H. Influenzae

Description

Results were tabulated on Mencevax + Infanrix Hexa Group and on Pooled Synflorix Group.

Time Frame

Prior to vaccination(Pre), 1 month post-vaccination (M1), 3 months post-vaccination (M3), 7 months post-vaccination (M7), 12 months post-vaccination (M12) and across all time points (Overall)

Title

Number of Nasopharyngeal Swabs With S. Pneumoniae and H. Influenzae

Description

Results were tabulated on Mencevax + Infanrix Hexa Group and on Pooled Synflorix Group.

Time Frame

Prior to vaccination(Pre), 1 month post-vaccination (M1), 3 months post-vaccination (M3), 7 months post-vaccination (M7), 12 months post-vaccination (M12) and across all time points (Overall)

Title

Number of Subjects With New Acquisition Associated to S. Pneumoniae Detected in Nasopharyngeal Swabs

Description

Results were tabulated on Mencevax + Infanrix Hexa Group and on Pooled Synflorix Group.

Time Frame

1 month post-vaccination (M1), 3 months post-vaccination (M3), 7 months post-vaccination (M7), 12 months post-vaccination (M12) and across all time points (Overall)

Title

Number of Subjects With New Acquisition Associated to H. Influentzae Detected in Nasopharyngeal Swabs.

Description

Results were tabulated on Mencevax + Infanrix Hexa Group and on Pooled Synflorix Group.

Time Frame

1 month post-vaccination (M1), 3 months post-vaccination (M3), 7 months post-vaccination (M7), 12 months post-vaccination (M12) and across all time points (Overall)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Months

Maximum Age & Unit of Time

15 Months

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study. A male or female between, and including, 12-15 months of age at the time of the vaccination. Written informed consent obtained from the parent or guardian of the subject. Free of obvious health problems as established by medical history and clinical examination before entering into the study. Subjects in the unprimed group • A male or female who previously participated in study 107017 and received 3 doses of pneumococcal conjugate vaccine GSK1024850A. Exclusion Criteria: For all subjects: 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 Indication, other than specified in the protocol, for prophylactic antipyretic treatment. Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within one month preceding the dose of study vaccines, or planned use during the entire study period. Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the dose of study vaccines. Planned administration/administration of a vaccine not foreseen by the study protocol, during the period starting one month before the dose of study vaccines and up to one month after the dose of study vaccines. History of, or intercurrent, diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b disease. History of allergic disease or reactions likely to be exacerbated by any component of the vaccines. History of seizures (this criterion does not apply to subjects who have had a single, uncomplicated febrile convulsion in the past) or progressive neurological disease. Acute disease at the time of enrolment. Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination. A family history of congenital or hereditary immunodeficiency. Major congenital defects or serious chronic illness. Administration of immunoglobulins and/or any blood products within three months preceding administration of the dose of study vaccines or planned administration during the study period. Subjects of which both parents have a history of atopia. Subject has received systemic antibiotic therapy for acute illness within 24 hours prior to the vaccination. Subject is likely to receive antipyretic treatment as a result of a concomitant illness or has been treated with paracetamol within the past 24 hours. DTPa-HBV-IPV/Hib vaccine: Known hypersensitivity after previous administration of diphtheria, tetanus, pertussis, polio, hepatitis B and Hib vaccines or to any component of the vaccines. Encephalopathy. As with other vaccines, administration of DTPa-HBV-IPV/Hib should be postponed in subjects suffering from acute mild, moderate or severe illness. For subjects in the AP-AP, AP-NAP and NAP groups: • Administration of any pneumococcal, diphtheria, tetanus, pertussis, polio, hepatitis B and/or Haemophilus influenzae type b vaccines other than allowed and used in study 107017. For subjects in the AP-AP group: • Subject with any contraindication to treatment with paracetamol. For subjects in the unprimed group: Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C, W-135 and/or Y. Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroups A, C, W-135 and/or Y. Planned administration of a hepatitis B vaccine not foreseen by the study protocol during the period starting one month after the dose of study vaccines and up to study end. Previous vaccination with tetanus toxoid containing vaccines including T, DTP, DT, DTP-IPV, DTP-HBV-IPV and Hib-TT vaccines six months prior to study entry. History of meningococcal disease due to serogroup A, C, W, or Y. Administration of any pneumococcal vaccine since birth. Full vaccination history since birth not available.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Brno

ZIP/Postal Code

628 00

Country

Czechia

Facility Name

GSK Investigational Site

City

Hradec Kralove

ZIP/Postal Code

500 01

Country

Czechia

Facility Name

GSK Investigational Site

City

Jindrichuv Hradec

ZIP/Postal Code

377 01

Country

Czechia

Facility Name

GSK Investigational Site

City

Nachod

ZIP/Postal Code

547 01

Country

Czechia

Facility Name

GSK Investigational Site

City

Ostrava

ZIP/Postal Code

728 92

Country

Czechia

Facility Name

GSK Investigational Site

City

Pardubice

ZIP/Postal Code

532 03

Country

Czechia

Facility Name

GSK Investigational Site

City

Praha 5

ZIP/Postal Code

150 00

Country

Czechia

Facility Name

GSK Investigational Site

City

Praha 6

ZIP/Postal Code

1600

Country

Czechia

Facility Name

GSK Investigational Site

City

Praha 9

ZIP/Postal Code

190 00

Country

Czechia

Facility Name

GSK Investigational Site

City

Znojmo

ZIP/Postal Code

669 00

Country

Czechia

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Citations:

PubMed Identifier

19837254

Citation

Prymula R, Siegrist CA, Chlibek R, Zemlickova H, Vackova M, Smetana J, Lommel P, Kaliskova E, Borys D, Schuerman L. Effect of prophylactic paracetamol administration at time of vaccination on febrile reactions and antibody responses in children: two open-label, randomised controlled trials. Lancet. 2009 Oct 17;374(9698):1339-50. doi: 10.1016/S0140-6736(09)61208-3.

Results Reference

background

PubMed Identifier

21215830

Citation

Prymula R, Hanovcova I, Splino M, Kriz P, Motlova J, Lebedova V, Lommel P, Kaliskova E, Pascal T, Borys D, Schuerman L. Impact of the 10-valent pneumococcal non-typeable Haemophilus influenzae Protein D conjugate vaccine (PHiD-CV) on bacterial nasopharyngeal carriage. Vaccine. 2011 Feb 24;29(10):1959-67. doi: 10.1016/j.vaccine.2010.12.086. Epub 2011 Jan 6.

Results Reference

background

Citation

Prymula R et al. Does prophylactic paracetamol influence the effect of 10-valent pneumococcal non-typeable Haemophilus influenzae protein-D conjugate vaccine (PHiD-CV) on pneumococcal nasopharyngeal carriage? Abstract presented at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14-18 March 2010.

Results Reference

background

Citation

Prymula R et al. Effects on serotype 6A and 6B nasopharyngeal carriage following immunization with 10-valent pneumococcal non-typeable Haemophilus influenzae protein-D conjugate vaccine. Abstract presented at the 28th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID). Nice, France, 4-8 May 2010.

Results Reference

background

Citation

Prymula R et al. Limited clinical benefit but reduced antibody responses to paediatric vaccines following prophylactic paracetamol administration. Abstract presented at the 4th Europaediatrics, Moscow, Russia, 03-06 July 2009.

Results Reference

background

Citation

Prymula R et al. The 10-valent pneumococcal vaccine conjugated to protein-D (PHiD-CV) reduces nasopharyngeal carriage of Streptococcus pneumoniae (SP) vaccine serotypes in Czech children. Abstract presented at the 6th World Congress of the World Society for Pediatric Infectious Diseases (WSPID). Buenos Aires, Argentina, 19-22 November 2009.

Results Reference

background

Links:

URL

https://www.clinicalstudydatarequest.com

Description

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Available IPD and Supporting Information:

Available IPD/Information Type

Individual Participant Data Set

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

107137

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Statistical Analysis Plan

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

107137

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Dataset Specification

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

107137

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Study Protocol

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

107137

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Informed Consent Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

107137

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Annotated Case Report Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

107137

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Clinical Study Report

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

107137

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

Prophylactic Antipyretic Treatment in Children Receiving Booster Dose of Pneumococcal Conjugate Vaccine GSK1024850A

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Prophylactic Antipyretic Treatment in Children Receiving Booster Dose of Pneumococcal Conjugate Vaccine GSK1024850A

Infections, Streptococcal

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial