Back to results

Assess Reacto- and Immunogenicity of Pneumococcal Conjugate Vaccine When Given as Booster or a 2 Dose Catch up Schedule

Primary Purpose

Infections, Streptococcal

Status

Completed

Phase

Phase 2

Locations

Chile

Study Type

Interventional

Intervention

Synflorix

Infanrix Hexa

Havrix

About this trial

This is an interventional prevention trial for Infections, Streptococcal focused on measuring Immunogenicity, Pneumococcal disease, Safety, Booster vaccination, Pneumococcal vaccine

Eligibility Criteria

18 Months - 21 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Male or female between, and including, 18-21 months of age at the time of vaccination.
Subjects who previously participated in the primary study and received 3 doses of study or control vaccines during the primary study.
Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
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.

Exclusion Criteria:

Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the booster doses of study vaccines, or planned use during the study period (active phase and extended safety follow-up).
Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month (30 days) before the booster doses of vaccine(s) and during the active phase of the study (up to the follow-up visit (Visit 3)).
History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
History of seizures (subjects who have had a single, uncomplicated febrile convulsion in the past can be included) or progressive neurological disease.
Acute disease at the time of enrolment.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the booster doses of study vaccines.
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 the last 3 months prior to booster or follow-up vaccination or planned administration during the active phase of the study.

Sites / Locations

GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Synflorix Booster Group

Synflorix Catch-up Group

Arm Description

Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).

Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).

Outcomes

Primary Outcome Measures

Number of Subjects Reporting Grade 3 Symptoms (Solicited and Unsolicited)

Grade 3 symptoms are symptoms which prevent normal, everyday activities (e.g. in a young child such symptom would prevent attendance at school/ kindergarten/ a day-care center and would cause the parents/guardians to seek medical advice).

Secondary Outcome Measures

Number of Subjects Reporting Solicited Local Symptoms

Solicited local symptoms assessed include pain, redness and swelling.

Number of Subjects Reporting Solicited General Symptoms

Solicited general symptoms assessed include drowsiness, fever, irritability and loss of appetite. Fever was defined as rectal temperature ≥ 38 degrees Celsius.

Number of Subjects Reporting Unsolicited Adverse Events

An Adverse Event is 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.

Number of Subjects Reporting Serious Adverse Events During the Active Phase of the Study

A serious adverse event (SAE) is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.

Number of Subjects Reporting Serious Adverse Events Throughout the Entire Study Period

An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.

Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value

Anti-pneumococcal antibody cut-off value assessed was 0.20 microgram per milliliter (μg/mL). The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F.

Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value

Cut-off value for opsonophagocytic activity against pneumococcal antibody assessed was ≥ 8 The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F.

Number of Subjects With Anti-protein D Antibody Concentrations Above the Cut-off Value

Anti-protein D antibody cut-off value assessed was ≥ 100 Enzyme-Linked Immuno Sorbent Assay (ELISA) unit per milliliter (EL.U/mL).

Anti-hepatitis A Virus Antibodies Concentration

Concentration of anti-hepatitis A antibodies given as geometric mean concentration (GMC) in milli-international units per milliliter (mIU/mL).

Number of Subjects With Anti-hepatitis A Antibody Concentrations Above the Cut-off Value

Anti-hepatitis A antibodies cut-off value assessed was ≥ 15 mIU/mL.

Full Information

NCT ID

NCT00513409

First Posted

August 7, 2007

Last Updated

June 8, 2018

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00513409

Brief Title

Assess Reacto- and Immunogenicity of Pneumococcal Conjugate Vaccine When Given as Booster or a 2 Dose Catch up Schedule

Official Title

Phase II, Observer-blind Follow-up Study to Assess reacto-and Immunogenicity of GSK Biologicals' Pneumococcal Conjugate Vaccine (GSK1024850A), When Given as Booster in Primed Children or as 2-dose Catch-up in Unprimed Children.

Study Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Completed

Study Start Date

August 22, 2007 (undefined)

Primary Completion Date

February 20, 2008 (Actual)

Study Completion Date

August 28, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary

This is a booster study in 2 groups of healthy children less than 3 years old to measure the reactogenicity, safety and immunogenicity of GSK Biologicals' pneumococcal conjugate vaccine, when given as a booster or as a two-dose catch-up vaccination. This protocol posting deals with objectives and outcome measures of the booster phase. The objectives and outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00338351).

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

Immunogenicity, Pneumococcal disease, Safety, Booster vaccination, Pneumococcal vaccine

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Care ProviderInvestigator

Allocation

Non-Randomized

Enrollment

163 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Synflorix Booster Group

Arm Type

Experimental

Arm Description

Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).

Arm Title

Synflorix Catch-up Group

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

Synflorix

Intervention Description

Intramuscular injection, 1 or 2 doses

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)

Havrix

Intervention Description

1 Intramuscular injection

Primary Outcome Measure Information:

Title

Number of Subjects Reporting Grade 3 Symptoms (Solicited and Unsolicited)

Description

Time Frame

Within 4 days after the administration of any study vaccine dose

Secondary Outcome Measure Information:

Title

Number of Subjects Reporting Solicited Local Symptoms

Description

Solicited local symptoms assessed include pain, redness and swelling.

Time Frame

Within 4 days after the administration of any study vaccine dose

Title

Number of Subjects Reporting Solicited General Symptoms

Description

Solicited general symptoms assessed include drowsiness, fever, irritability and loss of appetite. Fever was defined as rectal temperature ≥ 38 degrees Celsius.

Time Frame

Within 4 days after the administration of any study vaccine dose

Title

Number of Subjects Reporting Unsolicited Adverse Events

Description

Time Frame

Within 31 days after the administration of any study vaccine dose

Title

Number of Subjects Reporting Serious Adverse Events During the Active Phase of the Study

Description

Time Frame

Throughout the active phase of the study ( from the beginning of the booster phase up to 1 month after the second booster dose)

Title

Number of Subjects Reporting Serious Adverse Events Throughout the Entire Study Period

Description

Time Frame

Throughout the entire study period (from the beginning of the booster phase up to the end of the 6-month extended safety follow-up)

Title

Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value

Description

Anti-pneumococcal antibody cut-off value assessed was 0.20 microgram per milliliter (μg/mL). The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F.

Time Frame

Before (pre) and one month after (post) the administration of Dose 2

Title

Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value

Description

Cut-off value for opsonophagocytic activity against pneumococcal antibody assessed was ≥ 8 The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F.

Time Frame

Before (pre) and one month after (post) the administration of Dose 2

Title

Number of Subjects With Anti-protein D Antibody Concentrations Above the Cut-off Value

Description

Anti-protein D antibody cut-off value assessed was ≥ 100 Enzyme-Linked Immuno Sorbent Assay (ELISA) unit per milliliter (EL.U/mL).

Time Frame

Before (pre) and one month after (post) the administration of Dose 2

Title

Anti-hepatitis A Virus Antibodies Concentration

Description

Concentration of anti-hepatitis A antibodies given as geometric mean concentration (GMC) in milli-international units per milliliter (mIU/mL).

Time Frame

Before (pre) and one month after (post) the administration of Dose 2

Title

Number of Subjects With Anti-hepatitis A Antibody Concentrations Above the Cut-off Value

Description

Anti-hepatitis A antibodies cut-off value assessed was ≥ 15 mIU/mL.

Time Frame

Before (pre) and one month after (post) the administration of Dose 2

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Months

Maximum Age & Unit of Time

21 Months

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female between, and including, 18-21 months of age at the time of vaccination. Subjects who previously participated in the primary study and received 3 doses of study or control vaccines during the primary study. Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol. 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. Exclusion Criteria: Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the booster doses of study vaccines, or planned use during the study period (active phase and extended safety follow-up). Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month (30 days) before the booster doses of vaccine(s) and during the active phase of the study (up to the follow-up visit (Visit 3)). History of allergic disease or reactions likely to be exacerbated by any component of the vaccines. History of seizures (subjects who have had a single, uncomplicated febrile convulsion in the past can be included) or progressive neurological disease. Acute disease at the time of enrolment. Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the booster doses of study vaccines. 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 the last 3 months prior to booster or follow-up vaccination or planned administration during the active phase of the study.

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

Santiago

State/Province

Región Metro De Santiago

Country

Chile

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

21441782

Citation

Lagos RE, Munoz AE, Levine MM, Lepetic A, Francois N, Yarzabal JP, Schuerman L. Safety and immunogenicity of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Chilean children. Hum Vaccin. 2011 May;7(5):511-22. doi: 10.4161/hv.7.5.14634. Epub 2011 May 1.

Results Reference

background

Citation

Lagos R et al. 10-valent pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV) given as booster dose or 2-dose catch-up in Chilean children. Abstract presented at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14-18 March 2010.

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

110031

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

110031

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

110031

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

110031

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

110031

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

110031

Available IPD/Information Comments

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

Learn more about this trial

Assess Reacto- and Immunogenicity of Pneumococcal Conjugate Vaccine When Given as Booster or a 2 Dose Catch up Schedule

We'll reach out to this number within 24 hrs