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Primary Vaccination With Either Synflorix™ or Prevenar 13™ or Both Vaccines and Booster Vaccination With Synflorix™

Primary Purpose

Infections, Streptococcal, Streptococcus Pneumoniae Vaccines

Status

Completed

Phase

Phase 3

Locations

Mexico

Study Type

Interventional

Intervention

Synflorix (3-Dose)

Synflorix (2-Dose)

Synflorix (Single Dose)

Prevenar 13 (Single Dose)

Prevenar 13 (2-Dose)

About this trial

This is an interventional prevention trial for Infections, Streptococcal focused on measuring pneumococcal conjugate vaccine, Synflorix, Prevnar 13, Pneumococcal diseases

Eligibility Criteria

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

Inclusion Criteria:

Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol.
A male or female between, and including, 6-12 weeks of age at the time of the first vaccination.
Healthy subjects as established by medical history and clinical examination before entering into the study.
Born after a gestation period of at least 36 weeks.
Written informed consent obtained from the parent(s)/LAR(s) of the subject.

Exclusion Criteria:

Child in care.
Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccines, or planned use during the entire study period.
Chronic administration of immunosuppressants or other immune-modifying drugs since birth or planned use during the study.
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.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
History of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccine.
Major congenital defects or serious chronic illness.
History of any seizures or progressive neurological disease.
Administration of immunoglobulins and/or blood products since birth or planned use during the study.
Acute disease and/or fever at the time of enrolment.
Previous vaccination or planned vaccination during the study with any pneumococcal vaccine.

Sites / Locations

GSK Investigational Site
GSK Investigational Site
GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

Synflorix Group

Prevnar 1 Group

Prevnar 2 Group

Arm Description

Subjects who were primed with two doses of Synflorix vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.

Subjects who were primed with Prevnar 13 and Synflorix vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.

Subjects who were primed with two doses of Prevnar 13 vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.

Outcomes

Primary Outcome Measures

Number of Subjects With Grade 3 Adverse Events (AEs) (Solicited and Unsolicited) - Primary Period

The number of subjects with Grade 3 AEs (solicited and unsolicited), during the 31-day post-vaccination period following each primary dose is reported.

Secondary Outcome Measures

Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Primary Period

Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (>) 30 millimeters (mm). "Any" is defined as incidence of the specified symptom regardless of intensity.

Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Booster Period

Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period

Solicited general symptoms assessed include drowsiness, fever (defined as axillary temperature ≥ 37.5°C), irritability, and loss of appetite. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (axillary temperature) above (>) 39.5 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/preventing normal activity. Grade 3 loss of appetite was defined as the subject not eating at all. "Any" is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination.

Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Booster Period

Number of Subjects Reporting Any and Grade 3 Symptoms (Solicited and Unsolicited) - Booster Period

The number of subjects with any and grade 3 symptoms (solicited and unsolicited), during the 31-day post-booster vaccination period is reported.

Number of Subjects With Unsolicited AEs - Primary Period

An unsolicited AE 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. "Any" is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.

Number of Subjects With Unsolicited AEs - Booster Period

Number of Subjects With Serious Adverse Events (SAEs)

SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Antibody Concentrations Against Pneumococcal Serotypes

Antibodies assessed for this outcome measure were those against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F-inhibition enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL.

Concentrations of Antibodies Against Protein D (Anti-PD)

Anti-PD antibody concentrations were measured by Enzyme-linked Immunosorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The cut-off of the assay was an anti-PD antibody concentration higher than or equal to (≥) 153 EL.U/mL.

Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes

The immunogenicity assessment was based on multiplex opsonophagocytic activity assay (MOPA). Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (OPA-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). The cut-off of the assay was a serotype specific titer for opsonophagocytic activity higher than or equal to (≥) the Lower Limit of Quantification (LLOQ) i.e.: 14 for OPA-1, 11 for OPA-3; 40 for OPA-4; 15 for OPA-5; 45 for OPA-6A; 29 for OPA-6B; 28 for OPA-7F; 39 for OPA-9V; 16 for OPA-14; 40 for OPA-18C; 13 for OPA-19A; 33 for OPA-19F and 40 for OPA-23F.

Full Information

NCT ID

NCT01641133

First Posted

July 12, 2012

Last Updated

February 8, 2021

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT01641133

Brief Title

Primary Vaccination With Either Synflorix™ or Prevenar 13™ or Both Vaccines and Booster Vaccination With Synflorix™

Official Title

Two-dose Primary Vaccination With Either GSK Biologicals' 10-valent Pneumococcal Vaccine (Synflorix™) or Pfizer's Prevenar 13™ or Both Vaccines Followed by a Booster Dose of Synflorix™

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Completed

Study Start Date

September 4, 2012 (Actual)

Primary Completion Date

July 15, 2013 (Actual)

Study Completion Date

May 7, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary

The primary aim of this study is to assess the reactogenicity of Synflorix vaccine and Prevenar 13 vaccine after primary vaccination at 2 and 4 months of age with either Synflorix or Prevenar 13 vaccine or Prevenar 13 and Synflorix, respectively. In addition, this study aims at assessing the safety, reactogenicity, immunogenicity and antibody persistence (approximately 8-11 months following primary vaccination) of the Synflorix vaccine and Prevenar 13 vaccine after primary vaccination at 2 and 4 months of age with either Synflorix or Prevenar 13 vaccine or Prevenar 13 and Synflorix, respectively. This study also aims at assessing the safety, reactogenicity and immunogenicity of the Synflorix vaccine when given as a booster dose at 12-15 months of age following primary vaccination at 2 and 4 months of age with either Synflorix vaccine or Prevenar 13 vaccine or Prevenar 13 and Synflorix respectively.

Detailed Description

This study is partially blinded as the primary phase will be conducted in an observer-blind method and booster phase will be open method.

6. Conditions and Keywords

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

Infections, Streptococcal, Streptococcus Pneumoniae Vaccines

Keywords

pneumococcal conjugate vaccine, Synflorix, Prevnar 13, Pneumococcal diseases

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

457 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Synflorix Group

Arm Type

Active Comparator

Arm Description

Arm Title

Prevnar 1 Group

Arm Type

Experimental

Arm Description

Arm Title

Prevnar 2 Group

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

Synflorix (3-Dose)

Intervention Description

3 doses administered intramuscularly

Intervention Type

Biological

Intervention Name(s)

Synflorix (2-Dose)

Intervention Description

2 doses administered intramuscularly

Intervention Type

Biological

Intervention Name(s)

Synflorix (Single Dose)

Intervention Description

1 dose administered intramuscularly

Intervention Type

Biological

Intervention Name(s)

Prevenar 13 (Single Dose)

Intervention Description

1 dose administered intramuscularly

Intervention Type

Biological

Intervention Name(s)

Prevenar 13 (2-Dose)

Intervention Description

2 doses administered intramuscularly

Primary Outcome Measure Information:

Title

Number of Subjects With Grade 3 Adverse Events (AEs) (Solicited and Unsolicited) - Primary Period

Description

The number of subjects with Grade 3 AEs (solicited and unsolicited), during the 31-day post-vaccination period following each primary dose is reported.

Time Frame

Within 31-day (Day 0-Day 30) after any dose of primary vaccination

Secondary Outcome Measure Information:

Title

Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Primary Period

Description

Time Frame

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

Title

Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Booster Period

Description

Time Frame

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

Title

Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period

Description

Time Frame

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

Title

Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Booster Period

Description

Time Frame

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

Title

Number of Subjects Reporting Any and Grade 3 Symptoms (Solicited and Unsolicited) - Booster Period

Description

The number of subjects with any and grade 3 symptoms (solicited and unsolicited), during the 31-day post-booster vaccination period is reported.

Time Frame

During the 31-day (Days 0-30) post-booster vaccination period

Title

Number of Subjects With Unsolicited AEs - Primary Period

Description

Time Frame

During the 31-day (Days 0-30) post-primary vaccination period

Title

Number of Subjects With Unsolicited AEs - Booster Period

Description

Time Frame

During the 31-day (Days 0-30) post-booster vaccination period

Title

Number of Subjects With Serious Adverse Events (SAEs)

Description

SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Time Frame

From first vaccination (Month 0) up to study end (11-14 months)

Title

Antibody Concentrations Against Pneumococcal Serotypes

Description

Time Frame

At study Month 3 (one month after the primary vaccination), at study Month 10 (prior to booster vaccination) and at study Month 11 (one month after the booster vaccination)

Title

Concentrations of Antibodies Against Protein D (Anti-PD)

Description

Time Frame

At study Month 3 (one month after primary vaccination) and at study Month 11 (one month after booster vaccination)

Title

Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes

Description

Time Frame

At study Month 3 (one month after the primary vaccination), at study Month 10 (prior to booster vaccination) and at study Month 11 (one month after the booster vaccination)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Weeks

Maximum Age & Unit of Time

12 Weeks

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol. A male or female between, and including, 6-12 weeks of age at the time of the first vaccination. Healthy subjects as established by medical history and clinical examination before entering into the study. Born after a gestation period of at least 36 weeks. Written informed consent obtained from the parent(s)/LAR(s) of the subject. Exclusion Criteria: Child in care. Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccines, or planned use during the entire study period. Chronic administration of immunosuppressants or other immune-modifying drugs since birth or planned use during the study. 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. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. History of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccine. Major congenital defects or serious chronic illness. History of any seizures or progressive neurological disease. Administration of immunoglobulins and/or blood products since birth or planned use during the study. Acute disease and/or fever at the time of enrolment. Previous vaccination or planned vaccination during the study with any pneumococcal vaccine.

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

Cuernavaca

State/Province

Morelos

ZIP/Postal Code

62210

Country

Mexico

Facility Name

GSK Investigational Site

City

Monterrey

State/Province

Nuevo León

ZIP/Postal Code

64460

Country

Mexico

Facility Name

GSK Investigational Site

City

Mexico

ZIP/Postal Code

04530

Country

Mexico

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

IPD for this study is available via the Clinical Study Data Request site.

IPD Sharing Time Frame

IPD is available via the Clinical Study Data Request site (copy the URL below to your browser)

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 URL

https://clinicalstudydatarequest.com/Posting.aspx?ID=20769

Citations:

PubMed Identifier

33297773

Citation

de Los Santos AM, Rodriguez-Weber MA, Sanchez-Marquez P, Traskine M, Carreno-Manjarrez R, Cervantes-Apolinar MY, Strezova A, Ruiz-Guinazu J, Ortega-Barria E, Borys D. Can two different pneumococcal conjugate vaccines be used to complete the infant vaccination series? A randomized trial exploring interchangeability of the 13-valent pneumococcal conjugate vaccine and the pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine. Expert Rev Vaccines. 2020 Nov;19(11):995-1010. doi: 10.1080/14760584.2020.1843431.

Results Reference

background

Learn more about this trial

Primary Vaccination With Either Synflorix™ or Prevenar 13™ or Both Vaccines and Booster Vaccination With Synflorix™

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