NCT01641133

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
457

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 2012

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 16, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

September 4, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2013

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 7, 2014

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

February 27, 2017

Completed
Last Updated

March 2, 2021

Status Verified

February 1, 2021

Enrollment Period

10 months

First QC Date

July 12, 2012

Results QC Date

January 9, 2017

Last Update Submit

February 8, 2021

Conditions

Infections, StreptococcalStreptococcus Pneumoniae Vaccines

Keywords

pneumococcal conjugate vaccineSynflorixPrevnar 13Pneumococcal diseases

Outcome Measures

Primary Outcomes (1)

  • 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.

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

Secondary Outcomes (11)

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

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

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

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

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

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

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

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

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

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

  • +6 more secondary outcomes

Study Arms (3)

Synflorix Group

ACTIVE COMPARATOR

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.

Biological: Synflorix (3-Dose)

Prevnar 1 Group

EXPERIMENTAL

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.

Biological: Synflorix (2-Dose)Biological: Prevenar 13 (Single Dose)

Prevnar 2 Group

EXPERIMENTAL

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.

Biological: Synflorix (Single Dose)Biological: Prevenar 13 (2-Dose)

Interventions

Synflorix (3-Dose)BIOLOGICAL

3 doses administered intramuscularly

Synflorix Group
Synflorix (2-Dose)BIOLOGICAL

2 doses administered intramuscularly

Prevnar 1 Group
Synflorix (Single Dose)BIOLOGICAL

1 dose administered intramuscularly

Prevnar 2 Group
Prevenar 13 (Single Dose)BIOLOGICAL

1 dose administered intramuscularly

Prevnar 1 Group
Prevenar 13 (2-Dose)BIOLOGICAL

2 doses administered intramuscularly

Prevnar 2 Group

Eligibility Criteria

Age6 Weeks - 12 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

GSK Investigational Site

Cuernavaca, Morelos, 62210, Mexico

Location

GSK Investigational Site

Monterrey, Nuevo León, 64460, Mexico

Location

GSK Investigational Site

México, 04530, Mexico

Location

Related Publications (1)

  • 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.

    PMID: 33297773BACKGROUND

MeSH Terms

Conditions

Streptococcal InfectionsPneumococcal Infections

Interventions

PHiD-CV vaccine13-valent pneumococcal vaccine

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Results Point of Contact

Title
GSK Response Center
Organization
GlaxoSmithKline
866-435-7343

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2012

First Posted

July 16, 2012

Study Start

September 4, 2012

Primary Completion

July 15, 2013

Study Completion

May 7, 2014

Last Updated

March 2, 2021

Results First Posted

February 27, 2017

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
IPD is available via the Clinical Study Data Request site (copy the URL below to your browser)
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.
More information

Locations

ME(3)