Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' Pneumococcal Vaccine 2830930A Administered in Toddlers

NCT01485406 | Completed Phase 1

• 2 other identifiers: 1153732011-002225-22
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to assess the safety, reactogenicity and immunogenicity of the GSK Biologicals' pneumococcal vaccine 2830930A in toddlers aged 12 to 23 months at study entry.

Conditions

Infections, Streptococcal

Keywords

Haemophilus influenzae; Safety; Pneumococcal vaccine; Streptococcus pneumoniae; Immunogenicity; Toddlers

Outcome Measures

Primary Outcomes (3)

• Occurrence of each grade 3 solicited adverse event with relationship to vaccination

  Within 7 days (Day 0-Day 6) after vaccination

• Occurrence of grade 3 unsolicited adverse events with relationship to vaccination

  Within 31 days (Day 0-Day 30) after vaccination

• Occurrence of serious adverse events with relationship to vaccination

  During the entire study (from Month 0 up to Month 1)

Secondary Outcomes (4)

• Occurrence of each solicited adverse event

  Within 7 days (Day 0-Day 6) after vaccination

• Occurrence of each unsolicited adverse event

  Within 31 days (Day 0-Day 30) after vaccination

• Occurrence of serious adverse event

  During the entire study (from Month 0 up to Month 1)

• Evaluation of the immune responses to the components of the 2830930A vaccine

  One month post-vaccination

Study Arms (2)

Pn Group

EXPERIMENTAL

Toddlers 12-23 months of age receiving GSK2830930A vaccine.

Biological: Pneumococcal vaccine GSK2830930A

Control Group

ACTIVE COMPARATOR

Toddlers 12-23 months of age receiving Synflorix.

Biological: Synflorix™

Interventions

Pneumococcal vaccine GSK2830930A BIOLOGICAL

1 dose administered intramuscularly

Pn Group

Synflorix™ BIOLOGICAL

1 dose administered intramuscularly

Control Group

Eligibility Criteria

• Age: 12 Months - 23 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LARs) can and will comply with the requirements of the protocol.
• A male or female between, and including 12 to 23 months of age at the time of vaccination.
• Written informed consent obtained from the parents/LAR(s) of the subject.
• 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.
• Previously completed three-dose vaccination course with Synflorix.

You may not qualify if:

• Child in care.
• Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
• Planned administration/administration of a vaccine containing diphtheria- or tetanus- toxoid or CRM197 and not foreseen by the study protocol during any time of the study period, or of any other vaccines not foreseen by the protocol in the period starting from 30 days before the vaccine dose and ending 30 days after, with the exception of licensed influenza vaccines.
• The licensed influenza vaccines are always allowed, even if concomitantly administered with the study vaccines but should be documented in the "Concomitant vaccination" of the electronic Case Report Form.
• 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
• Family history of congenital or hereditary immunodeficiency.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
• Major congenital defects or serious chronic illness, including Kawasaki's syndrome.
• History of any neurological disorders or seizures, including conditions such as hypotensive-hyporesponsive episodes, encephalopathy and any convulsions (afebrile and febrile).
• Acute disease and/or fever at the time of enrolment.
• Administration of immunoglobulins and/or any blood products within the 3 months preceding vaccination or planned administration during study period.
• Any medical condition which might interfere with the assessment of the study objectives in the opinion of the investigator.
• Previous receipt of a booster dose (fourth dose) of Synflorix.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (4)

GSK Investigational Site

Kehl, Baden-Wurttemberg, 77694, Germany

Location

GSK Investigational Site

Berchtesgaden, Bavaria, 83471, Germany

Location

GSK Investigational Site

Braunatal, Hesse, 34225, Germany

Location

GSK Investigational Site

Berlin, 13055, Germany

Location

Related Publications (1)

• Horn M, Behre U, Traskine M, Dobbelaere K, Borys D. Safety, reactogenicity, and immunogenicity of a 12-valent pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine in healthy toddlers: results from a phase I, randomized trial. Hum Vaccin Immunother. 2021 May 4;17(5):1463-1469. doi: 10.1080/21645515.2020.1810493. Epub 2020 Nov 11.

  PMID: 33175600 BACKGROUND

Related Links

• Results for study 115373 can be found on the GSK Clinical Study Register

MeSH Terms

Conditions

Streptococcal Infections; Haemophilus Infections

Interventions

PHiD-CV vaccine

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Pasteurellaceae Infections; Gram-Negative Bacterial Infections

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2011
• First Posted: December 5, 2011
• Study Start: December 12, 2011
• Primary Completion: March 15, 2012
• Study Completion: March 15, 2012
• Last Updated: February 10, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• 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.

Locations

DE (4)