Primary and Booster Vaccination Study With Pneumococcal Vaccine GSK1024850A in Healthy Japanese Children

NCT01027845 | Completed Phase 3 Results

• 2 other identifiers: 1126402011-003710-16
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 16

Brief Summary

This study will aim to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline Biologicals' 10-valent pneumococcal conjugate vaccine GSK1024850A when co-administered with Japanese DTPa vaccine as a 3-dose primary immunization course in healthy Japanese children at 3, 4 and 5 months of age and as a booster vaccination at 17-19 months of age.

Conditions

Infections, Streptococcal

Keywords

Pneumococcal disease; Immunogenicity; Booster vaccination; Pneumococcal vaccine; Primary vaccination; Safety

Outcome Measures

Primary Outcomes (1)

• Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Primary Immunization)

  Concentrations were expressed as geometric mean concentrations (GMCs). Antibodies assessed for this outcome measure were those against the vaccine 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). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 microgram per milliliter (µg/mL).

  1 month following primary immunization (at Month 3)

Secondary Outcomes (20)

• Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization)

  Prior to (PRE, at Month 14-16 ) and one month after booster (POST, at Month 15-17) immunization

• Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Primary Immunization)

  1 month following primary immunization (at Month 3)

• Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization)

  Prior to (PRE, at Month 14-16) and one month after booster (POST, at Month 15-17) immunization

• Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Primary Immunization)

  1 month following primary immunization (at Month 3)

• Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Booster Immunization)

  Prior to (PRE, at Month 14-16) and one month after booster (POST, at Month 15-17) immunization

Study Arms (2)

10Pn Group

EXPERIMENTAL

Healthy male or female subjects, between 90 and 118 days of age who received 3 doses of Synflorix (10Pn) vaccine, administered intramuscularly on alternating (left/right) sides of the anterolateral thigh and DPT "KAKETSUKEN" Syringe (DTPa) vaccine administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm. Both vaccines were administered at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age.

Biological: Pneumococcal vaccine GSK1024850A; Biological: DTPa

DTPa Group

ACTIVE COMPARATOR

Healthy male or female subjects, between 90 and 118 days of age who received 3 doses of the DPT "KAKETSUKEN" Syringe (DTPa) vaccine, administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age.

Biological: DTPa

Interventions

Pneumococcal vaccine GSK1024850A BIOLOGICAL

Intramuscular injection, 4 doses

Also known as: Synflorix

10Pn Group

DTPa BIOLOGICAL

Subcutaneous injection, 4 doses

Also known as: DPT "KAKETSUKEN" Syringe

10Pn Group; DTPa Group

Eligibility Criteria

• Age: 90 Days - 118 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Subjects who the investigator/co-investigator believes that their 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, 90 and 118 days of age (3 months) at the time of the first vaccination.
• Written informed consent obtained from the parent(s)/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 36 to 42 weeks inclusive.

You may not qualify if:

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine(s), or planned use during the study period.
• Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
• Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before the first dose of study vaccine(s) and ending on the last study visit, with the exception of Haemophilus influenzae type b vaccine, Hepatitis B Vaccine, Bacille Calmette-Guérin vaccine, Oral Polio Vaccine, Japanese encephalitis, measles and rubella, varicella, mumps, and flu vaccines.
• 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 (pharmaceutical product or device).
• Administration of any pneumococcal vaccine since birth except for the DTPa group for whom vaccination with a licensed pneumococcal vaccine by catch-up schedule will be allowed only if the 2 vaccine doses are administered between Study Visit 4 and 5, i.e. from the second blood sampling timepoint (Visit 4) onwards and up to 7 days before the booster dose of the DTPa vaccine.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
• History of, or intercurrent diphtheria, tetanus, pertussis disease.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccines.
• Major congenital defects or serious chronic illness.
• History of any seizures or progressive neurological disease.
• Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
• Child in care.
• Acute disease and/or fever at the time of enrolment.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (16)

GSK Investigational Site

Aichi, 451-0052, Japan

Location

GSK Investigational Site

Chiba, 299-4503, Japan

Location

GSK Investigational Site

Hiroshima, 720-8520, Japan

Location

GSK Investigational Site

Hiroshima, 730-8562, Japan

Location

GSK Investigational Site

Hokkaido, 003-0021, Japan

Location

GSK Investigational Site

Kagawa, 765-8501, Japan

Location

GSK Investigational Site

Kanagawa, 238-8567, Japan

Location

GSK Investigational Site

Kanagawa, 243-8551, Japan

Location

GSK Investigational Site

Kanagawa, 247-8533, Japan

Location

GSK Investigational Site

Nagasaki, 856-8562, Japan

Location

GSK Investigational Site

Niigata, 957-8588, Japan

Location

GSK Investigational Site

Okayama, 701-0205, Japan

Location

GSK Investigational Site

Osaka, 555-0001, Japan

Location

GSK Investigational Site

Osaka, 560-0004, Japan

Location

GSK Investigational Site

Osaka, 591-8025, Japan

Location

GSK Investigational Site

Tokyo, 152-0021, Japan

Location

Related Publications (1)

• Iwata S, Kawamura N, Kuroki H, Tokoeda Y, Miyazu M, Iwai A, Oishi T, Sato T, Suyama A, Francois N, Shafi F, Ruiz-Guinazu J, Borys D. Immunogenicity and safety of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) co-administered with DTPa vaccine in Japanese children: A randomized, controlled study. Hum Vaccin Immunother. 2015;11(4):826-37. doi: 10.1080/21645515.2015.1012019.

  PMID: 25830489 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Streptococcal Infections; Pneumococcal Infections

Interventions

PHiD-CV vaccine; Pentetic Acid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Polyamines; Amines; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids

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: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2009
• First Posted: December 9, 2009
• Study Start: December 8, 2009
• Primary Completion: August 13, 2010
• Study Completion: September 17, 2011
• Last Updated: November 29, 2019
• Results First Posted: November 29, 2019

Record last verified: 2019-11

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 (click on the link provided below)
• 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

JP (16)