Primary Vaccination Course in Children Receiving the Pneumococcal Vaccine GSK 1024850A, Zilbrix™ Hib and Polio Sabin™

NCT00678301 | Completed Phase 3 Results

• 2 other identifiers: 1105212011-004650-25
• Study Type: interventional
• Target: 365
• Locations: 2 countries
• Sites: 2

Brief Summary

The purpose of this study is to assess the immunogenicity in terms of antibody response and the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse events following primary vaccination of African Sub-Saharan infants with pneumococcal conjugate vaccine GSK 1024850A co-administered with a diphtheria, tetanus, whole cell pertussis (DTPw)-combined vaccine and oral polio vaccine in children during the first 4 months of life.

Conditions

Infections, Streptococcal

Keywords

pneumococcal conjugate vaccine; Streptococcus pneumoniae

Outcome Measures

Primary Outcomes (2)

• Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes

  Pneumococcal serotypes assessed were vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Seropositivity cut-off for the assay was an anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) concentrations greater than or equal to (≥) 0.05 microgram per milliliter (μg/mL).

  At Month 3, one month after the administration of the third dose of Synflorix vaccine

• Antibody Concentrations Against Protein D (Anti-PD Antibodies)

  Anti-PD antibody concentrations were expressed in enzyme-linked immunsorbent assay (ELISA) units per milliliter (EL.U/mL). Seropositivity cut-off for the assay was an anti-PD antibody concentrations ≥ 100 EL.U/mL.

  At Month 3, one month after the administration of the third dose of Synflorix vaccine

Secondary Outcomes (24)

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

  At Month 3, one month after the administration of the third dose of Synflorix vaccine

• Titers for Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes

  At Month 3, one month after the administration of the third dose of Synflorix vaccine

• Titers for Opsonophagocytic Activity (OPA) Against Cross-reactive Pneumococcal Serotypes

  At Month 3, one month after the administration of the third dose of Synflorix vaccine

• Number of Subjects Seropositive for Antibodies Against Vaccine Pneumococcal Serotypes

  At Month 3, one month after the administration of the third dose of Synflorix vaccine

• Number of Subjects Seroprotected Against Vaccine Pneumococcal Serotypes

  At Month 3, one month after the administration of the third dose of Synflorix vaccine

Study Arms (2)

SYNFLORIX™ + ZILBRIX™ HIB + POLIO SABIN™

EXPERIMENTAL

Subjects in this group received 3 doses of Synflorix™ vaccine, according to a 3-dose schedule at 6-10-14 weeks of age co-administered with 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to the same schedule. The Synflorix™ and Zilbrix™ Hib vaccines were administered by intramuscular injection, in the right and left thigh respectively. The Polio Sabin™ vaccine was administered orally.

Biological: GSK Biologicals' Synflorix™; Biological: GSK Biologicals' Polio Sabin™; Biological: GSK Biologicals' Zilbrix™ Hib

ZILBRIX™ HIB + POLIO SABIN™

EXPERIMENTAL

Subjects in this group received 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to a 3-dose schedule at 6-10-14 weeks of age. The Zilbrix™ Hib vaccine was administered by intramuscular injection, in the left thigh. The Polio Sabin™ vaccine was administered orally.

Biological: GSK Biologicals' Polio Sabin™; Biological: GSK Biologicals' Zilbrix™ Hib

Interventions

GSK Biologicals' Synflorix™ BIOLOGICAL

3 IM doses.

Also known as: 10Pn

SYNFLORIX™ + ZILBRIX™ HIB + POLIO SABIN™

GSK Biologicals' Polio Sabin™ BIOLOGICAL

3 oral doses

Also known as: OPV

SYNFLORIX™ + ZILBRIX™ HIB + POLIO SABIN™; ZILBRIX™ HIB + POLIO SABIN™

GSK Biologicals' Zilbrix™ Hib BIOLOGICAL

3 IM doses.

Also known as: DTPw-HBV/Hib vaccine

SYNFLORIX™ + ZILBRIX™ HIB + POLIO SABIN™; ZILBRIX™ HIB + POLIO SABIN™

Eligibility Criteria

• Age: 6 Weeks - 10 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Male or female subjects between, and including 6-10 weeks of age at the time of the first vaccination.
• Subjects for whom the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol should be enrolled in the study.
• Written or oral, signed or thumb-printed informed consent obtained from the parent(s)/guardian(s) of the child/ward. Where parent(s)/guardian(s) are illiterate, the consent form will be countersigned by a witness.
• Free of any known or suspected health problems (as established by medical history and clinical examination before entering into the study), that would contraindicate the initiation of routine immunizations outside a clinical trial context.

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 the study vaccines, or planned use during the study period.
• 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).
• Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
• A family history of congenital or hereditary immunodeficiency.
• Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
• Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period (Hepatitis B immunoglobulins at birth are allowed).
• Previous vaccination against, diphtheria, tetanus, pertussis, Haemophilus influenzae type b and/or Streptococcus pneumoniae.
• History of, or intercurrent diphtheria, tetanus, pertussis, hepatitis B, Streptococcus and Haemophilus influenzae type b disease.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
• History of any neurological disorders or seizures.
• Major congenital defects or serious chronic illness.
• Acute disease at the time of enrolment. Study entry should be delayed until the illness has improved.
• Babies for which birth weight is \< 2 kilogram (if known) at Visit 1

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (2)

GSK Investigational Site

Bamako, Mali

Location

GSK Investigational Site

Ikeja / Lagos, P.M.B. 21266, Nigeria

Location

Related Publications (3)

• Dicko A, Odusanya OO, Diallo AI, Santara G, Barry A, Dolo A, Diallo A, Kuyinu YA, Kehinde OA, Francois N, Borys D, Yarzabal JP, Moreira M, Schuerman L. Primary vaccination with the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in infants in Mali and Nigeria: a randomized controlled trial. BMC Public Health. 2011 Nov 23;11:882. doi: 10.1186/1471-2458-11-882.

  PMID: 22112189 BACKGROUND

• Odusanya OO, Kuyinu YA, Kehinde OA, Francois N, Yarzabal JP, Moreira M, Borys D, Schuerman L. Immunogenicity, safety and reactogenicity of the 10-valent pneumococcal non-typeable haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Nigerian Infants: a randomised trial. Niger Postgrad Med J. 2013 Dec;20(4):272-81.

  PMID: 24633268 BACKGROUND

• Silfverdal SA, Coremans V, Francois N, Borys D, Cleerbout J. Safety profile of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV). Expert Rev Vaccines. 2017 Feb;16(2):109-121. doi: 10.1586/14760584.2016.1164044. Epub 2016 Sep 30.

  PMID: 26954689 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

Condition Hierarchy (Ancestors)

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

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: May 13, 2008
• First Posted: May 15, 2008
• Study Start: June 18, 2008
• Primary Completion: November 9, 2009
• Study Completion: December 10, 2009
• Last Updated: November 15, 2019
• Results First Posted: October 27, 2017

Record last verified: 2019-10

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

MA (1); NG (1)