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

NCT ID: NCT00678301

Last Updated: 2019-11-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 365 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-18
• Study Completion Date: 2009-12-10

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.

Detailed Description

Vaccination course at 6, 10, 14 weeks of age.

Conditions

Infections, Streptococcal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

SYNFLORIX™ + ZILBRIX™ HIB + POLIO SABIN™

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.

Group Type: EXPERIMENTAL

GSK Biologicals' Synflorix™

Intervention Type: BIOLOGICAL

3 IM doses.

GSK Biologicals' Polio Sabin™

Intervention Type: BIOLOGICAL

3 oral doses

GSK Biologicals' Zilbrix™ Hib

Intervention Type: BIOLOGICAL

3 IM doses.

ZILBRIX™ HIB + POLIO SABIN™

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.

Group Type: EXPERIMENTAL

GSK Biologicals' Polio Sabin™

Intervention Type: BIOLOGICAL

3 oral doses

GSK Biologicals' Zilbrix™ Hib

Intervention Type: BIOLOGICAL

3 IM doses.

Interventions

GSK Biologicals' Synflorix™

3 IM doses.

Intervention Type: BIOLOGICAL

GSK Biologicals' Polio Sabin™

3 oral doses

Intervention Type: BIOLOGICAL

GSK Biologicals' Zilbrix™ Hib

3 IM doses.

Intervention Type: BIOLOGICAL

Other Intervention Names

10Pn; OPV; DTPw-HBV/Hib vaccine

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 6 Weeks
• Maximum Eligible Age: 10 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Bamako, , Mali

GSK Investigational Site

Ikeja / Lagos, , Nigeria

Countries

Mali; Nigeria

References

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.

Reference Type: BACKGROUND

PMID: 22112189 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24633268 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26954689 (View on PubMed)

Study Documents

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

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Other Identifiers

2011-004650-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

110521

Identifier Type: -

Identifier Source: org_study_id