Immunization of Children Between 8 Weeks and 2 Years of Age With GSK Pneumococcal Vaccine GSK1024850A

NCT ID: NCT01175083

Last Updated: 2019-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-01
• Study Completion Date: 2013-05-23

Brief Summary

The aim of the study is to evaluate the immunogenicity, safety and reactogenicity of GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A.

Children that are below 6 months at the time of enrolment will also receive the DTPw-HBV/Hib and OPV vaccines.

Detailed Description

This protocol posting has been updated according to Protocol Amendment 2, September 2010. The impacted sections are arms and inclusion criteria.

Conditions

Infections, Streptococcal

Study Design

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

Study Groups

Tritanrix-HepB/Hib+Polio Sabin <6S Group

Children below (\<) 6 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8.

Group Type: EXPERIMENTAL

GSK1024850A (Synflorix)

Intervention Type: BIOLOGICAL

2, 3 or 4 intramuscular injection

Tritanrix-HepB/Hib

Intervention Type: BIOLOGICAL

Intramuscular injection, 4 doses

Polio Sabin

Intervention Type: BIOLOGICAL

4 oral doses

Tritanrix-HepB/Hib+Polio Sabin <6NS Group

Healthy children, below (\<) 6 months of age at time of enrolment, who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8.

Group Type: ACTIVE_COMPARATOR

GSK1024850A (Synflorix)

Intervention Type: BIOLOGICAL

2, 3 or 4 intramuscular injection

Tritanrix-HepB/Hib

Intervention Type: BIOLOGICAL

Intramuscular injection, 4 doses

Polio Sabin

Intervention Type: BIOLOGICAL

4 oral doses

Synflorix 7-11S Group

Children between 7-11 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3.

Group Type: EXPERIMENTAL

GSK1024850A (Synflorix)

Intervention Type: BIOLOGICAL

2, 3 or 4 intramuscular injection

Synflorix 7-11NS Group

Healthy children between 7-11 months of age at time of enrolment, who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3.

Group Type: ACTIVE_COMPARATOR

GSK1024850A (Synflorix)

Intervention Type: BIOLOGICAL

2, 3 or 4 intramuscular injection

Synflorix 12-23S Group

Children between 12-23 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.

Group Type: EXPERIMENTAL

GSK1024850A (Synflorix)

Intervention Type: BIOLOGICAL

2, 3 or 4 intramuscular injection

Synflorix 12-23NS Group

Healthy children between 12-23 months of age at time of enrolment, who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.

Group Type: ACTIVE_COMPARATOR

GSK1024850A (Synflorix)

Intervention Type: BIOLOGICAL

2, 3 or 4 intramuscular injection

Interventions

GSK1024850A (Synflorix)

2, 3 or 4 intramuscular injection

Intervention Type: BIOLOGICAL

Tritanrix-HepB/Hib

Intramuscular injection, 4 doses

Intervention Type: BIOLOGICAL

Polio Sabin

4 oral doses

Intervention Type: BIOLOGICAL

Other Intervention Names

DTPw-HBV/Hib; OPV

Eligibility Criteria

Inclusion Criteria

• Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits).
• A male or female between, and including:

• 8 and 11 weeks of age at the time of the first vaccination for subjects in the <6S and <6NS groups or
• 7 and 11 months at the time of the first vaccination for subjects in the 7-11S and 7-11NS groups or
• 12 and 23 months at the time of first vaccination for subjects in the 12-23S and 12-23NS groups (Note the second dose should be administered at 23 Months of age at the latest to allow, if needed, compliance with the National Recommendations on administration of the 23-valent polysaccharide pneumococcal vaccine in children with SCD as of 24 months of age).
• Written informed consent, signed or thumb printed, obtained from the parent(s)/LAR(s) of the subject. Where parent(s)/LAR(s) are illiterate, the consent form will be countersigned by a witness.

• Children with diagnosis of sickle cell disease [homozygous sickle cell disease (hemoglobin SS disease), double heterozygous sickle hemoglobin C disease (hemoglobin SC disease) and the sickle ß-thalassemias] and confirmed hemoglobin status by hemoglobin chromatography and electrophoresis (<6S group) or electrophoresis (7-11S and 12-23S groups).
• Free of any other 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

• Healthy subjects as established by medical history and clinical examination before entering into the study.
• Children with negative diagnosis of sickle cell disease and confirmed hemoglobin status by hemoglobin chromatography and/or electrophoresis.

Exclusion Criteria

• Child in care
• Use of any investigational or non-registered product (drug or vaccine) 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 (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone ≥ 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
• Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of study vaccines and ending 30 days after. Locally recommended vaccines (recommended through the EPI program or through national immunization campaigns) for example inactivated influenza vaccine are always allowed, even if concomitantly administered with the study vaccines, but should be documented in the eCRF.
• 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).
• Previous vaccination or planned vaccination during the study with any pneumococcal vacccine.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
• Major congenital malformations.
• History of any neurological disorders or seizures.
• Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
• Birth weight below 1500g.
• Serious chronic illness other than SCD.
• Acute disease and/or fever at the time of enrolment.

• Fever is defined as temperature ≥ 37.5°C on oral, axillary or tympanic setting, or ≥ 38.0°C on rectal setting. The preferred route for recording temperature in this study will be tympanic.
• Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.

• Any confirmed or suspected immunosuppressive or immunodeficient condition, (including human immunodeficiency virus (HIV) infection) other than SCD related conditions, based on medical history and physical examination (no laboratory testing required).

• Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection, based on medical history and physical examination (no laboratory testing required).

• Minimum Eligible Age: 8 Weeks
• Maximum Eligible Age: 23 Months
• 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

Ouagadougou, , Burkina Faso

Countries

Burkina Faso

References

Sirima SB, Tiono A, Gansane Z, Siribie M, Zongo A, Ouedraogo A, Francois N, Strezova A, Dobbelaere K, Borys D. Immunogenicity and Safety of 10-valent Pneumococcal Nontypeable Haemophilus influenzae Protein D Conjugate Vaccine (PHiD-CV) Administered to Children With Sickle Cell Disease Between 8 Weeks and 2 Years of Age: A Phase III, Open, Controlled Study. Pediatr Infect Dis J. 2017 May;36(5):e136-e150. doi: 10.1097/INF.0000000000001518.

Reference Type: BACKGROUND

PMID: 28403055 (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: Informed Consent 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: 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: Clinical Study Report

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

Related Links

https://www.clinicalstudydatarequest.com

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Other Identifiers

2012-000254-64

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

114056

Identifier Type: -

Identifier Source: org_study_id