Impact of GSK Biologicals' 2189242A Vaccine on Nasopharyngeal Carriage, Safety & Immunogenicity in Children & Infants

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

1320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-09

Study Completion Date

2013-03-18

Brief Summary

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This study will assess the impact on nasopharyngeal carriage, safety and immunogenicity of GSK Biologicals' pneumococcal vaccine 2189242A given as a 3-dose vaccination course and co-administered with other routine paediatric vaccines in infants in The Gambia. Two formulations containing different doses of pneumococcal antigen and two different schedules will be tested in infants.

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Detailed Description

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There will be two cohorts in the study: Cohort 1 (children aged 2-4 years) and Cohort 2 (infants aged 8-10 weeks), and two steps in the study, Step 1 and Step 2. Step 1 will consist in a safety evaluation of the GSK Biologicals' pneumococcal vaccine 2189242A (GSK 2189242A or 10PP vaccine). Before evaluating the two formulations of the 10PP vaccine in infants (Cohort 2), safety and reactogenicity of the highest dose formulation of this vaccine will be evaluated in children (Cohort 1). Prevnar 13™ will be used as a control. In the second step of the study, Step 2, two investigational formulations of the 10PP vaccine will be tested in infants (Cohort 2) as regards immunogenicity, reactogenicity and safety. Both formulations of the 10PP vaccine will be evaluated according to the Expanded Programme on Immunization (EPI) schedule i.e. a 2, 3, 4 months vaccination schedule, using licensed Synflorix™ and Prevnar 13™ vaccines as comparators. The higher dose (HD) formulation of the 10PP vaccine will be also evaluated according to the 2, 4, 9 months vaccination schedule using licensed Synflorix™ vaccine as comparator. The study in infants will also assess the immune responses to routine vaccines when co-administered with the candidate pneumococcal vaccine, using licensed Synflorix™ and Prevnar 13™ vaccines as comparators.

Conditions

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Infections, Streptococcal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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10PP-HD 1d Group

This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.

Group Type EXPERIMENTAL

Pneumococcal vaccine GSK 2189242A (HD formulation 2)

Intervention Type BIOLOGICAL

Intramuscular injection

Prevnar13 1d Group

This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.

Group Type ACTIVE_COMPARATOR

Prevnar13™

Intervention Type BIOLOGICAL

Intramuscular injection

10PP-LD 3+0d Group

This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.

Group Type EXPERIMENTAL

Pneumococcal vaccine GSK 2189242A (LD formulation 1)

Intervention Type BIOLOGICAL

Intramuscular injection

Tritanrix™-HepB/Hib

Intervention Type BIOLOGICAL

Intramuscular injection

Polio Sabin™

Intervention Type BIOLOGICAL

Orally

M-Vac™

Intervention Type BIOLOGICAL

Intramuscular injection

Stamaril™

Intervention Type BIOLOGICAL

Intramuscular injection

10PP-HD 3+0d Group

This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.

Group Type EXPERIMENTAL

Pneumococcal vaccine GSK 2189242A (HD formulation 2)

Intervention Type BIOLOGICAL

Intramuscular injection

Tritanrix™-HepB/Hib

Intervention Type BIOLOGICAL

Intramuscular injection

Polio Sabin™

Intervention Type BIOLOGICAL

Orally

M-Vac™

Intervention Type BIOLOGICAL

Intramuscular injection

Stamaril™

Intervention Type BIOLOGICAL

Intramuscular injection

Synflorix 3+0d Group

This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.

Group Type ACTIVE_COMPARATOR

Synflorix™

Intervention Type BIOLOGICAL

Intramuscular injection

Tritanrix™-HepB/Hib

Intervention Type BIOLOGICAL

Intramuscular injection

Polio Sabin™

Intervention Type BIOLOGICAL

Orally

M-Vac™

Intervention Type BIOLOGICAL

Intramuscular injection

Stamaril™

Intervention Type BIOLOGICAL

Intramuscular injection

Prevnar13 3+0d Group

This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.

Group Type ACTIVE_COMPARATOR

Prevnar13™

Intervention Type BIOLOGICAL

Intramuscular injection

Tritanrix™-HepB/Hib

Intervention Type BIOLOGICAL

Intramuscular injection

Polio Sabin™

Intervention Type BIOLOGICAL

Orally

M-Vac™

Intervention Type BIOLOGICAL

Intramuscular injection

Stamaril™

Intervention Type BIOLOGICAL

Intramuscular injection

10PP-HD 2+1d Group

This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.

Group Type EXPERIMENTAL

Pneumococcal vaccine GSK 2189242A (HD formulation 2)

Intervention Type BIOLOGICAL

Intramuscular injection

Tritanrix™-HepB/Hib

Intervention Type BIOLOGICAL

Intramuscular injection

Polio Sabin™

Intervention Type BIOLOGICAL

Orally

M-Vac™

Intervention Type BIOLOGICAL

Intramuscular injection

Stamaril™

Intervention Type BIOLOGICAL

Intramuscular injection

Synflorix 2+1d Group

This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.

Group Type ACTIVE_COMPARATOR

Synflorix™

Intervention Type BIOLOGICAL

Intramuscular injection

Tritanrix™-HepB/Hib

Intervention Type BIOLOGICAL

Intramuscular injection

Polio Sabin™

Intervention Type BIOLOGICAL

Orally

M-Vac™

Intervention Type BIOLOGICAL

Intramuscular injection

Stamaril™

Intervention Type BIOLOGICAL

Intramuscular injection

Interventions

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Pneumococcal vaccine GSK 2189242A (LD formulation 1)

Intramuscular injection

Intervention Type BIOLOGICAL

Pneumococcal vaccine GSK 2189242A (HD formulation 2)

Intramuscular injection

Intervention Type BIOLOGICAL

Synflorix™

Intramuscular injection

Intervention Type BIOLOGICAL

Prevnar13™

Intramuscular injection

Intervention Type BIOLOGICAL

Tritanrix™-HepB/Hib

Intramuscular injection

Intervention Type BIOLOGICAL

Polio Sabin™

Orally

Intervention Type BIOLOGICAL

M-Vac™

Intramuscular injection

Intervention Type BIOLOGICAL

Stamaril™

Intramuscular injection

Intervention Type BIOLOGICAL

Other Intervention Names

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10PP LD Formulation 10PP HD Formulation

Eligibility Criteria

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Inclusion Criteria

* Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol
* Male or female between, and including,

* 2 to 4 years of age at the time of the first vaccination for subjects in Cohort 1 (children).
* 8 to 10 weeks (56-76 days) of age at the time of the first vaccination for subjects in Cohort 2 (infants).
* Signed or thumb-printed 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.
* Permanent residence in the study area and no intention of leaving during the study period.

• Previously completed three-dose primary course of diphtheria-tetanus-pertussis (DTP) vaccination.

Exclusion Criteria

* 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 within six months prior to the first vaccine dose.
* Planned administration/administration of a vaccine not foreseen by the study protocol during the study period starting from 30 days before each dose and ending 30 days after each dose of vaccine(s), with the exception of licensed 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
* Previous vaccination against S. pneumoniae.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* Malnutrition
* A 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 any chronic illness.
* History of any neurologic disorders or seizures.
* Acute disease and/or fever at the time of enrolment.
* Administration of immunoglobulins and/ or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
* Contraindications to any co-administered vaccine.
* Any medical condition that would contraindicate the initiation of routine immunization outside a clinical trial context.

• Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b with the exception of vaccines where the first dose should be given within the first two weeks of life according to the national recommendations (for example Bacillus Calmette-Guérin \[BCG\] and hepatitis B vaccination).

Minimum Eligible Age

56 Days

Maximum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Banjul, , The Gambia

Site Status

Countries

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The Gambia

References

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Odutola A, Antonio M, Owolabi O, Bojang A, Foster-Nyarko E, Donkor S, Adetifa I, Taylor S, Bottomley C, Greenwood B, Ota M. Comparison of the prevalence of common bacterial pathogens in the oropharynx and nasopharynx of gambian infants. PLoS One. 2013 Sep 23;8(9):e75558. doi: 10.1371/journal.pone.0075558. eCollection 2013.

Reference Type BACKGROUND

PMID: 24086570 (View on PubMed)

Odutola A, Ota MO, Ogundare EO, Antonio M, Owiafe P, Worwui A, Greenwood B, Alderson M, Traskine M, Verlant V, Dobbelaere K, Borys D. Reactogenicity, safety and immunogenicity of a protein-based pneumococcal vaccine in Gambian children aged 2-4 years: A phase II randomized study. Hum Vaccin Immunother. 2016;12(2):393-402. doi: 10.1080/21645515.2015.1111496.

Reference Type BACKGROUND

PMID: 26618243 (View on PubMed)

Odutola A, Ota MOC, Antonio M, Ogundare EO, Saidu Y, Foster-Nyarko E, Owiafe PK, Ceesay F, Worwui A, Idoko OT, Owolabi O, Bojang A, Jarju S, Drammeh I, Kampmann B, Greenwood BM, Alderson M, Traskine M, Devos N, Schoonbroodt S, Swinnen K, Verlant V, Dobbelaere K, Borys D. Efficacy of a novel, protein-based pneumococcal vaccine against nasopharyngeal carriage of Streptococcus pneumoniae in infants: A phase 2, randomized, controlled, observer-blind study. Vaccine. 2017 May 2;35(19):2531-2542. doi: 10.1016/j.vaccine.2017.03.071. Epub 2017 Apr 4.

Reference Type BACKGROUND

PMID: 28389097 (View on PubMed)

Odutola A, Ota MOC, Antonio M, Ogundare EO, Saidu Y, Owiafe PK, Worwui A, Idoko OT, Owolabi O, Kampmann B, Greenwood BM, Alderson M, Traskine M, Swinnen K, Verlant V, Dobbelaere K, Borys D. Immunogenicity of pneumococcal conjugate vaccine formulations containing pneumococcal proteins, and immunogenicity and reactogenicity of co-administered routine vaccines - A phase II, randomised, observer-blind study in Gambian infants. Vaccine. 2019 May 1;37(19):2586-2599. doi: 10.1016/j.vaccine.2019.03.033. Epub 2019 Apr 8.

Reference Type BACKGROUND

PMID: 30975570 (View on PubMed)

Study Documents

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