Safety & Immunogenicity of Pneumococcal Vaccine 2189242A Co-administered With DTPa-HBV-IPV/Hib in Healthy Infants

NCT ID: NCT01204658

Last Updated: 2019-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 576 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-27
• Study Completion Date: 2012-10-01

Brief Summary

This study will assess the safety, reactogenicity and immunogenicity of two formulations of GSK Biologicals' pneumococcal vaccine 2189242A given as a 3-dose primary vaccination course during the first 6 months of life followed by a booster dose at 12-15 months of age and co-administered with DTPa-HBV-IPV/Hib vaccine.

Detailed Description

This study will assess the safety, reactogenicity, immunogenicity and persistence of two formulations of GSK Biologicals' pneumococcal vaccine 2189242A [high dose (HD) or low dose (LD)] given as a 3-dose primary vaccination course during the first 6 months of life followed by a booster dose at 12-15 months of age when co-administered with Infanrix hexa™ and compared to the vaccination with Synflorix™ and with Prevnar 13™ similarly co-administered with the Infanrix hexa™ vaccine.

Conditions

Infections, Streptococcal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

10PP-LD/Infanrix hexa Group

This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.

Group Type: EXPERIMENTAL

Infanrix Hexa (DTPa-HBV-IPV/Hib)

Intervention Type: BIOLOGICAL

Intramuscular injection

Pneumococcal vaccine GSK 2189242A (LD formulation 1)

Intervention Type: BIOLOGICAL

Intramuscular injection

10PP-HD/Infanrix hexa Group

This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.

Group Type: EXPERIMENTAL

Infanrix Hexa (DTPa-HBV-IPV/Hib)

Intervention Type: BIOLOGICAL

Intramuscular injection

Pneumococcal vaccine GSK 2189242A (HD formulation 2)

Intervention Type: BIOLOGICAL

Intramuscular injection

Synflorix/Infanrix hexa Group

This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.

Group Type: ACTIVE_COMPARATOR

Synflorix

Intervention Type: BIOLOGICAL

Intramuscular injection

Infanrix Hexa (DTPa-HBV-IPV/Hib)

Intervention Type: BIOLOGICAL

Intramuscular injection

Prevnar 13/Infanrix hexa Group

This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.

Group Type: ACTIVE_COMPARATOR

Prevenar 13

Intervention Type: BIOLOGICAL

Intramuscular injection

Infanrix Hexa (DTPa-HBV-IPV/Hib)

Intervention Type: BIOLOGICAL

Intramuscular injection

Interventions

Synflorix

Intramuscular injection

Intervention Type: BIOLOGICAL

Prevenar 13

Intramuscular injection

Intervention Type: BIOLOGICAL

Infanrix Hexa (DTPa-HBV-IPV/Hib)

Intramuscular injection

Intervention Type: BIOLOGICAL

Pneumococcal vaccine GSK 2189242A (LD formulation 1)

Intramuscular injection

Intervention Type: BIOLOGICAL

Pneumococcal vaccine GSK 2189242A (HD formulation 2)

Intramuscular injection

Intervention Type: BIOLOGICAL

Other Intervention Names

GSK 2189242A; 10PP-LD; GSK 2189242A; 10PP-HD

Eligibility Criteria

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, 6 and 14 weeks (42-104 days) of age at the time of the first vaccination.
• Written 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.
• Born after a gestation period of 36 to 42 weeks inclusive.

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 since birth.
• 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 since birth.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• A family history of congenital or hereditary immunodeficiency.
• Major congenital defects or any chronic illness.
• History of any neurologic disorders or seizures.
• Acute disease and/or fever at the time of enrolment.
• Fever is defined as temperature >= 38.0°C on rectal setting or >= 37.5°C on oral or axillary setting.
• Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
• Administration of immunoglobulins and/ or any blood products since birth or planned administration during the primary epoch and during the period starting three months before booster vaccination and ending one month after the booster vaccination.

• Minimum Eligible Age: 6 Weeks
• Maximum Eligible Age: 14 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

Benešov, , Czechia

GSK Investigational Site

Brno, , Czechia

GSK Investigational Site

Děčín, , Czechia

GSK Investigational Site

Jindřichův Hradec, , Czechia

GSK Investigational Site

Kladno, , Czechia

GSK Investigational Site

Liberec, , Czechia

GSK Investigational Site

Náchod, , Czechia

GSK Investigational Site

Ostrov, , Czechia

GSK Investigational Site

Pardubice, , Czechia

GSK Investigational Site

Prague, , Czechia

GSK Investigational Site

Schwäbisch Hall, Baden-Wurttemberg, Germany

GSK Investigational Site

Tuttlingen, Baden-Wurttemberg, Germany

GSK Investigational Site

Detmold, North Rhine-Westphalia, Germany

GSK Investigational Site

Frankenthal, Rhineland-Palatinate, Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Dębica, , Poland

GSK Investigational Site

Krakow, , Poland

GSK Investigational Site

Poznan, , Poland

GSK Investigational Site

Siemianowice Śląskie, , Poland

GSK Investigational Site

Warsaw, , Poland

GSK Investigational Site

Wroclaw, , Poland

GSK Investigational Site

Örebro, , Sweden

GSK Investigational Site

Östersund, , Sweden

GSK Investigational Site

Umeå, , Sweden

Countries

Czechia; Germany; Poland; Sweden

References

Prymula R, Szenborn L, Silfverdal SA, Wysocki J, Albrecht P, Traskine M, Gardev A, Song Y, Borys D. Safety, reactogenicity and immunogenicity of two investigational pneumococcal protein-based vaccines: Results from a randomized phase II study in infants. Vaccine. 2017 Aug 16;35(35 Pt B):4603-4611. doi: 10.1016/j.vaccine.2017.07.008. Epub 2017 Jul 17.

Reference Type: BACKGROUND

PMID: 28729019 (View on PubMed)

Other Identifiers

2010-019730-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

113994

Identifier Type: -

Identifier Source: org_study_id